HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld. Read More
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol (CBD), eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy. Read More
Chinese cancer and autoimmune specialist Innocare Pharma Ltd. raised HK$3.04 billion ($392 million) in private placements with two Hillhouse Capital subsidiaries and Vivo Opportunity Fund to advance its pipeline, especially its core asset, the BTK inhibitor orelabrutinib. Read More
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration (NMPA), two days after filing for conditional market authorization. Read More
CAJICA, Colombia – China’s Anticancer Bioscience, a company focused on developing precision oncology medicines, has raised ¥66 million (US$10.2 million) to expand its small-molecule and natural product screening libraries and move two programs into IND-enabling studies. Read More
HONG KONG – Xuanzhu Biopharmaceutical Co. Ltd., a subsidiary of Beijing-based Sihuan Pharmaceutical Holdings Group Ltd., has acquired antibody technology firm Beijing Combio Pharmaceutical for an undisclosed amount. Read More
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. And after 40 years, they look to be getting a targeted therapy, or even two. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Actinogen Medical, Anpac Bio-Medical Science, Astellas, Astrazeneca, Celltrion, Eli Lilly, Innocare, Innovent Biologics, Johnson & Johnson, Novavax, Russian Direct Investment Fund, Sinovac. Read More
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: EMA, Therapeutic Goods Administration, U.S. Department of Justice, U.S. Patent and Trademark Office. Read More