Beijing Microkpro Medical Instrument Co. Ltd. has received marketing approval for its artificial cornea from China’s NMPA. Miok Keratoprosthesis is the world’s first artificial cornea made of 100% non-biological materials and does not require co-implantation of donor corneas, according to Microkpro Medical.
Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
Peijia Medical Ltd. has acquired exclusive rights to Jenavalve Technology Inc.’s transcatheter aortic valve replacement (TAVR) products for the treatment of aortic regurgitation (AR) and aortic stenosis (AS). Suzhou, China-based Peijia is now able to develop, manufacture, and commercialize the TAVR products in Greater China.
In vitro diagnostic (IVD) company Virtue Diagnostics (Suzhou) Co. Ltd. has raised $100 million in a series B round to develop its clinical diagnostics and bring them to other markets. “With the latest funding, Virtue Diagnostics will hire talent, introduce technology, and expand to other markets,” said Johnson Zhang, CEO of Virtue Diagnostics.
China’s med-tech products exports declined in 2021 as manufacturing in other countries picked up, while med-tech imports to the country increased. In the first half of 2021, China’s med-tech exports amounted to $47.931 billion, a decrease of 23.1% year-on-year. But imports for the same period amounted to $24.392 billion, an increase of 25.2% year-on-year, according to med-tech data company Guangzhou Joinchain Big Data Technology Co. Ltd.
Citing recent events that highlighted the risks of investing in companies based in China or that have the majority of their operations there, the U.S. SEC’s Division of Corporation Finance is seeking more specific disclosures from those companies about the legal and operational risks of investing in their securities.
With the U.S. Securities and Exchange Commission (SEC) and Cyberspace Administration of China (CAC) imposing stricter regulatory requirements on listing companies, more Chinese companies are likely to decide to list on stock exchanges closer to home.
Even as it strives for self-reliance, India is struggling to wean itself off a reported 75% increase in med-tech imports from China. China led the contribution to India’s med-tech imports with ₹91.12 billion (US$1.2 billion) worth of goods in the 2021 fiscal year (April 2020 to March 2021), according to an analysis of data from India’s Department of Commerce by the Association of Indian Medical Device Industry (AIMED).
Venus Medtech (Hangzhou) Inc. reported it has acquired 100% equity interest and corresponding equity in Cardiovalve Ltd. for $300 million. Or Yehuda, Israel-based Cardiovalve produces the Cardiovalve system, a transcatheter interventional replacement product for mitral or tricuspid regurgitation.
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition. The technology delivers up to six times more medication to the lungs compared to jet nebulizers. It also enables consistency and drug denaturing to improve efficacy. Cansino and Aerogen did not disclose the deal’s commercial terms.
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