证券代码：688382 证券简称：益方生物 公告编号：2024-046 益方生物科技（上海）股份有限公司 自愿披露关于 D-2570 II 期临床试验结果的公告 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。 益方生物科技（上海）股份有限公司（以下简称"公司"）自主研发的靶 向 TYK2 的新型口服选择性抑制剂 D-2570 已于近日完成针对银屑病的 II 期临床 试验，并取得了积极的临床试验结果，现将有关情况公告如下： 一、药品基本情况 三、风险提示 本次临床试验结果不会对公司业绩产生重大影响。由于新药研发有投入大、 周期长、风险高等特点，产品从立项到最终获批上市商业化需要经历较长的过 程，研发进度、试验结果及商业化情况可能受各种因素影响，存在一定的不确 定性。敬请广大投资者谨慎决策，注意防范投资风险。 特此公告。 D-2570 是公司自主研发的一款靶向 TYK2 的新型口服选择性抑制剂，用于 治疗银屑病等自身免疫性疾病。银屑病是一种遗传与环境共同作用诱发的免疫 介导的慢性、复发性、炎症性、系统性疾病。随着对银屑病发病机 ...

Investment Rating - The report assigns a "Buy" rating to the company [2] Core Views - The company has successfully launched Garsorasib, a second-line treatment for NSCLC, which is expected to have significant commercial potential [2][70] - The company is advancing its pipeline in three major disease areas, maintaining a leading position in the development of core products [2][29] - D-0502 is the only oral SERD in clinical phase III in China, with promising early clinical results [5][116] Summary by Sections Company Overview - The company focuses on unmet medical needs, developing innovative small molecule drugs in oncology, metabolism, and autoimmune diseases [28] - The core R&D team has extensive experience, with over 90% of employees involved in R&D [40] Product Pipeline - Garsorasib (D-1553) has been approved for the treatment of KRAS G12C mutation in NSCLC, with ongoing trials for other indications [2][70] - D-0502 is in phase III trials and shows good safety and efficacy in ER-positive, HER2-negative breast cancer patients [5][134] - D-0120 is progressing in phase II trials for hyperuricemia and gout, with strong efficacy and safety data [6][166] Financial Projections - The company expects revenues of 1.30 billion, 2.87 billion, and 3.82 billion RMB for 2024, 2025, and 2026 respectively, with net losses projected for the same period [7][179] - The total equity value of the company is estimated at 7.475 billion RMB, indicating a potential upside compared to the current market value [7][7] Market Potential - The market for KRAS G12C inhibitors is expanding, with increasing patient numbers and a need for effective therapies [85][89] - The company’s products are positioned to meet significant clinical needs in oncology and metabolic diseases, with a focus on innovative therapies [2][6] Competitive Landscape - The competitive landscape for oral SERDs is favorable, with D-0502 being the only one in phase III in China [5][116] - The company is actively exploring partnerships and collaborations to enhance its market presence and product development [29][51]

证券代码：688382 证券简称：益方生物 公告编号：2024-045 益方生物科技（上海）股份有限公司 关于持股 5%以上股东部分股份解除质押的公告 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。 | | | | | | | | 已质押股份 | | 未质押股份 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | 占其 | 占公 | 情况 | | 情况 | | | | | 持股 | 本次解除 | 本次解除 | 所持 | 司总 | 已质 | 已质 | 未质 | 未质 | | 股东 | 持股数量 | 比例 | 质押前累 | 质押后累 | 股份 | 股本 | 押股 | 押股 | 押股 | 押股 | | 名称 | | （%） | 计质押数 | 计质押数 | | | 份中 | 份中 | 份中 | 份中 | | | | | 量 | 量 | 比例 （%） | 比例 （%） | 限售 | 冻结 | 限售 | 冻结 | | | ...

证券代码：688382 证券简称：益方生物 公告编号：2024-044 益方生物科技（上海）股份有限公司 自愿披露关于格索雷塞片获批上市的公告 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。 近日，根据国家药品监督管理局网站公示，益方生物科技（上海）股份有 限公司（以下简称"公司"）与正大天晴药业集团股份有限公司（以下简称 "正大天晴"）合作开发的 1 类创新药格索雷塞片（商品名称：安方宁）获得国 家药品监督管理局批准上市，该药适用于治疗至少接受过一种系统性治疗的鼠 类肉瘤病毒癌基因（KRAS）G12C 突变型的晚期非小细胞肺癌（NSCLC）成人 患者。 格索雷塞（D-1553）是公司自主研发的一款新型、高效的 KRAS G12C抑制 剂，用于治疗带有 KRAS G12C突变的非小细胞肺癌、结直肠癌等多种癌症。现 将相关情况公告如下： 规格：0.2g 注册分类：化学药品 1 类 上市许可持有人：上海正大天晴医药科技开发有限公司 适应症：适用于治疗至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因 （KRAS）G12C 突变型的晚 ...

Company Overview - Yifang Bio is an innovative drug development company with a product pipeline that includes one product in the NDA stage, one in registration clinical trials, two in Phase II clinical trials, and multiple preclinical projects [1]. Product Pipeline 1. Beifu's Nib (Third-generation EGFR Inhibitor) - Beifu's Nib has been approved for both second-line and first-line treatment indications in 2023 and is included in the National Medical Insurance Directory [1]. - Approximately 800,000 new cases of non-small cell lung cancer (NSCLC) are reported annually in China, with projections of 1,000,000 cases by 2030, of which about 40% are EGFR mutations [1]. 2. Garsorasib (D-1553, KRAS G12C Inhibitor) - D-1553 is designed for treating KRAS G12C mutation-positive NSCLC and colorectal cancer, with KRAS G12C mutations occurring in about 14% of NSCLC cases and 4% of colorectal cancer cases [1]. - In the Chinese population, KRAS mutations are found in approximately 4.3% of lung cancer, 2.5% of colorectal cancer, and 2.3% of cholangiocarcinoma patients [1]. - D-1553's new drug application was accepted by CDE in December 2023 and is undergoing priority review [1]. Clinical Trial Progress D-1553 - A Phase III clinical trial comparing D-1553 to docetaxel for KRAS G12C mutation-positive NSCLC has commenced [4]. - Recent results from a Phase II study showed an objective response rate (ORR) of 52%, disease control rate (DCR) of 88.6%, median duration of response (DOR) of 12.5 months, median progression-free survival (PFS) of 9.1 months, and median overall survival (OS) of 14.1 months [4]. D-0502 (Selective Estrogen Receptor Degrader) - D-0502 is currently in a Phase III trial against fulvestrant for ER-positive, HER2-negative breast cancer, with a clinical benefit rate (CBR) of 47.1% and an ORR of 15.7% reported [4]. Other Products - D-0120, a URAT1 inhibitor, is in a Phase IIb trial in China, while D-2570, a TYK2 inhibitor, has completed Phase I and is in a Phase II trial for psoriasis [4].

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook based on the potential of its technology platform and leading strategic positioning [2]. Core Insights - The company is steadily advancing its clinical development pipeline, with significant progress on existing products and collaborations, particularly with D-1553, which is nearing approval for market launch [1][2]. - Research and development expenditures totaled 296 million yuan in the first three quarters of 2024, reflecting a year-on-year decrease of 15.28%, with Q3 2024 expenditures at 87 million yuan, down 22.39% year-on-year [1]. - D-1553 has shown promising results in clinical trials, including a Phase II study for KRAS G12C mutation non-small cell lung cancer, which was presented at the AACR annual meeting and published in a prestigious journal [2]. - The company reported a significant decline in revenue, with Q3 2024 revenue at 4.28 million yuan, down 90.92% year-on-year, and a net loss of 910 million yuan for the same period [3]. Summary by Sections Clinical Development Progress - The company is advancing its clinical projects, including collaborations with Betta Pharmaceuticals for postoperative adjuvant therapy and ongoing Phase I studies for D-1553 in combination with other treatments [1]. - D-1553 has been included in the breakthrough therapy program by the CDE for two new indications, indicating regulatory support for its development [1]. Financial Performance - For the first three quarters of 2024, the company reported total revenue of 19 million yuan, a decrease of 84.94% year-on-year, and a net loss of 305 million yuan [3]. - The net profit forecast for 2024 and 2025 has been revised down to -360 million yuan and -191 million yuan, respectively, with a new forecast for 2026 at -150 million yuan [2]. Market Outlook - The commercial prospects for D-1553 post-approval are considered promising, with expectations for significant market potential once it is launched [2].

Financial Performance - The company's operating revenue for Q3 2024 was ¥4,283,084.62, a decrease of 90.92% compared to the same period last year[2]. - The net profit attributable to shareholders for Q3 2024 was -¥91,088,164.68, with a year-to-date net profit of -¥305,306,509.72[2]. - Total operating revenue for the first three quarters of 2024 was ¥19,156,299.24, a significant decrease from ¥127,169,811.32 in the same period of 2023, representing a decline of approximately 84.9%[15]. - Net profit for the first three quarters of 2024 was -¥305,306,509.72, compared to -¥241,261,887.25 in 2023, indicating a worsening loss of approximately 26.6%[16]. - The basic and diluted earnings per share for the first three quarters of 2024 were both -¥0.53, compared to -¥0.42 in 2023, indicating a decline in earnings performance[17]. - Other comprehensive income after tax attributable to shareholders was -¥1,629,834.88 in 2024, compared to -¥592,304.62 in 2023, indicating a worsening of approximately 174.5%[16]. Research and Development - Research and development expenses totaled ¥86,765,416.51 in Q3 2024, a decrease of 22.39% year-over-year, representing 2,025.77% of operating revenue[4]. - The proportion of R&D expenses to operating revenue increased by 1,788.75 percentage points in Q3 2024 compared to the previous year[7]. - Research and development expenses were ¥295,676,116.12 in 2024, down from ¥349,006,011.76 in 2023, a decrease of about 15.3%[16]. - The company has ongoing investments in new technologies and product development, although specific figures were not disclosed in the report[11]. Assets and Liabilities - Total assets at the end of Q3 2024 were ¥1,891,407,290.62, down 12.53% from the end of the previous year[4]. - The company's current assets totaled RMB 1,831,610,771.86, down 13.8% from RMB 2,123,120,943.27 at the end of 2023[12]. - The company's total liabilities were RMB 156,430,452.54, a slight decrease of 5% from RMB 164,669,523.57[13]. - The company's total equity attributable to shareholders decreased to ¥1,734,976,838.08 from ¥1,997,602,519.77, a decline of approximately 13.1%[14]. - The total liabilities and equity decreased from ¥2,162,272,043.34 to ¥1,891,407,290.62, reflecting a reduction of about 12.5%[14]. Cash Flow - The net cash flow from operating activities was -289,602,708.75, compared to -234,600,234.01 in the previous period, indicating a decline in operational cash flow[19]. - Total cash inflow from operating activities amounted to 32,905,278.31, while cash outflow was 322,507,987.06, resulting in a significant cash outflow[19]. - The cash flow from investment activities was -181,557,575.16, a decrease from a positive cash flow of 1,919,032.28 in the previous period[19]. - Cash and cash equivalents at the end of the period were 739,523,993.87, down from 1,995,728,106.17 at the end of the previous period[20]. - The net cash flow from financing activities was -2,466,864.08, compared to -9,658,953.38 in the previous period, showing an improvement in financing cash flow[20]. Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 12,542[8]. - InventisBio Hong Kong Limited held 19.13% of the shares, totaling 110,329,937 shares[8]. - There were no significant changes in the shareholding structure among the top shareholders during the reporting period[11]. Government Subsidies and Tax - The company recognized government subsidies of ¥6,900,000.00 during the reporting period[5]. - The company received tax refunds amounting to 27,584,642.95 during the reporting period[19]. Market and Operational Strategy - The company experienced a significant decline in revenue primarily due to a high base from last year's technology licensing and cooperation income[7]. - The company is exploring market expansion opportunities, particularly in the Asia-Pacific region, to enhance its competitive position[11]. Accounting Standards - The company did not apply new accounting standards for the current reporting period[21].

益方生物科技（上海）股份有限公司 章 程 2024 年 10 月修订 | 第一章 | 总则 - | 1 - | | --- | --- | --- | | 第二章 | 经营宗旨和范围 - | 2 - | | 第三章 | 股份 - | 2 - | | 第一节 | 股份发行 - | 2 - | | 第二节 | 股份增减和回购 - | 5 - | | 第三节 | 股份转让 - | 6 - | | 第四章 | 股东和股东大会 - | 7 - | | 第一节 | 股东 - | 7 - | | 第二节 | 股东大会的一般规定 - | 9 - | | 第三节 | 股东大会的召集 - | 12 - | | 第四节 | 股东大会的提案与通知 - | 14 - | | 第五节 | 股东大会的召开 - | 15 - | | 第六节 | 股东大会的表决和决议 - | 18 - | | 第五章 | 董事会 - | 21 - | | 第一节 | 董事 - | 21 - | | 第二节 | 独立董事 - | 24 - | | 第三节 | 董事会 - | 28 - | | 第四节 | 董事会秘书 - | 33 - | | 第六章 | 总经理 ...

二、《公司章程》修订情况 根据有关法律、法规、规范性文件等的规定，基于上述公司股份总数和注 册资本的变更情况，拟对《公司章程》相关条款进行如下修订： | 序号 | 修订前 | | 修订后 | | --- | --- | --- | --- | | 1 | 第六条 | 公司的注册资本为人民币 | 第六条 公司的注册资本为人民币 | | | 57,671.7665 万元。 | | 57,674.5195 万元。 | | 2 | 第二十条 | 公 司 的 股 份 总 数 为 | 第二十条 公 司 的 股 份 总 数 为 | | | 57,671.7665 | 万股，均为普通股， | 57,674.5195 万股，均为普通股， | | | 每股面值人民币 1 | 元。 | 每股面值人民币 元。 1 | 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）。 证券代码：688382 证券简称：益方生物 公告编号：2024-043 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 ...

证券代码：688382 证券简称：益方生物 公告编号：2024-042 益方生物科技（上海）股份有限公司 关于召开 2024 年第三季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 10 月 30 日发布公司 2024 年第三季度报告，为便于广大投 资者更全面深入地了解公司 2024 年第三季度经营成果、财务状况，公司计划于 2024 年 11 月 4 日下午 14:00-15:00 举行 2024 年第三季度业绩说明会，就投资者 关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 2024 年第三季度的经 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 （一）会议召开时间：2024 年 11 月 4 日 下午 14:00-15:00 会议召开时间：2024 年 11 月 4 日（星期一）下午 14:00-15:00 会 议 召 开 地 点 ...