Central text name! What can shenzhen comprehensive reform pilot bring to the pharmaceutical industry?

On October 14th, the country's top leaders attended the 40th anniversary celebration of the establishment of the Shenzhen Special Economic Zone and delivered an important speech. The
speech proposed that the CPC Central Committee, after in-depth study, decided to take the 40th anniversary of the establishment of the Special Economic Zone as an opportunity to support Shenzhen to implement a pilot comprehensive reform, to give Shenzhen more autonomy in key areas and key links of reform by means of bulk licensing, a package of 27 reform initiatives and 40 first authorization matters.
, 27 reform measures have been issued in the "Shenzhen Pilot Implementation Plan for the Comprehensive Reform of the First Demonstration Zone for The Construction of Socialism with Chinese Characteristics" (2020-2025) issued by the General Office of the CPC Central Committee and the General Office of the State Council.
the implementation plan, the 17th reform measures clearly will innovate the medical service system, "support the development of international cutting-edge pharmaceutical clinical applications in Shenzhen."
"01" international frontier" Shenzhen in China's pharmaceutical city map has been occupying a seat.
as early as 2018 E drug manager statistics of the "China Pharmaceutical City Market Capitalization TOP20" list, Shenzhen with 13 companies, 248.685 billion yuan of total market value in Shanghai ranked second.
is not only the total market value, Shenzhen is not short of high-value representative companies such as Huada Gene, Meirui Medical, Xinlitai.
this is due to "openness", "technology" and "innovation" rooted in the Shenzhen gene.
, which has been leading the way, is not without worries.
the huge medical device industry, Shenzhen's advantages in the field of innovative drug research and development are not outstanding.
the first half of this year, the latest statistics of E drug managers in China's pharmaceutical city rankings, Shenzhen slipped out of the top three.
, with a market capitalisation of 450.7 billion yuan from 20 listed companies, Shenzhen is still firmly in the top tier of the pharmaceutical industry, but the number of listed companies is only half that of Shanghai, the first.
, the market value of Meirui Medical, which returned from U.S. stocks in 2019, exceeded 200 billion yuan, and a medical company such as Kaiser Medical, Libang Instruments and Pumen Technology supported more than half of the market value of Shenzhen's pharmaceutical industry.
and now with the deepening of globalization, a group of cities with the desire to develop biomedicine as one of the pillar industries began to rise.
, Shenzhen is also immune to the challenges of Changsha and Hangzhou, the "new front-line" cities in the field of pharmaceutical innovation.
to re-create new value growth points is a problem that Shenzhen, as a sharp soldier of reform, needs to think about.
" in Shenzhen to carry out international cutting-edge pharmaceutical clinical applications.
" may be one of the answers.
Hong Kong Chinese University (Shenzhen) School of Life and Health Sciences, Ye Dequan, in an interview with First Financial News, said that Shenzhen's positioning should not only aim at the "international frontier" of medical research, equipped with advanced medical facilities and treatment methods, but also pay attention to Shenzhen's localization services, multi-party combination, in order to be more conducive to the government's rational allocation of resources, so that Shenzhen in a relatively short period of time, medical teaching and medical services quality, to upgrade to the level that should be in big cities.
and Shenzhen doesn't need to touch a stone to cross the river.
02 Boao Lecheng's test water CCTV Shenzhen reform and opening up 40th anniversary of the propaganda film mentioned that in the reform and opening-up proposition, Shenzhen's big drastic for the later Hainan Special Economic Zone brought a demonstration role.
in the clinical application of cutting-edge medicine, Hainan Boao Lecheng is ahead of Shenzhen.
"International Frontier Drug Clinical Application" initiative in Shenzhen has landed in Boao LeCheng.
February 2013, the International Medical Tourism Advance Zone of Boao Lecheng, Hainan Province, was established with the approval of the State Council to pilot the development of international medical tourism-related industries such as licensed medical treatment, cancer prevention and treatment, health management, nursing rehabilitation, medical treatment and anti-aging.
As the first industrial park open to the outside world in the field of medical care in China, Boao Lecheng was established to achieve the "three synchronizations" of medical technology, equipment, medicines and international standards, among which the core policy measures are to "accelerate the import approval of medical devices and medicines in the advance area".
since then, from the State Council to Hainan Province has issued a number of documents gradually form and improve the first area of drugs and medical devices import management of the special system and new regulatory logic.
2018, the central government issued guidance in support of Hainan's comprehensive deepening of reform and opening-up on the occasion of the 30th anniversary of the Hainan Special Economic Zone. The
opinion clearly states, "We will fully implement and improve the policy of the Boao Lecheng International Medical Tourism Advance Zone, encourage the research and development and application of new medical technologies, new equipment and new drugs, and formulate a policy of facilitation to support overseas patients to the Advance Zone for diagnosis and treatment."
'' followed by the "clinically urgent need" of imported drugs and medical devices approval authority to Hainan Province, the level of approval and step reduction, giving the advance area and even the entire Hainan Province in the import of drugs and medical devices to take the lead in the use of a great advantage.
August 2019, the Provincial Government directly led the Lecheng Administration, in September the four departments jointly promulgated the "On supporting the construction of Boao LeCheng International Medical Tourism Advance Zone Implementation Program."
has a concrete implementation plan, Boao Le City accelerated the upgrade.
21 specific measures not only proposed to expand the scope of application of the special policy of clinically urgently needed imported pharmaceutical equipment, the State Drug Administration will also set up a national imported drugs and medical devices in the advance area of the audit and scoring center, accelerate the advance of drug medical device import approval.
According to public information, as of the first half of this year, the first case of imported licensed drug varieties in Boao Lecheng's advance area has exceeded 100 cases, and the number of new anti-tumor drugs and rare disease drugs available in the advance area has reached 100.
lung cancer targets the new drug Platini in Boao Le City in September 2020.
Platini is used to treat RET fusion-positive non-small cell lung cancer, less than a month from FDA approval to landing in Hainan.
implementation program also took the lead in allowing Boao Lecheng to pilot the application of real-world clinical data research, which enables Hainan to pilot the import and use of drugs and medical devices clinical data can be used as the basis for national registration and approval, greatly reducing the economic and time costs of clinical trials.
is a huge attraction for pharmaceutical companies.
2019 Shanghai Expo, Medtron, Roche, Johnson and Johnson, Pfizer and many other pharmaceutical giants are scrambling to sign a strategic cooperation agreement with Boao Lecheng.
November 2019, the glauco eye drain pipe products of the multinational pharmaceutical company Aljian collected real-world data through clinical practice in Boao Le City.
only five months later, in March 2020, glauco-eye drain pipe was approved and listed by the State Drug Administration, becoming the first real-world research results in Boao Lecheng to land in the whole country.
has Boao Lecheng's Pearl Jade in front, I believe that Shenzhen to carry out international cutting-edge drug clinical applications will be faster.
.