On August 25, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported the publication of primary analysis results from the global Phase III HARMONi clinical trial in The Lancet Oncology. In HARMONi, ivonescimab in combination with platinum-doublet chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI).

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The manuscript, titled "Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small cell lung cancer after EGFR-TKI progression (HARMONi): a randomised, double-blind, multi-centre phase 3 trial," reports primary efficacy and safety results from the study conducted at 114 cancer centers and hospitals across Asia, Europe, and North America. The study was designed to evaluate whether ivonescimab plus chemotherapy could improve clinical outcomes in a setting where treatment options remain limited after progression on EGFR-directed therapy.

"Once a patient with EGFR-mutated lung cancer progresses after a third-generation EGFR TKI, there are limited treatment options for those patients and the survival may be limited," said Xiuning Le, M.D., Ph.D., Associate Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, and lead author of the HARMONi manuscript. "In this patient population, traditional anti-PD-(L)1 therapies have not established a clear benefit in prior Phase III studies. The HARMONi results suggest that ivonescimab’s mechanism of action, targeting of PD-1 and VEGF simultaneously in one construct, may offer a clinically meaningful strategy with the potential to improve outcomes for patients."

HARMONi Primary Analysis Results

At the primary analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, as assessed by independent radiographic review committee, compared to placebo plus chemotherapy. Median PFS was 6.8 months in the ivonescimab-plus-chemotherapy arm compared to 4.4 months in the placebo-plus-chemotherapy arm, with a hazard ratio of 0.52 (95% CI: 0.41–0.66; p<0.0001). The PFS benefit was consistent across preplanned subgroups. At the time of the primary overall survival (OS) analysis, ivonescimab plus chemotherapy showed a positive OS trend but did not reach statistical significance. The safety profile observed with ivonescimab plus chemotherapy was manageable and consistent with prior clinical experience; treatment-related grade 3–5 hemorrhage events occurred in less than 1% of patients in the ivonescimab-plus-chemotherapy arm.

"The publication of HARMONi in The Lancet Oncology provides peer-reviewed support for the scientific rationale behind ivonescimab and its dual targeting of PD-1 and VEGF in a Phase III setting with high unmet need," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "In a patient population where outcomes after EGFR TKI progression remain challenging, these data further support our ongoing development of ivonescimab, and we continue to evaluate longer-term results from HARMONi as the data mature. Our commitment remains focused on bringing meaningful new options to patients with significant unmet medical need."

"The publication of the HARMONi primary analysis data is a meaningful milestone for the patients, caregivers, investigators, and clinical teams who contributed to this global study," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit Therapeutics. "Together with Akeso, we remain focused on advancing ivonescimab with urgency, discipline, and purpose as we work to translate promising science into meaningful impact for patients."

Additional HARMONi OS Follow-Up Data to Be Presented at WCLC 2026

On July 22, 2026, Summit announced an updated OS analysis from HARMONi based on a June 2026 data cut-off that showed ivonescimab plus chemotherapy continued to demonstrate a positive OS trend and a consistent efficacy and safety profile in Asian and western patients compared with chemotherapy alone; western patients achieved an OS hazard ratio of 0.76, consistent with the global study population. Additional details from the updated HARMONi data analysis will be presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) on September 15, 2026, at 1:02–1:12 p.m. KST (12:02–12:12 a.m. EDT), in the session entitled, "OA14 The Breakthrough Immunotherapy for Advanced NSCLC" (abstract #OA14.04).

As previously communicated, the FDA has assigned a Prescription Drug User Fee Act goal action date of November 14, 2026, for Summit’s Biologics License Application for ivonescimab in combination with platinum-doublet chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI).

About EGFR-Mutated NSCLC

Lung cancer is the second most commonly diagnosed cancer worldwide and remains the leading cause of cancer-related death globally, with an estimated 2.6 million new cases and 1.9 million deaths in 2024.1 In the United States, the American Cancer Society estimates that approximately 230,000 new lung cancer cases will be diagnosed and nearly 125,000 deaths from lung cancer will occur in 2026.2 Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing approximately 80% to 85% of all cases.1,3

EGFR mutations are among the most common actionable oncogenic drivers in non-squamous NSCLC, occurring in approximately 10-15% of patients in western populations and 40-50% of patients in Asia.4,5 Activating EGFR mutations can drive tumor growth through aberrant EGFR signaling.6 EGFR tyrosine kinase inhibitors (TKIs), including third-generation EGFR TKIs, are an important treatment approach for patients with advanced EGFR-mutated NSCLC.4

Despite advances with EGFR-targeted therapy, most patients with locally advanced or metastatic EGFR-mutated NSCLC eventually experience disease progression after treatment with a third-generation EGFR TKI.7 In patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a third-generation EGFR TKI, treatment options remain limited, underscoring the need for new therapeutic approaches after progression on EGFR-targeted therapy.7

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.

HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering.

HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

Four Phase III ivonescimab clinical trials have read out to date, all four with positive data, in NSCLC. In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in both the HARMONi-A and HARMONi-6 studies. A manageable, consistent safety profile was achieved in each of these studies.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

(Press release, Summit Therapeutics, AUG 25, 2026, View Source [SID1234670330])

On August 25, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that a pre-specified interim analysis assessed by the Independent Data Monitoring Committee (IDMC) of the randomized, controlled, double-blinded, multicenter, registrational Phase III clinical study (AK112-309/HARMONi-GI1) of ivonescimab in combination with chemotherapy versus durvalumab (PD-L1 monoclonal antibody) in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC), showed that the study met its primary endpoint of overall survival (OS), achieving a clinically meaningful and statistically significant positive result. The study also met all key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

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Detailed results from this study will be presented at an upcoming international academic conference and published in a peer-reviewed journal.

Durvalumab in combination with chemotherapy is currently the preferred first-line immunotherapy regimen recommended by international guidelines and is regarded as the optimal standard of care (SOC). HARMONi-GI1 is the first Phase III study in biliary tract cancer to demonstrate a statistically significant positive OS result versus the global gold standard (PD-L1 monoclonal antibody plus chemotherapy), representing a major milestone in the treatment of this difficult disease.

Dr. Michelle Xia, Founder, Chairwoman, President and CEO of Akeso:
"We are delighted the Phase III clinical study of ivonescimab in combination with chemotherapy versus durvalumab in combination with chemotherapy for the first-line treatment of biliary tract cancer has achieved a statistically significant positive OS result. This is a major breakthrough for the treatment of biliary tract cancer.

"We sincerely thank the investigators, study teams, and patients who made HARMONi-GI1 possible. Their important contributions bring us closer to an innovative, safe, and highly effective new treatment option against this aggressive cancer.

"The positive result of HARMONi-GI1 marks the first positive Phase III study for ivonescimab in gastrointestinal tumors, following four positive Phase III results in lung cancer. The breakthrough clinical value of ivonescimab is now expanding from lung cancer to a broader range of solid tumors. We look forward to making this innovative therapy available to patients worldwide as soon as possible."

(Press release, Akeso Biopharma, AUG 25, 2026, View Source [SID1234670329])

On August 25, 2026 Senhwa Biosciences, Inc. (TPEx: 6492) reported that it has completed enrollment in its Phase 1b expansion trial evaluating pidnarulex (CX-5461) monotherapy in patients with advanced solid tumors harboring BRCA1/2, PALB2, or other homologous recombination deficiency (HRD)-associated alterations. With enrollment complete, the study will proceed to data review and reconciliation, database lock, and comprehensive statistical analysis. The Clinical Study Report (CSR) is expected in the first quarter of 2027.

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The final analysis is expected to inform decisions on indication prioritization, biomarker-based patient selection, potential combination strategies, and the next stage of CX-5461’s clinical development. The findings may also support Senhwa’s global licensing and strategic partnering efforts.

Patients who continue to derive clinical benefit at the end of the main treatment period, as determined by investigators, may enter the protocol-defined extension phase and continue receiving CX-5461. Ongoing treatment and follow-up will provide additional data on the durability of disease control, longer-term safety, and overall clinical benefit.

The Phase 1b trial evaluates CX-5461 monotherapy in heavily pretreated patients with advanced DNA repair-deficient solid tumors. Enrolled tumor types include pancreatic, breast, and ovarian cancers. Patients had received a median of six prior lines of therapy (range, 1-14), and most had received multiple standard-of-care treatments, including PARP inhibitors. This population has limited treatment options and substantial unmet medical need.

"Completing enrollment marks an important clinical milestone for the CX-5461 Phase 1b expansion trial," Senhwa said. "Our focus now is on data reconciliation, database lock, and comprehensive statistical analysis to assess the safety, antitumor activity, durability of disease control, and overall clinical benefit of CX-5461 in this heavily pretreated population. These mature data will inform our next clinical development steps."

PARP inhibitors remain central to the treatment of homologous recombination deficiency (HRD)-associated cancers, including ovarian, breast, pancreatic, and prostate cancers.

HRD and DNA damage response (DDR) remain major areas of development in precision oncology. However, many patients eventually develop resistance to PARP inhibitors or experience disease recurrence, underscoring the need for effective later-line treatment options.

CX-5461 is a first-in-class G-quadruplex stabilizer designed to exploit vulnerabilities in DNA repair-deficient tumors through a mechanism distinct from PARP inhibition. Preliminary data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed that, in an exploratory advanced ovarian cancer cohort led by Dr. Amit Oza, CX-5461 achieved a disease control rate of nearly 60% among 16 patients with BRCA mutations, all of whom had previously received PARP inhibitor therapy.

These preliminary findings indicate antitumor activity in a heavily pretreated population and support further evaluation of CX-5461 as a potential later-line option, including for patients previously treated with PARP inhibitors. They also provide a clinical rationale for evaluating CX-5461 in combination with PARP inhibitors, immunotherapies, antibody-drug conjugates, and other precision oncology agents.

As the HRD treatment landscape moves beyond PARP inhibitor monotherapy toward resistance-overcoming and biomarker-driven combinations, Senhwa believes CX-5461’s differentiated mechanism and emerging clinical data may support its use in future HRD/DDR combination regimens.

(Press release, Senhwa Biosciences, AUG 25, 2026, View Source [SID1234670326])

On August 25, 2026 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported its 2026 interim results and 2030 strategic vision.

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Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "Looking back over the past fifteen years, Innovent has completed two key transformations: from 2016 to 2020, we transformed from an R&D-driven biotech company into a biopharmaceutical company with full-value-chain capabilities spanning R&D, manufacturing, and commercialization; from 2021 to 2025, we progressed from a long-term investment phase into a biopharmaceutical company that achieved revenue over RMB 10 billion and full-scale profitability. 2026 marks Innovent’s best strategic window to date, and it is against this backdrop that we have set forth our new strategic goals for 2030. We have both the resolve and the confidence to drive our third critical transformation: evolving from a regional leading biopharmaceutical company into a global premier biopharma with global business operational capabilities.

In the first half of 2026, Innovent delivered strong growth in both revenue and profit, further reinforcing our leading position in China’s biopharmaceutical industry and highlighting our scarce value in both certainty and growth potential. At the same time, over the past ten months, we have reached multiple strategic collaborations with global multinational pharmaceutical leaders including Takeda, Eli Lilly, and Pfizer, while also partnering with biotechs such as Ollin and Spero to advance the global development of our differentiated pipeline. Our partnered pipeline now spans more than 20 assets, including 5 co-development and co-commercialization ("Co-Co") programs, with an aggregate deal value reaching USD 34 billion, representing more than 30% of the total out-licensing value among Chinese pharmaceutical companies over the same period1. Innovent stands at the most favorable strategic window in its development. We will continue to pursue high-quality growth in revenue and profit, guided by clear strategy and disciplined execution — strengthening and amplifying our ‘dual-engine’ advantage across oncology and general biomedicine, accelerating our global expansion, and advancing toward our 2030 strategic goals, so as to continue creating long-term value for our shareholders and society."

A Visible Growth Path: Scale and Profitability Advancing in Parallel

In the first half of 2026, Innovent reached RMB 8.6 billion in total revenue, representing 45% year-over-year growth, while product revenue reached RMB 8.2 billion, up 57% year over year. Building on the RMB 10 billion-plus revenue scale, Innovent maintained strong growth momentum, with its dual-engine strategy of oncology and general biomedicine continuing to deliver.

Rapid revenue growth, coupled with continued improvements in operational efficiency, further drove improvements in profitability. IFRS net profit for the first half of the year was approximately RMB 1.3 billion, representing approximately 50% year-over-year growth, while Non-IFRS net profit reached RMB 1.7 billion, up 41% year over year. Innovent has entered a new stage characterized by simultaneous expansion in scale and improvement in earnings quality, setting a new paradigm for high-quality growth among biopharmaceutical companies.

As of July 31, 2026, Innovent held RMB 30.2 billion in cash reserves, equivalent to approximately US$4.5 billion. In addition, we continued to generate positive cash flow, providing a strong financial foundation for long-term growth.

Vision 2030: From China Leader to Global Premier Biopharma

Building on high-quality growth and systematic portfolio development, the Company has underpinned its 2030 development goals.

Revenue Scale: By 2030, we target to achieve total revenue of RMB 35–40 billion, largely driven by organic expansion from the existing business and pipeline.
Sustainable Profitability: By 2030, we aim to benchmark our profit margin to top-tier pharmaceutical companies, through continued revenue expansion and efficiency improvements.
Global Innovation: By 2030, we aim to advance at least five molecules into global MRCT Phase 3 development, achieve product launches in key markets, i.e. U.S. and Europe with international revenue emerging.
Globalization: building global infrastructure and business operating capabilities, truly transforming into a global premier biopharmaceutical company.
From "Product-led Growth" to "Portfolio-Driven Growth," with Dual Growth Engines Unleashing New Momentum

China’s Leading Oncology Franchise: Strengthening Core Oncology Leadership While Expanding Strategically into Key Growth Areas

In oncology, Innovent has established a strong product portfolio and brand presence across core indications including lung cancer, gastrointestinal cancers and hematological malignancies. Focusing on the next-generation "IO + ADC" innovation strategy, the Company is advancing next-generation assets including IBI363 (PD-1/IL-2α-biased), IBI343 (CLDN18.2 ADC), and IBI3003 (GPRC5D/BCMA/CD3) into late-stage clinical development, establishing long-term growth drivers and competitive advantages across multiple strategic areas.

Meanwhile, through its collaboration with Lilly on Verzenio (abemaciclib) in breast cancer, we have strategically gained an important entry point into this major high-incidence tumor type. This asset lays the foundation for upcoming in-house pipeline programs such as IBI354(HER2 ADC) and IBI3014(PD-L1/TROP2 ADC), and paves the way for a more systematic presence in breast cancer.

General Biomedicine Franchise Emerged as a New Growth Engine

In general biomedicine, Innovent has established a clear framework across four major chronic disease areas—metabolic, cardiovascular, ophthalmology and autoimmune—and this franchise has become another core pillar of Innovent.

SYCUME (Teprotumumab, IGF-1R antibody), China’s first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world’s first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025.

At the same time, our next‑generation metabolic and obesity pipeline – including IBI3032 (once‑daily oral GLP‑1), IBI3042 (once‑weekly oral GLP‑1), IBI3040 (Amylin), IBI3046 (INHBE siRNA) and IBI3030 (monthly PCSK9‑GGG) – provides deep, long‑term growth reserves in global obesity and metabolic disease. In cardiovascular & metabolism, autoimmune and ophthalmology, we are following a "flagship products life cycle management + next‑generation innovation" strategy to build focused product clusters and durable competitive positions in each area.

Three Late-Stage Global Assets Unlocking More Than US$60 Billion Total Addressable Market (TAM), and 20+ Partnered Programs Accelerating Global Innovation

Innovent is advancing global development of its core assets through multiple collaboration models. Three key assets have entered, or are about to enter, global multi-regional Phase 3 trials, with a combined addressable market estimated at over US$60 billion, and are expected to be major value drivers in the coming years:

IBI363 (PD-1/IL-2α-biased, Takeda R&D Code: TAK-928): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications, global co-development with Takeda

A global multi-regional Phase 3 study (MarsLight-11) in IO-resistant squamous non-small cell lung cancer (NSCLC) is ongoing, and with expansion into IO-resistant non-squamous NSCLC in preparation.
A pivotal Phase 2 study of IBI363 in melanoma in China is expected to read out in the second half of 2026, potentially supporting the first NDA submission for IBI363.
IBI363 has demonstrated preliminary positive PoC results in first-line NSCLC. PoC studies in first-line NSCLC and first-line colorectal cancer are ongoing, with additional PoC studies being advanced across other tumor types, further supporting its potential as a next-generation IO backbone therapy.
Arcotatug Tavetecan (CLDN18.2 ADC, Innovent/Takeda R&D Code: IBI343/TAK-921): Globally First NDA stage Next-Generation Fc-Silenced CLDN18.2 ADC, potential TAM over US$8 billion

The China-Japan multicenter Phase 3 study completed its first interim analysis and achieved primary endpoint. The NDA submission has been accepted by NMPA for the treatment of CLDN18.2-positive advanced gastric cancer in later-line settings.
A Phase 3 study in first-line pancreatic cancer is planned to initiate in China.
International multicenter Phase 1 and PoC studies in first-line pancreatic cancer and first-line gastric cancer are ongoing.
IBI324 (VEGF/ANG2, Ollin R&D Code: OLN324): Potential best-in-disease retinal therapy, potential TAM US$15 billion

Our partner Ollin Biosciences reported positive results from the Phase 1b JADE head-to-head study against faricimab in nAMD and DME patients in the U.S.
Ollin plans to initiate global multi-regional Phase 3 studies in DME and nAMD in the second half of 2026, and through collaboration with Innovent, to conduct patient enrollment in China and South Korea.
Diversified Partnerships to Accelerate Global Innovation

Over the past 10 months, Innovent has entered into strategic multi-product collaborations with global multi-national pharmaceutical companies including Takeda, Lilly and Pfizer, while partnering with biotech companies such as Ollin and Spero to rapidly validate differentiated pipeline programs in selected disease areas. The aggregate deal value reaching US$34 billion, covering more than 20 pipeline programs, among which five are "Co-Co" assets.
Leveraging diversified partnership models, the Company will progressively build overseas R&D and commercialization capabilities and evolve into a truly world-class biopharmaceutical company with global business operating capabilities.
High-Quality Manufacturing Standards

Innovent operates advanced manufacturing facilities built to international standards and our Suzhou manufacturing site has recently undergone and successfully passed a Good Manufacturing Practice (GMP) inspection conducted by the European Medicines Agency (EMA), and has obtained the corresponding GMP certificate.
Total operational capacity of 140,000 liters, accounting for 20% of China’s total biologic manufacturing capacity. Suzhou site houses 60,000 liters of antibody capacity and ADC commercial lines; Hangzhou site has 80,000 liters of antibody capacity, supporting global supply and CDMO services.
Sustainable Development and ESG Commitment

9,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou.
Over 3,000 new cancer patients initiate Innovent therapies daily; more than 10 million patients have benefited to date.
Maintained MSCI ESG AAA rating, leading China’s biopharmaceutical industry.
First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status).
Launched community health initiatives including the MV ‘Weight Management Made Easy’ and documentary ‘Down in Weight, Up in Life’ to promote science-based healthy weight management.
Published patient education materials on thyroid eye disease and weight management to enhance public health awareness.
Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 4 billion.
Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise".
Created over 2,700 jobs for new graduates.
Cumulative taxes and contributions exceeding RMB 9 billion.

(Press release, Innovent Biologics, AUG 25, 2026, View Source [SID1234670324])

On August 25, 2026 Fosun Pharma ("the Company", stock code: 600196.SH; 02196.HK) reported its interim results for 2026. In the first half of 2026 ("the Reporting Period", or 1H2026), the Company recorded revenue of RMB 20.442 billion, a year-on-year increase of 4.75%, or 7.17% at constant exchange rates. Profit attributable to shareholders of the listed company, net of non-recurring gains and losses, stood at RMB 1.144 billion, up 19.09% year-on-year. Profit growth outpaced revenue growth, reflecting sustained improvement in earnings quality. Net cash generated from operating activities reached RMB 2.424 billion, rising 13.59% year-on-year.

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Innovation and globalization stand as the dual core engines driving business performance. Revenue from Innovative Drugs hit RMB 4.911 billion, representing a 13.84% year-on-year increase and accounting for 33.21% of pharmaceutical segment revenue, 2.17 percentage points higher than the same period last year. Business revenue from regions outside Chinese mainland and other countries totaled RMB 6.379 billion, growing 16.45% year-on-year and making up 31.21% of total revenue, a year-on-year uplift of 3.14 percentage points. The Group’s revenue mix continues to improve.

Focusing on Core Therapeutic Areas and Accelerating Clinical Translation of Innovative Drugs

Guided by clinical-value-driven innovation, Fosun Pharma prioritises three core therapeutic areas: oncology, immunology and inflammation, and neurodegenerative diseases. It also expands into CVRM (cardiovascular, renal and metabolic), anti-infectives, rare diseases and other segments. Leveraging an open-innovation framework that combines in-house R&D, two-way licensing and fund-incubation models, the Company accelerates clinical translation and pushes forward its innovation-led transformation.

In 1H2026, Fosun Pharma’s total R&D investment amounted to RMB 3.247 billion, up 25.66% year-on-year. Among this, R&D investment related to Innovative Drugs accounted for 81.61% of total R&D investment, primarily directed towards pipelines such as HLX43, HLX22, GR1803, FXR0906, as well as next-generation small molecule drugs, radiopharmaceuticals, and other cutting-edge technology platforms.

During the reporting period, Fosun Pharma’s Innovative Drugs entered a period of intensive approvals and value realization, with a total of 20 indications of 7 Innovative Drugs were approved for launch both domestically and overseas. In solid tumor areas including lung cancer, breast cancer, and gastrointestinal tumors, the Company has established differentiated competitive advantages through multi-product synergy and global commercialization. Han Li Kang (Rituximab), Han Qu You (trastuzumab), and Akynzeo continue to maintain leading positions in their respective market segments, consistently contributing stable cash flow.

During H1 2026, Han Si Zhuang (Serplulimab) gained approval in China for the perioperative treatment of gastric cancer, filling a global unmet clinical need. In the EU, it obtained three additional first-line approvals for squamous non-small-cell lung cancer, esophageal squamous-cell carcinoma and non-squamous non-small-cell lung cancer. To date, serplulimab has been launched in approximately 50 countries and regions worldwide and is reimbursed under national health-insurance or public-reimbursement schemes in 12 markets including the United Kingdom, Germany, Italy, Spain and Sweden. Han Bei You (Pertuzumab) received successive marketing approvals in the EU and China. It works in synergy with breast-cancer portfolio assets including Han Qu You, Han Nai Jia and Fu Tuo Ning to drive commercial uptake. Fu Mai Ning (luvometinib tablets) secured a new indication for pediatric and adolescent patients aged two years and older with relapsed/refractory Langerhans-cell histiocytosis (LCH) following systemic therapy, addressing an unmet clinical need in China.

With regulatory applications accepted for multiple innovative drugs and international multi-center clinical trials for key pipelines moving forward efficiently, Fosun Pharma continues to fuel its long-term commercial growth.
– The NDA for SAF-189 (foritinib succinate capsules), an ALK inhibitor for non-small-cell lung cancer, has been accepted by the NMPA.
– The NDA of Fu Mai Ning for adult patients with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1 (NF1) has been accepted and granted priority review by the NMPA.
– The NDA for Velinotamig (GR1803), a BCMA × CD3 bispecific antibody for multiple myeloma, has been accepted.

Lead pipeline candidates HLX43 and HLX22 are progressing in international multi-center trials across China, the US, Europe, Australia, Japan and other geographies. As a potential best-in-class pan-tumor PD-L1-targeting ADC, HLX43 has demonstrated promising preliminary clinical efficacy featuring high potency and favorable safety profiles across multiple solid tumors types including non-small-cell lung cancer.

In the immunology and inflammation field, the Company strengthened its in-house R&D while continuously enriching its pipeline through BD collaborations, obtaining the rights to develop, manufacture, and commercialize roconkibart (anti-IL-17A monoclonal antibody) in Chinese mainland, Hong Kong SAR, Macau SAR, and Taiwan region. The complement inhibitor FXS6837 for the treatment of IgA nephropathy and other glomerular diseases associated with complement dysregulation initiated Phase 2b clinical trials in Chinese mainland. The DPP1 inhibitor FXS7553 is in Phase 2 clinical stage in Chinese mainland for two indications: non-cystic fibrosis bronchiectasis and COPD.

In the neurodegenerative diseases field, the integrated diagnosis and treatment layout continues to strengthen. The post-marketing confirmatory clinical trial for Sodium Oligomannate Capsules in Chinese mainland is progressing steadily; as of July 31, 2026, cumulative enrollment exceeded 1,000 cases, reaching over 50% of the planned enrollment target. HT001, an investigational drug for Parkinson’s disease, has initiated Phase 1 clinical trials in Australia. Parallel work is underway on the clinical deployment of magnetic-resonance-guided focused-ultrasound therapy and the R&D of companion diagnostic reagents.

Rooted in evidence-based medicine, Fosun Pharma presented three oral abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, including the Phase 3 study of Fu Mai Ning in adult NF1 patients, the Phase 3 study of serplulimab injection in the perioperative setting for gastric cancer, and the clinical study of HLX43 in non-small cell lung cancer. 10 studies were selected for poster presentations at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, including data from two Phase 3 studies of Fu Tuo Ning and a study of HLX43 in nasopharyngeal carcinoma. The Company continues to deliver high-quality clinical outcomes in top-tier global journals such as The Lancet and Nature Medicine, as well as at global industry academic conferences, providing solid academic support for international registration and commercial expansion of its products.

Deep Globalization: Global Capabilities Accelerate Value Delivery of Innovation

Among China’s early-movers in global pharmaceutical expansion, Fosun Pharma is evolving from mere product exports toward system-level global deployment. It strengthens cross-border capabilities across R&D, regulatory affairs, manufacturing and commercialization to maximize the global value of its innovative assets.

In terms of out-licensing, Shanghai Henlius, a subsidiary of Fosun Pharma, has entered strategic partnerships with Eisai and Abbott for serplulimab. Eisai obtains development, manufacturing and exclusive commercialization rights for Japan and agreed territories. Abbott receives exclusive commercial-license rights covering 42 countries and regions across Asia, the Middle East, Africa and Eastern Europe. These collaborations accelerate global roll-out of home-grown innovations for patients worldwide.

In terms of in-licensing, Fosun Pharma entered into a global exclusive option agreement with AriBio for AR1001, an investigational drug for Alzheimer’s disease. Building on the existing rights in China and Southeast Asia, Fosun Pharma is entitled to further expand its right to global core markets including the US, Europe, and Japan, with the Company serving as the marketing authorization holder for the product in the corresponding territories. The international multi-center Phase 3 clinical trial of AR1001 for the treatment of early Alzheimer’s disease has completed the last patient’s last visit, with top-line results to be announced within 2026.

Drawing on years of global GMP-compliant manufacturing experience, Fosun Pharma presses ahead with its internationalization drive. Its biotech manufacturing site supplies products routinely to global markets including China, Europe, Canada, Latin America, Southeast Asia and India. As of period-end, installed biologic capacity totaled 84,000 liters, of which 48,000 liters are commercially operational.

Fosun Pharma’s subsidiary Gland Pharma, as the first injectable manufacturer in India to receive U.S. FDA approval, possesses one-stop development and manufacturing capabilities for complex dosage forms including vials, lyophilized products, ampoules, and pre-filled syringes. Gland Pharma recently entered into a strategic supply agreement with a global leading pharmaceutical company for 55 SKUs of sterile injectable, further validating its technological expertise and customer stickiness in the high-barrier complex formulation segment. This platform also provides Fosun Pharma with a unique strategic resource for its globalization layout, creating a differentiated competitive advantage in the process of going global.

Bolstered by its innovation and globalization strengths, Fosun Pharma keeps elevating its industry standing and has achieved an MSCI ESG rating upgrade to AAA[1]. Domestically, it has ranked among the top 10 of MIIT’s China Top 100 Pharmaceutical Enterprises for eight consecutive years. Globally, its innovative-pipeline scale places it within the world’s top tier, ranking top 20 in Citeline’s Global Top 25 Pipeline Scale Pharmaceutical Companies.

"Amidst challenging industry dynamics, Fosun Pharma responded to external uncertainties with strategic focus, achieving steady revenue growth." Chen Yuqing, Chairman of Fosun Pharma, said, "We stay firmly committed to innovation and globalization. Concentrating on oncology, immuno-inflammation and neurodegenerative diseases, we leverage our global footprint and two-way BD synergies to build stronger commercial capabilities. Amid global-expansion opportunities for China’s innovative drugs, we take a long-term view and advance resolutely toward high-quality development."

(Press release, Fosun Pharma, AUG 25, 2026, View Source [SID1234670323])