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...
Kelonia JNJ Partnership Targets In Vivo CAR-T for Multiple Myeloma
Kelonia Therapeutics announced a strategic collaboration with Johnson & Johnson (J&J, NYSE: JNJ) to develop...
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...
Wuzhong Pharma Faces Mandatory Delisting After CSRC Violations
Jiangsu Wuzhong Pharmaceutical Group Corp. (SHA: 600200) received an Administrative Penalty Decision ( No. 145) from...
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...
Rimag Partners with Qingyang Government on AI Medical Imaging Infrastructure
Jiangxi Rimag Group Co., Ltd. (HKG: 2522) announced a Strategic Framework Cooperation Agreement with the...
Biogen Dayra Partnership Targets Immunology with Macrocyclic Peptides
Biogen Inc. (NASDAQ: BIIB) and Dayra Therapeutics announced a research collaboration to discover and develop...
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...
HBM and AstraZeneca Deepen ADC/TCE Collaboration as AstraZeneca Exercises License Options
HBM Holdings Limited (HKG: 2142) announced the renewal and deepening of its global strategic collaboration...