On the afternoon of December 29, the 38th plenary meeting of the Standing Committee of Shanghai Municipal People’s Congress voted and adopted the provisions of Shanghai Pudong New Area on promoting the construction of Zhangjiang biomedical industry to a new high (hereinafter referred to as the provisions). There are 34 provisions in the regulations. In view of the pain points and blocking points that have affected industrial development for a long time, the existing laws and regulations are adjusted, implemented and filled in from five aspects: improving the management system, promoting reform and breakthrough, innovating service mechanism, promoting industrial integration and strengthening resource guarantee.
The reporter of the securities times learned that the highlights of the regulations focus on the following two aspects: first, the flexibility of powers at the national level, such as the multi-point entrustment of biological products in Shanghai, and the relevant management measures for the self-development and use of in vitro diagnostic reagents formulated by Shanghai; The second is to solidify and improve the administrative power and legal system at the Shanghai level, such as establishing a customs clearance facilitation mechanism for the import and export of biomedical R & D articles and special articles, promoting the supply guarantee of experimental animals and the management of animal biosafety laboratories, etc. in addition, it also involves the guarantee of a number of resource elements of industrial development.
At the press conference held by the Standing Committee of the Shanghai Municipal People’s Congress on the promulgation of laws and regulations, Liu Ping, deputy director of the Shanghai Municipal Commission of economic information technology, said that the first of the provisions is to promote reform initiatives based on the implementation of the relevant tasks of the opinions of the leading area. On the one hand, the contents directly related to the biomedical industry in the opinions of the leading zone, such as the pilot application of self-developed in vitro diagnostic reagents and the bonded maintenance of “two ends out” high-end medical equipment; On the other hand, implement the matters related to the development and extension of the biomedical industry in the opinions of the leading area, such as establishing an international vocational qualification certificate recognition system, optimizing the access standards of industrial land and increasing the supply of mixed land.
Second, based on solidifying and learning from innovative practice, promote the legalization of practice mechanism. The institutionalization and legalization of innovative practices in Pudong New Area through legislation, such as the entry and exit of special goods and the customs clearance of biomedical R & D goods, is the solidification and improvement of the “white list” system of pilot biological special goods and R & D goods in Pudong New Area. Another example is to learn from the successful practices in Boao, Hainan, Guangdong, Hong Kong and Macao Dawan District, Beijing free trade zone and other places, import drugs and machinery for licensing, and establish human genetic resources management service institutions.
Third, based on the demands and pain points of industrial development, adapt and optimize the existing regulations. Grasp the development direction of Pudong’s high-level reform and opening up, and make modifications to existing laws and regulations according to the opinions of the leading area, such as supporting diversified investors to carry out R & D and industrialization of human cells and gene technology according to the requirements of promoting first try, proposing pilot multi-point entrustment and optimizing review and approval services according to the innovative management service mode, According to the sound factor market, put forward terms such as laboratory animal guarantee, talent incentive and guarantee, strengthening financial services, industrial land support, etc.
Liu Ping revealed that the reform of promoting innovation in the field of biomedicine through the opinions of Pudong leading area will be tried first in Pudong New Area. After its application is mature, it will promote the replication and promotion of some matters to Shanghai, such as terms such as multi-point entrustment and self-development and use of in vitro diagnostic reagents, so that other regions can also enjoy the dividends of the reform.
As early as the 1990s, Shanghai planned to build a “Zhangjiang pharmaceutical Valley” leading the innovative development of biomedical industry in Zhangjiang, Pudong. In 1996, the Ministry of science and technology, the Ministry of health, the State Food and Drug Administration and the Shanghai Municipal People’s government signed a co construction agreement in the Great Hall of the people, and the Chinese Academy of sciences joined the co construction agreement that year and proposed to build a national Shanghai biomedical science and technology industrial base Zhangjiang biomedical base in Shanghai Shanghai Zhangjiang Hi-Tech Park Development Co.Ltd(600895) Technology Park, Focus on gathering and developing innovative enterprises in the field of biotechnology and modern pharmaceutical industry.
At present, Zhangjiang has more than 600 innovative enterprises in the field of biotechnology and pharmaceutical industry, including more than 300 innovative R & D center enterprises and more than 40 cro technical service companies. The only two car-t products in China were born in Zhangjiang. According to statistics, 1 / 3 of the national new drug R & D institutions gather in Zhangjiang, 1 / 3 of the national major new drug creation projects are located in Zhangjiang, and 1 / 3 of the approved class I innovative drugs come from Zhangjiang. Zhangjiang enterprises have carried out more than 50 international multi center clinical trials of innovative drugs in the world, Shanghai Junshi Biosciences Co.Ltd(688180) treprizumab injection, and yellow medicine innovative tumor drug suofetinib, and many other Zhangjiang innovative pharmaceutical enterprises have successfully “gone to sea”, and Zhangjiang has truly become an innovation highland of the global biomedical industry.
(Securities Times)
