Bortezomib

精彩内容6月17日，CDE官网显示，齐鲁制药的1类新药注射用QLS32015、2.2类新药QL2109注射液同日获得临床试验默示许可，均用于治疗多发性骨髓瘤。今年以来，齐鲁制药已有14款新药获批临床；其中9款为1类新药，均为抗肿瘤和免疫调节剂。来源：CDE官网注射用QLS32015是齐鲁制药自主研发的一款靶向G蛋白偶联受体家族C组5成员D（GPRC5D）和CD3的新型双特异性抗体，可用于联合泊马度胺、或联合达雷妥尤单抗、或联合泊马度胺和达雷妥尤单抗、或联合硼替佐米和来那度胺治疗多发性骨髓瘤。QL2109注射液为齐鲁制药开发的达雷妥尤单抗生物类似药皮下注射剂型，可用于联合QLS32015、或联合QLS32015和泊马度胺治疗多发性骨髓瘤。米内网数据显示，强生的达雷妥尤单抗2024年以116.7亿美元的销售额高居全球畅销药榜单TOP8；而在中国三大终端六大市场（统计范围详见本文末），其2024年销售额超过16亿元，同比增长16.47%。近年来中国三大终端六大市场达雷妥尤单抗销售趋势（单位：万元）来源：米内网格局数据库近年来，齐鲁制药持续推进“创新驱动”战略，加大研发投入力度支持药品研发创新。今年以来，公司已有14款新药获批临床，包括9款1类新药和4款2.2类改良型新药，均为抗肿瘤和免疫调节剂，其中帕妥木单抗注射液（转移性结直肠癌）已报产在审，QL2109注射液（多发性骨髓瘤）、QL2107注射液（非鳞状非小细胞肺癌）已步入Ⅲ期临床，注射用QLS31905（胃或胃食管结合部腺癌）、QLP2117注射液（晚期肿瘤）正处于Ⅱ期临床阶段；1款3.3类新药重组人促卵泡激素注射液处于Ⅰ期临床，拟开发适应症为促卵泡激素。今年以来齐鲁制药获批临床的新药情况来源：米内网中国申报进度（MED）数据库在中国三大终端六大市场，抗肿瘤和免疫调节剂（化+生）近年来销售规模逐年扩容，2022-2024年分别同比增长1.31%、5.44%和6.4%；2024年拿下创新高的超2300亿元，稳居治疗大类TOP1之位，市场份额达18.7%。资料来源：米内网数据库、CDE官网注：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17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

iStock, Wel_nofri Venclexta, when combined with azacitidine, elicited an overall survival benefit below 10% in patients with myelodysplastic syndromes. Roche and AbbVie ’s Venclexta, when used in combination with chemotherapy, does not improve survival in high-risk patients with myelodysplastic syndrome, adding to a growing list of setbacks for the blood cancer drug. According to a press announcement on Monday, Venclexta plus azacitidine improved overall survival by under 10%, an effect that failed to reach statistical significance. Venclexta’s survival miss will not affect any of its existing approvals, the companies insisted. Monday’s data come from the Phase III VERONA trial , a randomized study that pitted Venclexta plus azacitidine against azacitidine alone. The study enrolled more than 530 patients deemed intermediate, high or very high risk as per international assessment standards. Full data from VERONA will be available at a future scientific meeting and publication, the companies said. Venclexta is an oral small molecule blocker of BCL-2, a protein that prevents cell death. Cancer cells overexpress BCL-2, which promotes the survival of the tumor and has been linked to treatment resistance. Venclexta first received FDA approval in 2016 for chronic lymphocytic leukemia, garnering a handful of other approvals since then, including for acute myeloid leukemia. But further efforts to expand the drug’s label have run into roadblocks. In September 2023, for instance, AbbVie and Roche revealed that the Phase III CANOVA trial of Venclexta in relapsed or refractory multiple myeloma failed to demonstrate a significant benefit in progression-free survival (PFS). CANOVA combined Venclexta with dexamethasone and compared it against pomalidomide plus dexamethasone. Years before, in 2019, the FDA slapped a clinical hold on all multiple myeloma Venclexta trials at the time after detecting a higher rate of deaths in a Phase III trial versus placebo. The regulator lifted the pause a few months later and in 2021, the study that triggered the freeze, dubbed BELLINI, demonstrated a significant PFS benefit to Venclexta plus bortezomib—but also detected a higher risk of mortality. Venclexta remains a strong market asset for AbbVie and Roche. It made $2.6 billion in 2024, growing nearly 16% year-on-year on an operational basis.