公司本次使用部分暂时闲置募集资金进行现金管理，不会影响公司募集资金 投资项目的正常实施，符合《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》《上海证券交易所科创板股票上市规则》《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》等的有关规定，可以提高暂 时闲置募集资金使用效率，获取一定的投资回报，符合公司及全体股东的利益。 监事会同意公司使用额度不超过 10 亿元的部分闲置募集资金进行现金管理事项。 表决结果：同意 3 票；反对 0 票；弃权 0 票。 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 年第五次会议于 2024 年 8 月 21 日以现场结合通讯形式召开,本次会议通知已于 2024 年 8 月 16 日以书面形式发出。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 ...

Financial Performance - The company is currently not profitable and has accumulated losses due to its focus on innovative drug research and development, with only one product approved for external authorization [3]. - The company reported a revenue of CNY 14,873,214.62 for the first half of 2024, a decrease of 81.41% compared to CNY 80,000,000.00 in the same period last year [17]. - The net profit attributable to shareholders was CNY -214,218,345.04, compared to CNY -167,749,388.63 in the previous year [17]. - The net cash flow from operating activities was CNY -187,770,647.09, slightly improved from CNY -202,806,781.41 year-on-year [17]. - The company's total assets decreased by 8.72% to CNY 1,973,823,412.28 from CNY 2,162,272,043.34 at the end of the previous year [17]. - The net assets attributable to shareholders decreased by 8.98% to CNY 1,818,303,388.22 from CNY 1,997,602,519.77 [17]. - The basic earnings per share for the first half of 2024 was CNY -0.37, compared to CNY -0.29 in the same period last year [18]. - The net loss attributable to shareholders increased compared to the same period last year, with earnings per share and weighted average return on equity declining [19]. - The company confirmed that the significant revenue decrease was primarily due to a high base from last year's milestone revenue recognition [18]. Research and Development - The company focuses on innovative drug development targeting major diseases such as cancer, metabolic disorders, and autoimmune diseases [22]. - Research and development expenses accounted for 1,404.61% of revenue, an increase of 1,108.10 percentage points compared to 296.51% in the previous year [18]. - The company has established a comprehensive drug development system covering all stages from drug discovery to post-marketing research, ensuring robust R&D capabilities [29]. - The company has a robust R&D capability with a one-stop innovation drug development system, covering target screening, preclinical drug development, CMC, and clinical development, which enhances the success rate of products in the pipeline and shortens the drug development cycle [65]. - The company has developed its own pharmacodynamics and early toxicology assessment platforms to ensure the safety and efficacy of innovative drugs [47]. - The company utilizes artificial intelligence for pharmacokinetic predictions, aiding in the selection of clinical candidate compounds [47]. - The company has established a pharmacology and efficacy platform that allows for accurate evaluation of compound activity, expanding the range of clinical indications and improving drug viability [53]. Product Pipeline and Clinical Trials - The product pipeline includes drugs for non-small cell lung cancer, breast cancer, and gout, with various stages of clinical development [22]. - Bafotinib (BPI-D0316) has received approval for both first-line and second-line treatment indications for EGFR mutation-positive non-small cell lung cancer (NSCLC) in 2023, with the second-line indication included in the National Medical Insurance Catalog [24]. - Garsorasib (D-1553), a KRAS G12C inhibitor, is the first domestically developed KRAS G12C inhibitor entering clinical trials, with international multi-center trials ongoing in multiple countries [25]. - D-1553 demonstrated a 50% objective response rate (ORR) and an 89% disease control rate (DCR) in a II phase study, with a median duration of response (DOR) of 12.8 months and a median progression-free survival (PFS) of 7.6 months [25]. - D-0502 is currently in a head-to-head Phase III clinical trial against standard treatment for ER-positive, HER2-negative breast cancer patients in China [27]. - D-0120 is also undergoing a multi-center, randomized, parallel-controlled Phase IIb clinical trial in China, with plans for a Phase II trial in the U.S. in collaboration with allopurinol [28]. - The company has ongoing projects in the preclinical stage and is exploring new drug candidates for psoriasis and tumor immunity [23]. Market and Competitive Landscape - The company faces significant risks in drug development, including long cycles and high investment requirements, which may lead to continued losses [3]. - The company lacks experience in commercializing products, with only one authorized product on the market, and faces competition from established players [3]. - The company is subject to regulatory uncertainties in both domestic and international markets, affecting its ability to achieve commercial success [3]. - The competitive landscape in the innovative drug market poses risks, as competitors may have stronger financial resources and marketing strategies [79]. Financial Risks and Challenges - The company has not established a comprehensive commercialization team, which may hinder market acceptance of its products [3]. - The company faces financial risks due to the need for substantial funding in clinical trials and regulatory approvals, which may impact its operational sustainability [81]. - The company is exposed to foreign exchange risks due to international clinical trials conducted in multiple currencies, affecting cash flow and R&D costs [81]. - The company reported a net cash outflow from operating activities of -187.77 million yuan, indicating ongoing financial challenges [85]. - The company has not disclosed any profit distribution plans for the reporting period [5]. Shareholder and Governance Matters - The controlling shareholder, Hong Kong Yifang, and others have committed to a lock-up period of 42 months starting from the listing date, which is August 27, 2022 [104]. - The company has implemented strict compliance with regulations regarding shareholding and share reduction, agreeing to compensate for any losses caused by violations of these commitments [107]. - Shareholders are prohibited from transferring or entrusting their shares for 36 months from the listing date, which is July 25, 2022 [109]. - The company has established a commitment to adhere to the relevant laws and regulations regarding shareholding and share changes for directors and senior management [107]. Environmental and Social Responsibility - The company has established pollution prevention facilities, including activated carbon adsorption devices and wastewater collection and pretreatment facilities [100]. - The company has completed environmental impact assessments for all new, modified, and expanded projects in accordance with relevant laws and regulations [100]. - The company is not classified as a key pollutant discharging unit and has not faced any administrative penalties for environmental issues [99].

证券代码：688382 证券简称：益方生物 公告编号：2024-033 益方生物科技（上海）股份有限公司 关于变更公司注册资本并修订《公司章程》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、准确性和完整性依法承担法律责任。 除上述条款修订外，《公司章程》其他条款不变，修订后的《公司章程》于 同日披露于上海证券交易所网站（www.sse.com.cn）。 根据公司于 2023 年 1 月 9 日召开的 2023 年第一次临时股东大会审议通过的 《关于提请股东大会授权董事会办理公司股权激励计划相关事宜的议案》的相 关授权，本次变更注册资本并修订《公司章程》事项无需提交股东大会审议， 董事会授权相关人员就上述事宜办理工商变更登记。 特此公告。 益方生物科技（上海）股份有限公司（以下简称"公司"）于 2024 年 8 月 22 日召开第二届董事会 2024 年第六次会议，审议通过了《关于变更公司注册资 本并修订<公司章程>的议案》，同意公司变更公司注册资本并修订《公司章程》， 现将有关情况公告如下： 益方生物科技（上海）股份有限公司董事会 一、公司注册资 ...

证券代码：688382 证券简称：益方生物 公告编号：2024-026 益方生物科技（上海）股份有限公司 关于使用部分闲置募集资金进行现金管理的公告 （一）投资目的 为提高募集资金使用效率，合理利用部分闲置募集资金，在确保不影响募 集资金投资项目建设、保障募集资金安全的情况下，增加公司的收益，为公司 及股东获取更多回报。 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。 （二）投资产品品种 益方生物科技（上海）股份有限公司（以下简称"公司"）于2024年8月21 日召开第二届董事会2024年第五次会议及第二届监事会2024年第五次会议，审 议通过《关于使用部分闲置募集资金进行现金管理的议案》，同意公司使用不 超过人民币10亿元（包含本数）的暂时闲置募集资金进行现金管理，用于购买 安全性高、流动性好、保本型的理财产品或存款类产品（包括但不限于协定性 存款、结构性存款、定期存款、大额存单、收益凭证等）。使用期限自董事会 审议通过之日起12个月内有效，在上述额度和期限内，资金可循环滚动使用。 闲置募集资金现金管理到期后将归还至募集 ...

君合律师事务所上海分所 关于益方生物科技（上海）股份有限公司 2022 年限制性股票激励计划预留授予部分第一个归属期归属条件 成就的法律意见书 中国上海石门一路 288 号 兴业太古汇香港兴业中心一座 26 层 邮编：200041 电话：（86-21）5298 5488 传真：（86-21）5298 5492 益方生物科技（上海）股份有限公司： 君合律师事务所上海分所（以下简称"本所"）接受益方生物科技（上海） 股份有限公司（以下简称"公司"或"益方生物"）的委托，担任益方生物 2022 年限制性股票激励计划（以下简称"本次激励计划"）的专项法律顾问，根据《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》"）、《上市公司股权激励管理办法》（以下简称"《管 理办法》"）、《上海证券交易所科创板股票上市规则》（以下简称"《上市规 则》"）、《科创板上市公司自律监管指南第 4 号——股权激励信息披露》（以 下简称"《监管指南》"）以及中华人民共和国（以下简称"中国"）其他相关 法律、法规及规范性文件的有关规定，就本次激励计划预留授予部分第一个归属 期归属条件成就（ ...

证券代码：688382 证券简称：益方生物 公告编号：2024-025 会议召开时间：2024 年 8 月 26 日（星期一）上午 10:00-11:00 会议召开地点：上海证券交易所上证路演中心（网址： https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2024 年 8 月 19 日（星期一）至 8 月 23 日（星期五）16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过益方生 物科技（上海）股份有限公司（以下简称"公司"）邮箱 ir@inventisbio.com 进行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 （二）会议召开地点：上证路演中心 （三）会议召开方式：上证路演中心网络互动 益方生物科技（上海）股份有限公司 关于召开 2024 年半年度业绩说明会的公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 公司将于 2024 年 8 月 23 日发布公司 2024 年半年度报告，为便于广大投资 者更全面深入地了 ...

国内做肺癌知名的企业贝达达成了合作我们觉得对于两方企业来说其实都是一个合作共鸣的授权合作因为对于贝达来说它自己本身有一代的ECFRHG艾克提尼所以它非常需要有贝辅这样一个很好的三代的产品作为补充对于一方来说 凭借着贝达在肺癌领域商业化的优势可以尽快地把第一个产品的商业化市场份额不断提升 那第二个产品在肿瘤领域主要就是KRAS的G12C就是隔出类肌那KRAS呢本身它的这个突变呢就广泛存在于多种肿瘤那它整个这个突变呢其中又以G12C这种突变呢最为常见大概整体国内现在KRAS G12C突变阳性的这个肿瘤的人群大概是超过4万人 那从这个药物研发的这个进度来看呢一方的这个产品也进度是非常领先的目前国内就一共是三款产品 就看这个表上会比较清楚那么前面分别是信达的胡德雷塞然后公司的葛舒卫西以及后面一个是加克斯的德莱雷塞这三款药物那公司的一个进展的预计是今年年底或者明年年初就能货批上市有望成为国内首个货批的PIRAS D12第一支剂那我们从右图上面这个数据的角度去看在后线的这个飞角里面 公司产品的这个单药数据是优于目前已获批的这个进口药物的那尤其是像他今年的ECHO会议上也更新了他的一个OR2的数据那在31名这个可评估的患者 ...

证券代码：688382 证券简称：益方生物 公告编号：2024-024 益方生物科技（上海）股份有限公司 关于持股 5%以上股东部分股份质押的公告 重要内容提示： 益方生物科技（上海）股份有限公司（以下简称"公司"）股东 ABA-Bio （Hong Kong） Limited（以下简称"ABA-Bio"）持有公司股份 32,940,037 股， 占公司总股本的 5.71%。ABA-Bio 本次质押股份 9,230,037 股，本次质押后累计 质押公司股份 32,940,037 股，占其持股总数的 100%，占公司总股本的 5.71%。 一、本次股份质押情况 公司于近日收到股东 ABA-Bio 的通知，其所持部分公司股份已办理质押， 具体情况如下： 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。 单位：股 | | | | | | | 已质押股份 | | 未质押股份 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | 占其 | ...

Investment Rating - The report gives a "Buy" rating for the company with a target price of 8.75 RMB [1][3] Core Views - The company focuses on high-barrier targeted drug development in oncology and autoimmune diseases, with a strong R&D team and multiple drugs in clinical trials or already approved [1] - In oncology, the company targets high-difficulty targets and large indications, with one drug already approved and others in late-stage trials [1] - In autoimmune and metabolic diseases, the company has two drugs in development targeting high-prevalence diseases with significant unmet clinical needs [1] Oncology Pipeline - The company's drug Bifatinib, a third-generation EGFR TKI, has been approved for NSCLC and shows superior survival and intracranial efficacy data compared to competitors [1][21] - Gersuresib, a KRAS G12C inhibitor, is expected to be the first approved in China for NSCLC and is also in trials for CRC and pancreatic cancer [1][13] - D-0502, an oral SERD, is the fastest progressing oral SERD in China, currently in Phase III trials [1][14] Autoimmune and Metabolic Pipeline - D-0120, a URAT1 inhibitor, targets hyperuricemia and gout, with a large market and high unmet need [1] - D-2570, a TYK2 inhibitor, targets psoriasis, another large market with significant unmet clinical needs [1] Financial Projections - The company is expected to report net losses of -310 million, -226 million, and -337 million RMB for 2024-2026 [1][2] - Revenue is projected to grow from 149 million RMB in 2024 to 395 million RMB in 2026, with a CAGR of 32.1% [2] Market and Industry Insights - The NSCLC market is large, with EGFR mutations present in about 40% of Chinese NSCLC patients, creating a significant opportunity for EGFR TKIs [15][17] - KRAS G12C mutations are prevalent in multiple cancers, including NSCLC, CRC, and pancreatic cancer, with no approved drugs in China, indicating a significant market opportunity [13][32] - The oral SERD market is growing, with D-0502 leading the development in China, targeting the large ER+ breast cancer market [19][21]

证券代码：688382 证券简称：益方生物 | --- | --- | |--------------|----------| | | 2024-004 | | | | | 投资者关系 | | | 活动类别 | | | | | | | | | | | | 参与单位名称 | | | | | | | | 时间 2024 年 7 月 18 日、2024 年 7 月 24 日 地点 公司会议室 上市公司 接待人员姓名 YUEHENG JIANG（董事会秘书） 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 II 期临床试验阶 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 投资者关系活动主 据来看，三代产品已经成为 EGFR 非 ...