Major Pharma Deals and Leadership Moves: Merck, BMS, and Novo Nordisk Complete Acquisitions; Former Fosun Pharma Chairman Wu Yifang Joins CBC Group

Li Jiaying Authors: Interns Chen Chuan, Zheng Ao, He Duo

New Drug Developments

Nuo# Remibrutinib Approved by FDA for RefractoryChronic Urticaria in Adults

On September 30, Novartis announced that the U.S. Food and Drug Administration (FDA) had formally approved its new drug Rhapsido® (remibrutinib) for marketing. This oral Bruton’s tyrosine kinase (BTK) inhibitor works by targeting BTK to suppress the release of histamine and other pro-inflammatory mediators, and is indicated for the treatment of adult patients with chronic spontaneous urticaria (CSU) who have an inadequate response to H1 antihistamines. Rhapsido is the first BTK inhibitor approved by the FDA for CSU. Novartis has submitted applications in multiple countries and regions, including the European Union, Japan, and China, and filed for marketing approval in China in February 2025.

AbbVie Announces Positive Results from Phase II Clinical Trial of OnabotulinumtoxinA (BOTOX®) for the Treatment of Upper Limb Essential Tremor

On October 6, AbbVie announced positive top-line results from the Phase 2 ELATE trial evaluating onabotulinumtoxinA (BOTOX®) for the treatment of upper limb essential tremor. The results, presented on October 8 at the International Congress of Parkinson’s Disease and Movement Disorders, demonstrated that patients in the BOTOX® group achieved statistically significant improvements in the Tremor Research Disability Scale–Revised (TREDS-R) at Week 18 compared with placebo.

Lilly Initiates Phase III Clinical Trial of FRα ADC LY4170156

On October 9, Eli Lilly officially registered the Phase III clinical trial FRAmework-01 for its folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) LY4170156 on the ClinicalTrials.gov website.

U.S. FDA Approves First New Drug for Idiopathic Pulmonary Fibrosis in Over a Decade

On October 10, Boehringer Ingelheim announced that JASCAYD® (nerandomilast) tablets have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. JASCAYD® is the first and only approved oral selective phosphodiesterase 4B (PDE4B) inhibitor for IPF, featuring a novel mechanism of action with both anti-fibrotic and immunomodulatory effects. This marks the first new therapy for this disease area in over a decade.

Transaction Trends

Merck Completes Acquisition of Verona Pharma

On October 7, Merck & Co. announced the completion of its acquisition of Verona Pharma plc, which has now become a wholly-owned subsidiary of Merck. Under the terms of the acquisition agreement, the total transaction value is approximately $10 billion. The core asset in this acquisition is Verona’s breakthrough chronic obstructive pulmonary disease (COPD) therapy, Ohtuvayre, which received approval from the U.S. Food and Drug Administration (FDA) in June 2024 as the world’s first non-inhaled maintenance treatment for COPD.

Novo Nordisk to Acquire Akero for $5.2 Billion, Gaining Its FGF21 Pipeline

On October 9, Akero announced that it had entered into a definitive acquisition agreement with Novo Nordisk. Under the terms of the deal, Novo Nordisk will acquire Akero for up to $5.2 billion in cash, comprising an upfront equity value of approximately $4.7 billion and total consideration of around $5.2 billion including potential contingent value right (CVR) payments. Akero’s efruxifermin (EFX) program is focused on developing a best-in-class therapy for MASH, complementing Novo Nordisk’s leading position in GLP-1-based treatments for metabolic diseases. Novo Nordisk will advance the evaluation of EFX in its Phase III “SYNCHRONY” trial.

BMS Acquires In Vivo CAR-T Company Orbital Therapeutics for $1.5 Billion

On October 10, Bristol Myers Squibb (BMS) and Orbital Therapeutics (“Orbital”) announced a definitive agreement under which BMS will acquire Orbital, a private biotechnology company pioneering the development of next-generation RNA medicines. These medicines are designed to reprogram the immune system in vivo, thereby delivering therapies with the precision, control, and flexibility needed to address the underlying biology and unique complexities of each disease. The acquisition includes Orbital’s leading preclinical RNA immunotherapy candidate, OTX-201, which is currently undergoing studies in support of an Investigational New Drug (IND) application.

Personnel Changes

GSK Appoints Luke Miels as CEO-Designate

On September 29, GSK announced the appointment of Luke Miels as CEO Designate. An industry veteran who joined GSK in 2017 and currently serves as Chief Commercial Officer, Miels will officially assume the role of CEO and join the Board of Directors on January 1, 2026, succeeding Dame Emma Walmsley, who has led GSK for nine years. This leadership transition is the result of GSK’s long-term succession planning.

New Drug Developments

FDA Approves Lurbinectedin Combination Therapy, Revolutionizing First-Line Maintenance Treatment for Small Cell Lung Cancer

Recently, PharmaMar, a partner of Luye Pharma Group, announced that the U.S. Food and Drug Administration (FDA) has approved lurbinectedin in combination with atezolizumab for first-line maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). This marks the first globally approved combination therapy for this indication.

Data from the Phase III IMforte study showed that, compared with atezolizumab monotherapy as maintenance treatment, the combination therapy significantly reduced the risk of disease progression or death by 46% and the risk of death by 27%. The median overall survival in the combination therapy group was extended to 13.2 months, superior to the 10.6 months observed in the monotherapy group.

RemeGen and Santen Pharmaceutical Jointly Announce the Submission of Eylefupα Intravitreal Injection for Marketing Approval in China

On September 30, Santen Pharmaceutical Co., Ltd. and RemeGen Co., Ltd. jointly announced that the New Drug Application (NDA) for RC28-E, a VEGF/FGF dual-target fusion protein for intravitreal injection indicated for the treatment of diabetic macular edema (DME), has been formally accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This NDA is based on a multicenter, randomized, double-blind, active-controlled Phase III clinical trial led by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences.

Genfleet Therapeutics Initiates Phase I/II Clinical Study of Molecular Glue Pan-RAS(ON) Inhibitor GFH276

On September 29, GenFleet Therapeutics announced that the first subject had recently been enrolled in its Phase I/II clinical trial of GFH276 for the treatment of advanced solid tumors with RAS mutations. GFH276 is a molecular glue Pan-RAS(ON) inhibitor independently developed by GenFleet, which holds global rights to the product. Its clinical trial application was approved by the National Medical Products Administration earlier this month, allowing it to proceed into an open-label, multicenter study.

CARsgen Therapeutics’ GPRC5D CAR-T Product CT071 Research Published in The Lancet

On October 8, CARsgen Therapeutics announced that the research findings from its investigator-initiated clinical trial (NCT05838131) evaluating CT071, an autologous CAR-T cell product targeting GPRC5D, for the treatment of relapsed/refractory multiple myeloma (R/R MM), have been published in *The Lancet Haematology*. The trial aimed to assess the safety and preliminary efficacy of CT071 in patients with R/R MM. Results showed no dose-limiting toxicities were observed. At a median follow-up of 10.71 months, the objective response rate was 100%, with a median time to minimal residual disease (MRD) negativity of 29 days (IQR 29–29). Median duration of response (DoR), progression-free survival (PFS), and overall survival (OS) had not yet been reached.

Icotinib Phase III Clinical Trial Results in Asia Top The Lancet Subjournal

On October 9, Everest Medicines announced that the results of a multicenter Phase III clinical study of its innovative drug etrasimod in patients with moderately to severely active ulcerative colitis in Asia were recently published in the prestigious international journal The Lancet Gastroenterology & Hepatology.

Studies have shown that etrasimod demonstrates significant advantages across all primary and secondary efficacy endpoints. After 52 weeks of treatment, the mucosal healing rate reached 51.9%, with a complete mucosal normalization rate of 45.5%, significantly surpassing current standards.

CSPC’s SYH2070 Injection Receives Clinical Trial Approval in the United States

On October 9, CSPC Pharmaceutical Group announced that its independently developed novel Class 1 chemical drug, SYH2070 injection (a double-stranded small interfering RNA [siRNA] therapeutic), has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The product was also approved for clinical trials in China in September 2025.

This product is an siRNA therapeutic that achieves liver-targeted delivery through conjugation with N-acetylgalactosamine (GalNAc). Administered subcutaneously, it targets angiopoietin-like protein 3 (ANGPTL3) and effectively reduces ANGPTL3 levels. By employing strategies of sequence optimization and chemical modification, the product achieves more durable gene silencing effects. It holds promise as an ultra-long-acting siRNA drug for lowering ANGPTL3, suitable for the treatment of hypertriglyceridemia or mixed dyslipidemia, and demonstrates the potential to effectively reduce the risk associated with elevated remnant cholesterol levels.

Market Dynamics

Jingyin Pharmaceutical’s HKEX IPO Application Accepted

On September 28, Jingyin Pharmaceutical’s Hong Kong IPO application was accepted. Founded in 2021, Jingyin Pharmaceutical is dedicated to fully leveraging the clinical and commercial value of siRNA therapies.

First Domestically Produced Quadrivalent HPV Vaccine Approved for Market Launch

On September 28, the first domestically developed quadrivalent HPV vaccine (Hansenula polymorpha yeast), jointly researched and developed by Chengdu Institute of Biological Products Co., Ltd. under China National Biotec Group (CNBG) and the National Institutes for Food and Drug Control (NIFDC) affiliated with CNBG, was approved for market launch. It is indicated for women aged 18–45 years to prevent cervical cancer caused by HPV types 16 and 18, as well as genital warts caused by HPV types 6 and 11. Phase III clinical trials demonstrated 100% efficacy in preventing cervical intraepithelial neoplasia grade 2 or higher (CIN2+). This marks the first domestically produced quadrivalent HPV vaccine approved for marketing in China.

BinHui Biologics Files for Hong Kong IPO

On September 30, Binhui Biotechnology’s application for an initial public offering (IPO) on the Hong Kong Stock Exchange was accepted. As an oncolytic virus therapy company, its lead candidate, BS001, has entered Phase III clinical trials.

Contec Medical Receives FDA Warning Letter

On October 10, Contec Medical Systems announced that the Company received a Warning Letter from the U.S. Food and Drug Administration (FDA) on October 2, 2025. The Warning Letter was issued based on the results of an FDA onsite inspection conducted at the Company’s facility in Qinhuangdao City, Hebei Province, from June 9 to June 12, 2025. The FDA raised observations and requested corrective actions regarding non-compliances with the Quality System Regulation (QSR) under 21 CFR Part 820 of the U.S. Federal Regulations, pertaining to the production, packaging, storage, or installation of medical device products exported by the Company to the U.S. market.

M&A and Financing Trends

Innovent Biologics Completes Nearly RMB 600 Million in Series C2 Financing

On September 30, Tianjing Bio announced the completion of its C2 financing round, raising nearly RMB 600 million. The round was led by a fund under CICC Capital, with participation from Yijing Capital, Oriental Fortune Capital, Zhike Fund, Chunling Investment, and Xinyi Investment. Existing shareholders Heda Investment, Qingsong Capital, Yiyuan Investment, and Qiantang Urban Development also increased their stakes. Haoyue Capital served as the exclusive financial advisor. Tianjing Bio stated that the proceeds will be primarily used to advance Phase III clinical trials and regulatory filings for its first-tier product candidates, while accelerating the research and development of its second-tier global innovative drug candidates.

InnoCare Pharma and Zenas BioPharma Reach Licensing Agreement, with Total Transaction Value Exceeding $2 Billion

On October 8, InnoCare Pharma announced a landmark licensing agreement with Zenas BioPharma. Under the agreement, Zenas will obtain global development and commercialization rights for orelabrutinib in the field of multiple sclerosis, as well as development and commercialization rights for orelabrutinib in other non-oncology therapeutic areas. Zenas also secured rights to two preclinical molecules: a novel oral IL-17A/F inhibitor and a brain-penetrant oral TYK2 inhibitor. According to the terms of the agreement, Zenas will pay InnoCare Pharma an upfront payment and near-term milestone payments totaling up to $100 million, with additional payments tied to clinical development, regulatory approval, and commercialization milestones, bringing the total potential transaction value to over $2 billion.

Personnel Changes

Former Fosun Pharmaceutical Chairman Wu Yifang Takes New Post

On October 9, Qiao Capital announced a key executive appointment via its official WeChat account: Mr. Wu Yifang, former Chairman and CEO of Fosun Pharmaceutical, has officially joined the firm as Executive Operating Partner. On October 10, Everest Medicines announced the appointment of Mr. Wu Yifang as Chairman of the Board of Directors. Mr. Wu was also appointed as Chairman of the Nomination Committee and as a member of the Remuneration Committee.