证券代码：002755 证券简称：奥赛康 公告编号：2025-049 北京奥赛康药业股份有限公司 持股 5%以上股东股份变动触及 1%的公告 1．基本情况 信息披露义务人 江苏苏洋投资实业有限公司 住所 南京市江宁区秣陵街道科学园龙眠大道 618 号 权益变动时间 2025 年 2 月 27 日-2025 年 9 月 12 日 权益变动过程 苏洋投资出于自身经营发展需要，于 2025 年 2 月 27 日至 2025 年 9 月 12 日通过集中竞价和大宗交易方式 共减持公司股份 10,160,232 股，减持后，苏洋投资持 股比例由 14.00%下降至 12.91%，权益变动触及 1%。 苏洋投资减持股份是按照已披露的减持计划进行，本 一、股份变动情况 | 次减持股份不会导致公司控制权发生变更，不会对公 | | | | | | | --- | --- | --- | --- | --- | --- | | 司的经营产生重大影响。 | | | | | | | 股票简称 奥赛康 | | 股票代码 | | 002755 | | | 变动方向 上升□ 下降 | 有□ | 一致行动人 | | 无 | | | 是否 ...

Core Viewpoint - As of September 15, 2023, Aosaikang's stock price has shown significant volatility, with a year-to-date increase of 76.65% but a recent decline in the last 20 days by 15.41% [1] Financial Performance - For the first half of 2025, Aosaikang reported a revenue of 1.007 billion yuan, representing a year-on-year growth of 9.20%, and a net profit attributable to shareholders of 160 million yuan, which is a substantial increase of 111.64% [2] - Cumulative cash dividends since Aosaikang's A-share listing amount to 721 million yuan, with 111 million yuan distributed over the past three years [3] Shareholder Structure - As of August 20, 2023, Aosaikang had 18,300 shareholders, a decrease of 1.26% from the previous period, with an average of 50,724 circulating shares per shareholder, an increase of 1.28% [2] - Notable changes in institutional holdings include new entries such as Yongying Pharmaceutical Innovation Mixed Fund and Hong Kong Central Clearing Limited, while some funds like China Europe Medical Health Mixed Fund have exited the top ten shareholders list [3] Market Activity - On September 15, 2023, Aosaikang's stock experienced a decline of 2.03%, trading at 22.24 yuan per share, with a total market capitalization of 20.642 billion yuan [1] - The stock has seen a net inflow of 3.5584 million yuan from major funds, with significant buying activity accounting for 11.74% of total transactions [1]

Summary of Osai Kang's Conference Call Company Overview - Osai Kang started as a traditional PPI (Proton Pump Inhibitor) business and expanded into biopharmaceutical innovation since 2012, focusing on oncology and infectious diseases. The company has diversified its dosage forms from injectables to oral and sustained-release formulations. The strategy involves parallel development of generic and innovative drugs, where generics ensure cash flow and innovative drugs support valuation [2][3][4]. Key Business Segments - **Generic Drugs**: Osai Kang has made significant progress in the generic drug sector since 2021, with multiple products approved, contributing to revenue growth. The impact of centralized procurement is expected to diminish by 2024, leading to stable performance. The company focuses on first generics and difficult-to-generate products, leveraging integrated raw material and formulation advantages to reduce costs and enhance competitiveness [2][6]. - **Innovative Drugs**: The company is concentrating on oncology, infectious diseases, and chronic diseases, with several products entering clinical trials. Notable products include: - **Third-generation EGFR TKI small molecule inhibitors** for lung cancer, which, despite a slower development pace, are expected to achieve good sales due to strong academic promotion capabilities from partners. - **Colo 80.2 monoclonal antibody** for lung and gastric cancer, with only four similar products in Phase III trials in China, indicating a competitive edge [2][7]. Financial and Market Position - The actual controllers of Osai Kang are Chen Qingcai and his wife. Key subsidiaries include: - **Nanjing Hairong Pharmaceutical**: Raw material production base with cost advantages. - **Nanjing Haiguang Applied Chemistry Research Institute**: Main generic drug R&D base. - **AskGin**: An overseas subsidiary responsible for biopharmaceutical innovation, in which Osai Kang holds a 60% stake [2][4][5]. Product Highlights - **SKB589**: A leading 18.2 monoclonal antibody triple therapy showing an objective response rate (OR) of 80%, indicating best-in-class potential. The progression-free survival (PFS) data is also promising, showcasing significant advantages over competitors like AstraZeneca, which uses a dual therapy approach [2][9]. - **Maifen Capsule**: An oral iron supplement that combines the convenience of traditional oral supplements with the efficacy of intravenous options while minimizing gastrointestinal side effects. This product is expected to capture significant market share in both hospital and outpatient settings [2][10]. - **VEGFR2 Dual-target Ophthalmic Drug**: Targeting AMD and DME, this drug extends the dosing interval to 4-5 months or even six months, significantly improving patient convenience. It is currently in Phase 2B clinical trials, with Phase 3 expected to start in 2026 [2][11]. Future Directions - Osai Kang aims to maintain a dual strategy of ensuring stable cash flow through first generics and difficult generics while actively advancing innovative drug development for higher market returns. The company plans to strengthen international collaborations to enhance R&D capabilities and expand into emerging markets [2][8]. Upcoming Catalysts - Important data releases are anticipated in the coming months, including updates on SKB589's overall survival (OS) data at the ISMO conference in October and preliminary data for interleukin-15 dual antibodies by the end of the year. Additionally, AstraZeneca's Phase II data for its 18.2 monoclonal antibody targeting pancreatic cancer will be closely monitored as potential catalysts for Osai Kang's stock price [2][13].

Core Viewpoint - As of September 4, 2023, Aosaikang's stock price has shown significant volatility, with a year-to-date increase of 82.29% but a recent decline in the last five and twenty trading days [1] Financial Performance - For the first half of 2025, Aosaikang reported a revenue of 1.007 billion yuan, representing a year-on-year growth of 9.20%, and a net profit attributable to shareholders of 160 million yuan, which is a substantial increase of 111.64% [2] - Cumulative cash dividends since Aosaikang's A-share listing amount to 721 million yuan, with 111 million yuan distributed over the past three years [3] Shareholder Structure - As of August 20, 2025, Aosaikang has 18,300 shareholders, a decrease of 1.26% from the previous period, with an average of 50,724 circulating shares per shareholder, an increase of 1.28% [2] - The top ten circulating shareholders include new entrants such as Yongying Pharmaceutical Innovation Mixed Fund and Hong Kong Central Clearing Limited, while some existing shareholders like E Fund Medical Health Mixed Fund have reduced their holdings [3] Market Activity - Aosaikang's stock experienced a trading volume of 1.04 billion yuan on September 4, 2023, with a turnover rate of 0.48% and a total market capitalization of 21.301 billion yuan [1] - The stock has appeared on the "Dragon and Tiger List" twice this year, with the most recent occurrence on July 16 [1]

Core Viewpoint - The company announced the completion of the first patient dosing in a Phase III clinical trial for its innovative drug ASKC202, which is being developed for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification/overexpression after failure of EGFR-TKI therapy [1][2]. Group 1: Drug Development and Clinical Trials - ASKC202 is a novel oral cMET inhibitor developed by the company's subsidiary, targeting EGFR mutation-positive NSCLC patients who have progressed after EGFR-TKI treatment [1]. - The drug is being studied in combination with the third-generation EGFR-TKI, Lapatinib, showing promising efficacy and safety in early-phase trials [2]. - The company plans to present the latest clinical research data on ASKC202 combined with Lapatinib at the 2025 ESMO conference [2]. Group 2: Financial Performance - For the first half of 2025, the company reported a revenue of 1.007 billion yuan, a year-on-year increase of 9.20%, and a net profit attributable to shareholders of 160 million yuan, up 111.64% [3]. - The company invested 200 million yuan in R&D during the reporting period, with 90 million yuan classified as expensed R&D [3]. - The growth in revenue is attributed to the commercialization of several new products over the past two years, enhancing the company's profitability [3].

Core Viewpoint - The company announced that its wholly-owned subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., has completed the first patient dosing in a Phase III registration clinical study for the innovative drug ASKC202 in combination with Lapatinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification/overexpression after failure of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] Group 1 - The innovative drug ASKC202 is being developed for a specific patient population that has not responded to existing EGFR-TKIs [1] - The clinical study is a Phase III registration trial, indicating a significant step towards potential market approval [1] - The focus on MET amplification/overexpression highlights a targeted approach in cancer treatment, which may address unmet medical needs in NSCLC [1]

Core Viewpoint - The announcement highlights the completion of the first patient dosing in a Phase III clinical trial for ASK202, a novel oral cMET inhibitor developed by Jiangsu Aosaikang Pharmaceutical Co., Ltd, targeting advanced non-small cell lung cancer (NSCLC) patients with EGFR mutations and MET amplification/overexpression after failure of EGFR-TKI treatment [1] Group 1 - The clinical trial is a registration study for ASK202 in combination with Lapatinib for patients with locally advanced or metastatic NSCLC [1] - ASK202 is characterized as a first-class innovative drug with independent intellectual property rights and significant activity [1] - The target patient population includes those who have progressed after EGFR-TKI therapy and exhibit MET amplification or overexpression [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., has completed the first patient dosing in a Phase III clinical trial for the innovative drug ASKC202 in combination with Lapatinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification/overexpression after failure of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] Group 1 - The Phase III clinical study for ASKC202 in combination with Lapatinib targets patients who have experienced treatment failure with EGFR-TKIs and have MET amplification/overexpression [1] - The company has also conducted Phase I/II clinical studies for ASKC202 as a monotherapy and in combination with the third-generation EGFR-TKI Lapatinib, as well as a food effect study for ASKC202 [1] - Preliminary results from the Phase I/II study of ASKC202 in combination with Lapatinib show significant efficacy, along with good tolerability and safety [1] Group 2 - The company plans to present the latest clinical research data for ASKC202 in combination with Lapatinib at the 2025 ESMO conference [1]

Core Viewpoint - The announcement indicates that the clinical trial for the innovative drug ASK202, developed by the company's wholly-owned subsidiary, has commenced with the first patient dosed, targeting a specific type of lung cancer [1] Group 1: Company Developments - The company’s subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., is responsible for the development of the innovative drug ASK202 [1] - The drug is intended for use in patients with locally advanced or metastatic non-small cell lung cancer who have failed treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and have MET amplification or overexpression [1] Group 2: Clinical Research - The registration clinical phase III study for ASK202 has successfully completed the first patient dosing [1] - This study represents a significant step in the development of new treatment options for a challenging patient population in oncology [1]

北京奥赛康药业股份有限公司（以下简称"公司"）的全资子公司江苏奥赛 康药业有限公司（以下简称"子公司"）开发的 1 类创新药 ASKC202 联合利厄 替尼用于经表皮生长因子酪氨酸激酶抑制剂（EGFR-TKI）治疗失败伴 MET 扩 增/过表达的局部晚期或转移性非小细胞肺癌的注册性临床 III 期研究已完成首例 患者给药，相关情况如下： 一、产品基本情况 证券代码：002755 证券简称：奥赛康 公告编号：2025-048 北京奥赛康药业股份有限公司 关于子公司创新药 ASKC202 注册性临床 III 期研究完成首例患者给药的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整， 没有虚假记载、误导性陈述或重大遗漏。 截至本公告披露之日，ASKC202 已开展包括单药、联合子公司已上市第三 代 EGFR TKI 利厄替尼的 I/II 期临床研究、以及 ASKC202 的食物影响研究。在 ASKC202 联合利厄替尼用于 EGFR TKI 治疗后进展的 EGFR 突变伴 MET 扩增 /过表达的晚期 NSCLC 的 I/II 期研究中，展现出突出的疗效，同时具有良好的 耐受性和安全性。子公司将在 2 ...