Core Viewpoint - Kangyuan Pharmaceutical (600557.SH) has received approval from the National Medical Products Administration for a new indication of its Jin Zhen Oral Liquid for treating children's influenza (heat toxin attacking the lung syndrome) [1] Company Summary - Jin Zhen Oral Liquid is a proprietary traditional Chinese medicine developed by the company, consisting of eight ingredients including goat horn, Pingbei mother, Huangqin, and Dahuang [1] - The product was granted a new drug certificate and production license in 1997 and is included in the National Essential Medicines List and the National Medical Insurance Directory [1] - It is also listed in the 2025 edition of the "Chinese Pharmacopoeia" and represents the company's product line for respiratory and infectious diseases [1] - The company has invested approximately 2.69 million yuan in the research and development of the new indication for Jin Zhen Oral Liquid [1] Industry Summary - The new indication for Jin Zhen Oral Liquid targets influenza, a respiratory infectious disease caused by the influenza virus [1] - Pharmacological studies indicate that Jin Zhen Oral Liquid significantly reduces the viral load in lung tissue and improves lung index elevation caused by viral infection [1] - Toxicological studies from GLP laboratories show that the drug has good safety [1] - Clinical efficacy observations have demonstrated significant effectiveness of Jin Zhen Oral Liquid in alleviating symptoms such as cough, phlegm, and fever caused by influenza in children [1]

白云山和黄中药方面表示，从剂量和工艺上进行调整开发出来的儿童装药物，可以进一步满足儿童细分 人群安全用药的需求。未来在深耕药物市场的同时也将长期致力于社会公益活动，其中就包括关爱儿童 健康等。 （文章来源：广州日报） 广州的部分儿童药生产企业备受鼓舞。一品红药业集团股份有限公司是广州市生物医药及高端医疗器械 产业链链主企业，该公司有关负责人表示："一品红聚焦于儿童药及慢病药研发、生产，目前公司拥有 26个儿童药注册批件，治疗范围全面覆盖0~14岁儿童全年龄段，涵盖儿童疾病领域70%以上病种。一品 红旗下的芩香清解口服液，纳入《2024年全国儿童呼吸道感染中医药防治方案》。"据悉，一品红药业 在研儿童药项目十多个，涵盖癫痫、流感、哮喘等多种高发疾病，其致力于重点解决儿童用药依从性 差、安全隐患多等临床难题，开发更多适合儿科患者的特殊专用制剂产品。"在国家政策大力支持下， 公司将继续坚持创新引领，积极开展医药创新和高端药品研发，不断丰富产品管线，与国家政策同频共 振，为生育友好型社会的建设添砖加瓦。" 无独有偶，广药集团旗下白云山和黄中药的"明星药"白云山板蓝根颗粒占据全国市场份额半壁江山，企 业还特别研发出儿童 ...

Investment Rating - The industry investment rating is "Outperform the Market," indicating an expected relative increase of over 10% in the industry index compared to the broader market within the next six months [5][8]. Core Insights - The National Medical Products Administration (NMPA) has reduced the review and approval time for clinical trial applications of eligible innovative drugs from 60 days to 30 days, aiming to accelerate the market entry of innovative drugs and shift domestic new drug development from "Fast-Follow" to "First-in-Class" [3]. - The focus of this policy includes pediatric drugs, rare diseases, and globally synchronized research products, with the NMPA encouraging the development of pediatric and rare disease medications through various incentives [3]. - Data from Yaozhi Network indicates that leukemia is the most common cancer among children, accounting for approximately 30% of all cases, while brain and spinal cord tumors account for about 25% [3]. - The overall trend shows that the domestic innovative drug review and approval policy has transitioned from "passive approval" to "active empowerment," enhancing the global competitiveness of domestic innovative drugs [3]. Summary by Sections Regulatory Changes - The draft proposal outlines that eligible innovative drugs must be either traditional Chinese medicine, chemical drugs, or biological products that meet specific criteria, including being supported by the state or included in special programs for children and rare diseases [2]. - Applications for eligible innovative drugs will be reviewed and approved within 30 working days [2]. Market Implications - The policy aims to facilitate early global synchronized research and international multi-center clinical trials for eligible innovative drugs [2]. - If a review cannot be completed within 30 days due to technical reasons, the NMPA will inform the applicant, and the subsequent timeline will follow a 60-day implied approval process [2]. Industry Performance - The report indicates that the pharmaceutical and biotechnology sector has shown a relative performance against the CSI 300 index, with a notable increase in the sector's attractiveness for investment [5][6].