Melphalan hydrochloride

前言： 近日，汇宇制药（股票代码：688553）发布2024年年度业绩预告： 预计实现营收10.7~11.3亿元，同比增长15.42~21.89%。 预计实现归母净利润3~3.6亿元，同比增长114.61~157.54%。 预计实现归母扣非净利润0.95~1.1亿元，同比增长43.92~66.64%。 2024年，在全球医药行业面临严峻挑战的背景下，汇宇制药通过制定“适应集采、全面拥抱创新、加速国际化”的战略方向，在财务业绩上取得了突破性增长。公司优化仿制药生产成本、拓展销售渠道，推动创新药研发取得重大进展，并加速国际化布局，逐步实现从“以仿养创”到“仿创结合”、从国内市场到国际市场的华丽转身。2025年，汇宇制药正以更加坚定的步伐，向世界展示中国药企的创新力量。 多管线发力 市场增长显著 2024年，公司国内业务表现亮眼，普乐沙福注射液、氟维司群注射液、克拉屈滨注射液、奥沙利铂注射液等产品的销售收入较去年增加约9,200万元，增长11%。其中，注射用培美曲塞二钠、多西他赛注射液、注射用阿扎胞苷、奥沙利铂注射液、注射用盐酸苯达莫司汀、普乐沙福注射液、硫代硫酸钠注射液在国内市场份额均居前三（数据来源：米内网）。 截止目前，汇宇制药共计39款产品在境内上市。其中，17款为2024年新上市产品，包括克拉屈滨注射液（首家过评）、乙酰半胱氨酸注射液（首家过评）、注射用氨磷汀等。这些新上市产品的稳步入市将为公司提供持续的增量销售收入。 在适应集采方面，汇宇制药从拥有绝对政策优势的单一大单品模式，逐步过渡到了集采模式下不同产品矩阵、不同政策背景、不同价格策略、不同销售渠道、不同代理模式的立体多维模式。公司已有10个产品中标国采及其接续，同时在省集中斩获重要准入机会，多个产品低价中标，进一步扩大了市场份额。 此外，汇宇制药不断提升复杂注射剂的研发能力，羧基麦芽糖铁等复杂注射制剂产品进展顺利。公司还拥有包括注射用塞替派、注射用盐酸美法仑等在内的10款注册待批品种，未来获批后将为业绩增长提供强劲动力。 凭借产品创新能力和可持续发展能力，汇宇制药被认定为“国家高新技术企业”（复认定）、“国家技术创新示范企业”、“国家级博士后科研工作站”，并成功入选“中国化药百强”“四川企业技术创新能力百强”等榜单，市场影响力显著提升。 创新药研发 迈向新的里程碑 自汇宇制药成立以来，研发驱动便是公司坚定不移的发展战略。在大分子创新药领域，公司聚焦于多特异性抗体、抗体偶联药物(ADC)、MRNA肿瘤疫苗；在小分子创新药领域，则侧重于双靶点化合物等首创性(FIC)或具有突破性治疗优势的创新药。2024年，公司自研产品HY-0002a持续推进临床1期研究，另有HY-0006、HY-0007和HY-2003三个项目获得IND批件并启动临床1期研究。 HY-0006项目是一个高选择性SOS1小分子抑制剂, 该靶点相关通路机制研究非常明确、且靶点本身较新颖，可以与KARS抑制剂、EGFR抑制剂联用发挥协同增效、克服耐药的作用，该靶点药物在肺癌、胰腺癌、结直肠癌具有广泛的联合用药空间，特别是和3代EGFR奥希替尼的联用，具有巨大潜力。 HY-0007项目是自主研发的抗PD-1、抗TIGIT、IL-15三抗融合蛋白, 一方面可以补充增加瘤内免疫效应细胞的数量；另一方面可以从多角度将因持续战斗而耗竭的免疫细胞恢复功能，并且克服部分免疫治疗患者获得性耐药问题，有望成为2代免疫治疗的重磅产品。 HY-0007项目亮相2024CSCO HY-2003项目是公司首个获得IND的溶脂改良型新药，已经完成首例人体试药，为去氧胆酸的新剂型，旨在降低注射部位的不良反应、缩短用药间隔、加快起效时间以及减少给药周期。 国际化进程加速 出海再进阶 伴随汇宇国际化进程向纵深迈进，公司在欧洲、北美和新兴市场等国际市场业务较去年增加约9,000万元，增长103%，发展势头良好。2024年共增获批件100个，累计海外批件达约430个，覆盖近70个国家， 同时，公司严格遵循中国GMP、欧盟GMP及美国FDA法规要求，建立了严谨的药品全生命周期质量管理体系，多次通过中国GMP、欧盟GMP、英国GMP、美国FDA等认证，确保了产品的顺利出口。目前，公司已有25个一线抗肿瘤注射剂及其他领域制剂品种在海外获批上市。 此外，公司国际CDMO业务业务也实现强劲增长，成功入选四川省2024年定制化生产重点企业名单。这些成绩不仅展示了汇宇制药在国际市场的竞争力，也为公司未来的全球化布局提供了强有力的支撑。 战略投资布局 拓展发展新势能 2024年8月，汇宇制药D轮领投的“氘代药物第一股”同源康医药（股票代码：02410.HK）在港股上市，公司直接持有的其股权在报告期内确认公允价值变动收益为2.11 亿元。 同源康医药成立于2017年，是一家专注于小分子药物和其他相关创新药物种类的临床阶段生物制药公司，致力于发现、开发及商业化差异化靶向疗法，解决癌症领域特别是肺癌领域未满足的医疗需求。 展望未来 持续创新，迈向更高台阶 2024年，汇宇制药在创新研发、国际化布局和适应集采政策等方面取得了显著进展，展现出强大的市场竞争力和发展潜力。展望未来，公司将继续以创新驱动和国际化布局为双轮驱动，迎接医药行业的新机遇，迈向更高的台阶。 说明：本次业绩预告相关财务数据未经注册会计师审计，具体准确的财务数据以公司正式披露的经审计后的2024年年度报告为准。

QUEENSBURY, N.Y.--( BUSINESS WIRE )--Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for the treatment of metastatic uveal melanoma (mUM). Our proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT ® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver. The updated NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma. Previously, the guidelines limited its use to patients with metastases confined to the liver. This revision aligns with the HEPZATO KIT label. Given that over 90% of mUM patients develop liver metastases, and the liver is typically the life-limiting organ, this update expands the recommended patient population for which HEPZATO KIT may be considered an appropriate treatment option. A previously published subgroup analysis from the Phase 3 FOCUS trial demonstrated no significant differences in objective response rate, progression-free survival, or overall survival between patients with and without extrahepatic disease. “We are encouraged by the NCCN’s decision to expand HEPZATO’s recommendation in the guidelines to include patients with extrahepatic disease, recognizing the critical role hepatic progression plays in the course of metastatic uveal melanoma,” said Gerard Michel, Chief Executive Officer of Delcath. “This update underscores the growing recognition of HEPZATO as an important treatment option for patients battling this challenging disease.” About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT ® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information , including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Safe Harbor / Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.