“Science and Technology Innovation Board Daily”, April 8 (Reporter Zheng Bingxun) Recently, many places, including Beijing, Guangzhou, and Zhuhai, have successively issued relevant policies (draft for comments) to support the high-quality development of the biomedical industry or innovative pharmaceutical devices. The intensive introduction of support policies and the tight schedule have attracted great attention from the industry.

The “Science and Technology Innovation Board Daily” reporter found that compared to the “full chain supports innovative drugs” rumor that was widely circulated on the Internet last month but was not officially confirmed, the current Beijing, Guangzhou, and Zhuhai documents all set out detailed implementation rules and clarified the corresponding responsible units, but in terms of specific implementation, each region has its own priorities.

In response, some companies told the “Science and Technology Innovation Board Daily” reporter that it is particularly important to encourage innovative drugs with real clinical value to enter the market as soon as possible and receive commercial returns to support innovation. However, some companies said they still need to look forward to a more clear implementation path.

▌Full chain support: different focuses from R&D to payment

Among them, the Beijing side's support policy was issued by the Beijing Municipal Health Insurance Administration. The full name is “Beijing's Certain Measures to Support the High-Quality Development of Innovative Medicines (2024) (Draft for Comments)”. Its highlights are efforts from both the R&D side and the payment side, pointing out that it is necessary to speed up approval speed in research and development, loosen restrictions on innovative drugs in terms of payment, and encourage diversified payments.

Specifically, on the R&D side, this includes but is not limited to supporting the reduction of overall clinical trial initiation time to less than 28 weeks, and supporting key enterprises to achieve simultaneous global clinical trials; promoting the implementation of the national innovation pilot “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”; increasing the total number of varieties included in project management to 200 by the end of 2024; and in terms of going overseas, promoting 5 varieties to “go global” in 2024.

On the payment side, key measures include lifting restrictions on the quantity of drugs in medical institutions, holding pharmaceutical meetings within one month after the publication of the Guozhang Drug Catalogue, and holding pharmaceutical meetings no less than 4 times throughout the year, incorporating Guozhan drugs used in outpatient treatment of special diseases under basic medical insurance, increasing the reimbursement ratio, including Guozhan drugs with higher treatment costs in fixed proportion payments, and not including the DRG patient group's payment standards, separate payments, etc.

In contrast, the relevant policies issued by the Science and Technology Innovation Bureau of the Guangzhou Development Zone focus on providing financial support for the entire chain.

For top global projects, full chain support such as talent rewards, R&D and industrialization rewards, investment and interest rate loans, etc., with a maximum support amount of 5 billion yuan, national platform achievements of up to 100 million yuan, innovative drugs, improved new drugs, and biosimilar drugs that complete phase I/II/III clinical trials are given up to 10 million/20 million/30 million yuan of support, and clinical approvals and registration certificates can receive 50-1000w government funding.

In terms of supporting enterprises to go overseas, a grant of 300,000 yuan is given for new drugs that have obtained the FDA's clinical trial approval for the first time, with a maximum funding of 2 million yuan per year for a single enterprise. A one-time subsidy of up to 1 million yuan is given for each type of drug newly approved by the FDA and sold in foreign markets.

Similar to Guangzhou, the policy introduced by Zhuhai also proposes promotion measures around various stages such as introduction, implementation, R&D, and industrialization, and provides financial support at various stages.

▌Enterprise: Looking forward to a more clear implementation path

In fact, voices supporting the development of innovative drugs did not come out of nowhere.

Looking at it more closely, at this year's two conferences, “innovative drugs” first appeared in government work reports and have already sparked a round of heated discussion; from a distance, at the end of last year, Bi Jingquan, deputy director of the Economic Committee of the National Committee of the Chinese People's Political Consultative Conference and executive vice chairman of the China Center for International Economic Exchanges, had already publicly called for “full chain support for innovative drugs” in an interview with the media.

“Supporting pharmaceutical innovation, especially vigorous promotion in approval, R&D, and payment, etc., is definitely a good thing for enterprises. The introduction of policies is to some extent related to recent proposals to develop new quality productivity. Innovative drugs and innovative medical devices all fall under the category of new technologies.” Zhao Heng, founder of medical strategy consulting firm Latitude Health, told the “Science and Technology Innovation Board Daily” reporter.

However, he also said, “This may have something to do with the current decline in the pharmaceutical market. Pharmaceuticals can be used as a key industry for policy support.”

Zhang Xiaolin, founder, chairman and CEO of Dizhe Pharmaceutical, told the “Science and Technology Innovation Board Daily” reporter that from the perspective of industry development, the goal of policy encouragement is to develop innovative drugs with real clinical value, especially innovations that can fill gaps and solve unmet needs.

According to Zhang Xiaolin, what innovation at the source did was develop drugs with new targets, new structures, and new mechanisms from 0 to 1 to fill clinical gaps and break through existing treatment bottlenecks, so that innovative drugs with global competitiveness can be made. As a result, the corresponding investment and risk will also be higher.

“Therefore, it is particularly important to encourage innovative drugs with real clinical value to enter the market as soon as possible and receive commercial returns to support innovation.” Zhang Xiaolin said.

According to reports, almost at the same time as the relevant policy was released, the innovative drug Suvortinib tablets (Schwartner) under Dizhe Pharmaceuticals received FDA breakthrough therapy certification for first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 (exon20ins) mutations.

This is another important milestone after treating advanced EGFR exon20ins mutant NSCLC, after Schwarzhe became the first “breakthrough therapy” drug in the field of lung cancer between China and the US. As a result, it became the only drug in the world that was fully certified as a breakthrough therapy by the FDA to treat EGFR exon20ins mutant NSCLC.

“After local innovative drugs are marketed, they need to face admission processes such as medical insurance admission and hospital admission. We look forward to more policies that will facilitate the entry and implementation of innovative drug markets, and help innovative drugs with clinical value benefit patients as soon as possible.” Zhang Xiaolin further added, “The introduction of a series of incentive policies in Beijing and Guangzhou is of great significance to the development of the biomedical industry, helping to further promote innovative pharmaceutical companies to speed up R&D and reduce financial pressure.”

Some companies told the “Science and Technology Innovation Board Daily” reporter that policies at this stage are still preliminary, and have only been introduced in some cities. We still need to look forward to a more clear implementation path for the specific impact on enterprises.

As stated by the company, although the support policies in each region mentioned above clearly state the responsible units, the number of units involved is very large, and no detailed operating guidelines have been issued.

Among them, the Beijing side requires coordination among various departments, including the Municipal Drug Administration, the Municipal Health Insurance Bureau, the Municipal Bureau of Commerce, Customs, the Municipal Bureau of Economy and Information Technology, and district governments; the Guangzhou side also needs cooperation from various departments such as the Science and Technology Bureau, the Market Supervision Bureau, the Health Bureau, the Finance Bureau, and the Bureau of Industry and Information Technology in the corresponding regions.