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BioPharma Drug Approval

Bristol Myers Squibb’s Opdivo Plus Yervoy Wins FDA Nod as First-Line Treatment for Advanced Liver Cancer

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® ...

April 14, 2025 | News

Halozyme and argenx Secure FDA Nod for VYVGART® Hytrulo Prefilled Syringe for Self-Injection

Halozyme Therapeutics, Inc. announced that argenx has received U.S. Food and Drug Administration (FDA) approval of VYVGART® Hytrulo prefilled syri...

April 11, 2025 | News

Belief BioMed and Takeda China Announce NMPA Approval of China’s First Gene Therapy for Hemophilia B

Belief BioMed ("BBM") and Takeda China jointly announced that BBM-H901 (generic name: Dalnacogene Ponparvovec Injection), has be...

April 11, 2025 | News

Nona Biosciences Partners with Atossa Therapeutics to Advance Next-Generation Antibody Therapies for Breast Cancer

Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), ranging from target validation and antibody ...

April 11, 2025 | News

Senhwa’s CX-4945 Shows Promising Disease Control and Durability in Refractory Basal Cell Carcinoma

Basal Cell Carcinoma CSR Highlights CX-4945 Monotherapy: Progression-free survival (PFS) exceeded 21 months in two patients. Optimal Treatment Res...

April 03, 2025 | News

Yingli Pharma Receives FDA Clearance to Launch Global Phase 3 Trial of Linperlisib for Relapsed/Refractory PTCL

Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic...

April 02, 2025 | News

Ascletis’ ASC30 SQ Injection Shows 36-Day Half-Life in Phase Ib Obesity Trial

-Ultra-long-acting subcutaneous (SQ) injection formulation of small molecule ASC30 demonstrated a 36-day half-life in patients with obesity, supp...

April 01, 2025 | News

Luye Pharma’s Twice-Weekly Rivastigmine Patch Approved in Japan for Alzheimer’s

Luye Pharma Group announced that marketing approval for its innovative formulation Rivastigmine Twice Weekly Transdermal Patch has been granted by the Japa...

April 01, 2025 | News

IASO Bio Secures First Approval Outside Mainland China for Equecabtagene Autoleucel in Macau

IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative ce...

March 31, 2025 | News

Langhua Pharmaceutical Receives FDA EIR Following Successful cGMP Inspection for the Fourth Time

Zhejiang Langhua Pharmaceutical Co., Ltd. ("Langhua Pharmaceutical"), a wholly-owned subsidiary of Viva Biotech Holdings ("Viva Biotech"), underwent a cGMP...

March 31, 2025 | News

ZEISS and DORC Secure NMPA Approval in China for ILM-Blue®, Advancing Retinal Surgery Standards

ZEISS Medical Technology announced today that the ILM staining dye ILM-Blue® from DORC (Dutch Ophthalmic Research Center (International) B.V...

March 28, 2025 | News

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

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