2023年11月全球在研新药与靶点月报

—2023年11月 目录 1.2本月获批新药简介......................................................................................................................................11 ➢罗氏CD3/CD20双抗「格菲妥单抗」在华获批上市.................................11➢合源生物CAR-T产品「纳基奥仑赛」获NMPA批准上市，治疗白血病................12➢海特生物注射用重组变构人肿瘤坏死因子相关凋亡诱导配体获NMPA批准上市.........12➢国家药监局附条件批准天然药物创新药香雷糖足膏上市..............................12➢NMPA附条件批准鞍石生物「伯瑞替尼肠溶胶囊」上市..............................12➢住友制药拉法姆林片和拉法姆林注射液获NMPA批准上市...........................12 二、全球获孤儿药/突破性/快速通道资格认定品种盘点.....................................................................................14 ➢辉瑞流感mRNA疫苗达3期试验双主要终点......................................................................................21➢40%晚期实体瘤患者缓解！创新细胞疗法达主要终点........................................................................21➢中位无进展生存期达24.3个月！恒瑞医药“吡咯替尼”乳腺癌3期研究结果发表...........................21➢首个！显著改善癌症OS，默沙东重磅PD-1抑制剂3期试验积极结果公布...................................22➢显著减少致病蛋白水平，CRISPR疗法3期试验即将启动.................................................................22➢显著改善慢性肾病！勃林格殷格翰小分子组合疗法3期试验即将启动............................................22➢降低慢性肾病指标达52.5%！达格列净组合疗法迈入3期试验........................................................23➢信达生物公布2款双靶点眼科新药最新临床数据................................................................................23➢ORR达100%！邦耀生物口头报告CAR-T产品最新临床数据..........................................................23➢超半数患者银屑病症状完全清除，创新纳米抗体疗法可有效缓解银屑病........................................24➢每年长高8厘米！创新疗法达临床试验主要终点................................................................................24➢TIGIT疗法再现曙光？治疗晚期胃肠道癌症，ORR达80%...............................................................24➢艾威药业眼科新药2期临床获积极结果................................................................................................25➢诺华潜在“best-in-class”抑制剂双项关键3期试验达主要终点............................................................25➢改善肝癌PFS，阿斯利康重磅PD-L1抑制剂组合3期试验结果积极...............................................26➢改善转移性癌症生存期！口服免疫激活剂组合疗法临床结果积极....................................................26 ➢歌礼公布皮下注射抗PD-L1抗体乙肝2b期临床最新结果.................................................................26➢星汉德生物公布TCR-T疗法治疗肝癌最新临床数据..........................................................................27➢旨在功能性治愈乙肝，组合疗法最新2期临床试验结果积极............................................................27➢入选LBA！翰森制药乙肝新药3期临床144周数据发表...................................................................27➢显著降低乙肝表面抗原水平！创新免疫疗法双项临床试验结果积极................................................28➢持久降低高血压，长效疗法一针可维持半年........................................................................................28➢一针可降低关键血脂指标94%！长效疗法效果持续近一年...............................................................29➢肝病3期试验达主要终点！潜在“first-in-class”小分子全球上市申请递送在即................................29➢首款！FDA批准新药可降低这种感染风险71%..................................................................................30➢肿瘤缩小超40%，创新疗法计划明年递交上市申请...........................................................................30➢荣昌生物口头报告“泰它西普”治疗类风湿关节炎的3期临床数据....................................................30➢CAR-T与RNA疫苗联合对抗实体瘤，超三成患者达缓解................................................................31➢里程碑进展！靶向蛋白降解剂扩展至非肿瘤临床应用........................................................................31➢改善复发性癌症OS达63%！创新疗法2期积极结果公布................................................................32➢施维雅潜在“first-in-class”疗法最新临床数据在SNO年会发布..........................................................32➢无进展生存率达84.3%！强生/Genmab一线组合疗法3期试验积极.................................................32➢小分子抑制剂revumenib关键性2期试验获积极结果.........................................................................33➢信达生物公布“玛仕度肽”治疗中国2型糖尿病患者最新临床数据....................................................33➢一线治疗宫颈癌，康方生物“卡度尼利”3期研究达PFS主要终点.....................................................33➢主要终点缓解率近翻倍！MorphoSys创新疗法3期临床获积极结果................................................34➢难治性癌症生存率达57.4%，创新组合疗法早期临床结果积极........................................................34➢复发癌症PFS显著改善！强生/艾伯维/基因泰克小分子组合3期试验结果积极.............................34➢疾病控制率达100%！恒瑞医药联合疗法临床数据获《柳叶刀》子刊发表.....................................35 四、国产创新药国际化动态...................................................................................................................................36 ➢一周一次！晟斯生物血友病长效疗法在美国获批临床........................................................................36➢CD38抗体获FDA突破性疗法认定.......................................................................................................36➢针对HPV相关肿瘤！仁景生物治疗性mRNA疫苗在美国获批临床................................................36➢华奥泰生物靶向CD73的ADC在美国获批临床..................................................................................37➢康弘药业又一款1类新药在美国获批临床............................................................................................37 ➢和誉医药新一代FGFR4抑制剂在美国获批临床..................................................................................37➢和黄医药/武田「呋喹替尼」获美国FDA批准上市.........................................