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Singapore's Biosyngen Gets FDA Nod for BRL03 Trials in Advanced Solid Tumors

Notably, BRL03 is also the first TCR-T product developed by Biosyngen to enter clinical trials. This significant achievement is attributed to the...

September 12, 2023 | News

Gloria Biosciences' Zimberelimab Approved in China for Recurrent Cervical Cancer

Guangzhou Gloria Biosciences ("GloriaBio"), a commercial stage biopharmaceutical company focusing on the discovery, development and commercialization of bi...

September 07, 2023 | News

Menarini's ELZONRIS® (Tagraxofusp) Receives Orphan Drug Designation for BPDCN by Japanese Ministry of Health

The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-own...

August 31, 2023 | Regulatory

HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer

The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savoli...

August 29, 2023 | News

EU Commission Approves Pfizer's ABRYSVO™ for Infant and Elderly RSV Protection

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company’s bival...

August 25, 2023 | News

Akeso's Ebdarokimab NDA Accepted by China NMPA for Psoriasis

Ebdarokimab is Akeso's 6th self-developed innovative drug that has been successfully approved for marketing/NDA submitted, the first patented domestic inno...

August 25, 2023 | News

CanariaBio's MAb-AR20.5 for Pancreatic Cancer Granted FDA Orphan Drug Designation

CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, anno...

August 22, 2023 | News

Everest Medicines' Partner Calliditas Therapeutics Gets FDA Priority Review for Nefecon® in IgA Nephropathy

"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-d...

August 22, 2023 | Regulatory

Innovent's SINTBILO® Receives NMPA Approval for Treating Hypercholesterolemia

The prevalence of cardiovascular diseases is continuously increasing in China, among which atherosclerotic cardiovascular disease (ASCVD) is the leadi...

August 17, 2023 | News

FDA Grants Priority Review for Cefepime-Taniborbactam to Treat cUTI

Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's N...

August 16, 2023 | News

Ascentage Pharma Gets FDA Clearance for Global Phase III Trial of Lisaftoclax in CLL/SLL Patients

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related...

August 07, 2023 | News

US FDA Grants Orphan Drug Status to ABM-1310 for BRAF V600 Glioblastoma

Orphan Drug Designation is a significant recognition bestowed by the FDA to the drugs used in the treatment of rare diseases. This designation intends to e...

August 03, 2023 | News

Doer Biologics Initiates Phase I MAD Trial of DR10624, Receives NMPA IND Approval

The Phase I MAD study is a randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics ...

August 02, 2023 | News

NMPA and FDA Approve First-in-Human Trial for LBL-034 in Multiple Myeloma

This is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion clinical study, and plans to enroll patients with relapsed/ref...

August 01, 2023 | News

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