BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

Drug Approval

Ono Pharmaceutical Wins EU Approval for Vimseltinib as First TGCT Therapy

Vimseltinib is the first and only therapy with marketing authorization for the treatment of TGCT in the European Union Ono Pharmaceutical Co., a...

September 19, 2025 | News

US, China and Australia Begin Phase 2 Trial of Atom Therapeutics’ ABP-745 for Acute Gout Flares

ABP-745 is an oral small molecule drug with potential applications, for other inflammatory conditions such as cardiovascular disease Atom T...

September 17, 2025 | News

Pfizer Advances Australian-Discovered KAT6 Inhibitor PF-07248144 into Phase 3 Trial for Advanced Breast Cancer

Australian biotechnology investment and commercialisation incubator, Oncology One Pty Ltd, is pleased to report that PF-07248144, Pfizer Inc's clinica...

September 16, 2025 | News

Akeso Doses First Patient in Global Phase II Registrational Trial of Cadonilimab Plus Lenvatinib for IO-Pretreated Advanced HCC

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II regi...

September 16, 2025 | News

Biostar Pharma Doses First Patients in Two Global Phase II/III Trials of Oral Utidelone Capsule for Gastric and Ovarian Cancers

Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biolo...

September 16, 2025 | News

BioAge Advances BGE-102 into Phase 1 Trials Triggering Milestone Payment to HitGen as DEL Technology Accelerates Drug Discovery

BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technolog...

September 16, 2025 | News

Alphamab Oncology’s NDA for KN026 Accepted by NMPA for HER2-Positive Gastric Cancer

Alphamab Oncology announced that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed ...

September 15, 2025 | News

China Grants First Approval for Tzield to Delay Onset of Type 1 Diabetes

Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight year...

September 11, 2025 | News

Takeda Wins U.S. FDA Approval to Expand VONVENDI Use in Adults and Children with Von Willebrand Disease

Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand D...

September 08, 2025 | Regulatory

Stallergenes Greer and Nuance Pharma Enter Exclusive Partnership to Develop and Commercialise Actair® in China

Stallergenes Greer, a global leader in allergy therapeutics, and Nuance Pharma, an innovation-focused biopharmaceutical company based in China, announced t...

September 05, 2025 | News

China’s Bon Natural Life Unveils Tea-Derived Compounds for Weight Management Through AI-Powered Drug Discovery

Bon Natural Life Limited , a leading bio-ingredient solution provider in the natural, health and personal care industry, announced a groundbreaking identif...

September 03, 2025 | News

Daiichi Sankyo Europe Initiates Development of Oral Triple Combination Tablets to Enhance LDL-C Management

Daiichi Sankyo Europe announced the initiation of the development of new oral triple combination tablets in Europe containing bempedoic acid, ezetimibe, an...

September 02, 2025 | News

FDA Approves Subcutaneous Leqembi Iqlik, Ushering in a New Era of Alzheimer’s Treatment

U.S. Food and Drug Administration (FDA) announced its approval of a subcutaneous formulation of Leqembi (lecanemab), branded as Leqembi Iql...

September 01, 2025 | News

China’s D3 Bio Secures FDA Breakthrough and Orphan Drug Designations for KRAS G12C Inhibitor D3S-001

Breakthrough Therapy Designation was granted for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cel...

August 29, 2025 | News

Stay Connected