Socazolimab

3月14日，2025中欧多学科前沿论坛暨宫颈癌专题病例魔方会议顺利召开，中欧病例魔方会议是由意大利帕多瓦大学联合李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”，股份编号：00950）共同发起的跨国教育项目，本期为本项目宫颈癌专题第一期会议，主题为—晚期宫颈癌的综合治疗。本期会议特邀荆州市中心医院陈亚君教授担任中方主席，意大利巴里大学Marco Marinaccio教授担任欧方主席。武汉中南医院孙绍星教授担任中方讲者，巴里大学综合医院Christopher Clark博士担任欧方讲者。讨论嘉宾分别为四川省肿瘤医院谢可教授、深圳市人民医院周亚燕教授、重庆大学附属第一医院周勤教授、武汉大学中南医院杨春旭教授、佛山市第一人民医院闵燕飞教授。各位专家共同就肿瘤免疫治疗相关领域热点问题进行深入交流和探讨。会议主席致辞会议伊始，陈亚君主任和Marinaccio教授分别对中欧方专家学者出席本次会议表示欢迎，也提出在宫颈癌免疫治疗如火如荼进展的今天，选取何种治疗方式可以带给患者更大的生存获益，是临床医生需要认真考虑的一个议题。学术交流01武汉大学中南医院 妇科肿瘤科 孙绍星教授：索卡佐利单抗治疗宫颈癌临床案例及思考孙绍星教授指出肿瘤免疫治疗的出现为更多患者带来治疗希望，本次所分享的两例患者也切实证明了免疫治疗在宫颈癌治疗中的强大疗效。第一例患者2017年6月外院初诊发现宫颈癌接受了腹腔镜下宫颈癌根治术，术后病理为中分化鳞癌，PD-L1阳性，术后FIGO分期IIIC1p期，接受了术后辅助放化疗。18个月后出现复发，遂就诊我院进行了多线多周期化疗及姑息性放疗，疗效不佳，所幸当时索卡佐利单抗治疗宫颈癌的临床研究在本中心开展，评估后该患者入组接受治疗，4个月用药后达到PR，并持续缓解，后续随访患者仍处于良好的疾病缓解状态中，最近一次复查评估时间为2024年3月，缓解持续时间已达49个月，期间仍在接受索卡佐利单抗治疗，患者耐受性良好，无明显不良反应的发生，为该名患者带来新的希望。第二例为患者为一例PD-L1阴性晚期宫颈癌患者，分期cT2bN1M1，IVb期。基于对索卡佐利单抗对于PD-L1阴性患者有效，因此在一线治疗方案选择索卡佐利单抗联合TP+贝伐珠单抗，6周期后使用索卡单药维持，患者肿瘤标志物SCC值快速下降，持续稳定在低水平，宫颈肿瘤、腹膜后/锁骨上淋巴结近乎完全消失，达到接近CR的满意疗效。02巴里大学综合医院 Christopher Clark博士：宫颈旁淋巴结切除术与前哨淋巴结活检作为Ib2/Ib3期宫颈癌分期的核心依据——年轻患者L.F.病例报告Clark博士分享了一例年轻患者病例，患者为28岁女性，2024年05月因阴道出血就诊，病理诊断为浸润性低分化腺癌，根据临床表现及影像学/体格检查，患者分期为Ib3或IIb期，因患者肿瘤侵及宫旁，虽然患者影像学检查未报告盆腔淋巴结异常，但应对此保持警惕，因此在经过团队MDT讨论及ESGO指南推荐诊断路径，选择给患者进行了诊断性腹腔镜手术，对宫旁及盆腔前哨淋巴结进行切除及病理检测，术后病理证实存在宫旁侵犯及淋巴结转移，确定患者分期为III期。后续患者接受了腹腔镜下宫颈癌切除根治术，术后接受同步放化疗。后续随访患者病情稳定，影像学评效达到CR。综合讨论环节陈亚君教授主持了讨论环节，各位教授以自身临床经验与体会围绕中外分享的病例展开了热烈讨论。Marinaccio教授表示索卡佐利单抗对于PD-L1阴性患者依然发挥强效的抗肿瘤效应令人印象深刻，并且药物保持了良好的安全性，这一点也受到其他参会教授的认同。而对于欧方分享的病例，多位中方教授针对该患者所采用的悬吊卵巢的术式展开讨论，对于年轻未生育女性，保持良好的卵巢功能可能使患者能够在未来有更高质量的日常生活，但同时应考虑，该例患者病理类型属易复发的腺癌，如采用此类术式，患者卵巢部位不进行放射治疗，未来是否会提高复发风险，这也是中欧在治疗观念方面的碰撞，给各位临床专家均带来更多思考。同时，对于该患者进行诊断性腹腔镜前哨淋巴结切除和活检引发多位中方专家的共鸣，对于此类无法通过体格检查和影像学检查明确分期的患者，通过诊断性的腹腔镜检查手术，可以明确患者分期，更好的指导后续治疗，对于保障患者长期预后具有重大意义。另外，各位教授在讨论中对于治疗中如何综合性考虑药物选取阐述了观点，多位教授认为在药物有效性的基础上，良好的安全性是药物选用的优先标准，尤其对于高龄人群，或伴有较多基础疾病或并发症，体力情况较差的患者，选取如索卡佐利单抗这类毒性更低的药物将是优选。会议主席总结致词最后，陈亚君教授与Marinaccio教授为本次会议进行总结发言。两位中方主席对本次会议中欧双方专家的热烈讨论表达感谢，也强调免疫治疗新时代下，如何综合选择治疗药物是每位临床医生的必修课，使患者达到最大获益。同时，中欧双方的诊疗观念碰撞也为大家带来新的思考，希望在未来能够有更多合作与交流的机会。  参考文献：[1]An J, Tang J, Li BX, et al. Efficacy and Safety of the Anti-PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study. Clin Cancer Res. 2022;28(23):5098-5106. [2]Monk BJ, Colombo N, Tewari KS, et al. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023;41(36):5505-5511. doi:10.1200/JCO.23.00914下滑查看更多*本会议报道仅限医学专业人士学术交流，不涉及任何药品推广，不作为诊疗依据。免责声明：本公众号发布或转载企业宣传资讯，仅供读者参考之用，并不构成收购、购买或认购依据，并不构成任何个人化的投资劝诱或建议。因本公布全部或任何部分内容而产生或因倚赖该等内容而引致的任何损失不承担任何责任。与“李”同行招商热线020-39062882

Financial Performance: Strong Year-over-Year Improvemen t - Total Revenue: RMB 407.2 million, including RMB 232.1 million in licensing and royalty income. - Net Loss Reduction: 71.5% year-over-year improvement. Key Product Advancements - Sugemalimab (Anti-PD-L1 mAb) - Regulatory Milestones: - China: Approved for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). - EU & UK: Approved for first-line treatment of stage IV non-small cell lung cancer (NSCLC); stage III NSCLC new indication application submitted to EMA. - Global Partnerships: Three strategic partnerships across 40+ countries, to accelerate global commercialization. - Avapritinib (AYVAKIT® ) - Localized Production: Approved for localized manufacturing in China, enhancing cost efficiency. - Commercial Collaboration: Partnered with Hengrui to expand market access in China. Clinical Pipeline Progress - CS5001 (ROR1 ADC): - Leading Position: Top 2 globally in clinical development for ROR1-targeted ADCs. - Phase I Clinical Data: Demonstrated encouraging monotherapy efficacy in aggressive/indolent lymphomas with a manageable safety profile; positioned for accelerated registration. - Phase Ib Expansion: Evaluating first-line/frontline, monotherapy/combination therapies in lymphomas and solid tumors across the U.S., Australia, and China. - CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody): - First-in-Human Trial: Global Phase I study initiated in Australia; first patient dosed. - Preclinical Differentiation: Superior tumor suppression vs. benchmarked competitors; potential first-in-class/best-in-class IO backbone therapy. Pipeline 2.0: Fueling Long-Term Innovation - More than 9 Differentiated Candidates: Focus on first-in-class/best-in-class assets, including multispecific antibodies and ADCs, with global rights and broad therapeutic potential. - Proprietary ADC Platform: Enables rapid development of high-value candidates, reinforcing leadership in next-generation oncology. SUZHOU, China, March 27, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today reported 2024 annual results and recent business updates. Business Highlights For the year ended December 31, 2024 and up until the date of this results announcement, key milestones have been achieved across regulatory approvals, clinical advancements, and strategic collaborations, reinforcing our position as a leader in innovative therapeutics. A shortlist of our achievements over this period includes: Commercial Products • CEJEMLY® (sugemalimab), anti-PD-L1 antibody – Global expansion and regulatory approvals Sugemalimab secured three new drug application approvals in 2024, including its fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). Sugemalimab also gained approvals in the EU and UK for first-line treatment of stage IV NSCLC, marking its entry into major international markets. We have recently completed the regulatory submission to the European Medicines Agency (EMA) for the new indication application of sugemalimab in the treatment of Stage III NSCLC. – Strategic alliances drive global commercialization Partnered with Ewopharma AG in May 2024 for commercialization in Central and Eastern Europe (CEE) and Switzerland. Collaborated with Pharmalink Store – L.L.C – O.P.C in November 2024 to expand access across the Middle East, North Africa (MENA) Region and South Africa. Entered an agreement with SteinCares in January 2025 for Latin America (LATAM). Additional partnerships in Western Europe, Southeast Asia, and Canada are anticipated in 2025. – Robust clinical data reinforce efficacy GEMSTONE-304 Study: Final progression-free survival (PFS) and interim overall survival (OS) data for the first-line esophageal squamous cell carcinoma (ESCC) published in Nature Medicine (February 2024). GEMSTONE-302 Study: Four-year OS data for stage IV NSCLC presented at the 2024 Congress of European Society for Medical Oncology (ESMO), confirming sustained survival benefits. GEMSTONE-303 Study: Final PFS and OS analysis for GC/GEJC with combined positive score (CPS) ≥5 published in the top-tier medical journal-Journal of the American Medical Association (JAMA) (February 2025). ESMO Guideline Recognition: CEJEMLY® recommended as first-line NSCLC therapy in ESMO's 2025 Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines, covering both squamous and non-squamous NSCLC (February 2025). • AYVAKIT ® (avapritinib), KIT/PDGFRA inhibitor – Localized manufacturing in China The National Medical Products Administration of China (NMPA) approved domestic production of AYVAKIT ® tablets (300 mg and 100 mg) in June and August 2024 respectively. Full transition to localized supply is expected in 2025, improving cost efficiency. – NRDL inclusion enhances accessibility AYVAKIT® (avapritinib) has been included to China's National Reimbursement Drug List (NRDL), effective January 1, 2024 for unresectable or metastatic gastrointestinal stromal tumor (GIST), harboring the PDGFRA exon 18-mutated, including PDGFRA D842V mutations. This significantly improves AYVAKIT ®'s affordability for eligible patients. – Commercial partnership with Hengrui In July 2024, we forged a new partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., granting them the exclusive promotion rights in mainland China to amplify commercial reach and profitability. • GAVRETO ® (pralsetinib), RET inhibitor – Progress towards localized manufacturing The NMPA's Center for Drug Evaluation (CDE) accepted the manufacturing localization and bioequivalence (BE) study application in April 2024, and regulatory review is ongoing. – Sustained collaboration with Allist Commercial operations has been transferred to Shanghai Allist Pharmaceuticals Co., Ltd in the first half of 2024 under an exclusive agreement signed in November 2023. Collaboration remains strong to maximize market penetration. Clinical Stage Core Assets • CS5001 (ROR1 ADC) – Phase Ib clinical trial with registration potential A global multicenter clinical trial of CS5001 is actively enrolling patients across the United States of America (U.S.), Australia and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas with potential to be expanded into a Phase II single-arm registrational study. Additional cohorts, including CS5001 in combination with R-CHOP (Rituximab + Cyclophosphamide + Hydroxydaunorubicin + Vincristine + Prednisone) for the first-line diffuse large B-cell lymphoma (DLBCL), and CS5001 in combination with standard of cares (SOC) for front-line DLBCL will be initiated to expand the therapeutic potential of CS5001 across all DLBCL stages. CS5001 is also being studied as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors, underscoring its versatility across oncology indications. – Compelling clinical data at ASCO & ASH 2024 Phase Ia data for CS5001 presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 66th American Society of Hematology (ASH) Annual Meeting demonstrated that CS5001 is so far the first receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC) known to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas. Clinical data of CS5001 revealed superior efficacy and favorable safety profile as a monotherapy for both aggressive and indolent advanced lymphomas. At the tentative recommended Phase II dose (RP2D) (125 μg/kg), CS5001 achieved an objective response rate (ORR) of 70% in non-Hodgkin lymphoma (NHL) and 100% in Hodgkin lymphoma (HL). These results support its potential as a faster-to-market candidate and a frontline combination therapy backbone. • CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) – Global Phase I clinical trial initiated A global multicenter first-in-human (FIH) trial among solid tumors has been launched in Australia in December 2024, with subsequent expansion to China and the U.S.. The first patient was dosed in March 2025. – Potential FIC/BIC next-generation I/O backbone Preclinical data presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) highlighted its first-in-class (FIC) or best-in-class (BIC) potential with superior antitumor activity compared to potential competitors benchmarks, including PD-1/CTLA-4 or PD-1/VEGF bispecific antibody and PD-1/ CTLA-4 combination therapies. Unique trispecific mechanism positions CS2009 as a next-generation immuno-oncology backbone with broad applicability. Preclinical/IND-enabling Stage Programs and ADC Platform CStone's preclinical pipeline includes more than nine promising candidates, each with global rights and focusing on FIC/BIC profiles with broad indications. These candidates include multispecific antibodies, ADCs and radionuclide drug conjugates (RDC) covering various therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. The Company is dedicated to delivering clinical value through the development of these Pipeline 2.0 candidates, which will undergo international, multi-center clinical trials to maximize their global potential. CStone has also developed an in-house ADC technology platform featuring proprietary linkers, optimized for diverse targets and payloads. This platform supports multiple upcoming ADC projects in Pipeline 2.0, including CS5007 (dual targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3)), CS5005 (targeting somatostatin receptor 2 (SSTR2)), CS5008 (dual targeting delta-like ligand 3 (DLL3) & SSTR2) and CS5006 (targeting ITGB4). Future and Outlook As we look to the future, we reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments. Concurrently, we aim to maximize the global commercial potential of our approved therapies through strategic collaborations and localized manufacturing enhancements. Key growth drivers in 2025 include: • Clinical milestones – Progress CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 trispecific) towards pivotal trials and in parallel pursue global partnerships to expedite development. – Advance early-stage candidates (e.g., CS2011, CS5007, CS5005, CS5008, CS5006) into clinical stages within the next two years. • Commercial excellence – Maximize the value of approved products through strategic collaborations and manufacturing localization (e.g., AYVAKIT®, GAVRETO®) to enhance profitability and market reach. – Accelerate ex-China commercialization of CEJEMLY® (sugemalimab) via regional partnerships. • Innovation and technology – Strengthen proprietary platforms (e.g., ADC technology) to sustain pipeline growth. – Present key clinical data at major conferences (e.g., AACR, ESMO, ASH) Financial Highlights International Financial Reporting Standards (IFRS) Measures: • Revenue was RMB407.2 million for the year ended December 31, 2024, composed of RMB175.1 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB204.0 million in license fee income and RMB28.1 million in royalty income of sugemalimab, representing a year-on-year increase of RMB108.3 million, or 113.1%, in license fee which was largely offset by a decrease in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB56.6 million, or 12.2%, year on year. • Research and development expenses were RMB134.7 million for the year ended December 31, 2024, representing a decrease of RMB393.1 million from RMB527.8 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third-party contracting costs. • Administrative expenses were RMB77.8 million for the year ended December 31, 2024, representing a decrease of RMB104.9 million from RMB182.7 million for the year ended December 31, 2023, primarily due to the decrease in employee costs. • Selling and marketing expenses were RMB133.8 million for the year ended December 31, 2024, representing a decrease of RMB65.5 million from RMB199.3 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs and others which was partially offset by an increase in channel service fee. • Loss for the year was RMB91.2 million for the year ended December 31, 2024, representing a decrease of RMB276.0 million, or 75.2%, from RMB367.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. • Cash and cash equivalents and time deposits were RMB672.9 million as of December 31, 2024. Non-International Financial Reporting Standards (Non-IFRS) Measures: • Research and development expenses excluding the share-based payment expenses were RMB124.7 million for the year ended December 31, 2024, representing a decrease of RMB410.0 million from RMB534.7 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third party contracting costs. • Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB224.4 million for the year ended December 31, 2024, representing a decrease of RMB113.8 million from RMB338.2 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs. • Loss for the year excluding the share-based payment expenses was RMB94.0 million for the year ended December 31, 2024, representing a decrease of RMB236.2 million, or 71.5%, from RMB330.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. 2024 Annual Results Conference Call The Company will host a 2024 annual results conference call at 10:00 a.m. (Beijing Time) on Friday March 28, 2025. Please attend the conference call through the link: (Password:067784). About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. 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