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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

Transcenta's Anti-sclerostin Antibody TST002 Approved for Phase II Trial in China for Reduced Bone Density Patients

This study aims to evaluate the safety, tolerability, and pharmacokinetics of TST002(Blosozumab) after single and multiple intravenous administrations in p...

July 31, 2023 | News

China's Mabwell Announces NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND

B7-H3 is a member of the B7 ligand family and is overexpressed in most cancer types but expressed at a low level in normal tissues. In malignant tissues, B...

July 24, 2023 | News

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