FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...
Drug
Fosun Pharma’s Luvometinib Cleared for Phase II NSCLC Combination Trial – MEK Inhibitor Plus Anlotinib Targets KRAS Mutations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced NMPA approval to initiate a Phase...
3SBio’s SSGJ-611 NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Kexing Biopharma’s GB19 Wins NMPA IND Approval – Novel BDCA2 Targeted Therapy for Lupus Enters Clinic
Kexing Biopharma (SHA: 688136) announced that China’s National Medical Products Administration (NMPA) has cleared GB19 Injection...
Lepu Biopharma’s GPC3 ADC MRG006A Wins NMPA Approval for HCC Combination Trials – First‑in‑Class Asset Advances
Lepu Biopharma Co., Ltd (HKG: 2157) announced that China’s National Medical Products Administration (NMPA) has approved...
FDA Approves AstraZeneca’s Calquence Plus Venetoclax for CLL/SLL – First All‑Oral Fixed‑Duration Regimen
AstraZeneca (AZ, NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved the...
Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label
Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
Bio-Thera’s BAT4406F BLA Accepted by NMPA – Next‑Gen Anti‑CD20 mAb for Rare Disease NMOSD
Bio-Thera Solutions Inc. (SHA: 688177) announced that China’s National Medical Products Administration (NMPA) has accepted the...
SinoMab’s First‑in‑Class IL‑25R Antibody SM17 Wins NMPA IND Approval – Novel IBD Therapy Enters Clinic
SinoMab BioScience Limited (HKG: 3681) announced that China’s National Medical Products Administration (NMPA) has approved the...
Hengrui’s ANGPTL3 Antibody SHR-1918 NDA Accepted by NMPA – Priority Review for Rare Disease HoFH
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA)...
Pharscin Pharma’s PARP7 Inhibitor HSN002066C1 Wins NMPA IND Approval – First Class 1.1 Innovative Drug Enters Clinic
Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) announced that China’s National Medical Products Administration (NMPA) has...
CanSino Biologics Wins NMPA Approval for Menhycia Age Expansion – MCV4 Now Covers Children Up to 6 Years
CanSino Biologics (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has approved a supplementary...
J&J’s RYBREVANT SC Dosing Approved by EC – Expands Subcutaneous Options Across All NSCLC Indications
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved an extension...
CSPC Pharmaceutical Wins NMPA Approval for Phase II Study of SYS6023 HER3 ADC in Metastatic Breast Cancer
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has granted...
Sichuan Biokin’s Iza‑Bren Hits PFS and OS Endpoints in Phase III TNBC Study – First Bispecific ADC to Show Dual Survival Benefit
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that its iza‑bren, a first‑in‑class EGFR×HER3 bispecific antibody‑drug...
Sino Biopharma’s Benmelstobart Secures Fourth NMPA Approval for Stage III NSCLC – Expanding PD‑L1 Franchise in China
Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart, a Category 1 innovative humanized anti‑PD‑L1 monoclonal antibody...
Mabworks’ Obexelimab β Wins NMPA Approval as First Domestic NMOSD Therapy
Beijing Mabworks Biotech Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved...
3SBio’s Amdokitug Wins NMPA Approval for Moderate-to-Severe Plaque Psoriasis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...