公司在回复中同时表示，在呼吸道合胞病毒方面，金振口服液对呼吸道合胞病毒有显著抑制作用，可以 改善肺组织的炎性浸润，减少气道炎性反应，降低神经源性介质，调节咳嗽敏感性从而发挥止咳作用； 在流感方面，可以抑制流感病毒H1N1、H3N2，包括耐药病毒株，显著减轻流感导致的肺组织损伤，调 控炎症平衡，调节肠道菌群及机体免疫功能。 目前，金振口服液已被列入《手足口病中西医结合诊疗指南（2024年版）》《儿童呼吸道感染后咳嗽中 西医结合诊治专家共识（2024年版）》《儿童肺炎支原体肺炎诊疗指南（2025年版）》等多项指南共 识。 中证报中证网讯（记者 孟培嘉）近日，投资者在上交所e互动平台向康缘药业提问"面对秋冬流感多 发，公司抗病毒、抗流感产品热毒宁注射液和金振口服液11月销量情况"，康缘药业回复称金振口服液 等产品四季度市场需求回暖，公司正加紧排产来满足市场需求。 康缘药业在回复中表示，公司在呼吸与感染性疾病领域已建立丰富产品组合，包括热毒宁注射液、金振 口服液、杏贝止咳颗粒、散寒化湿颗粒、银翘清热片、温阳解毒颗粒等。 公开资料显示，2024年康缘药业总营收为38.98亿元，其中金振口服液销售量同比增长5.13%、实 ...

Core Viewpoint - The company is closely monitoring the recent announcement from the National Medical Products Administration regarding the public consultation on policies related to traditional Chinese medicine injections, indicating a proactive approach to regulatory changes [2]. Company Summary - Kangyuan Pharmaceutical has acknowledged the recent draft announcement from the National Medical Products Administration and is in the process of monitoring its developments [2]. - The company's core product, Rendu Ning injection, has accumulated years of evidence regarding its clinical value, safety, and efficacy, and is included in several authoritative guidelines [2]. - The company believes that the government's initiative to advance the research and evaluation of traditional Chinese medicine injections aims to promote industry competition and high-quality development [2]. - The company plans to leverage this opportunity to continue driving technological innovation and support the sustainable development of the traditional Chinese medicine industry [2].

Core Insights - Kangyuan Pharmaceutical reported a significant decline in both revenue and net profit for the first three quarters of 2025, with revenue at 2.00 billion yuan, down 35.63% year-on-year [1] - The company faced challenges due to a complex external environment and changes in pharmaceutical industry policies, leading to a strategic adjustment in sales and increased academic promotion efforts [1] Revenue Performance - For the first three quarters of 2025, the company's total revenue was 2.343 billion yuan, a decrease of 24.59% year-on-year [1] - In Q3 2025, revenue was 701 million yuan, down 17.42% year-on-year [1] - Injection products saw a revenue drop of 31.23% to 770 million yuan, while oral products decreased by 24.24% to 1.359 billion yuan; however, external products grew by 10.38% to 186 million yuan [2] Profitability - The net profit attributable to the parent company for the first three quarters was 200 million yuan, a decline of 35.63% year-on-year [1] - In Q3 2025, the net profit was 57.27 million yuan, down 20.88% year-on-year [1] Product Performance - Sales of core products such as Heat Toxicity Ning Injection and Jin Zhen Oral Liquid declined due to fluctuations in terminal market demand [1] - The company is focusing on a specialized and academic transformation, with stable sales growth in orthopedic products like Compound Naxing Pain Relief Plaster and Waist Pain Relief Capsules [1] - The introduction of specialized agents for kidney disease has led to steady sales growth for Can Wu Yi Shen Pian [1]

Core Viewpoint - The company reported a decline in revenue and net profit for the third quarter of 2025 due to external market conditions and changes in the pharmaceutical industry policy, despite efforts to adjust sales strategies and enhance academic promotion [7][13]. Financial Performance - The company's revenue from injection products decreased by 31.23% compared to the same period last year, while the cost of sales for these products fell by 34.10%, primarily due to a decline in sales of the core product, Heat Poisoning Ning Injection [13]. Business Strategy - The company is focusing on a specialized and academic transformation, implementing line management for the marketing team, which has led to stable sales growth in orthopedic products such as Compound Nanshing Pain Relief Plaster and Waist Pain Relief Capsules [7]. - The company is enhancing customer maintenance and development through a professional academic promotion team, aiming to effectively communicate clinical research results to target doctors and healthcare professionals [7]. Market Expansion - The company is diversifying its channels in the external market, with a focus on restoring terminal sales of key products and strengthening comprehensive evaluations and graded management of agents [8]. - In the new retail sector, the company is integrating O2O, B2C self-operated, and third-party channel resources to enhance brand strength and sales through various promotional activities [8]. R&D Innovations - The company has made progress in R&D, with several new drugs approved for market, including a Class 1 new drug for treating pelvic inflammatory disease and a Class 1 innovative drug for treating atopic dermatitis [8]. - Ongoing clinical trials for innovative drugs targeting obesity and type 2 diabetes are progressing as planned, with the aim of entering Phase III clinical trials in the third quarter of 2026 [9].

Core Insights - The company reported a revenue of 701 million yuan and a net profit attributable to shareholders of 57.27 million yuan for Q3 2025, facing performance pressure due to external environment complexities and market demand fluctuations [1] - Despite challenges, the company is not slowing down its development pace and is focusing on strengthening its operational foundation for future growth [1] Academic Marketing and Product Value - The company is enhancing its academic marketing system by focusing on evidence-based research, updating academic materials, and promoting products into authoritative guidelines [2] - A total of 248 sets of academic materials have been updated, covering key product lines such as respiratory and cardiovascular diseases, which align clinical value with market needs [2] - The company has successfully integrated 10 core products into 6 authoritative guidelines, which is expected to boost prescription willingness among doctors and drive sales growth [2] Diversified Sales Channels - To mitigate risks from single-channel dependency, the company is actively developing a multi-faceted sales strategy, including agency recruitment, OTC, channel sales, and clinic distribution [3] - The company is enhancing the quality and academic promotion capabilities of its agents through standardized admission criteria and professional training [3] - In the OTC sector, the company is focusing on core products and collaborating with new retail channels to stabilize market prices while achieving success in expanding into small chain and generic drug markets [3] Operational Improvements and Future Outlook - The company is strengthening evidence-based medical support and building an academic marketing team to enhance professional and academic capabilities [4] - Despite facing performance pressure, the company is implementing precise measures to solidify its operational foundation, showing signs of marginal improvement in its fundamentals [4] - With the continued expansion of terminal coverage for core products and the gradual release of academic promotion effects, the company is expected to gradually reverse the performance volatility and achieve more stable growth [4]

江苏康缘药业股份有限公司 关于 2025 年前三季度主要经营数据的公告 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"）根据上海证券交易所发布 的《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， 现将公司 2025 年前三季度主要经营数据披露如下： 证券简称：康缘药业 证券代码：600557 公告编号：2025-034 单位：元 币种：人民币 | | | 主营业务分行业情况 | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | | | 营业收入 | 营业成本 | | | 分行业 | 营业收入 | 营业成本 | 毛利 | 比上年同 | 比上年同 | 毛利率比上年同期增 | | | | | 率（%） | 期增减 | 期增减 | 减（%） | | | | | | （%） | （%） | | | 工业销售 | 2,315,350,747.40 | 696,926,494.03 | 69.90 | -2 ...

Core Viewpoint - The National Medical Products Administration (NMPA) of China is accelerating the post-marketing research and evaluation of traditional Chinese medicine (TCM) injections, signaling a push for improved safety and efficacy standards in the industry [1][5][9]. Regulatory Developments - The NMPA, along with the National Health Commission and the State Administration of Traditional Chinese Medicine, has drafted a proposal to enhance post-marketing research for TCM injections, which is currently open for public consultation [1][5]. - A "淘汰令" (elimination order) has been introduced, stating that TCM injections that do not comply with research and evaluation requirements may face deregistration or cancellation of their drug registration certificates [5][7]. Industry Context - TCM injections have been controversial in China, with a history of safety concerns, including reported deaths following their use. The NMPA has highlighted the need for ongoing monitoring and evaluation of these products [3][5]. - The market for TCM injections has grown significantly, with annual sales exceeding 100 billion RMB, indicating a substantial commercial scale despite regulatory scrutiny [3][9]. Product Focus - The proposal prioritizes TCM injections listed in the National Essential Medicines List and the National Medical Insurance Catalog, such as Qingkailing Injection and Heduoning Injection, for post-marketing research [6][7]. - The National Essential Medicines List includes 10 TCM injections, while the National Medical Insurance Catalog includes 58, indicating a broad scope for evaluation [7]. Market Impact - The acceleration of post-marketing research may lead to the exit of less viable products from the market, promoting a competitive environment that favors high-quality offerings [8][9]. - Major TCM injections have historically generated significant revenue, with products like Qingkailing Injection projected to exceed 1 billion RMB in sales in 2024 [9][11]. Historical Context - Previous regulatory actions have included the proposal to eliminate certain TCM injection products, reflecting ongoing efforts to ensure safety and efficacy in the market [12][13].

Core Viewpoint - Innovation has become the core driving force for the development of companies in the pharmaceutical industry, as exemplified by Kangyuan Pharmaceutical's strategic focus on innovation and quality to explore new growth points and protect its existing market position [1][7]. Financial Performance and R&D Investment - In the first half of 2025, Kangyuan Pharmaceutical achieved revenue of 1.642 billion yuan, with R&D investment accounting for 15.02% of revenue, maintaining a high level compared to industry standards [1][2]. - The company has seen a steady increase in R&D investment ratio over the past three years, with a current R&D team of 782 people, indicating strong talent reserves and investment intensity [2]. R&D Pipeline and Strategy - Kangyuan Pharmaceutical has a rich product pipeline, with 28 products in preclinical stages, 15 in Phase I, 12 in Phase II, and 8 in Phase III, covering multiple therapeutic areas [2]. - The company emphasizes deep development and value re-creation of existing products, exploring new indications and technological upgrades to extend product life cycles [2][5]. - The strategic focus is on unmet clinical needs, aiming to develop innovative drugs with significant clinical value and unique advantages [2]. Unique R&D Framework - The company has established a unique "industry-university-research-application" integrated R&D system, collaborating closely with top institutions like Nanjing University of Chinese Medicine and Shanghai Institute of Materia Medica [3]. - Kangyuan Pharmaceutical leads the "National Key Laboratory of Process Control and Intelligent Manufacturing Technology for Traditional Chinese Medicine," addressing key technical challenges in the pharmaceutical process [3]. Innovation Achievements - Kangyuan Pharmaceutical has maintained a leading position in TCM innovation, with 58 new TCM drugs, 47 of which are exclusive varieties [4]. - The approval of the TCM new drug Yunu Jian Granules exemplifies the modernization of ancient classic formulas [4]. - The company has made significant breakthroughs in chemical and biological drugs, with KYS2301 gel being the world's first CCR8 peptide inhibitor approved for clinical trials [4]. Market Strategy and Future Outlook - The company adopts a "one body, two wings" development strategy, focusing on TCM while expanding into chemical and biological drugs, particularly in gynecology, respiratory, and cardiovascular fields [6]. - Kangyuan Pharmaceutical is progressing in internationalization with a dual reporting strategy in China and the U.S., marking new advancements in its international market expansion [6]. - The period of 2025-2026 is expected to be crucial for the company's R&D output, with key milestones anticipated in clinical data and product launches [6]. Strategic Balance - Kangyuan Pharmaceutical's strategy balances innovation and tradition, allowing it to navigate industry policy changes and market competition effectively [7]. - The company's 15.02% R&D investment is viewed as essential ammunition for its long-term strategic "offensive and defensive" approach [7].

Core Viewpoint - Kangyuan Pharmaceutical has reported a significant decline in performance for the first half of 2025, with a notable drop in both revenue and net profit, raising concerns about its future growth potential and operational efficiency [1] Financial Performance - The company achieved a revenue of 1.642 billion yuan, a year-on-year decrease of 27.29% [1] - The net profit attributable to shareholders was 142 million yuan, down 40.12% year-on-year [1] - In Q1 2025, revenue was 878 million yuan, a decline of 35.38%, with net profit at 83.41 million yuan, down 38.37% [1] - Q2 revenue was 760 million yuan, a year-on-year decrease of 15.09% [1] Product Line Performance - The main product lines experienced a comprehensive decline, with injection solutions generating approximately 506 million yuan, a drop of 39.73% [1] - Oral solutions saw a revenue of 279 million yuan, down 48.78%, marking the largest decline among product lines [1] - Capsule, granule, and powder solutions also performed poorly, with revenues of 383 million yuan and 134 million yuan, reflecting declines of 4.78% and 17.61% respectively [1] Cost Management - To address the performance decline, the company significantly reduced expenses, with sales expenses dropping from 854 million yuan to 571 million yuan, a decrease of 33.13% [1] - Management expenses fell from 211 million yuan to 167 million yuan, down 21.05% [1] - R&D expenses also saw a reduction of over 30%, raising concerns about the company's long-term innovation capabilities [1] Strategic Moves - The company recently completed the acquisition of Jiangsu Zhongxin Pharmaceutical Co., Ltd. for 270 million yuan, which is seen as a move towards innovation in biopharmaceuticals [1] - However, the acquisition has raised market concerns due to high premiums and the lack of commercialized products from the acquired company [1] - The company has faced regulatory scrutiny, receiving multiple notices regarding related party transactions, indicating potential governance and internal control issues [1]

Core Viewpoint - Kangyuan Pharmaceutical (600557.SH) has reported its 2025 semi-annual results, showing pressure on performance but significant advancements in R&D innovation, attracting attention from major securities firms for potential value reassessment [1] Group 1: Company Overview - Kangyuan Pharmaceutical is a leading enterprise in the Chinese traditional medicine sector, with core products including Re Du Ning Injection, Jin Zhen Oral Liquid, and Ginkgo Biloba Diterpene Glycoside Injection [1] - The company follows a strategic framework of "one body and two wings," focusing on traditional Chinese medicine while expanding into chemical and biological drugs [1] Group 2: R&D Innovations - The company has expanded its innovative business layout, acquiring 100% of Zhongxin Pharmaceutical for 270 million yuan to enhance its biological drug portfolio, particularly in the metabolic field [1] - Zhongxin Pharmaceutical is developing ZX2021, a long-acting weight loss (anti-diabetic) fusion protein targeting three pathways, which has shown promising results in clinical trials [1][2] Group 3: Market Potential - The market for type 2 diabetes and obesity drugs in China is projected to reach 109.8 billion yuan and 47.2 billion yuan by 2032, with GLP-1 drugs becoming mainstream [2] - Kangyuan Pharmaceutical aims to enter the lucrative metabolic sector with its dual-target and tri-target drugs from Zhongxin Pharmaceutical [2] Group 4: Clinical Development - The company has made significant progress in its self-developed products, with five drugs approved for IND and nine drugs in clinical phases III and above, all being traditional Chinese medicine [3] - In the chemical and biological drug sector, a key product targeting Alzheimer's disease has completed phase II clinical trials and is expected to start phase III trials within the year [3] Group 5: Institutional Support - The company has received recommendations from approximately 10 securities firms, with 16 research reports published this year, emphasizing its innovative R&D pipeline [3] - Despite facing complex internal and external challenges, the company is enhancing its professional and compliant marketing strategies, which are expected to support its long-term healthy development [3]