BEIJING – While acknowledging that China still needs to play catch up in med-tech innovation, Chinese cardiovascular experts are striving to make breakthroughs in bioabsorable stents and transcatheter heart valves with government-backed research projects underway.
“Devices such as vascular stents, drug coatings and valvuloplasty balloons are areas of focus of the country’s 13th Five-Year Plan and the government has rolled out a string of policies to support the development in these areas,” said Yunbing Wang, vice president of the Chinese Society for Biomaterials, at the 6th China Cardiovascular Healthcare Industry Investment CEO Conference in Beijing.
“There are many research projects in these areas, such as on minimally invasive aortic valve replacement, bioabsorbable stents and drug coatings,” he added.
Under the five-year plan, nine national key research and development programs are being carried out. The country vowed to seek technological breakthroughs in controlled degradation and drug release in vascular stents, anti-coagulation and anti-thrombosis in small caliber artificial blood vessels, anti-calcification in aortic valves and so forth.
Wang is leading a number of research projects in the cardiovascular space. He is best known for developing bioresorbable stent technologies for vascular restoration therapy in the industry.
Optimizing material preparation
At the National Engineering Research Center for Biomaterials located at Sichuan University, Wang and his team optimized material preparation, stent design, coating composition and surface conditions to improve healing of blood vessels after surgery.
He also developed a transcatheter aortic valve implant for heart disease treatment, which won NDA approval in China in 2017.
Wang said frontier research projects for minimally invasive aortic valve replacement are underway in China. Chinese med-tech researchers are seeking technological advancement in anti-calcification, transcatheter aortic valve replacement, mitral regurgitation technology, pre-mounted artificial heart valves and anti-microcoagulation.
Chinese researchers also have a vision for using 3D printing to customize stents and using chitosan, a sugar obtained from the hard outer skeleton of shellfish, in bioabsorbable stents.
Translating research into products
While research is in full swing in tertiary institutions, industry players are also translating the researchers’ work into a commercial product.
Venus Medtech (Hangzhou) Inc. is a forerunner in China’s transcatheter heart valve industry. Its Venusp-Valve is a transcatheter pulmonary valve system designed for percutaneous implantation via cardiac catheterization into the right ventricular outflow tract (RVOT) to treat the dysfunction of RVOT, including pulmonary valve backflow as a result of treatment for patients with congenital heart disease. It is the first transcatheter pulmonic valve developed by a Chinese company that won IND approvals in China and Europe.
In the 24-month follow-up with 55 patients who enrolled in the clinical trials in China, the all-cause mortality rate was 3.6% at 24 months and their cardiac function had significantly improved.
The company said Venusp-Valve is on its way to become the first transcatheter pulmonary valve replacement (TPVR) product approved in China. The med-tech company also expects it to be the first self-expanding TPVR product globally and the first TPVR product for patients who suffer from the dysfunction of right ventricular outflow tract after receiving transannular patching treatment globally.
“We are in the process of animal trials for Venusp-Valve in the U.S. and plan to submit a pre-submission meeting request to the FDA in late 2019,” said Zhenjun Zi, general manager of Venus, at the conference.
Venus has also passed post hearing for their IPO on the Hong Kong Stock Exchange, set to be the first pre-revenue med-tech company to list on the bourse this month.
Beijing Med-Zenith Medical Scientific Co. Ltd. is another prominent player in the space, Wang said. Its Med-Zenith PT Valve is now in clinical trials and was implanted in a patient for the first time in 2018.
More China-made valves have won and are waiting for marketing approval.
Suzhou Jiecheng Medical Technology Co. Ltd.’s J-Valve was approved in May 2017 for treating patients with aortic stenosis and aortic regurgitation. Shanghai Microport Cardioflow Medtech Co. Ltd.’s Vitaflow, a transcatheter aortic valve and delivery system, cleared NMPA in July this year. Suzhou-based Peijia Medical Co. Ltd. is also waiting approval for its heart valve product Taurus One.
Experts at the conference said Chinese players will go from copying foreign devices to upgrading them and eventually developing original innovative devices. But Jiang Feng, CEO of China Association for Medical Devices Industry, believes there are still hurdles to clear before this can happen.
Currently, China’s med-tech sector is still small and highly fragmented, with most of the players being low-end manufacturers. Out of around 17,000 players, only 11% of them are developing advanced, high-tech devices. Very little of the revenue goes into R&D as well.
“Small companies which dominate the med-tech industry cannot build up innovation capability alone. It is very unlikely for them to carry out R&D and commercialization all by themselves,” Jiang said.
The intellectual property (IP) regulatory environment is also still developing in China. More work needs to be done, he pointed out.
“While we need to ensure IP protection for players from developed countries to bring their products to China, we also need to protect our own IP when we come up with upgraded products,” he added.