Fosun Pharma and Akeso Release Latest Financial Results; Boehringer Ingelheim's New Drug Approved | Arterial Weekly Medical Report

Daphne Author: Intern Chen Chuan, Zheng Ao, He Duo

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Enterprise Dynamics in China

New Drug Development

3SBIOINC's Individualized rhTPO Regimen Shows Superior Efficacy to Eltrombopag

8On the 21st, Professor Zhang Lei's team from the Blood Disease Hospital of the Chinese Academy of Medical Sciences published the "TE-ITP Study" findings in *eClinicalMedicine* (a subsidiary journal of *The Lancet*). The study confirmed for the first time in a head-to-head comparison that an individualized rhTPO dosing regimen based on platelet count significantly outperforms eltrombopag in treating adult immune thrombocytopenia (ITP).The study showed that the median time for platelet increase to target levels in the rhTPO group was only 7 days, significantly shorter than in the eltrombopag group (15 days) (p<0.001), with a 47.7% reduction in bleeding risk. This regimen provides high-level evidence for individualized treatment of ITP and is expected to change clinical practice.

Innovent Bio's IBI363 First Global Multi-Center Phase III Clinical Trial Application Approved by FDA

On August 25, Innovent Bio announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the first global Phase III clinical study (MarsLight-11) of IBI363, a globally pioneering PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by the company, for the treatment of squamous non-small cell lung cancer (NSCLC) patients with immune resistance. To date, IBI363 has also received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) and Fast Track Designation (FTD) from the U.S. FDA for this indication.

Zai Lab's Efgartigimod Phase 3 Study in AChR Antibody-Negative Myasthenia Gravis Meets Primary Endpoint

8On the 25th, Zai Lab's partner argenx announced that the pivotal Phase 3 ADAPT SERON study of efgartigimod intravenous infusion for the treatment of AChR antibody-negative generalized myasthenia gravis (gMG) patients met its primary endpoint (p=0.0068). Compared with placebo, patients in the efgartigimod treatment group showed statistically significant and clinically meaningful improvements in the Myasthenia Gravis Activities of Daily Living score (MG-ADL). Argenx plans to submit a supplemental Biologics License Application to the U.S. FDA by the end of 2025 to expand the drug’s indications. Detailed results will be presented at future medical conferences.

Boehringer Ingelheim and Sino Biopharm's Targeted Drug Approved in China

8On the 29th, Boehringer Ingelheim and Sino Biopharm announced that their jointly promoted product, Sheng Hetu® (Zong Aitinib Tablets), was approved by the China National Medical Products Administration for the treatment of adult patients with HER2-mutated advanced non-small cell lung cancer who have previously received at least one systemic therapy. This drug is the world's first oral HER2 tyrosine kinase inhibitor.

Market Dynamics

Walvax Vaccine Export to El Salvador

8On the 26th, Walvax announced that its 23-valent pneumococcal polysaccharide vaccine had been exported to El Salvador for the first time, officially entering the Latin American market. This vaccine is the world's first 23-valent pneumococcal vaccine that does not contain preservatives, suitable for high-risk populations aged 2 years and above. The global cumulative sales have exceeded 14 million doses, and its safety and efficacy have been clinically verified both domestically and internationally.This supply was efficiently completed in response to the emergency procurement needs of the Salvadoran government and will provide pneumonia prevention and control support for high-risk groups among the local population of 6 million. To date, multiple vaccines from Walvax have been exported to more than 20 countries and regions worldwide, covering Southeast Asia, Africa, and other areas.

Financial Report Data

Fosun Pharmaceutical Releases 2025 Semi-Annual Report

On August 26, Fosun Pharmaceutical released its semi-annual performance report for 2025. During the reporting period, the company achieved revenue of 19.514 billion yuan and a net profit attributable to shareholders of 1.702 billion yuan. Revenue from innovative drugs exceeded 4.3 billion yuan, representing a year-on-year increase of 14.26%, while operating cash flow grew by 11.90% year-on-year to 2.134 billion yuan. Meanwhile, Fosun Pharmaceutical announced an authorization partnership with UK-based biotechnology company Sitala Bio, granting it global development, production, and commercialization rights (excluding China, Hong Kong, Macao, and Taiwan) for its self-developed small molecule inhibitor FXS6837.

Akeso Releases 2025 Interim Results

On August 27, Akeso released its interim performance report. The report showed that Akeso's product sales revenue for the first half of 2025 reached 1.401 billion yuan, representing a year-on-year increase of 49.20%. This significant growth was mainly driven by the substantial increase in sales of the company’s core products, Eveci (PD-1/VEGF bispecific antibody) and Cadonilimab (PD-1/CTLA-4 bispecific antibody), following their inclusion in the National Medical Insurance Drug Catalog since January 2025, as well as contributions from newly approved products. In terms of R&D, Akeso continued to maintain high investment intensity, with R&D expenses amounting to approximately 731 million yuan in the first half of the year, accounting for 52.17% of commercial sales revenue, marking a year-on-year increase of 23% compared to 594 million yuan in the same period last year.

Harbour BioMed Announces 2025 Interim Results

On August 27, Harbour BioMed announced its mid-term performance for 2025. The total revenue in the first half of the year was approximately RMB 725 million (approximately USD 101 million), representing a year-on-year increase of 327%; the profit was approximately RMB 523 million (approximately USD 73 million), marking a year-on-year increase of 51 times.

During the reporting period, Harbour BioMed also reached several licensing and collaboration agreements with global partners. In January 2025, the company, together with Kelun-Biotech, signed a licensing agreement with Windward Bio for HBM9378/SKB378, granting it exclusive rights to research, develop, manufacture, and commercialize HBM9378/SKB378 worldwide. In June 2025, Harbour BioMed entered into a global strategic collaboration agreement with Otsuka Pharmaceutical Co., Ltd. to advance the development of HBM7020, a BCMAxCD3 bispecific T-cell engager for the treatment of autoimmune diseases.

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Multinational Pharmaceutical Companies' Dynamics

New Drug Progress

AstraZeneca's Drug Dazhuyou Approved in China for HR-Positive, HER2-Negative Metastatic Breast Cancer Patients Previously Treated

8On the 22nd, AstraZeneca announced that Datroway® (generic name: Dostarlimab for Injection) has officially been approved by the China National Medical Products Administration for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced disease stage.

Amgen's Repatha® (Repatha) is now approved for adult patients at risk of major adverse cardiovascular events due to poorly controlled low-density lipoprotein cholesterol.

8On the 25th, Amgen announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of Repatha® (evolocumab) to include adult patients at risk of major adverse cardiovascular events (MACE) due to poorly controlled low-density lipoprotein cholesterol (LDL-C, commonly referred to as "bad cholesterol"). This update removes the previous requirement for patients to have a confirmed diagnosis of cardiovascular disease.

Eli Lilly's Two New Drugs Achieve Breakthrough Progress in Phase III Clinical Trials Successively

8On the 26th, Eli Lilly announced that its oral GLP-1 receptor agonist orforglipron for obesity or overweight with type 2 diabetes patients in the ATTAIN-2 Phase III trial met all primary and key secondary endpoints. The results showed that the 36mg dose group reduced body weight by an additional 10.5% compared to placebo after 72 weeks of treatment, with significant improvements in glycated hemoglobin and cardiovascular metabolic indicators. The completion of this study marks that the clinical data required for the global registration application of orforglipron has been completed, and the application will be initiated this year.8On the 27th, Eli Lilly further announced positive overall survival results from the Phase III monarchE study of the breast cancer drug Verzenio® (abemaciclib). In patients with HR+, HER2-negative high-risk early breast cancer, a two-year treatment course of Verzenio combined with endocrine therapy significantly extended overall survival compared to endocrine therapy alone, demonstrating both statistical and clinical significance.

Pfizer and BioNTech's COVID-19 Vaccine Receives FDA Approval

8On the 27th, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics License Application (sBLA) for the LP.8.1 adaptive monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) from the two companies. The vaccine is indicated for adults aged 65 years and older, as well as individuals aged 5-64 with at least one high-risk underlying medical condition.

Transaction Trends

AbbVie Acquires Gilgamesh Pharmaceuticals' Lead Candidate

8On the 25th, AbbVie announced a definitive agreement to acquire Gilgamesh's lead candidate drug Bretisilocin for up to $1.2 billion (including upfront and development milestone payments). The drug is a novel short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser intended for treating patients with moderate to severe major depressive disorder (MDD), currently in Phase IIa trials. As part of the deal, Gilgamesh will spin off a new company under the name Gilgamesh Pharma Inc. to retain its employees and other ongoing research projects.