China's New Drug Approvals for Children Grow for Five Consecutive Years, 138 Approved in 2025

Each summer, a "shortage alert" for children's medications seems to echo faintly in pediatric clinics. However, this year's data brings a glimmer of hope unlike before. According to the latest announcement from the National Medical Products Administration, 138 pediatric drugs were approved in China in 2025, marking a historic high and the fifth consecutive year of growth. Over the past five years, a total of 449 new pediatric drugs have been approved. This upward growth curve is attempting to straighten out the long-standing "inverted triangle" problem in the industry—an abundance of medications for adults, but a scarcity of drugs specifically designed for children.

Policy drive is the most prominent catalyst behind this growth curve. In recent years, from national-level reforms in drug review and approval processes to the release of the Suggested List of Encouraged Pediatric Drug R&D and Applications, and the倾斜 (in倾斜) of the medical insurance catalog toward pediatric medications, a "package of measures" has clearly pointed toward the same goal: using institutional design to leverage market and R&D resources toward the field of children's medicines. Behind this lies a profound correction of consensus—children are by no means "miniature adults"; their medication safety concerns lives and cannot be sustained through crude methods like "guessing dosages and splitting pills." The continuous intensification of policies is now compensating for historical shortcomings in this field.

Behind the numerical growth is a quiet transformation in the R&D paradigm. In the past, pediatric drug R&D was often viewed as an "appendage to adult medications," with weak motivation, high difficulty, and a small market. Today, five years of consecutive growth indicates that the momentum from the enterprise side has truly been activated. This is not just the result of "green lights" in approval but also signifies that R&D project planning is now starting earlier. Innovations in dosage forms tailored to children's physiological characteristics (such as oral solutions, granules, patches, etc.) and optimizations in specifications have become key focus areas. A virtuous cycle is taking shape: policy encouragement has created market expectations, market expectations have guided R&D investment, and approved products, in turn, demonstrate the effectiveness of policies and market potential. This marks a shift in China's pediatric drug industry from passive supplementation to proactive development.

However, the figure of 138 should prompt us to look beyond relief and engage in more sober reflection. First, does the growth in numbers equate to improved "accessibility" and "equity"? Whether new drugs can smoothly enter hospital pharmacies, whether prices are within the reach of patients' families, and whether medical insurance reimbursement is seamless—these "last-mile" issues are equally critical. If new drugs gather dust after approval, the improvement in patients' experiences will remain limited. Second, structural issues in growth deserve attention. Is the growth concentrated in common and frequently occurring diseases, or are there breakthroughs in more urgent areas like rare diseases and tumors? Do the dosage forms cover the nuanced needs of different age groups, from newborns to adolescents? True "problem-solving" requires not only quantity but also high-quality, precise, and full-chain coverage.

In the long run, this "historic high" should not be the endpoint but a normalized starting point. Ensuring access to pediatric medications is a systematic project that tests not only regulatory wisdom but also the maturity of the industrial ecosystem, the coordination capabilities of the healthcare system, and sustained investment of social resources. From "splitting pills for dosing" to "tailoring treatments," this path of transformation is already on the fast track. Only when the growth in approval numbers gradually translates into tangible safety and efficacy in children's medicine cabinets can we say that this long-standing difficulty is truly being overcome. In the future, we need to measure and promote this vital public health endeavor from the dimensions of "whether it exists" to "whether it is good" and "whether it is accessible."