South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator dorzagliatin that show the drug significantly improved early phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes.
China has granted a green light for Glaxosmithkline plc’s human papillomavirus (HPV) vaccine, Cervarix, for girls ages 9 to 14. The HPV bivalent vaccine is used against types 16 and 18 in a two-dose course to prevent cervical cancer. It’s the first imported two-dose HPV vaccine for the age group to be approved in China, the company said. A three-dose schedule of Cervarix won Chinese approval in July 2016 for girls and women ages 9 to 25. To date, the two-dose regimen has been approved in about 100 global markets.
China’s National Medical Products Administration (NMPA) released a new draft amendment to its Drug Administration Law (DAL) that introduces some important changes to the regulatory framework and is aimed at codifying initiatives implemented in the current DAL, such as patent linkage and regulatory data protection.
Turning Point Therapeutics Inc. has picked up near-global rights to develop and commercialize an antibody drug conjugate (ADC) targeting Claudin18.2 from Lanova Medicines Ltd. for $25 million up front. The deal excludes greater China and South Korea.
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.