Core Viewpoint - Kangyuan Pharmaceutical (600557.SH) has received the clinical trial approval notice from the National Medical Products Administration for its product, Yunpihua Phlegm-Resolving Granules, aimed at treating adenoid hypertrophy in children [1] Group 1: Product Details - Yunpihua Phlegm-Resolving Granules are indicated for the treatment of adenoid hypertrophy with spleen deficiency and phlegm obstruction in children, presenting symptoms such as snoring during sleep, mouth breathing, prolonged nasal congestion, nasal itching, fatigue, poor appetite, and irregular bowel movements [1] - Preclinical efficacy studies show that the granules have a significant therapeutic effect on adenoid hypertrophy, reducing the size of nasal lymph nodes and lymphoid tissue in model animals, and lowering serum inflammatory factors IL-1β, IL-4, MIP-3α, and IL-17A levels [1] - Toxicological studies indicate that the granules have good safety profiles with a wide safety dosage range [1]

Group 1 - Jiangsu Kangyuan Pharmaceutical Co., Ltd. has received a clinical trial approval notice from the National Medical Products Administration for its product "Yunpi Huatan Tongqiao Granules" [1] Group 2 - The international gold price has surpassed $5000, marking a 280% increase over the past seven years [1]

证券简称：康缘药业 证券代码：600557 公告编号：2026-002 江苏康缘药业股份有限公司 运脾化痰通窍颗粒药物安全性好，安全剂量范围宽。 三、同类药品及市场情况 腺样体肥大是儿科及耳鼻咽喉科常见病之一，多发于 2~12 岁儿童。系统研究显 示，在有症状的随机样本中，儿童和青少年中腺样体肥大的患病率约为 46.42%，且 发病率呈上升趋势。腺样体肥大常合并慢性扁桃体炎、鼻窦炎等病症，迁延难愈，目 前手术治疗为首选治疗方案，但存在术后出血、易复发等问题[1]。此外，腺样体属于 免疫器官，不宜过早进行手术切除。 关于收到运脾化痰通窍颗粒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 签发的运脾化痰通窍颗粒《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： | 药品名称 | 运脾化痰通窍颗粒 | | --- | --- | | 适应症 | 儿童腺样体肥 ...

Core Viewpoint - Jiangsu Haobo Biopharmaceutical Co., Ltd. has been established with a registered capital of 200 million RMB, fully owned by Jiangsu Kangyuan Pharmaceutical Co., Ltd. [1] Company Overview - Company Name: Jiangsu Haobo Biopharmaceutical Co., Ltd. [1] - Legal Representative: Xiao Lihao [1] - Registered Capital: 200 million RMB [1] - Shareholder: Jiangsu Kangyuan Pharmaceutical Co., Ltd. holds 100% [1] - Business Scope: Includes drug production, drug wholesale (subject to approval), technical services, technology development, consulting, marketing planning, and enterprise management consulting [1] Industry Classification - National Standard Industry: Scientific research and technical service industry, technology promotion and application service industry, technical promotion services [1] - Business Address: Changzhou Xitaihu Technology Industrial Park, Longyang Road, Building F3, 3rd Floor [1] - Company Type: Limited liability company (wholly owned by a natural person) [1] - Business Duration: Until January 23, 2026, with no fixed term thereafter [1] - Registration Authority: Changzhou Wujin District Administrative Service Management Office [1]

Core Viewpoint - Jiangsu Kangyuan Pharmaceutical Co., Ltd. has received the clinical trial approval notice for Cheqianzi Tablets, which will be used for the treatment of diabetic kidney disease (DKD) [1][2]. Group 1: Drug Development and Related Information - Cheqianzi Tablets are indicated for diuresis and dampness elimination, specifically targeting the treatment of DKD with damp-heat syndrome. Preclinical studies have shown significant therapeutic effects on DKD, including reductions in blood glucose, insulin resistance index, and glycosylated hemoglobin levels [2]. - In spontaneous diabetic mouse models, Cheqianzi Tablets significantly reduced 24-hour urinary microalbumin, total protein, and the microalbumin/creatinine ratio, while effectively improving kidney pathology [2]. - Toxicological studies indicate that Cheqianzi Tablets have good safety profiles and a wide safety dosage range [2]. Group 2: Market Situation and Product Approval Process - DKD is a common and severe microvascular complication of diabetes, with approximately 20% to 40% of diabetic patients eventually developing DKD, and the incidence is trending younger [2]. - Current clinical treatments primarily focus on controlling blood pressure, blood glucose, and diet to slow the progression of DKD [2]. - The development of Cheqianzi Tablets is expected to have significant clinical value and a promising market outlook, as there are limited traditional Chinese medicine options specifically targeting DKD with damp-heat syndrome [3]. - Following the receipt of the clinical trial notice, the company must complete clinical trials and obtain approval from the National Medical Products Administration before the product can be manufactured and marketed [3].

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。 证券简称：康缘药业 证券代码：600557 公告编号：2026-001 江苏康缘药业股份有限公司 关于收到车前子片临床试验批准通知书的公告 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 签发的车前子片《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： | 药品名称 | 车前子片 | | --- | --- | | 适应症 | 糖尿病肾脏病 | | 注册分类 | 中药创新药 类 1.1 | | 剂型 | 片剂 | | 申请人 | 江苏康缘药业股份有限公司;上海图锋医药科技有限公司; 上海中医药大学 | | 受理号 | CXZL2500108 | | 通知书编号 | 2026LP00143 | 一、《药物临床试验批准通知书》主要内容 车前子片审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 2025 年 11 月 5 日受理的车前子片临床试验申请符合药品注册的有关要 ...

Group 1 - The core point of the article is that 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] - Cheqianzi tablets have shown significant therapeutic effects in preclinical studies, including lowering blood glucose, insulin resistance index, and glycosylated hemoglobin levels in diabetic kidney disease models [1] - The tablets also significantly improved various kidney disease markers, such as 24-hour urinary microalbumin and total protein levels, indicating their potential effectiveness in treating DKD [1] Group 2 - 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, but there is a limited selection of traditional Chinese medicine (TCM) options specifically targeting damp-heat syndrome in DKD [2] - The development of Cheqianzi tablets is expected to have significant clinical value and a promising market outlook due to the lack of specialized TCM treatments for this condition [2]

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]