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Lynk Pharma’s Zemprocitinib Sustains Strong Rheumatoid Arthritis Responses Through 76 Weeks in Phase III Trial

Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on immune and inflammatory diseases,&...

October 30, 2026 | News

Kelun-Biotech Secures China NMPA Review for Sac-TMT and Pembrolizumab Combination in First-Line Lung Cancer

This is the seventh indication application for sacituzumab tirumotecan (sac-TMT) and the second application for the ADC plus IO combination regimen o...

October 29, 2026 | News

Lynk Pharmaceuticals Reports Sustained Phase III Efficacy of Zemprocitinib in Rheumatoid Arthritis Through Week 76

Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on immune and inflammatory diseases, ...

October 29, 2026 | News

17 APAC-Made Biosimilars Approved in the US or EU in 2026

Seventeen times in 2026, the US Food and Drug Administration or the European Commission cleared a biosimilar that was developed or made in Asia-Pacific. Ni...

October 28, 2026 | Analysis

TJ Biopharma Doses First Patient in Phase I Trial of CLDN6 × 4-1BB Bispecific Antibody for Advanced Solid Tumours

TJ-C64B is an internally developed CLDN6 × 4-1BB bispecific antibody for which TJ Biopharma retains global rights, and is among the leading pro...

October 28, 2026 | News

Innovent Seeks China Approval for Sintilimab and Nolgileucel Combination in Advanced Melanoma

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

October 28, 2026 | News

Orphan Drug Incentives in 9 APAC Markets, Compared

Every January, regulatory affairs teams across Asia-Pacific rebuild the same spreadsheet. Which markets will designate this asset as an orphan? Which will ...

October 27, 2026 | Analysis

HanchorBio and Aston Sci Join Forces to Advance Dual-Action Cancer Immunotherapy Targeting Solid Tumours

Strategic collaboration pairs HCB101 (macrophage CD47-SIRPα blockade) with Aston Sci's Phase 2 HER2-directed DNA vaccine (AST-301) to drive durable...

October 27, 2026 | News

Tairex Unveils AI-Powered Agent Hospital Ecosystem to Transform Multidisciplinary Clinical Decision-Making

Tairex, an AI healthcare technology company incubated by the Institute for AI Industry Research (AIR) at Tsinghua University, unveiled the Multidisciplinar...

October 27, 2026 | News

Harbour BioMed Secures China’s NMPA Approval for Batoclimab, Expanding Treatment Options for Myasthenia Gravis

Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics i...

October 26, 2026 | News

ESTEVE CDMO Invests Over $80 Million to Expand Pharmaceutical Manufacturing Capabilities in China

After more than two decades in China, ESTEVE CDMO marks a new chapter in its commitment to the country and the region. With more than $...

October 23, 2026 | News

Akeso and Summit Advance Ivonescimab into Seventh Global Registrational Trial Targeting Biliary Tract Cancer

Akeso, Inc. announced that Summit Therapeutics Inc. (NASDAQ: SMMT), its global partner for ivonescimab, has entered into a clinical trial collaboration wit...

October 23, 2026 | News

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

Chipscreen Biosciences Secures China IND Approval for First-in-Class Cancer Immunotherapy NW001

Shenzhen Chipscreen Biosciences Co., Ltd. announced that NW001, a first-in-class epigenetic immune-modulating antibody conjugate (EIMAC) co-developed with ...

October 21, 2026 | News

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