Hengrui’s HRS-4642 KRAS G12D Inhibitor Wins NMPA Nod for Phase 1b/2 Solid Tumor Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑4642, a home‑developed KRAS...
Clinical trial approval / initiation
Jiangsu Hengrui Secures NMPA Approval for Tegileridine in Mechanically Ventilated ICU Patients
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its μ‑opioid receptor (MOR)‑biased...
Akeso Secures NMPA Approval for AK152 – First Bispecific Antibody Targeting Alzheimer’s in China
Akeso Inc. (HKG: 9926) announced that its self‑developed bispecific antibody AK152 has received regulatory approval...
Zhejiang Jianfeng Group Secures NMPA Approval for JFAN‑1001/ Vinorelbine Combination in Advanced NSCLC
Zhejiang Jianfeng Group Co., Ltd. (SHA: 600668) announced that its subsidiary Jianfeng Yien Biotechnology has obtained...
Hangzhou Bio‑Sincerity Pharma‑Tech Secures NMPA Approval for BIOS2242 Oral Solution in Acute Ischemic Stroke
Hangzhou Bio‑Sincerity Pharma‑Tech Corp., Ltd. (SHE: 301096) announced that its BIOS2242 oral solution has received...
WestVac BioPharma & West China Hospital Secure NMPA Clearance for China’s First Acne Therapeutic Vaccine
WestVac BioPharma Co., Ltd. announced that the National Medical Products Administration (NMPA) has granted clinical‑trial...
Changchun GeneScience Secures NMPA Approval for GS3‑007a Dry Suspension & Green‑lights GenSci140 ADC Trials
Changchun GeneScience Pharmaceutical Co., Ltd. announced two pivotal regulatory milestones from the China National Medical...
BrightGene Secures NMPA Nod for BGM1812 Obesity Trial, FDA Grants Trial Clearance
BrightGene Bio-Medical Techonology Co., Ltd. (SHA: 688166) disclosed that China’s National Medical Products Administration (NMPA) has...
Changchun GeneScience Secures FDA Approval for GenSci143 – Bispecific ADC Targeting B7‑H3 & PSMA in Advanced Solid Tumors
Changchun GeneScience Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted...
Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N – Long‑Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis
Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that China’s National Medical Products Administration (NMPA) has...
Suzhou Zelgen Secures NMPA Trial Approval for ZG006 (Alveltamig) – First‑In‑Class Trispecific Antibody for Advanced Neuroendocrine Carcinoma
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA)...
Corxel Secures FDA IND Clearance for CX11 Phase 2 Trial in Type 2 Diabetes
Corxel Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has cleared...
Jiangsu Hengrui’s Rezvilutamide Clears NMPA Hurdle, Moves Into Phase III Prostate‑Cancer Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced today that its second‑generation androgen‑receptor inhibitor...
BCHT Receives NMPA Approval for First Adult DTaP Vaccine Covering Pertussis, Diphtheria, and Tetanus
Changchun BCHT Biotechnology Co., Ltd. (SHA: 688276) announced that its Adsorbed Acellular Pertussis (Two‑Component) Diphtheria...
Humanwell Initiates Phase 2 Trial of HW231019 Tablets for Post‑Abdominal Surgery Analgesia
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that it has begun a Phase 2 clinical...
Lepu Biopharma Secures FDA IND Clearance for CDH17‑Targeted ADC MRG007
Lepu Biopharma Co., Ltd. (HKG: 2157) announced that the U.S. Food and Drug Administration (FDA)...
Simcere Launches Phase II Trial of T‑Reg‑Selective IL‑2 Fusion (SIM0278) for Moderate‑to‑Severe Atopic Dermatitis in China
Simcere Pharmaceutical Group Ltd. (HKG: 2096) announced that the Phase II clinical study of its proprietary...
Mabwell’s 9MW3811 Gains NMPA Approval to Launch World‑First IL‑11‑Targeting Phase 2 Trial for Pathological Scarring
Mabwell Bioscience (SHA: 688062) announced that its proprietary monoclonal antibody 9MW3811 has received clearance from...
Hangzhou Bio‑Sincerity Secures NMPA Approval for BIOS‑0625 Tablet – First‑in‑Class Ulcerative Colitis Therapy
Hangzhou Bio‑Sincerity Co., Ltd. (SHE: 301096) announced today that its BIOS‑0625 tablet, a Class 1 small‑molecule...
Jiangsu Hengrui Pharmaceuticals Announces HRS‑2430 Injection Approval for Clinical Trials
China‑listed Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that its novel intravenous...