Roivant’s Lisraya Wins FDA Approval as First Targeted Therapy for Dermatomyositis
Roivant (NASDAQ: ROIV) announced that the US Food and Drug Administration (FDA) has approved Lisraya...
Drug
CSPC’s PD-1/IL-15 Bispecific SYS6090 (JMT108) Granted FDA Fast Track for MSS/pMMR Metastatic Colorectal Cancer
CSPC Pharmaceutical Group (HKG: 1093) announced that SYS6090 (JMT108), a PD‑1/IL‑15 bispecific fusion protein, has...
Huadong Medicine’s ROR1 ADC HDM2005 Granted FDA Fast Track Designation — First Domestic ROR1 ADC to Achieve the Status
Huadong Medicine (SHE: 000963) announced that its investigational drug HDM2005 has been granted Fast Track...
Micot’s First‑in‑Class TrkB Agonist MT200605 Meets Primary Endpoint in Phase 2 Acute Ischemic Stroke Trial
Shaanxi Micot Pharmaceutical Technology Co., Ltd. (HKG: 2355) announced that the Phase 2 trial of...
Astellas Doses First Patient in Phase 3 Trial of Bispecific ASP2138 for First‑Line Gastric Cancer
Astellas Pharma Inc. (TYO: 4503) announced that the first patient has been dosed in a...
FDA Approves Revolution Medicines’ Rasonque (daraxonrasib), an Oral Multi‑Selective RAS(ON) Inhibitor, for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ Rasonque (daraxonrasib) for the...
NMPA Approves Novartis’ Pluvicto Plus ARPI for PSMA‑Positive mHSPC in China, Advancing Radioligand Therapy to Earlier Prostate Cancer
Novartis (NYSE: NVS) announced that the National Medical Products Administration (NMPA) has approved the radioligand...
FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab
Johnson & Johnson (J&J, NYSE: JNJ) announced that the US FDA has approved the second...
FDA Approves BeOne’s Tevimbra Plus Zanidatamab and Chemotherapy for First‑Line HER2‑Positive Gastroesophageal Adenocarcinoma
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced that the US FDA has...
MHLW Approves Takeda’s First‑in‑Class ORZEYFUL (Oveporexton) for Narcolepsy Type 1 in Japan
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the Japanese Ministry of Health,...
EC Approves Gilead’s Trodelvy Plus Keytruda for First‑Line PD‑L1‑Positive Metastatic TNBC – 35% Reduction in Progression Risk
Gilead Sciences (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorisation for...
GSK’s Jemperli Wins FDA Priority Review for dMMR/MSI‑H Locally Advanced Rectal Cancer – PDUFA Date Set for February 2027
GlaxoSmithKline Plc (GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has...
Hengrui’s NMPA Accepts NDA for HRG2010, a Novel Levodopa/Carbidopa Combination for Parkinson’s Disease
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
Antengene Clears Australian Regulatory Hurdles for Phase I ATTRACT Study of UCB‑Licensed ATG‑201
Antengene Corporation Limited (HKG: 6996) announced that the Phase I ATTRACT study of its proprietary...
Leads Biolabs Files NDA for Opamtistomig in EP-NEC — World’s First 4-1BB Bispecific Nears Potential First Approval
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that it has submitted a New Drug...
Yipinhong Wins NMPA Clinical Trial Approval for Category 1 URAT1 Inhibitor APH03867 in Gout and Hyperuricemia
Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced that its Category 1 chemical drug APH03867 Tablets...
ImmuneOnco’s IMM0306 Wins FDA IND Clearance for SLE — World’s First CD47/CD20 Bispecific in Clinic Enters U.S.
ImmuneOnco Biopharmaceuticals (HKG: 1541) announced that its drug IMM0306 has received Investigational New Drug (IND)...
North China Pharma Wins NMPA Clinical Trial Approval for World-First Hexavalent Norovirus Vaccine Candidate
North China Pharmaceutical Co., Ltd. (SHA: 600812) announced that its hexavalent recombinant norovirus vaccine (Hansenula...
Hengrui Pharma Wins NMPA Approval for Three Clinical Trials Led by First‑in‑Class SHR‑7012 for Cutaneous Lupus
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that three investigational drugs —...
CStone’s CS5007 IND Approved by NMPA, Advancing EGFR/HER3 Bispecific ADC for EGFR‑Resistant Tumors
CStone Pharmaceuticals (HKG: 2616) announced that the Investigational New Drug (IND) application for CS5007 has...