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

Quarterly snapshots from biopharma companies with marketed products, including: Amgen. Read More

Biopharmas in Asia-Pacific raising money in public or private financings, including: Biophytis, Kaleido, Maruho, Mybiotics. Read More

Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Agenus, Astrazeneca, Atea, Bioarctic, Biophytis, Botanix, Corvus, Covaxx, Daiichi Sankyo, Dong-A, Dynavax Technologies, Eiger, Eisai, Enlivex, Eucure, Glaxosmithkline, Golden, I-Mab, Innocare, Junshi, Neurorx, Reistone, Sanofi, Sinovac, Vaxart, Veru. Read More

Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: Absci, Abzena, Aligos, Alphageneron, Angiotensin, Astella, Astrazeneca, Avid Bioservices, Beroni, Beximco, Bioaegis, BNC Korea, Bristol Myers Squibb, Curevac, Edesa, Elicio, Glaxosmithkline, Golden, Humanigen, Immunome, Moderna, Molecular Partners, Multimmune, Nanoviricides, Navigo Proteins, Novartis, Novavax, Olix, Penao, Repligen, Scancell, Serum Institute of India, Sunshine, Wuxi. 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