中信证券股份有限公司 关于益方生物科技（上海）股份有限公司 2023 年度持续督导工作现场检查报告 根据《上海证券交易所上市公司自律监管指引第 11 号——持续督导》等有 关法律、法规的规定，中信证券股份有限公司（以下简称"中信证券"或"保荐 人"）作为正在对益方生物科技（上海）股份有限公司（以下简称"益方生物" "公司""上市公司"）进行持续督导工作的保荐人，对 2023 年度（以下简称"本 持续督导期间"）的规范运作情况进行了现场检查，现就现场检查的有关情况报 告如下： 一、本次现场检查的基本情况 （一）保荐人 中信证券股份有限公司 （二）保荐代表人 杨沁、褚晓佳 （三）现场检查人员 杨沁、周增骏、黄中一 （四）现场检查时间 2024 年 4 月 22 日至 26 日、2024 年 4 月 30 日、2024 年 5 月 13 日 （五）现场检查内容 现场检查人员对本持续督导期内发行人公司治理和内部控制情况、信息披露 情况、公司的独立性以及与控股股东、实际控制人及其他关联方资金往来情况、 募集资金使用情况、关联交易、对外担保、重大对外投资情况、经营状况等方面 进行了现场检查，具体检查内容详见本报告"二、本 ...

证券代码：688382 证券简称：益方生物 益方生物科技（上海）股份有限公司投资者关系活动记录表 编号：2024-002 特定对象调研 □分析师会议 投资者关系 □媒体采访 □业绩说明会 活动类别 □新闻发布会 □路演活动 □现场参观 □其他 参与单位名称 新华资管 华商基金 中银基金 拾贝投资 时间 2024年4月30日 地点 线上 上市公司 YUEHENG JIANG（董事会秘书） 接待人员姓名 一、公司情况及产品管线介绍 益方生物是一家创新药研发企业。目前，除对外授权产品贝 福替尼已进入商业化阶段外，公司有一款处于NDA阶段的产品， 一款处于注册临床试验阶段的产品，两款处于临床 II 期试验阶 段的产品和多个临床前在研项目。 （一）贝福替尼（三代 EGFR 抑制剂）：目前中国非小细胞 肺癌（NSCLC）每年新发约80万患者，根据沙利文的预测，2030 年新发非小细胞肺癌患者数量可能达到100万，这其中约有40%- 50%是EGFR突变。从近两年三代EGFR抑制剂产品公开销售数 据来看，三代产品已经成为EGFR非小细胞肺癌一线治疗的主要 处方产品。 投资者关系活动主 贝福替尼二线及一线治疗适应症已于 2 ...

Financial Performance - The company's operating revenue for Q1 2024 was CNY 8,606,045.10, with a significant reliance on technology licensing and collaboration income [5]. - The net profit attributable to shareholders was a loss of CNY 83,177,667.08, indicating ongoing financial challenges [5]. - The net cash flow from operating activities was negative at CNY -89,720,647.28, reflecting cash outflows during the quarter [5]. - Total revenue for Q1 2024 was CNY 8,606,045.10, compared to CNY 0 in Q1 2023 [16]. - Net loss for Q1 2024 was CNY 83,177,667.08, compared to a net loss of CNY 117,870,350.59 in Q1 2023, showing an improvement of approximately 29.3% [17]. - Total comprehensive income for Q1 2024 was a loss of ¥83,771,183.23, compared to a loss of ¥117,451,215.04 in Q1 2023, indicating a reduction in losses of about 28.7% [18]. - Basic and diluted earnings per share for Q1 2024 were both -¥0.14, an improvement from -¥0.20 in Q1 2023 [18]. Research and Development - Research and development expenses totaled CNY 84,752,226.60, accounting for an extraordinary 984.80% of operating revenue, a decrease of 23.07% compared to the previous year [6]. - R&D expenses for Q1 2024 were CNY 84,752,226.60, down from CNY 110,164,964.97 in Q1 2023, indicating a decrease of about 23.1% [17]. Assets and Liabilities - The total assets at the end of the reporting period were CNY 2,076,769,526.09, down 3.95% from the previous year [6]. - Total assets decreased to CNY 2,076,769,526.09 from CNY 2,162,272,043.34, reflecting a decline of about 4.0% [13]. - Total liabilities decreased to CNY 142,133,254.45 from CNY 164,669,523.57, a reduction of approximately 13.7% [14]. - The company's equity attributable to shareholders decreased to CNY 1,934,636,271.64 from CNY 1,997,602,519.77, a decline of about 3.2% [14]. - The company reported a decrease in accounts payable from CNY 72,521,670.83 to CNY 58,137,728.24, a reduction of approximately 19.9% [13]. - The company’s long-term assets totaled CNY 36,951,398.91, down from CNY 39,151,100.07, indicating a decrease of about 5.6% [13]. Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 13,691 [9]. - The largest shareholder, InventisBio Hong Kong Limited, held 19.13% of the shares, totaling 110,329,937 shares [9]. - There were no significant changes in the shareholding structure of the top ten shareholders compared to the previous period [10]. Cash Flow - Cash and cash equivalents as of March 31, 2024, were CNY 1,837,074,642.19, down from CNY 1,919,444,422.57 at the end of 2023 [12]. - Cash inflows from operating activities totaled ¥5,819,313.65 in Q1 2024, down from ¥6,175,514.74 in Q1 2023 [20]. - Cash outflows from operating activities increased to ¥95,539,960.93 in Q1 2024, compared to ¥87,849,840.57 in Q1 2023, resulting in a net cash flow from operating activities of -¥89,720,647.28 [20]. - Cash and cash equivalents at the end of Q1 2024 were ¥1,129,626,308.86, down from ¥1,645,819,421.57 at the end of Q1 2023 [21]. - The company raised ¥7,215,958.35 from financing activities in Q1 2024, compared to a net outflow of -¥3,848,655.96 in Q1 2023 [21]. - The net cash flow from financing activities for Q1 2024 was ¥4,734,864.59, a significant turnaround from the previous year's negative cash flow [21]. - The company reported a cash flow impact from exchange rate changes of -¥365,816.87 in Q1 2024, compared to -¥1,910,163.60 in Q1 2023 [21]. Product Development - The company did not report any significant new product developments or market expansions during this quarter [22].

证券代码：688382 证券简称：益方生物 公告编号：2024-016 益方生物科技（上海）股份有限公司 2023 年度募集资金存放与实际使用情况的专项报告 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、准确性和完整性依法承担法律责任。 根据中国证券监督管理委员会《上市公司监管指引第 2 号——上市公司募 集资金管理和使用的监管要求（2022年修订）》以及《上海证券交易所科创板上 市公司自律监管指引第 1 号——规范运作》的相关规定，益方生物科技（上海） 股份有限公司（以下简称"公司"或"益方生物"）董事会将 2023 年度募集资 金存放与使用情况报告如下： 一、募集资金基本情况 （一）实际募集资金金额、资金到账时间 根据中国证券监督管理委员会于 2022 年 4 月 1 日出具的《关于同意益方生 物科技（上海）股份有限公司首次公开发行股票注册的批复》（证监许可（2022） 682 号），公司获准向社会公开发行人民币普通股 11,500 万股，每股发行价格为 人民币 18.12 元，募集资金总额为 208,380.00 万元，扣除承销及保荐费用、发行 登 ...

益方生物科技(上海)股份有限公司 内部控制审计报告 大华内字[2024]0011000097 号 大华会计师事务所(特殊普通合伙) Da Hua Certified Public Accountants (Special General Partnership) 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://acc.mof.gov.cn） 益方生物科技(上海)股份有限公司 内部控制审计报告 (截止 2023 年 12 月 31 日) 页 次 日 录 内部控制审计报告 | r 1-2 二、 事务所及注册会计师执业资质证明 大华会计师事务所(特殊 北京市海淀区西四环中路 16号院 7 号楼 12 层 [100039] 电话: 86 (10) 5835 0011 传真: 86 (10) 5835 0006 内部控制审计报告 大华内字|2024|0011000097号 益方生物科技(上海)股份有限公司全体股东: 二、注册会计师的责任 我们的责任是在实施审计工作的基础上,对财务报告内部控制 的有效性发表审计意见,并对注意到的非财务报告内部控制的重大 缺陷进行披露。 三、内部控制的固有局限性 内 ...

益方生物科技（上海）股份有限公司 第二届监事会 2024 年第三次会议决议公告 本公司监事会及全体监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、准确性和完整性依法承担法律责任。 一、监事会会议召开情况 益方生物科技（上海）股份有限公司（以下简称"公司"）第二届监事会 2024 年第三次会议于 2024 年 4 月 25 日以现场结合通讯形式召开，会议通知已 于 2024 年 4 月 15 日以书面等形式发出。会议应出席监事 3 名，实际出席监事 3 名。本次会议的召集、召开程序符合《中华人民共和国公司法》（以下简称《公 司法》）及《益方生物科技（上海）股份有限公司章程》（以下简称《公司章程》） 的有关规定。本次会议由监事会主席冯清华先生主持。 二、监事会会议审议情况 证券代码：688382 证券简称：益方生物 公告编号：2024-015 表决结果：同意 3票；反对 0票；弃权 0票。本议案尚需提交公司股东大会 审议。 （四）审议通过《关于 2024 年财务预算报告的议案》 表决结果：同意 3票；反对 0票；弃权 0票。本议案尚需提交公司股东大会 审议。 （五）审议通过《关 ...

益方生物科技（上海）股份有限公司 2023 年度会计师事务所履职情况评估报告 益方生物科技（上海）股份有限公司（以下简称"公司"）聘请大华会计师 事务所（特殊普通合伙）以下简称（"大华会计师事务所"）作为公司 2023 年度 财务及内部控制审计机构。根据财政部、国资委及证监会颁布的《国有企业、上 市公司选聘会计师事务所管理办法》，公司对大华会计师事务所 2023 年审计过程 中的履职情况进行评估，具体情况如下： 一、会计师事务所基本情况 1、资质条件 机构名称：大华会计师事务所（特殊普通合伙） 成立日期：2012 年 2 月 9 日成立（由大华会计师事务所有限公司转制为特 殊普通合伙企业） 组织形式：特殊普通合伙 注册地址：北京市海淀区西四环中路 16 号院 7 号楼 1101 首席合伙人：梁春 截至 2023 年末，大华会计师事务所拥有合伙人 270 人、注册会计师 1,471 人，其中签署过证券服务业务审计报告的注册会计师 1,141 人。 因执业行为分别受到刑事处罚 0 次、行政处罚 5 次、监督管理措施 46 次、自律 监管措施 7 次、纪律处分 3 次。 二、会计师事务所履职情况评估 1、人力及其他 ...

Financial Performance - The net loss attributable to shareholders for 2023 was CNY 283.98 million, with a net loss excluding non-recurring items of CNY 293.68 million, showing a reduction compared to the previous year[4]. - The cumulative unabsorbed losses reached CNY 2.30 billion by the end of the reporting period[4]. - The company's operating revenue for 2023 reached ¥185,526,866.85, with no comparative data available for 2022[26]. - The company reported a net loss attributable to shareholders of approximately ¥283.98 million in 2023, a decrease from ¥483.49 million in 2022, indicating an improvement in financial performance[27]. - The basic earnings per share for 2023 was -¥0.49, an improvement from -¥0.95 in 2022, reflecting a positive trend in earnings[28]. - The company's total assets decreased by 7.90% year-on-year, from ¥2.35 billion in 2022 to ¥2.16 billion in 2023[27]. - The company's net asset attributable to shareholders decreased by 9.81% year-on-year, from ¥2.21 billion in 2022 to ¥1.99 billion in 2023[27]. - The net cash flow from operating activities showed a reduced outflow of approximately ¥307.75 million, an improvement from ¥476.89 million in 2022, due to increased cash receipts from technology licensing[29]. - The company has not yet achieved profitability, with only one product approved for external licensing, while others remain in the R&D phase[146]. - The company faces risks of significant performance decline or losses due to the lengthy and capital-intensive nature of drug development[147]. Research and Development - Research and development expenses amounted to CNY 442.91 million, with multiple products in critical registration clinical stages or under application for market approval[4]. - The company plans to maintain high levels of R&D investment due to the long and costly nature of drug development, which poses risks of significant losses[5]. - Research and development expenses accounted for 238.73% of operating revenue, indicating a strong commitment to innovation and product development[28]. - The company is investing in research and development for new products, particularly targeting hormone receptor-positive breast cancer treatments[18]. - The company has established various platforms for drug discovery and development, enhancing its R&D capabilities and talent acquisition[48]. - The company has established a comprehensive R&D system covering drug discovery, preclinical research, clinical trials, and regulatory affairs, ensuring a robust pipeline of clinical candidates[69]. - The company has established a drug design platform that enhances the success rate of drug molecule design, reducing R&D costs and timelines[114]. - The company’s core technologies include precise target screening and drug molecular design, which are proprietary and not industry-standard[121]. - The company aims to continuously increase R&D investment to support the development of innovative targeted drugs for unmet medical needs[198]. Product Development and Pipeline - The company focuses on drug development, particularly in oncology, with ongoing clinical trials for new therapies[18]. - The product BPI-D0316 received NMPA approval for first-line and second-line treatment indications in May and October 2023, respectively, with the second-line indication entering the National Medical Insurance Directory in December 2023[39]. - D-1553, a KRAS G12C inhibitor, completed patient enrollment for its key Phase II clinical trial in May 2023, with its marketing application accepted by NMPA in December 2023[41]. - D-0502, an oral selective estrogen receptor degrader, is undergoing a Phase III clinical trial for ER-positive, HER2-negative breast cancer, with results presented at the SABCS in December 2023[44]. - D-2570, a novel oral selective TYK2 inhibitor, completed enrollment for its Phase I clinical trial in June 2023 and initiated a Phase II trial for psoriasis in December 2023[46]. - The company has multiple ongoing clinical trials for various products, including D-0120 for hyperuricemia and D-2570 for psoriasis, which are in the preclinical stage[51]. - The company has one product that has been launched, one product in the NDA stage, three products in clinical trials, and multiple preclinical projects, with the three clinical products approved for Phase II or III trials, leading in global or Chinese progress[104]. - The company is focusing on expanding its product pipeline, with several products in clinical trial stages, including D-0120, D-0502, and D-1553[76]. - The company aims to enhance its product pipeline through innovative drug formulations and delivery methods[18]. Market Strategy and Expansion - The company plans to expand its market presence through strategic partnerships and potential acquisitions in the biotech sector[18]. - The company is exploring opportunities for international market expansion, particularly in North America and Europe[18]. - The company is prioritizing licensing or authorized sales models for international market entry of its products, collaborating with capable pharmaceutical companies[76]. - The company plans to commercialize its products through a combination of licensing partnerships and direct sales, focusing on maximizing commercial value[74]. - The company aims to enhance drug development efficiency through a one-stop R&D system, which has successfully advanced five small molecule compounds to clinical research stages[136]. - The company will adopt a diversified commercialization strategy for its products, including independent sales teams and partnerships, to increase market share and sales scale[200]. - The company plans to expand its international market presence through collaborative R&D and licensing agreements, aiming to register and export products overseas[200]. Regulatory and Compliance - The company is actively pursuing regulatory approvals from both NMPA and FDA for its drug candidates[18]. - The company is committed to maintaining high standards in clinical trial quality management, adhering to GCP guidelines[18]. - The company must navigate regulatory changes in the pharmaceutical industry, which could impact its operational strategies and market positioning[152]. Risks and Challenges - The company faces risks related to competition in the innovative drug market, where competitors may have stronger financial and technical resources[6]. - The company relies on third-party CMO for production, which introduces risks related to supply and quality control[7]. - The company is exposed to operational risks, including competition from better-resourced rivals and the need for effective market expansion strategies[149]. - Financial risks include the need for substantial funding for ongoing clinical trials and potential delays in achieving profitability[151]. - The company is exposed to macroeconomic risks due to its international operations in various countries, which may affect business outcomes[153]. Clinical Trials and Results - The Phase III clinical study of BPI-D0316 was published in The Lancet Respiratory Medicine in May 2023, and its Phase II clinical research OS data was presented at the ESMO Asia conference in December 2023[40]. - D-1553 demonstrated an objective response rate (ORR) of 40.5% and a disease control rate (DCR) of 91.9% in evaluable patients as of June 30, 2022[57]. - D-0502 demonstrated a clinical benefit rate (CBR) of 47.1% and an ORR of 15.7% in a Phase Ib study presented at the 2023 San Antonio Breast Cancer Symposium[62]. - D-0120 shows strong inhibition of URAT1, significantly reducing blood uric acid levels, with an 80% target achievement rate at a daily dose of 4 mg in Phase IIa trials[65]. - D-2570 exhibits high oral bioavailability and better selectivity for JAK1 compared to similar drugs, indicating a larger safety window in clinical applications[67]. Intellectual Property and Innovation - The company has filed for a total of 315 invention patents, with 103 granted, reflecting a strong commitment to R&D[126]. - The company holds global rights to its product pipeline, with 43 new patent applications filed during the reporting period, totaling 103 authorized patents globally[142]. - The company has developed all products independently and holds global intellectual property rights, collaborating with renowned pharmaceutical companies such as Betta Pharmaceuticals and Pfizer[50].

益方生物科技（上海）股份有限公司董事会审计委员会 对会计师事务所履行监督职责情况的报告 一、2023 年年审会计师事务所基本情况 在执行审计工作的过程中，大华会计师事务所就会计师事务所和相关审计人 员的独立性、审计工作小组的人员构成、审计计划、风险判断、风险及舞弊的测 试和评价方法、年度审计重点、审计调整事项、初审意见等与公司管理层和治理 层进行了沟通。 （一）会计师事务所基本情况 大华会计师事务所成立于 1985 年，2012 年 2 月由大华会计师事务所有限公 司转制为特殊普通合伙。注册地址在北京市海淀区西四环中路 16 号院 7 号楼 1,101，首席合伙人为梁春。截至 2023 年 12 月 31 日，大华会计师事务所拥有合 伙人 270 人，注册会计师 1,471 人，其中签署过证券服务业务审计报告的注册会 计师 1,141 人。大华会计师事务所在国内重要城市设立了 30 家分支机构。2022 年度业务总收入 33.27 亿元、审计业务收入 30.74 亿元、证券业务收入 13.89 亿 元。 （二）聘任会计师事务所履行的程序 公司于 2023 年 10 月 13 日召开第一届董事会 2023 年第 ...

益方生物科技（上海）股份有限公司 （一）个人工作履历、专业背景及兼职情况 戴欣苗，1963 年生，中国国籍，无境外永久居留权，毕业于上海财经大学 （原上海财经学院）会计学专业，研究生学历，会计学院副教授。1984 年 7 月至 2023 年 2 月，于上海财经大学任教；2023 年 4 月至今，于合肥汇通控股股份有 限公司任独立董事；2020 年 12 月至今，任公司独立董事。 （二）独立性情况说明 作为公司的独立董事，本人符合《上市公司独立董事管理办法》《上海证券 交易所科创板上市公司自律监管指引第 1 号——规范运作》中关于独立性的要 求，不存在影响独立性的情况。 二、独立董事 2023 年度履职概况 （一）出席董事会和股东大会情况 2023 年，公司共召开 4 次股东大会，8 次董事会会议，本人均出席会议，不 存在缺席和委托其他董事出席董事会的情况；对公司董事会各项议案均投了赞成 票，无提出异议的事项，也无反对、弃权的情形。具体出席会议情况如下： 独立董事 2023 年度述职报告 本人作为益方生物科技（上海）股份有限公司（以下简称"公司"或"益方 生物"）第一届和第二届董事会独立董事，严格按照《公司法》 ...