继发布了CS2009（PD-1/VEGF/CTLA-4）最新临床前研究结果后，2025年5月7日，基石药业（02616）再度宣布，公司在 2025年美国癌症研究协会（AACR）年会上，以壁报形式公布研发管线2.0重磅产品CS2011（EGFR/HER3双特异性抗体）、 CS5007（EGFR/HER3双特异性抗体药物偶联物 [ADC]）、CS5005（SSTR2抗体药物偶联物 [ADC]）、CS5006（整合素β4 [ITGB4] 抗体药物偶联物 [ADC]）的临床前研究结果。 根智通财经了解，EGFR和HER3属于人类表皮生长因子受体（HER）家族，也是晚期实体瘤临床治疗中经过充分验证的靶 点：EGFR过表达存在于约70%的结直肠癌（CRC）、60%的肺癌以及90%以上的头颈部鳞状细胞癌（HNSCC）中；同时， HER3表达上调通常是针对MAPK/PI3K抑制剂、EGFR酪氨酸激酶抑制剂（TKIs）以及内分泌治疗耐药的机制之一。 CS2011是一款具有EGFR与HER3高亲和力的双特异性抗体，可有效阻断两个靶点的下游信号传导，从而抑制EGFR/HER3 阳性肿瘤细胞的生长。 关键亮点 · CS2011几乎可 ...

CStone Pharmaceuticals 基石藥業 (Incorporated in the Cayman Islands with limited liability) ( 於開曼群島註冊成立的有限公司 ) Stock Code 股份代號 : 2616 年度報告 2024 Annual Report Annual Report 2024 年度報告 | 目錄 | | --- | | | 頁次 | | 頁次 | | --- | --- | --- | --- | | 公司資料 | 2 | 綜合損益及其他全面收益表 | 96 | | 財務摘要 | 4 | 綜合財務狀況表 | 97 | | 業務摘要 | 6 | 綜合權益變動表 | 99 | | 主席致辭 | 10 | 綜合現金流量表 | 100 | | 管理層討論及分析 | 12 | 綜合財務報表附註 | 102 | | 董事及高級管理層 | 29 | 釋義 | 172 | | 董事會報告 | 39 | | | | 企業管治報告 | 72 | | | | 獨立核數師報告 | 92 | | | 公司資料 董事會 執行董事 楊建新博士 （首席執行官） 非執行董事 ...

智通财经APP获悉，2025年4月25日至30日，美国癌症研究协会(AACR)年会于芝加哥召开。基石药业 (02616)5款自主研发创新药物的最新临床前研究成果将同时亮相这一国际顶级学术舞台，包括三抗 CS2009、双抗CS2011及出自公司自有抗体偶联药物(ADC)平台的三款创新ADC分子CS5006、CS5007与 CS5005。相关研究摘要将于美国东部时间4月11日发表于AACR官方期刊《Cancer Research》。 CS2009是一款靶向PD-1、VEGFA及CTLA-4的三特异性抗体，其创新的分子设计预期能通过优先结合 肿瘤微环境(TME)中的PD-1/CTLA-4双阳性T细胞提升疗效，同时避免作用于CTLA-4单阳性细胞以降低 系统性毒性，是潜在的同类首创/同类最优的下一代肿瘤免疫骨架产品。临床前研究显示，相较于潜在 竞品(如PD-1/CTLA-4双抗、PD-1/VEGF双抗及抗PD-1/抗CTLA-4联合疗法)，CS2009具有更强的抑瘤 效力，且安全性突出。CS2009的全球多中心I期临床试验正在澳大利亚开展，涵盖多种晚期癌症，例如 非小细胞肺癌、卵巢癌、肾细胞癌、宫颈癌、肝细胞癌、胃癌 ...

Financial Performance - In 2024, the total revenue of CStone Pharmaceuticals reached RMB 407.2 million, with licensing and royalty income contributing RMB 232.1 million; the net loss for the year decreased by 71.5% year-over-year [1][6]. Product Development and Approvals - The company achieved significant progress with the drug Sugliumab, receiving three approvals for marketing applications, including first-line treatment for gastric adenocarcinoma and stage IV non-small cell lung cancer (NSCLC) in China and the EU; an application for a new indication for stage III NSCLC has also been submitted to the European Medicines Agency (EMA) [1][11][12]. - CStone has established three international strategic collaborations for Sugliumab, covering 40 countries across three major regions, enhancing its global commercialization efforts [1][13]. Local Production and Commercialization - The local production application for the drug Tazemetostat has been approved in China, and CStone has formed a strategic partnership with Hengrui Medicine to enhance the accessibility and affordability of Tazemetostat in the domestic market [1][19]. Clinical Development Progress - The clinical development of CS5001 (ROR1 ADC) is advancing with global multi-center trials ongoing in the US, Australia, and China, showing promising efficacy and safety for treating aggressive and indolent late-stage lymphomas [2][30]. - The first patient has been dosed in the global multi-center phase I trial of CS2009 (a trispecific antibody targeting PD-1, VEGF, and CTLA-4), which has demonstrated superior preclinical anti-tumor activity compared to potential competitors [2][35]. Pipeline and Innovation - CStone is actively promoting its Pipeline 2.0, which includes over nine candidates with global rights and broad indication potential, focusing on next-generation antibody-drug conjugates (ADCs) and bispecific antibodies [2][36]. - The company has developed a proprietary ADC technology platform that supports the expansion of its innovative pipeline [2][44]. Strategic Outlook - CStone aims to enhance its growth trajectory by deepening strategic collaborations, localizing production, and accelerating the clinical development of its key assets, including CS5001 and CS2009 [4][48].

Group 1 - The company reported a revenue of RMB 407 million for the year ending December 31, 2024, representing a year-on-year decrease of 12.21% [1] - The net loss for the year was RMB 91.207 million, a reduction of 75.16% compared to the previous year [1] - Research and development expenses amounted to RMB 134.7 million, down 74.49% year-on-year [1] - The revenue included sales of drugs (Avaratnib and Pralsetinib) totaling RMB 175 million, licensing fee income of RMB 204 million, and royalties from Shuglikizumab of RMB 28.81 million [1] - Licensing fee income increased by RMB 108 million or 113.1%, which significantly offset the decline in drug sales revenue [1] - The company has successfully launched four innovative drugs and received 16 NDA approvals covering nine indications since its establishment [1] - The current research pipeline includes 16 candidate drugs, featuring potential first-in-class or best-in-class ADCs, multi-specific antibodies, immunotherapies, and precision medicines [1] Group 2 - The company aims to enhance its internal development capabilities and continue investing in R&D to advance a strong and distinctive pipeline [2] - The goal is to maximize the global commercial potential of approved drugs through strategic partnerships and localized production [2]

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 407.2 million, a decrease of RMB 56.6 million or 12.2% year-on-year[3]. - Loss for the year decreased by RMB 276.0 million or 75.2% to RMB 91.2 million, attributed to a significant reduction in operating expenses[5]. - The company reported a net loss of RMB 91.207 million for the year ended December 31, 2024, compared to a net loss of RMB 367.234 million in 2023, reflecting a 75.2% improvement[48]. - The total comprehensive loss for the year was RMB 90.22 million, compared to RMB 368.00 million in the previous year[73]. - The company's revenue for the year ended December 31, 2024, was RMB 407.2 million, a decrease of RMB 56.6 million or 12.2% compared to the previous year[73]. - Revenue from drug sales (Apatinib and Pemetrexed) amounted to RMB 175.1 million, while licensing income increased by RMB 108.3 million or 113.1% to RMB 204.0 million[73]. - Sales of pharmaceuticals amounted to RMB 175,100 thousand, down 47.9% from RMB 336,712 thousand in the previous year[57]. - Other income decreased to RMB 27.06 million from RMB 50.61 million, with significant declines in bank interest income and government subsidies[62]. Research and Development - R&D expenses decreased from RMB 527.8 million to RMB 134.7 million, a reduction of RMB 393.1 million, primarily due to decreased milestone fees and third-party contract costs[3]. - The company has over nine potential candidates in its preclinical pipeline, focusing on first-in-class and best-in-class characteristics across various therapeutic areas[19]. - CS5001 (ROR1 ADC) is currently in a Phase Ib clinical trial with potential for registration, showing promising results in treating aggressive and indolent advanced lymphomas[15]. - CS2009 (PD-1/VEGF/CTLA-4 tri-antibody) has initiated a global Phase I trial, with the first patient dosed in March 2025[17]. - The company is advancing its proprietary ADC technology platform to enhance stability and tumor selectivity, with multiple upcoming ADC projects in the pipeline[44]. - The company is expanding its clinical pipeline with innovative candidates in immunology and oncology, including next-generation antibodies and antibody-based therapies[43]. - The company is actively exploring opportunities for internal and external licensing and strategic partnerships to accelerate value creation[47]. Product Approvals and Partnerships - The company achieved three new drug application approvals for its product, Sugliumab, in 2024, including a fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma[7]. - Sugliumab was approved for first-line treatment of stage IV non-small cell lung cancer in the EU and the UK, marking its entry into major international markets[7]. - The company established a new partnership with Jiangsu Hengrui Medicine Co., Ltd. in July 2024, granting exclusive promotion rights in mainland China to expand commercial coverage and profitability[11]. - The inclusion of Tazemetostat in the National Reimbursement Drug List (NRDL) effective January 1, 2024, significantly improved affordability for eligible patients[10]. - The company has established a strategic commercialization partnership with Ewopharma, which will receive commercialization rights for Sugliame in Switzerland and 18 Central and Eastern European countries, with potential upfront payments of up to $51.3 million[29]. - A second strategic partnership with Pharmalink has been formed for the commercialization of Sugliame in the Middle East, North Africa, and South Africa, with additional milestone payments based on net sales[29]. - The company has established a strategic commercialization partnership with SteinCares for 10 Latin American countries, including Brazil and Mexico, with expected upfront and milestone payments, as well as revenue from drug supply sales[31]. Financial Position and Management - Cash and cash equivalents and time deposits amounted to RMB 672.9 million as of December 31, 2024[5]. - The company's non-current assets decreased to RMB 303,558 thousand in 2024 from RMB 332,212 thousand in 2023, reflecting a decline of 8.6%[49]. - Current liabilities decreased to RMB 682,006 thousand in 2024, down 19.8% from RMB 850,338 thousand in 2023[49]. - Cash and cash equivalents dropped to RMB 387,937 thousand, a significant decrease of 61.1% from RMB 996,671 thousand in the previous year[49]. - The debt-to-asset ratio increased to 73.9% as of December 31, 2024, compared to 72.5% on December 31, 2023[86]. - The company has adopted a prudent capital management policy, utilizing multiple funding sources for operations and development needs[83]. - The company raised approximately RMB 2,090.16 million from its IPO after deducting related expenses[84]. Clinical Trials and Efficacy - CS5001 demonstrated an objective response rate (ORR) of 70% for non-Hodgkin lymphoma (NHL) and 100% for Hodgkin lymphoma (HL) at the recommended Phase II dose of 125 µg/kg, indicating strong efficacy and safety[16]. - The ongoing global multi-center clinical trials for CS5001 include combinations with R-CHOP and standard therapies for DLBCL patients, with plans for a Phase II single-arm registration study[35]. - In the Phase I trial, no dose-limiting toxicities (DLT) were observed across nine dose levels (7 to 156 μg/kg), indicating good tolerability for patients with advanced solid tumors and lymphomas[36]. - The overall objective response rate (ORR) for CS5001 in B-cell lymphomas was 48.4%, with a higher ORR of 76.9% observed in the DL8 (125 μg/kg) dose group[39]. - CS2009's design allows for selective blocking of PD-1 and CTLA-4 on double-positive TILs while preserving the function of single-positive T cells, potentially reducing systemic toxicity[39]. - The company plans to present updated clinical data for CS5001 at the 66th ASH Annual Meeting in December 2024, showcasing its ongoing development[36]. Corporate Governance and Compliance - The audit committee, composed of three independent non-executive directors, has reviewed the financial performance and confirmed compliance with accounting standards[102]. - The company has maintained compliance with corporate governance codes and has not noted any breaches by its directors during the reporting period[93]. - The company did not declare or pay any dividends for the years ended December 31, 2023, and 2024[67]. - The company does not recommend a final dividend for the year ending December 31, 2024, consistent with the previous year[104].

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 6.75 per share, compared to the current price of HKD 3.32 [4]. Core Insights - The company, 基石药业, is focused on the research and development of innovative oncology drugs, with a balanced pipeline of 16 candidate drugs, including antibody-drug conjugates (ADC), bispecific antibodies, immunotherapies, and precision therapies [1][10]. - The company has successfully launched 4 innovative drugs and received approval for 16 new drug applications (NDA) and 9 indications as of February 2025 [1][10]. - The key clinical projects in the new pipeline (Pipeline 2.0) are CS5001 and CS2009, which are expected to drive business growth due to their significant commercial potential [2][4]. Summary by Sections Pipeline 2.0: New Strategic Direction - CS5001 (ROR1 ADC) shows promising benefits in multiple hematological indications and solid tumors, with a global clinical progress ranking of second [2]. - CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) has demonstrated superior anti-tumor activity in preclinical studies and has a broad applicable range across various tumor types [2]. Pipeline 1.0: Commercialization of Potential Products - The commercialized product,舒格利单抗, has received approval for five indications in mainland China and is expected to generate royalty income from its commercialization by Pfizer [3]. - Both普拉替尼 and阿伐替尼, introduced in 2018, are expected to accelerate sales growth post-local production completion, enhancing drug accessibility [3]. Profit Forecast - The company anticipates total revenues of HKD 3.86 billion, HKD 5.16 billion, and HKD 8.29 billion for 2024, 2025, and 2026, respectively, with year-on-year growth rates of -16.68%, 33.59%, and 60.62% [4]. - The net profit attributable to shareholders is projected to be HKD -0.03 billion, HKD 0.29 billion, and HKD 0.93 billion for the same years [4].

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 6.75 per share, compared to the current price of HKD 3.32 [4]. Core Viewpoints - The company, 基石药业, is focused on the research and development of innovative oncology drugs, with a balanced pipeline of 16 candidate drugs, including antibody-drug conjugates (ADC), bispecific antibodies, immunotherapies, and precision therapies [1][10]. - The company has successfully commercialized three main products:舒格利单抗 (PD-L1), 普拉替尼 (RET), and 阿伐替尼 (KIT/PDGFRA), and is expected to continue driving business growth through its key clinical projects CS5001 and CS2009 [1][2]. Summary by Sections Pipeline 2.0: New Strategic Direction - CS5001 (ROR1 ADC) shows promising potential in multiple hematological indications and solid tumors, with a global clinical progress ranking second [2][25]. - CS2009 (PD-1/VEGF/CTLA-4) has demonstrated superior antitumor activity in preclinical studies and has a broad applicable range across various tumor types [2][22]. Pipeline 1.0: Commercialization Progress - 舒格利单抗 has received approval for five indications in mainland China and is expected to generate royalty income from its commercialization by Pfizer [3][15]. - Both 普拉替尼 and 阿伐替尼 are anticipated to accelerate in volume post-local production, enhancing accessibility through pricing strategies [3][15]. Profit Forecast - The company forecasts total revenues of HKD 3.86 billion, HKD 5.16 billion, and HKD 8.29 billion for 2024, 2025, and 2026, respectively, with net profits projected at HKD -0.03 billion, HKD 0.29 billion, and HKD 0.93 billion [4][15].

Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 254.2 million, a decrease of RMB 7.3 million or 2.8% year-on-year[5]. - The company reported a profit of RMB 15.7 million for the six months ended June 30, 2024, compared to a loss of RMB 209.2 million in the same period last year[5]. - Gross profit for the six months ended June 30, 2024, was RMB 172.0 million, compared to RMB 153.4 million for the same period in 2023, reflecting improved cost management[43]. - The net profit for the period was RMB 15,699 thousand, a turnaround from a loss of RMB 209,226 thousand in the same period last year[124]. - The company reported a basic and diluted earnings per share of RMB 0.01, compared to a loss per share of RMB 0.17 in the previous year[124]. Revenue Breakdown - Revenue from drug sales (Apatinib and Pralsetinib) was RMB 118.3 million, while licensing income was RMB 122.6 million, and Sugli monoclonal antibody royalty income was RMB 13.3 million[5]. - Revenue for the first half of 2024 was reported at $150 million, representing a 30% increase compared to the same period last year[121]. - Revenue from China (excluding Hong Kong and Taiwan) was RMB 232,106 thousand, down 10.1% from RMB 258,145 thousand in the previous year[135]. Research and Development - R&D expenses decreased from RMB 186.8 million to RMB 66.2 million, a reduction of RMB 120.6 million, primarily due to lower milestone fees and employee costs[5]. - Non-IFRS R&D expenses, excluding share-based payment expenses, decreased from RMB 198.1 million to RMB 71.0 million, a reduction of RMB 127.1 million[6]. - The company achieved significant progress in its product pipeline and business operations during the reporting period[7]. - The company is focused on advancements in immunotherapy as a key highlight of its pipeline[7]. - The company plans to advance the research and development of innovative pipeline drugs and maximize the commercial value of existing products, with significant catalysts expected in 2024[16]. Product Pipeline and Approvals - Sugli monoclonal antibody (PD-L1) received EU approval for first-line treatment of metastatic NSCLC in adults, marking the first successful overseas launch of a domestic PD-L1[8]. - Completion of global Phase III trial for Nofazinlimab combined with LENVIMA for first-line treatment of unresectable or metastatic HCC, with no new safety signals observed[9]. - CS5001, a ROR1 ADC, is in the first-in-human trial phase with encouraging anti-tumor activity and no dose-limiting toxicities reported[10]. - CS2009, a tri-specific antibody targeting PD-1/CTLA4/VEGF, is in the IND preparation stage, expected to be submitted in 2024 or 2025[11]. - The company has successfully launched 4 innovative drugs and received 15 NDA approvals covering 9 indications since its establishment in 2015[18]. Strategic Collaborations - Strategic collaboration with Ewopharma AG for commercialization rights in Switzerland and 18 Central and Eastern European countries, with potential milestone payments up to $51.3 million[8]. - A strategic partnership with Heng Rui was formed in July 2024, granting exclusive promotion rights for Avelumab in mainland China, with an upfront payment of up to RMB 35 million[36]. - The company is collaborating with multiple partners to accelerate value creation through licensing, external partnerships, and strategic collaborations[42]. Financial Management - Cash and cash equivalents amounted to RMB 813.9 million, down from RMB 1,026.7 million as of December 31, 2023, primarily due to inventory procurement and R&D expenses[57]. - The company's debt-to-asset ratio as of June 30, 2024, was 69.5%, a decrease from 72.5% as of December 31, 2023[58]. - The company reported a total bank loan of RMB 306.42 million as of June 30, 2024, with a floating interest rate reduced by 45 basis points from the market rate[62]. Employee and Management - The total cash compensation for key management personnel was RMB 11,996,000 for the six months ended June 30, 2024, down from RMB 15,904,000 in the same period of 2023, representing a decrease of approximately 24%[177]. - The company has implemented various employee incentive plans to reward contributions to business success[55]. - The total number of stock options available for grant under the Pre-IPO Incentive Plan as of January 1, 2024, and June 30, 2024, is 128,247,234 and 78,456,898 respectively[104]. Market Expansion and Future Outlook - The company is actively pursuing market expansion strategies, with plans to enter two new international markets by the end of 2024[121]. - CStone Pharmaceuticals plans to expand its market presence in Europe and the United States, aiming for a 30% increase in international sales by the end of 2025[182]. - The company anticipates a significant increase in user data from its clinical trials, projecting a 40% rise in patient enrollment by mid-2024[182]. Stock Options and Incentive Plans - The company has adopted three stock incentive plans, including the Pre-IPO Incentive Plan and the Post-IPO Employee Stock Ownership Plan[101]. - The total number of restricted share units granted in 2024 is 11,197,900, with a total value of 13,418,650 HKD[111]. - The employee stock ownership plan has been revised, allowing for a maximum of 10% of the total shares to be allocated to employees upon full exercise of options[120].

Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company achieved its first profit with a revenue of 250 million RMB and a net profit of 15.7 million RMB in the first half of 2024, alongside cash reserves of 810 million RMB [2]. - CS5001, a ROR1 ADC, is expected to initiate a phase Ib trial with registration potential in 2024, aiming for global business development partnerships by 2024 or 2025 [2]. - The approval of Shugli monoclonal antibody in the EU and a commercialization partnership with Ewopharma is a significant milestone, with potential upfront payments of up to 51.3 million USD [2]. - The company is transitioning to Pipeline 2.0, with multiple innovative products expected to submit IND applications in 2024 or 2025 [2]. Revenue Forecast - The company is focused on R&D and is projected to have revenues of 480 million RMB, 590 million RMB, and 740 million RMB for the years 2024, 2025, and 2026 respectively [3][9]. - The expected revenue from commercialized products includes 230 million RMB from Pralsetinib and 50 million RMB from Avapritinib in 2024 [8][9]. - The report anticipates a gradual increase in revenue from Shugli monoclonal antibody, with projections of 200 million RMB, 250 million RMB, and 300 million RMB for 2024, 2025, and 2026 respectively [8].