证券代码：688382 证券简称：益方生物 公告编号：2025-006 益方生物科技（上海）股份有限公司 第二届监事会 2025 年第一次会议决议公告 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 2025 年第一次会议于 2025 年 1 月 16 日以现场结合通讯形式召开，本次会议通知已于 2025 年 1 月 10 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》及《益方生物科技（上 海）股份有限公司章程》的有关规定。监事会主席冯清华先生召集并主持本次会 议。 二、监事会会议审议情况 出席会议的监事审议通过以下议案： （一）审议通过《关于 2022 年限制性股票激励计划首次授予部分第二个归 属期及预留授予部分（第二批）第一个归属期符合归属条件的议案》 监事会认为，公司 2022 年限制性股票激励计划首次授予部分第二个归属期 及预留授予部分（第二批）第一个归属 ...

Financial Performance - The company expects a net loss attributable to shareholders of approximately -244.36 million yuan for the fiscal year 2024, compared to a net loss of -283.98 million yuan in 2023, indicating a decrease in loss of 13.95% year-over-year[3][5]. - The projected net loss after deducting non-recurring gains and losses for 2024 is estimated at -254.24 million yuan[3]. - The company reported a net loss of -283.98 million yuan for the fiscal year 2023, with a loss per share of -0.49 yuan[5][6]. Revenue Expectations - Revenue for 2024 is expected to primarily come from technology licensing and collaboration, as the main products are still in the R&D phase and have not yet commenced commercial production and sales[7]. - The company anticipates that losses in 2024 will decrease due to the approval and sales of externally licensed products, although technology licensing and collaboration revenue will not cover all costs and expenses[8]. Research and Development - The company is maintaining a high level of R&D investment in 2024, focusing on key clinical trials for multiple products, including D-1553 and D-0502[8]. Earnings Forecast - As of the announcement date, there are no significant uncertainties that could affect the accuracy of the earnings forecast[9]. - The financial data provided is preliminary and subject to change, with the final audited figures to be disclosed in the official annual report[10].

财联社1月6日电，益方生物公告，公司收到美国新泽西地区法院书面裁定，就美国倍而达对公司、 Yueheng Jiang (江岳恒)、Wansheng Jerry Liu和Fox Rothschild, LLP提起的民事诉讼事项，法院裁定驳回 原告诉讼请求。 原告可在30日内向州法院提起诉讼。 本次诉讼不会对公司损益产生负面影响。 但鉴于原告可在判决后一定期限内向州法院提起诉讼，公司将密切关注案件后续情况并及时履行信息披 露义务。 裁定驳回了原告第一项诉讼请求（即违反联邦《保护商业秘密法》项下的商业秘密盗窃）且原告对同一 事由不得再次提起诉讼。 此外，基于其余诉讼请求不属于联邦法院管辖，本案件被驳回。 ...

证券代码：688382 证券简称：益方生物 公告编号：2024-047 益方生物科技（上海）股份有限公司 关于诉讼事项进展的公告 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。 2022 年 11 月，米拉蒂公司向上海知识产权法院提起诉讼，称公司、公司全 资子公司美国益方、公司董事XING DAI（代星）侵害米拉蒂公司和亚雷生物医 药股份有限公司（以下简称"亚雷公司"）技术秘密。米拉蒂公司要求法院判 令上述被告停止侵权行为，要求法院确认相关专利权/专利申请权归米拉蒂公司 与亚雷公司所有，并要求公司、美国益方及XING DAI（代星）共同赔偿米拉蒂 公司经济损失及合理费用合计人民币 9,900 万元。具体内容详见公司于 2022 年 11 月 16 日披露于上海证券交易所网站（www.sse.com.cn）及指定媒体的《益方 生物科技（上海）股份有限公司关于公司及全资子公司涉及诉讼的公告》（公 告编号：2022-012）。 2023 年 8 月 3 日、2023 年 11 月 16 日、2024 年 3 月 14 日、202 ...

证券代码：688382 证券简称：益方生物 公告编号：2024-048 益方生物科技（上海）股份有限公司股东减持股份 计划公告 本公司董事会、全体董事及相关股东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： 公司于近日收到股东 LAV Apex、LAV Alpha、LAV Inventis、苏州礼康出具 的《关于股东减持计划的告知函》，现将相关减持计划公告如下： | | | 一、减持主体的基本情况 1 大股东及其一致行动人持股的基本情况：截至本公告披露日，益方生物科技 （上海）股份有限公司（以下简称"公司"）股东 LAV Apex Hong Kong Limited（以下简称"LAV Apex"）持有公司股份 24,079,222 股，占公司总 股本的 4.18%；LAV Alpha Hong Kong Limited（以下简称"LAV Alpha"）持 有公司股份 12,039,582 股，占公司总股本的 2.09%；LAV Inventis Hong Kong Limited（以下简称"LAV Inventis"）持有公司 ...

Investment Rating - The investment rating for the company is "Buy" with a 6-month target price maintained at 12.95 CNY [1][39]. Core Insights - The company has a rich pipeline of products focusing on major diseases such as cancer and metabolic disorders, showcasing its self-research advantages and competitive potential [6][42]. - The TYK2 inhibitor D-2570 has shown excellent Phase II clinical trial data, outperforming existing similar drugs and demonstrating significant efficacy in treating psoriasis [13][38]. - The company’s product, Beifu Tini, has received approval for both first-line and second-line treatment of EGFR mutation-positive NSCLC and is included in the national medical insurance directory [42][44]. Summary by Sections Investment Rating - The company maintains a "Buy" rating with a target price of 12.95 CNY, indicating an expected return of over 20% within the next six months [1][39]. Clinical Pipeline - The company’s pipeline includes several products such as D-0502, D-0120, and D-2570, with D-0502 in Phase III trials for HR+/HER2- breast cancer, D-0120 showing an 80% efficacy rate in lowering uric acid for gout, and D-2570 demonstrating a PASI 75 response rate of 85.0%-90.0% in psoriasis patients [12][21][38]. - The KRAS G12C inhibitor D-1553 has been approved for NSCLC, addressing a significant unmet clinical need in a rapidly progressing patient population [20][42]. Financial Forecast - The company’s revenue forecast for 2024 has been adjusted from 0.90 billion CNY to 1.30 billion CNY, with a projected net loss of 2.92 billion CNY [39]. - The expected revenue for 2025 has been revised down to 2.30 billion CNY, with a forecasted net loss of 1.80 billion CNY for 2026 [39]. Market Position - The company’s products are positioned in a favorable competitive landscape, particularly with the KRAS G12C inhibitor, which is the first of its kind developed in China and has a strong market potential due to limited competition [20][42].

Group 1: Company Overview and Product Pipeline - Yifang Bio is an innovative drug development company with a product pipeline that includes two marketed products, one in registration clinical trials, two in Phase II clinical trials, and several preclinical projects [5]. - The company’s marketed products include: - **Befotertinib**: An EGFR tyrosine kinase inhibitor for treating EGFR mutation-positive non-small cell lung cancer (NSCLC), approved for both first-line and second-line treatment in 2023 and included in the National Medical Insurance Directory [5]. - **D-1553 (Gosorese)**: A KRAS G12C inhibitor for treating various cancers, with its new drug application accepted by CDE in December 2023 and approved for marketing in November 2024 [5]. - **D-0502 (Taragarestrant)**: An oral selective estrogen receptor degrader (SERD) for treating ER-positive, HER2-negative breast cancer, currently in Phase III clinical trials [5]. - **D-0120**: A URAT1 inhibitor for treating hyperuricemia and gout, with ongoing clinical trials in China and the US [5]. - **D-2570 (TYK2)**: A selective oral TYK2 inhibitor for treating psoriasis, with a Phase II clinical trial initiated in December 2023 [5]. Group 2: Clinical Trial Results and Efficacy - The Phase II clinical trial for D-2570 showed significant efficacy, with PASI 75 response rates between 85.0% and 90.0%, compared to 12.5% in the placebo group (P<0.001) [6]. - Other efficacy metrics for D-2570 included: - PASI 90 response rates of 70.7% to 77.5% vs. 5.0% in the placebo group - PASI 100 response rates of 39.0% to 50.0% vs. 2.5% in the placebo group - sPGA 0/1 response rates of 80.5% to 87.5% vs. 20.0% in the placebo group [6]. - D-1553 demonstrated an objective response rate (ORR) of 52% and a disease control rate (DCR) of 88.6% in a Phase II study, with a median progression-free survival (PFS) of 9.1 months [7]. Group 3: Market Potential and Strategic Partnerships - The market for gout treatments is significant, with over 100 million patients in China, highlighting the need for more effective and safer products like D-0120 [5]. - In August 2023, Yifang Bio granted exclusive rights to Zhengda Tianqing for the development, registration, production, and commercialization of D-1553 in mainland China [5].

Investment Rating - The report assigns a "Buy" rating to the company with a target price of 22.48 RMB, compared to the last closing price of 13.60 RMB [1][10][184]. Core Insights - The company focuses on developing small molecule targeted drugs, with pipelines in oncology, metabolism, and autoimmune diseases nearing harvest periods [1][10]. - The core investment logic is based on three points: stable cash flow from oncology pipelines, approaching data and business development harvest periods for metabolism and autoimmune pipelines, and significant upside potential with a projected peak revenue of 6.6 billion RMB for five core products [3][10]. - The company has successfully commercialized two oral targeted drugs for lung cancer and is advancing several products in clinical trials for breast cancer, gout, and psoriasis [10][23]. Summary by Sections Company Overview - The company is a leading player in small molecule drug development, established in January 2013 and listed on the STAR Market in July 2022 [23][24]. - It has two approved products in the lung cancer field: the third-generation EGFR TKI, Beifu, and the KRAS G12C inhibitor, Gesorese [23][24]. Oncology Pipeline - Beifu has shown excellent efficacy data and has been approved for both first-line and second-line treatment of EGFRm NSCLC, with ongoing expansion into postoperative adjuvant therapy [60][62]. - Gesorese has been approved for second-line KRAS G12C NSCLC treatment, with ongoing clinical trials for other indications [72][73]. Breast Cancer Pipeline - D-0502, an oral SERD, is in phase 3 clinical trials for HR+ breast cancer and is positioned as a leading product in the domestic market [90][105]. - The drug has shown promising early data, outperforming competitors in clinical trials [106]. Metabolism and Autoimmune Pipeline - D-0120, a URAT1 inhibitor for gout, has demonstrated an 80% response rate in phase 2 trials and is progressing in both China and the US [126][147]. - D-2570, a TYK2 inhibitor for psoriasis, has shown best-in-class potential with significant efficacy data in clinical trials [173][177]. Financial Projections and Valuation - The report forecasts a target market value of 13 billion RMB for the company, with a corresponding stock price of 22.48 RMB based on DCF and NPV methods [10][184]. - Revenue projections indicate a significant increase in sales from core products, with peak sales estimates for Beifu, Gesorese, D-0502, D-0120, and D-2570 reaching 30 billion RMB, 8.2 billion RMB, 7.5 billion RMB, 13.6 billion RMB, and 6.4 billion RMB respectively [186].

Summary of Conference Call Company and Industry - The conference call primarily discusses a biopharmaceutical company focused on developing treatments for chronic diseases, particularly in the area of autoimmune diseases and coagulation disorders. The specific compound mentioned is a small molecule developed by the company, referred to as "Qilin" [2][7]. Core Points and Arguments - The company has completed Phase II clinical trials for the Qilin compound, which began clinical trials in 2022. The results from these trials are promising, showing significant improvement in patient conditions [2][6]. - The clinical trial design included a randomized method with multiple dosage groups and a placebo group to assess the efficacy and safety of the treatment. The disease being targeted is chronic, and factors such as genetics and environmental conditions were considered in the trial [3][4]. - Key efficacy indicators were evaluated at the end of a 12-week treatment period, with a focus on achieving a 75%, 90%, or 100% improvement in patient conditions. The results indicated that approximately 85% to 90% of patients showed significant improvement [5][6]. - Safety assessments during the trials indicated that the majority of adverse events were mild to moderate, suggesting a favorable safety profile for the Qilin compound [6][7]. - The company is optimistic about the potential for further development and international collaboration, particularly in the U.S. market, as initial data has shown efficacy comparable to existing treatments [9][10][11]. Other Important Content - The company is considering expanding its clinical trials to include international sites, particularly in the U.S., based on the positive results from the domestic trials [9][10]. - There is a significant unmet need for oral treatments in the market, particularly for chronic conditions, which the company aims to address with its Qilin compound [12][13]. - The company has two commercialized products already in the market, indicating a robust pipeline and potential for future growth [16]. - Future disclosures and detailed reports on the clinical trial results are anticipated at upcoming international and domestic conferences [8][15]. This summary encapsulates the key points discussed during the conference call, highlighting the company's advancements in clinical trials, the promising results of its lead compound, and its strategic plans for future development and market expansion.

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 ...