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.
A feasibility study conducted by the University of Queensland (UQ) confirmed the utility of Inoviq Ltd.’s exosome-based ovarian cancer screening test for isolating extracellular vesicle (EV) biomarkers. The Ovarian Cancer 97 study (OC97) screened data from 97 plasma samples and identified significant differences between the EV biomarker content of ovarian cancer and healthy control samples.
When a drug prevents bacteria from synthesizing their own folate, an essential compound for their survival, they take it directly from the host. This antibiotic resistance mechanism had not been detected until now because bacteria behave differently in the laboratory than they do in vivo during an infection.
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.
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.
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.
Jiangsu Bioda Life Science Co. Ltd.’s artificial blood vessel has gained class III medical devices approval from China’s NMPA, marking the first domestic artificial blood vessel to get such approval. Nantong, China-based Bioda’s vessel is used for aortic coarctation and aneurysms.
As IPOs have slowed significantly in 2022, so have the debuts of special purpose acquisition companies (SPACs) targeting the life sciences industry, primarily due to two looming threats. This time a year ago, BioWorld had tracked 60 IPOs of SPACs searching for biopharma or med-tech targets and nearly 30 SPACs that had secured acquisitions. For 2022, there are 21 SPACs currently searching, and only two of those went public this year. As for completed M&As involving SPACs, there have been 17 this year and another nine that are pending.
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.