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...
Drug
LongBio Pharma’s LP‑003 BLA Accepted by NMPA for Seasonal Allergic Rhinitis, Advancing Novel Anti‑IgE Antibody Toward China Approval
LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that China’s National Medical Products Administration (NMPA)...
Ultomiris Wins NMPA Approval for PNH in China, Bringing Long‑Acting Ravulizumab C5 Inhibitor to Adult and Pediatric Patients
Ultomiris (ravulizumab injection), a long‑acting C5 complement inhibitor under AstraZeneca’s (NYSE: AZN) Rare Disease business,...
Hengrui Wins NMPA Approval for HRS‑5965 – Complement Factor B Inhibitor for Complement Inhibitor‑Naive PNH Patients
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
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...
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...
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)...
European Commission Revokes EU Marketing Authorisation for CSL and VFMCRP’s TAVNEOS – Avacopan Withdrawn Across EU and EEA Markets
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced that the European Commission (EC)...
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,...
CANbridge Pharmaceuticals’ Livmarli Granted NHIA Reimbursement Approval in Taiwan – IBAT Inhibitor Coverage for ALGS and PFIC Takes Effect September 1
CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that its rare disease drug Livmarli (Maralixibat Chloride Oral...
AstraZeneca Launches Tezspire in China, Bringing First‑In‑Class TSLP Inhibitor Tezepelumab to Severe Asthma and CRSwNP Patients
AstraZeneca plc (NYSE: AZN) announced the official market launch in China of Tezspire (generic name:...
Guangdong Regulator Issues Recall, Traceability and Emergency Response Rules for Imported Hong Kong–Macao Pharmaceuticals and Medical Devices in GBA
The Guangdong Medical Products Administration issued three landmark policy documents governing imported Hong Kong and...
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...