Machinery / Industrial Parts & Tools

The first Chinese self-developed new anti-cancer drug "Zebutinib Capsule" approved for listing in the United States; "Colopavir Hydrochloride Capsules" that treat chronic hepatitis C virus infection, cure rate and safety equivalent to the international first-line program; Domestically; The first bioabsorbable stent for the treatment of intravascular stenosis in patients with primary coronary atherosclerosis; the first domestic "non-invasive blood glucose meter" product... In recent years, with the comprehensive reform of the review and approval system for drugs and medical devices With the advancement, a number of innovative drugs and medical devices with high quality and good price, definite curative effect, leading the development of the industry, and filling the relevant gaps were born in Beijing.

▍The reform of the review and approval system for drugs and medical devices has achieved remarkable results in Beijing

Recently, when reporters participated in the "14th Five-Year Plan, Safeguarding Drug Safety" organized by the State Food and Drug Administration, the reporter Zhang Dianxiang, the second-level inspector of the Beijing Municipal Food and Drug Administration, said that since the State Council’s review and approval of the reform of drugs and medical devices Since the publication of the “Opinions on the System” and other documents, 27 third-class innovative medical devices developed by enterprises in Beijing have been approved by the State Food and Drug Administration, ranking first in the country; the number of third-class innovative medical device applications, the number of innovative approval channels and approvals The number of registrations ranks among the top in the country, accounting for about 1/5, 1/5 and 1/4 of the country respectively. Thirteen second-class innovative medical devices have been approved, and some products have played an important role in the field of medical rehabilitation and epidemic prevention and control.

It is understood that from 2020 to the present, 7 innovative drugs and clear medicines including total alkaloid tablets of mulberry branch, fencycloquinium bromide nasal spray, clopavir hydrochloride capsules, and obetinib tablets independently developed and produced by enterprises in Beijing The classic recipes of Fei Paidu Granules have successively obtained marketing approvals from the National Food and Drug Administration, accounting for a quarter of the total number of domestically-made innovative drugs approved in the same period this year.

These dazzling data are the strong evidence that Beijing has made every effort to build a drug and medical device innovation center in recent years, and actively serve and guide enterprises to develop and register innovative drugs and medical device products.

▍Beijing’s "One North and One South" medical and health industry cluster highlights their respective advantages

At present, there are 223 pharmaceutical production enterprises in Beijing, 64 pharmaceutical research and development institutions, and 41 preparation rooms of medical institutions. There are 960 medical device manufacturers in Beijing, ranking fifth in the country in number and number one in municipalities directly under the Central Government. Among them, there are 291 medical device manufacturers in the third category, ranking first in number in the country, accounting for about 15% of the country. Regarding the large number of supervisory targets, Zhang Dianxiang said: "Beijing Food and Drug Administration has firmly established in its work the "two goals" of keeping the bottom line to ensure safety and chasing the top line to promote development: that is, to firmly maintain the "bottom line" of drug safety and pursue The high-quality development of the industry is the'high line'."

Industrial development has gradually become an industrial cluster. At present, Beijing has basically formed an industrial cluster of “one north and one south” for basic research and development in the north and high-end manufacturing in the south. The north (Haidian and Changping) takes advantage of the scientific research advantages of Zhongguancun Science City and Future Science City in basic medical and health research and cutting-edge technology. Form a strong support for industrial development; the southern part (Economic and Technological Development Zone, Daxing) guides the centralized layout of enterprises and projects in land planning and utilization, and enhances the advantages of high-end manufacturing. The reporter learned that this "one north and one south" industrial cluster has witnessed the development and growth of a large number of enterprises and scientific research institutions in the fields of R&D and inspection, biopharmaceuticals, modern Chinese medicine, innovative medicines, medical devices, and general health. Industry's contribution rate reaches 68%

▍Improving inspection and testing capabilities to "escort" the development of the industry

The medical and health industry needs to be supported by a powerful inspection and testing system to ensure its orderly development. The Beijing Institute of Drug Control and the Beijing Institute of Medical Device Inspection are just examples of this kind of strong support.

Yang Wenliang, director and secretary of the Beijing Institute of Drug Control, introduced: "Beijing Institute for Drug Control is not only an inspection institution, but also a scientific research institution." It has many scientific research results. Among them, the key laboratory of quality evaluation of Chinese patent medicines , Decoction pieces and the quality control of Chinese patent medicines have made outstanding contributions. In terms of Ginkgo biloba extract and its preparations, qualitatively and quantitatively describe multiple components in the fingerprints of Ginkgo biloba medicinal materials, Ginkgo biloba extract and Shuxuening injection, making quality control more accurate and reflecting the product more truthfully Quality status. In the research of Liuwei Dihuang series varieties and Banlangen granules, a complete set of scientific, economic and effective quality evaluation standard system has been formed, which can realize the comprehensive control of the quality of Chinese medicinal materials, decoction pieces and Chinese patent medicines.

Beijing Medical Device Inspection Institute is a comprehensive medical device inspection institution. It has successively established the first 10-meter electromagnetic compatibility laboratory for medical devices in China, the first laboratory with the ability to inspect biological safety cabinets, and the first medical protective product inspection. Laboratory, the first blood cell reference measurement laboratory accredited by CNAS, and a group of laboratories with international advanced level. In recent years, the Beijing Institute of Medical Device Inspection has given full play to the advantages of laboratory resources to provide technical services for the research and development of innovative medical device products, and successively support enterprises to complete implantable brain pacemakers (won the first prize of National Science and Technology Progress Award in 2018), surgery Navigation robot, aortic interventional valve, abdominal aorta stent graft, proton/heavy ion therapy device (the first imported from China and the first independently developed by China) and other scientific research projects.

▍Enterprises move forward on the road of independent innovation to improve people's livelihood, health and well-being

Household medical equipment is the "first stop" for medical equipment to protect people's health. Beijing's medical device companies benefited from policy dividends such as the registrant system and continued to innovate, solving many pain points of users' use of machinery.

In the past, my country’s medical device-related policies were based on the “bundled” model of product registration and production licenses. The listing of medical device products must be developed and produced by the company itself. At the same time, the regulatory authorities will also conduct on-site inspections of the company’s production, including plant facilities, personnel management, Legal compliance and compliance of equipment management, operation procedures, quality control and other links. In this mode, enterprises have a large investment in fixed assets, which limits the development of industrial innovation to a certain extent. Take Bobang Fangzhou Medical Technology (Beijing) Co., Ltd. as an example. The company was established in 2005 and has cooperated with Tsinghua University to complete the transformation of scientific and technological achievements in non-invasive blood glucose meter products. On September 10, 2020, Bobang Fangzhou and its entrusted manufacturing company Futaijing formally submitted the application materials to the Beijing Municipal Drug Administration, and passed the on-site inspection by the Beijing Municipal Drug Administration in October, and finally succeeded Approved, obtained the first medical device production license under the pilot work of the Beijing Medical Device Registrant System, and subsequently successfully obtained the changed registration certificate. The implementation of the medical device registrant system has effectively "unbound" the registration certificate and production license. With the help of the automated and refined production management of the entrusted production enterprise, Bobang Fangzhou helps control production costs and improve product quality, effectively reducing the cost of production. The proportion of sexual input.