BioPharma Drug Approval

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 26, 2026 | Analysis

Menarini and Georgiamune Strike $1.1 Billion Licensing Deal to Advance Next-Generation Cancer Immunotherapy

GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. Georgiamune to...

 October 26, 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

Geneos Launches Global Phase 2 Trial of Personalised Cancer Vaccine to Prevent Liver Cancer Recurrence

Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of neoantigen-based personalized immunotherapy for cancer (PIC), a...

 October 23, 2026 | News

Patronus Biotech Secures Australian Approval for First-in-Human Trial of Next-Generation Malaria Vaccines

Bellberry Limited Research Ethics Committee approves first-in-human study in Australia of Patronus Biotech's novel multi-stage virus-like-particle (VLP)-ba...

 October 22, 2026 | News

Metabolon Launches AI-Enabled Splash & Ripple to Accelerate Metabolomics-Driven Drug Discovery

New bioinformatics application combines curated metabolite-protein knowledge, advanced network algorithms, interactive exploration, and optional AI interpr...

 October 22, 2026 | News

Ascletis Reports Promising Preclinical Data for Once-Weekly Oral Obesity Treatments, Advances US Phase 1 Trial

  Ascletis' industry-leading once-weekly oral peptide pipeline covers all four validated targets, with multiple first-in-class fixed-dose combina...

 October 21, 2026 | News

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

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

Takeda’s First-in-Class Narcolepsy Drug ORZEYFUL Enters Japan and China Markets Following Regulatory Approvals

ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (...

 October 16, 2026 | News

Shanghai Ark Biopharmaceutical Secures US FDA IND Clearance for Phase II Trial of Long-Acting Influenza Prevention Drug AK0406

Shanghai Ark Biopharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK...

 October 14, 2026 | News

Asieris Pharmaceuticals and Theramex Sign Over $250 Million Licensing Deal for Cervical Precancer Therapy CEVIRA

Agreement is expected to grant Theramex exclusive rights to CEVIRA® in Europe, Australia, New Zealand and Turkey, while Asieris retains rights for th...

 October 13, 2026 | News

Semaglutide Generics, Six Months In: Every Launch in India, Every Price, and Where China Stands

AT A GLANCE 12 generic makers with a public launch in India, selling 20 brands between them Rs 1,290 lowest stated monthly price, for vials...

 October 09, 2026 | Analysis

FDA Expands Lilly’s Jaypirca Approval to First-Line CLL/SLL Treatment

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Jaypirca (pirto...

 October 06, 2026 | News


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