Chinese authorities this year for the first time allowed access for complete U.S. Public Company Accounting Oversight Board (PCAOB) audit inspections and investigations of PCAOB-registered public accounting firms headquartered in China and Hong Kong, in accordance with U.S. securities law.
3D Medicines Inc. has raised HK$408 million (US$52.5 million) in a listing on the Hong Kong Stock Exchange. Its shares opened at HK$29 apiece, jumped by more than 20% by the middle of the day, and closed at HK$31.45 on the first trading day of Dec. 15.
Shanghai Microport Endovascular Medtech Co. Ltd.’s Hercules balloon dilation catheter has been approved for marketing approval in China to be used in endovascular aneurysm repair (EVAR) procedures.
Full-Life Technologies Ltd. reported that it will acquire Focus-X Therapeutics Inc. to expand its radiopharmaceutical oncology therapy pipeline in a deal worth up to $245 million.
Wangli Technology, a subsidiary of Adai Technology (Beijing) Co. Ltd., has raised ¥100 million (US$14 million) to continue developing digital therapeutics aimed at mental health indications.
Lepu Medical Technology (Beijing) Co. Ltd. has been given the green light from China’s NMPA for its disposable micro-guidewire. Beijing, China-based Lepu Medical confirmed to BioWorld that this micro-guidewire was approved for fractional flow reserve (FFR) measurements in adult patients with coronary artery lesions during coronary angiography and interventional procedures.
Full-Life Technologies Ltd. reported that it will acquire Focus-X Therapeutics Inc. to expand its radiopharmaceutical oncology therapy pipeline in a deal worth up to $245 million.
Both the Hong Kong Stock Market and the Shanghai STAR Market have seen med-tech companies, namely Orbusneich Medical Group Holdings Ltd. and Shanghai Genext Medical Technology Co. Ltd., making a rush to be listed by the end of 2022.
Microport Neurotech Ltd.’s intracranial visualized stent Rebridge has been included in the green channel, a priority review for medical devices, by China’s NMPA.
As China seeks to be more independent in medical device development, authorities have released several guidelines to enhance the quality of its medical devices, as well as accelerate their registration.