BEIJING, May 28 (Xinhua) -- At the end of April, Andamertinib Benzoate Capsules, an independently developed Chinese medication for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer, received market approval from China's National Medical Products Administration (NMPA).
According to an NMPA statement, the drug, classified as a "Class 1" medication, which refers to innovative drugs that have not previously been marketed in China or abroad, received conditional approval through the administration's priority review and approval process.
This indicates that the innovative drug, which began clinical trials in 2020, has benefited from more than one of the NMPA's four fast-track approval pathways, a major government effort driving China's notably accelerated pharmaceutical innovation in recent years.
EXPEDITED PATHWAYS
As shown on the NMPA website, the administration has approved the marketing of 19 innovative drugs so far this year, including 15 from Chinese manufacturers. In 2025, it approved 76 innovative drugs, a record number and a significant hike from the 48 approved in 2024.
To accelerate the market entry of innovative drugs, the NMPA launched four fast-track review pathways in the Provisions for Drug Registration issued in 2020. They were later incorporated into the new implementing regulations of China's Drug Administration Law, which took effect on May 15, further strengthening the legal basis for expedited drug approval.
The new regulations, which are the fourth revision to the previous version issued in 2024, state that the national drug regulatory authority may accelerate drug marketing through breakthrough therapy designation, conditional approval, priority review and approval, and special review and approval.
All four fast tracks are primarily designed for new drugs targeting serious conditions with unmet medical needs. For example, the breakthrough therapy designation allows drug manufacturers to benefit from mechanisms expediting the development and review process. Conditional approval, which has been applied to Andamertinib Benzoate Capsules, permits the authorization of new drugs based on early clinical evidence to meet urgent medical needs.
Priority review and approval procedure, on the other hand, shortens the review period set for new drugs. "The review period can be shortened from the normal length of 200 work days to 130 work days," said Yuan Lijia, an official in charge of new drug review at the NMPA.
According to a report released by the NMPA in mid-May, since the issue of the Provisions for Drug Registration in 2020, 629 drug registration applications had been included in the priority review and approval procedure, more than 40 percent of which were targeted at tumors.
Liu Pengcheng, an associate professor at China Pharmaceutical University, said reforms to the drug review and approval system have provided strong support for China's rise in pharmaceutical innovation in recent years.
INSURANCE SUPPORT
Meanwhile, China's universal basic medical insurance, which remains the country's primary source of medical payment, has expanded its coverage of innovative medications, indicating an expedited procedure.
According to Liu, the price negotiations between the government and pharmaceutical companies on the annually updated national reimbursement drug list, with each year's renewal enlisting more new drugs, have stabilized the market expectation and therefore encouraged pharmaceutical innovation.
According to the National Healthcare Security Administration (NHSA), the time required for newly approved drugs to be included in the reimbursement list has been shortened from around five years to about one year, and about 80 percent of innovative drugs approved for marketing in China have been included in the list within two years of their entry to the market.
For innovative drugs that are beyond the affordability limits of basic medical insurance but are recommended for commercial insurance, in December 2025, the country introduced its first commercial insurance innovative drug list, which includes 19 such innovative drugs.
"We encourage high-value innovative drugs to first enter the commercial health insurance list during the early stage after market launch, and later be incorporated into the basic medical insurance system after accumulating data and reducing costs through clinical use," Huang Xinyu, an NHSA official, said earlier this month at a briefing about this year's drug price negotiation that has recently started.
"This year's update to the national reimbursement drug list will place greater emphasis on supporting genuine innovation and differentiated innovation -- these have also been a clear stance taken in the adjustments to the list toward drug innovation in recent years," he said.
GLOBAL REACH
Beyond the domestic market, Chinese innovative drug manufacturers have been reaching out for broader international cooperation.
In the first quarter of this year, the total value of overseas out-licensing deals for Chinese innovative drugs exceeded 60 billion U.S. dollars, nearly half of the more than 130 billion U.S. dollars recorded for the whole of 2025.
"This is a natural result of the rising strength of China's pharmaceutical industry aligning with the rigid demand in the global market," said Han Sheng, deputy director of the International Research Center for Medicinal Administration at Peking University.
Moreover, instead of the out-licensing of single products, more Chinese innovative drug developers have explored approaches for deeper cooperation, such as co-development and co-commercialization.
In 2025, more than half of China's overseas-licensed innovative drugs were still in the preclinical or Phase I trials at the time of licensing.
A cooperation agreement reached at the beginning of this year between China's Innovent Biologics and the U.S. pharmaceutical giant Eli Lilly, aimed at jointly advancing the global development of innovative drugs in the fields of oncology and immunology, was an example of cooperation moving to an earlier stage.
"It broke away from the traditional overseas licensing model by launching joint innovation planning at the early stage of candidate molecule development," said You Fei, chief financial officer of Innovent Biologics.
Li Xin, executive director and senior vice president of government affairs at Chinese drug manufacturer Junshi Biosciences, said licensing cooperation enables Chinese companies to share risk through overseas partnerships while expanding their global market share.
"Companies can quickly recover capital and reinvest it in research and development, while leveraging the well-established overseas networks of multinational pharmaceutical companies to bring products to the global market and gain more experience in global operations through such partnerships," she said. ■
