On May 7th, eight departments including the National Health Commission and the Ministry of Industry and Information Technology jointly issued the "Implementation Opinions on Reforming and Improving the Supply and Security Mechanism for Pediatric Medications." The document outlines 16 specific measures aimed at enhancing the pediatric drug research and development innovation system, diversifying clinical R&D models for children's medicines, and standardizing pediatric medication information in drug instructions. The overarching goal is to better meet the needs for pediatric disease prevention and treatment medications and comprehensively improve pediatric drug supply and usage capabilities.
Lu Kelin, founder and CEO of Lukedao Technology, stated that while China's pediatric drug supply can generally meet the needs for common clinical diseases in children, issues persist such as an imbalanced drug structure, non-standardized information in drug instructions, and an overall shortage of pediatric pharmaceutical services. The introduction of the Implementation Opinions directly addresses these industry pain points, aiming to improve mechanisms across the entire supply chain and accelerate efforts to bridge gaps in pediatric drug security and services.
In recent years, the state has placed high importance on ensuring pediatric medication, introducing multiple policies to guide industry development. In January of this year, the State Council promulgated the newly revised "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China." Article 21 stipulates that the state supports the research, development, and innovation of pediatric drugs and medications for rare diseases. For pediatric drug varieties, new dosage forms or specifications for pediatric drugs, and drugs with new pediatric indications that meet certain conditions, a market exclusivity period of up to two years may be granted.
Local governments are also taking proactive steps. For instance, in May 2025, ten departments including the Fujian Provincial Health Commission jointly issued the "Implementation Plan for Promoting High-Quality Development of Pediatric Medical and Health Services in Fujian Province," which calls for addressing the shortcomings in pediatric medication. The plan emphasizes a pediatric clinical demand-oriented approach, encouraging local drug marketing authorization holders to engage in R&D for pediatric drug varieties, and to develop suitable new varieties, dosage forms, and specifications for children's medications. It also encourages medical institutions to research and apply pediatric traditional Chinese medicine preparations.
"Currently, China is gradually forming a multi-level policy system for pediatric medications, led by central top-level legislation and supported by local policy implementation. Relevant policies cover various aspects including R&D, evaluation, and medical insurance," said Li Jing, Deputy General Manager of Pengyang Fund. "The improvement of the policy system can effectively boost the R&D motivation of pharmaceutical companies, guide enterprises to develop new dosage forms and specifications for pediatric drugs, and thereby promote the enhancement, expansion, and high-quality development of the pediatric drug supply."
As policy dividends continue to be released, the value of China's pediatric medication sector is becoming increasingly prominent. Many listed pharmaceutical companies are accelerating their entry into this field to seize industry development opportunities.
For example, in April of this year, Haisco Pharmaceutical Group Co., Ltd. announced that its innovative drug HSK42360 tablets were officially included by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in the pilot project of the "Children's Anticancer Drug R&D Encouragement Pilot Plan (Starlight Plan)." This product is a self-developed small molecule inhibitor targeting BRAF V600 mutations with brain permeability, intended for clinical use in advanced solid tumors with BRAF V600 mutations. It is expected to provide a new treatment option for pediatric glioma in China.
Kui Hua Pharmaceutical Group Co., Ltd. has been deeply involved in the field of pediatric traditional Chinese patent medicines. Its "Xiao Kuihua" brand has become a landmark brand in the pediatric medication market. The company's recently disclosed 2025 financial report shows that by the end of 2025, there were over 60 "Xiao Kuihua" pediatric drug products on the market, covering multiple areas including the respiratory system, gastrointestinal digestive system, growth and development, immune supplementation, and the nervous system. The brand leads the industry in terms of sales scale, number of products, and number of large-scale single products.
Some companies are also actively focusing on niche segments, aiming to fill gaps in the domestic market for special pediatric medications. For instance, in 2025, the domestic marketing application for melatonin granules, submitted by Suzhou Yifan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical Co., Ltd., was accepted by the National Medical Products Administration. It is reported that this product is mainly used to improve sleep onset difficulties in children aged 6 to 15 with neurodevelopmental disorders. Currently, only the original imported product is approved for marketing in China. This application is the first generic submission domestically and is expected to further improve the security system for special pediatric medications.
In Lu Kelin's view, China's pediatric medication industry is in a growth stage characterized by accelerated market entry by companies and continuous optimization of the supply structure. While the supply of medications for common diseases is relatively sufficient, gaps remain in niche areas such as oncology and rare diseases. In the long term, as clinical demands continue to evolve, the industry is expected to accelerate its development towards greater innovation in R&D, more suitable dosage forms, and finer segmentation of market tracks.
In this regard, Li Jing stated that relevant pharmaceutical companies should closely follow policy directions and clinical needs. On one hand, they should increase R&D investment in areas such as pediatric critical illnesses, rare diseases, and untapped niche segments, and deepen innovation in suitable dosage forms. On the other hand, they should clarify their market positioning based on their own advantages to build differentiated brand competitiveness. Additionally, companies should reasonably plan their production capacity layout, balancing the stable supply of daily medications with the industrialization of innovative varieties, in order to align with the pace of high-quality development in pediatric medications.
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