ImmuneOnco’s IMM0306 Wins FDA IND Clearance for SLE — World’s First CD47/CD20 Bispecific in Clinic Enters U.S.
ImmuneOnco Biopharmaceuticals (HKG: 1541) announced that its drug IMM0306 has received Investigational New Drug (IND)...
Clinical trial approval / initiation
North China Pharma Wins NMPA Clinical Trial Approval for World-First Hexavalent Norovirus Vaccine Candidate
North China Pharmaceutical Co., Ltd. (SHA: 600812) announced that its hexavalent recombinant norovirus vaccine (Hansenula...
Hengrui Pharma Wins NMPA Approval for Three Clinical Trials Led by First‑in‑Class SHR‑7012 for Cutaneous Lupus
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that three investigational drugs —...
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...
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...
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...
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...
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...
Shanghai Yizhong’s First‑in‑Class Tri‑Specific Biologic YXC‑001 Wins NMPA Clinical Trial Approval for Advanced Solid Tumors
Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that its Category 1 therapeutic biologic YXC‑001,...
Fosun Pharma Launches Phase 2 Trial of FXS7553 DPP‑1 Inhibitor for COPD in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that FXS7553 has initiated a...
Asieris Pharmaceuticals Wins FDA Clearance for APL‑2501, an Anti‑CLDN6/9 ADC in Advanced Solid Tumors
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its independently developed APL‑2501 has received...
Hengrui Pharmaceuticals Wins NMPA Clearance for Phase II Trial of HRS‑4729, a Triple‑Agonist Peptide Drug for Type 2 Diabetes
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its drug HRS‑4729 has...
Easton Pharmaceutical Doses First Patient in Phase I/II Trial of HP‑002, a Brain‑Penetrant BTK PROTAC for B‑Cell Non‑Hodgkin Lymphoma
Easton Pharmaceutical Co., Ltd. (SHA: 688513) announced that Phase I/II clinical trials are underway for...
Shanghai Ark Biopharmaceutical Wins FDA Clearance for Ziresovir Phase II Trials in Severe Pediatric RSV
Shanghai Ark Biopharmaceutical Co., Ltd. announced that the US Food and Drug Administration (FDA) has...
Chongqing Pharscin Wins China Clinical Trial Approval for ORIC‑1327 in Glaucoma and Ocular Hypertension
Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) announced that its drug candidate ORIC‑1327 has received...
Celgenyx Secures FDA IND Clearance for CG101 Off‑the‑Shelf iPSC‑Derived Cell Therapy in Acute Myeloid Leukemia – Multicenter Phase I Study to Begin
Celgenyx, Inc. announced today that CG101, its self‑developed off‑the‑shelf immune cell therapy product for the...
Ark Biopharmaceutical’s First-in-Class AFC AK0406 Wins NMPA Approval for Influenza Prevention Clinical Trials
Shanghai Ark Biopharmaceutical Co., Ltd. announced that its independently developed first-in-class long-acting antiviral drug-Fc conjugate...
Youcare Pharmaceutical’s YKYY033 siRNA Injection Wins US FDA Approval to Conduct Clinical Trials for Arterial and Venous Thrombosis
Youcare Pharmaceutical (SHA: 688658) announced that YKYY033 injection has received approval from the US Food...