证券简称：康缘药业 证券代码：600557 公告编号：2025-028 江苏康缘药业股份有限公司 关于收到健脾疏肝固本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。 健脾疏肝固本颗粒处方源于临床经验方，功能主治为舒肝健脾缓急，温肾燥湿固 本。用于腹泻型肠易激综合征肝郁脾虚证，症见腹痛，腹胀，腹泻，泻后痛减，心烦 易怒，神疲乏力，纳呆食少，肠鸣矢气，便下黏液等。 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 签发的健脾疏肝固本颗粒《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： 一、《药物临床试验批准通知书》主要内容 药品名称 健脾疏肝固本颗粒 适应症 腹泻型肠易激综合征肝郁脾虚证 注册分类 中药创新药 1.1 类 剂型 颗粒剂 申请人 江苏康缘药业股份有限公司 受理号 CXZL2500032 通知书编号 2025LP02056 健脾疏肝固本颗粒审批结论：根据《中华人民共和国药品管理法》及有关 ...

康缘药业(600557.SH)公告称，近日收到国家药品监督管理局签发的健脾疏肝固本颗粒《药物临床试验 批准通知书》。该药品为中药创新药1.1类，适应症为腹泻型肠易激综合征肝郁脾虚证。公司拥有该新 药独立完整的知识产权，累计研发投入约782万元。健脾疏肝固本颗粒在临床前主要药效学研究中表现 出良好的治疗效果和安全性。目前国内市场上尚无针对"健脾温肾、舒肝理气"的药物，预计该药品具有 良好的市场前景。 ...

Summary of Tianjin Tasly Pharmaceutical Conference Call Company Overview - **Company**: Tianjin Tasly Pharmaceutical - **Industry**: Traditional Chinese Medicine, Biopharmaceuticals, Chemical Pharmaceuticals Key Points and Arguments Performance and Growth - Tianjin Tasly has effectively absorbed the impact of centralized procurement on its flagship product, Compound Danshen Dripping Pills, and expects steady growth moving forward [2][3] - The company is experiencing overall stable growth, with a strong focus on traditional Chinese medicine innovation and new indications for existing products [2][4] Product Focus and Revenue Contribution - The company is concentrating on cardiovascular, digestive metabolism, tumor immunity, and liver disease treatment areas, with cardiovascular products contributing significantly to revenue [2][8] - Compound Danshen Dripping Pills has surpassed sales of 2 billion, with the price drop effects being gradually absorbed [2][9] - The market potential for diabetic retinopathy (糖网) is substantial, with projected sales exceeding 2 billion [2][10] Strategic Partnerships - The acquisition by China Resources Sanjiu is expected to enhance Tianjin Tasly's performance in the outpatient market, leveraging Sanjiu's strengths in retail channels and brand development [2][5][6] Financial Outlook - The company is streamlining operations and focusing on core business areas, leading to improved profitability [2][7] - Projected net profit for 2025 is estimated at 1.15 billion, corresponding to a market valuation of 22 times [2][7][15] Product Pipeline and Innovation - The biopharmaceutical segment's core product, ProUK, has stabilized its decline, with expectations for steady growth in myocardial infarction indications and potential approval for cerebral infarction in 2025 [2][13][14] - The company is actively developing multiple innovative drug pipelines, including stem cell and CAR-T therapies, which are anticipated to contribute positively to future earnings [2][15] Risks and Challenges - The company faces industry policy risks, market competition risks, and research and development risks, which investors should monitor [2][16] Other Notable Products - Other products like Yangxue Qingnao and Qi Li Yi Qi are expected to grow steadily, with potential growth rates possibly exceeding that of Compound Danshen Dripping Pills due to their urgent demand and established market presence [2][12] Conclusion - Tianjin Tasly Pharmaceutical is positioned for stable growth with a strong product pipeline and strategic partnerships, despite facing certain industry risks. The focus on innovation and market expansion, particularly in the outpatient sector, presents significant opportunities for future profitability.

Investment Rating - The report maintains an "Outperform" rating for the biopharmaceutical industry [1] Core Insights - The market for traditional Chinese medicine (TCM) in musculoskeletal diseases is expected to grow significantly due to an aging population and increasing prevalence of related conditions [2][18] - The oral medication segment presents structural opportunities, while external patches are anticipated to continue expanding [3][32] Summary by Sections 1. Demand Growth in Musculoskeletal TCM Market - The aging population in China reached 202 million people aged 65 and above in 2023, leading to a rise in musculoskeletal disorders [2][18] - The penetration rate of musculoskeletal pain among the population aged 56 and above is 60.8%, while it is 42.2% among those aged 35 and below, indicating a younger demographic is increasingly affected [2][23] - The global pain management drug market is projected to reach $110.4 billion by 2030, with significant growth potential in China compared to markets in the US and Japan [2][28] 2. Structural Opportunities in Oral Medications - The oral TCM market is stable, with the top 10 products each generating sales below 1 billion yuan, indicating a lack of large-scale products [3][47] - Three innovative TCM products in the musculoskeletal field are expected to be approved and enter the national medical insurance directory from 2020 to 2024, which may lead to rapid market growth [3][53] - The basic drug policy aims to increase the usage of essential medicines, providing a competitive advantage for unique insurance products [3][69] 3. Expansion of External Patches - Compared to mature markets like Japan and South Korea, China's external patch market has significant room for growth, with external patches likely to gradually replace oral medications [3][30] - The concentration of external patches in public medical institutions and retail pharmacies is high, allowing leading companies to increase their market share [3][30] - Price increases are expected to continue driving growth in the external patch industry [3][32] 4. Investment Recommendations - Companies to watch include Fangsheng Pharmaceutical, Panlong Pharmaceutical, Lingrui Pharmaceutical, and Qizheng Tibetan Medicine, which have significant advantages in musculoskeletal TCM products [4]

Core Viewpoint - Fangsheng Pharmaceutical (603998) announced that its wholly-owned subsidiary, Yunnan Fangsheng Ronghe Pharmaceutical Co., Ltd., has received the clinical trial approval notice from the National Medical Products Administration for the innovative traditional Chinese medicine, Xiangqin Jietuo Granules, which is intended for the treatment of adult influenza with damp-heat syndrome [1] Company Summary - The innovative drug Xiangqin Jietuo Granules is classified as a Category 1 traditional Chinese medicine and is currently not available in domestic or international markets [1] - As of June 30, 2025, the cumulative research and development investment for this drug project is approximately 16.0569 million yuan [1] Industry Summary - Traditional Chinese medicine is widely used in the treatment of respiratory diseases, with sales of traditional Chinese medicine for respiratory conditions exceeding 80 billion yuan across three major terminals and six major markets in China in recent years [1]

Core Viewpoint - The innovative traditional Chinese medicine (TCM) product Yiqi Tongqiao Wan has successfully completed phase III clinical trials and is now available for treating allergic rhinitis, with plans for a large-scale real-world study involving 10,000 samples to validate its clinical efficacy [1][3]. Group 1: Product Development and Efficacy - Yiqi Tongqiao Wan is developed by integrating modern medicinal components from the effective formula "Allergy Decoction" and employs modern pharmaceutical techniques [2]. - Clinical trial results show significant efficacy, with a nasal discharge symptom disappearance rate of 52.65% and a tear symptom disappearance rate of 80.97%. Additionally, 30% of patients did not experience a recurrence of rhinitis within a year after two weeks of treatment [3]. Group 2: Quality Control and Technological Integration - The quality of raw materials is crucial for modern pharmaceutical companies, and Yiqi Tongqiao Wan's 14 ingredients are sourced from high-quality regions and standardized cultivation bases [5]. - The production process utilizes digital technology for quality traceability throughout the entire supply chain, enhancing the stability and uniformity of the extract's quality [5][6]. Group 3: Market Expansion and Cultural Promotion - The company is expanding the application of TCM by developing diverse product lines, including health foods and beverages that incorporate TCM ingredients [8]. - Efforts to promote TCM culture include public health services and community engagement activities, aiming to enhance public understanding and acceptance of TCM [8].

Group 1 - The company has received a notice of acceptance for the registration application of "Children's Constipation Granules" from the National Medical Products Administration, marking the entry into the review stage for domestic production registration [1][2] - The product is derived from a patented formula by Dr. Chen Yonghui, aimed at treating pediatric constipation with specific efficacy in strengthening the spleen and stomach, and promoting digestion [1][2] - Currently, there are no similar registered products in China specifically for treating pediatric constipation, positioning this product as a potential first in its category following the release of new clinical guidelines in 2024 [2] Group 2 - The project has accumulated an investment of approximately 51.42 million yuan [2] - The acceptance of the registration application does not have a significant immediate impact on the company's current performance, but the sales post-launch may be subject to various market factors [2]

Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, highlighting innovative drugs and left-side sector recovery as the main investment opportunities [4][44]. Core Insights - The innovative drug sector remains in a high prosperity state, with significant collaborations continuing to emerge. The upcoming 85th American Diabetes Association (ADA) Scientific Sessions in June 2025 is expected to provide important clinical and research updates from endocrine and metabolic drug companies, suggesting investment opportunities in this area [11][44]. - The report emphasizes the increasing approval and quality of new drugs in China, indicating a recovery in the innovative drug sector that has been undervalued for several years. The global recognition of China's technological capabilities is also drawing renewed attention from capital markets towards domestic pharmaceutical companies [27][44]. - The report suggests focusing on leading companies with international expansion and innovation progress, such as Heng Rui Medicine, BeiGene, Innovent Biologics, and others, as well as ADC leaders like Keren Pharmaceutical and Bai Li Tianheng [27][44]. Summary by Sections Pharmaceutical Sector - UroGen Pharma's FDA approval of Zusduri, the first and only drug for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, marks a significant breakthrough in drug delivery systems [20][21]. - The report highlights the progress in chronic disease metabolism, with Eli Lilly's oral Lp(a) lowering drug being considered for breakthrough therapy designation, indicating a growing pipeline of innovative treatments [23][27]. - Merck's oral PCSK9 inhibitor Enlicitide has shown positive results in Phase III trials, representing a significant advancement in cholesterol management therapies [28][29]. Medical Devices - The launch of the MAGLUMI X10, a high-speed automated chemiluminescence immunoassay analyzer, reflects the increasing demand for innovative medical devices in China [33][35]. - The investment by Xianjian Technology in Jianhu Medical to develop electrophysiology products indicates a strategic move to enhance capabilities in high-end medical devices [36][38]. Medical Services - The successful initiation of China's first invasive brain-computer interface clinical trial signifies a major advancement in medical technology, with potential applications for improving the quality of life for patients with spinal cord injuries and amputations [39][40]. - The report anticipates rapid growth in related industries, including high-end imaging equipment and surgical robots, driven by technological advancements and policy support [40]. Traditional Chinese Medicine - The approval of Fangsheng Pharmaceutical's innovative traditional Chinese medicine product marks a significant step in the development of new drugs in this sector, with an expected increase in new drug applications in the coming years [41][43].

Group 1: Company Performance Overview - The company expects a double-digit revenue growth in 2025, with net profit matching revenue growth levels [3] - In Q1, the incidence of flu and respiratory diseases decreased compared to last year, leading to a slight adjustment in performance due to high base effects [2] - The CHC (Consumer Health Care) business is anticipated to have market opportunities in categories such as cold, skin, gastrointestinal, and orthopedics throughout the year [2] Group 2: CHC Business Development - The CHC business has entered a multi-category development phase, expanding beyond the core three categories to include pediatrics, orthopedics, liver and gallbladder, and gynecology [4] - The company aims to enhance its product line and market share in pediatric cold medications despite facing some pressure [4] - New products like the vitamin D drops are being introduced to support pediatric category growth [4] Group 3: Prescription Drug Strategy - The prescription drug business is developing steadily, with a focus on adapting to policy changes such as centralized procurement [6] - The company aims to increase the proportion of innovative drugs in its prescription drug portfolio [7] - The integration with Tianjin Pharmaceutical is expected to enhance the company's brand influence in the medical sector [7] Group 4: Online Business Growth - The company has seen rapid growth in its online business, targeting a 10% share by 2025 [8] Group 5: Mergers and Acquisitions - The company plans to pursue both internal and external growth strategies, focusing on mergers and acquisitions in strategic emerging industries [9] Group 6: Shareholder Engagement and Dividends - The company has a stable cash dividend ratio of 50% and aims to enhance shareholder satisfaction through its incentive plans [10] Group 7: Future Integration with Tianjin Pharmaceutical - The focus will be on innovation-driven business development in key therapeutic areas, enhancing R&D capabilities, and fostering collaboration between Tianjin Pharmaceutical and the company [12] Group 8: Formula Granules Business Outlook - The formula granules business is expected to achieve recovery growth in 2024 and maintain growth in 2025, despite being affected by policy changes [13]

Core Viewpoint - The Chinese medicine sector is experiencing a collective pullback in the A-share market, while the Chinese Medicine ETF (560080) has shown resilience, rising nearly 1% and reaching a new high since January 8 of this year [1] Company News - Huawen Pharmaceutical announced the approval from the Singapore Health Sciences Authority for the registration of its traditional Chinese medicine, Tongxie Ning Granules, for sale in Singapore. This marks the fourth overseas registration for the company, following previous approvals for other products [3] - Tongxie Ning Granules is the first natural plant medicine globally for treating IBS-D, demonstrating significant efficacy and high safety, with the ability to prevent recurrence [3] Industry Insights - Huafu Securities indicates that the pressure from high base numbers in the Chinese medicine sector has cleared in the first quarter, with expectations for gradual improvement in performance from Q2 to Q3 of 2025 due to low valuation and low allocation [4] - The firm identifies three major catalysts for the Chinese medicine industry: 1. Accelerated approval and market entry of innovative Chinese medicines, with 9 new drugs approved in 2023 and an expected increase to 16 in 2024 [6] 2. Anticipated adjustments to the essential drug catalog, which will favor innovative Chinese medicines, with a significant increase in the number of traditional Chinese medicine varieties included [6] 3. A decline in the prices of Chinese medicinal materials and expectations for product price increases, which could enhance performance for companies using these materials [7] Key Indicators - The core indicators for the Chinese medicine sector include flu data and the price index of medicinal materials. The flu cases have returned to normal levels, and the pressure on revenue growth for most companies is expected to ease from Q2 2025 [8] - The price index of medicinal materials has been declining since mid-July 2024, with common materials like Lianqiao and Dangshen also showing price decreases, which may alleviate gross margin pressures for companies in 2025 [8]