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BioPharma Drug Approval

CJ BIO’s BiomeNrich™ POST M005 Becomes First Akkermansia muciniphila-Based Ingredient to Gain FDA NDIN Acknowledgment

CJ BIO's BiomeNrich™ POST M005 is the first Akkermansia muciniphila-based ingredient to receive New Dietary Ingredient Notification (NDIN) ...

March 28, 2025 | News

GSK’s Omjjara Receives Local Approval in Singapore for Myelofibrosis Patients with Moderate to Severe Anaemia

Approval is for use in myelofibrosis patients with moderate to severe anaemia who are JAK-naive or previously treated with ruxolitinib Nearly all myelof...

March 25, 2025 | News

SineuGene Therapeutics Receives FDA IND Clearance for First-in-Class ALS Gene Therapy SNUG01

SineuGene Therapeutics Co., Ltd. ("SineuGene"), a clinical-stage biotech company pioneering innovative therapies for neurological disorders, announce...

March 25, 2025 | News

Sungen Biomedical Secures FDA Fast Track Designation for AMI Drug Candidate SGC001

Sungen Biomedical—an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., Ltd. (SH.688068)—received Fast Track Designa...

March 25, 2025 | News

TiumBio and Hansoh Pharma Gain Clinical Trial Approval in China for Merigolix in ART-Related Controlled Ovarian Stimulation

Clinical Trial Approval of merigolix (TU2670, HS-10518) for the inhibition of premature LH (luteinizing hormone) surges in women undergoing COS (con...

March 21, 2025 | News

LISCure Biosciences Secures World’s First Regulatory Approval for Hair Health Probiotic, Mobiome®, in South Korea

LISCure Biosciences Inc. ("LISCure") announced on the 2025 Feb that it has received approval from the Korean Ministry of Food and Drug Safety (KM...

March 21, 2025 | News

Shanghai Henlius Secures FDA Orphan Drug Designation for HLX22 in Gastric Cancer

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for...

March 20, 2025 | News

Telix and R2PHARMA Secure ANVISA Approval for Illuccix®, Expanding PSMA-PET Imaging in Brazil

Telix Pharmaceuticals Limited announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or 'ANVISA') has approv...

March 19, 2025 | News

Shilpa Medicare’s Nor UDCA Approved by SEC for NAFLD Treatment

Shilpa Medicare Limited , a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved it...

March 12, 2025 | News

Ascletis’ ASC47 Shows Promise as a Long-Acting, Muscle-Preserving Obesity Treatment in Phase Ib Study

ASC47, an adipose-targeted muscle-preserving weight loss drug candidate for the treatment of obesity, demonstrated a half-life of up to 26 days and ...

March 12, 2025 | News

Japan Grants Orphan Drug Designation to Lundbeck’s Amlenetug for Multiple System Atrophy

The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetu...

March 11, 2025 | News

Sichuan Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan Secures NMPA Approval for EGFR-Mutant NSCLC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company's trophoblast cell-surface antigen 2 (TROP...

March 11, 2025 | News

Fosun Pharma’s Foritinib Secures NMPA Nod for ALK+ NSCLC with Strong CNS Control and Improved Safety

Fosun Pharma announced that the National Medical Products Administration (NMPA) has officially accepted the marketing authorization application for Foritin...

March 10, 2025 | News

GenAssist Gains FDA IND Clearance for First-in-Class Base Editing Therapy for Duchenne Muscular Dystrophy

GenAssist Ltd (GenAssist), a pioneering gene-editing biotechnology company specializing in genome medicines, is thrilled to announce that it has received&n...

March 07, 2025 | News

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