Carfilzomib

精彩内容在刚刚过去的2025年上半年，扬子江药业产品管线进展不断：3个品种获批生产并视同过评，1类新药冲刺上市，5个品种以新注册分类报产等。目前公司有173个品种过评或视同过评（37个为首家/独家），19个品种备战国家集采。在研管线中，25款新药处于申请临床及以上阶段，3款已提交NDA；30个新品瞄准百亿市场，9个暂无首仿获批。进展频频！1类新药报产、3个新品获批......扬子江药业创建于1971年，至今已在医药健康领域深耕半个多世纪。目前公司拥有300余个药品（不含非制剂产品）的生产批文，其中有53个为扬子江药业独家品种（含独家剂型）。米内网数据显示，今年上半年，扬子江药业仿制药管线持续推进，有3个品种获批生产并视同过评，其中艾拉莫德片、泊马度胺胶囊均为国内第3家获批，2024年在中国三大终端六大市场（统计范围详见本文末）的销售额分别超过17亿元、3亿元。2025年以来扬子江药业获批上市的品种来源：米内网中国申报进度（MED）数据库产品申报方面，化药1类新药法赞雷生片提交NDA，中药1类新药ZYY-742凝胶提交IND并获批临床；5个品种以新注册分类报产，分别为美洛昔康纳米晶注射液、钆特酸葡胺注射液、酒石酸布托啡诺注射液、比拉斯汀片、阿瑞匹坦注射液。2025年以来扬子江药业申报的品种来源：米内网中国申报进度（MED）数据库今年上半年，扬子江药业的柴芩清宁胶囊、双花百合片2个独家中药品种申请保护（初保）获受理。2023及2024年，扬子江药业均有1个独家中药品种申请保护（初保）获受理，分别为散风通窍滴丸、苏黄止咳胶囊，其中苏黄止咳胶囊为公司核心产品，2024年在中国三大终端六大市场的销售额超过29亿元。2023年以来扬子江药业申请保护的中药品种来源：国家药监局，米内网整理173个品种过评！19个品种备战国家集采截至目前，扬子江药业有173个品种通过/视同通过一致性评价，在过评品种数TOP10集团中排位第三。从治疗大类看，173个品种涵盖13个治疗大类，集中在全身用抗感染药物（33个）、神经系统药物（22个）、消化系统及代谢药（21个）、抗肿瘤和免疫调节剂（21个）等领域。扬子江药业过评情况（以品种名称计）来源：米内网一致性评价进度数据库173个品种中，有37个为首家或独家过评，其中头孢克洛缓释片(Ⅱ)、盐酸奈康唑乳膏、伏立康唑分散片等品种为独家过评。凭借庞大的过评产品集群，扬子江药业在国家开展的九批十轮化药集采中收获满满，分别有2个、4个、7个、8个、10个、12个、2个、6个、11个品种中选，合计62个品种（盐酸帕洛诺司琼注射液不同批次重复计算），为集采头部供应商之一。米内网数据显示，目前扬子江药业有19个过评品种满足国采入围门槛，符合申报资格企业数达7家及以上，包括7个口服常释剂型、6个口服液体剂、4个注射剂、1个吸入剂及1个滴眼剂。扬子江药业过评且满足国采入围门槛的品种注：销售额低于1亿元用*代替来源：米内网综合数据库从2024年市场竞争格局看，扬子江在15个品种中所占市场份额较低或为0，其中甲苯磺酸艾多沙班片为2025年新获批品种，ω-3脂肪酸乙酯90软胶囊、醋酸加尼瑞克注射液、依托咪酯中/长链脂肪乳注射液、他氟前列素滴眼液、吸入用乙酰半胱氨酸溶液、磷酸特地唑胺片等为2024年获批品种。20余款1类新药出击！30个新品瞄准百亿市场扬子江药业以创新研发为发展驱动力，通过“自主研发+外部引进”的方式，“仿制+创新”双轮驱动，产品研发管线日益丰满。米内网数据显示，含引进的产品在内，目前扬子江药业有25款新药（不含已上市新药及拓展新适应症）处于申请临床及以上阶段，包括16款化学药、8款中成药及1款生物药，其中1类新药占比超八成。6款新药处于III期临床及以上阶段，上市可期。其中，PDE-5抑制剂盐酸妥诺达非片、新型PPI抑制剂盐酸非苏拉生片、食欲素受体OX1/OX2拮抗剂法赞雷生片已提交NDA在审，感冒双解颗粒、复方蓉术颗粒2款中药新药，以及MOR激动剂YZJ-4729酒石酸盐注射液步入III期临床。仿制药方面，目前扬子江药业有30个新注册分类品种在审（不含已有批文、主动撤回、联合申报品种），形成了梯度丰富的研发管线，主要集中在神经系统药物（6个）、消化系统及代谢药（6个）、呼吸系统用药（4个）等。扬子江药业以新注册分类申报且在审的品种来源：米内网中国申报进度（MED）数据库30个品种2024年在中国三大终端六大市场的销售额合计超过100亿元。其中，注射用紫杉醇(白蛋白结合型)超过25亿元，酒石酸布托啡诺注射液、洛索洛芬钠凝胶贴膏、糠酸莫米松鼻喷雾剂均超过10亿元，注射用雷贝拉唑钠超过8亿元等。9个品种暂无首仿（含剂型首仿）获批上市，包括布瑞哌唑片、注射用卡非佐米、注射用盐酸达巴万星、奥贝胆酸片、雷诺嗪缓释片、注射用德拉沙星、富马酸卢帕他定口服溶液、甲磺酸沙芬酰胺片等。此外，美洛昔康纳米晶注射液、脂肪乳氨基酸(17)葡萄糖(19%)注射液、普瑞巴林缓释片、糠酸莫米松鼻喷雾剂等品种获批国产企业数均只有1家。资料来源：米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至6月30日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone If approved, it would represent the fourth indication in the EU and second in the front-line setting globally June 23, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months. Olivier Nataf Global Head, Oncology “The CHMP’s recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.” The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study (clinical study identifier: NCT03617731), presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology. GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation. Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using VRd as a backbone in TE NDMM. The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant. Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant. GMMG-HD7 is an investigational pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available at a later time. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety. MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization. Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with pomalidomide and dexamethasone for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. 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