Alteogen Licenses ALT‑B4 Hyaluronidase to Tesaro for $285M Subcutaneous Dostarlimab Deal
Alteogen Inc. (KOSDAQ: 196170) announced an exclusive license agreement with Tesaro, a GSK subsidiary, granting worldwide...
Drug
Shanghai Pharma’s iNKT Cell Therapy B023 Gets NMPA Nod for Advanced Solid Tumors
Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that its B023 cell...
Biokin’s Iza-bren ADC Receives NMPA Filing Acceptance for ESCC, World’s First EGFR×HER3 Bispecific
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...
Kawin Technology Withdraws Hepatitis B Filing for Peginterferon Alfacon‑2 After NMPA Feedback
Kawin Technology (SHA: 688687) announced it has voluntarily withdrawn its market filing for peginterferon alfacon‑2...
Merson’s Bemejing Wins First CNMR “Overseas Version” Drug Price Certificate
Beijing Merson Pharmaceutical Co., Ltd. announced that its Bemejing (timolol maleate gel) has obtained China’s...
Ocumension’s OT-703 DME Implant Enrolls 195 Patients in China Real-World Study
Ocumension Therapeutics (HKG: 1477) announced completion of enrollment for a real‑world study of OT-703 (fluocinonide...
AIM Vaccine’s PCV20 Gets NMPA Clinical Approval, Challenging Pfizer’s Monopoly
AIM Vaccine Co., Ltd (HKG: 6660) announced that China’s National Medical Products Administration (NMPA) has...
Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China
Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68...
D3 Bio’s KRAS Programs Advance: FDA Clears Phase I G12D Inhibitor D3S‑003 and Phase II G12C‑ERK Combo
D3 Bio announced FDA clearance for two clinical programs: a Phase I first‑in‑human study for D3S‑003,...
Aidea’s ADC205 HIV Combo Gets NMPA Nod for Clinical Trials, Targeting $2.8B Market
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that China’s National Medical Products Administration (NMPA)...
Shionogi’s Fetroja Wins China NMPA Approval for Complicated UTIs, Targets Resistant Gram‑Negative Infections
Shionogi Co., Ltd announced that China’s National Medical Products Administration (NMPA) has granted marketing approval...
Chiesi’s Raxone Begins LHON Treatment in China, First World‑Approved Therapy
Chiesi Group announced that the first patients have initiated treatment with Raxone (idebenone 150 mg) at...
Novartis’s Ianalumab Wins FDA Breakthrough Therapy Designation for Sjögren’s Disease
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...
Akeso’s Gumokimab NMPA Filing for Ankylosing Spondylitis Expands IL‑17A Franchise
Akeso Biopharma (HKG: 9926) announced that the Center for Drug Evaluation (CDE) of NMPA has...
Duality’s DB‑1317 ADC Receives IND Approval for ADAM9‑Targeted Solid Tumor Therapy
Duality Biologics (HKG: 9606) announced that its ADAM9‑targeting ADC candidate DB‑1317 has received Investigational New...
Biogen’s High‑Dose SPINRAZA Wins EU Approval for 5q SMA After Japan Nod
Biogen Inc. (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for a...
Gan & Lee’s Insulin Glargine Wins Ethiopia Approval, Challenging Sanofi’s Dominance
Gan & Lee Pharmaceuticals (SHA: 603087) announced that its insulin glargine injection and pre‑filled insulin...
Zelgen’s ZGGS18 & ZG005 Cleared by NMPA for Advanced Solid Tumor Studies
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA)...
Signet Therapeutics Completes Preclinical Study for SIGX2649, Pan‑TEAD Inhibitor for Solid Tumors
Signet Therapeutics, incubated by Xtalpi Inc. (HKG: 2228), announced completion of preclinical studies for SIGX2649,...
Vitalgen’s VGN‑R08b Gene Therapy Earns FDA Orphan Drug Designation for Gaucher Disease
Shanghai Vitalgen BioPharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has...