Melphalan hydrochloride

3月30日，李氏大药厂控股有限公司（简称：李氏大药厂或李氏集团，股份编号：00950.HK）2025年业绩报告正式公布。2025年，集团以稳健的步伐和前瞻性的战略布局，交出了令人瞩目的成绩单。我们不仅在收益上实现了持续增长，更在产品研发、市场拓展、生产优化等多个维度，取得了显著进展，为未来的长远发展奠定了坚实基础。 据悉，截至2025年12月31日，集团全年收益达到1,435,980,000港元，同比增长2.6%。这一成绩的取得，得益于集团多元化产品组合的强劲表现。其中，引进产品销售额达到564,335,000港元，占总收益的39.3%，整体销售额更是保持2.0%的同比增长。布累迪宁®、菲普利®、芮舒延®等重点产品表现突出，销售额分别增长10.3%、30.3%和8.0%。专利及仿制产品销售额达871,645,000港元，占总收益的60.7%，成为集团收益增长的主要驱动力。专利产品方面，集采产品立腾菁®增长11.3%，善克钰®和尤靖安®等产品也凭借着稳定的市场表现，为集团发展提供了有力支撑。仿制产品方面，芮旎爾®、立畅青®等产品表现优秀，进一步巩固了集团在仿制药市场的地位。 在研发创新方面，面对2025年医药行业的风云变幻，李氏大药厂秉持着“科学，我们的信仰与追求”的企业精神,始终将研发创新作为核心战略。本年度，集团投入占比达年度收益的25.1%，这不仅体现在资金上，更体现在研发项目的深度和广度上。集团在研产品覆盖心血管健康、女性健康、儿科、罕见病、皮肤科及产科等多个治疗领域，形成了强大而均衡的产品管线。其中包括注射用盐酸美法仑和注射用美沙拉嗪原料药进口注册等后期阶段项目，以及用于治疗成骨不全症的奈立磷酸盐、用于治疗血栓性血小板低下紫斑症的安菲博肽等罕见病项目，均展现了集团在研发创新方面的深厚底蕴。 更值得一提的是，2025年12月，集团成功收购了美国制药企业Alexza公司，不但拥有了研发、生产全球的药械结合气溶胶吸入剂的技术平台和先进的生产设施，而且与世界著名大药企UCB公司建立了战略合作伙伴关系，为其独家生产治疗癫痫的快速起效气溶胶吸入剂，用于全球开发和销售。同时集团获得了至少四个处于临床试验阶段II期药物的全球权利。这一举措不仅提升了集团在气雾化给药领域的技术实力，更为集团全球战略布局提供了有力支持。 在生产优化，新质生产力提升方面，集团持续优化生产设施，提升生产能力和效率。李氏-兆科合肥基地全新预灌封生产线的投入使用，有效提高了药品集采产品的产能，总产量较上一年度提升10%。李氏-兆科南沙基地则通过扩大生产规模、推进验证批次生产等措施，进一步提升了制造效率。此外引人注目的是，集团通过收购美国资产，成功进军美国市场，构建了更加多元化且具韧性的生产网络。这一战略举措不仅为集团带来了新的增长点，更为其全球扩张和国际化发展奠定了坚实基础。 在市场开拓方面，集团通过灵活多变的营销模式和因时制宜的营销策略，成功覆盖了多个治疗领域，满足了不断演变的市场需求。目前，集团共有10款产品已纳入最新版国家医保药品目录，反映了集团在扩大市场准入和提高患者负担能力方面的持续努力。 2026年，集团将继续加大研发投资力度，充分利用多元化的产品组合，密切关注行业动态和政策变化，不断提升自身竞争力，为提升患者生活质量、推动医药行业进步贡献更大力量，实现“企业、患者、社会”三赢局面！ （如需快速了解公告核心内容，可前往阅读本公众号第二篇推文"一图读懂"版本） 往期回顾 ◆  李氏快讯 | 3月要闻速览 ◆  快讯！李氏大药厂(00950.HK)：普拉睾酮阴道栓（茵若飒®）3月17日获国家药监局批准，用于治疗绝经后女性外阴阴道萎缩 ◆  惠及2亿更年期女性——李氏大药厂普拉睾酮阴道栓（茵若飒®）正式获批！ ◆  质量第一，内化于心，外化于形 | 兆科药业（广州）首届质量年活动正式启幕 关于李氏大药厂 - 亞太地區最具創新力的上市企業 - 李氏大药厂控股有限公司（简称：李氏大药厂或李氏集团，股份编号: 00950.HK）成立于1994年，是一家结合了研发驱动和市场导向的生物医药集团公司，总部位于香港。李氏大药厂于2002年7月在香港联合交易所（简称：“港交所”）创业板上市，并于2010年5月成功转至港交所主板上市。李氏大药厂在全球拥有三大综合性生产研发基地和两大中心，即：李氏-兆科合肥基地（位于安徽省合肥市高新区）、李氏-兆科南沙基地（位于广东省广州市南沙区）、美国加州基地和集团研发中心、集团营销中心，目前员工总数超过1100人。 李氏大药厂立足中国大陆，放眼国际，通过坚实和稳固的投入建设，全面覆盖整合了药物研发、临床研究、药政注册、生产制造、销售与市场推广等各个环节。集团集中于心血管科、妇科与产科、儿科、罕见病、肿瘤科、皮肤科、精神科等多个重要疾病领域开发不同阶段的专利新药和高端仿制药。李氏大药厂与20余家国际公司建立了广泛的合作关系，目前在中国大陆、香港、澳门及台湾地区推广及销售25种包含专利新药、仿制药物及授权引进的国外已上市进口药品。 李氏大药厂现有超过40个处于不同开发阶段的产品，既有自主研发产品，也有通过来自美国、欧洲及日本等公司通过授权引进进行研发、生产以及商业化的产品。 李氏大药厂的使命是致力于研发新药，治疗顽疾，改善生活质量，为患者带来福音，目标成为亚洲成功的生物制药集团，提供治疗疾病和改善生活质量的创新产品。 下滑查看更多 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。 企业文化公共关系部出品 文章来源：集团官网 编辑：丁雪森 与“李”同行 招商热线 020-39062882 公众号 小程序 视频号 小红书

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced that its proprietary CHEMOSAT ® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026) . M-PHP is also recognized in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT™ (also referred to as melphalan/HDS), is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma (mUM). M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT. The ESMO-EURACAN guideline recognizes M-PHP under regional treatments for patients with liver-dominant mUM. Two Phase 3 trials of M-PHP (NCT02678572 and NCT00324727) are cited as key supporting data, demonstrating improved hepatic and overall progression-free survival, and overall response rates compared with best alternative care. The guideline also assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 to M-PHP in the supplementary materials, for patients with unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease or limited extrahepatic disease amenable to local therapy. M-PHP is listed first among regional treatment options for patients with multifocal liver-only metastases, either as monotherapy or in combination with systemic treatments, based on HLA-A*02:01 status. In addition, the guideline notes that the M-PHP may be an option in HLA-A*02:01-positive cases (e.g., following tebentafusp or when systemic options are not suitable), as well as HLA-A*02:01-negative cases or those not candidates for other systemic therapies. The ESMO–EURACAN guidelines emphasize a multidisciplinary approach for mUM and position liver-directed therapies such as M-PHP alongside systemic options including tebentafusp and anti-PD-1 immunotherapy in the treatment algorithm for metastatic disease. “This inclusion in the ESMO–EURACAN guidelines represents an important validation of PHP with melphalan as a meaningful liver-directed therapy for patients with mUM,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “With up to 90% of mUM patients developing liver metastases, and limited effective options available, the recognition of our therapy in the European guidelines further supports its role in multidisciplinary care and highlights the clinical benefit observed in the FOCUS trial and real-world experience. We are pleased that the CHEMOSAT platform is now explicitly addressed in this updated standard of care.” 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. Contacts Investor Relations: ICR Healthcare investorrelations@delcath.com