A blockbuster new policy for innovation in the pharmaceutical industry has been introduced, indicating that a major turning point for the industry has arrived.

The pharmaceutical circle is in an uproar!

Yesterday, the National Healthcare Security Administration and the National Health Commission issued the "Several Measures to Support the High - quality Development of Innovative Drugs" (hereinafter referred to as the "Several Measures"), which further improved the measures to support the development of innovative drugs throughout the entire chain.

As the development of innovative drugs in China has reached a certain stage and the number of approved products has increased, pharmaceutical companies are not only concerned about the review and approval process but also focus on aspects such as hospital access, payment, and market competition.

The reason why the new policy provides "full - chain support" for innovative drugs is mainly that the "Several Measures" put forward policies for each link from the R & D and investment of innovative drugs to their access to medical insurance and commercial insurance, clinical application, and diversified payment methods, aiming to solve the practical problems of innovative drugs and set the tone for the evolution direction of these key points.

Considering the previous years' medical insurance policies and the overall trend of the new medical reform, the "Several Measures" mark that the pharmaceutical policy has officially entered the stage of "promoting innovation" from "squeezing out the water", becoming a watershed in the industry.

Boost the better alignment of innovative drug R & D with clinical needs

In the past decade, innovative drugs in China have experienced a period of rapid development: innovation - related venture capital is active, and the R & D pipeline is rich. However, the problem of homogenization has also emerged, and there is also a phenomenon of "chasing hot spots" in the layout of targets and pipelines.

Currently, the homogenization phenomenon has become a major bottleneck restricting the sustainable development of the innovative drug industry. For example, homogeneous competition has driven up the prices of resources such as clinical trials, and low - level repetition has led to over - capacity in some fields; enterprises lacking differentiation face difficulties in financing when the "capital winter" comes and become the bubbles after the upsurge of innovation - related venture capital; it also suppresses the motivation for original innovation to some extent, ignoring the real unmet clinical needs, resulting in insufficient overall competitiveness of domestic innovative drugs in the global market.

To avoid these problems, the National Healthcare Security Administration also proposed at the press conference for the release of the "Several Measures" yesterday that it will promote the formation of a pattern of "truly supporting innovation, supporting real innovation, and supporting differentiated innovation".

Since the R & D cycle of innovative drugs is long and the manifestation of the involution phenomenon is also somewhat delayed, how to provide better support for the R & D of innovative drugs from the source as early as possible. In response, the "Several Measures" put forward a breakthrough measure for the application of medical insurance data, that is:

● Support the use of medical insurance data for the R & D of innovative drugs. On the basis of ensuring data security, legality, and compliance, explore providing necessary medical insurance data services for the R & D of innovative drugs. Relying on the national unified medical insurance information platform, collect and analyze data such as disease spectra and clinical medication needs, develop data products suitable for the R & D needs of innovative drugs, and support pharmaceutical companies, scientific research institutions, and medical institutions to reasonably determine R & D directions and layout R & D pipelines, thereby improving innovation efficiency.

Medical insurance data can help pharmaceutical companies more accurately identify unmet clinical needs, especially the medication needs for chronic diseases, tumors, and other diseases during the process of population aging, discover the limitations of existing therapies, and develop new - generation drugs more targeted. The opening up of medical insurance data will accelerate the entry of the Chinese innovative drug industry into the era of data - driven precision R & D.

At the same time, post - marketing research on innovative drugs can still continuously promote their alignment with clinical needs. Therefore, the "Several Measures" mentioned:

● Strengthen real - world research on innovative drugs. Explore and establish a scientific real - world research method, encourage innovative drug companies to conduct real - world research, and promote the linkage between research results and drug catalog access, renewal, and adjustment of medical insurance payment scope.

Introduce patient capital for innovative drugs

Capital is of great significance in the development process of innovative drug companies. However, the problem is that the average duration of RMB funds is about 7 - 8 years, which does not match the often 10 - year R & D cycle of innovative drugs.

In the past, IPO was one of the main ways for investment institutions to exit. However, the IPO channel has been narrowed in the past two years, resulting in difficulties in exiting. More importantly, as the funds established around 2015 have successively expired, investment institutions have to consider exiting as soon as possible.

An unfortunate phenomenon is that innovative companies and capital may have conflicts due to the exit problem, and even break up and end up in court. Capital investment in innovative drugs requires more long - term investment preparations; at the same time, innovative drugs increasingly need the support of patient capital.

In January 2025, the "Guiding Opinions of the General Office of the State Council on Promoting the High - quality Development of Government - invested Funds" pointed out that it is necessary to develop and expand long - term capital and patient capital. Reasonably determine the duration of government - invested funds, give play to the cross - cycle and counter - cycle adjustment role of funds as long - term capital and patient capital, and actively guide long - term capital such as the National Social Security Fund and insurance funds to invest.

Currently, the duration of newly established government - guided funds in many places has been extended to 15 - 20 years. Hard - technology companies, including those in the innovative drug field, are expected to receive longer - term capital support. The "Several Measures" issued yesterday also correspondingly mentioned:

● Encourage commercial health insurance to expand the investment scale in innovative drugs. Encourage commercial health insurance companies to provide stable long - term investment for the R & D of innovative drugs through various means such as innovative drug investment funds, and cultivate patient capital to support innovative drugs.

It has always been common for commercial insurance companies to invest in medical and health enterprises, but their investment fields are mostly concentrated in areas such as medical services, Internet healthcare, health management, and elderly care that can be coordinated with insurance. In 2024, the original insurance premium income of commercial health insurance in China reached 977.3 billion yuan, a year - on - year increase of 8.2%. How much of this huge amount can be used for investment in innovative drugs? On the one hand, it depends on the risk assessment of innovative drug investment by insurance companies; on the other hand, it also depends on whether subsequent implementation rules will be introduced to further support the implementation of "commercial health insurance investment in innovative drugs".

In any case, the "Several Measures" still put forward a new idea for the introduction of patient capital for innovative drugs.

Substantial progress has been made in the payment of innovative drugs by commercial insurance

As China's innovative drugs have entered the harvest period, the number of Class 1 innovative drugs approved for marketing from 2018 to 2024 has shown a significant upward trend. In 2024, the number of approved drugs reached 48, more than five times that in 2018. In the first half of 2025, nearly 40 drugs were approved, showing an obvious blowout effect.

Policy support in the payment link is particularly important for the commercialization of innovative drugs.

In recent years, a dynamic adjustment mechanism for the medical insurance drug catalog suitable for the access of new drugs has been gradually established. Data from the National Healthcare Security Administration shows that the proportion of newly launched drugs within five years in the newly added varieties of the medical insurance catalog in that year increased from 32% in 2019 to 98% in 2024. Among the 91 drugs newly included in the medical insurance catalog in 2024, 33 achieved "being approved and included in the same year". The time from the approval and listing of new drugs to their inclusion in the medical insurance catalog for reimbursement has been reduced from about five years to about one year, and about 80% of innovative drugs can be included in the medical insurance payment scope within two years of listing. After innovative drugs are included in the medical insurance catalog through negotiation, most of them have achieved an increase in both sales volume and sales amount.

However, the National Healthcare Security Administration also mentioned that problems such as the gap between the price expectations of innovative drug companies and the medical insurance payment ability and the weak diversified payment ability have not been completely solved.

Next, while improving the dynamic adjustment mechanism of the medical insurance catalog and reasonably determining the medical insurance payment standards for innovative drugs, the National Healthcare Security Administration will also strongly support the implementation of commercial health insurance payment for innovative drugs, as mentioned in the "Several Measures":

● Establish a commercial health insurance innovative drug catalog. Focus on including innovative drugs with high innovation levels, great clinical value, significant patient benefits, and beyond the scope of basic medical insurance, and recommend that multi - level medical security systems such as commercial health insurance and medical mutual assistance refer to and use this catalog.

● Give full play to the functions of the multi - level medical security system. The medical insurance department will provide cooperation and support in terms of data sharing, settlement, and clearing for eligible commercial health insurance. Innovative drug application cases within the scope of relevant commercial health insurance can be excluded from the scope of disease - based payment, and payments will be made after the review and evaluation process.

In fact, the National Healthcare Security Administration has mentioned the work arrangement of the commercial health insurance drug catalog several times before. Also yesterday, this work made a substantial progress: the National Healthcare Security Administration officially released the "Work Plan for the Adjustment of the 2025 National Basic Medical Insurance, Maternity Insurance, and Work - related Injury Insurance Drug Catalog and the Commercial Health Insurance Innovative Drug Catalog (Draft for Comment)" and the "Application Guide for the Adjustment of the 2025 National Basic Medical Insurance, Maternity Insurance, and Work - related Injury Insurance Drug Catalog and the Commercial Health Insurance Innovative Drug Catalog (Draft for Comment)".

The latest policy arrangement for the commercial health insurance drug catalog. Image source: National Healthcare Security Administration

The National Healthcare Security Administration also introduced that the application and adjustment of the commercial insurance innovative drug catalog are carried out simultaneously with those of the medical insurance catalog, and the procedures are basically the same. Enterprises can independently apply to be included in the medical insurance catalog or the commercial insurance innovative drug catalog, or they can apply for both at the same time. The difference from the adjustment of the medical insurance catalog is that the commercial insurance innovative drug catalog will fully respect the market - leading position of commercial health insurance companies. Insurance companies, industry experts, etc. will fully participate in each link such as plan formulation, expert review, and price negotiation. Commercial health insurance experts have important decision - making power on whether a drug can enter the commercial insurance innovative drug catalog and price negotiation.

In the past, Huimin Insurance has made many explorations on the payment of innovative drugs by commercial insurance. With the formulation of the commercial insurance innovative drug catalog, whether it is Huimin Insurance or other commercial insurance, it will cooperate with medical insurance to form a more complete multi - level payment system.

Break the bottleneck of "innovative drugs are in the catalog but cannot enter the hospital"

As mentioned above, the progress of including innovative drugs in the medical insurance catalog has accelerated in recent years. However, in practice, due to factors such as the reform of medical insurance payment methods, the drug ratio, or the assessment of the use of centralized - procurement drugs, medical institutions often cannot prescribe innovative drugs, and it is difficult to break through the "last mile" of the clinical application of innovative drugs.

Previously, some cities have introduced policies to open a "green channel" for the "last mile" of innovative drugs entering hospitals. For example, they explored separate settlement of the costs of innovative drugs such as national - negotiated drugs incurred by designated medical institutions or included them in the disease - based payment (DIP) system with additional scores; for national medical insurance - negotiated drugs, the costs are not included in the performance assessment indicators of public medical institutions such as average outpatient expenses, average outpatient drug expenses, average inpatient expenses, and average inpatient drug expenses; a special case negotiation mechanism for DRG was established to support medical institutions in using innovative drugs and medical devices and applying new medical technologies.

The "Several Measures" issued this time also affirmed similar exploration directions from the top - level design and clearly proposed:

● Encourage designated medical insurance institutions to hold a pharmacy committee meeting within three months after the update and release of the drug catalog, adjust the drug supply in a timely manner according to needs, or establish a temporary procurement green channel to ensure clinical diagnosis and treatment needs and the reasonable drug - using rights of patients. Negotiated drugs in the medical insurance catalog and drugs in the commercial insurance innovative drug catalog are not subject to the "one product, two specifications" restriction.

● For cases where innovative drugs in the medical insurance catalog are reasonably used but are not suitable for disease - based standard payment, support medical institutions to independently apply as special cases.

The new policy aims to address the concerns of medical institutions. If effectively implemented, the accessibility of innovative drugs in hospitals is expected to be further improved.

Support "real innovation" and promote a virtuous cycle in the industry

Looking back at the medical insurance policies in the past few years, whether it is the reform of payment methods, the negotiation of the medical insurance catalog, or the centralized procurement of drugs and medical consumables, the fundamental task has been to "squeeze out the water". According to the overall direction of the new medical reform, the space squeezed out from these tasks is mainly used for the clinical application of new drugs and new diagnosis and treatment projects.

In the past two years, cities such as Beijing, Shanghai, Guangzhou, and Shenzhen have implemented relevant measures to support innovative drugs and medical devices with medical insurance after the new medical reform has advanced to a certain stage.

Relevant policies of medical insurance support for innovative drugs and medical devices in some regions. Source: Official websites of local governments

The introduction of the "Several Measures" by the National Healthcare Security Administration marks that the top - level design is also promoting the industry to enter the stage of "promoting innovation" from "squeezing out the water", determining the development direction of multiple links in the industry and becoming a watershed in the industry.

Meanwhile, the new policy does not simply "promote innovation" in a broad sense. Instead, it addresses the previous innovation bubbles and more precisely supports innovation around the clinical value of innovative drugs. In the future, "real innovation" projects will be more capable of obtaining resource support from medical insurance data, innovative investment, and diversified payment methods, and their achievements will also play a more positive role in clinical application, thus forming a virtuous cycle.

Thanks to the following people for their strong support for this article:

Yu Jianlin, Deputy General Manager of GTJIA Investment

Wei Qiang, Investment Director of Guoke Venture Capital

Shan Jialiang, Managing Partner of Haibang Fund

Meng Xiaoying, Partner of Yida Capital

Yi Renxin, Senior Investment Manager of Yida Capital

Wang Meng, General Manager of Youjia Biotech

This article is from the WeChat public account "Arterial Network" (ID: vcbeat), author: Zhang Xiaoxu. Republished by 36Kr with permission.