Domestic drugmakers take center stage in development, innovation

Profound reforms

In China, 2015 is seen as the seminal year for pharmaceutical innovation, as the nation began implementing a series of profound drug regulatory reforms.

According to an analysis by researchers at Tsinghua University and pharmaceutical consultancy PharmCube, a key State Council policy in 2015 initiated a comprehensive reform of the drug review and approval process, emphasizing the reduction of application backlogs and the encouragement of innovation.

A 2017 document issued by central authorities laid out further critical reform measures, which were instrumental in reducing the review timeline, establishing a registration system for qualified clinical trial institutions and enabling mutual recognition of ethics reviews.

In 2020, a revision of the Provisions for Drug Registration introduced priority review, conditional approval and breakthrough therapy designations, among other expedited channels for innovative therapies.

"These reforms have transformed China's pharmaceutical ecosystem, enhancing research and development efficiency through shortened development cycles, increased capital inflows into biopharmaceutical innovation and growing global market penetration of domestically developed therapies," said the study published in the journal Nature Reviews Drug Discovery in July.

Innovent Biologics, developer of Sycume, the new thyroid eye disease drug, said it took about three years and three months from filing clinical trial applications of the product to gaining market approval in March 2025. Just nine months later, the drug was added to the national drug reimbursement list.

"The inclusion of innovative drugs in the national reimbursement list has created another significant motivation for drug innovation as this policy opens up sales and streamlines payment channels for us drugmakers," the company said.

While rolling out systematic changes within the domestic regulatory framework, the nation has taken active steps to align with international standards.

Zhou, from the NMPA, said that China's top drug regulator joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in 2017 and was elected as a member of the council's management committee in 2018.

"Since then, China's drug review standards have been fully aligned with international norms. This has effectively facilitated the simultaneous global development and registration of pharmaceuticals, and accelerated the pace of domestically developed innovative drugs entering the international market," he said.

Zhu Yi, founder and chairman of Biokin Pharmaceutical, said in an interview with Caijing Magazine that the regulatory reforms replaced a system that was like a network of "old, local country lanes" with a "modern, international, standardized expressway", enabling drugmakers to move forward rapidly.

The improved policy environment has attracted substantial and steady capital investment, he added. Along with stock market reforms around 2018 and 2019 that opened new funding channels, the domestic pharmaceutical sector has become a strong magnet for overseas talent. A dynamic innovation ecosystem is also in full swing.

"Another key ingredient is the nation's alignment with international clinical trial standards. This ensures that China's vast, rapid, cost-effective and high-quality clinical research resources can meet international benchmarks and gain a competitive advantage globally," he said.

Ward, from Clarivate, said that China's innovation focus is similar to that of international pharmaceutical priorities. They cover oncology, metabolic and cardiovascular diseases, autoimmune or inflammatory conditions, and advanced technology platforms.

Three out of the four major clinical research advances in lung cancer in 2025 were driven by domestic products, said Zhou Caicun, director of the oncology department at Shanghai East Hospital.

In China, lung cancer caused 1.06 million new cases and 730,000 deaths in 2022. Lung cancer is also the world's deadliest cancer, with an estimated 1.8 million related deaths globally in 2020.

"Chinese researchers made one-third of oral presentations during the 2025 American Society of Clinical Oncology annual meeting, which was unimaginable two decades ago,"Zhou said. "Their contributions during the World Conference on Lung Cancer last year increased to 30 to 40 percent."

Zhou identified the return of Chinese scientists educated and trained overseas in pharmaceutical giants as a key catalyst for the proliferation of Chinese biopharma companies. These experts are attracted by burgeoning domestic opportunities and favorable government policies.

"Our teams' overall capabilities, including technologies, mindsets and management strategies, have all caught up with those in developed countries," he said. "Meanwhile, domestic researchers have actively participated in international multicenter clinical trials to accumulate experience and learn from standard practices," he added.

The strong policy support has significantly enhanced infrastructure development, exemplified by the creation of government-funded clinical research platforms across major cities, Zhou said. Combined with the growing enthusiasm for clinical studies among medical practitioners, this has fostered a positive research ecosystem.