Focus Interview: China’s Innovative Medicines Accelerate into the Fast Lane

Source: CCTV.com

CCTV.com — Focus Interview: Since the beginning of this year, 27 innovative medicines have been approved for marketing in China, including 22 domestically developed innovative medicines. This progress has been driven by reforms to the drug review and approval system focused on innovative medicines. During the 14th Five-Year Plan period, China’s innovative drug development has made significant advances in both quantity and quality, ranking second globally and gaining international recognition. Recently, the National Medical Products Administration (NMPA) issued the Implementation Measures for the Protection of Drug Trial Data, continuing to strengthen support for innovative drug development. So, what qualitative changes have taken place in China’s innovative pharmaceutical sector?

Li Haiyan is Chief Physician of the Department of Cardiology at Peking University Third Hospital and is also responsible for clinical trials of innovative medicines.

Li Haiyan, Chief Physician, Department of Cardiology, Peking University Third Hospital; Director, Drug Clinical Trial Institution:

“During the 14th Five-Year Plan period, a total of 230 innovative medicines were approved in China. For physicians, this means more treatment options, especially for severe diseases, rare diseases, and pediatric diseases. In the past, there were often no medicines available for these conditions. Now, they can be treated.”

In simple terms, an innovative medicine is a new drug independently developed by a pharmaceutical company from the ground up. It is either the first of its kind globally or demonstrates superior efficacy compared with existing medicines. According to data released by the NMPA, 76 innovative medicines were approved for marketing in China in 2025, up from 48 in 2024, setting a new record. Among chemical drugs, domestically developed innovative medicines accounted for 80.85%; among biologics, the proportion reached 91.30%. Domestically developed innovative medicines are entering the market at an unprecedented pace.

Wang Junzhi, Academician of the Chinese Academy of Engineering and Chair of the Academic Committee of the National Institutes for Food and Drug Control:

“First, a strong innovative drug system reflects a country’s core competitiveness. It is closely linked to public health and can meet major unmet clinical needs. Second, it is a strategic emerging industry characterized by high added value and advanced technologies, capable of generating significant economic benefits.”

In the past, China’s pharmaceutical industry was dominated by generic drugs, with relatively few independently developed innovative medicines. During the 14th Five-Year Plan period, the number of innovative medicines approved in China surged, while outbound licensing transactions reached record highs. China has moved from being a “major producer of generic drugs” toward becoming a “major exporter of innovative medicines.”

So, why have domestically developed innovative medicines experienced such explosive growth and risen to the world’s second position in less than a decade?

The rapid growth of domestically developed innovative medicines has been driven by a series of innovation policies. Globally, countries generally use two approaches to define a new drug: it may be new to the country or new to the world. To promote pharmaceutical industry development and encourage innovation, China first redefined the criteria for new drugs at the policy level. In other words, the definition has shifted from being “new to China” to being “new to the world.”

Zhang Qiang, Academician of the Chinese Academy of Engineering and Boya Distinguished Professor at Peking University:

“New requirements have been introduced for the pharmaceutical industry. For example, if a drug is still essentially a generic and does not demonstrate significant clinical advantages, it will be difficult to obtain approval, and even if it is approved, its market potential will be very limited. This has compelled pharmaceutical companies to seriously consider innovation.”

Without innovation, companies may be left behind. For pharmaceutical companies, however, the pressure did not stop there. In June 2017, the NMPA officially joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Zhang Qiang:

“ICH is an international organization through which drug standards are recognized and mutually accepted internationally. Joining ICH means that medicines in China must comply with relevant ICH requirements. This means that standards must be raised across every stage, including product quality, research capabilities, development capabilities, and the quality of clinical research. All of these must meet international requirements in order to achieve international recognition.”

Joining ICH has imposed higher requirements on China’s drug regulatory authorities and the pharmaceutical industry as a whole, while also providing clear guidance for innovative drug development.

Yu Huan, Deputy Director of the Center for Drug Evaluation, National Medical Products Administration:

“On the basis of adopting international standards, the Center for Drug Evaluation has continuously improved China’s own system of technical guidelines for drug development. More than 600 technical guidelines have now been issued, covering traditional Chinese medicines, chemical drugs, and biologics, as well as various professional fields including pharmaceutical sciences, pharmacology and toxicology, and clinical medicine. These guidelines provide companies with clear and predictable standards. The internationalization of drug review standards also provides important technical support for Chinese innovative medicines to enter overseas markets and for overseas innovative medicines to enter the Chinese market more rapidly.”

The clear technical guidelines issued by China’s drug regulatory authorities based on international standards have created favorable conditions for companies to develop innovative medicines and achieve “global novelty.” They not only provide a clear development pathway, but also allow R&D and clinical trial data generated under a globally aligned regulatory framework to gain recognition in multiple countries, thereby reducing R&D costs for companies.

On average, nearly 4,000 drug marketing applications are submitted in China each year. In the past, a drug could face years of waiting during the review and approval process before reaching the market. In response, the NMPA has fully implemented reforms to the drug review and approval system, introducing preferential policies for innovative medicines.

Yu Huan:

“For medicines intended to treat diseases that are life-threatening and have no effective treatment options, such as medicines for the prevention and treatment of major infectious diseases, anticancer drugs, and medicines for rare diseases, the Center for Drug Evaluation will significantly shorten review timelines for eligible products, accelerating the availability of new and effective medicines to meet urgent clinical needs.”

Pharmaceutical companies can apply to the Center for Drug Evaluation for priority review and approval. For eligible products, the review timeline is shortened from 200 working days to 130 working days. The review timeline for clinical trial applications is 60 working days, while for key innovative medicines supported by national strategic priorities, the timeline can be shortened to 30 working days.

While improving the efficiency of review procedures, China is also working to help companies avoid unnecessary detours in innovative drug development. The NMPA has adopted the guiding principle of “early engagement, tailored policies for each company, full-process guidance, and coordinated R&D and review,” proactively supporting innovative medicines throughout development and commercialization to reduce unnecessary costs and delays.

Yu Huan:

“Our review teams become involved at an early stage of innovative drug development, helping R&D teams clarify their research strategies and improve study plans, thereby comprehensively enhancing the quality and efficiency of drug development. During the 14th Five-Year Plan period, the Center for Drug Evaluation devoted resources equivalent to more than 400,000 person-visits to communication and consultation activities, conducted more than 25,000 communication sessions, and provided services to more than 4,000 companies.”

Innovative drug development is like a marathon characterized by high investment and long development cycles. In the pharmaceutical industry, the difficulty of innovative drug development is often described by the “Three Tens Rule”: investments of more than US$1 billion, development cycles of 10 years or longer, and a success rate of less than 10%.

In the past, many companies were unwilling or unable to pursue innovation. Today, a series of supportive policies have made innovative drug development more predictable and attractive to capital, strengthening the capabilities of pharmaceutical companies. A favorable innovation ecosystem has fueled explosive growth in innovative medicines during the 14th Five-Year Plan period.

A total of 230 innovative medicines were approved for marketing during this period, including 199 domestically developed innovative medicines, covering therapeutic areas such as oncology, infectious diseases, endocrinology, dermatology and ophthalmology/otolaryngology, and cardiovascular and cerebrovascular diseases. As innovative medicines continue to emerge, China’s quality regulatory system is also becoming increasingly scientific and sophisticated.

Statistics from the National Healthcare Security Administration show that the time from marketing approval to inclusion in the national medical insurance reimbursement catalog has fallen from around five years to approximately one year. About 80% of innovative medicines can be included in medical insurance reimbursement within two years of market approval.

This represents a win-win situation. For pharmaceutical companies, faster access to reimbursement enables them to recover substantial upfront R&D investments more quickly, further stimulating incentives for innovation.

The other beneficiary is the patient.

For patients, the growing availability of domestically developed innovative medicines in clinical practice has significantly reduced medication costs and helped address urgent unmet clinical needs.

Li Ning, Deputy Director of the Cancer Hospital, Chinese Academy of Medical Sciences:

“When targeted therapies first emerged 10 or 20 years ago, a single box could cost RMB 20,000 to 30,000, with annual treatment costs reaching RMB 300,000 to 400,000. When China’s own innovative medicines emerged, the arrival of third-generation therapies immediately drove down the prices of second-generation therapies, while the prices of the third-generation drugs introduced during the same period also declined. Today, after medical insurance reimbursement, the annual cost of targeted therapy and immunotherapy is only tens of thousands of yuan.”

Domestically developed innovative medicines are increasingly targeting unmet clinical needs, bringing significant benefits to patients.

Li Ning:

“Lung cancer is the most common cancer worldwide and also the cancer with the highest incidence in China. The five-year survival rate for lung cancer patients has increased from 16.8% to 28.4%, nearly doubling. Compared with 27% in the United States during the same period, our data suggest that treatment outcomes may be even better.”

According to available data, by the end of 2025, the total value of outbound licensing transactions for Chinese innovative medicines reached US$135.655 billion, with 157 transactions completed throughout the year. This was far higher than the US$51.9 billion and 94 transactions recorded in 2024.

The value of Chinese innovative drug transactions is catching up with that of the United States, with major deals emerging frequently. The technological value of Chinese innovative medicines is gaining global recognition. At the same time, overseas expansion is evolving from a predominantly licensing-based model toward deeper forms of collaboration, including joint development and independent international commercialization.

China entered the innovative drug development race relatively late. It still lags behind the United States in areas such as original innovation from “0 to 1,” foundational innovation, and exploration of entirely new mechanisms of action. However, supported by a favorable innovation ecosystem, China’s innovative pharmaceutical industry is expected to make the transition from “running alongside” global leaders to “taking the lead” in more fields.

Li Haiyan:

“China now ranks first globally in the total number of clinical studies. Innovative drug candidates in China’s pipeline account for 30% of the global total, and in some fields the proportion exceeds 50%. Over the next five years, China’s innovative pharmaceutical industry is certain to experience explosive growth.”

In May 2026, the newly revised Regulation on the Implementation of the Drug Administration Law of the People’s Republic of China officially took effect. The regulation further strengthens legal support for improving drug R&D and registration systems, accelerating drug review and approval, and continuously stimulating innovation and development across the pharmaceutical industry.

Yu Huan:

“China is currently transitioning from a major pharmaceutical producer to a pharmaceutical powerhouse. We will further increase support for drug innovation, particularly for original innovative medicines based on new targets and new mechanisms of action, as well as independently developed innovative medicines, in order to promote the high-quality development of the pharmaceutical industry.”

The Outline of the 15th Five-Year Plan explicitly calls for support for the clinical use of innovative medicines, optimization of the review and approval processes for innovative medicines and medicines in urgent clinical need, improvement of mechanisms to support the high-quality development of innovative medicines and medical devices through medical insurance, refinement of the innovative medicine catalog, and encouragement of commercial insurance to expand coverage for innovative medicines.

These measures further strengthen the position of innovative medicines within China’s national healthcare strategy and send a clear signal of continued support for high-quality innovation.

As long as policy guidance and support continue to be strengthened, basic research is further reinforced, efforts to overcome key technological challenges are intensified, ecosystem collaboration is enhanced, and market vitality is fully unleashed, China will accelerate its transformation from a “major pharmaceutical nation” into a “pharmaceutical powerhouse driven by innovation.”