证券代码：002755 证券简称：奥赛康 公告编号：2023-053 北京奥赛康药业股份有限公司 关于子公司创新药 ASKC202 片与 ASK120067 片 联合用药获批开展临床试验的公告 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。 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"）申报的 ASKC202 片与 ASK120067 片联合用 药临床试验，于近日收到国家药品监督管理局（以下简称"药监局"）签发的临床 试验批准通知书，相关情况如下： 一、药品基本情况 产品名称：ASKC202 片 申请事项：新药申请 申请人：江苏奥赛康药业有限公司 受理号：CXHL2300901、CXHL2300902 通知书编号：2023LP02217、2023LP02218 审评结论：同意开展 ASKC202 片与 ASK120067 片联合用于晚期实体瘤的 临床试验。 二、联合用药临床试验申请情况 ASKC202 片与 ASK120067 片联合用药将开展一项评价 ASKC202 片在晚期 实体瘤患者中的安全性、耐 ...

证券代码：002755 证券简称：奥赛康 公告编号：2023-052 北京奥赛康药业股份有限公司 关于子公司替莫唑胺胶囊获得药品注册证书 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。 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"）于近日收到国家药品监督管理局（以下 简称"药监局"）下发的替莫唑胺胶囊《药品注册证书》，相关情况如下： 一、药品基本情况 药品名称：替莫唑胺胶囊 剂型：胶囊 规格：20mg、100mg 注册分类：化学药品 4 类 上市许可持有人：江苏奥赛康药业有限公司 药品批准文号：国药准字 H20234424、国药准字 H20234425 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，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品的其他相关情况 替莫唑胺是一种咪唑并四嗪类烷化剂，主要适应症为新诊断的多形性胶质母 细胞瘤，开始先与放疗联合治疗，随后作为维持治疗；常规治疗后复发或进展的 多形性胶质母细胞瘤（GBM）或间变性星形细胞瘤。最初由美国默沙 ...

Financial Performance - The net profit for Q3 2023 was -219,963,187.35 CNY, a decrease of 129.46% compared to -95,859,950.66 CNY in the same period last year[8] - Total operating revenue for the current period was ¥1,119,748,100.35, a decrease of 25.7% compared to ¥1,506,190,272.21 in the previous period[18] - Net loss for the current period was ¥219,963,187.35, compared to a net loss of ¥95,859,950.66 in the previous period, indicating a significant increase in losses[21] - Basic and diluted earnings per share for the current period were both -0.20, compared to -0.07 in the previous period[23] - Net profit attributable to shareholders is -¥26,203,305.57, an increase of 67.55% year-over-year[37] - Net profit after deducting non-recurring gains and losses is -¥40,392,934.16, a decrease of 55.96% compared to the previous year[37] - Cumulative net profit from the beginning of the year to the reporting period is -¥184,655,635.86, a decrease of 170.58% compared to the same period last year[37] Cash Flow - Operating cash flow for Q3 2023 was -9,404,569.09 CNY, down 123.36% from 40,252,389.49 CNY in Q3 2022[8] - Cash inflow from operating activities totaled 1,446,666,613.62 RMB, down 24.5% from 1,915,896,844.89 RMB in the previous period[29] - Cash outflow from operating activities was 1,456,071,182.71 RMB, a decrease of 22.3% compared to 1,875,644,455.40 RMB in the previous period[29] - Cash inflow from financing activities was 220,498,700.00 RMB, up 40.3% from 157,018,000.00 RMB in the previous period[29] - Net cash flow from financing activities increased to 167,186,491.72 RMB, compared to 62,818,814.30 RMB in the previous period[29] - Cash flow from operating activities shows a net outflow of -¥9,404,569.09, a decrease of 123.36% year-over-year[37] Assets and Liabilities - The total assets as of September 30, 2023, amounted to 3,443,082,484.66 CNY, compared to 3,414,367,396.12 CNY at the end of the previous year[14] - The total liabilities increased to ¥598,777,570.21 from ¥401,028,107.04, reflecting a rise of 49.2%[18] - Total equity attributable to shareholders of the parent company decreased to ¥2,801,580,742.63 from ¥2,962,969,644.26, a decline of 5.4%[18] - Total assets at the end of the reporting period are ¥3,443,082,484.66, an increase of 0.84% from the end of the previous year[37] - Shareholders' equity attributable to the parent company is ¥2,801,580,742.63, a decrease of 5.45% compared to the previous year[37] Investment Activities - The company reported a 61.30% increase in prepayments, totaling 15,232,625.26 CNY, primarily due to advances for materials and R&D expenditures[8] - The company’s other equity instrument investments increased by 267.05%, reaching 13,987,632.46 CNY, attributed to new minority equity investments[8] - Cash inflow from investment activities amounted to 2,607,205,258.17 RMB, an increase of 5.0% from 2,482,392,813.28 RMB in the previous period[29] - The company received 2,588,000,000.00 RMB from investment recoveries, an increase from 2,482,000,000.00 RMB in the previous period[29] Other Comprehensive Income - Other comprehensive income after tax for the current period was ¥14,058,092.57, slightly up from ¥13,402,542.91 in the prior period[21] - The company experienced a decrease in investment income to ¥22,227,327.77 from ¥23,125,015.03, a decline of 3.9%[21] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 21,174[9] - The company’s cash and cash equivalents increased to 822,594,495.77 CNY from 772,714,279.67 CNY at the beginning of the year[14] - The ending balance of cash and cash equivalents was 814,241,824.54 RMB, slightly down from 833,144,628.84 RMB in the previous period[29] - The company reported a net increase in cash and cash equivalents of 53,565,585.10 RMB, contrasting with a decrease of 327,753,229.67 RMB in the previous period[29]

一、审议通过《关于公司 2023 年第三季度报告的议案》 表决结果：3 票同意，0 票反对，0 票弃权。 经审核，监事会认为：董事会编制和审核《2023 年第三季度报告》的程序符合 法律、行政法规和中国证监会的规定，报告内容真实、准确、完整地反映了公司的 实际情况，不存在任何虚假记载、误导性陈述或者重大遗漏。 证券代码：002755 证券简称：奥赛康 公告编号：2023-050 北京奥赛康药业股份有限公司 第六届监事会第九次会议决议公告 本公司及监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。 北京奥赛康药业股份有限公司（以下简称"公司"）第六届监事会第九次会议于 2023 年 10 月 20 日以电子邮件、专人送达的方式通知各位监事，会议于 2023 年 10 月 30 日以现场、通讯表决的方式在南京江宁科学园科建路 699 号 A 楼 3102 会议室 召开。本次会议应到监事 3 人，实到监事 3 人。本次会议符合《中华人民共和国公 司法》（以下简称"《公司法》"）、《中华人民共和国证券法》（以下简称"《证券法》"） 等法律、行政法规、部门规章、规范性文件和《公司章 ...

第六届董事会第十一次会议决议公告 《公司第六届董事会第十一次会议决议》 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。 北京奥赛康药业股份有限公司（以下简称"公司"）第六届董事会第十一次会议 于 2023 年 10 月 20 日以电子邮件、专人送达的方式通知各位董事，会议于 2023 年 10 月 30 日以现场、通讯表决的方式在南京江宁科学园科建路 699 号 A 楼 3102 会 议室召开。本次会议应到董事 9 人，实到董事 9 人。公司监事、高级管理人员列席 了会议。本次会议符合《中华人民共和国公司法》（以下简称"《公司法》"）、《中华 人民共和国证券法》（以下简称"《证券法》"）等法律、行政法规、部门规章、规范 性文件和《公司章程》的相关规定。 会议由董事长陈庆财先生主持，经与会董事认真审议，一致形成如下决议： 一、审议通过《关于公司 2023 年第三季度报告的议案》 表决结果：9 票同意，0 票反对，0 票弃权。 议案内容详见发布于巨潮资讯网（www.cninfo.com.cn）的《2023 年第三季度报 告》。 证券代码：002755 证券简称：奥 ...

证券代码：002755 证券简称：奥赛康 公告编号：2023-048 北京奥赛康药业股份有限公司 一、关于 ASKB589 注射液Ⅲ期关键性临床研究 本次获批开展的研究是一项评价 ASKB589 注射液（靶向 CLDN18.2 单克隆 抗体）或安慰剂联合 CAPOX（奥沙利铂和卡培他滨）及 PD-1 抑制剂一线治疗 CLDN18.2 阳性的不可切除的局部晚期、复发性或转移性胃及食管胃交界处腺癌 （G/GEJ）患者的有效性和安全性的 III 期临床研究。 同时靶向 CLDN18.2 和 PD-1, 可以通过提高先天免疫和适应性免疫能力, 为 治疗一线治疗局部晚期不可切除或转移性 HER2 阳性胃癌或 GEJ 腺癌患者提供 最新的治疗方案。 二、关于 ASKB589 注射液相关情况 ASKB589 注射液是 AskGene 自主研发的、拥有国际自主知识产权的 ADCC 增强型第二代抗 CLDN18.2 人源化单克隆抗体，研发进度处于全球前三家。目前 国内外尚无同靶点药物上市。 2023 年 6 月，AskGene 在第十五届国际胃癌大会（2023 IGCC）上以口头 汇 报 形 式 公 布 了 ASKB589 注 ...

Product Development and Innovation - The company has successfully passed quality consistency evaluations for multiple generic drugs, confirming their quality and efficacy equivalent to original research drugs, which lays a solid foundation for further exploring the potential of existing products [4]. - The company has developed a range of new products targeting various therapeutic areas, including oncology and chronic diseases, enhancing its product portfolio [2]. - ASKC202 is a first-class innovative drug with independent intellectual property rights, targeting c-Met for treating non-small cell lung cancer in patients resistant to first and third-generation EGFR inhibitors [8]. - ASKG915, a dual-function fusion molecule, has shown significant anti-tumor activity in preclinical studies and is expected to fill market gaps in cancer immunotherapy [19]. - The company has developed an international leading cytokine prodrug technology platform, emphasizing innovation in drug development [9]. - The company aims to develop "First in Class" biopharmaceuticals based on its proprietary technology platforms, focusing on differentiated therapeutic approaches [17]. - The company is actively expanding its product pipeline with several innovative drug projects in various stages of clinical research [13]. - The company has 43 ongoing research projects, including 11 key innovative drugs in development such as ASK120067 tablets and injectable ASK0912 [84]. - The company has successfully licensed its Smartkine® cytokine technology platform to Xilio Therapeutics, enhancing its platform value through international collaborations [141]. - The company has developed a rich pipeline of innovative drugs, including ASK120067, a third-generation EGFR TKI for treating EGFR mutation non-small cell lung cancer, which is undergoing phase III clinical trials [164]. Market Strategy and Expansion - The company is focusing on expanding its market presence through innovative product development and strategic partnerships [4]. - The company is exploring new strategies for market expansion, including potential mergers and acquisitions to enhance its competitive edge [4]. - The company is focusing on expanding its market presence through centralized procurement, which is expected to create new market opportunities despite price pressures [76]. - The company’s subsidiaries, including AskGene and AskPharma, are involved in overseas operations to enhance its global footprint [68]. - The company plans to actively seek external collaboration and licensing opportunities to create new growth points for performance [172]. Financial Performance - The company’s revenue for the reporting period was ¥711,848,179.82, a decrease of 29.56% compared to ¥1,010,521,190.03 in the same period last year [46]. - The net profit attributable to shareholders was -¥158,452,330.29, representing a significant decline of 1,368.02% from ¥12,496,010.08 in the previous year [46]. - The net cash flow from operating activities was -¥96,141,046.79, which is a 172.97% increase in losses compared to -¥35,220,435.74 in the same period last year [46]. - The basic earnings per share were -¥0.17, a decrease of 1,800.00% from ¥0.01 in the previous year [46]. - Total assets at the end of the reporting period were ¥3,233,503,311.40, down 5.30% from ¥3,414,367,396.12 at the end of the previous year [46]. - The net assets attributable to shareholders decreased by 5.48% to ¥2,800,476,458.00 from ¥2,962,969,644.26 at the end of the previous year [46]. - The company plans not to distribute cash dividends or issue bonus shares [56]. Regulatory and Compliance - The company has maintained a strong focus on product quality, achieving GMP certification for 42 consecutive times, ensuring rigorous quality management throughout the production process [16]. - The company is committed to ensuring compliance with GMP standards to maintain product quality and safety [70]. - The company emphasizes quality management and compliance with the latest regulations, aiming to enhance product quality standards and improve market competitiveness [196]. - The company is conducting consistency evaluation work for its products, which will support their procurement in medical institutions and enhance their technical advantages [196]. Challenges and Industry Trends - The pharmaceutical industry faces significant challenges due to intensified competition and rising costs from policies promoting centralized drug procurement [51]. - The implementation of the DRG/DIP payment reform is expected to change the cost control logic of medical institutions, impacting the demand for certain drugs [54]. - The average price reduction for drugs in the eighth batch of centralized procurement was 56%, impacting the profitability of market participants [75]. - A total of 333 drug varieties have been included in the centralized procurement from the first to the eighth batch, with most major varieties being included [75]. - The new drug catalog implemented on March 1, 2023, includes 24 major innovative domestic drugs, with a negotiation success rate of 83.3% [77]. - The pharmaceutical manufacturing industry in China saw a revenue of CNY 1,249.6 billion in the first half of 2023, a year-on-year decrease of 2.9% [101]. Research and Development - R&D expenditure reached 326.90 million yuan, accounting for 45.92% of total revenue, with capitalized R&D costs making up 40.59%, a year-on-year increase of 37.80% [122]. - The company has received approval for 16 new products from 2021 to date, focusing on differentiated innovation in the fields of digestion, anti-infection, and oncology [110]. - The company has established a comprehensive new drug R&D capability covering the entire process from drug design to clinical research, prioritizing the clinical development of existing innovative drugs [156]. - The company has established multiple R&D platforms, including the SmartKine® cytokine prodrug platform, aimed at enhancing drug efficacy and reducing side effects [170]. Product Quality and Safety - The company is committed to improving patient outcomes through the introduction of advanced therapies and maintaining high standards in drug quality [4]. - The company has established a comprehensive drug safety management system to effectively manage product quality post-market [16]. - The company emphasizes a quality management goal to enhance efficiency and has implemented stricter internal quality standards beyond national regulations [184]. - The company focuses on unmet clinical needs in the anti-infection field, developing a series of products to enhance its competitive advantage [185].

Group 1: Company Overview and R&D Focus - The company, Beijing Ausun Pharmaceutical Co., Ltd., focuses on four major therapeutic areas: digestion, oncology, anti-infection, and chronic diseases [1] - The R&D investment is expected to maintain the same scale as in 2022 for the next 2-3 years, with a careful evaluation of clinical and commercial value for each project [2] - As of December 2022, the R&D team consists of 372 members, with a strong background in innovative drug development [2] Group 2: R&D Strategy and Pipeline - The company has established a clinical team of over 100 members with extensive experience in innovative drug development [3] - The R&D strategy includes internal incubation, licensing in, and business development to enhance the pipeline [3] - The small molecule pipeline includes innovative anti-tumor drugs like ASK120067, which is a third-generation EGFR TKI for NSCLC, and ASK202, a c-Met inhibitor for resistant patients [4] Group 3: Clinical Progress and Product Launches - The innovative drug ASKB589 is currently in Phase II clinical trials, with positive safety and tolerability results reported [4] - The company has a self-operated and third-party combined approach for product promotion, with over 200 members in the self-operated team [3] - Two IL-15 cytokine drugs, ASKG315 and ASKG915, are in clinical trials, with ASKG915 approved by the FDA for clinical trials in the U.S. [5]

证券代码：002755 证券简称：奥赛康 北京奥赛康药业股份有限公司 投资者关系活动记录表 编号：2023-003 投资者关系活动类 □√特定对象调研 □分析师会议 别 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 □现场参观 □√其他 （电话会议） 参与单位名称 天风证券：李妞妞 及人员姓名 Point72 Hong Kong Limited 分析员：李大蔚、吴雪璐 时间 2023 年 5 月 5 日 地点 电话会议 上市公司接待人员 总经理、董事会秘书 马竞飞 姓名 证券事务部长 王燕燕 一、公司基本情况介绍 介绍公司基本情况。 二、主要沟通问答 问题 1、公司小分子创新药目前有哪些布局及进展？ 投资者关系活动主 答：公司已布局多款小分子创新药，其中主要产品有抗肿瘤创 要内容介绍 新药 ASK120067 片，是第三代 EGFR TKI，用于治疗 EGFR 突变非 小细胞肺癌（NSCLC），已申报生产。同步也在开展一线用药关于 存在 EGFR 敏感突变的初诊或手术治疗后复发的局部晚期或转移性 非小细胞肺癌的Ⅲ期临床研究试验。 抗肿瘤创新药 ASKC202 片，是一种强效、高选择性的口服小分 子 c- ...

Financial Performance - The company's operating revenue for Q1 2023 was ¥338,557,552.24, a decrease of 36.78% compared to ¥535,530,478.60 in the same period last year[18]. - The net profit for Q1 2023 was -¥75,383,018.82, representing a decline of 578.78% from a profit of ¥15,744,769.03 in the previous year[18]. - The total comprehensive income attributable to the parent company was -¥64,219,728.17, compared to ¥21,168,998.78 in the previous year[4]. - The total comprehensive income for the period was -¥69,360,660.14, contrasting with a positive figure of ¥17,869,761.02 in the previous year[4]. - Net profit attributable to shareholders of the listed company was -¥68,591,234.11, a decline of 454.23% from ¥19,363,474.87 in the previous year[28]. - Basic and diluted earnings per share were both -¥0.07, a decrease of 450.00% compared to ¥0.02 in the previous year[28]. Cash Flow - The net cash flow from operating activities was -¥110,779,210.22, a significant decrease of 665.11% compared to ¥19,603,258.69 in the same period last year[18]. - The net cash flow from operating activities was negative at -¥110,779,210.22, compared to a positive ¥19,603,258.69 in the previous period[40]. - Investment activities generated a net cash flow of ¥64,925,880.98, a significant improvement from a negative cash flow of -¥309,240,973.28 in the prior period[40]. - The cash outflow for operating activities totaled ¥514,876,351.57, compared to ¥668,515,802.93 in the previous period, showing a reduction of about 23.1%[40]. Expenses - Research and development expenses increased by 33.32% to ¥122,347,542.93, driven by ongoing investments in innovative and biological drug development[18]. - The company's sales expenses decreased by 36.84% to ¥214,979,509.61, reflecting the decline in revenue[18]. - Operating costs for the quarter were ¥66,056,085.50, compared to ¥62,513,029.96 in the previous year[24]. - The company reported a total operating cost of ¥431,430,413.60, down from ¥522,904,935.40 in the same period last year[24]. - The company experienced a significant increase in credit impairment losses, totaling ¥483,515.78 compared to ¥1,828,840.71 in the previous year[25]. Assets and Liabilities - Total assets at the end of the reporting period were ¥3,343,052,135.42, a decrease of 2.09% from ¥3,414,367,396.12 at the end of the previous year[28]. - The total liabilities amounted to ¥398,340,507.37, a slight decrease from ¥401,028,107.04 in the previous period, indicating a reduction of approximately 0.4%[36]. - Non-current liabilities totaled ¥87,558,087.12, up from ¥77,285,435.67, reflecting an increase of about 13.6%[36]. - The company's total equity was ¥2,944,711,628.05, a decrease from ¥3,013,339,289.08, reflecting a decline of approximately 2.3%[36]. Shareholder Information - The company had a total of 22,075 common shareholders at the end of the reporting period[19]. Inventory and Compensation - The company's inventory increased to ¥158,779,979.08 from ¥141,533,272.91, marking an increase of approximately 12.2%[43]. - The company reported a decrease in employee compensation payable to ¥15,450,807.12 from ¥41,419,835.05, a reduction of about 62.7%[43].