Core Viewpoint - Yifang Biotech (688382) faces significant operational challenges and financial difficulties, with a reported revenue of 169 million yuan and a net loss of 240 million yuan in 2024, marking a 14.5% increase in losses year-on-year [1] Revenue Structure - In 2024, 96% of the company's revenue came from technology licensing and sales commissions, with milestone revenue from Gexolex (151 million yuan, 89%) and sales commissions from Befotizumab (16.38 million yuan, 9.7%) [2] - The company recognizes revenue based on accounting standards, with significant milestone payments being a major component, leading to a "not applicable" gross margin due to the reliance on one-time payments [2] Accounts Receivable and Bad Debt - The overdue milestone payment of 180 million yuan from Betta Pharmaceuticals accounts for 77% of total accounts receivable, raising concerns about the company's ability to recover these funds [3] - The company has made a provision for bad debts amounting to 18 million yuan (10% of the overdue amount), but the recoverability of older receivables remains uncertain [3] Product Challenges - Befotizumab faces pricing pressure from insurance reductions and competition from six similar products already on the market, despite its superior efficacy [4] - Gexolex, while being the second approved product in its category, is projected to have a modest global market growth of 27% from 2023 to 2032, with competition from domestic products [4] R&D Pipeline - The company has a promising oral SERD drug D-0502 for breast cancer in Phase III trials, expected to be approved by 2026, while the URAT1 inhibitor D-0120 for gout is facing delays in clinical trials [5] - R&D investment has decreased by 13% to 384 million yuan, with a reduction of 36 staff members, raising concerns about the potential impact on R&D capabilities [5] Fund Utilization and Future Outlook - The company's fundraising projects have undergone changes, with the headquarters project being adjusted twice, leading to a reduced funding amount and a low utilization rate of 45.31% for new drug development [6] - The company is under pressure to turn a profit, with risks associated with delayed receivables and increased market competition, particularly if later-stage pipelines do not launch on schedule [6]

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年年度报告的信息披露监管问询函回复的核查意见 上海证券交易所： 根据贵所《关于益方生物科技（上海）股份有限公司2024年年度报告的信 息披露监管问询函》（上证科创公函【2025】0228号，以下简称"问询函"） 的要求，中信证券股份有限公司（以下简称"中信证券""保荐机构"）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 次公开发行股票并在科创板上市持续督导工作的保荐机构，对问询函所提及的 事项进行了逐项落实。现将问询函所涉及问题出具核查意见如下，本核查意见 中的简称或名词的释义与《益方生物科技（上海）股份有限公司2024年年度报 告》中的含义相同： 问题 1、关于经营业绩 年报显示，2024 年公司实现部分技术授权和技术合作收入，对外授权产品 贝福替尼、格索雷塞上市后销售亦带来部分销售提成收益，全年营业收入为 16,879.04万元，营业成本为392.39万元，归母净利润为-24,020.38万元。此外， 公司期末应收账款为 16,534.16 万元，毛利率披露为不适用。请公司：（1）区分 产品、项目列示本期技术 ...

关于对益方生物科技(上海)股份 有限公司 2024 年报问询函的专项说明 信会计师事务所(特殊普通; INA SHU LUN PAN CERTIFIED PUBLIC ACCOUNT/ 立信会计师事务所(特殊普通合伙) 关于对益方生物科技(上海)股份有限公司 2024 年报问询函的专项说明 信会师函字[2025]第 ZA284 号 立信会计师事务所(特殊普通合伙)(以下简称"会计师"或"我们")于 2025 年 6 月 4 日收到益方生物科技〈上海〉股份有限公司(以下简称"益方生物"或 "公司")转来的贵部下发的《关于益方生物科技(上海)股份有限公司2024年 年度报告的信息披露监管问询函》(上证科创公函【2025】0228 号)(以下简称 "年报问询函"),根据贵部要求,我们对年报问询函中需要会计师发表专业意见 的问题进行了审慎核查,现回复如下: 专项说明 第1页 一、关于经营业绩。年报显示,2024年公司实现部分技术授权和技术合作收 入,对外授权产品贝福替尼、格索雷塞上市后销售亦带来部分销售提成收益,全 年营业收入为 16,879.04 万元,营业成本为 392.39 万元,归母净利润为-24,020.3 ...

证券代码：688382 证券简称：益方生物 公告编号：2025-025 益方生物科技（上海）股份有限公司 关于2024年年度报告的信息披露监管问询函的回复公告 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"）于近日收到上 海证券交易所下发的《关于益方生物科技(上海)股份有限公司2024年年度报告 的信息披露监管问询函》（上证科创公函【2025】0228号）（以下简称"《问 询函》"）。根据《问询函》的要求，公司与保荐机构中信证券股份有限公司 （以下简称"保荐机构"）及年审会计师立信会计师事务所（特殊普通合伙） （以下简称"会计师"）对《问询函》所提及的事项进行了认真核查，现就《 问询函》所涉及问题回复如下： 本回复中若出现总计数尾数与所列数值总和尾数不符的情况，均为四舍五 入所致。本回复中所列示的包括但不限于收入、成本、投资等数据的相关测算 和预计均不构成业绩承诺或盈利预测。如无特别说明，本回复中使用的简称或 名词的释义与《益方生物科技（上海）股份有限公司2024年年度报 ...

| 证券代码：688382 证券简称：益方生物 | | | | 公告编号：2025-024 | | | | --- | --- | --- | --- | --- | --- | --- | | 益方生物科技（上海）股份有限公司 | | | | | | | | 本公司董事会及全体董事保证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： | | | | | | | | ? 本次会议是否有被否决议案：无 | | | | | | | | 一、 会议召开和出席情况 | | | | | | | | 股东大会召开的时间：2025 （一） | 6 年 | 20 月 | 日 | | | | | （二） 股东大会召开的地点：上海市浦东新区张衡路 | | | 1000 | 弄 63 号 | | | | （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 | | | | | | | | 其持有表决权数量的情况： | | | | | | | | 普通股股东人数 | | | | ...

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 junhesh@junhe.com 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 致：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，指派本所律师列席 了公司于 2025 年 6 月 20 日在上海市浦东新区张衡路 1000 弄 63 号召开的 2024 年年度股东大会（以下简称"本次股东大会"）的现场会议。现本所根据《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》《上 市公司股东会规则》（以下简称"《股东会规则》"）等中国现行法律、法规和 规范性文件以及《益方生物科技（上海）股份有限公司章程》（以下简称"《公 司章程》"）《益方生物科技（上海）股份有限公司股东大会议事规则》的有关 规定，就本次股东大会有关事宜出具法律意见书。 本法律意见书仅就本次股东大会的召集和召开程序是否符合中国有关法律、 行政 ...

证券代码：688382 证券简称：益方生物 公告编号：2025-024 益方生物科技（上海）股份有限公司 2024年年度股东大会决议公告 本公司董事会及全体董事保证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： （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 135 | | --- | --- | | 普通股股东人数 | 135 | | 2、出席会议的股东所持有的表决权数量 | 258,155,916 | | 普通股股东所持有表决权数量 | 258,155,916 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 44.6383 | | 例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例（%） | 44.6383 | （四） 表决方式是否符合《公司法》及公司章程的规定，大会主持情况等。 本次会议由公司董事会召集，YAOLIN WANG（王耀林）先生主持，采用现 场投票与网络投票相结合的方式进行表决，本次会议的 ...

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，指派本所律师列席 了公司于 2025 年 6 月 20 日在上海市浦东新区张衡路 1000 弄 63 号召开的 2024 年年度股东大会（以下简称"本次股东大会"）的现场会议。现本所根据《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》《上 市公司股东会规则》（以下简称"《股东会规则》"）等中国现行法律、法规和 规范性文件以及《益方生物科技（上海）股份有限公司章程》（以下简称"《公 司章程》"）《益方生物科技（上海）股份有限公司股东大会议事规则》的有关 规定，就本次股东大会有关事宜出具法律意见书。 本法律意见书仅就本次股东大会的召集和召开程序是否符合中国有关法律、 行政法规、《股东会规则》和《公司章程》的规定，以及出席本次股东大会人员 的资格、召集人资格、会议的表决程序和表决结果是否合法有效发表意见，并不 对本次股东大会所审议的议案内容以及该等议案所表述的相关事实或数据的真 实性、准确性、完整性或合法性发表意见。 上海石门一路 288 号 兴业太古汇香港兴业中心一 ...

Core Insights - The article highlights the long-term value of Yifang Biotech, a leading domestic small molecule drug development company, focusing on high-barrier targeted therapies in oncology, autoimmune diseases, and metabolism [1][2]. Group 1: Product Pipeline and Approvals - As of March 2025, the company has two drugs approved for market: the third-generation EGFR-TKI, Befotnib, and the KRAS G12C inhibitor, Gsorese [1]. - Befotnib is the fourth approved third-generation EGFR-TKI in China, indicated for EGFR mutation-positive NSCLC in 1st and 2nd line treatments, with mPFS of 22.1 months, significantly extending the duration compared to the control group [1][2]. - Gsorese is the second KRAS G12C inhibitor in China, expected to be approved in November 2024 for treating KRAS G12C mutation NSCLC patients, with an ORR of 52% and DCR of 88.6% in Phase II trials [2]. Group 2: Strategic Collaborations - The company has partnered with Betta Pharmaceuticals for the commercialization of Befotnib, leveraging Betta's established operational and sales capabilities to enhance market penetration [1]. - An exclusive licensing agreement was signed with Zhengda Tianqing for Gsorese, which may accelerate its growth potential in the market [2]. Group 3: Research and Development Potential - The company is advancing several promising candidates, including the oral TYK2 inhibitor D-2570, which has shown strong efficacy in treating moderate to severe plaque psoriasis with a PASI75 response rate of 85.0%-90.0% [2][3]. - The oral SERD D-0502 for HR+/HER2- breast cancer is in critical Phase III clinical trials, indicating its potential to be a best-in-class (BIC) therapy [3]. - The URAT1 inhibitor D-0120 for hyperuricemia and gout has completed Phase IIb clinical trials, showcasing its promising drug development potential [3]. Group 4: Financial Projections - The company forecasts revenues of 191 million yuan, 255 million yuan, and 399 million yuan for the years 2025, 2026, and 2027, respectively, indicating a positive growth trajectory [3].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [11]. Core Insights - The company, Yifang Biotech, is a leading domestic biotech firm focused on small molecule targeted innovative drugs, with a strong pipeline in oncology, autoimmune diseases, and metabolic disorders. The company has two drugs approved for market, with several others in advanced clinical stages, indicating a need for re-evaluation of its value [4][7][21]. Summary by Sections Company Overview - Yifang Biotech specializes in high-barrier small molecule drug development, with a pipeline that includes drugs for cancer, autoimmune diseases, and metabolic disorders. The company has received significant investment and successfully listed on the STAR Market in July 2022 [21][30]. Product Pipeline - The company has two commercialized drugs: the third-generation EGFR-TKI, Beifuteni, and the KRAS G12C inhibitor, Gesolezib. Additionally, it has several promising candidates in development, including the TYK2 inhibitor D-2570 and the oral SERD D-0502, which are in advanced clinical stages [7][8][10][34]. Commercialization and Partnerships - Beifuteni has shown competitive efficacy in treating EGFR mutation-positive NSCLC, with a median progression-free survival (mPFS) of 22.1 months, significantly longer than the comparator drug. The company has partnered with Beida Pharmaceutical for commercialization, leveraging their established sales channels [8][38]. - Gesolezib, another key product, has demonstrated strong clinical data with an overall response rate (ORR) of 52% and a disease control rate (DCR) of 88.6%. The company has signed an exclusive licensing agreement with Zhengda Tianqing to enhance its commercialization potential [8][9]. Financial Projections - Revenue forecasts for the company are projected at 191 million yuan, 255 million yuan, and 399 million yuan for the years 2025 to 2027, respectively [11].