Irinotecan Hydrochloride Lioposome

The DEMETHER trial, whose principal investigator is Dr. Javier Cortés, explores an innovative therapeutic de-escalation strategy for patients with previously untreated HER2-positive advanced breast cancer. New therapeutic perspectives for brain metastases: the PHENOMENAL and TUXEDO-4 studies in metastatic breast cancer Additionally, a total of five studies are being presented at San Antonio Breast Cancer Symposium 2024, strengthening its global leadership in oncology innovation and research. SAN ANTONIO, Dec. 5, 2024 /PRNewswire/ -- MEDSIR, a leading company dedicated to advancing independent clinical research in oncology on an international level and part of Oncoclínicas & Co, the largest oncology treatment group in Latin America with significant strength in the clinical and outpatient setting, will participate in the prestigious San Antonio Breast Cancer Symposium 2024 (SABCS) with the presentation of five innovative studies, including one of particular significance in advanced breast cancer: the DEMETHER study. These landmark studies demonstrate remarkable progress in the development of more personalized and less invasive therapies, offering the potential to enhance patients' quality of life and redefine the treatment approach for advanced breast cancer. The DEMETHER clinical trial explores an innovative treatment strategy for previously untreated HER2-positive advanced breast cancer. The study employs a dual-phase approach, beginning with an induction phase using trastuzumab deruxtecan (T-DXd), followed by a maintenance phase with subcutaneous administration of trastuzumab and pertuzumab. This strategy aims to prolong progression-free survival, improve overall survival rates at three years, and provide enhanced safety and quality of life compared to standard treatments. By offering an alternative to conventional chemotherapy and prolonged T-DXd administration, DEMETHER aims to redefine therapeutic de-escalation. This strategy seeks to minimize the side effects associated with traditional therapies, thereby significantly improving patients' quality of life. Furthermore, it underscores a commitment to making advanced breast cancer treatments more accessible, less invasive, and patient centered. 23 active centers in 4 countries and several Highly Cited Researchers 2024 The trial is currently being conducted at 23 active centers across the United States, Spain, Italy and Germany. Additionally, the study benefits from the involvement of leading international researchers renowned for their excellence. Among them are several scientists featured in the Highly Cited Researchers 2024 list by Clarivate, including Dr. Javier Cortés, Dr. Hope Rugo, Dr. Nadia Harbeck, Dr. Sara M. Tolaney, and Dr. Peter Schmid, whose expertise and contributions bring exceptional value to the project. The DEMETHER study seeks to further advance personalized medicine, exploring less invasive, safer, and potential more effective alternatives to conventional treatments. "This study reflects the collaborative efforts of international experts, leading centers, the pharmaceutical industry and MEDSIR in designing therapeutic strategies that enhance patients' quality of life through treatment de-escalation." highlights Dr. Javier Cortés, principal investigator of the DEMETHER study. New therapeutic options for patients with metastatic breast cancer: exploring advances in brain metastases with PHENOMENAL and TUXEDO-4 Both the PHENOMENAL and TUXEDO-4 studies presented at SABCS are particularly relevant as they address a critical and historically underserved population: patients with metastatic breast cancer (MBC) and brain metastases (BMs). BMs occur in up to 25% of patients with MBC 1, significantly impacting prognosis and quality of life. These studies stand out by exploring innovative therapeutic strategies tailored to overcome the unique challenges of treating brain metastases. The PHENOMENAL study focuses on nanoliposomal irinotecan, Nal-IRI, to enhance drug delivery to brain tumors while reducing systemic toxicity. Meanwhile, the TUXEDO-4 study investigates the use of T-DXd, a novel antibody-drug conjugate targeting HER2-low tumors, with the goal of achieving meaningful intracranial tumor shrinkage. An innovative therapeutic regimen with the potential to expand treatment options and improve the quality of life for patients with advanced breast cancer The Phase III ADELA study, in collaboration with the MENARINI Group, explores new perspectives in the treatment of advanced ER+ and HER2-negative breast cancer, specifically in patients with mutations in the ESR1 gene whose cancer has progressed after receiving standard first-line of therapy. This gene produces estrogen receptor proteins that can stimulate the growth of this type of breast cancer. ADELA has the potential, if successful, to pave the way for regulatory approval of this therapeutic combination, making it accessible to a broader patient population. In addition to this study, MEDSIR is presenting the PRIMED trial, which evaluates the efficacy of prophylactic administration of granulocyte colony-stimulating factor (G-CSF) and loperamide during the initial treatment cycles of sacituzumab govitecan (SG) therapy to mitigate the incidence of neutropenia and diarrhea, aiming to enhance treatment tolerability and patient safety. The presentation of these results at an event of SABCS 2024's magnitude not only positions MEDSIR as a leader in oncology research excellence but also highlights its ability to lead transformative projects addressing unmet needs in breast cancer treatment. References: Le Rhun E, et al. Ann Oncol. 2021;32(11):1332-1347 About MEDSIR   Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials.   With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America.   For further information:     About Oncoclínicas & CO   Oncoclínicas & Co is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care, and high specialization through a medical team composed of over 2,700 specialist physicians with an emphasis on oncology. With its mission to democratize cancer treatment, it offers a comprehensive system that integrates outpatient clinics with high-complexity cancer centers. The company operates 145 units across 39 Brazilian cities, allowing high-quality access in all regions it serves, aligned with world-class standards.  Focusing on technology, precision medicine, and genomics, Oncoclínicas performed approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana Farber Cancer Institute, affiliated with Harvard Medical School, one of the world's leading cancer research and treatments centers. The company also owns Boston Lighthouse Innovation, a bioinformatics firm based in Cambridge, United States, and holds shares in Medsir, a company dedicated to the development and management of clinical trials for independent cancer research, based in Barcelona, Spain. Recently, Oncoclínicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission to beat cancer to a new continent and providing advanced oncology care on a global scale by combining oncological hyperspecialization with innovative treatment approaches.  The company is part of the IDIVERSA index, launched by B3, highlighting companies committed to gender and racial diversity. For more information, visit:    SOURCE MEDSIR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

今日（11月15日），石药集团公布2024年前三季度业绩，报告期内，收入为人民币226.86亿元，较去年同期下跌4.9%。主要受到成药业务收入下跌的影响，股东应占基本溢利39.99亿元，较去年同期下跌15.2%，股东应占溢利较去年同期下跌15.9%至人民币37.78亿元。 据公告披露，石药集团成药业务收入为人民币186.70亿元，同比下降3.5%，以下为按主要治疗领域的销售情况： 神经系统治疗领域于第三季度的收入较去年同季下跌15.8%，然而，与去年同期（前三季度）相比，本期该领域的收入取得整体增长4.5%。恩必普（®丁苯酞软胶囊、丁苯酞氯化钠注射液）主要因医院在严格控制医疗费用的环境下，对在医院用量排名靠前的药品实施较严格的管控，使其本年第三季度销售有较大幅度的下跌。另一方面，明复乐®（注射用重组人TNK组织型纤溶酶原激活剂）用于治疗急性缺血性卒中患者的新适应症于年初获得上市批准后，于本期取得理想的销售收入。 抗肿瘤治疗领域于第三季度和本期的收入分别较去年同季和同期下跌31.2%和17.6%。下跌主要由于津优力（®聚乙二醇化重组人粒细胞刺激因子注射液）及多美素（®盐酸多柔比星脂质体注射液）两款产品的价格于京津冀「3+N」联盟药品集中采购中分别下调了约58%和23%。新产品方面，多恩益（®盐酸伊立替康脂质体注射液）、多恩达（®盐酸米托蒽醌脂质体注射液）及戈瑞特（®甲磺酸仑伐替尼胶囊）的销售于期内仍保持较高增长。 心血管治疗领域于第三季度和本期的收入分别较去年同季和同期下跌26.7%和11.1%。下跌主要由于玄宁®（马来酸左氨氯地平片及分散片）并没有在2023年的国家第八批集中采购中中选，使其在严格执行集采政策的医院的销售受到较大冲击，尤其本年第二季度及第三季度的跌幅较为显着。另外，恩存®（硫酸氢氯吡格雷片）及意舒宁®（硝苯地平控释片）于期内的销售保持增长。 呼吸系统治疗领域于第三季度和本期的收入分别较去年同季和同期下跌35.1%和18.8%。期内琦效（®盐酸阿比多尔片）的销售收入因市场需求减少而有较大幅度的下跌。另外，受惠于有效的推广策略及强劲的市场需求，伊络达®（乙磺酸尼达尼布软胶囊）及诺一安®（孟鲁司特钠片╱咀嚼片）的销售收入于期内保持理想增长。 消化代谢治疗领域于第三季度的收入较去年同季下跌11.2%，然而，与去年同期相比，本期该领域的收入大幅增长30.7%。其中，欧倍妥®（艾司奥美拉唑镁肠溶胶囊）及得必欣®（奥美拉唑肠溶胶囊╱片╱注射剂）受惠于有效的推广策略及市场需求，增长尤其显着。 2024年前三季度，石药集团研发费用为人民币38.80亿元，较去年同期增加5.5%，约占成药业务收入20.8%。目前逾60个重点在研药物已进入临床或申报阶段，其中6个已递交上市申请，24个产品（30个适应症）处于注册临床阶段。 自年初至今，于中国有2款创新药（新增适应症）、1款生物类似药、1款特殊制剂获批上市，及在研药物获得34项临床试验批件，7款仿制药获得药品注册批件；于北美地区有3款在研创新药物获得临床试验批准，1项快速通道资格认定。 临床管线概览：