South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Novavax Inc.’s Nuvaxovid, making it the first protein-based COVID-19 vaccine to be approved for commercial use in the country. The regulatory win for Novavax adds to emergency use authorizations (EUA) for the product, also known as NVX-CoV2373, in India, Indonesia and the Philippines, as well as an emergency use listing from the World Health Organization. On Jan. 12, the company said it expects to submit an EUA request to the FDA after one month.
Targeting the toxic alpha-synuclein protein found in the brains of people with Parkinson’s is one of the most promising approaches to treat the disease in the clinic – but getting any drug into the brain is a challenge. Sanofi SA has joined with ABL Bio Inc. to solve this problem, in-licensing ABL-301, a preclinical bispecific antibody that locks on to misfolded alpha-synuclein but also includes a molecular “shuttle” that allows it to penetrate the blood-brain barrier.
Cellusion Inc. recently closed a ¥1.1 billion ($9.5 million) financing, bringing its total 2021 fundraising to ¥1.7 billion. The company is preparing to enter the clinic with CL-S001, its corneal endothelial substitute cell candidate for treating corneal edema due to endothelial dysfunction, or bullous keratopathy.
Shanghai-based Everest Medicines Ltd. has won exclusive global rights to a set of viral 3C-like (3CL) protease inhibitors from Singapore's national drug discovery platform, the Experimental Drug Development Centre (EDDC), in a deal worth up to $214.5 million.
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Accuredit, Adagio, Bharat Biotech International, Bold, Curateq Biologics, Glaxosmithkline, Iaso, Immune Biosolutions, Innovent, Insilico Medicine Hong Kong, N1 Life, Neocura Bio Medical Technology, Neurorx, Ocugen, Orion, Phoremost, Relief, Revelation, Sana, Shanghai Fosun, Vir.
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