Core Viewpoint - Kangzhi Pharmaceutical has received approval from the National Medical Products Administration for its traditional Chinese medicine "Cough Orange Granules" to conduct clinical trials for new indications [1] Summary by Categories Product Development - The approval allows the company to conduct clinical trials for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstructing the lungs [1] - "Cough Orange Granules" is already a product that has been produced and sold by the company, previously classified as a national secondary protected traditional Chinese medicine [1] Regulatory Approval - The clinical trial application was deemed to meet the requirements for drug registration, indicating a positive regulatory response to the company's submission [1] - The approval is based on the latest clinical research and expert consensus, showcasing the company's commitment to expanding the therapeutic applications of its products [1]

Core Points - Kangzhi Pharmaceutical has received approval from the National Medical Products Administration for its "Cough Orange Granules" clinical trial [2] Group 1 - The company announced the approval of its clinical trial application for "Cough Orange Granules" [2]

Core Viewpoint - Kangzhi Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its product "Cough Orange Granules," which is already in production and sale [2]. Group 1 - The product "Cough Orange Granules" is a national secondary protected traditional Chinese medicine, with its protection period ending on September 13, 2016 [2]. - The current therapeutic functions of the product include "clearing the lungs, relieving cough, and resolving phlegm," specifically for cough with phlegm due to phlegm-heat obstructing the lungs, chest fullness, shortness of breath, and dry throat [2]. - The company has submitted a clinical trial application to add a new indication for "acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstructing the lungs" based on recent clinical research and expert consensus [2].

Core Viewpoint - Kangzhi Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of "Cough Orange Granules" aimed at treating acute exacerbations of chronic obstructive pulmonary disease [1] Group 1 - The company announced the approval of the clinical trial for "Cough Orange Granules" [1] - The clinical trial will focus on patients with acute exacerbations of chronic obstructive pulmonary disease characterized by phlegm heat obstructing the lungs [1] - The company will further refine the clinical trial protocol before proceeding [1]

Core Viewpoint - Kangzhi Pharmaceutical has received approval from the National Medical Products Administration for its "Cough Orange Granules" to conduct clinical trials for chronic obstructive pulmonary disease during acute exacerbation [1] Group 1 - The company has been granted a "Drug Clinical Trial Approval Notice" for its product [1] - The clinical trial will focus on the application of Cough Orange Granules for acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat obstructing the lung syndrome) [1] - The company is in the process of further refining the clinical trial protocol [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its product "Cough Orange Granules," which is already in production and sales [1] Group 1: Product Information - "Cough Orange Granules" is a national secondary protected traditional Chinese medicine with functions for "clearing the lungs, stopping cough, and resolving phlegm" [1] - The product is indicated for cough with phlegm due to phlegm-heat obstructing the lungs, characterized by symptoms such as excessive phlegm, chest fullness, shortness of breath, dry throat, and itching [1] Group 2: Clinical Trial Approval - The company submitted an application to add a new indication for "acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat obstructing the lungs)" and received approval for clinical trials [1] - This approval represents a milestone in the company's drug development efforts [1] Group 3: Financial Impact - The approval of the clinical trial does not have a significant impact on the company's short-term financial status or operating performance [1] - The sales of the product will not be affected by the receipt of the clinical trial approval notification [1]

Core Viewpoint - Kangzhi Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of its product "Cough Orange Granules," which is already in production and sales [1] Group 1: Product Information - "Cough Orange Granules" is a product with the approval number Z10980105 and is classified as a national secondary protected traditional Chinese medicine, with its protection period ending on September 13, 2016 [1] - The current indications for the product include "clearing the lungs, stopping cough, and resolving phlegm," specifically for cough with phlegm due to phlegm-heat obstructing the lungs, characterized by excessive phlegm, chest fullness, shortness of breath, and dry throat [1] Group 2: Clinical Trial Approval - The company submitted a clinical trial application to add a new indication for "acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat obstructing the lungs)" based on the latest clinical research and expert consensus [1] - The approval for the clinical trial signifies a potential expansion of the product's therapeutic applications [1]

Core Viewpoint - Kangzhi Pharmaceutical (300086.SZ) has received approval from the National Medical Products Administration for clinical trials of its "Cough Orange Granules" for use in acute exacerbations of chronic obstructive pulmonary disease (COPD) [1] Group 1 - The product "Cough Orange Granules" is already in production and on sale [1] - It was previously classified as a national secondary protected traditional Chinese medicine [1]

Group 1: Product Overview - The company produces over 50 types of medicines, with more than 100 specifications, of which over 30 are pediatric drugs, covering the highest proportion of respiratory, digestive, anti-allergy, antibiotic, and nutritional supplements for children [1] - Pediatric drugs account for approximately 70% of the company's product mix, while adult drugs, including gynecological products, make up about 30% [1] Group 2: Market Potential - China's medical expenditure is expected to grow significantly, driven by increasing health awareness and a large base of approximately 250 million children aged 0-14, despite a declining birth rate [2] - The demand for pediatric medicines is stable, supported by parents' increasing focus on children's health, with certain segments like ADHD showing rising demand [2] Group 3: R&D Focus - The company has over 30 years of experience in pediatric drug R&D, continuously innovating in taste, dosage forms, and packaging to enhance competitiveness [2] - Future R&D will focus on pediatric medications, emphasizing dosage form innovation and expanding the pediatric population for existing drugs [4][5] Group 4: Sales Strategy - The company plans to enhance its sales channels, including increasing online sales and participating in national medical insurance negotiations [6] - The company is exploring acquisition opportunities primarily in the children's health sector, focusing on technology complementarity and channel synergy [7]

Group 1: Investor Relations Activity - The investor relations activity was conducted as an earnings briefing on May 13, 2025, from 14:00 to 17:00 via an online platform [2] - The meeting was attended by key company representatives including the Chairman, independent directors, and financial executives [2] Group 2: Product Launch and Development - The company is preparing to launch the product "Reyaning Granules" by July to August 2025 [2] - The company emphasizes its commitment to the development of traditional Chinese medicine, focusing on secondary development of existing products [2] Group 3: Current Product Offerings - The company currently produces and sells various traditional Chinese medicine products, including: - Zhenrong Dan Decoction - Cough Orange Granules - Antiviral Oral Liquid - Cold and Heat Relief Granules - Children's Heat Relief Granules - And several others [3]