格隆汇1月20日丨康缘药业(600557.SH)公布，江苏康缘药业股份有限公司近日收到国家药品监督管理局 签发的车前子片《药物临床试验批准通知书》。 糖尿病肾脏病是糖尿病最常见且严重的微血管并发症之一，也是导致终末期肾脏病的主要原因。糖尿病 肾脏病早期起病多隐匿，且无明显临床症状。大约20%~40%的糖尿病患者最终会发展成为 DKD，且发 病率呈年轻化趋势。临床治疗主要通过控制血压、血糖及饮食等，以延缓糖尿病肾脏病的进展。 中医临床在长期诊疗中归纳总结出"湿热不除，蛋白难消"的核心病机认识。当前临床针对 DKD 适应症 治疗的中成药选择相对有限，且中医临床治疗DKD多从"补肾固本、益气活血、祛风除湿"等治法治则 着手，而专门针对糖尿病肾脏病湿热证的中成药尚属空白。车前子片的研发预期具有明显的临床价值和 良好的市场前景。 车前子片功能主治为利水渗湿、泄热化浊，用于糖尿病肾脏病(diabetickidneydisease, DKD)湿热证的治 疗。临床前主要药效学研究显示，车前子片对糖尿病肾脏病具有良好的治疗效果。在自发性糖尿病小鼠 肾脏病模型中，车前子片能显著降低模型小鼠血糖、胰岛素抵抗指数和糖化血红蛋白水平， ...

Core Insights - Kangyuan Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of Cheqianzi Tablets, which are intended for the treatment of diabetic kidney disease (DKD) with a focus on damp-heat syndrome [1][2] - Preclinical studies indicate that Cheqianzi Tablets show significant therapeutic effects on DKD, including reductions in blood glucose, insulin resistance, and various proteinuria markers in diabetic mouse models [1] - The development of Cheqianzi Tablets is expected to fill a gap in the market for traditional Chinese medicine targeting DKD, which currently has limited options [2] Company Summary - Kangyuan Pharmaceutical has announced the approval for clinical trials of Cheqianzi Tablets, which are aimed at treating DKD [1] - The company’s research highlights the safety and efficacy of Cheqianzi Tablets, showing a wide safety margin in toxicological studies [1] Industry Summary - Diabetic kidney disease is a common and severe microvascular complication of diabetes, affecting approximately 20% to 40% of diabetic patients, with an increasing incidence among younger populations [2] - Current clinical treatments for DKD primarily focus on controlling blood pressure, blood sugar, and diet, indicating a need for more targeted therapies [2] - The lack of traditional Chinese medicine options specifically addressing damp-heat syndrome in DKD presents a significant opportunity for Cheqianzi Tablets in the market [2]

Core Viewpoint - Kangyuan Pharmaceutical has received the Clinical Trial Approval Notice for Cheqianzi Tablets from the National Medical Products Administration, indicating progress in its drug development pipeline for treating diabetic kidney disease [1] Group 1: Company Developments - The approval pertains to Cheqianzi Tablets, which are indicated for promoting diuresis, clearing heat, and transforming dampness, specifically for the treatment of diabetic kidney disease with damp-heat syndrome [1]

Core Viewpoint - The company is actively embracing "AI + smart manufacturing" to inject new vitality into pharmaceutical innovation, responding to national strategies for developing new productive forces [1] Group 1: R&D Innovations - The company has established an "AI-driven active substance discovery" and "drug screening evaluation and new drug development" technical system [1] - The KYS2301 gel utilizes an AI drug discovery platform with deep learning algorithms to analyze vast compound data, significantly shortening the preclinical research cycle [1] - Exploratory research is being conducted in AI-enabled traditional Chinese medicine (TCM) development, focusing on discovering effective substances, identifying potential indications, and optimizing compound analysis [1] Group 2: Manufacturing Advancements - The company has pioneered a smart manufacturing technology system centered on effective ingredient groups, establishing the first intelligent production factory for TCM in China [1] - The self-developed Pharmaceutical Knowledge System (PKS) overcomes the bottleneck of big data application in the pharmaceutical industry, transitioning TCM production from traditional experience-based methods to precise and intelligent processes [1] Group 3: Future Directions - The company plans to continue deepening the application of AI technology across the entire chain of R&D, production, and quality control, aiming for innovative outcomes that benefit investors [1]

Group 1 - The company, Kangyuan Pharmaceutical, emphasizes its commitment to addressing unmet clinical needs by focusing on traditional Chinese medicine and biopharmaceuticals with significant clinical value, particularly in areas such as cardiovascular diseases, metabolic disorders, autoimmune diseases, and neurological disorders [2] - The company is advancing its core pipeline of chemical drugs, specifically the Class 1 new drugs KY1701 and KY0467, which are currently in clinical stages, and plans to systematically progress the development of these products according to its existing pipeline [2]

Core Insights - The article discusses the competitive landscape of the hair medical industry in China, highlighting key players and market dynamics [1][5]. Group 1: Competitive Landscape - The Chinese hair medical industry features various competitive factions, with companies like Yonghe Medical, Damaik, and Qingyi focusing on hair transplant medical services, while SanSheng Pharmaceutical, Zhendong Pharmaceutical, and Xianju Pharmaceutical are involved in medical nurturing services [1]. - In the hair transplant sector, the first tier consists of leading national chain brands such as Yonghe Medical, Bilian Sheng, and Damaik, which collectively hold a significant market share and possess nationwide direct chain layouts, mature technology systems, and strong brand recognition [1]. Group 2: Hair Growth Pharmaceuticals - In the hair growth pharmaceuticals market, the first tier includes SanSheng Pharmaceutical, Zhendong Pharmaceutical, and Merck, with the former two holding major shares in the minoxidil market, while Merck is recognized as the original manufacturer of finasteride [5]. - The second tier comprises Xianju Pharmaceutical, Kang En Bei, and Xiamen Meishang Pharmaceutical, which have accelerated the launch of minoxidil and finasteride products in recent years, gaining notable market recognition [5]. Group 3: Sales Performance - In the online pharmacy sector, Zhejiang SanSheng's minoxidil tincture product achieved sales exceeding 1 billion yuan, while Zhendong Anxin's minoxidil lotion surpassed 300 million yuan in sales, and SanSheng's minoxidil foam also exceeded 100 million yuan [9]. - In the offline market during the first quarter of 2025, Zhejiang SanSheng's minoxidil tincture and Zhendong Anxin's minoxidil lotion both recorded sales above 20 million yuan, with market shares of 50.61% and 38.82%, respectively [10]. - The sales ranking for minoxidil products shows Zhejiang SanSheng's minoxidil tincture leading with over 34 million yuan in sales (50.61% market share), followed by Zhendong Anxin's minoxidil lotion with over 26 million yuan (38.82% market share) [11].

Group 1 - The flu epidemic in China is at a high level, primarily driven by the H3N2 strain, with increased transmission risk due to upcoming population movements during the New Year holiday [1] - Demand for antiviral and symptomatic medications has surged, with a reported over 500% increase in flu-related drug purchases on Alibaba Health and over 100% increase in orders for traditional Chinese medicine on Meituan [1] - The pharmaceutical industry is responding effectively across the supply chain, from vaccine production to drug distribution, indicating a well-coordinated effort to manage the public health challenge [1][2] Group 2 - Vaccine companies are ramping up production, with Hualan Vaccine reporting 55 batches of flu vaccine issued since November, reflecting increased public willingness to get vaccinated [2] - Diagnostic companies like Dian Diagnostics and Kingmed Diagnostics are seeing increased business, supporting the trend of testing before treatment, which enhances rational drug use [2] - The treatment landscape is diversifying, with both chemical and traditional Chinese medicines being utilized, indicating a shift in market dynamics [3][5] Group 3 - Traditional Chinese medicine is gaining traction, with companies like China Resources Sanjiu and Kangyuan Pharmaceutical seeing strong growth in their antiviral product lines [5] - The distribution sector is crucial, with companies like Yiyigou ensuring rapid delivery of essential medications during peak demand periods [5] - The clinical relevance of traditional Chinese medicine is increasing, supported by government policies that endorse its use in flu treatment, leading to a rise in evidence-based research [6][9] Group 4 - Companies are focusing on clinical research to validate the efficacy of traditional Chinese medicines, with Kangyuan Pharmaceutical conducting head-to-head trials against conventional drugs [7][9] - The competitive landscape in the respiratory system traditional Chinese medicine market is diverse, with companies like China Resources Sanjiu and Yiling Pharmaceutical leveraging brand strength and market recognition [9] - As the industry moves towards evidence-based medicine, companies with strong research capabilities and clinical data are likely to capture more market opportunities [9]

Group 1 - The company, Kangyuan Pharmaceutical, announced that it will hold its first extraordinary shareholders' meeting on December 29, 2025 [2] - The agenda includes the proposal to cancel the supervisory board and amend related articles [2]

江苏康缘药业股份有限公司 董事会议事规则 第一章 总 则 第一条 为了规范公司董事会的议事方式和程序，保证董事会工作效率，提 高董事会决策的科学性和正确性，切实行使董事会的职权，根据《中华人民共和 国公司法》《中华人民共和国证券法》《上市公司独立董事管理办法》（以下简称 《管理办法》）、《上海证券交易所股票上市规则》《上海证券交易所上市公司自律 监管指引第 1 号——规范运作》和《江苏康缘药业股份有限公司章程》（以下简 称《公司章程》）的有关规定，制定本规则。 (四)决定公司的年度财务预算方案、决算方案； (五)制订公司的利润分配方案和弥补亏损方案； (六)制订公司增加或者减少注册资本、发行债券及其他证券的方案； 第二条 董事会在公司治理结构中处于重要地位。董事会应当依法履行职责， 确保公司遵守法律法规和《公司章程》的规定，公平对待所有股东，并关注其他 利益相关者的合法权益。 第三条 董事会实行集体领导、民主决策制度。董事个人不得代表董事会， 未经董事会授权，也不得行使董事会的职权。 第四条 本规则对公司全体董事、董事会秘书、列席董事会会议的其他有关 人员都具有约束力。 第二章 董事会职权 第五条 董事会有权 ...

江苏康缘药业股份有限公司 募集资金管理办法 第一章 总则 第一条 为了规范江苏康缘药业股份有限公司(以下简称"公司")募集资金 的管理和使用，提高募集资金使用的效率和效果，防范资金使用风险，确保资金 使用安全，切实保护投资者利益，依据《中华人民共和国公司法》《中华人民共 和国证券法》《上市公司证券发行注册管理办法》《上海证券交易所股票上市规则》 《上市公司募集资金监管规则》《上海证券交易所上市公司自律监管指引第 1 号 ——规范运作》及《江苏康缘药业股份有限公司章程》（以下简称《公司章程》） 等有关法律、法规和规范性文件的规定，结合本公司实际情况，制定本管理办法。 公司发现控股股东、实际控制人及其他关联人占用募集资金的，应当及时要 求归还，并披露占用发生的原因、对公司的影响、清偿整改方案及整改进展情况。 第七条 保荐人或者独立财务顾问应当按照《证券发行上市保荐业务管理办 法》及本办法对公司募集资金的管理和使用履行保荐职责，进行持续督导工作。 第二条 公司募集资金应当专款专用。公司使用募集资金应当符合国家产业 政策和相关法律法规，践行可持续发展理念，履行社会责任，原则上应当用于主 营业务，有利于增强公司竞争能力 ...