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益方生物(688382) - 益方生物第二届董事会2025年第二次会议决议公告
2025-04-25 12:06
证券代码:688382 证券简称:益方生物 公告编号:2025-015 益方生物科技(上海)股份有限公司 第二届董事会 2025 年第二次会议决议公告 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。 一、董事会会议召开情况 益方生物科技(上海)股份有限公司(以下简称"公司"或"益方生物") 第二届董事会 2025 年第二次会议于 2025 年 4 月 25 日以现场结合通讯形式召开, 本次会议通知已于 2025 年 4 月 15 日以书面等形式发出。会议应出席董事 9 名, 实际出席董事 9 名,公司监事及高级管理人员列席本次会议。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。 公司董事长 YAOLIN WANG(王耀林)先生召集并主持本次会议。 二、董事会会议审议情况 出席会议的董事审议通过以下议案: (一)审议通过《关于 2024 年度总经理工作报告的议案》 表决结果:同意 9 票;反对 0 票;弃权 ...
益方生物(688382) - 益方生物关于2024年度利润分配方案的公告
2025-04-25 12:05
证券代码:688382 证券简称:益方生物 公告编号:2025-019 益方生物科技(上海)股份有限公司 关于 2024 年度利润分配方案的公告 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: 一、利润分配方案内容 (一)利润分配方案的具体内容 经立信会计师事务所(特殊普通合伙)审计,公司 2024 年度归属于上市公 司股东的净利润为-24,020.38 万元,母公司净利润为-12,007.84 万元;截至 2024 年 12 月 31 日,母公司累计未分配利润为-90,646.22 万元。为保障和满足公司正 常经营和持续发展需要,根据《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》及《公司章程》等的有关规定, 经董事会决议,公司 2024 年度利润分配方案为:不派发现金红利,不送红股, 不以资本公积金转增股本。本议案尚需提交公司股东大会审议。 (二)是否可能触及其他风险警示情形 本次利润分配方案不会触及《科创板股票上市规则》第 12.9.1 条第一款第 (八)项规 ...
益方生物:2024年报净利润-2.4亿 同比增长15.49%
Tong Hua Shun Cai Bao· 2025-04-25 11:34
前十大流通股东累计持有: 13644.76万股,累计占流通股比: 34.13%,较上期变化: -1252.14万股。 | 名称 | 持有数量(万股) | 占总股本比例(%) | 增减情况(万股) | | --- | --- | --- | --- | | ABA-Bio (Hong Kong) Limited | 3294.00 | 8.24 | 不变 | | LAV Apex Hong Kong Limited | 2407.92 | 6.02 | 不变 | | OAP III (HK) Limited | 1992.93 | 4.99 | 不变 | | HH SPR-XIV HK Holdings Limited | 1257.67 | 3.15 | -721.74 | | LAV Alpha Hong Kong Limited | 1203.96 | 3.01 | 不变 | | 博山投资有限公司 | 936.22 | 2.34 | 不变 | | 中欧医疗健康混合A | 671.60 | 1.68 | 新进 | | 鹏华医药科技股票A | 666.75 | 1.67 | 不变 | | Sunflower ...
益方生物(688382) - 关于益方生物非经营性资金占用及其他关联资金往来情况汇总表的专项审计报告
2025-04-25 11:27
关于益方生物科技(上海)股份有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 2、 附表 委托单位:益方生物科技(上海)股份有限公司 审计单位:立信会计师事务所(特殊普通合伙) 联系电话:021-23280000 益方生物科技(上海)股份有限公司 非经营性资金占用及其他关联资金 往来情况的专项报告 目 录 1、 专项审计报告 2024 年度 关于益方生物科技(上海)股份有限公司 非经营性资金占用及其他关联资金往来情况 信会师报字[2025]第 ZA11565 号 益方生物科技(上海)股份有限公司全体股东: 我们审计 物")2024 年度的财务报表,包括 2024 年 12 月 31 日的合并及母公司 量表、合并及母公司所有者权益变动表和相关财务报表附注,并于 2025 年 4 月 25 日出具了报告号为信会师报字[2025]第 ZA11562 号的 无保留意见审计报告。 益方生物管理层根据中国证券监督管理委员会《上市公司监管 指引第 8 号——上市公司资金往来、对外担保的监管要求》(证监会 公告〔2022〕26 号)和上海证券交易所《科创板上市公司自律监管 指南第 7 号——年度报告相关 ...
益方生物(688382) - 关于益方生物2024年度募集资金存放与使用情况专项报告的鉴证报告
2025-04-25 11:27
益方生物科技(上海)股份有限公司 募集资金存放与使用情况 专项报告的鉴证报告 2024年度 您可使用手机"扫一扫" 此码用于证明该审计报告是否由具有执业许可的会计师事务 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)"为 the with the first of the country of the country of the support of 2018 立信会计师事务所(特殊普通合伙) DO CHINA SHU LUN PAN CERTIFIED PUBLIC ACCOUNTANTS LLP 益方生物董事会的责任是按照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)》(证监会公告〔2022〕15号)、《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》以及《上海证券 交易所上市公司自律监管指南第1号 -- 公告格式》的相关规定编制 募集资金专项报告。这种责任包括设计、执行和维护与募集资金专项 报告编制相关的内部控制,确保募集资金专项报告真实、准确、完整, 不存在虚假 ...
益方生物(688382) - 益方生物科技(上海)股份有限公司审计报告及财务报表(2024年度)
2025-04-25 11:27
益方生物科技(上海)股份有限公司 审计报告及财务报表 二〇二四年度 iiE明该审计报告是否由具有执业许可的会计师行业统一些 您可使用手机"扫一扫"或进入"注册会 益方生物科技(上海)股份有限公司 审计报告及财务报表 (2024年01月01日至2024年12月31日止) | 目录 | 页次 | | --- | --- | | 审计报告 | 1-4 | | 财务报表 | | | 合并资产负债表和母公司资产负债表 | 1-4 | | 合并利润表和母公司利润表 | 5-6 | | 合并现金流量表和母公司现金流量表 | 7-8 | | 合并所有者权益变动表和母公司所有者权益变动表 | 9-12 | | 财务报表附注 | 1-87 | 审计报告 第1页 Í I I 立信会计师事务所(特殊普通合伙) DO CHINA SHU LUN PAN CERTIFIED PUBLIC ACCOUNTANTS LI 审计 报告 信会师报字[2025]第 ZA11562 号 益方牛物科技(上海)股份有限公司全体股东: 一、审计意见 我们审计了益方生物科技(上海)股份有限公司(以下简称益方 生物)财务报表,包括2024年12月31日的合并 ...
益方生物(688382) - 益方生物内部控制审计报告
2025-04-25 11:27
益方生物科技(上海)股份有限公司 内部控制审计报告 2024 年 12 月 31 日 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 立信会计师事务所(特殊普通合伙) DO CHINA SHU LUN PAN CERTIFIED PUBLIC ACCOUNTANTS LLP 内部控制审计报告 信会师报字[2025]第 ZA11563 号 益方生物科技(上海)股份有限公司全体股东: 按照《企业内部控制审计指引》及中国注册会计师执业准则的相 关要求,我们审计了益方生物科技(上海)股份有限公司(以下简称 益方生物)2024年12月31日的财务报告内部控制的有效性。 一、企业对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企 业内部控制评价指引》的规定,建立健全和有效实施内部控制,并评 价其有效性是益方生物董事会的责任。 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 内部控制具有固有局限性,存在不能防止和 ...
益方生物(688382) - 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2024年度募集资金存放与使用情况的专项核查意见
2025-04-25 11:27
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 2024 年度募集资金存放与使用情况的专项核查意见 中信证券股份有限公司(以下简称"中信证券"或"保荐人")作为益方 生物科技(上海)股份有限公司(以下简称"益方生物"或"公司")首次公 开发行的保荐人,根据《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上市公司自律监管指引第 1 号— —规范运作》等有关规定,对益方生物 2024 年度募集资金的存放和使用情况进 行了专项核查,核查情况如下: 一、募集资金基本情况 (一)实际募集资金金额、资金到位时间 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、 发行登记费以及累计发生的其他相关发行费用(共计人民币 101,646,630.18 元, 不含税)后,募集资金净额为 1,9 ...
益方生物(688382) - 2024 Q4 - 年度财报
2025-04-25 11:25
Financial Performance - The net loss attributable to shareholders for the year 2024 was CNY 240.20 million, with a net loss of CNY 250.14 million after deducting non-recurring gains and losses, showing a reduction compared to the same period last year [4]. - The cumulative unabsorbed losses as of the end of the reporting period amounted to CNY 2,544.93 million [4]. - The company's revenue for 2024 was CNY 168.79 million, a decrease of 9.02% compared to CNY 185.53 million in 2023 [27]. - The net loss attributable to shareholders for 2024 was CNY 240.20 million, improving from a loss of CNY 283.98 million in 2023 [27]. - The basic earnings per share for 2024 was -CNY 0.42, compared to -CNY 0.49 in 2023 [28]. - The total assets decreased by 11.17% from CNY 216.23 million in 2023 to CNY 192.08 million in 2024 [27]. - The net assets attributable to shareholders at the end of 2024 were CNY 181.08 million, a decrease of 9.35% from CNY 199.76 million in 2023 [27]. - The cash flow from operating activities for 2024 was -CNY 241.97 million, compared to -CNY 307.75 million in 2023 [27]. - The company's total sales revenue for the year reached 168.79 million RMB, with the top five customers accounting for 100% of this total [163]. - The largest customer contributed 90.30% of the total sales, amounting to 152.41 million RMB, while the second largest customer accounted for 9.70% with sales of 1.64 million RMB [164]. Research and Development (R&D) - The company plans to maintain a high level of R&D investment to support multiple ongoing projects, despite the risk of continued losses [5]. - The company's R&D expenditure as a percentage of revenue was 227.71% in 2024, down from 238.73% in 2023, a reduction of 11.02 percentage points [28]. - The company maintained a high level of R&D investment at 384.35 million yuan in 2024 [40]. - 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 [63]. - The company has established R&D centers in Shanghai, Beijing, and the United States, enhancing its global competitiveness and innovation capabilities [133]. - The R&D team consists of 169 members, accounting for 91.35% of total employees, with significant expertise in drug development, including 19 PhDs and 64 Master's degrees [138]. - The company’s R&D investment as a percentage of total assets is 21.23%, indicating a strong focus on innovation [183]. - The average R&D investment among comparable companies in the industry is 68,033.73 million RMB, highlighting the company's significant commitment to R&D [183]. Product Pipeline and Clinical Trials - The company has two authorized products, Beifu Tini and Gesorase, which have been launched, and expects to receive milestone payments and sales sharing as clinical research and commercialization progress [5]. - The company has not yet established a commercial sales team, which may impact the market acceptance of its products post-approval [145]. - The company has five clinical products, with two already approved for market, while three are in clinical trial stages [176]. - The company is focusing on developing multiple preclinical pipelines in areas such as kinase, tumor driver genes, tumor immunity, and synthetic lethality pathways [176]. - The company’s clinical pipeline includes drugs targeting unmet medical needs, with a focus on oncology and autoimmune diseases [132]. - D-0502, an oral selective estrogen receptor degrader (SERD), is in Phase III clinical trials for ER-positive, HER2-negative breast cancer, with the first patient enrolled in September 2022 [42]. - D-0120, a URAT1 inhibitor for hyperuricemia and gout, has completed multiple Phase I trials and is currently in a Phase II trial in China, expected to complete by November 2024 [42]. - D-2570, a novel oral selective TYK2 inhibitor for psoriasis, started Phase II clinical trials in December 2023, showing significant efficacy compared to placebo and existing TYK2 inhibitors [43]. - The company has made significant progress in clinical research for its main products in 2024 [40]. - The product Gexorese (Anfangning®) received approval from the National Medical Products Administration (NMPA) in November 2024 [40]. - The product Beifu Tini (BPI-D0316) received NMPA approval for its second-line treatment indication in December 2023 and for its first-line treatment indication in November 2024 [41]. Market and Competitive Landscape - The global pharmaceutical market grew from $1,266.7 billion in 2018 to $1,495.0 billion in 2022, with a CAGR of 4.2% from 2018 to 2022 [70]. - In 2022, the Chinese pharmaceutical market reached ¥1,554.1 billion, with projected CAGR of 8.1% from 2022 to 2025 and 6.0% from 2025 to 2030 [73]. - The global anti-tumor drug market increased from $110.6 billion in 2017 to $181.7 billion in 2021, with a CAGR of 13.2% [79]. - China's anti-tumor drug market grew from ¥139.4 billion in 2017 to ¥231.1 billion in 2021, with a CAGR of 13.5% [79]. - The global metabolic disease market expanded from $105.0 billion in 2018 to $160.0 billion in 2022, with a CAGR of 10.9% [82]. - The global autoimmune disease drug market was approximately $132.3 billion in 2022, expected to reach $147.3 billion by 2025, with a CAGR of 3.6% from 2022 to 2025 [93]. - The Chinese autoimmune disease drug market was about $2.9 billion in 2022, projected to grow to $6.1 billion by 2025, reflecting a CAGR of 27.4% [93]. Risks and Challenges - The company faces significant risks in drug development, including long cycles and high investment requirements, which may lead to substantial performance declines or losses [5]. - The company has not established a complete commercialization and sales team, which may hinder market acceptance of its products [8]. - The company relies on third-party CMO for production, which introduces risks related to supply and quality control [8]. - The company emphasizes the uncertainty of entering the National Medical Insurance Directory, which could impact the pricing competitiveness of its products [8]. - The company is currently not profitable, with ongoing R&D investments and cumulative losses, relying on milestone payments and sales shares from its two approved products to improve financial conditions [141]. - The company faces risks related to significant financial investments in drug development, potential competition from established players, and uncertainties in market acceptance and reimbursement for its products [145]. Corporate Governance - The company held one annual and one temporary shareholders' meeting during the reporting period, ensuring compliance with relevant laws and regulations [198]. - The board of directors consists of 9 members, including 3 independent directors, and held 8 meetings during the reporting period to review all proposals [198]. - The annual general meeting held on June 21, 2024, approved 8 resolutions without any being rejected [200]. - The first extraordinary general meeting of 2024 took place on September 9, 2024, where 2 resolutions were approved without any rejections [200]. - All resolutions discussed in the shareholder meetings complied with relevant laws and regulations [200].
益方生物(688382) - 益方生物独立董事年度述职报告(WEN CHEN)
2025-04-25 11:24
益方生物科技(上海)股份有限公司 独立董事 2024 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")第一届董事会和第二届董事会独立董事,严格按照《公司法》《证券法》《上 市公司独立董事管理办法》等有关法律法规、规范性文件的要求以及《公司章程》 等相关制度,忠实、勤勉、尽责地履行独立董事职责,维护公司整体利益和全体 股东尤其是中小股东的合法权益,较好地发挥了独立董事的作用。现将 2024 年 度履职情况汇报如下: 一、独立董事的基本情况 (一)个人工作履历、专业背景及兼职情况 WEN CHEN(陈文),1968 年生,美国国籍,毕业于美国圣路易华盛顿大学 医学院生物学及生物医学专业、英国杜伦大学商学院工商管理专业,研究生学历。 1997 年至 2009 年,曾先后任职于美国安进公司、中药通医药科技(成都)有限 公司、上海单抗制药技术有限公司、上海华谊生物技术有限公司、美国沪亚生物 技术有限公司上海代表处以及辉源生物科技(上海)有限公司;2009 年至 2020 年,于杭州泰格医药科技股份有限公司任资深副总裁;2020 年至今,于上海涌 铧投资管理有限公司任生物医药投资 ...