Luye’s LY03017 Wins FDA Nod for Psychosis Trials in Alzheimer’s and Parkinson’s
Luye Pharma Group Limited (HKG: 2186) announced that its independently developed LY03017 received U.S. FDA...
Clinical trial approval / initiation
Pien Tze Huang’s PZH2108 Cancer Pain Drug Enrolls First Phase IIa Patient
Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436) announced the enrollment of the first...
Sino Biopharm’s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials
Sino Biopharmaceutical Limited (HKG: 1177) announced that its self‑developed LM‑350, a CDH17‑targeting Antibody‑Drug Conjugate (ADC),...
Hengrui’s HRS-6209 CDK4 Inhibitor Wins NMPA Nod for Breast Cancer Combo Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑6209 capsules, a novel...
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...
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)...