Core Viewpoint - Zhejiang Kangnbei Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of TFA003 tablets, aimed at treating diabetic nephropathy [1][2]. Group 1: Drug Clinical Trial Approval - The drug TFA003 is classified as a traditional Chinese medicine under categories 2.1 and 2.3, with the application for clinical trials focusing on oral administration for diabetic nephropathy [1][2]. - The approval notice indicates that the drug meets the requirements for drug registration and can proceed with clinical trials after refining the trial protocol [1]. Group 2: R&D Status - The company has invested approximately RMB 29.57 million in the research and development of TFA003, which has shown significant efficacy in improving renal function indicators in animal studies [2]. - The drug has the potential to be developed as a new traditional Chinese medicine for diabetic nephropathy, showing improvements in glomerular filtration and renal tubular reabsorption functions [2]. Group 3: Market Situation - There are currently few drugs available for the treatment of diabetic nephropathy in both domestic and international markets, primarily relying on antihyperglycemic and antihypertensive medications [3][4]. - The market for traditional Chinese medicine related to diabetic nephropathy is projected to reach a total sales volume of RMB 27 billion in 2024, reflecting a year-on-year growth of 5.25% [6].

Group 1 - The core point of the article is that Kang En Bei announced the approval of its subsidiary's clinical trial for TFA003 tablets by the National Medical Products Administration [2] Group 2 - Kang En Bei's wholly-owned subsidiary, Hangzhou Kang En Bei Pharmaceutical Co., Ltd., received the clinical trial approval notice for TFA003 tablets [2]

Core Viewpoint - Kang En Bei (600572.SH) has received approval from the National Medical Products Administration for the clinical trial of TFA003 tablets, which are intended for the treatment of diabetic kidney disease [1] Company Summary - Kang En Bei's wholly-owned subsidiary, Hangzhou Kang En Bei Pharmaceutical Co., Ltd., has been granted the Clinical Trial Approval Notice for TFA003 tablets [1] - The approval indicates that TFA003 tablets meet the registration requirements for pharmaceuticals as per the relevant regulations [1] - The clinical trial is set to proceed after further refinement of the clinical trial protocol [1]

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。 近日，浙江康恩贝制药股份有限公司（以下简称"公司"）全资子公司杭州康恩贝制 药有限公司（以下简称"杭州康恩贝"）收到国家药品监督管理局（以下简称"国家药监 局"）核准签发的 TFA003 片的《药物临床试验批准通知书》，现将相关情况公告如下： 一、药物临床试验批准通知书的主要内容 药物名称：TFA003片(以下简称"本品") 浙江康恩贝制药股份有限公司 证券简称：康恩贝 证券代码：600572 编号：2026-011 关于子公司 TFA003 片获得药物临床试验批准通知书的公告 1 三、其他相关情况 通知书编号：2026LP00030 制剂剂型：片剂 申请适应症：糖尿病肾病 注册分类：中药2.1类（改变已上市中药给药途径）和2.3类（增加功能主治） 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10月16 日受理的TFA003片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 本品开展用于糖尿病肾脏疾病的临床试验。 申请事项：境内生产药品注 ...

Core Viewpoint - Kang En Bei (600572) has received approval from the National Medical Products Administration for clinical trials of TFA003, a drug aimed at treating diabetic kidney disease [1] Group 1: Company Developments - Kang En Bei's wholly-owned subsidiary, Hangzhou Kang En Bei Pharmaceutical Co., Ltd., has been granted a Clinical Trial Approval Notice for TFA003 [1] - The drug has shown significant efficacy in improving renal function indicators in both urine and blood, as well as enhancing glomerular filtration and tubular reabsorption functions in animal studies [1] Group 2: Drug Potential - TFA003 demonstrates potential as a new drug for diabetic kidney disease, based on its pharmacological and pharmacokinetic results from preclinical studies [1] - The drug's ability to improve renal pathological morphology further supports its development as a treatment option for diabetic nephropathy [1]

Core Viewpoint - Kangnbei (600572.SH) has received approval from the National Medical Products Administration for the clinical trial of TFA003 tablets, aimed at treating diabetic nephropathy, indicating a significant step in addressing a market gap for effective treatments in this area [2] Company Summary - Kangnbei's wholly-owned subsidiary, Hangzhou Kangnbei Pharmaceutical Co., Ltd., has been granted a Clinical Trial Approval Notice for TFA003 tablets, which are classified as Traditional Chinese Medicine (TCM) under categories 2.1 and 2.3 [2] - The company has invested approximately 29.57 million yuan in the research and development of TFA003 [2] Industry Summary - There is a limited number of drugs available in both domestic and international markets for the treatment of diabetic nephropathy, with current clinical treatments primarily consisting of hypoglycemic and antihypertensive medications [2] - No other TCM products with significant efficacy for the same indication have been launched in the market, highlighting a unique opportunity for Kangnbei with TFA003 [2]

Core Viewpoint - Kangnbei (600572.SH) has received approval from the National Medical Products Administration for the clinical trial of TFA003 tablets, which are intended for the treatment of diabetic kidney disease [1] Company Summary - Kangnbei's wholly-owned subsidiary, Hangzhou Kangnbei Pharmaceutical Co., Ltd., has been granted the Clinical Trial Approval Notice for TFA003 tablets [1] - The approval indicates that TFA003 tablets meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - The clinical trial is set to proceed after further refinement of the clinical trial protocol [1] Industry Summary - The approval of TFA003 tablets aligns with the growing focus on treatments for diabetic kidney disease, a significant health concern [1] - The development of new therapies in this area may enhance competition and innovation within the pharmaceutical industry [1]

Core Viewpoint - Kang En Bei (600572.SH) has received approval from the National Medical Products Administration for the clinical trial of TFA003 tablets, which are aimed at treating diabetic nephropathy [1] Group 1: Company Developments - The full subsidiary of Kang En Bei, Hangzhou Kang En Bei Pharmaceutical Co., Ltd., is responsible for the clinical trial application of TFA003 tablets [1] - TFA003 is classified under Traditional Chinese Medicine categories 2.1 and 2.3, with oral administration as the delivery method [1] Group 2: Clinical Trial Insights - The clinical trial approval indicates that the optimal dosage for TFA003 will be confirmed after the completion of the clinical trials [1] - Preliminary pharmacodynamic and pharmacokinetic animal studies have shown that TFA003 significantly improves renal function indicators in urine and blood, enhances glomerular filtration and tubular reabsorption functions, and improves renal pathological morphology [1] - TFA003 demonstrates potential for development as a new Traditional Chinese Medicine for diabetic nephropathy [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Hangzhou Kangnbei Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of TFA003 tablets, which are aimed at treating diabetic nephropathy [1] Group 1 - The clinical trial approval is for TFA003 tablets, which are classified as traditional Chinese medicine under categories 2.1 and 2.3 [1] - The administration route for TFA003 is oral, and the optimal dosage will be confirmed after the completion of clinical trials [1] - Preliminary pharmacological and pharmacokinetic animal studies indicate that TFA003 has significant therapeutic effects on diabetic nephropathy, improving renal function indicators in urine and blood, as well as enhancing glomerular filtration and tubular reabsorption functions [1] Group 2 - The company has invested approximately RMB 29.57 million in the research and development of TFA003 to date [1] - The drug shows potential for development as a new traditional Chinese medicine for diabetic nephropathy based on its efficacy and safety profile demonstrated in preclinical studies [1]

春节团圆，少不了美食盛宴与走亲访友的热闹。但长途奔波、饮食油腻、作息紊乱等因素，让腹泻成为 春节期间的"高频困扰"，不仅打乱团圆节奏，还可能因肠道炎症引发持续不适。如何科学应对春节腹 泻，守护全家肠胃健康？专业医生提醒，除了做好预防，备好对症药物至关重要，康恩贝肠炎宁片凭 借"止泻快、能消肠炎、温和不刺激"的优势，成为不少家庭的春节必备好物。 春节期间腹泻高发，背后藏着多重诱因。一方面，团圆饭多是大鱼大肉、生冷辛辣兼具，暴饮暴食易加 重肠胃消化负担，刺激肠道黏膜引发炎症；另一方面，长途旅行中饮食卫生难以保障，不洁食物中的细 菌、病毒易侵入肠道，诱发感染性腹泻；此外，气温波动、熬夜守岁导致的免疫力下降，也让肠胃功能 变得脆弱，稍有不慎就会出现腹痛、腹泻等症状。 腹泻虽常见，却不能掉以轻心。频繁腹泻不仅会导致脱水、电解质紊乱，若伴随肠道炎症未及时干预， 还可能发展为慢性肠炎，影响后续消化功能。因此，一旦出现腹泻症状，需及时选择既能快速止泻，又 能消除肠道炎症的药物，避免"只止泻、不消炎"导致症状反复。 针对春节期间的肠胃需求，康恩贝肠炎宁片成为家庭常备的"肠胃守护者"。其核心优势在于采用纯中草 药配方，精选地锦草 ...