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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) - 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 ...
益方生物(688382) - 益方生物独立董事年度述职报告(戴欣苗)
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: 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 2024 年度履职概况 (一)出席董事会和股东大会情 ...
益方生物(688382) - 益方生物独立董事年度述职报告(严嘉)
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 严嘉,1971 年生,中国国籍,拥有香港永久居留权,毕业于香港城市大学 国际金融法专业,博士学历。1999 年至 2001 年,于美国宝维斯律师事务所任律 师;2001 年至 2006 年,于香港中华法律集团任运营总监;2006 年至 2008 年, 于美国普衡律师事务所任律师;2008 年至 2024 年,于美国普衡律师事务所任合 伙人、上海代表处首席代表;2024 年至今,于美国普盈律师事务所任合伙人、 中国业务联席主席;2021 年 5 月至今,任上海飞乐音响股份有限公司独立董事; 2022 年 ...
益方生物:2024年净亏损2.4亿元
news flash· 2025-04-25 11:14
益方生物公告,2024年度营业收入1.69亿元,归属于上市公司股东的净亏损为2.4亿元,归属于上市公司 股东的扣除非经常性损益的净亏损为2.5亿元,亏损幅度较上年同期均有所减少。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。 ...
益方生物科技(上海)股份有限公司关于召开2024年度业绩说明会的公告
Core Viewpoint - The company, Yifang Biotechnology (Shanghai) Co., Ltd., is set to hold its 2024 annual performance briefing on April 28, 2025, to discuss its operational results and financial status for the year 2024, allowing investors to engage in a Q&A session [2][3][6]. Group 1: Event Details - The annual performance briefing will take place on April 28, 2025, from 13:00 to 14:00 [6][7]. - The event will be conducted in an interactive online format via the Shanghai Stock Exchange Roadshow Center [3][6]. - Investors can submit questions for the briefing from April 21 to April 25, 2025, through the Roadshow Center or via the company's email [2][8]. Group 2: Participation Information - Investors can participate in the briefing by logging into the Shanghai Stock Exchange Roadshow Center website [6][8]. - The company will address commonly asked questions during the briefing, ensuring transparency and engagement with investors [3][5].
益方生物(688382) - 益方生物关于召开2024年度业绩说明会的公告
2025-04-18 07:51
证券代码:688382 证券简称:益方生物 公告编号:2025-014 益方生物科技(上海)股份有限公司 关于召开 2024 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: 益方生物科技(上海)股份有限公司(以下简称"公司")将于 2025 年 4 月 26 日发布公司 2024 年度报告,为便于广大投资者更全面深入地了解公司 2024 年度经营成果、财务状况,公司计划于 2025 年 4 月 28 日(星期一)13:00-14:00 举行 2024 年度业绩说明会,就投资者关心的问题进行交流。 一、说明会类型 本次业绩说明会以网络互动形式召开,公司将针对 2024 年度的经营成果及 财务指标的具体情况与投资者进行互动交流和沟通,在信息披露允许的范围内就 投资者普遍关注的问题进行回答。 二、说明会召开的时间、地点 董事长、总经理:YAOLIN WANG(王耀林) 董事会秘书:YUEHENG JIANG(江岳恒) 财务总监:史陆伟 独立董事:戴欣苗 (如有特殊情况,参会人员可能进行调整) ...
医药行业周报:贸易冲突加剧,关注供给变化-2025-04-07
Huaxin Securities· 2025-04-07 04:51
Investment Rating - The industry investment rating is "Recommended" [1] Core Insights - The report highlights the impact of escalating trade conflicts on the supply chain of pharmaceuticals, particularly regarding the exemption of certain drugs from tariffs, which reflects the U.S.'s reliance on global pharmaceutical supply chains [3] - The report emphasizes the importance of international markets for Chinese pharmaceutical exports, with a projected export value of $107.96 billion in 2024, indicating a growth of 5.9% year-on-year [4] - The report discusses the potential changes in the supply landscape for blood products due to new tariffs, which may accelerate domestic substitution opportunities [6] - The report notes the ongoing evolution of raw material applications, particularly in the nicotine sector, as companies explore new production avenues [8] - The report indicates that the optimization of centralized procurement policies may alleviate pricing pressures on traditional pharmaceutical companies [10] - The report outlines advancements in CAR-T cell therapies, with significant sales growth and the potential for cost reductions in the future [12] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 2.57 percentage points in the past week, ranking third among 31 primary industry indices [23] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's index has shown a 3.15% increase over the past month, outperforming the CSI 300 index by 4.20 percentage points [40] - The current PE (TTM) for the pharmaceutical sector is 31.25, which is below the historical average of 32.95 [45] 3. Recent Research Achievements - The report lists various deep-dive studies conducted by the research team, focusing on supply and demand dynamics in the blood products sector and the impact of policy support on inhalation drug markets [49] 4. Important Industry Policies and News - Recent policy updates include the release of the 2025 edition of the Pharmacopoeia of the People's Republic of China, which will take effect on October 1, 2025 [52] - Significant industry news includes the approval of new drug applications by major pharmaceutical companies, indicating ongoing innovation and market activity [54][55]
医药行业周报:中国创新药逐步进入收获期,关注技术革新与BD潜力-2025-04-06
Tebon Securities· 2025-04-06 13:08
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [2] Core Insights - The Chinese innovative drug sector is entering a harvest period, with a focus on technological innovation and business development (BD) potential [5] - Companies such as Sangfor Biopharma, Kexing Pharmaceutical, and Yifang Biotech are highlighted for their strong growth prospects and innovative pipelines [4][5] Summary by Sections 1. Chinese Innovative Drugs Entering Harvest Period - **Sangfor Biopharma**: Core products are showing steady growth, and the innovative pipeline is gradually yielding results. The PD-1/VEGF dual antibody AK112 has become the first drug to outperform K drug in head-to-head Phase III clinical trials, enhancing the development enthusiasm for PD(L)-1/VEGF dual antibodies. The company has three ongoing clinical trials demonstrating excellent efficacy and BD potential [7][8] - **Kexing Pharmaceutical**: The CAR-T therapy shows significant potential, with its first product, CT053, approved for treating multiple myeloma in February 2024. Another product, CT041, is a potential first-in-class CAR-T for Claudin18.2, with a Phase II trial for gastric cancer completed. The company is well-positioned in the universal CAR-T technology space [11][12] - **Yifang Biotech**: The drug D-2570 shows promising data for treating psoriasis, with clinical results indicating significant efficacy compared to placebo. The drug is in Phase II trials and ranks third among domestic products, with a large patient population and a competitive landscape [14][15] 2. Weekly Market Review and Hotspot Tracking (March 31 - April 3, 2025) - The pharmaceutical and biotechnology sector index rose by 1.2%, outperforming the CSI 300 index by 2.57%. Year-to-date, the sector index has increased by 4.77%, also outperforming the CSI 300 index by 6.64 [16][18] - The top five performing stocks during this period included Duorui Pharmaceutical (up 56.32%), Weisi Medical (up 31.80%), and Hasanlian (up 31.15%) [29][32] 3. Overall Investment Strategy and Allocation Thoughts - The development of AI is driving the widespread adoption of AI in healthcare, with many medical companies exploring AI applications. Companies with extensive patient data and those with health insurance data are expected to have significant application potential. The report suggests focusing on innovative drugs and companies with a turning point in fundamentals [4][5]