In the middle of the night of April 7, the Beijing Municipal Medical Security Administration suddenly issued a “Notice on Public Consultation on the “Certain Measures to Support the High-Quality Development of Innovative Medicines by 9 Departments Including the Beijing Municipal Medical Security Administration (2024) (Draft for Comments)”. The public submission period for this consultation draft is only 3 working days. The first section of the clinical study clearly proposed reducing the overall time required to start a clinical trial to 28 weeks.
Meanwhile, Guangzhou and Zhuhai have also issued relevant policies to promote and encourage the high-quality development of the biomedical industry.
Judging from the policy orientation, a pattern has formed where Guangdong is paying money and Beijing is speeding up. Analysts believe this should not be a coincidence. At a time when US biosafety laws continue to take effect, this advantage can also play a good hedging role.
Major benefits for Beijing
In the middle of the night of April 7, the Beijing Health Insurance Administration suddenly announced significant benefits for innovative drugs. According to the announcement, according to the spirit of the State Council's approval of documents such as the “Work Plan to Support Beijing's Deepening the Expansion and Opening up of the National Service Industry Chain” and our city's “Implementation Plan on the Open Up of the Biomedical Industry Chain”, 9 departments including the Beijing Municipal Medical Security Administration have formulated “Beijing's Certain Measures to Support the High-Quality Development of Innovative Medicines (2024) (Draft for Comments)”. Comments and suggestions are welcome from all sectors of society. The public comment period is: April 7, 2024 to April 9, 2024. Due to the urgency of time, the public comment period was shortened to 3 working days.
A total of 8 parts and 32 articles were submitted for review: focusing on improving the quality and efficiency of clinical research on innovative drugs (4 sections), vigorously promoting pharmaceutical trade facilitation (3 sections), strengthening clinical application of innovative drugs (section 8), striving to expand payment channels for innovative medicines (section 3), encouraging health data to enable innovation (section 5), and strengthening investment and financing support for innovative pharmaceutical companies (section 3) and safeguard measures (section 2).
In product research and development, clinical trials, review and approval, manufacturing, distribution and trade, clinical application, etc., we support the development of innovative pharmaceuticals through policy collaboration; promote medical data to enable innovation, enrich application scenarios, support the digitization and intelligent upgrading of the healthcare industry, rely on artificial intelligence, health models, etc.; promote the collaborative development of the city's biomedical industry and insurance finance industry; improve the use of innovative pharmaceutical equipment and diversified payment systems to effectively reduce the burden of medical expenses on the masses and continuously meet the growing health needs of the masses.
It is worth noting that Beijing's policy has clearly played the role of an “acceleration package” this time. According to the document, promote the implementation of a national innovation pilot project of “reducing the review time limit for drug supplementation applications from 200 days to 60 days and reducing the time limit for drug clinical trial approval from 60 days to 30 days”; reduce the overall time required to start clinical trials to less than 28 weeks; establish a foreign exchange platform to optimize the drug export process to promote the “going global” of 5 varieties in 2024; seek support from relevant national departments, advance evaluation and optimization processes, and establish a green channel for approval of clinically urgently needed pharmaceutical devices in 2024.
The two places in Guangdong resonate at the same frequency
In addition to Beijing, Guangzhou's Huangpu District and Zhuhai also introduced similar policies at the same time.
The Guangzhou Development Zone Management Committee and the Guangzhou Huangpu District People's Government issued a notice yesterday on measures to promote high-quality development of the biomedical industry in the Guangzhou Development Zone (Huangpu District). For innovative drugs, improved new drugs, and biosimilar drugs, those that invest more than 10 million yuan in domestic clinical trial research and development expenses will be funded in stages according to their clinical research and development progress: those that have completed phase I, II, and III clinical trials will be supported up to 10 million yuan, 20 million yuan, and 30 million yuan respectively, respectively, with a maximum funding of 100 million yuan per year.
Medical institutions are encouraged to improve clinical trial capabilities for new drugs, and clinical trial institutions that meet the National Drug Clinical Trial Quality Management Specification (GCP) are given 300,000 yuan of support for each additional GCP specialty, up to 1.5 million yuan per year for each additional GCP specialty. For drugs that have obtained clinical drug approval from the National Drug Administration (NMPA), the maximum funding for each approval is 500,000 yuan.
For drugs that have obtained a drug registration certificate (different specifications are considered the same variety), a one-time subsidy of up to 10 million yuan is given for each type. For drugs already on the market that have passed the consistent evaluation of the quality and efficacy of generic drugs or are classified as reference preparations (different specifications are treated as the same variety), a subsidy of 1 million yuan will be given for each type. The maximum annual funding for a single enterprise is 20 million yuan.
The Zhuhai Municipal Bureau of Industry and Information Technology also issued “Certain Measures to Promote High-Quality Development of the Biomedical and Health Industry in Zhuhai (Consultation Draft)”. The opinion draft also strengthened financial support. Rewards are given for 1-2 types of chemicals, biological products (excluding diagnostic reagents managed according to drug management), and traditional Chinese medicines (innovative traditional Chinese medicine drugs, new drugs improved by traditional Chinese medicine) according to the results of each stage of research and development.
A one-time reward of up to 3 million yuan, 5 million yuan, and 10 million yuan will be given for completing phase I, II, and III clinical trials (completion of key clinical trials can be judged as completion of phase I, II, or III clinical trials based on actual conditions), respectively. Those who obtain a drug registration certificate and achieve sales will be rewarded up to 10 million yuan according to drug registration classification standards.
An additional 1 million yuan will be rewarded for the first registration certificate for a single type of innovative high-end formulation (including innovative dosage forms such as nanoparticles, microspheres, liposomes, controlled release, and microneedles). An additional reward of 1 million yuan will be given to those that receive breakthrough treatments and conditional approval during the development of innovative drugs. The maximum annual reward for new drug research and development for a single enterprise is no more than 20 million yuan.
As a result, the three regions formed a pattern of “Guangdong pays, Beijing accelerates” in response to the major benefits of the release of innovative drugs.
How big is the impact?
So, how big will the benefits be?
First, Beijing gave a lot of policies, and Guangdong gave quite a bit of money. Under this kind of demonstration, it is expected that various regions will introduce similar favorable policies one after another. After all, innovative drugs fall into the category of new quality productivity, which is a real benefit for the entire sector;
Second, since the US Biosafety Act was introduced in January, the domestic innovative drug sector has been severely suppressed. On April 4, Endpoints published a report that once again stirred up waves in the market. According to the original article, the list of companies covered by the US Biosecure Act (The Biosecure Act) may cover more Chinese CRO/CDMO companies. The introduction of these favorable policies can better hedge against the impact of the US Biosafety Act.
Dongwu Securities believes that Beijing took the lead in implementing innovative drug industry chain support policies, and Guangzhou simultaneously issued innovative drug support policy notices. The support attitude is basically the same as the online documents. Previously, Shanghai included biomedicine in one of the 4 trillion yuan industrial clusters. The implementation of national support documents can be expected, and the policy restrictions on the development of the innovative drug industry will be fully untied; Beijing has drafted an explanatory document to promote the collaborative development of the biomedical industry and the insurance finance industry, improve the use of innovative drug equipment and a diversified payment system. In the future, the commercialization environment for innovative drugs in China will be revitalized.
editor/tolk