Johnson & Johnson’s Nipocalimab Secures EU Approval for Myasthenia Gravis
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission has granted Marketing Authorisation...
Drug
Humanwell’s HWS117 Long-Acting FSH Secures NMPA Clinical Trial Approval for Assisted Reproduction
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its Class 1 biological product HWS117 injection...
Mabwell’s 9MW1911 Cuts COPD Exacerbations by 30% in Phase 2a, FDA Accepts US Trial Application
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its ST2‑blocking monoclonal antibody 9MW1911 has...
Imugene and JW Therapeutics Partner to Evaluate onCARlytics CAR‑T Combination for Advanced Solid Tumors
Imugene Ltd (ASX: IMU) and JW Therapeutics (Shanghai) Co., LTD (HKG: 2126) announced a co‑development...
iRegene’s NouvNeu004 Wins FDA Special Exemption for MSA Cell Therapy
iRegene Therapeutics announced that the U.S. FDA granted Special Exemption status to NouvNeu004 injection, approving...
Pfizer-Astellas’ PADCEV Wins FDA Approval for Perioperative Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food...
GenSci’s GenSci142 Wins NMPA Nod for Bacterial Vaginosis Clinical Trials
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary GenSci...
Jiuzhou Pharmaceutical Wins Tentative FDA Approval for Generic Janumet XR
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (SHA: 603456) announced that its Abbreviated New Drug Application (ANDA)...
Hengrui’s Ivarmacitinib Wins NMPA Nod for Vitiligo Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that Ivarmacitinib Tablets and SHR0302...
Juventas CAR-T Wins Second China Approval for Lymphoma, Expands Hematology Franchise
Juventas Cell Therapy Ltd. announced that inaticabtagene autoleucel (CNCT 19), China’s first self‑developed CD19‑targeting CAR‑T...
Innovent’s Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor
Innovent Biologics, Inc. (HKG: 1801) announced that Picankibart Monoclonal Antibody Injection (IBI112), branded XINMEIYUE, received...
Boan Biotech’s Boyoujing Aflibercept Wins NMPA Approval for Retinal Diseases
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that its self‑developed Aflibercept Intravitreal Injection (Boyoujing)...
IASO-Bio’s Fucaso Wins Hong-Kong Approval as First China CAR-T
IASO Biotherapeutics announced that Fucaso (equecabtagene autoleucel injection), its proprietary fully human BCMA‑targeted CAR‑T cell...
BeOne’s Sotoclax Wins FDA Priority Review for Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. FDA has accepted its...
Gene Key’s iNKT Cell Therapy Wins NMPA Nod for ARDS, First Allogeneic Ready-to-Use
Beijing Gene Key Life Technology Co., Ltd. announced that its GKL‑006RTU Injection, China’s first novel...
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...
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...