China’s Novel Cancer Drug Approvals Surpass U.S. Levels, Study Reveals

China has recently surpassed the United States in the number of new cancer drug approvals, indicating potential shifts in the global drug development landscape.

Image credit:©iStock.com, MariaGisina

The United States has maintained a leadership position in drug development for several decades, rapidly bringing new therapies to patients.1,2 However, regulatory authorities in other countries, particularly in China, have recently introduced new policies aimed at enhancing their drug development pipelines.3

These developments prompted researchers at Friends of Cancer Research, a nonprofit organization that engages with stakeholders in drug development and approval processes to gather evidence for potential policy recommendations, to investigate the trend. Mark Stewart, the organization’s vice president of science policy, led a team that compared cancer drug approval rates between China and the United States to gain insights into these developments.

According to a study published in Health Affairs Scholar, China approved a greater number of novel cancer drugs than the United States between 2020 and 2025, with the most significant increase occurring in the final three years of the study period.4 Nevertheless, the U.S. Food and Drug Administration (FDA) maintains a shorter median review time for individual drug applications compared to China’s National Medical Products Administration (NMPA).

“This does not indicate that the United States has lost its leadership position in drug development,” Stewart explained. “However, it does offer valuable insights and underscores the rapid evolution of the competitive and drug development landscapes.”

Between 2020 and 2025, the FDA granted approval to 87 new cancer drugs, while the NMPA approved 94. Although the total number of approvals is similar, China outpaced the United States in oncology drug approvals during each of the final three years of the study period, whereas the U.S. approval rate remained relatively stable. Stewart noted that this development raises important questions regarding how the United States can maintain its competitiveness in the global drug development arena.

An analysis of review timelines revealed that most applications to both regulatory agencies utilized some form of expedited review pathway. When compared to non-expedited oncology drug applications, the FDA processed expedited applications a median of 119 days faster, while the NMPA reduced review times by a median of 149 days through similar pathways. Despite this, the FDA’s overall review process for cancer drug applications remains faster than that of the NMPA.

Stewart noted that these findings suggest the FDA’s review speed does not require immediate improvement. Instead, he indicated that upstream factors—such as the timing of clinical trial initiation and patient enrollment, along with associated costs—warrant further investigation as potential avenues for enhancing the drug development pipeline.

The researchers also assessed the prevalence of first-in-class therapies within the dataset. Of the 167 cancer drugs approved by either country during the study period, 36 represented first-in-class treatments. The FDA was the first to approve 30 of these innovative therapies, 13 of which later received approval from the NMPA. By the conclusion of the study period, the FDA had not approved any of the six first-in-class drugs that had been authorized by the NMPA.

So-Yeon Kang, a health policy researcher at Georgetown University who did not participate in the study, commented that the findings are noteworthy. She observed that current drug pricing models often assume the United States remains the primary driver of drug innovation. “It is essential to closely monitor these trends and consider the potential implications of these developments, given the critical need for these medications by patients,” Kang stated.

Kang, who has previously examined the impact of recent regulatory changes on China’s early-stage drug development, noted that the reforms are now yielding tangible results from the country’s investments in its regulatory system. However, she cautioned that the current study does not directly assess whether these reforms influenced the observed approval numbers. “This research describes the recent trend,” she said, “but further investigation is needed to uncover the underlying forces driving these changes and differences.”

Source link