China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
AI pulled in major financings and approvals for Asia med-techs in 2024 as Asia Pacific countries played to individual strengths to maximize AI’s applications in the health care sector. While breakaway AI technologies like OpenAI’s ChatGPT reshaped and boosted many industries, AI also drove major financings for APAC med-techs weathering a wider macroeconomic downturn, with AI-based companies accounting for five out of 11 IPOs tracked on BioWorld’s med-tech IPOs list.
The Biosecure Act missed its expected ride through the U.S. Congress via the National Defense Authorization Act, but it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed “biotechnology companies of concern.”
China’s Tencent Technology Co. Ltd. has invested S30 million in Insighta Ltd., an early cancer detection company that was set up as a $200 million joint venture by Prenetics Global Ltd. and inventor Dennis Lo to revolutionize multi-cancer detection.
China’s National Medical Products Administration wrapped up a revision of its device classification procedures, providing entries into one of the world’s largest markets a mechanism for obtaining means for determining the risk of a novel device type.
Creo Medical Group plc entered into an agreement to sell a 51% stake in its European consumable business to Chinese medical device distributor, Micro-Tech Co. Ltd. for approximately €36.7 million (US$41 million) in cash on a cash free, debt free basis.
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
The U.S. FDA issued warning letters to a pair of non-clinical testing labs located in China for violations of good laboratory practices, but the fall-out may reach existing marketing authorizations.
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
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