BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

BioPharma Drug Approval

Australia Grants CTA For First In Human KMCAR T Cell Therapy Targeting Multiple Myeloma

Clinical Trial Approval (CTA) granted by Australia’s Therapeutic Goods Administration (TGA) for KMCAR™ T-cell, a first-in-human CAR-T cell th...

March 18, 2026 | News

Hong Kong Approves Ohtuvayre For COPD Maintenance Treatment Under 1 Plus Regulatory Pathway

Approval marks the second regulatory approval outside of the U.S. Food and Drug Administration, further expanding access to COPD patients in select Special...

March 16, 2026 | News

PRISM BioLab And Receptor.AI Partner To Build AI Guided Platform For Challenging Drug Targets

PRISM BioLab Co., Ltd. ("PRISM") and Receptor.AI Inc. announced that they have entered into a drug discovery collaboration agreement (the "Collaborat...

March 16, 2026 | News

Biophytis And LynxKite Expand AI Drug Discovery Alliance To Advance Next Generation Longevity Therapies

Biophytis and LynxKite launch new modalities beyond MASSIVE: AI-driven drug discovery for next-generation longevity therapies This partnership will...

March 16, 2026 | News

Vimgreen Pharmaceuticals Secures China IND Approval For VG081821 In NASH Clinical Development

Vimgreen Pharmaceuticals, a leading innovator in adenosine signaling modulation, announced the approval of its Investigational New Drug (IND) application f...

March 16, 2026 | News

Curatis Partners With Neupharma To Advance Corticorelin Development For Brain Tumour Related Edema In Japan

Japan is one of the world's most important pharmaceutical markets after the US and Europe. Neupharma’s team has extensive experience in developi...

March 12, 2026 | News

Ascletis Reports Positive Phase II Results For Monthly ASC30 Injection In Obesity Treatment

- ASC30 subcutaneous (SQ) depot formulation achieved statistically significant and clinically meaningful placebo-adjusted mean weight loss of ...

March 11, 2026 | News

Senhwa Biosciences And CellType Partner To Advance AI Driven Development Of CX 4945 Cancer Therapy

Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and inf...

March 05, 2026 | News

Innovent Secures China Approval For Jaypirca In Previously Treated CLL And SLL

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality m...

March 03, 2026 | News

Japan Launches Elevidys Gene Therapy For Young Children With Duchenne Muscular Dystrophy

- Japan now offers ELEVIDYS gene therapy to children with Duchenne muscular dystrophy aged 3 years to less than 8 years - Company is eligible ...

February 27, 2026 | News

Japan Approves Alpha DaRT To Expand Treatment Options In Head And Neck Cancer

Offering a New Option for Head and Neck Cancer Treatment HekaBio K.K., (Headquarters: Chuo-ku, Tokyo) announces that the innovative solid tumor tr...

February 27, 2026 | News

Sciwind Biosciences And Pfizer China Forge Strategic Commercialisation Pact For Ecnoglutide In Mainland China

Hangzhou Sciwind Biosciences Co., Ltd. announced a strategic commercialization collaboration with Pfizer China for Ecnoglutide injection (Ecnoglutide), a n...

February 25, 2026 | News

Hansa Biopharma Announces FDA Acceptance of Imlifidase Biologics License Application

Hansa Biopharma AB, ("Hansa" or "the Company"), announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. F...

February 24, 2026 | News

Telix Submits European Marketing Application For TLX101 Px To Expand Glioma PET Imaging Access

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that it has submitted a marketing authorization application (MAA) in Europe ...

February 19, 2026 | News

Stay Connected