BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

BioPharma Drug Approval

NS Pharma Parent Nippon Shinyaku Secures Global Option Rights to Develop Elixirgen's DMD Therapy EXG-7001

NS Pharma, Inc. (NS Pharma; Headquarters, Paramus, NJ; President, Yukiteru Sugiyama) announced that its parent company, Nippon Shinyaku Co., Ltd. (Nippon S...

June 30, 2026 | News

Anivive Wins Full U.S. FDA Approval for Laverdia, First At-Home Oral Treatment for Canine Lymphoma

Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model &md...

June 30, 2026 | News

AbbVie Secures U.S. FDA Approval for SKYRIZI in Children with Plaque Psoriasis and Psoriatic Arthritis

SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or activ...

June 30, 2026 | News

CStone Partners with Arrotex to Commercialize Sugemalimab in Australia and New Zealand

Arrotex, the pharmaceutical commercialization platform of DBG, Australia's leading diversified healthcare group, will be responsible for the registration...

June 29, 2026 | News

Everest Medicines' LEROCHOL® BLA Accepted in China for Third-Generation PCSK9 Inhibitor

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

June 29, 2026 | News

AnHorn Medicines Secures FDA IND Clearance for First-in-Class CIPN Prevention Candidate

AnHorn Medicines announced that its lead neuroprotective candidate AH-008, being developed for the prevention of chemotherapy-induced peripheral neuro...

June 24, 2026 | News

Incyte Biosciences Japan Secures Japanese Approval for Minjuvi–Lenalidomide Combination in Relapsed/Refractory DLBCL

Incyte Biosciences Japan G.K. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi® (tafasitamab)...

June 23, 2026 | News

Halia Therapeutics Receives FDA Fast Track Designation for Ofirnoflast in Lower-Risk Myelodysplastic Syndromes

Designation follows Phase 2 data showing durable transfusion independence and multilineage hematological improvement; full results presented at EHA2026 Ha...

June 17, 2026 | News

Agility or Corner-Cutting? Asia's Accelerated-Approval Gamble

On 1 April 2026, Japan's Pharmaceuticals and Medical Devices Agency did something no other major medicines regulator had done before it: from that date, ev...

June 17, 2026 | Analysis

China Approves First-in-Human Trial of Antengene’s ATG-201 for Autoimmune Diseases

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, d...

June 12, 2026 | News

XtalPi Lands $400M+ AI-Driven Drug Discovery Partnership for Metabolic GPCR Target

XtalPi (2228.HK), a leading platform in artificial intelligence (AI) and robotics-driven drug discovery, announced a strategic partnership with a pro...

June 12, 2026 | News

Harbour BioMed Secures China IND Acceptance for Novel Bispecific Cancer Therapy HBM7004

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

June 12, 2026 | News

China Clears Adcentrx’s ADRX 0405 For Clinical Development In Advanced Solid Tumours

Follows initiation of Phase 1a/1b study in the U.S. Adcentrx intends to include clinical centers in China to broaden geographic repr...

June 10, 2026 | News

Everest Medicines Acquires Greater China Rights to Presbyopia Therapy LNZ100

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, a...

June 09, 2026 | News

Stay Connected