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...
Akeso’s Manfidokimab NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Akeso, Inc. (HKG: 9926) announced that China’s National Medical Products Administration (NMPA) has formally accepted the...
Jumpcan Pharma Secures China Rights to Thederma’s TAP-1503 – First AhR Modulator for Atopic Dermatitis
Jumpcan Pharmaceutical (SHA: 600566) announced a cooperation agreement with Shanghai‑based Thederma, securing exclusive commercialization rights in...
BeOne Medicines Reports $5.3B Full‑Year Revenue – Brukinsa Drives 40% Growth, 2026 Guidance Raised
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced Q4 and full‑year 2025 financial results, with global...
FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...
WuXi XDC Licenses WuXiTecan-2 Technology to Earendil Labs – $885M Deal Powers AI‑Driven ADC Development
WuXi XDC (HKG: 2268), a leading global end‑to‑end CRDMO, announced a strategic collaboration with Earendil Labs,...