Drug Approval
Takeda’s HYQVIA Becomes First Facilitated Subcutaneous Immunoglobulin Approved in Japan for Immune Deficiency Disorders
HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is the First and Only Facilitated Subcutaneous Immunoglobulin (f...
December 30, 2024 | News
Alphamab Oncology Receives NMPA Approval for Phase I/II Trial of Groundbreaking Subcutaneous Co-Formulation JSKN033
Alphamab Oncology (stock code: 9966.HK) announced that a phase I/II clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co...
December 27, 2024 | News
Keymed Biosciences Secures NMPA Approval for Stapokibart to Treat Chronic Rhinosinusitis with Nasal Polyposis
Keymed Biosciences Inc. announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New D...
December 24, 2024 | News
Vertex Announces FDA Approval of ALYFTREK™: A Once-Daily CFTR Modulator for Cystic Fibrosis Patients Aged 6 and Older
ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not re...
December 23, 2024 | News
Innovent Biologics Secures NMPA Approval for DOVBLERON®, a Next-Generation Precision Therapy for ROS1-Positive NSCLC
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...
December 23, 2024 | News
CStone Pharmaceuticals Submits Clinical Trial Application in Australia for CS2009, a Tri-Specific Antibody Targeting Solid Tumors
CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therap...
December 23, 2024 | News
Sanofi Acquires Greater China Rights for Aficamten from CORXEL, Expanding HCM Treatment Reach
Cytokinetics, Incorporated announced that Sanofi will acquire exclusive rights to develop and commercialize aficamten from Corxel Pharmaceuticals (CORXEL...
December 20, 2024 | News
Hong Kong DoH Approves AGAMREE® for Duchenne Muscular Dystrophy Treatment
Department of Health (DoH) of Hong Kong approved AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older...
December 20, 2024 | News
Everest Medicines’ VELSIPITY® Prescribed in Mainland China, Pioneering New Ulcerative Colitis Treatment under Hong Kong-Macau Connect
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...
December 18, 2024 | News
Everest Medicines Announces First Prescription of VELSIPITY® for Ulcerative Colitis in Macau, Marking a Key Milestone in Asia
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...
December 13, 2024 | News
CureGene Secures NMPA Approval for Clinical Trial of Novel Antiplatelet Drug CG-0255 in China
CureGene Pharmaceutical ("CureGene"), a biotechnology company dedicated to innovative treatments for critical unmet medical needs in cardio-cerebrovascular...
December 13, 2024 | News
Skyhawk Therapeutics Gains Australian Approval to Extend SKY-0515 Huntington’s Disease Trial to 12 Weeks
Australian Human Research Ethics Committees approves SKY-0515 treatment for up to 12 weeks in the company's ongoing Phase 1 trial in patients with Hun...
December 10, 2024 | News
Innovent and HUTCHMED Secure Conditional Approval in China for TYVYT® and ELUNATE® Combo in Advanced Endometrial Cancer
Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of...
December 04, 2024 | News
Everest Medicines’ New Drug Application for VELSIPITY® (etrasimod) Accepted in Hong Kong for Ulcerative Colitis
Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeut...
December 03, 2024 | News
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