China's New Drug Approvals for Children Grow for Five Consecutive Years, 138 Approved in 2025 我国儿童新药连续五年增长，2025年批准138个

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."

每年夏季，儿童用药的“短缺警报”总会在儿科诊室隐约响起。但今年的数据带来了一丝不同以往的曙光。国家药监局最新发布显示，2025年我国批准儿童用药达138个，创历史新高，且这已是连续第五年增长。过去五年，累计449个儿童新药获批，这条向上的增长曲线，正试图拉直那个困扰行业已久的“倒三角”困境——成人药多，儿童专用药少。

政策驱动是这条增长曲线最显眼的推手。 近年来，从国家层面的药品审评审批制度改革，到《鼓励研发申报儿童药品建议清单》的发布，再到医保目录对儿童用药的倾斜，一套“组合拳”清晰地指向同一个目标：通过制度设计，撬动市场与研发资源流向儿童用药领域。这背后是一种深刻的共识纠偏——儿童绝不是“缩小版的成人”，其用药安全关乎生命，不能依靠“剂量靠猜、用药靠掰”的粗放方式延续。政策的持续加码，正在为这一领域补上历史欠账。

数字增长的背后，是研发范式的悄然转变。 过去，儿童用药研发常被视为“成人药的附属品”，开发动机弱、难度大、市场小。如今，连续五年的增长表明，企业端的动力被真正激活了。这不仅仅是审批“绿灯”的结果，更意味着研发立项开始前置，专门针对儿童生理特点的剂型创新（如口服溶液、颗粒剂、贴剂等）和规格优化成为重点。一个良性循环正在形成：政策鼓励创造了市场预期，市场预期引导了研发投入，而获批产品又反过来证明了政策的有效性和市场的潜力。这标志着我国儿童用药产业从被动补充，转向主动布局。

然而，138这个数字在感到欣慰的同时，也应促使我们进行更冷静的审视。 第一，数量的增长是否等同于“可及性”与“公平性”的提升？新药能否顺利进入医院药房，价格是否在患儿家庭承受范围之内，医保报销是否顺畅，这些“最后一公里”的问题同样关键。如果新药获批后束之高阁，患者的体感改善依然有限。第二，增长的结构性问题值得关注。是集中在常见病、多发病领域，还是在罕见病、肿瘤等更急需的领域也有突破？剂型是否覆盖了从新生儿到青少年不同年龄段的精细化需求？真正的“困境破解”，不仅需要数量，更需要高质量、精准化、全链条的覆盖。

长远来看，这次的“历史新高”不应成为终点，而应是一个常态化的起点。儿童用药保障是一项系统工程，它考验的不仅是监管的智慧，更是产业生态的成熟度、医疗体系的衔接能力以及社会资源的持续投入。从“用药靠掰”到“量体裁衣”，这条转型之路已经踏上了快车道。当审批数字的增长逐渐沉淀为孩子们药箱里实实在在的安全与有效时，我们才可以说，这个困扰已久的难题，正在被真正攻克。未来，我们需要更多从“有没有”到“好不好”、“用得上”的维度，去衡量和推动这项至关重要的民生事业。