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CompanyDrug

Haisco Pharmaceutical Wins NMPA Clinical Approval for Nav1.8 Inhibitor HSK51155 – Pain Drug Licensed to AbbVie in USD 700 Million Deal Advances in China

CompanyDrug

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

Policy / Regulatory

FDA Issues Discussion Paper on GenAI‑Enabled Medical Devices – Seeks Feedback on Risk Framework, Premarket Evaluation and Postmarket Monitoring by October 19

CompanyMedical Device

Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting

Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary's Resignation
Policy / Regulatory

Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary’s Resignation

CompanyDrug

Shanghai Yizhong Pharmaceutical’s YXC‑002 Wins IND Approval – Fourth‑Generation Brain‑Penetrant EGFR‑TKI for Non‑Small Cell Lung Cancer Overcomes C797S Resistance

CompanyDrug

Genrix Bio’s GR2302 Bispecific Antibody Receives NMPA IND Approval for Chronic Hepatitis B – TCR‑Mimic T‑Cell Engager Targets HBV‑Infected Hepatocytes

Company

Novo Nordisk China Launches Organizational Restructuring – Merges Diabetes and Insulin Divisions into Hospital Business Division, Creates New Emerging Channels Division

CompanyDrug

Nhwa Pharmaceutical Wins NMPA IND Approval for Two Category 1 Chemical Drugs – NH130 for Schizophrenia & Alzheimer’s Psychosis, NH302 for Acute Pain

CompanyDrug

CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China

CompanyDeals

Bio-Thera Solutions Expands Partnership with Avalon Pharma: Exclusive MENA Licensing Deal for Dupixent Biosimilar BAT2406 – Second Collaboration After BAT3306

CompanyDrug

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