证券代码：002424 证券简称：贵州百灵 公告编号：2025-043 贵州百灵企业集团制药股份有限公司 关于全资子公司获得药物临床试验批准通知书的 公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 2025 年 10 月 15 日，贵州百灵企业集团制药股份有限公司（以 下简称"公司"）全资子公司百灵毓秀（珠海）医药有限公司（以下 简称"百灵毓秀"）收到国家药品监督管理局（NMPA）核准签发的《药 物临床试验批准通知书》（通知书编号：2025LP02703），由百灵毓秀 申报的糖宁通络片临床试验申请获得批准，同意本品开展用于 2 型糖 尿病的临床试验。现将相关情况公告如下： 一、药物基本信息 药品名称：糖宁通络片 剂型：片剂 受理号：CXZL2500055 申请人：百灵毓秀（珠海）医药有限公司 适应症：用于 2 型糖尿病（湿热蕴结证）的适应症 结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 糖宁通络片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 2 型糖尿病的临床试验。 本品曾于 2024 年获得用于 ...

Group 1 - The core point of the article is that Guizhou Bailing (002424.SZ) announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the clinical trial of Tangning Tongluo tablets, which are intended for the treatment of type 2 diabetes [1] Group 2 - The approval allows Bailing Yuxiu to conduct clinical trials for Tangning Tongluo tablets, marking a significant step in the company's development of diabetes treatment options [1]

Core Viewpoint - Guizhou Bailing (002424.SZ) announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the clinical trial of its drug, Tangning Tongluo Tablets, aimed at treating type 2 diabetes [1] Group 1 - The clinical trial application for Tangning Tongluo Tablets has been approved, allowing the drug to enter clinical trials for type 2 diabetes [1] - Tangning Tongluo Tablets is a Class 1 new traditional Chinese medicine that has been in development for over ten years and has been used in clinical settings since 2014 as a hospital preparation [1] - The drug has accumulated significant human usage experience and has shown good efficacy in improving symptoms and reversing biochemical indicators in both treated and untreated type 2 diabetes patients [1] Group 2 - The approval for the clinical trial of Tangning Tongluo Tablets is based on prior clinical research, and it is noteworthy that it is the first traditional Chinese medicine to transition from a hospital preparation to a new drug, bypassing Phase I and II trials to directly enter Phase III trials [1] - The drug is designed to adjust the body's endocrine functions, demonstrating its pharmacological effects in treating type 2 diabetes [1]

Core Viewpoint - Guizhou BaiLing's wholly-owned subsidiary has received approval for clinical trials of a new traditional Chinese medicine for type 2 diabetes, enhancing the company's product line in diabetes treatment [1] Group 1: Clinical Trial Approval - The company announced that its subsidiary BaiLing YuXiu received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration, allowing the clinical trial of Tang Ning Tong Luo Pian for type 2 diabetes [1] - This approval is based on over ten years of research and development, with the product already used in clinical settings since 2014 as a hospital preparation, accumulating significant human usage experience [1] Group 2: Product Development and Market Position - Tang Ning Tong Luo Pian is classified as a Class 1 traditional Chinese medicine and is notable for being the first to transition from a hospital preparation to a new drug under the "Special Regulations on the Registration of Traditional Chinese Medicine" [1] - The drug has demonstrated good efficacy in treating both treated and untreated type 2 diabetes patients by adjusting endocrine functions and improving disease symptoms, thus reversing biochemical indicators [1]

Core Viewpoint - Guizhou Bailing (002424.SZ) announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for the clinical trial of Tangning Tongluo tablets, which are intended for the treatment of type 2 diabetes [1] Group 1 - The clinical trial approval is a significant milestone for the company, indicating progress in its pharmaceutical development pipeline [1] - The approved clinical trial will focus on the efficacy and safety of Tangning Tongluo tablets in patients with type 2 diabetes [1] - This development may enhance the company's position in the diabetes treatment market, which is experiencing growing demand [1]

Core Viewpoint - Guizhou Bailing's subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its drug, Tangning Tongluo Pian, aimed at treating type 2 diabetes [1] Group 1: Company Developments - The clinical trial application for Tangning Tongluo Pian, a Class 1 new traditional Chinese medicine developed over ten years, has been approved for use in type 2 diabetes [1] - The drug previously received clinical trial approval in 2024 for non-proliferative diabetic retinopathy [1] - The current clinical trial will explore the drug's efficacy for type 2 diabetes with damp-heat syndrome, indicating an expansion of its therapeutic indications [1] Group 2: Product Efficacy - Tangning Tongluo Pian is designed as a pure traditional Chinese medicine to treat both treated and untreated type 2 diabetes patients [1] - The drug aims to adjust the body's endocrine functions, improve disease symptoms, and reverse biochemical indicators, demonstrating promising efficacy [1]

Core Insights - Guizhou Bailing reported that as of September 19, 2025, the total number of shareholders is 83,901 [2] Company Summary - Guizhou Bailing has engaged with investors through an interactive platform, providing updates on shareholder numbers [2] - The company is actively communicating with its investors, indicating a focus on transparency and shareholder engagement [2]

Core Viewpoint - Huachuang Yuxin (600155.SH) announced a lawsuit against Guizhou Bailing (002424.SZ) major shareholder Jiang Wei and his associates, involving a total amount of 1.761 billion yuan, which has attracted significant attention in the capital market [1] Company Overview - Guizhou Bailing, originally Anshun Pharmaceutical Factory, transformed from a loss-making entity to a leading national herbal medicine company under Jiang Wei's leadership, achieving a production value increase from 2 million to 10 million yuan in the same year [1] - The company went public in June 2010 and is known as the "first stock of herbal medicine," holding 167 approved drug licenses and 11% of the national herbal medicine licenses by 2018 [1] Financial Performance - Guizhou Bailing's stock price has declined significantly since 2017, with its market value shrinking to approximately 12 billion yuan by the end of 2018 [1] - From 2019 to 2021, Guizhou Bailing experienced a continuous decline in net profit, with decreases of 48.27%, 46.11%, and 18.49% respectively [2] - R&D investment dropped by 30% during the same period, contributing to a loss of market share and a more than 75% decline in net profit compared to its peak in 2018 [2] Debt and Legal Issues - The lawsuit stems from a 2019 financial support plan where Huachuang Securities provided 1.4 billion yuan to Jiang Wei, acquiring 11.54% equity in Guizhou Bailing [2] - Jiang Wei has reportedly paid approximately 2.1 billion yuan in interest and a total of 4.2 billion yuan in principal and interest by the second quarter of 2025 [3] - The lawsuit seeks repayment of the principal amount of 1.4 billion yuan and related costs due to insufficient stock value to recover the funds [3] Strategic Developments - Guizhou Bailing is expanding into international markets, establishing a company in Macau for overseas trade and registering products in various countries [4] - The company projects a revenue of 4 billion yuan and a net profit of 120 million yuan by 2025, aiming to enhance profitability through product integration [4] Market Performance - Since hitting a low in June 2024, Guizhou Bailing's stock has rebounded strongly, with an increase of nearly 90% from its previous low [5]

Group 1: Core Development Strategy - The core strategy revolves around four major platforms: scale manufacturing, industry chain integration, omnichannel sales, and large variety R&D [2][3] - The scale manufacturing platform aims to increase the company's herbal material processing capacity from 25,000 tons to 60,000 tons annually, supporting future sales growth [2][3] - The industry chain integration platform seeks to enhance product lines through licensing and branding strategies [2][3] Group 2: R&D Focus Areas - The company is focusing on the "Tian Ning Tong Luo" project for diabetes and its complications, which has over 10 years of clinical experience and is currently in Phase 3 clinical trials [3][4] - The "Huang Lian Jie Du Wan" project, a new type of traditional Chinese medicine, has completed Phase 2 and 3 clinical trials with 840 cases enrolled, targeting various diseases [4] Group 3: Sales and Marketing Optimization - High sales expense rates are attributed to a previous "big package" model, unclear product planning, and weak channel management [5] - The company is reforming its marketing system, transitioning from a big package model to a direct sales model, with 15 provinces already completed [5] - A market supervision department has been established to enhance oversight of business activities and financial management [5] Group 4: Financial Goals and Recovery Path - The revenue target for 2025 is projected at 4 billion CNY, with a net profit of 120 million CNY [6] - Recovery strategies include product price optimization, improving sales efficiency through direct sales reforms, and integrating advantageous products to enhance profitability [6] Group 5: Investment in Subsidiaries - Chengdu Zeling Biopharmaceutical Technology Co., Ltd. is a subsidiary in which the company holds a 17.6926% stake, focusing on innovative drug research and development [6]

Group 1 - The core viewpoint of the news highlights the financial performance and stock activity of Guizhou Bailing Pharmaceutical Co., Ltd. as of August 25, 2025, showing a stock price of 6.25 yuan, a 1.79% increase, and a trading volume of 48.40 million shares with a transaction value of 300 million yuan [1] - The company reported total operating revenue of 1.462 billion yuan for the first half of 2025, a year-on-year decrease of 31.77%, and a net profit attributable to shareholders of 51.83 million yuan, down 40.73% year-on-year [1] - The company's liquidity ratios include a current ratio of 1.005 and a quick ratio of 0.746, with a debt-to-asset ratio of 52.26% [1] Group 2 - Guizhou Bailing has made investments in 26 companies and participated in 5,000 bidding projects, indicating active engagement in business expansion [2] - The company holds 371 trademark registrations and 253 patents, reflecting its focus on intellectual property and innovation [2] - Additionally, Guizhou Bailing possesses 397 administrative licenses, showcasing its compliance and operational capabilities [2]