Sciwind’s Ecnoglutide Wins NMPA Nod as First cAMP‑Biased GLP‑1 Agonist
Sciwind Biosciences Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved ecnoglutide...
Drug
Ab&b Bio-Tech’s Trivalent Influenza Vaccine Wins NMPA Nod for All Ages
Ab&b Bio-Tech Co.,Ltd. (HKG: 2627) announced that the National Medical Products Administration (NMPA) has granted...
Sanofi Rezurock Wins EU Backing for Graft‑Versus‑Host Disease
Sanofi (NASDAQ: SNY) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human...
CMS-D017 Gets NMPA Nod for PNH Clinical Trial
China Medical System Holdings (CMS; HKG: 0867) announced that the National Medical Products Administration (NMPA) has...
J&J AKEEGA Gets CHMP Nod for BRCA-Mutated Prostate Cancer
Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products for Human Use...
Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
CDE Seeks Feedback on 103rd Batch of Generic Reference Preparations
The Center for Drug Evaluation (CDE) is seeking industry feedback on the 103rd batch of...
Chiesi Fabry Drug Pegunigalsidase Alfa Wins CHMP Backing for Extended Dosing
Chiesi Group announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended...
China Medical’s Opzelura Cream Gets NMPA Approval for Vitiligo
China Medical System Holdings (CMS; HKG: 0867) announced that the National Medical Products Administration (NMPA) has...
Zhaoke Ophthalmology’s Yuvezzi Gets FDA Nod for Presbyopia
Zhaoke Ophthalmology (HKG: 6622) announced that its UK partner Tenpoint Therapeutics has received FDA clearance...
CSPC’s SYS 6055 CAR-T Gets NMPA Nod for Lymphoma Trials
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the National Medical Products Administration (NMPA) has approved...
Ascletis ASC40 Phase III Success in Acne Vulgaris
Ascletis Pharma Inc (HKG: 1672) announced positive top‑line results from the open‑label Phase III study (NCT06248008)...
TYK Medicines Asandeutertinib Gets China Priority Review for NSCLC Brain Metastases
TYK Medicines, Inc. (HKG: 2410) announced that its Category 1 drug asandeutertinib (TY‑9591), a third‑generation EGFR...
Hengrui Cancer Combo Gets NMPA Nod for Liver Cancer Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that a supplementary Biologics License Application (sBLA)...
United Labs TUL108 Gets FDA Nod for Antibiotic Resistance Trial
United Laboratories International Holdings Ltd (HKG: 3933) announced that the U.S. Food and Drug Administration (FDA)...
MicuRx MRX-5 Gets FDA Nod for Phase II NTM Lung Disease Study
MicuRx Pharmaceuticals Inc., (SHA: 688373) a Sino‑US biopharmaceutical company, announced it has received approval from...
Huiyu Pharma HYP-6589 Gets NMPA Nod for NSCLC Osimertinib Combo
Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced that the National Medical Products Administration (NMPA)...
Changchun High‑Tech’s Firsekibart Filing Accepted for Non‑Infectious Uveitis
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that the National Medical Products...
Sino Biopharm’s TQA3605 Meets Endpoint in Hepatitis B Phase II Trial
Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category 1 drug TQA3605 has met the primary...
J&J Darzalex Faspro Gets FDA Nod for NDMM D-VRd Regimen
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved...