China’s provincial government for Hainan Province has two sets of medical devices going through the urgent medical device needs program, but leveraging this program for regulatory approval in China is still no small undertaking. One complication is that any real-world evidence gathered in Hainan might not suffice for nationwide regulatory approval, but patient recruitment is also difficult.
Precision oncology company Genetron Holdings Ltd. will help develop a liquid biopsy-based malignant tumor screening and early detection testing kit based on its mutation capsule technology.
LONDON – Ion Beam Applications SA (IBA) has taken a giant step into China, sealing a €100 million-plus (US$118.2 million) licensing deal with a local company to manufacture, install and maintain its proton beam cancer therapy systems.
HONG KONG – China’s Arctic Vision (Shanghai) Biotechnology Co. Ltd. has entered an exclusive deal with New York’s Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Under the deal, Arctic Vision will commercialize Eyenovia’s Micropine and Microline formulations in Greater China and South Korea in exchange for $45.75 million in upfront payments and additional milestone and royalty payments.
HONG KONG – A Chinese med-tech company plans to take to market what it claims is the first electrocardiography (ECG) diagnostic machine powered by AI, but as it moves to markets beyond China, it could face significant competition.
The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.
Diagnostic firm AnchorDx Medical Co. Ltd. is now working with the Lung Cancer Initiative at Johnson & Johnson in a four-year lung cancer study that aims to enable early detection and diagnosis of the disease in China. The study takes place at six hospitals in the country and is expected to be completed in December 2024.
The alleged activities of two Chinese hackers outlined in a federal indictment unsealed Tuesday offer “concrete examples of two concerning trends,” U.S. Assistant Attorney General John Demers said, as U.S.-China relations further soured with the news of the charges.
HONG KONG – Hong Kong’s emerging med-tech sector is getting a boost from a government-funded program aimed at sharing technology with other jurisdictions, a program driven in part by the need to contain the COVID-19 pandemic and continue opening regional economies.
Hong Kong – China’s Kangji Medical Holdings Ltd. has made a memorable debut on the Hong Kong Stock Exchange (HKEX), with shares jumping 98.84% from their opening price of HK$13.88 (US$1.79) to close at HK$27.60 (US$3.56) on the first day of trading on June 29.