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.
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.
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.
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.
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.
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.
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