GenFleet’s GFH375 Wins CDE Breakthrough Therapy Designation – Oral KRAS G12D Inhibitor for NSCLC
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that GFH375, an oral KRAS G12D (ON/OFF) inhibitor, has...
InnoCare’s Zurletrectinib Wins Priority Review for Pediatric NTRK Tumors – Next‑Gen TRK Inhibitor Expands Label
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that the Center for Drug Evaluation (CDE) of China’s...
Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis
Sino Biopharmaceutical Limited (HKG: 1177) announced that the National Medical Products Administration (NMPA) has approved rovadicitinib...
Antengene’s XPOVIO Secures Second South Korea Reimbursement – Selinexor Combo Approved for Multiple Myeloma
Antengene Corporation Limited (HKG: 6996) announced that South Korea’s National Health Insurance Service (NHIS) has approved...
Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China
Zhejiang Hangyu Pharmaceutical Co., Ltd., a subsidiary of Jemincare, announced that China’s National Medical Products...
NMPA CDE Launches “Caring Program – Extension” Pilot – Accelerates Rare Disease Drug Development Pathway
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
QL Biopharma Raises 500M+ RMB Series C – OrbiMed Leads Round for Monthly GLP‑1 Zovigrutide
Beijing QL Biopharmaceutical Co., Ltd. announced the completion of a Series C financing round raising...
Hansoh Pharma’s Mirdametinib Plus Almonertinib NDA Accepted by NMPA – Dual‑Target Combination for EGFR‑Mutant NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that China’s National Medical Products Administration (NMPA) has...
Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion
Sanofi (NASDAQ: SNY) announced that Dupixent (dupilumab) has been approved by China’s National Medical Products Administration...
Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA
Eli Lilly (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the European Medicines Agency’s (EMA) Committee for...
Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Shionogi Files CORECTIM Lotion for Japan Approval – Expands Topical JAK Inhibitor Franchise in Atopic Dermatitis
Shionogi & Co., Ltd. and subsidiary Torii Pharmaceutical Co., Ltd. announced the submission of a...
Dupixent Wins CHMP Positive Opinion for Pediatric CSU – EU Approval Nears for Children Aged 2–11 Years
Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human...
Asieris’ APL-1702 MAA Accepted by EMA – First Photodynamic Therapy for Cervical HSIL Nears EU Approval
Asieris Pharmaceuticals (SHA: 688176) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
Novartis’ Remibrutinib Wins CHMP Positive Opinion – Oral BTK Inhibitor Nears EU Approval for Chronic Urticaria
Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
Tonghua Dongbao Partners with Huisheng Biopharma – Secures China Rights to First Domestic Insulin Degludec Biosimilars
Tonghua Dongbao Pharmaceuticals Co., Ltd (SHA: 600867) and Huisheng Biopharmaceutical Co., Ltd. announced a Commercialization Cooperation...
Zai Lab Reports $457M Full‑Year Revenue – 16% Growth Driven by Xacduro and Nuzyra Expansion
Zai Lab (NASDAQ: ZLAB, HKG: 9688) announced Q4 and full‑year 2025 financial results, with net product revenue...
Gan & Lee’s Insulin Biosimilars Win CHMP Positive Opinion – Bysumlog and Dazparda Near EU Market Entry
Gan & Lee Pharmaceuticals (SHA: 603087) and its European subsidiary Gan & Lee Europe announced that...
Kanghong Pharma’s Orexin Antagonist KHN707 Cleared for Insomnia Trials – First-in-Class Sleep Disorder Candidate
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced receiving clinical trial approval from China’s National...