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 ...

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].