SciClone’s Meropenem-Vaborbactam Wins GBA Approval as First Antibiotic Under Medical Connect
SciClone Pharmaceuticals Inc. announced that Meropenem/Vaborbactam for Injection has been approved under the “Hong Kong-Macau...
Drug
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...
Hengrui’s Three Oncology Assets Win NMPA Clinical Trial Approval
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that three of its investigational...
Humanwell’s Lisdexamfetamine NDA Accepted by NMPA for ADHD, First Generic Potential
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration (NMPA)...
Innovent’s mazdutide 9mg Obesity Application Accepted by NMPA
Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has accepted...
Fosun’s Luvometinib Gets NMPA Priority Review for Pediatric LCH
Fosun Pharma (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration (NMPA) has...
Otsuka’s VOYXACT Wins FDA Accelerated Approval for IgAN, First APRIL Blocker
Otsuka Pharmaceutical (OTCMKTS: OTSKY) announced that VOYXACT (sibeprenlimab‑szsi) received U.S. FDA Accelerated Approval for reducing...
Novartis’s Itvisma Wins FDA Approval as First Gene Therapy for SMA
Novartis AG (NYSE: NVS) announced that Itvisma (onasemnogene abeparvovec‑brve) received U.S. FDA approval for children...
Novo’s Kyinsu Wins EU Approval for Type 2 Diabetes, a Once-Weekly Combo First
Novo Nordisk A/S (NYSE: NVO) announced that the European Commission (EC) has granted marketing authorization...
Novo Nordisk’s Semaglutite Alzheimer’s Failure Sends Stock to 4-Year Low
Novo Nordisk A/S (NYSE: NVO) announced that semaglutide failed to slow disease progression in two...
Zelgen’s ZG006 Wins BTD for Neuroendocrine Carcinoma as First DLL3 Trispecific
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that ZG006, the world’s first trispecific antibody...
Hengrui’s Ivarmacitinib NDA Accepted for Non‑Radiographic Axial Spondyloarthritis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical...
AstraZeneca’s Durvalumab Wins China Approval for Stage III NSCLC After Sequential Chemoradiotherapy
AstraZeneca (AZ, NASDAQ: AZN) announced that Imfinzi (durvalumab) received National Medical Products Administration (NMPA) approval...
Qihan-Biotech’s QT-019B Universal CAR-T Wins Implied NMPA Approval
Hangzhou Qihan Biotech Co., Ltd. announced that its New Drug Clinical Trial (IND) application for...
Junshi’s JS001sc Subcutaneous PD-1 Meets Phase 3 Endpoint in NSCLC
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that its Phase 3 trial JS001sc-002-III-NSCLC...
CStone’s Sugemalimab Wins EU Approval for Stage III NSCLC, Expanding European Indication
CStone Pharmaceuticals (HKG: 2616) announced that the European Commission (EC) has approved a new indication...
Salubris’ SAL0139 Wins NMPA Nod for Hyperlipidemia Clinical Trial
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that its independently developed innovative small molecule...
Zhongsheng’s Onradivir Granules Enroll First Phase 3 Pediatric Influenza Patient
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced the enrollment and dosing of the first...
Kelun-Biotech’s Sac-TMT Achieves First ADC-IO NSCLC Success
Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that sacituzumab tirumotecan (sac-TMT), its proprietary TROP2 ADC,...
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...