BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

What Eight APAC Regulators Have Actually Published on AI in Drug Development

Ask a regulatory affairs lead in Tokyo, Seoul or Singapore what the rules are for using a machine learning model in a drug submission, and the honest answe...

October 22, 2026 | Analysis

PharmaEssentia Accelerates Global Expansion with US and Japan Drug Approvals and US$46 Million Manufacturing Investment

PharmaEssentia Corporation (TWSE: 6446), a Taiwan-based biopharmaceutical company, is expanding its global presence through new drug approvals, clini...

October 21, 2026 | News

How Long It Takes to Start a Clinical Trial in 8 APAC Markets, Timed

If you are building a 2027 trial budget this month, you are probably working from a spreadsheet with one row per country and a column headed "start-up". Mo...

October 19, 2026 | News

Caliway’s CBL-514 Hits Phase II Pain-Reduction Endpoint in Dercum’s Disease

Primary Endpoint Achieved in CBL-0202DD Phase 2 Trial—CBL-514 delivered statistically significant pain reduction across both FAS and PP populations...

September 23, 2026 | News

HORIEN Secures Thai FDA Class 4 Approvals for Three Regenerative Medical Devices

Market-entry initiative targets qualified Thai distributors across dental, surgical, wound-care, and regenerative medicine channels, while solidifying glob...

September 09, 2026 | News

US FDA Clears Acepodia’s ACE723 IND for Phase I Trial in Liver Cancer

FDA clearance enables initiation of a Phase 1 clinical trial and advances the first AD2C-generated candidate into clinical development Acepodia (6976: TT)...

September 07, 2026 | News

Formosa Pharmaceuticals Files European CTA for TSY-110, Potential First Kadcyla Biosimilar in Regulated Markets

TSY-110 is positioned to become the first biosimilar alternative to Roche's Kadcyla® (ado-trastuzumab emtansine) in major regulated markets. -- F...

August 31, 2026 | News

Caliway Secures FDA IND Clearance for CBL-514–Tirzepatide Phase 2 Trial, Advances SUPREME-01 Phase 3

FDA IND Clearance for CBL-0201WR—Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in...

August 27, 2026 | News

Taiwan’s Anbogen Partners University of Tokyo to Advance ABT-301 Across Solid Tumours

Anbogen Therapeutics Inc. (TPEx: 7784) ("Anbogen" or the "Company"), a clinical-stage precision oncology company, announced that it has entered into a Coll...

August 25, 2026 | News

HanchorBio Partners with Taiwan Cancer Moonshot Team to Advance Precision Immunotherapy

Collaboration connects internationally recognized cancer multi-omics research with HanchorBio's clinical-stage immuno-oncology platform to accelerate bioma...

August 11, 2026 | News

Pathos AI Secures Up to $2.2 Billion Global Licensing Deal for Alphamab's First-in-Class Bispecific ADC

Pathos AI, a clinical-stage AI and technology company advancing its own pipeline of cancer therapies, today announced a licensing agreement with Jiangsu Al...

August 06, 2026 | News

GlycoNex Doses First Patient in Phase I Trial of Novel Glycan-Targeting ADC GNX1021

GlycoNex Inc. announced that the first patient has been successfully dosed in the First-in-Human (FIH) Phase I clinical trial of GNX1021, the Company's nov...

August 04, 2026 | News

AnHorn Medicines Advances First-in-Class AH-008 into Phase I Trial for Chemotherapy-Induced Neuropathy Prevention

AnHorn Medicines announced the successful completion of the first subject first dose in the Phase I clinical trial of AH-008, a first-in-class neuroprotect...

July 27, 2026 | News

Menarini Asia-Pacific, Pharmacosmos Partner to Expand Cosela® Access Across APAC

Menarini Asia-Pacific announced an exclusive partnership with Pharmacosmos A/S to register, commercialise and distribute Cosela® (trilaciclib) acr...

July 23, 2026 | News

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