仿制药入局易对标难 儿童退热市场等待"中国答案" 据《 2016 中国儿童用药安全白皮书》，我国约有五成儿童用药不规范，每年因用药不当 导致失聪的儿童病例超 3 万例，致死案例超 7000 例。 数据显示，我国 2400 种儿童化学药中，专用化药不足 5% ，儿童依从性更好的口服溶液 剂、混悬剂不足 10% 。在退热药市场，"美林"长期占据国内线下药店终端超 90% 份额， 其缺货期间 3000 元每瓶的黄牛价更暴露市场畸形现状。 同时需要指出的是，仿制药入局易，对标却难。据 CDE 数据，国内目前已有 28 个布洛芬 混悬液生产批件，但由于家长普遍认为原研药质量更好、疗效更为稳定，因而给儿童选择药 物时更倾向于选择品牌知名度高的原研药，导致仿制药难以进入市场，实际生产规模十分有 限，强生制药的原研药物"美林"依旧一家独大。 近年来，患者对于仿制药质量问题的疑虑似乎从未真正消失过。从医生反应"麻药不 麻"、"泻药不泻"，到仿制药一致性评价数据雷同，再到 FDA 对多家中国药品检测公司发 出检测数据警告，仿制药的信任危机不断发酵，甚至愈发强烈。 高品质国药崛起正当时 近日，葵花药业宣布旗下重庆小葵花儿童制药有限 ...

Core Viewpoint - The approval of ibuprofen suspension by Kew Flower Pharmaceutical marks a significant step towards addressing the limited options in the domestic children's medication market, indicating the entry of high-quality domestic children's antipyretics into a new era of "quality equality" [1] Group 1: Market Context - Approximately 50% of children's medications in China are used improperly, leading to over 30,000 cases of hearing loss and more than 7,000 deaths annually due to improper medication [3] - Only 5% of the 2,400 types of chemical drugs for children are specifically formulated, and less than 10% are oral solutions or suspensions that are easier for children to take [3] - The antipyretic market is dominated by "Meilin," which holds over 90% market share in offline pharmacies, highlighting the distorted market situation [3][5] Group 2: Challenges for Generic Drugs - While there are currently 28 production licenses for ibuprofen suspension in China, parents tend to prefer original branded drugs due to perceived quality and efficacy, making it difficult for generic drugs to penetrate the market [3][5] - The trust crisis surrounding generic drugs has been exacerbated by concerns over quality, with reports of inconsistencies in efficacy and safety [3][5] Group 3: Quality and Innovation - Kew Flower Pharmaceutical's ibuprofen suspension has been developed to meet international quality standards, with key efficacy parameters matching those of Johnson & Johnson's "Meilin" [5][6] - The company has established 18 internal raw material control standards, exceeding pharmacopoeia standards by 8, and has improved content accuracy and drug release rates by 10% [7] - The product features a child-friendly strawberry flavor and a specially designed child-proof cap to enhance user experience and reduce the risk of accidental ingestion [7] Group 4: Strategic Expansion - Kew Flower Pharmaceutical is deepening its focus on children's health, having established a formulation research institute and partnered with universities to expand its product matrix [10] - The newly approved ibuprofen suspension and drops are part of a comprehensive product matrix that addresses various pediatric health needs, including fever and cough [10][11] - The company has built a portfolio of over 70 children's medications across seven therapeutic areas, achieving over 30% market share in the OTC children's medication market [11] Group 5: Sales Performance - Kew Flower Pharmaceutical has nearly 30 products with sales exceeding 100 million, with the "Little Kew Flower" brand selling over 300 million boxes annually [11] - The "Little Kew Flower" pediatric cough syrup achieved sales of over 400 million in 2023, reflecting a growth rate of 22.4% [11] - The company's success is attributed to its commitment to quality and user needs, positioning it well for future growth in the pediatric medication sector [11]