CStone’s CS5007 IND Approved by NMPA, Advancing EGFR/HER3 Bispecific ADC for EGFR‑Resistant Tumors
CStone Pharmaceuticals (HKG: 2616) announced that the Investigational New Drug (IND) application for CS5007 has...
LongBio Pharma’s LP‑003 BLA Accepted by NMPA for Seasonal Allergic Rhinitis, Advancing Novel Anti‑IgE Antibody Toward China Approval
LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that China’s National Medical Products Administration (NMPA)...
China NHC Mandates Priority Use of Essential Medicines as 2026 National List Takes Effect
China’s National Health Commission (NHC), together with the National Administration of Traditional Chinese Medicine and...
Boehringer Ingelheim Upgrades China Strategy with New Shanghai R&D Center, Deepening Investment in Pharma and Animal Health
Boehringer Ingelheim announced an upgrade to its strategic footprint in China, committing to increased investment...
Ultomiris Wins NMPA Approval for PNH in China, Bringing Long‑Acting Ravulizumab C5 Inhibitor to Adult and Pediatric Patients
Ultomiris (ravulizumab injection), a long‑acting C5 complement inhibitor under AstraZeneca’s (NYSE: AZN) Rare Disease business,...
Pharmaron Posts 17.9% First‑Half Revenue Growth as CRO Demand Rebounds; CDMO and All Core Segments Expand
Pharmaron Beijing Co., Ltd. (HKG: 3759), a leading integrated CRO and CDMO service provider, announced...
Genentech Pledges USD 750 Million for Oregon Device Fill‑Finish Plant, Expanding Roche’s U.S. Manufacturing Footprint
Genentech, a wholly owned subsidiary of Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY), announced plans...
Hengrui Wins NMPA Approval for HRS‑5965 – Complement Factor B Inhibitor for Complement Inhibitor‑Naive PNH Patients
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
Simcere Secures Greater China Rights to Reyoung Bio’s Long‑Acting RSV Antibody RB0026 Under Priority Review
Simcere Pharmaceutical Group Limited (HKG: 2096) announced a strategic collaboration with Reyoung (Suzhou) Biology Science...
China’s CDE Opens Public Comment on “Pioneer Program” for Cell and Gene Therapy Products, Capping Intake at 15 Drugs Per Year
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released work...
CARsgen 1H 2026: Satricabtagene Autoleucel Wins NMPA Approval as World’s First CAR‑T for Solid Tumors; Cash Runway Seen Into 2030
CARsgen Therapeutics (HKG: 2171) reported interim results for the first half of 2026, highlighted by...
Abbisko Wins NMPA IND Clearance for Pan‑KRAS Inhibitor ABSK211 in Advanced Solid Tumors, Following FDA Green Light
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that China’s National Medical Products Administration (NMPA) has...
VectorBuilder and Lir Therapeutics Forge AI Collaboration to Optimize AAV Capsids for Clinical Translation
VectorBuilder and Lir Therapeutics announced a strategic collaboration to integrate their respective technological strengths in...
Ascentage Pharma 1H 2026: Revenue Jumps 29% to RMB 302 Million as Olverembatinib and Lisaftoclax Power Commercial Growth
Ascentage Pharma Group International (NASDAQ: AAPG; HKG: 6855) reported first‑half 2026 revenue of RMB 302...
Jiangsu Hengrui 1H 2026: Innovative Drug Sales Jump 16.4% to RMB 8.8 Billion, Offset Generic Drag as R&D Spending Climbs 19%
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) reported first‑half 2026 results showing total...
LEO Pharma to Acquire Global Rights to Dersimelagon From Tanabe – Late‑Stage Oral Therapy for Rare Protoporphyrias Nears FDA Decision
LEO Pharma A/S announced that it has entered into an agreement with Tanabe Pharmaceutical to...
Haisco Pharmaceutical Wins NMPA Clinical Approval for Nav1.8 Inhibitor HSK51155 – Pain Drug Licensed to AbbVie in USD 700 Million Deal Advances in China
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving clinical approval for its pain...
Lepu Medical’s siRNA Drug MWN117 Wins NMPA Clinical Trial Approval for Overweight and Obesity – INHBE‑Targeting Therapy Shows Synergy Potential with GLP‑1 Agonists
Lepu Medical (SHE: 300003) announced that MWN117 injection has received approval from China’s National Medical...
FDA Issues Discussion Paper on GenAI‑Enabled Medical Devices – Seeks Feedback on Risk Framework, Premarket Evaluation and Postmarket Monitoring by October 19
The U.S. Food and Drug Administration (FDA) issued a discussion paper on considerations for the...
Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting
Johnson & Johnson (J&J, NYSE: JNJ) announced U.S. 510(k) regulatory clearance for MONARCH QUEST 3,...