Natera and Angiex Partner to Assess Response to Investigational Nuclear-Delivered Antibody-Drug Conjugate™ Using Signatera™

On August 27, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a new Signatera collaboration with Angiex, Inc., a privately held biotech company developing a portfolio of Nuclear-Delivered Antibody-Drug Conjugates (ND-ADCs).

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Angiex is conducting a Phase I clinical trial of AGX101, an investigational TM4SF1-directed ND-ADC. AGX101 is designed to bind TM4SF1 and deliver a cytotoxic payload to TM4SF1-expressing tumor cells and tumor-associated endothelial cells. This dual-targeting approach is intended to address both tumor cells and tumor vasculature.

The trial is currently enrolling patients with unresectable, locally advanced or metastatic solid tumors. The collaboration will include longitudinal Signatera testing for circulating tumor DNA (ctDNA) to explore its value for treatment response monitoring during AGX101 treatment.

Natera’s Signatera test provides a personalized measure of ctDNA that may complement radiologic assessment. Longitudinal ctDNA assessments may provide additional information in patients treated with AGX101, particularly when imaging shows metabolic or structural changes whose relationship to viable tumor is uncertain.

"We believe AGX101 has the potential to offer a differentiated therapeutic approach for patients with advanced solid tumors," said Paul Jaminet, Ph.D., co-founder and CEO of Angiex. "This collaboration will allow us to evaluate whether longitudinal ctDNA measurements can complement imaging and improve our understanding of treatment response."

"Signatera provides additional depth into early biologic response assessment that can meaningfully advance our understanding of this novel drug class," said Eric Matthews, general manager, biopharma, at Natera. "We look forward to working with the Angiex team to generate molecular response data that can inform the development of AGX101 and advance this promising therapeutic approach."

(Press release, Natera, AUG 27, 2026, View Source [SID1234670399])

QIAGEN Launches QIAsymphony Connect for Automated Clinical Nucleic Acid Extraction

On August 27, 2026 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the commercial launch of QIAsymphony Connect, an IVD-compliant platform for automated clinical nucleic acid extraction.

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Building on the trusted QIAsymphony platform, with more than 3,300 cumulative placements worldwide, QIAsymphony Connect helps clinical laboratories standardize extraction across diverse assay workflows. The platform delivers highly concentrated DNA and RNA for sensitive downstream assays, supporting reliable detection across clinical molecular testing applications including liquid biopsy, oncology and infectious disease diagnostics.

"Clinical laboratories need automation solutions that combine proven extraction performance with the standardization, traceability and productivity needed for today’s molecular testing workflows," said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. "The commercial launch of QIAsymphony Connect reflects our continued investment in automated sample preparation and strengthens our Sample to Insight portfolio by helping laboratories improve consistency and efficiency across clinical molecular testing."

QIAGEN has completed the FDA listing in the U.S. and the EUDAMED listing in Europe for QIAsymphony Connect, accomplishing significant regulatory milestones as the platform enters broader commercial availability.

Advancing routine clinical workflows

QIAsymphony Connect supports routine clinical molecular testing through following capabilities:

Standardized workflow automation: Integrated liquid handling, prefilled IVD reagent cartridges, automated load checks and guided workflow setup minimize run-to-run and operator-to-operator variability, enabling standardized walkaway workflows with less hands-on time while supporting reproducible nucleic acid extraction.
Complete sample traceability: Automated barcode reading of primary sample tubes and eluates, built-in audit trails and onboard process controls provide complete sample traceability and strengthen process safety throughout the extraction workflow.
High-throughput performance for sensitive molecular testing – in particular, liquid biopsy: Processing of up to 96 samples in four independent batches supports routine laboratory productivity. The novel bead collection and elution approach, together with sample input volumes ranging from a few microliters up to 10 mL, delivers highly concentrated DNA and RNA for sensitive downstream applications. This includes liquid biopsy, which analyzes tumor-derived material circulating in blood and requires sensitive detection of often low-abundance molecular targets, as well as other oncology and infectious disease applications.
Supporting existing and new customers

QIAsymphony Connect introduces enhanced usability, digital connectivity and workflow standardization while maintaining full backward compatibility with trusted QIAsymphony reagent kits and consumables. Their continued use across both platforms facilitates a smoother and faster migration to QIAsymphony Connect.

At the same time, laboratories implementing new molecular testing applications benefit from workflow enhancements designed to simplify routine operation and support standardized molecular testing.

QIAGEN has already received initial customer orders for QIAsymphony Connect, reflecting early market adoption as the platform enters broader commercial availability.

Early users have highlighted the platform’s intuitive guided workflow setup, comprehensive sample traceability and reduced hands-on time as important advantages for routine clinical testing. Users also cited the consistency of nucleic acid extraction and simplified run setup as key benefits across both established and newly implemented molecular testing workflows.

Learn more about QIAsymphony Connect at View Source

(Press release, Qiagen, AUG 27, 2026, View Source [SID1234670398])

Caris Life Sciences Publishes npj Precision Oncology Study Showing AI-Guided Therapy Selection is Predictive of Longer Survival in Patients with Pancreatic Cancer

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])

Fosun International Reports 1H2026 Results: Total Revenue RMB86.96 Billion, Net Profit RMB1.72 Billion

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])

Akeso 2026 Interim Results: Strong Commercialization Momentum; IO2.0+ Global Strategy Redefining Clinical Standards; Bispecific Advancement in ADC, I&I and Alzheimer’s

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])