On August 27, 2026 Caris Life Sciences (NASDAQ: CAI), a leading TechBio company, reported the publication of a study in npj Precision Oncology describing the development and validation of an AI-driven approach to optimize first-line treatment selection in pancreatic cancer, advancing a more personalized care path for one of the deadliest malignancies.

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The study demonstrates the performance of Caris AI Insights to predict first-line treatment benefit using an AI–based molecular signature. In the testing cohort, standard molecular risk patients predicted to benefit from FOLFIRINOX achieved substantially longer median overall survival when treated with FOLFIRINOX rather than gemcitabine plus nab-paclitaxel (gem/nab-p) (16.0 vs 9.9 months). Approximately half of the patients in the study received a different first-line therapy than the model would have recommended, highlighting the potential opportunity for more biologically informed treatment selection to improve survival and reduce toxicity.

The Caris AI Insights signature for pancreatic cancer is included in the Caris Molecular Tumor Board Report. This report, built using whole exome sequencing (WES) and whole transcriptome sequencing (WTS) data, is available upon request at no additional cost when ordering MI Cancer Seek. Caris AI Insights deliver clinically relevant findings across all tumor types, with disease-specific algorithms to support treatment decision-making in colon, breast, ovarian, pancreatic and lung cancer.

For patients with advanced pancreatic ductal adenocarcinoma (PDAC), first-line therapy options include FOLFIRINOX, gem/nab-p, and NALIRIFOX. The study focused on the first two of these regimens, both of which can extend survival but can also exact a significant physical toll on the patient. Despite differences in toxicity and intensity, clinical judgments about treatment selection are still not sufficiently guided by tumor biology. Currently, clinicians must make the call without a widely adopted biomarker to guide them. As a result, some patients endure unnecessary side effects for limited benefit, while others may never receive the intensity of therapy their disease demands.

"For too long, pancreatic cancer treatment decisions have forced clinicians to choose between toxicity and uncertainty," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "Pancreatic AI shows that tumor biology can help guide that decision, identifying patients who may not need the most aggressive therapy, while also flagging those who may derive greater benefit from aggressive treatment. This is about using data and AI to move beyond trial-and-error and toward more precise care from the very first line of treatment."

Rather than relying on individual biomarkers, the pancreatic signature applies machine learning techniques to identify complex molecular patterns associated with real-world treatment benefit. The validation study leveraged Caris’ large-scale clinico-genomic datasets, linking comprehensive molecular data with treatment outcomes across thousands of patients. Clinicians are provided with two results: risk stratification to categorize patients as standard or high molecular risk and guidance to help inform selection between FOLFIRINOX and gem/nab-p. The model identifies a meaningful subset of patients who may achieve similar or greater benefit from gem/nab-p, while also flagging patients who are more likely to require the intensity of FOLFIRINOX, potentially allowing greater flexibility in treatment selection.

Caris received FDA approval in November 2024 for MI Cancer Seek. This tissue-based assay is the first and only simultaneous WES and WTS-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

(Press release, Caris Life Sciences, AUG 27, 2026, View Source [SID1234670397])

On August 27, 2026 Fosun International Limited (HKEX stock code: 00656, "Fosun International"), together with its subsidiaries ("Fosun" or the "Group"), reported its interim results for the six months ended 30 June 2026 (the "Reporting Period").

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In the first half of 2026, Fosun continued to advance its business streamlining and core business-focused strategy. Powered by the twin engines of innovation and globalization, the operational quality of its core industries, including pharmaceuticals and healthcare, insurance and finance, and cultural tourism and consumer businesses, steadily improved and gained collective momentum, driving a notable increase in profitability. During the Reporting Period, the Group’s total revenue reached RMB86.96 billion, remaining broadly stable despite the continued divestment of non-strategic and non-core assets; industrial operation profit reached RMB3.69 billion, representing a year-on-year increase of 17%; and profit attributable to owners of the parent reached RMB1.72 billion, representing a significant year-on-year increase of 160.3%.

During the Reporting Period, Fosun’s asset base remained solid, with its subsidiaries Fosun Pharma, Yuyuan, Fosun Insurance Portugal (Fidelidade), and Fosun’s Tourism segment generating a total revenue of RMB63.88 billion, accounting for 73.5% of the Group’s total revenue. Overseas revenue reached RMB49.16 billion, representing a year-on-year increase of 5.3%. Its share of total revenue rose by 3 percentage points to 56.5%, underscoring the success of its globalization strategy.

Meanwhile, Fosun adhered to proactive and prudent liquidity and debt management, maintaining sufficient liquidity buffer. During the Reporting Period, the Group generated proceeds equivalent to more than RMB12.0 billion from the divestment of non-strategic and non-core assets. As at 30 June 2026, cash, bank balances and term deposits amounted to RMB61.214 billion, an increase compared to the end of 2025; the total debt to total capital ratio was 55.7%, a further decrease compared to the end of 2025. A healthy debt ratio and ample cash reserves strengthen the Group’s risk resilience while also enhancing its capacity to seize investment opportunities.

Guo Guangchang, Chairman of Fosun International, said: "Over the past few years, Fosun has steadfastly advanced its business streamlining and core business-focused strategy, and completed a systematic realignment of ‘repairing the roof on a sunny day’. The strong earnings recovery we delivered in the first half of this year validates our strategic direction and sustained focus. Fosun has now returned to a growth trajectory and is well-positioned to accelerate its growth going forward."

Adhering to Innovation-Driven Development, Innovative Drugs Enter a Period of Intensive Approvals and Value Realization

In the first half of 2026, Fosun remained committed to innovation-driven development, fully embraced AI applications, accelerated the conversion of its technology innovations into tangible value, and continued to enhance operational efficiency. During the Reporting Period, Fosun’s investment in technology innovation reached RMB4.2 billion, representing a year-on-year increase of 16.7%. Its global innovation system integrating "independent R&D + investment incubation + ecosystem collaboration" continued to gain momentum, fostering a series of globally competitive innovations.

With a focus on addressing unmet clinical needs, Fosun’s Health segment delivered notable technology innovation achievements. During the Reporting Period, innovative drugs entered a period of intensive approvals and value realization. Fosun Pharma had a total of 20 indications of 7 innovative drugs approved for launch both domestically and overseas. Among them, FUMAINING (luvoxmetinib tablets) was approved for the treatment of paediatric and adolescent patients with relapsed or refractory Langerhans cell histiocytosis (LCH), continuing to fill the gap in the treatment of rare diseases. In terms of neurodegenerative diseases, Fosun Pharma continued to advance its innovation pipeline. Building upon the rights obtained to develop, register, manufacture and exclusively commercialize AR1001 in Chinese mainland, Hong Kong SAR, Macau SAR, and 10 agreed Southeast Asian countries, Fosun Pharma further secured a global exclusive option for AR1001, with the right to exercise the option, thereby expanding the licensed territory to key global markets including the U.S., Europe and Japan, where it would act as the marketing authorization holder in such regions. Meanwhile, post-marketing confirmatory clinical trials for sodium oligomannate capsules in Chinese mainland have progressed steadily, with more than 1,000 patients enrolled as of 31 July 2026. In addition, HT001, an oral brain-penetrant NLRP3 inhibitor for the treatment of Parkinson’s disease in-licensed by Hengtai Bio, an investee and incubated company of Fosun Pharma, commenced its Phase I clinical trial in Australia.

As a core subsidiary in the Health segment, Fosun Pharma achieved operating revenue of RMB20.377 billion. Revenue from innovative drugs recorded a year-on-year increase of 13.84%, with their contribution to pharmaceutical business revenue rising to 33.35%, establishing innovative drugs as a key growth driver.

In terms of biologic innovative drugs, Fosun continued to deliver breakthroughs in the first half of the year. HANSIZHUANG, independently developed by Henlius, received approval from the National Medical Products Administration (NMPA) for its perioperative indication in gastric cancer, making it the world’s first and only anti-PD-1 monoclonal antibody approved for this indication and pioneering a postoperative "chemo-sparing" regimen. HLX43, a core asset in the innovative pipeline, is a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC. It has demonstrated preliminary clinical efficacy characterized by high efficacy and low toxicity across multiple solid tumors, including non-small cell lung cancer (NSCLC). To date, more than ten clinical studies of HLX43 as monotherapy or in combination regimens have been initiated, with over 1,500 patients enrolled globally, continuing to evaluate its broad therapeutic potential across multiple solid tumors.

During the Reporting Period, Henlius showcased strong organic growth momentum and sustainable earnings generation, with revenue reaching RMB3.5882 billion, representing a year-on-year increase of 27.3%, and net profit amounting to RMB430.4 million, up 10.3% year-on-year.

Amid the AI wave, Fosun deepened the application of AI across its core businesses and global industrial ecosystem, with a focus on harnessing AI to deliver "practical productivity" and creating tangible industry value.

Fosun Pharma completed the upgrade of its "PharmAID Pharmaceutical Intelligence Platform V2.0", establishing four key components to support AI-powered product development across the full lifecycle, from early-stage R&D and clinical validation to post-launch commercialization. As of the end of the Reporting Period, Fosun Pharma had rolled out more than 25 high-value AI projects, with more than 50 use cases simultaneously underway. These initiatives span multiple business functions, including pharmaceutical project evaluation, target prediction and molecule optimization. Two AI‑assisted and structurally generated new molecules have entered the preclinical candidate (PCC) stage. In March 2026, the next-generation recombinant human hyaluronidase (rHuPH20) injection, independently developed by Henlius, was approved to begin clinical trials in China. Leveraging its "AI for Science" platform, Henlius significantly shortened the enzyme-molecule design cycle from 18 months to 5 months.

Beyond pharmaceuticals, Fosun deeply integrated AI into its cultural tourism, insurance, and intelligent manufacturing businesses. Fosun’s Tourism segment accelerated the implementation of "AI G.O" and partnered with a leading technology company to engage in deep collaboration across three key areas: using AI to enhance guest experience, advancing its transition to cloud- and AI-native platforms, and supporting global growth. Leveraging the resource demand brought about by AI technologies, Hainan Mining swiftly expanded its presence in core upstream resources such as fluorite.

Deepening Global Operations to Enhance Quality and Efficiency, Domestic and Overseas Insurance Companies Deliver Broad-Based Improvements

Supported by its business presence and profound operations in more than 40 countries and regions worldwide, Fosun comprehensively advanced its strategy of "Combining Global Resources with China’s Capabilities", deeply integrating China’s manufacturing capabilities, service capabilities, and innovation dividends with the global market. During the Reporting Period, the Group’s overseas revenue reached RMB49.16 billion, accounting for 56.5% of total revenue.

In the first half of 2026, Fosun’s subsidiaries continued to build on their globalization capabilities, achieving a series of major breakthroughs in international expansion.

In the field of healthcare, Fosun Pharma’s overseas business revenue grew 16.45% year-on-year, accounting for 31.30% of total revenue.This represents an uplift of 3.11 percentage points, and the revenue mix continues to improve. Henlius’ HANSIZHUANG was approved for three new indications in the European Union (EU), while HLX11 (pertuzumab injection) was approved in the EU and two HLX14 (denosumab injection) products were approved and commercially launched in Canada. To date, Henlius has 10 products approved in over 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania, and has benefited over 1.1 million patients worldwide. Fosun Health continued to advance its internationalization strategy, actively expanding into markets such as Indonesia, Bangladesh, Mongolia, Hong Kong SAR, and Macau SAR, while building an open, stable, and professional international medical collaboration network. In addition, the International Medical Center of Foshan Fosun Chancheng Hospital was officially inaugurated, forming a full-process, closed-loop international medical service system.

In terms of the consumer and cultural tourism businesses, Yuyuan generated revenue of RMB532 million in Hong Kong SAR and Macau SAR in the first half of 2026, representing a year-on-year increase of 285.83%, while revenue from the Japanese market reached RMB306 million, representing a year-on-year increase of 6.09%. The jewelry business also made notable progress in overseas expansion. Laomiao opened 5 new stores in Hong Kong SAR, Macau SAR, overseas markets and duty-free channels, bringing the total number of stores across these channels to 15. Club Med continued to expand its global destination network. Club Med Urban Oasis Hangzhou Longwu officially opened in April 2026, while Club Med South Africa Beach & Safari had its soft opening in July 2026.

In the intelligent manufacturing segment, Hainan Mining’s integrated value chain of "Bougouni Lithium Mine in Mali + Hainan Xingzhihai Lithium Salt Processing" operated steadily, serving as a key driver of the company’s earnings growth. It completed the delivery of three shipments totaling 70,000 tons of lithium concentrate from Mali, Africa, to Yangpu Port in Hainan, China in the first half of the year. Wansheng’s phosphate ester flame retardant project at its Thailand facility successfully commenced operations, filling the gap in Wansheng’s overseas manufacturing footprint in this area and further strengthening the resilience of its global supply chain.

With the ongoing advancement of its globalization strategy, Fosun’s domestic and overseas insurance companies delivered broad-based improvements in the first half of 2026. As of the end of the Reporting Period, Fidelidade held a 30.1% overall market share in Portugal, its international business accounted for 26.7% of its consolidated total business, while gross written premiums from overseas markets reached EUR1.035 billion. Despite losses from multiple storms in Portugal during the Reporting Period, Fidelidade recorded net profit attributable to owners of the parent of EUR165 million, up 23.8% year-on-year.

Benefiting from its high-quality client base, disciplined underwriting and global business footprint, Peak Reinsurance maintained solid performance. During the Reporting Period, reinsurance revenue and gross written premiums increased by 25.0% and 11.8% year-on- year, respectively, while net profit after tax reached USD89.70 million. Building on its sound financial strength and growing market position, Moody’s upgraded Peak Re’s rating from Baa1 to A3 in April 2026, with a "stable" outlook.

In Chinese mainland, Pramerica Fosun Life Insurance recorded gross written premiums of RMB8.38 billion in the first half of 2026, up 52.2% year-on-year. Net profit reached RMB780 million, representing a year-on-year increase of 270% and exceeding its net profit for the full year of 2025. Fosun United Health Insurance reported a 36.2% year-on-year increase in revenue and net profit of RMB572 million.

Committed to Business for Good, MSCI ESG Rating Upgraded to AAA

During the Reporting Period, Fosun continued to gain international recognition for its environmental, social and governance (ESG) performance. Its MSCI ESG rating was upgraded to the highest rating of AAA. It was once again included in S&P Global’s Sustainability Yearbook 2026 and ranked among the top 1% in the Sustainability Yearbook (China Edition) 2026. In addition, its FTSE Russell ESG score remained above the global industry and Chinese corporate averages. It was selected as a constituent of the FTSE4Good Index Series for the fifth consecutive year.

Fosun consistently contributed the "China Solution" to malaria control efforts in Africa. As of the end of the Reporting Period, Fosun Pharma had cumulatively supplied more than 460 million vials of its independently developed artesunate for injection worldwide, saving more than 92 million patients with severe malaria. The "Seasonal Malaria Chemoprevention Program", centered on the SPAQ-CO series of products, has benefited more than 330 million children in Africa.

The "Rural Doctors Program", initiated by Fosun Foundation, continued to cover 78 project counties in 16 provinces, cities and autonomous regions, supporting 25,000 rural doctors and benefiting 3 million rural families and 16.34 million rural residents. In the first half of 2026, the program provided a total of more than 12,590 group accidental and critical illness insurance policies for rural doctors in project counties, carried out intelligent upgrading for 59 clinics or hospitals, and supported 263 rural doctors in obtaining the qualification of Assistant General Practitioner. Launched in May, the "AI Rural Doctor Assistant 2.0" achieved a 100% service-success rate and a 92% user-satisfaction rate among rural doctors.

Looking ahead, Guo Guangchang said: "The earnings recovery we delivered in the first half of the year was no coincidence. It was the result of Fosun’s long-term commitment and sustained focus on its core businesses. Going forward, we will continue to advance innovation-driven and global development in industries where we have established competitive advantages. With a clear path ahead, we are confident that we can steadily restore annual profit to the RMB10 billion level."

(Press release, Fosun, AUG 27, 2026, View Source [SID1234670396])

On August 27, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported its 2026 interim results. During the reporting period, the Company achieved record-high drug sales revenue, further advanced its global immuno-oncology (IO) 2.0 strategy, progressively built its IO2.0 + ADC2.0 therapeutic matrix, and continued orderly development of bispecific antibodies in major chronic disease areas, including autoimmune, respiratory, and central nervous system (CNS) disorders

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Commercialization Reaches Record High

Commercial sales revenue for the first half of 2026 reached approximately RMB 1,803.2 million, representing a 28.7% increase year-over-year. As of the reporting date, the Company’s total cash and cash equivalents, together with other short-term financial assets, stood at RMB 9,160.0 million.

By the end of 2025, all 12 indications across the Company’s five self-commercialized innovative drugs had been included in China’s National Reimbursement Drug List (NRDL). These include two non-small cell lung cancer (NSCLC) indications for ivonescimab (PD-1/VEGF bispecific antibody) and three cervical and gastric cancer indications for cadonilimab (PD-1/CTLA-4 bispecific antibody). NRDL inclusion has significantly expanded market coverage and patient access.

In August 2026, the National Medical Products Administration (NMPA) approved ivonescimab in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC), providing a new growth driver for commercialization.

Since the beginning of 2026, the Company has continued to strengthen its commercialization capabilities, with steady progress in market access, coverage, and penetration. These efforts lay a solid foundation for the sustained release of innovative drug value in the second half of the year and beyond.

IO2.0 Global Strategy Advances

Following the approvals of ivonescimab and cadonilimab – two first-in-class immuno-oncology (IO) cornerstone therapies – Akeso has continued to advance the Company’s global IO2.0+ strategy. The Company is building a bispecific antibody-based IO therapeutic matrix designed to treat multiple tumor types through combining different types of therapy.

Biliary tract cancer: In August 2026, the Phase III clinical study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy for the first-line treatment of advanced biliary tract cancer met its primary endpoint of overall survival (OS), demonstrating clinically meaningful and statistically significant OS benefit. This regimen represents a major advancement in first-line treatment of biliary tract cancer.

Squamous NSCLC: In August 2026, ivonescimab plus chemotherapy received NMPA approval for first-line treatment of sq-NSCLC. Based on the HARMONi-6 study, this is the first regimen to achieve dual positive OS and progression-free survival (PFS) results versus a PD-1 monoclonal antibody plus chemotherapy in a randomized, double-blind Phase III trial. Ivonescimab combination therapy marks a significant advance in first-line sq-NSCLC treatment.

EGFR-TKI-resistant NSCLC: In July 2026, an updated analysis of the global multicenter Phase III HARMONi study demonstrated continued OS improvement (HR = 0.76). The OS hazard ratio in Western patients was also 0.76, highly consistent with the China-conducted HARMONi-A study (HR = 0.74, P = 0.02). The Biologics License Application (BLA) for this indication is currently under review by the U.S. Food and Drug Administration (FDA). The HARMONi-A study is the first immuno-oncology trial globally to achieve dual positive OS and PFS results with both clinical benefit and statistical significance in this setting. Ivonescimab combination therapy represents a major advancement in the treatment of EGFR-TKI-resistant non-squamous NSCLC.

PD-L1-positive NSCLC: In the HARMONi-2 study, ivonescimab became the first therapy globally to demonstrate positive results versus pembrolizumab in a Phase III trial, establishing a new benchmark in first-line treatment of PD-L1-positive NSCLC.

Cadonilimab: Cadonilimab continues to advance across multiple indications, including gastric cancer and hepatocellular carcinoma (HCC). Key programs include an international multicenter Phase III study of cadonilimab plus chemotherapy versus nivolumab plus chemotherapy for first-line treatment of gastric/gastroesophageal junction (G/GEJ) adenocarcinoma, a perioperative Phase II study in collaboration with Memorial Sloan Kettering Cancer Center (MSKCC), and an international multicenter registrational study of cadonilimab plus lenvatinib in HCC patients who progressed after prior atezolizumab plus bevacizumab.

As cornerstone agents of global IO2.0, ivonescimab and cadonilimab are establishing a combination therapy ecosystem through novel mechanisms, with the potential to elevate the standard of care across multiple tumor types. Ivonescimab is currently being evaluated in combination trials with Revolution Medicines’ RAS(ON) inhibitor, ARCUS Biosciences’ HIF-2α inhibitor, Virogin Biotech’s VG201 oncolytic virus, and TransThera Biosciences’ tinengotinib, spanning NSCLC, pancreatic cancer, colorectal cancer, clear cell renal cell carcinoma, and hepatocellular carcinoma. Cadonilimab is advancing multi-pathway combination strategies, including combinations with small molecules such as axitinib and tinengotinib in renal and liver cancers, as well as collaborations with the Dana-Farber Cancer Institute and Mass General Brigham to evaluate cadonilimab in combination with INOVIO’s DNA medicine INO-5412 in glioblastoma (GBM).

Ivonescimab is currently being evaluated in more than 17 registrational Phase II/III studies, including seven global registrational trials and 8 studies that use standard-of-care regimens as active comparators. These programs encompass 8 registrational/Phase III studies in lung cancer, as well as first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with CD47 antibody versus pembrolizumab), first-line biliary tract cancer (versus a durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial cancer (versus pembrolizumab plus a Nectin-4 ADC).

Cadonilimab is being evaluated in more than 13 registrational/Phase III clinical studies covering major cancer types, including gastric cancer, HCC, lung cancer, cervical cancer, pancreatic cancer, and esophageal squamous cell carcinoma. Two of these are international multicenter registrational studies.

IO2.0 + ADC2.0 Therapeutic Matrix

Akeso is the only company globally with two approved immuno-oncology bispecific antibodies and is actively exploring combination therapies of ivonescimab and cadonilimab with both proprietary and partnered antibody-drug conjugates (ADCs).

The Company has developed a series of next-generation ADCs designed to address the narrow therapeutic window associated with the safety limitations of existing ADC therapies. Among these, the innovative TROP2/Nectin-4 bispecific ADC AK146D1, next-generation HER3 ADC AK138D1, next-generation B7H3 ADC AK157D1, and bispecific ADC AK158D1 have successively entered clinical development.

Multiple Phase II studies evaluating AK146D1 in combination with ivonescimab in NSCLC, breast cancer, and urothelial cancer, as well as AK138D1 in combination with ivonescimab in lung and breast cancers, are underway, with a focus on first-line treatment of various solid tumors.

In parallel, ivonescimab has entered combination therapy collaborations with high-potential ADCs from domestic and international partners, including Pfizer, GSK, Biokin, and MediLink. These collaborations cover agents such as EGFR/HER3 bispecific ADC, TROP2/HER3 bispecific ADC, B7H3 ADC, FGFR2b ADC, TROP2 ADC, and Nectin-4 ADC across high-incidence malignancies.

Looking further ahead, the Company’s frontier programs continue to push additional new therapies into the clinic. The global first-in-class trispecific antibody AK150 (ILT2/ILT4/CSF1R) has entered clinical development, with additional trispecific antibodies and T-cell engager (TCE) bispecific/multispecific candidates expected to enter the clinic in the next year.

Entering the Bispecific Era in Immunology, CNS, and Respiratory Diseases

In autoimmune, respiratory, and CNS diseases, Akeso is leveraging its expertise in bispecific and multispecific antibody development, with strategic momentum steadily building. A series of internally-developed novel candidates, including AK139, a bispecific antibody for Immunology & Inflammation that targets IL-4R and ST2, and AK152, a bispecific amyloid-beta + brain shuttle antibody for the treatment of Alzheimer’s disease have entered or are preparing to enter clinical development. These programs form a complementary pipeline alongside the Company’s already marketed non-oncology products: ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23), gumokimab (IL-17), and manfidokimab (IL-4Rα).

AI-Empowered Future Innovation Competitiveness

Akeso has adopted the use of AI in its R&D efforts for the past few years. The Company is further expanding the implementation of AI in many new scientific directions and therapeutic platforms.

Developed on Akeso’s AI-driven drug discovery platform, AK139, an IL-4Rα/ST2 bispecific antibody, has advanced into 7 Phase II trials across respiratory and autoimmune indications. AK150, an ILT2/ILT4/CSF1R trispecific antibody, is in Phase I development. AK154, a personalized mRNA cancer vaccine that leverages AI-powered selection of high-affinity immunogenic mutations to create precision oncology therapies. A Phase I study of AK154 as monotherapy or in combination with cadonilimab or ivonescimab as adjuvant therapy in pancreatic cancer is currently ongoing.

(Press release, Akeso Biopharma, AUG 27, 2026, View Source [SID1234670395])

On August 27, 2026 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported its interim results for the six months ended June 30, 2026.

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Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "In the first half of 2026, Harbour BioMed continued to advance our Phase 3.0 strategy, with meaningful progress across all three integrated growth engines. We continued to advance the global value of our mid- to late-stage innovative assets, further strengthened our technology platform capabilities, particularly in AI-driven next-generation antibody discovery capability, and continued to deepen long-term strategic partnerships with leading global pharmaceutical companies. The three growth engines are mutually reinforcing, creating stronger connections among our technology platforms, innovative pipeline and global partnership network, and continuously translating these capabilities into long-term value.

We also achieved a landmark milestone in intellectual property protection. Our historic and decisive victory in the U.S. patent litigation not only reaffirmed the validity of the intellectual property underlying our core antibody discovery platforms, but also demonstrated our firm commitment to protecting our core innovations and building global competitive advantages.

In terms of talent and organizational development, we have further streamlined our global management and scientific teams over the past six months. We have appointed experienced industry leaders, experts across multiple therapeutic areas, and world-renowned scientific advisors, who provide enhanced support for R&D innovation, portfolio strategy, and global collaboration.

Looking ahead, we will continue to drive strategic execution across our three integrated growth engines, accelerate the advancement of high-potential innovative assets into mid- to late-stage clinical development, unlock the global value of our technology platforms and pipeline, and further expand high-quality global partnerships. We are steadily advancing toward our 2028 vision of becoming a globally leading platform-based biopharmaceutical group."

2026 Interim Financial Highlights: Strong Revenue Growth and Sustained Profitability for Seven Consecutive Half-Years

Total revenue reached US$122.5 million, representing a 20.9% year-over-year increase, primarily driven by continued strategic collaborations with global multinational pharmaceutical companies, newly established out-licensing agreements for innovative products, and strong business growth of Nona Biosciences;
Profit for the period reached US$64.9 million, and adjusted net profit for the period[1] was approximately US$71.6 million, marking seven consecutive profitable half-years and confirming that Harbour BioMed has officially entered a phase of "normalized profitability," further validating the sustainability and replicability of the business model underpinning this platform-based biopharmaceutical group;
Cash and cash equivalents stood at approximately US$359.2 million as of June 30, 2026. The Company maintains strong financial resources and flexibility to support its strategic execution.
[1] Adjusted items of profit are mainly from share-based compensation expenses and other one-time expenses.

Multiple Milestones Achieved, Unlocking the Global Value of Mid- to Late-Stage Innovative Assets

Harbour BioMed continued to advance a differentiated portfolio across immunology, oncology, obesity and metabolic diseases, and central nervous system (CNS) disorders, with multiple high-potential programs progressing toward key clinical development milestones.

Key programs in mid- to late-stage clinical development

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody to have completed Phase I to pivotal trials in China. The Biologics License Application (BLA) for the treatment of generalized myasthenia gravis (gMG) was accepted by China’s National Medical Products Administration (NMPA) in July 2024 and is currently under review. Batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases.

HBM9378 is an ultra-long-acting fully human monoclonal antibody against TSLP generated from the H2L2 Harbour Mice platform, engineered to achieve an extended half-life and effector silencing with subcutaneous administration. In March 2026, the Company published first-in-human Phase I trial results in the peer-reviewed journal Drug Design, Development and Therapy, demonstrating favorable safety and an extended half-life (mean T1/2: 55.0–65.8 days).

In January 2025, it was announced that the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, our partner Windward Bio launched the Phase II/III POLARIS clinical study in asthma, with initial data expected in the second half of 2026 and the first Phase III study of HBM9378 in asthma is expected to begin in the fourth quarter of 2026. In June 2026, Windward Bio dosed the first patients in the Phase II SIRIUS study in COPD.

Note: HBM9378 is known as SKB378 in Kelun-Biotech’s pipeline and WIN378 in Windward Bio’s pipeline.

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. In October 2025, the Company published positive Phase II data in combination with tislelizumab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Of the 23 evaluable patients, the objective response rate (ORR) is 34.8%, disease control rate (DCR) is 60.9%, and 12-month overall survival (OS) Rate is 84%. In February 2026, the Company entered a license agreement and equity partnership with Solstice Oncology, a clinical stage biotechnology company established by a syndicate of major venture capital investors, for the exclusive development and commercialization of HBM4003 outside Greater China. Following this agreement, HBM4003 made meaningful global development progress during the reporting period.

HBM7575 is an ultra-long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, with the potential to achieve broader control of inflammation compared to single-target approaches. HBM7575 has been engineered to allow for longer dosing intervals and a convenient subcutaneous route of administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

In March 2026, an IND application for HBM7575 for the treatment of atopic dermatitis was approved by the NMPA, and the first participant has been dosed in a Phase 1 clinical study. In July 2026, an IND application for HBM7575 for the treatment of asthma was approved by the NMPA.

Note: HBM7575 is known as SKB575 in Kelun-Biotech’s pipeline. According to the collaboration agreement between Harbour BioMed and Kelun-Biotech, HBM7575 is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.

Key products in the next-generation innovation portfolio include:

HBM2001 is a potent TL1A×IL-23p19 bispecific antibody generated using the proprietary HBICA bispecific technology and Harbour Mice platform, offering a differentiated mechanism to address both inflammatory and fibrotic pathways in inflammatory bowel disease. In April 2026, HBM2001 obtained FDA IND clearance to commence a Phase I trial in the United States. In July 2026, HBM2001 obtained NMPA IND clearance to commence a Phase I trial in China.

HBM7020 is a BCMA×CD3 bispecific antibody generated using the HBICE technology and Harbour Mice platform. Following the global strategic collaboration with Otsuka Pharmaceutical established in June 2025, HBM7020 continued to advance product development as planned during the reporting period, with the Phase I clinical trial expected to initiate overseas in the second half of the year.

HBM7004 is a novel B7H4×CD3 bispecific antibody demonstrating strong anti-tumor efficacy and favorable safety in preclinical studies. In May 2026, the FDA cleared the IND application for HBM7004, enabling the initiation of a first-in-human Phase I clinical trial in the United States. In August 2026, the NMPA approved the IND application for HBM7004 for the treatment of advanced solid tumors.

LET003 is the first ACVR2A/2B dual-target blocking antibody developed using the Hu-mAtrIx artificial intelligence platform. ACVR2A and ACVR2B play critical roles in regulating muscle-fat metabolic homeostasis. Extensive preclinical and clinical studies have demonstrated that combining receptor-blocking antibodies targeting ACVR2A/2B with GLP-1-based weight loss therapies can further reduce body fat while effectively mitigating lean mass loss. In May 2026, the Company announced promising preclinical data for LET003. Data showed that LET003 exhibited superior pharmacokinetic characteristics compared to multiple competitor molecules. When combined with semaglutide, LET003 significantly enhanced fat reduction while effectively preserving lean mass. In addition, LET003 achieved lean mass-promoting effects at lower dose level comparable to bimagrumab at higher dose level, highlighting its potential to become a best-in-class therapy for obesity treatment. LET003 has advanced to the IND-enabling stage, with an IND submission expected in the third quarter of 2026.

CNS Disease Programs: the Company is advancing a next-generation CNS pipeline focused on Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative disorders. Multiple programs are in preclinical development, with NEU2005 expected to file an IND application in the first half of 2027.

HBM9013 (CRH Neutralizing Antibody): HBM9013/HAT001 is a potent and selective anti-CRH neutralizing antibody for various disorders including congenital adrenal hyperplasia (CAH). In February 2025, HBM Alpha Therapeutics (HBMAT), an innovative biotechnology company incubated by the Company, announced a strategic collaboration and license agreement with Spruce Biosciences. Under the agreement, Spruce Biosciences gains exclusive global rights, excluding Greater China (mainland China, Taiwan, Hong Kong, and Macau), to develop and commercialize HBM9013/HAT001.

AI-Driven Next-Generation R&D Infrastructure Continues to Enhance Innovation Efficiency

Technology platform innovation remains a core pillar of Harbour BioMed’s long-term strategy. The Company continues to integrate its Hu-mAtrIx AI platform with core antibody technology platforms including Harbour Mice, further embedding AI capabilities across the antibody drug discovery and development process to enhance R&D efficiency. The Company has established a technology platform matrix spanning a broad range of therapeutic modalities, including bispecific and multi-specific antibodies, T-cell engagers (TCEs), antibody-drug conjugates (ADCs) and more, providing technological support for the development of innovative therapies across multiple therapeutic areas.

During the Reporting Period, the Company continued to enhance the Hu-mAtrIx AI platform, strengthening capabilities including a fully human heavy-chain-only antibody model based on large-scale next-generation sequencing (NGS) HCAb sequence data, de novo design model, developability prediction, in silico screening and AI-guided engineering. The Company also continued to integrate AI with wet-lab experimental validation to explore more efficient approaches to drug discovery and development.

AI-enabled R&D capabilities are increasingly translating into tangible innovation. In May 2026, the Company announced positive preclinical data for LET003, its first next-generation candidate developed using the Hu-mAtrIx AI platform. The results showed promising pharmacokinetic characteristics, while combination with semaglutide significantly enhanced fat reduction and effectively preserved lean mass, highlighting its potential to become a best-in-class therapy for obesity.

Building on these capabilities, the Company is also exploring new R&D models powered by AI. In June 2026, Harbour BioMed entered into a long-term global strategic partnership with BioMap and jointly initiated MegaStream TechBio, focused on AI-driven discovery and development of complex biologics. MegaStream will integrate proprietary datasets, purpose-built large models, innovative pipeline assets and an intelligent dry-wet closed-loop R&D platform, further advancing AI-enabled discovery and development of next-generation complex biologics.

Deepening Long-Term Platform-Based Strategic Partnerships to Expand the Global Innovation Ecosystem

Leveraging its differentiated technology platforms and R&D capabilities, Harbour BioMed continued to establish multi-level partnerships with leading global pharmaceutical companies and biotechnology companies, and through diversified collaboration models including strategic collaboration, co-development, product licensing, technology licensing and technology services, has built a complete R&D chain spanning early discovery, clinical development and commercialization.

In December 2025, the Company entered into global strategic collaboration and license agreement with Bristol Myers Squibb (BMS) to discover and develop next-generation multi-specific antibodies. Under the terms of the agreement, Harbour BioMed could receive payments totaling $90 million, as well as development and commercial milestones of up to $1.035 billion, along with tiered royalties should BMS elect to advance all potential programs.

In the first half of 2026, the Company entered into a license agreement and equity partnership with Solstice Oncology for HBM4003. Under the terms of the agreement, the Company received upfront consideration valued at over $105 million and is eligible for additional development, regulatory and commercial milestones up to approximately $1.1 billion, plus tiered royalties on net sales outside Greater China. The Company also participated in Windward Bio’s US$165 million financing and continued to deepen collaboration with global partners in antibody discovery, CNS delivery and other innovative areas.

Additionally, Nona Biosciences, the wholly owned subsidiary of Harbour BioMed, entered into a multi-target antibody discovery collaboration with Link Cell Therapies in January 2026, leveraging Nona’s proprietary fully human HCAb Harbour Mice platform and its innovative direct CAR-function-based HCAb library screening platform, NonaCarFx, to generate novel CAR-T cell therapy candidates.

In June 2026, Nona Biosciences entered into a strategic collaboration with Lonza. This collaboration leverages Nona’s proprietary Harbour Mice fully human HCAb platform to discover and develop next-generation single-domain antibody-based blood-brain barrier (BBB)-crossing technologies. Leveraging the platform’s proven ability to generate fully human HCAbs and VHH binders with exceptional affinity and developability, the partnership aims to establish a best-in-class BBB-crossing technology capable of enabling the delivery of a diverse range of therapeutic modalities into the central nervous system (CNS) and unlocking new opportunities in CNS drug development and technology licensing. Under the terms of the agreement, Nona is entitled to receive upfront and option payments from Lonza. The parties will also share revenues generated from future licensing agreements pursuant to the collaboration.

This multi-level approach creates a resilient, scalable business model designed to generate long-term, predictable value.

Continuously Strengthening Innovation and Intellectual Property Barriers, Further Enhancing Global Team Capabilities

Alongside continued progress in pipeline development and business collaborations, Harbour BioMed further strengthened the technology, intellectual property and talent foundation supporting its long-term innovation.

As of June 30, 2026, the Company had filed 706 patent applications, including 19 invention patents granted by the China National Intellectual Property Administration, with 521 patent applications under review. At the same time, the Company continued to strengthen its global management and scientific team by bringing together experienced industry leaders, experts across multiple therapeutic areas, and world-renowned scientific advisors, further enhancing its professional capabilities in R&D innovation, asset strategy, external innovation and global collaboration.

During the Reporting Period, the Company achieved a decisive victory in its core U.S. patent litigation. The jury upheld the validity of the relevant core patent, found Amgen’s infringement to be willful and awarded Harbour BioMed US$20.20 million in damages – the full amount requested. The findings of willful infringement also entitle the Company to petition the judge to treble the award, potentially increasing the award to up to $60.6 million. The verdict further validated the validity and enforceability of the intellectual property underlying the Company’s core antibody discovery platform and provided important support for the Company’s continued expansion of global collaborations and platform value.

Accelerating 2026 Strategic Execution Toward the 2028 Vision

Looking ahead, Harbour BioMed will continue to drive business growth through its three integrated growth engines and steadily advance toward its 2028 vision of becoming a globally leading platform-based biopharmaceutical group.

In the second half of 2026, the Company expects to advance multiple high-potential programs toward key clinical milestones, including the initial data readout from the Phase II/III POLARIS study of HBM9378/WIN378, as well as potential significant milestones for porustobart (HBM4003). The Company will also continue to accelerate next-generation innovative candidates into clinical development and advance its differentiated pipeline across immunology, oncology, obesity and metabolic diseases, and central nervous system disorders. Additionally, the Company will actively explore diverse collaboration opportunities and further strengthen its position in the global innovation ecosystem by expanding strategic partnerships with global partners, continuing to bring transformative biotherapeutics to patients worldwide.

(Press release, Harbour BioMed, AUG 27, 2026, View Source [SID1234670394])

On August 27, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, reported its 2026 interim results and recent business highlights.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, "In the first half of 2026, CStone entered a pivotal stage of transition from innovation-driven accumulation to global value realization.

Our lead asset, CS2009, continues to advance rapidly through global clinical development. To date, we have accumulated clinical data from more than 300 patients, consistently demonstrating three key clinical validations: first, proof of safety; second, multidimensional confirmation of CTLA‑4 target activity and efficacy, evidenced by pharmacodynamic biomarkers and clinical activity in "cold tumors" and IO‑pretreated NSCLC; and third, broad‑spectrum and highly competitive antitumor efficacy across multiple tumor types. The most recent data show that CS2009’s antitumor activity continues to deepen and strengthen with longer follow-up, exhibiting particularly competitive efficacy and a well-tolerated safety profile in key patient populations, including NSCLC and mCRC. These robust data provide strong support for the upcoming global Phase III registrational trials. We look forward to presenting additional more mature clinical data on CS2009 in oral presentations at the ESMO (Free ESMO Whitepaper) Congress this October.

Beyond CS2009, other Pipeline 2.0 candidates are also progressing steadily toward clinical stage. CS5007, built on our proprietary ADC platform, has initiated a global Phase I clinical trial in both China and Australia. In addition, more than ten early-stage programs spanning next-generation ADCs, immunology & inflammation and other areas are advancing smoothly. The successive entry of these differentiated innovative assets into clinical development will serve as a critical driver for the Company’s sustained growth and global expansion.

On the commercial front, our three key products, sugemalimab, pralsetinib, and avapritinib, continued to achieve breakthroughs across domestic and international markets, contributing significant momentum to revenue growth. Notably, following pralsetinib’s first-time inclusion in the NRDL earlier this year, its in-market sales volume increased by almost 500% year-over-year during the first seven months of 2026, making it the primary driver of the Company’s revenue growth in the first half of 2026.

Looking ahead, CStone will focus on advancing the clinical value of its Pipeline 2.0 assets and actively pursue global partnerships to accelerate their development. Concurrently, the Company will continue to maximize the commercial potential of its marketed products through strategic partnerships and resource integration. Our goal is to foster a sustainable growth model where R&D and commercialization reinforce each other, creating a virtuous cycle between innovation and business operations."

Business Highlights

For the six months ended June 30, 2026 and up to the date of this results announcement, CStone made significant progress across both its proprietary Pipeline 2.0 portfolio and its commercial franchise, advancing the Company’s strategy to build a fully integrated, globally competitive biopharmaceutical company.

Clinical Stage Core Asset

CS2009, PD-1/VEGF/CTLA-4 trispecific antibody

Accelerating global clinical development toward Phase III registrational trials by year end
The ongoing global Phase I/II trial has enrolled more than 300 patients across China and Australia, with U.S. Investigational New Drug (IND) clearance obtained in February 2026.

CStone plans to initiate the first wave of global Phase III multi-regional clinical trials (MRCTs) for CS2009 by the end of 2026. Planned registrational studies include first-line non-small cell lung cancer (NSCLC) in combination with chemotherapy (versus pembrolizumab plus chemotherapy), and first-line mCRC in combination with chemotherapy (versus bevacizumab plus chemotherapy), with additional registrational studies planned for 2027 and following years.

CS2009 validates its potential as a next-generation I/O backbone
At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, CStone presented comprehensive Phase I/II data from the ongoing global multicenter trial. As of the data cutoff date of August 2026, updated monotherapy efficacy data from the ongoing global Phase I/II trial of CS2009, reflecting a longer follow-up and larger sample size than the ASCO (Free ASCO Whitepaper) 2026 presentation continued to demonstrate robust and deepening antitumor activity across multiple tumor types. Three important key clinical validations are achieved from over 300 patient data:

Proof of safety
Across all dose levels, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. In the ASCO (Free ASCO Whitepaper) 2026, the incidence of Grade ­3 treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) were 24.6% and 12.7%, respectively. Notably, the incidence of Grade ­3 VEGF-related TRAEs was only 5.1%. No excessive toxicities typically associated with CTLA-4/PD-(L)1 combinations were observed. As of August 2026, the safety profile of CS2009 remained consistent with that presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, with no new safety signals identified.

Proof of CTLA-4 activities and efficacy
Dose-dependent upregulation of ICOS on CD4+ T cells was observed as a pharmacodynamic biomarker of CTLA-4 blockade. Activity was also seen in "cold tumor" not sensitive to PD-(L)1 mAb:

Later-line monotherapy for mCRC (30 mg/kg): the objective response rate (ORR) was 20.0% (3/15) and the disease control rate (DCR) was 93.3% (14/15).
Later-line monotherapy for soft-tissue sarcoma (STS): the ORR was 38.5% (5/13) and the DCR was 69.2% (9/13). Later-line monotherapy for non-clear cell renal cell carcinoma (nccRCC): the ORR was 42.9% (3/7) and the DCR was 100.0% (7/7).
Promising anti-tumor activity in later-line post immuno-oncology (IO) NSCLC monotherapy: ORR was 23.8% (5/21), DCR was 61.9% (13/21). Among patients who had previously received immunotherapy plus platinum-based chemotherapy (n=13), ORR was 38.5% (5/13) and DCR was 84.6% (11/13).
Proof of broad efficacy
Monotherapy and chemo-combination activity in first-line and later-line NSCLC:

First-line NSCLC monotherapy (PD-L1 tumor proportion score [TPS]­ ≥1%; enrollment completed): ORR of 61.7% (29/47) and DCR of 93.6% (44/47), including ORR of 70.8% (17/24), DCR 91.7% (22/24) in patients treated at 30 mg/kg; in the PD-L1 TPS ≥­50% group (n=24), ORR was 83.3% (20/24) and DCR was 95.8% (23/24) (versus ORR of 81.3% [13/16] at the 2026 ASCO (Free ASCO Whitepaper) cutoff), including ORR of 100.0% (11/11) and DCR of 100.0% (11/11) in patients treated at 30 mg/kg. After median follow up of 6 months, median progression-free survival (PFS) and DOR have not been reached.
Second-line or later NSCLC monotherapy (30 mg/kg): ORR of 28.0% (7/25) and DCR of 60.0% (15/25), with a 6-month DOR rate of 83.3% (versus ORR of 24.0% and a 6-month DOR rate of 80.0% at the 2026 ASCO (Free ASCO Whitepaper) cutoff). Across all evaluated dose levels (n=54), ORR was 16.7% (9/54) and DCR was 68.5% (37/54), with a 6-month DOR rate of 87.5% (versus 85.7% at the 2026 ASCO (Free ASCO Whitepaper) cutoff).
Later-line NSCLC (second/third-line combination therapy, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data are as of the 2026 ASCO (Free ASCO Whitepaper) data cutoff and will be updated at ESMO (Free ESMO Whitepaper) 2026.
First-line squamous NSCLC combination therapy (PD-L1-low/negative, TPS ≤5%, n=8): ORR of 75.0% (6/8), DCR of 100.0% (8/8); notably, the ORR reached 100.0% (4/4) in the PD-L1-negative subgroup. Data are as of the ASCO (Free ASCO Whitepaper) 2026 data cutoff and will be updated at ESMO (Free ESMO Whitepaper) 2026.
Robust Chemo-combo efficacy in the first-line mCRC, mostly proficient mismatch repair or microsatellite stable (pMMR/MSS):

First-line mCRC (with XELOX, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data as of 2026 ASCO (Free ASCO Whitepaper) cutoff, will be updated at ESMO (Free ESMO Whitepaper) 2026.
Promising monotherapy activity observed in metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, triple-negative breast cancer, gastric cancer, esophageal cancer, as well as STS and nccRCC.

Upcoming two oral presentations of CS2009 at ESMO (Free ESMO Whitepaper) 2026
The clinical research results of CS2009 have been accepted for two Rapid Oral presentations at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The presentations will feature Phase I/II clinical data of CS2009 in patients with advanced NSCLC and mCRC.

Other Clinical Stage Asset

CS5007, EGFR/HER3 ADC

Global Phase I trial initiated in China and Australia
The Company initiated the Phase I first-in-human study in June 2026. This trial consists of dose-escalation and dose-expansion cohorts evaluating CS5007 as a monotherapy in patients with advanced solid tumors, and will be conducted concurrently in Australia and China. CStone presented preclinical data for CS5007 at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, further supporting its broad-spectrum anti-tumor potential.

Commercial Products

CEJEMLY (sugemalimab), anti-PD-L1 antibody

Global regulatory and scientific recognition
Following the initial marketing authorizations of sugemalimab in the European Union (EU) and the United Kingdom (U.K.) for Stage IV NSCLC, sugemalimab received additional approvals in the EU in November 2025 and subsequently in the U.K. in February 2026 as monotherapy for adults with unresectable Stage III NSCLC whose disease has not progressed following platinum-based chemoradiotherapy (CRT). Meanwhile, marketing authorization applications for sugemalimab have either been approved or are under active review in nearly 30 countries worldwide.

In March 2026, CEJEMLY (sugemalimab) was included in the ESMO (Free ESMO Whitepaper) Early and Locally Advanced NSCLC Living Guideline. Sugemalimab received a Level [I, A] recommendation for consolidation therapy in patients with unresectable Stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy.

Secured fifth international commercial partnership
In June 2026, CStone entered into an exclusive commercialization agreement with Arrotex Pharmaceuticals Pty Ltd (Arrotex), Australia’s largest privately owned pharmaceutical company with established oncology commercialization capabilities and distribution infrastructure across Australia and New Zealand. This milestone expands sugemalimab’s global commercialization network to five strategic partnerships, covering more than 60 countries and regions across Europe, the Middle East and Africa, Latin America, and Oceania.

Pralsetinib capsules, RET inhibitor

NRDL inclusion and accelerated commercial growth
Following the inclusion of pralsetinib capsules (100 mg) in China’s NRDL in late 2025, effective January 1, 2026, patient access has improved significantly. In the seven‑month period ending July  2026, pralsetinib’s in-market sales volume increased by almost 500% year-over-year.

Localized manufacturing approval supporting commercial scalability
Following the approval by China’s NMPA of the manufacturing localization application for pralsetinib capsules (100 mg), the first batch of locally-manufactured pralsetinib was released in China in 2026.

Preclinical/IND-enabling Stage Programs

A balanced, differentiated early-stage portfolio spanning oncology and immunology/inflammation

CStone’s preclinical Pipeline 2.0 comprises innovative candidates across multispecific antibodies, ADCs and other next-generation modalities, with potential first-in-class (FIC) or best-in-class (BIC) opportunities spanning oncology, immunology, inflammation and other high-value therapeutic areas.

The Company’s proprietary ADC platform incorporates optimized linker technologies designed to enable tumor-selective payload release and supports multiple Pipeline 2.0 ADC candidates, including CS5007 (EGFR and HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (DLL3 and SSTR2 bispecific ADC), etc. The Company is also exploring next-generation ADC technologies, including dual-payload ADCs (e.g., CS5009, a B7H3/PD-L1 bispecific dual-payload ADC, and CS5010, a HER2-targeting dual-payload ADC) and novel-payload ADCs (e.g., CS5012, a HER2-targeting novel-payload ADC). In April 2026, CStone presented preclinical data for CS5007, CS5006 and CS5008 at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, highlighting the breadth and differentiation of its next-generation ADC pipeline.

Beyond oncology, CStone has expanded Pipeline 2.0 into immunology and inflammation by leveraging its proprietary multispecific antibody platform. The Company has developed CS2015 (OX40L/TSLP bispecific antibody) targeting Type 2 inflammatory diseases, CS2013 (BAFF/APRIL bispecific antibody) targeting B cell-mediated autoimmune diseases, CS2016 (TL1A/α4β7 bispecific antibody), and CS1016 (PD-1 agonist antibody).

Future and Outlook

Our mission is to deliver transformative therapies through scientific excellence and technological innovation, making high-quality treatments accessible worldwide to benefit patients and their families.

We reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments, while executing strategic partnerships to unlock the global value of our in-market products. Key catalysts for the second half of 2026 include:

Clinical milestones

Accelerate global development of CS2009 by advancing interactions with global regulatory authorities, including the U.S. FDA and the CDE of NMPA, on Phase III registrational trial design, with the first wave of global Phase III MRCTs planned to be initiated by the end of 2026, while continuing to pursue global partnerships.
Advance clinical development of CS5007 (EGFR/HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (SSTR2/DLL3 ADC) and other early-stage candidates.
Innovation and technology

Further strengthen proprietary technology platforms, including multi-specific antibody and next-generation ADC technologies, to support sustained expansion of the preclinical pipeline.
Present key clinical data, including updated CS2009 data, at major international scientific conferences, including two Rapid Oral presentations of CS2009 Phase I/II data at the 2026 ESMO (Free ESMO Whitepaper) Congress.
Financial Highlights

International Financial Reporting Standards (IFRS) Measures:

Revenue was RMB205.1 million for the six months ended June 30, 2026. The revenue is composed of RMB183.2 million from sales of pharmaceutical products (avapritinib, pralsetinib and sugemalimab), RMB6.9 million from license fee income and RMB15.0 million from royalty income of sugemalimab. The substantial revenue growth was primarily driven by a significant increase in sales of pharmaceutical products, particularly pralsetinib, following its successful inclusion in the NRDL effective from January 2026, which led to a marked sales ramp-up.

Cost of revenue was RMB110.9 million for the six months ended June 30, 2026.

Research and development expenses were RMB205.5 million for the six months ended June 30, 2026, primarily due to increased costs for clinical trials.

Administrative expenses were RMB51.3 million for the six months ended June 30, 2026.

Selling and marketing expenses were RMB73.1 million for the six months ended June 30,2026.

Loss for the period was RMB252.3 million for the six months ended June 30, 2026.

Cash and cash equivalents and time deposits were RMB1,560.2 million as of June 30, 2026.

Non-International Financial Reporting Standards (Non-IFRS) Measures:

Research and development expenses excluding the share-based payment expenses were RMB193.4 million for the six months ended June 30, 2026, primarily due to increased costs for clinical trials.

Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB115.2 million for the six months ended June 30, 2026.

Loss for the period excluding the share-based payment expenses was RMB230.9 million for the six months ended June 30, 2026.

2026 Interim Results Conference Call

The Company will host its 2026 Interim results earnings call at 9:00 a.m. (Beijing Time) on Friday August 28, 2026. Please register for the conference in advance through the link: View Source .

(Press release, CStone Pharmaceauticals, AUG 27, 2026, View Source [SID1234670393])