Core Points - The 2025 National Medical Insurance Directory negotiations have officially commenced, highlighting the importance of pharmaceutical innovation and patient access to medications [1] - The atmosphere at the negotiations is characterized by a cautious and low-key approach from pharmaceutical representatives, with an increased emphasis on confidentiality [3][4] - A total of 535 drugs are under review, with 311 outside the directory and 224 within it, alongside 121 high-value drugs reviewed under the commercial insurance innovation drug directory [9][10] Group 1: Negotiation Atmosphere - The entry process for pharmaceutical representatives was notably quieter and more orderly compared to previous years, reflecting a more subdued approach [3][4] - Representatives from both domestic and multinational pharmaceutical companies, including notable names like 恒瑞医药 and 阿斯利康, participated in the negotiations [4][9] Group 2: Key Drug Categories - Antibacterial drugs are expected to be a significant focus in the afternoon session of the negotiations, with specific products like 万古霉素 being highlighted [9][10] - Innovative drugs, including CAR-T products and new lipid-lowering medications, are also under consideration, with 恒瑞医药 presenting multiple products for initial review [10][12] Group 3: Market Insights - The PCSK9 inhibitor 瑞卡西单抗 has gained attention for its long-acting properties, with a market size of 1.32 billion yuan in 2023, representing 7.8% of the national lipid-lowering drug market [10][11] - The long-acting 阿立哌唑微球 from 丽珠集团 is another product of interest, potentially replacing oral formulations and capturing market share if included in the insurance directory [12]

Group 1 - The core viewpoint of the article is that Kangyuan Pharmaceutical (600557.SH) reported a significant decline in both revenue and net profit for the first three quarters of 2025 compared to the previous year [1] Group 2 - The total operating revenue for the first three quarters reached 2.343 billion yuan, representing a year-on-year decrease of 24.59% [1] - The net profit attributable to shareholders of the parent company was 200 million yuan, down 35.63% year-on-year [1] - The basic earnings per share were reported at 0.35 yuan [1]

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 ...

Financial Performance - The company's operating revenue for Q3 2025 was ¥701,110,452.02, a decrease of 17.42% compared to ¥849,739,629.91 in the same period last year[5] - The net profit attributable to shareholders for the same period was ¥57,272,393.11, down 20.88% from ¥91,721,684.70 year-on-year[5] - The net profit after deducting non-recurring gains and losses decreased by 37.75% to ¥40,128,946.95 compared to ¥64,465,113.48 in the previous year[5] - The basic earnings per share for the year-to-date period was ¥0.35, reflecting a decline of 35.19% from ¥0.62 in the same period last year[5] - Total operating revenue for the first three quarters of 2025 was CNY 2,342,688,380.58, a decrease of 24.5% compared to CNY 3,106,799,761.83 in the same period of 2024[22] - Net profit for the first three quarters of 2025 was CNY 207,696,890.52, a decline of 30.2% from CNY 297,472,674.34 in 2024[23] - Earnings per share for the first three quarters of 2025 were CNY 0.35, compared to CNY 0.54 in the same period of 2024[23] Assets and Liabilities - The total assets at the end of the reporting period were ¥6,740,250,349.55, a decrease of 2.41% from the previous year-end[5] - The total assets as of the reporting date were CNY 6,740,250,349.55, compared to CNY 6,906,762,381.38 in the previous period[20] - Total liabilities decreased to CNY 1,827,462,967.59 from CNY 2,201,671,889.94 in the previous period[20] - The total equity increased to CNY 4,912,787,381.96 from CNY 4,705,090,491.44 in the previous period[20] Cash Flow - As of September 30, 2025, the total current assets amounted to approximately CNY 3.30 billion, a decrease from CNY 3.60 billion as of December 31, 2024[18] - Cash and cash equivalents were reported at CNY 2.16 billion as of September 30, 2025, compared to CNY 2.20 billion at the end of 2024[18] - The cash inflow from operating activities was CNY 2,862,659,766.36, a decrease of 24.3% compared to CNY 3,781,113,356.76 in the same period of 2024[24] - The net cash flow from operating activities was CNY 346,124,906.38, down 39.2% from CNY 569,040,298.71 year-on-year[24] - The cash inflow from investment activities totaled CNY 495,891,643.64, a decline of 68.8% compared to CNY 1,586,271,488.85 in the previous year[25] - The total cash and cash equivalents at the end of the period were CNY 2,157,376,554.50, compared to CNY 1,822,777,273.97 at the end of the same period last year[25] Research and Development - New product approvals include the launch of Canpu Granules for pelvic inflammatory disease and KYS2301 Gel for atopic dermatitis, indicating ongoing R&D efforts[12] - The innovative drug ZX2021 for treating obesity and type 2 diabetes completed the first subject enrollment in Phase II by June 2025, with all dosage groups showing weight loss effects, aiming for Phase III clinical trials in Q3 2026[13] - The innovative drug ZX2010 for treating type 2 diabetes and obesity completed the first subject enrollment in Phase II by July 2025, with plans to enter Phase III clinical trials in Q3 2026[13] - The innovative drug ZX1305E for treating neurotrophic keratitis completed the first subject enrollment in Phase II by June 2025, with plans for Phase III clinical trials in Q3 2026[13] - The innovative drug ZX1305 for treating optic nerve injury is currently in Phase IIb clinical trials, with all projects progressing according to clinical plans for early market launch[13] - Research and development expenses for the first three quarters of 2025 were CNY 351,637,702.25, a decrease of 31.2% from CNY 510,836,777.52 in 2024[22] Market and Sales - The company reported a significant decline in sales of core products such as Re Du Ning Injection and Jin Zhen Oral Liquid due to fluctuations in market demand[10] - The company is focusing on academic promotion and professional transformation to enhance sales stability in orthopedic products like Compound Nanjing Pain Relief Plaster[11] - The company is expanding its market presence through diverse channels, including new retail strategies and enhanced academic support for agents[12] Shareholder Information - The top ten shareholders include Jiangsu Kangyuan Group with 31.12% ownership, holding 176,173,467 shares[16] - The company has no significant changes in the participation of major shareholders in margin financing and securities lending activities[17] Other Financial Information - The company reported a decrease in cash and cash equivalents, impacting liquidity and operational flexibility[20] - The company did not report any cash inflow from new borrowings during the financing activities[25] - The company has not adopted new accounting standards or interpretations that would affect the financial statements for the year[26]

Group 1 - The core viewpoint of the article indicates that Kangyuan Pharmaceutical has experienced a significant decline in both revenue and net profit for the third quarter and the first three quarters of the year [1] Group 2 - In the third quarter, the company's revenue was 701 million yuan, representing a year-on-year decrease of 17.42% [1] - The net profit for the third quarter was 57.27 million yuan, down 20.88% year-on-year [1] - For the first three quarters, the total revenue amounted to 2.343 billion yuan, reflecting a year-on-year decline of 24.59% [1] - The net profit for the first three quarters was 200 million yuan, which is a decrease of 35.63% compared to the same period last year [1]

证券简称：康缘药业 证券代码：600557 公告编号：2025-033 江苏康缘药业股份有限公司（以下简称"公司"）全资子公司江苏中新医药有限 公司（以下简称"中新医药"）近日收到国家药品监督管理局签发的关于 ZX2021 注 射液新增用于治疗代谢功能障碍相关脂肪性肝病适应症的《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： 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 8 月 14 日受理的 ZX2021 注射液临床试验申请符合药品注册的有关要求，同意本品开 展临床试验，申请的适应症为代谢功能障碍相关脂肪性肝病。 提交的临床试验方案名称：评估 ZX2021 注射液治疗代谢功能障碍相关脂肪性肝 病有效性和安全性的随机、双盲、安慰剂对照、剂量递增 II 期临床研究。 二、药品研发及相关情况 药品名称 ZX2021 注射液 注册分类 治疗用生物制品 1 类 原适应症 超重或肥胖、2 型糖尿病 增加适应症 代谢功能障碍相关脂肪性肝病 剂型 注射剂 申请人 江苏中新医药有限公司 受理号 CXSL25006 ...

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个别及连带责任。 重要内容提示: 截至本公告披露日，持股 5%以上股东连云港康贝尔医疗器械有限公司（以下简 称"康贝尔"）持有江苏康缘药业股份有限公司（以下简称"公司"）31,870,567 股 无限售流通股股份，占公司总股本比例 5.63%；本次股份解除质押业务办理完成后， 康贝尔剩余累计质押的本公司股份数量为 7,000,000 股，占其持有公司股份的 21.96%，占公司总股本的 1.24%。 证券简称：康缘药业 证券代码：600557 公告编号：2025-032 江苏康缘药业股份有限公司 关于持股 5%以上股东部分股份解除质押的公告 近日，公司接到持股 5%以上股东康贝尔的通知，康贝尔将其所持有的公司部分 股份办理了解除质押，相关手续已办理完毕。具体情况如下： | 股东名称 | 连云港康贝尔医疗器械有限公司 | | | --- | --- | --- | | 本次解除质押股份 | 24,870,000 | 股 | | 占其所持股份比例 | 78.03% | | | 占公司总股本比例 ...

Core Viewpoint - Kangyuan Pharmaceutical's wholly-owned subsidiary, Jiangsu Zhongxin Pharmaceutical Co., Ltd., has received a clinical trial approval notice from the National Medical Products Administration for ZX2021 injection to treat metabolic dysfunction-related fatty liver disease [1] Group 1 - The approval signifies a potential expansion of ZX2021's therapeutic applications, which may enhance the company's product portfolio and market competitiveness [1] - This development aligns with the growing focus on metabolic diseases in the pharmaceutical industry, indicating a strategic move by the company to tap into this emerging market [1]

Market Overview - The Chinese medicine sector experienced a decline of 0.34% on October 23, with Zhongsheng Pharmaceutical leading the drop [1] - The Shanghai Composite Index closed at 3922.41, up 0.22%, while the Shenzhen Component Index closed at 13025.45, also up 0.22% [1] Stock Performance - Notable gainers included: - Qidi Pharmaceutical (Code: 000590) with a closing price of 12.68, up 9.97% and a trading volume of 261,000 shares, totaling 320 million yuan [1] - Zhendong Pharmaceutical (Code: 300158) closed at 7.32, up 4.27% with a trading volume of 1,012,600 shares, totaling 753 million yuan [1] - Major decliners included: - Zhongsheng Pharmaceutical (Code: 002317) closed at 18.43, down 4.75% with a trading volume of 569,600 shares, totaling 1.056 billion yuan [2] - Darentang (Code: 600329) closed at 43.15, down 3.68% with a trading volume of 75,800 shares, totaling 328 million yuan [2] Capital Flow - The Chinese medicine sector saw a net outflow of 897 million yuan from institutional investors, while retail investors contributed a net inflow of 989 million yuan [2] - The table of capital flow indicates that: - Qidi Pharmaceutical had a net inflow of 23.93 million yuan from institutional investors, while retail investors had a net outflow of 25.84 million yuan [3] - Zhendong Pharmaceutical experienced a net inflow of 19.97 million yuan from institutional investors, with retail investors seeing a net outflow of 2.25 million yuan [3]

Core Viewpoint - On October 9, a total of 11 listed companies had their restricted shares unlocked, with a total market value of approximately 24.303 billion yuan [1] Summary by Category Restricted Share Unlocking - The companies involved in the unlocking of restricted shares include: - Guo Xin Health (000503) with 1.6798 million shares from equity incentive restrictions - Kang Yuan Pharmaceutical (600557) with 315,500 shares from equity incentive restrictions - Sen Te Co., Ltd. (603098) with 270,000 shares from equity incentive restrictions - San Ren Xing (605168) with 165,300 shares from equity incentive restrictions - Hai Liang Data (603138) with 5.6629 million shares from equity incentive restrictions - Tian Yi Medical (301097) with 40.6 million shares from extended lock-up period - Ming Li Da (301268) with 19 million shares from extended lock-up period - Heng Yu Xintong (300965) with 3.51045 million shares from extended lock-up period - Pu Yuan Jing Dian (688337) with 11.8 million shares unlocked - Zhong Fu Shen Ying (688295) with 29.8 million shares unlocked - Chang Guang Hua Xin (688048) with 7.007 million shares unlocked [1]