Shanghai Microport Medbot (Group) Co. Ltd. plans to list on the Shanghai Stock Exchange on the Sci-Tech Board to raise ¥2.8 billion (US$420 million) to progress its surgical robots. The funds raised from the IPO would go toward research and development of the surgical robots, manufacturing, marketing and academic promotion, as well as replenishing working capital. The company also plans shareholder dividend distribution plans within three years following the IPO listing.
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.
Australia’s Therapeutic Goods Administration (TGA) has made a range of changes to its medical device regulations in recent years that have largely been driven by the need to keep pace with changing technologies, TGA head John Skerritt said during the Ausmedtech 2022 annual conference in Melbourne, Australia.
Otsuka Pharmaceutical Co. Ltd. and Ai-Brainscience Inc. signed an exclusive sales agreement for Japan that will see Otsuka market Ai-Brainscience’s eye-tracking application to test for cognitive function. The eye-tracking app, AiBS-01, could become the first dementia diagnosis application to receive regulatory approval in Japan. Ibaraki, Japan-based Ai-Brainscience (AiBS) is developing devices that use the eye-tracking based cognitive assessment test to detect early dementia beyond the conventional assessment methods performed by specialists.
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.
Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020.
After listing on the Nasdaq market on May 18, Hong Kong-based diagnostics and genetic testing company Prenetics Group Ltd. saw its shares fall nearly 30% in early trading, dropping from $8.40 per share on listing to $5.70 by the end of trading May 19. Trading under the ticker PRE, Prenetics formed a merger with Artisan Acquisition Corp., a special purpose acquisition company, which was founded by entrepreneur Adrian Cheng. The transaction values Prenetics at an enterprise value of $1.25 billion, making the company the first Hong Kong unicorn to list on the Nasdaq.
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.