Pyrazinamide

精彩内容 近日，重庆华邦制药申报的4类仿制药卡泊三醇倍他米松软膏获批生产，为国内首仿+首家过评，原研产品2023年在中国三大终端六大市场（统计范围详见本文末）的销售额接近2亿元。 来源：米内网中国申报进度（MED）数据库 卡泊三醇倍他米松软膏是由卡泊三醇和二丙酸倍他米松组成的复方制剂，其中卡泊三醇为维生素D类似物，二丙酸倍他米松具有抗炎、止痒、收缩血管和免疫抑制等特性，该复方制剂适合局部治疗的成人稳定性斑块状银屑病。 米内网数据显示，卡泊三醇倍他米松软膏已被纳入国家医保乙类目录，近年来在中国三大终端六大市场的销售额呈逐年上涨态势，2023年接近2亿元，2024上半年超过1亿元。 近年来中国三大终端六大市场卡泊三醇倍他米松软膏销售情况（单位：万元） 来源：米内网格局数据库 仿制药申报方面，重庆华邦制药的卡泊三醇倍他米松软膏于2023年12月底以新注册分类报产获受理，并于近日顺利获批生产，拿下国内首仿+首家过评；此外，杭州领业医药的产品正在开展BE试验。 2025年以来，重庆华邦制药有盐酸贝尼地平片、卡泊三醇倍他米松软膏2个品种获批生产并视同过评。截至目前，公司已过评或视同过评品种数达20个，集中在全身用抗感染药物。 重庆华邦制药已过评品种 来源：米内网一致性评价进度数据库 在过往的国家集采中，重庆华邦制药的注射用甲泼尼龙琥珀酸钠、吡嗪酰胺片、泊沙康唑注射液、阿那曲唑片、盐酸莫西沙星片、苯磺贝他斯汀片、盐酸左西替利嗪片顺利中选。 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3月26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

THURSDAY, Feb. 6, 2025 -- Three all-oral shortened regimens have noninferior efficacy compared with standard therapy for fluoroquinolone-susceptible, rifampin -resistant tuberculosis , according to a study published in the Jan. 30 issue of the New England Journal of Medicine . Lorenzo Guglielmetti, M.D., Ph.D., from Médecins Sans Frontières in Paris, and colleagues conducted a phase 3, multinational, noninferiority trial to compare standard therapy for treatment of fluoroquinolone-susceptible, rifampin-resistant tuberculosis to five nine-month oral regimens, including combinations of bedaquiline (B), delamanid (D), linezolid (L), levofloxacin (Lfx) or moxifloxacin (M), clofazimine (C), and pyrazinamide (Z). A total of 754 participants were randomly assigned to one of five combinations or standard therapy; 699 were included in the modified intention-to-treat analysis and 562 were included in the per-protocol analysis. The primary end point was a favorable outcome at week 73, defined by two negative sputum culture results or favorable bacteriologic, clinical, and radiologic evolution. The noninferiority margin was −12 percentage points. The researchers found that 80.7 percent of the patients in the standard-therapy group had favorable outcomes in the modified intention-to-treat analysis. In the modified intention-to-treat population, the risk difference between standard therapy and each of the four new regimens was noninferior: 9.8, 8.3, 4.6, and 2.5 percentage points for BCLLfxZ, BLMZ, BDLLfxZ, and DCMZ, respectively. In the per-protocol population, the differences were similar, apart from DCMZ, which was not noninferior. Across the regimens, the proportion of participants with grade 3 or higher adverse events was similar. "The results of this trial support the noninferior efficacy of three all-oral shortened regimens for the treatment of rifampin-resistant tuberculosis," the authors write. Two authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.