The rapid development of China's medical device industry for ten consecutive years, the market growth rate continues to reach 15% to 20%, the market size has exceeded 600 billion yuan, the second largest in the world. In 2019, it was a year of rapid update and improvement of China's medical device regulations. Looking back at the pilot expansion of the medical device registrant system, the introduction of the medical device regulatory system, the unique identification system for medical devices, and the release of AI medical device product approval points, etc., this series of regulatory changes and institutional updates will definitely bring profound benefits to the medical device industry. Impact. In addition, in the capital market, following the opening of the new channel on the Hong Kong Stock Exchange, this year, the science and technology board also opened up as scheduled, bringing more access to financing for many medical device companies.
A few days ago, at the site of DeviceChina2019 jointly organized by BioBAY and China Medical Device Industry Association, Pang Junyong, general manager of Suzhou Biomedical Industrial Park, Dr. Zhu Qingsheng, managing partner of Tonghe Yucheng, and Gong Yuyan, founder of Yinluo Medical, also visited the medical device industry. The innovation and development of "sports".
On August 30, the State Council issued the “Overall Plan for China (Shandong), (Jiangsu), (Guangxi), (Hebei), (Yunnan), (Heilongjiang) Free Trade Pilot Zone”. Among them, the implementation scope of Jiangsu Pilot Free Trade Zone is 119.97 square kilometers, covering three districts of Nanjing, Suzhou and Lianyungang. The Suzhou Industrial Park, where the Suzhou area is located, will focus on building a world-class high-tech industrial park and creating four high-end areas of openness, international innovation, high-end industries and modern governance. The program provides the biomedical industry with more innovation space for the comprehensive supervision mode of innovation trade, promoting the innovation and development of service trade, supporting the innovation and development of the manufacturing industry and promoting the development of modern service industry, so as to build biomedical integrity. The industrial chain will create a cluster of biomedical research and development industries with international influence.
Located in the Suzhou Area of Jiangsu Free Trade Zone, the Biomedical Industrial Park (BioBAY), which has been cultivated for more than ten years in the field of biomedicine, has also developed through this shareholder. Pang Junyong said that for medical devices and even the entire pharmaceutical industry, the free trade zone will bring a lot of benefits: most of the equipment, raw materials and R&D test samples of medical devices and biomedical enterprises depend on imports. The establishment of the Suzhou Free Trade Zone in Suzhou will bring about a huge breakthrough in the import of unregistered medical devices, special biological products and equipment, raw materials and reference reagents. At the same time, in terms of high-end talents and industrial talents, the Suzhou Area of the Free Trade Zone can provide more convenience in terms of residence, employment, and schooling for children to create a more livable environment for innovation and entrepreneurship. These will be the first bottleneck for the supply chain and talents for the long-term sustainable development of China's biomedical innovation and entrepreneurship enterprises.
For the unveiling of the free trade zone, Gong Yuyan is like a music to bring people to cheer. In his view, for enterprises, the free trade zone can break the monopoly of imports and the limitations of exports. In the future, it will have great convenience in introducing overseas R&D and experimental products. In February 2017, Yinlu, which specializes in the manufacture of products such as cardiac stents, received special approval for medical devices in China, and now the products have entered the clinic. Last month, the company's other intravenous stent also completed the approval of the green channel.
With the opening of the unprofitable bio-pharmaceutical market in the Hong Kong stock market, biotech issuers who have not yet made a profit or have no income can be listed on the Main Board after making additional disclosures and establishing safeguard measures. A large number of outstanding biopharmaceutical companies are seeking Hong Kong stocks to be listed. At present, BioBAY companies have witnessed the success of Cinda Biology and Cornerstone Pharmaceuticals at the Hong Kong Stock Exchange since the end of last year. In addition, there are still a number of innovative enterprises in the park ready to go, actively preparing for landing in the Hong Kong stock market.
In order to better serve the enterprises in the park, BioBAY quickly established a Hong Kong subsidiary under the Dongfeng of the Free Trade Zone. “In the context of the country's vigorous promotion of the development strategy of Guangdong, Hong Kong and Macao Dawan District, BioBAY Hong Kong subsidiaries can use international capital to quickly introduce overseas outstanding teams and innovative cutting-edge technologies to the park for conversion, and to plan for the market to go public in Hong Kong. The company will connect with better Hong Kong local resources, thereby further improving the bio-pharmaceutical industry ecosystem of Suzhou Industrial Park, forming a wider international influence, attracting more talents and capital, and forming a virtuous circle of enterprise development environment. “Pang Junyong said .
In the past year, with the friction of Sino-US trade wars, the United States has continued to impose tariffs on high-performance medical devices imported from China. China has also increased the support of domestic high-performance medical devices and introduced more medical treatment. The independent innovation policy of devices has accelerated the process of localization of medical devices.
Dr. Zhu Qingsheng, Managing Partner of Tonghe Yucheng
Dr. Zhu Qingsheng said that the trade wars of the past year have been affected more or less, especially since some domestic investment institutions want to invest in the United States, which has been significantly restricted. Of course, things are double-sided. Since capital can't go out, more capital can be invested in innovative medical projects in the country. With the continuous improvement of China's policies, there will be better development in medical innovation. He said, "We always have to serve patients and doctors, regardless of new drugs or device products. If it can prove its safety, reliability and effectiveness, the market will always be there, and capital will always chase these projects."
For companies, how to maintain innovation competitiveness? Gong Yanyan stressed that competitiveness is mainly based on strengths, and there is a principle of non-competition in business. This is also the principle that Yinlu has always adhered to. Many products still choose not to do despite the accumulation of Yinluo. Because we feel that innovation, direction is always more important than speed.
Regardless of how the external environment changes and how the market changes, companies must focus on doing valuable things. The attendees of DeviceChina2019 also pointed out that for the medical device industry, it is necessary to make products with clinical value, so as to generate market value. Further, it will also have a certain investment value. Therefore, the company still first fixes the "internal power" and concentrates on things.
Looking forward to the future of medical device innovation, the road is blue and blue, and will continue to open up. As Pang Junyong said, the medical device industry is exciting.