格隆汇8月22日丨康缘药业(600557.SH)公布，近日收到国家药品监督管理局签发的关于金振口服液新增 儿童流行性感冒（热毒袭肺证）适应症的《药物临床试验批准通知书》。金振口服液是公司研制的儿童 专用中药新药，由山羊角、平贝母、黄芩、大黄等八味药组成，于1997年获得新药证书及生产批件，为 公司独家品种，已被纳入国家基本药物目录和国家医保目录，并被收载于2025年版《中国药典》，是公 司呼吸与感染疾病产品线的代表品种之一。金振口服液增加的适应症为儿童流行性感冒（热毒袭肺 证），是一种由流感病毒引起的呼吸道传染病。药效学研究结果显示，金振口服液能够显著降低肺组织 的流感病毒载量，改善病毒感染引起的肺指数升高，减轻肺内细支气管及肺组织病变程度。GLP实验室 毒理学研究结果表明该药安全性良好。上市后多项临床疗效观察研究结果表明，金振口服液对流感病毒 引起的咳嗽、咳痰、发热等症状均有显著疗效，在治疗儿童流行性感冒方面具有一定的临床使用基础。 截至目前，公司对金振口服液上述新增适应症的累计研发投入约为269万元。 ...

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].