Core Viewpoint - Jiangsu Kangyuan Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of Jinzhen Oral Liquid for the treatment of children's influenza, indicating a significant step in expanding its market potential [1][2]. Group 1: Drug Development and Market Situation - Jinzhen Oral Liquid is a proprietary traditional Chinese medicine for children, composed of eight herbal ingredients, and has been included in the National Essential Medicines List and the National Medical Insurance Directory [2]. - The new indication for Jinzhen Oral Liquid targets children's influenza, a respiratory infectious disease caused by the influenza virus, with studies showing its efficacy in reducing viral load and improving lung health [2][3]. - The annual infection rate of influenza among children under five in China is reported to be as high as 20%-30%, with certain peak seasons reaching around 50%, highlighting the significant market opportunity for Jinzhen Oral Liquid [3]. Group 2: Financial Performance and Future Steps - The projected revenue for Jinzhen Oral Liquid in 2024 is approximately 81.52 million yuan [4]. - Following the receipt of the clinical trial approval, the company must complete Phase II and III clinical trials and submit the registration application for the drug [4].

Group 1 - The article reports that Jiangsu Zhongxin Pharmaceutical Co., Ltd. has applied for a "Type III meeting" with the CDE, which is currently in processing status [1] - Type III meetings are typically held within 75 days after the application and focus on significant issues at critical stages of drug development [1] - Jiangsu Zhongxin Pharmaceutical was established in 2011 and is primarily engaged in technology promotion and application services, with a registered and paid-in capital of 95 million RMB [1] Group 2 - The company has made one external investment, participated in one bidding project, and holds 8 trademark registrations and 13 patents [1] - Jiangsu Zhongxin Pharmaceutical has 40 administrative licenses [1] - The company is wholly owned by Jiangsu Kangyuan Pharmaceutical Co., Ltd. [1]

（文章来源：每日经济新闻） 康缘药业8月22日晚间发布公告称，公司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》。 ...

Core Viewpoint - Kangyuan Pharmaceutical has received clinical trial approval for the new indication of its Jin Zhen oral solution for treating children's influenza, indicating potential market growth opportunities for the product [1] Group 1: Company Developments - Kangyuan Pharmaceutical announced the receipt of a clinical trial approval notice from the National Medical Products Administration for the Jin Zhen oral solution, which now includes a new indication for treating children's influenza (heat toxin attacking the lung syndrome) [1] - The Jin Zhen oral solution is a pediatric-specific traditional Chinese medicine that has been included in the national essential drug list and the national medical insurance catalog [1] Group 2: Market Potential - The product is expected to have a promising market outlook for the prevention and treatment of influenza in children [1]

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]

证券简称：康缘药业 证券代码：600557 公告编号：2025-029 江苏康缘药业股份有限公司关于 金振口服液增加适应症获得临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 江苏康缘药业股份有限公司（以下简称"公司"）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》。按照《上海证券交易所上市公司自律监管指引第 3 号—行业信息披露》 的相关要求，现将相关情况公告如下： 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 06 月 09 日受理的金振口服液临床试验申请符合药品注册的有关要求，在进一步完善 临床试验方案的基础上，同意本品开展用于儿童流行性感冒（热毒袭肺证）的临床试 验。 二、药品研发及市场相关情况 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 药品名称 金振口服液 药品批件号 国药准字 Z10 ...

Market Overview - The hair medical concept sector declined by 1.01% as of the market close on August 22, ranking among the top decliners in concept sectors [1] - Major stocks in the sector that experienced significant declines include Shuiyang Co., Huabang Health, and Baicheng Pharmaceutical, while stocks that saw gains include Zhendong Pharmaceutical, Kangyuan Pharmaceutical, and International Medicine, with increases of 1.33%, 0.69%, and 0.37% respectively [1] Concept Sector Performance - The top-performing concept sectors today include: - China AI 50: +5.31% - National Big Fund Holdings: +5.00% - SMIC Concept: +3.67% - MCU Chips: +3.64% - Automotive Chips: +3.46% [2] - Conversely, the hair medical sector was among the worst performers, alongside soybean and high-pressure oxygen chamber sectors, which saw declines of 0.94% and 0.76% respectively [2] Capital Flow Analysis - The hair medical concept sector experienced a net outflow of 289 million yuan, with 15 stocks seeing net outflows and 10 stocks exceeding 10 million yuan in outflows [2] - The stock with the highest net outflow was Shuiyang Co., with a net outflow of 123.37 million yuan, followed by Kids King, Jiu Zhi Tang, and Kang En Bei with net outflows of 84.69 million yuan, 48.68 million yuan, and 23.36 million yuan respectively [2] - Stocks with the highest net inflows included Kangyuan Pharmaceutical, Zhendong Pharmaceutical, and Xianju Pharmaceutical, with net inflows of 42.76 million yuan, 31.16 million yuan, and 21.98 million yuan respectively [2][3] Individual Stock Performance - Notable declines in the hair medical sector include: - Shuiyang Co.: -4.82% with a turnover rate of 11.16% and a net outflow of 123.37 million yuan - Kids King: -0.16% with a turnover rate of 4.36% and a net outflow of 84.69 million yuan - Jiu Zhi Tang: -1.92% with a turnover rate of 5.92% and a net outflow of 48.68 million yuan [2] - Stocks with positive performance include: - Zhendong Pharmaceutical: +1.33% with a turnover rate of 6.15% and a net inflow of 31.16 million yuan - Kangyuan Pharmaceutical: +0.69% with a turnover rate of 4.39% and a net inflow of 42.76 million yuan [3]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Views - The company is advancing its innovative drug pipeline, with a focus on three target areas, and has updated its key product pipeline [1] - The acquisition of 100% equity in Zhongxin Pharmaceutical for 270 million yuan will enhance the company's portfolio with four innovative products, including a three-target weight loss drug [1] - The company is expected to face performance pressure in 2024 due to external pharmaceutical environment and internal reforms, but is projected to enter a recovery phase in 2025, with steady growth anticipated from 2026 to 2027 [2] Financial Summary - Revenue is projected to decline from 4.86 billion yuan in 2023 to 3.90 billion yuan in 2024, with a growth rate of -19.9% [4] - Net profit attributable to the parent company is expected to decrease from 464 million yuan in 2023 to 392 million yuan in 2024, reflecting a -15.6% year-on-year change [4] - The company’s R&D expenses are projected to be 638 million yuan in 2024, indicating a strong commitment to innovation despite short-term profit pressures [2][4] - Forecasted net profits for 2025, 2026, and 2027 are 400 million yuan, 462 million yuan, and 530 million yuan, respectively, with corresponding growth rates of 2%, 15.7%, and 14.6% [2] Product Pipeline - The company is developing multiple products across various therapeutic areas, including: - SIPI-2011 for treating ventricular arrhythmias, currently in Phase II clinical trials [2] - AAPB injection for acute ischemic stroke, in Phase I clinical trials [2] - KYS202002A, a CD38 monoclonal antibody for multiple myeloma and lupus, with dual submissions in China and the US [2] - KYS2301 gel, a first-in-class peptide inhibitor targeting CCR8 for atopic dermatitis [2]

Core Viewpoint - The avian influenza concept sector has seen a significant increase, with a rise of 2.45%, ranking third among concept sectors on the trading day ending August 19. Group 1: Sector Performance - The avian influenza sector had 18 stocks rising, with ST Xiangxue hitting a 20% limit up, and Kangyuan Pharmaceutical also reaching the limit up. Other notable gainers included Yongshun Biological, Lianhuan Pharmaceutical, and Zhongsheng Pharmaceutical, which rose by 9.35%, 6.08%, and 3.79% respectively [1] - The top-performing concept sectors included: - Reducer: +2.62% - Animal Vaccine: +2.47% - Avian Influenza: +2.45% [1] Group 2: Capital Flow - The avian influenza sector attracted a net inflow of 109 million yuan, with 15 stocks receiving net inflows. Five stocks had net inflows exceeding 10 million yuan, led by Kangyuan Pharmaceutical with a net inflow of 154 million yuan [1] - The top stocks by net capital inflow ratio included: - Kangyuan Pharmaceutical: 19.87% - ST Xiangxue: 14.18% - Zhongmu Stock: 5.23% [2]

证券之星消息，8月19日中药板块较上一交易日上涨0.57%，ST香雪领涨。当日上证指数报收于3727.29， 下跌0.02%。深证成指报收于11821.63，下跌0.12%。中药板块个股涨跌见下表： | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 300147 | ST香雪 | 10.54 | 20.05% | 66.89万 | | 6.52亿 | | 600594 | 益僧制药 | 4.59 | 10.07% | 42.52万 | | 1.89亿 | | 603139 | 康惠制药 | 25.18 | 10.00% | 3.83万 | | 9369.95万 | | 002873 | 新天药业 | 15.19 | 9.99% | 1 29.29万 | | 4.38亿 | | 600557 | 康家药业 | 19.83 | 9.98% | 39.16万 | | 7.74亿 | | 600671 | 天目药业 | 16.89 | 6.03% | 9.59万 | | 1.58亿 | | ...