BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

BioPharma Drug Approval

Vertex Gets Positive CHMP Opinion for First CRISPR Gene Therapy, CASGEVY™, for Sickle Cell Disease

- If approved by the European Commission, patients 12 years of age and older with severe sickle cell disease or transfusion-dependent beta thal...

December 15, 2023 | News

CStone's Sugemalimab Granted NMPA Approval for Esophageal Cancer

Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for use in combination with fluorouracil and platinum-based chemotherapy...

December 11, 2023 | News

FDA Prioritizes Review of PADCEV® Combo for Advanced Bladder Cancer

Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progres...

December 04, 2023 | News

Alecensa by Roche Cuts Risk in Asian ALK-Positive Lung Cancer Patients by Over 60%.

ALINA is the first and only Phase III study to show an improvement in disease-free survival in patients from Asia with early-stage resected ALK-posit...

December 04, 2023 | News

China Pharma Completes Third-Party Testing for Dry Eye Therapeutic Device

According to a disclosure by the Shanghai Public Health Clinical Center on June 6, 2023, an epidemiological survey of DED showed that approximately 34...

November 30, 2023 | News

Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

Astellas Pharma Inc. announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Appl...

November 27, 2023 | News

Valneva's Chikungunya Vaccine with Albumedix' Recombumin® Gets FDA Approval

Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in the world to be FDA approved against the viral disease, addressing an unm...

November 27, 2023 | News

Everest Medicines Gets NMPA Approval for Nefecon® in China for IgA Nephropathy

--Nefecon® is the first approved medicine with an IgAN indication in China-- --The approval marks a new era of IgAN treatment for Chinese patient...

November 27, 2023 | News

Ark Biopharmaceutical's AK0610 gets NMPA IND approval for RSV antibody

This antibody drug is bioengineered based on a neutralizing antibody originally isolated from a recovered child from respiratory syncytial virus (RSV) infe...

November 24, 2023 | News

Singapore's Ministry of Health (MOH) adds zanubrutinib to its cancer drug list for six indications

According to recent statistics, from 2017 to 2021, cancer claimed 29,500 lives in Singapore, with a total of 84,002 reported cancer cases[1]. BeiGene's Zan...

November 23, 2023 | News

BeiGene and Ensem Therapeutics Partner to Advance CDK2 Inhibitor

“We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership f...

November 23, 2023 | News

Merz Therapeutics Receives TGA Approval for XEOMIN® in Australia

This marks a significant milestone as XEOMIN® is the first approved neurotoxin for the treatment of this condition in the Australian market. Addit...

November 23, 2023 | News

Innovent and AnHeart's Taletrectinib NDA Accepted by China's NMPA

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...

November 23, 2023 | News

Ark Biopharma's AK0610 Receives NMPA IND Approval for RSV Neutralizing Antibody

It is anticipated to protect infants throughout an entire RSV season. ArkBio licensed the drug's intellectual properties from the Institute of Microb...

November 23, 2023 | News

Stay Connected