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,...
Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary’s Resignation
U.S. President Donald Trump has chosen White House policy advisor Heidi Overton to lead the...
Shanghai Yizhong Pharmaceutical’s YXC‑002 Wins IND Approval – Fourth‑Generation Brain‑Penetrant EGFR‑TKI for Non‑Small Cell Lung Cancer Overcomes C797S Resistance
Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that the Investigational New Drug (IND) application...
Genrix Bio’s GR2302 Bispecific Antibody Receives NMPA IND Approval for Chronic Hepatitis B – TCR‑Mimic T‑Cell Engager Targets HBV‑Infected Hepatocytes
Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced that its investigational product GR2302 (subcutaneous...
Novo Nordisk China Launches Organizational Restructuring – Merges Diabetes and Insulin Divisions into Hospital Business Division, Creates New Emerging Channels Division
Novo Nordisk A/S China (NYSE: NVO) announced the initiation of an organizational restructuring of its...
Nhwa Pharmaceutical Wins NMPA IND Approval for Two Category 1 Chemical Drugs – NH130 for Schizophrenia & Alzheimer’s Psychosis, NH302 for Acute Pain
Nhwa Pharmaceutical Co., Ltd. (SHE: 002262) announced that its two Category 1 chemical drugs, NH130...
CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
Bio-Thera Solutions Expands Partnership with Avalon Pharma: Exclusive MENA Licensing Deal for Dupixent Biosimilar BAT2406 – Second Collaboration After BAT3306
Bio-Thera Solutions, Ltd. (SHA: 688177) and Saudi Arabia‑headquartered Avalon Pharma announced the expansion of their...
Betta Pharmaceuticals Partner EyePoint Reports EYP‑1901 Misses Primary Endpoint in First Pivotal Phase III LUGANO Trial for Wet AMD – DURAVYU Fails Non‑Inferiority vs. Aflibercept
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that its partner EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT)...
OmniAb Signs Global Collaboration and License Agreement with Eli Lilly for Ion Channel Program – Up to $370 Million in Milestones Plus Royalties
OmniAb, Inc. (NASDAQ: OABI) announced a global collaboration and license agreement with Eli Lilly (NYSE:...