Celltrion Inc. is riding high after receiving full approval for Regkirona (regdanvimab), as a treatment for COVID-19 in South Korea, seven months after the Ministry of Food and Drug Safety (MFDS) granted it conditional marketing approval in February 2021.
South Korea’s Ministry of Health and Welfare (MHW) is currently discussing the implementation of a preferential drug pricing system and plans to initiate an expert survey in 2022. The preferential drug pricing system is part of a three-prong strategy that South Korea plans to adopt to promote the growth of eight leading companies in the pharmaceutical, medical device and cosmetic industries by 2030.
The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus increasing the caregivers’ workload. The psychological impact on the patient is also increased, for example when their sleep is disturbed.
China’s Personal Information Protection Law (PIPL) will take effect on Nov. 1, 2021, making it harder for tech firms, including health care companies, to access and use consumers’ personal information. The PIPL was officially passed by the National People’s Congress on Aug. 20.
Abion Inc., which focuses on precision oncology, raised ₩38.76 billion (US$33.36 million) in its debut on the Korean Stock Exchange’s Kosdaq board on Sept. 8.
India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others.
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
Innovent Biologics Inc. has inked a $312 million licensing deal for the development and commercialization of Genfleet Therapeutics Inc.’s KRAS G12C inhibitor, GFH-925, in mainland China, Hong Kong, Macau and Taiwan. Innovent also has additional option-in rights for global development and commercialization.
For the last few years, Hong Kong has been the preferred financial hub for many Chinese health care companies to go public and raise money from global investors. “Biotechnology is today the fastest-growing IPO market segment,” said Nicolas Aguzin, CEO of HKEX, during the Hong Kong Exchanges and Clearing Ltd. (HKEX) Biotech Summit 2021.
Zhejiang Jingxin Pharmaceutical Co. Ltd. has in-licensed JBPOS-0101, a class I new drug for epilepsy, from Bio-Pharm Solutions Co. Ltd. for mainland China, Hong Kong, and Macau. The partnership could bring South Korea’s Bio-Pharm more than $40 million, including an up-front payment of $5 million, milestone payments of up to $35 million, and potential royalties on future sales.