Thiotepa

每周药品注册获批数据，分门别类呈现，一目了然。(4.27-5.5） 新药上市申请 无 新药临床申请 药品名称 企业 注册分类 受理号 拉尼兰诺片 正大天晴(广州)医药有限公司 1 CXHL2600380 HRS-6209胶囊 江苏恒瑞医药股份有限公司 1 CXHL2600223 HRS-8080片 山东盛迪医药有限公司 1 CXHL2600216 HRS-8080片 山东盛迪医药有限公司 1 CXHL2600215 HRS-9813 胶囊 广东恒瑞医药有限公司 1 CXHL2600217 GLB-002胶囊 杭州格博生物医药有限公司 1 CXHL2600209 RFUS-188注射液 宜昌人福药业有限责任公司 1 CXHL2600189 注射用BXOS116 拜西欧斯(北京)生物技术有限公司 1 CXHL2600169 YL-18319片 上海璎黎药业有限公司 1 CXHL2600173 YL-18319片 上海璎黎药业有限公司 1 CXHL2600172 HS-10522片 江苏豪森药业集团有限公司 1 CXHL2600164 HS-10522片 江苏豪森药业集团有限公司 1 CXHL2600163 HS-10522片 江苏豪森药业集团有限公司 1 CXHL2600162 JY54注射液 杭州九源基因生物医药股份有限公司 1 CXHL2600160 HS-10522片 江苏豪森药业集团有限公司 1 CXHL2600158 HS-10522片 江苏豪森药业集团有限公司 1 CXHL2600157 HS-10522片 江苏豪森药业集团有限公司 1 CXHL2600156 WS-0101溶液 北京厚燊维康科技有限责任公司 1 CXHL2600155 QLS7320注射液 齐鲁制药有限公司 1 CXHL2600167 QLS7320注射液 齐鲁制药有限公司 1 CXHL2600165 INS018_055B雾化吸入剂 英矽智能科技(上海)有限公司 1 CXHL2600145 ICF004吸入粉雾剂 长风苏粤药业(广州)有限公司 1 CXHL2600133 ICF004吸入粉雾剂 长风苏粤药业(广州)有限公司 1 CXHL2600132 氨酚羟考酮缓释片 上海理想制药有限公司 2.2 CXHL2600207 ZD2202 浙江智达药业有限公司 2.2 CXHL2600186 甲磺酸伏美替尼片 上海艾力斯医药科技股份有限公司 2.4 CXHL2600194 TXA-070片 武汉科福新药有限责任公司 2.4 CXHL2600168 冻干乙型脑炎灭活疫苗(人二倍体细胞) 安徽智飞龙科马生物制药有限公司 2.2 CXSL2600147 GenSci161注射液 长春金赛药业有限责任公司 1 CXSL2600347 注射用SIM0613 上海先纬医药科技有限公司 1 CXSL2600239 注射用SHR-5421 苏州盛迪亚生物医药有限公司 1 CXSL2600237 SCTB35注射液 神州细胞工程有限公司 1 CXSL2600236 SCTB35注射液 神州细胞工程有限公司 1 CXSL2600235 SHR-3079注射液 苏州盛迪亚生物医药有限公司 1 CXSL2600231 SHR-3079注射液 苏州盛迪亚生物医药有限公司 1 CXSL2600230 注射用DEC003M 杭州多禧生物科技有限公司 1 CXSL2600221 注射用SIBP-A17 上海生物制品研究所有限责任公司 1 CXSL2600220 注射用QLS4131 齐鲁制药有限公司 1 CXSL2600210 注射用SIBP-A19 上海生物制品研究所有限责任公司 1 CXSL2600207 注射用ZL-6201 再鼎医药(上海)有限公司 1 CXSL2600217 ZHB118舌下片 江苏众红生物工程创药研究院有限公司 1 CXSL2600193 ZHB118舌下片 江苏众红生物工程创药研究院有限公司 1 CXSL2600190 EA5注射液皮下制剂 上海览屹医药科技有限公司 1 CXSL2600196 CG001注射液 上海康景生物医药科技有限公司 1 CXSL2600194 SSS68注射液 沈阳三生制药有限责任公司 1 CXSL2600191 SSS68注射液 沈阳三生制药有限责任公司 1 CXSL2600189 SSS68注射液 沈阳三生制药有限责任公司 1 CXSL2600188 注射用BG-T187(皮下注射) 广州百济神州生物制药有限公司 1 CXSL2600197 ZHB117舌下片 江苏众红生物工程创药研究院有限公司 1 CXSL2600184 ZHB117舌下片 江苏众红生物工程创药研究院有限公司 1 CXSL2600183 ALXN2220注射液 阿斯利康全球研发(中国)有限公司 1 CXSL2600185 9MW2821 迈威(上海)生物科技股份有限公司 1 CXSL2600177 XY101 西安血氧生物技术有限公司 1 CXSL2600148 RRG001眼内注射液 上海鼎新基因科技有限公司 1 CXSL2600141 QL2109注射液 齐鲁制药有限公司 2.2 CXSL2600211 埃诺格鲁肽注射液 杭州先为达生物科技股份有限公司 2.2 CXSL2600200 埃诺格鲁肽注射液 杭州先为达生物科技股份有限公司 2.2 CXSL2600199 重组人神经生长因子滴眼液 重庆科润生物医药研发有限公司 2.2 CXSL2600179 重组人神经生长因子滴眼液 重庆科润生物医药研发有限公司 2.2 CXSL2600178 仿制药申请 药品名称 企业 注册分类 受理号 艾曲泊帕乙醇胺干混悬剂 沈阳三生制药有限责任公司 3 CYHS2502182 碳酸氢钠注射液 南京赛瑞谱顿制药有限公司 3 CYHS2404225 碳酸氢钠注射液 南京赛瑞谱顿制药有限公司 3 CYHS2404224 洛索洛芬钠口服溶液 合肥启旸生物医药科技有限公司 3 CYHS2403938 盐酸普萘洛尔注射液 石家庄四药有限公司 3 CYHS2403897 盐酸普萘洛尔注射液 石家庄四药有限公司 3 CYHS2403896 尼麦角林片 华润双鹤利民药业(济南)有限公司 3 CYHS2403829 甲苯磺酸艾多沙班口腔崩解片 江苏和晨药业有限公司 3 CYHS2403760 复方葡萄糖/电解质颅脑手术冲洗液 昆明南疆制药有限公司 3 CYHS2403702 硝酸甘油注射液 海南未见药业有限公司 3 CYHS2403689 盐酸溴己新注射液 以岭万洲国际制药有限公司 3 CYHS2403484 西咪替丁注射液 大理药业股份有限公司 3 CYHS2403418 吡拉西坦注射液 山东力诺制药有限公司 3 CYHS2403348 吡拉西坦注射液 山东力诺制药有限公司 3 CYHS2403347 重酒石酸卡巴拉汀口服液 北京双鹭药业股份有限公司 3 CYHS2403319 重酒石酸卡巴拉汀口服液 北京双鹭药业股份有限公司 3 CYHS2403318 布瑞哌唑口腔崩解片 山东新时代药业有限公司 3 CYHS2403218 布瑞哌唑口腔崩解片 山东新时代药业有限公司 3 CYHS2403217 布瑞哌唑口腔崩解片 山东新时代药业有限公司 3 CYHS2403216 布美他尼注射液 平光制药股份有限公司 3 CYHS2403200 注射用硫酸多黏菌素B 海南合瑞制药股份有限公司 3 CYHS2403185 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(16)注射液 湖北一半天制药有限公司 3 CYHS2403133 盐酸艾司氯胺酮注射液 国药集团国瑞药业有限公司 3 CYHS2403135 盐酸左西替利嗪口服溶液 北京双鹭药业股份有限公司 3 CYHS2403020 盐酸左西替利嗪口服溶液 北京双鹭药业股份有限公司 3 CYHS2403019 西咪替丁注射液 石家庄凯达生物工程有限公司 3 CYHS2402968 尼美舒利片 上海理想制药有限公司 3 CYHS2402594 中性低钙腹膜透析液(碳酸氢盐-G4.25) 山东齐都药业有限公司 3 CYHS2402510 中性低钙腹膜透析液(碳酸氢盐-G2.5) 山东齐都药业有限公司 3 CYHS2402509 中性低钙腹膜透析液(碳酸氢盐-G1.5) 山东齐都药业有限公司 3 CYHS2402508 维生素B6注射液 苏州朗科生物技术股份有限公司 3 CYHS2402443 甲硫酸新斯的明注射液 成都百裕制药股份有限公司 3 CYHS2402410 甲硫酸新斯的明注射液 成都百裕制药股份有限公司 3 CYHS2402409 甲硫酸新斯的明注射液 成都百裕制药股份有限公司 3 CYHS2402408 硝普钠注射液 重庆药友制药有限责任公司 3 CYHS2402082 注射用塞替派 黑龙江福和制药集团股份有限公司 3 CYHS2402000 琥珀酸亚铁片 安徽佳和药业有限公司 3 CYHS2401771 烟酸缓释片 北京世桥生物制药有限公司 3 CYHS2401697 琥珀酸亚铁片 北京斯利安药业有限公司 3 CYHS2401069 布美他尼注射液 山东致泰医药技术有限公司 3 CYHS2400453 氧(气态) 渭南市临渭区新永安医用氧有限责任公司 4 CYHS2502237 氧(液态) 石家庄陕鼓气体有限公司 4 CYHS2502148 氧 韩城市红光制气有限责任公司 4 CYHS2502024 美阿沙坦钾片 浙江高跖医药科技股份有限公司 4 CYHS2500510 美阿沙坦钾片 浙江高跖医药科技股份有限公司 4 CYHS2500509 ω-3脂肪酸乙酯90软胶囊 山西鑫煜制药股份有限公司 4 CYHS2500369 硫酸氢氯吡格雷片 华泰民康(沈阳)科技有限公司 4 CYHS2500311 利格列汀片 湖南千金协力药业有限公司 4 CYHS2500147 黄体酮软胶囊 株洲千金药业股份有限公司 4 CYHS2500097 黄体酮软胶囊 株洲千金药业股份有限公司 4 CYHS2500096 地屈孕酮片 嘉亨(珠海横琴)医药科技有限公司 4 CYHS2500043 氟伐他汀钠缓释片 浙江华海药业股份有限公司 4 CYHS2404664 地屈孕酮片 北京金城泰尔制药有限公司 4 CYHS2404601 枸橼酸氢钾钠颗粒 成都恒瑞制药有限公司 4 CYHS2404449 阿托伐他汀钙片 浙江江北药业有限公司 4 CYHS2404380 阿托伐他汀钙片 浙江江北药业有限公司 4 CYHS2404379 盐酸氨溴索口服溶液 合肥创新医药技术有限公司 4 CYHS2404232 盐酸氨溴索口服溶液 合肥创新医药技术有限公司 4 CYHS2404231 盐酸氨溴索口服溶液 合肥创新医药技术有限公司 4 CYHS2404230 盐酸氨溴索口服溶液 合肥创新医药技术有限公司 4 CYHS2404229 枸橼酸西地那非片 河北常山生化药业股份有限公司 4 CYHS2404130 枸橼酸西地那非片 河北常山生化药业股份有限公司 4 CYHS2404129 注射用阿奇霉素 南京海纳医药科技股份有限公司 4 CYHS2403967 盐酸氨溴索口服溶液 石药集团中诺药业(石家庄)有限公司 4 CYHS2403954 盐酸氨溴索口服溶液 石药集团中诺药业(石家庄)有限公司 4 CYHS2403953 乌帕替尼缓释片 江苏华阳制药有限公司 4 CYHS2403925 注射用头孢他啶/氯化钠注射液 北京锐业制药(潜山)有限公司 4 CYHS2403850 注射用头孢他啶/氯化钠注射液 北京锐业制药(潜山)有限公司 4 CYHS2403849 米力农注射液 云南药科院生物医药股份有限公司 4 CYHS2403835 吡美莫司乳膏 浙江华海药业股份有限公司 4 CYHS2403786 非那雄胺片 海南药谷云生物科技有限公司 4 CYHS2403791 非那雄胺片 海南药谷云生物科技有限公司 4 CYHS2403790 注射用盐酸地尔硫䓬 石家庄四药有限公司 4 CYHS2403777 阿法骨化醇软胶囊 人福普克药业(武汉)有限公司 4 CYHS2403728 阿法骨化醇软胶囊 人福普克药业(武汉)有限公司 4 CYHS2403727 卡前列素氨丁三醇注射液(预充式) 湖州亚瑟制药有限公司 4 CYHS2403675 复方托吡卡胺滴眼液 深圳市瑞霖医药有限公司 4 CYHS2403681 兰索拉唑肠溶胶囊 成都欣捷高新技术开发股份有限公司 4 CYHS2403547 他克莫司缓释胶囊 上海安必生制药技术有限公司 4 CYHS2403522 他克莫司缓释胶囊 上海安必生制药技术有限公司 4 CYHS2403521 氨甲环酸片 浙江兄弟药业有限公司 4 CYHS2403465 熊去氧胆酸胶囊 葵花药业集团(唐山)生物制药有限公司 4 CYHS2403427 奥卡西平口服混悬液 贵州科伦药业有限公司 4 CYHS2403387 达格列净二甲双胍缓释片(III) 辰欣药业股份有限公司 4 CYHS2403410 达格列净二甲双胍缓释片(I) 辰欣药业股份有限公司 4 CYHS2403409 盐酸屈他维林注射液 福州基石医药科技有限公司 4 CYHS2403341 盐酸莫西沙星氯化钠注射液 辽宁民康制药有限公司 4 CYHS2403230 恩他卡朋双多巴片(II) 四川科伦药业股份有限公司 4 CYHS2403149 盐酸屈他维林注射液 浙江高跖医药科技股份有限公司 4 CYHS2403087 玻璃酸钠滴眼液 黑龙江省知润药业有限公司 4 CYHS2402940 比拉斯汀片 安徽泰恩康制药有限公司 4 CYHS2402936 美沙拉秦肠溶片 浙江美迪深生物医药有限公司 4 CYHS2402885 骨化三醇注射液 桂林朗科制药有限公司 4 CYHS2402855 乳果糖口服溶液 河南合智医药科技有限公司 4 CYHS2402770 二甲双胍恩格列净片(I) 上海现代制药股份有限公司 4 CYHS2402748 盐酸乙哌立松片 上海安必生制药技术有限公司 4 CYHS2402671 盐酸氮卓斯汀鼻喷雾剂 广州市桐晖药业有限公司 4 CYHS2402515 盐酸阿莫罗芬搽剂 浙江恒研医药科技有限公司 4 CYHS2401938 罗沙司他胶囊 安徽省先锋制药有限公司 4 CYHS2401907 罗沙司他胶囊 安徽省先锋制药有限公司 4 CYHS2401906 甲硝唑凝胶 浙江寰领医药科技有限公司 4 CYHS2401398 沙库巴曲缬沙坦钠 华北制药华胜有限公司 CYHS2360504 醋酸地非法林注射液 成都青山利康药业股份有限公司 3 CYHL2600022 进口申请 药品名称 企业 注册分类 受理号 亚甲蓝注射液 Provepharm SAS 5.1 JXHS2500006 亚甲蓝注射液 Provepharm SAS 5.1 JXHS2500005 枸橼酸铁胶囊 PANION & BF BIOTECH INC. 5.1 JXHS2300078 注射用A型肉毒毒素 AbbVie Limited 3.1 JXSS2500098 注射用A型肉毒毒素 AbbVie Limited 3.1 JXSS2500097 注射用A型肉毒毒素 AbbVie Limited 3.1 JXSS2500096 度伐利尤单抗注射液 AstraZeneca UK Limited 3.1 JXSS2500028 度伐利尤单抗注射液 AstraZeneca UK Limited 3.1 JXSS2500027 度伐利尤单抗注射液 AstraZeneca UK Limited 3.1 JXSS2500014 度伐利尤单抗注射液 AstraZeneca UK Limited 3.1 JXSS2500013 Tremelimumab注射液 AstraZeneca AB 3.1 JXSS2500016 Tremelimumab注射液 AstraZeneca AB 3.1 JXSS2500015 盐酸头孢卡品酯颗粒 Yungjin Pharm Co., Ltd. 5.2 JYHS2400039 Nemtabrutinib片 Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. 1 JXHL2600063 Nemtabrutinib片 Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. 1 JXHL2600062 Nemtabrutinib片 Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. 1 JXHL2600061 Brenipatide注射液 Eli Lilly and Company 1 JXHL2600048 TAK-360片 Takeda Development Center Americas, Inc. 1 JXHL2600042 TAK-360片 Takeda Development Center Americas, Inc. 1 JXHL2600041 TAK-360片 Takeda Development Center Americas, Inc. 1 JXHL2600040 TAK-360片 Takeda Development Center Americas, Inc. 1 JXHL2600039 TAK-360片 Takeda Development Center Americas, Inc. 1 JXHL2600038 BIIB115注射液 Biogen Idec Research Limited 1 JXHL2600036 依普隆特生钠注射液 AstraZeneca AB 2.4 JXHL2600033 盐酸艾司氯胺酮鼻喷雾剂 Janssen-Cilag International NV 5.1 JXHL2600030 AZD0486 AstraZeneca AB 1 JXSL2600054 AZD0486 AstraZeneca AB 1 JXSL2600053 PF-08634404 Pfizer Inc. 1 JXSL2600049 PF-08634404 Pfizer Inc. 1 JXSL2600048 Pegozafermin注射液 89bio, Inc. 1 JXSL2600052 Pegozafermin注射液 89bio, Inc. 1 JXSL2600051 JNJ-79635322 Janssen Research & Development, LLC 1 JXSL2600041 JNJ-79635322 Janssen Research & Development, LLC 1 JXSL2600040 JNJ-79635322 Janssen Research & Development, LLC 1 JXSL2600038 JNJ-79635322 Janssen Research & Development, LLC 1 JXSL2600039 Nipocalimab注射液 Janssen Research & Development, LLC 2.1 JXSL2600047 Nipocalimab注射液 Janssen Research & Development, LLC 2.1 JXSL2600046 中药相关申请 药品名称 企业 注册分类 受理号 芦荟多糖提取物 广州市东源药业科技有限公司 1.2 CXZL2600016 芦荟多糖乳膏 广州市东源药业科技有限公司 1.2 CXZL2600015 西帕依麦孜彼子口服液 新奇康药业股份有限公司 2.3 CXZL2600022 注：橙色字体部分结论为不批准或收到通知件；

1、研究机构：赛诺菲制药、健赞生物制药、Principia Biopharma 2、别名：PRN-2246、SAR-442168、Cenrifki、托莱布替尼 3、靶点：BTK 4、剂型及给药途径：普通片剂; 口服给药 5、结构式 6、适应症及进展 适应症 进展 最新进展日期 多发性硬化 申请上市 2026-03-07 2026-03-07 I期 2025-02-07 7、发表论文 标题 内容类型 适应症 企业 技术平台 来源 发表日期 BTK regulates microglial function and neuroinflammation in human stem cell models and mouse models of multiple sclerosis 药理研究 多发性硬化 赛诺菲制药 武田药品工业株式会社 Voyager Therapeutics Nat Commun IF=15.7 2024-11-22 8、交易 交易名称 交易类型 转让方 受让方 交易时研发状态 权益类型 权益地区 权益适应症 交易金额 交易时间 Sanofi completes Principia Biopharma Inc. acquisition收购完成 转让/收购 Principia Biopharma 赛诺菲制药 临床III期 开发/商业化权 交易总额：3680百万美元  2020-09-28 Sanofi to acquire Principia Biopharma 转让/收购 Principia Biopharma 赛诺菲制药 临床III期 开发/商业化权 交易总额：3680百万美元  2020-08-17 Bay Area's Principia Biopharma Scores $765M MS Licensing Deal With Drug Giant Sanofi 授权/许可 Principia Biopharma 赛诺菲制药 临床II期 开发/商业化权 交易总额：765百万美元首付款：40百万美元 2017-11-09 9、专利布局 公开（公告）号 专利主题 发明名称 申请日 法律状态 CN106459049B 化合物 酪氨酸激酶抑制剂 2016-06-02 CN118434732A 晶型 Tolebrutinib的晶型及其制备方法和用途 2021-11-22 实质审查 CN117897381A 晶型 Tolebrutinib的晶型及其制备方法和用途 2022-06-02 实质审查 CN118434734A 晶型 (R)-1-(1-丙烯酰基哌啶-3-基)-4-氨基-3-(4-苯氧基苯基)-1H-咪唑并[4,5-C]吡啶-2(3H)-酮及其盐的晶型 2022-12-20 实质审查 CN119212708A 用途 用于髓鞘少突胶质细胞糖蛋白抗体疾病(MOGAD)的治疗性酪氨酸激酶抑制剂 2023-05-12 实质审查 CN119384411A 制备工艺 制备托勒替尼的方法 2023-06-13 实质审查 CN119343340A 制备工艺 制备修饰的BTK抑制剂的方法 2023-06-21 实质审查 CN119421712A 用途 用于多发性硬化和重症肌无力的治疗性酪氨酸激酶抑制剂 2023-06-29 实质审查 CN120435291A 用途 用于多发性硬化的治疗性酪氨酸激酶抑制剂 2023-10-06 实质审查 CN120379652A 制剂 (R)-1-(1-丙烯酰基哌啶-3-基)-4-氨基-3-(4-苯氧基苯基)-1H-咪唑并[4,5-c]吡啶-2(3H)-酮的药物制剂 2023-12-19 实质审查 CN121620370A 用途 通过检测脑脊液中的生物标志物诊断和治疗多发性硬化的方法 2024-01-31 实质审查 10、研究历程 2025年02月01日，由赛诺菲向美国食品药品管理局FDA提交上市申请，用于治疗慢性进行性多发性硬化。（https://www.sanofi.com/en/our-science/our-pipeline） 2024年05月20日，由Sanofi Winthrop Industrie SA在中国香港和中国大陆开展临床三期试验，用于治疗多发性硬化。（CTR20240417） 2024年04月16日，由赛诺菲（中国）投资有限公司、Sanofi Winthrop Industrie SA、Sanofi-Aventis Recherche & Developpement和赛诺菲在澳大利亚、加拿大和智利等国家和地区开展临床三期试验，用于治疗多发性硬化和慢性进行性多发性硬化。（CTR20240417; NCT06372145） 2023年03月10日，治疗重症肌无力的研究终止。（NCT05132569） 2022年12月14日，治疗重症肌无力的研究终止。（CTR20220329） 2022年06月22日，由赛诺菲（中国）投资有限公司、Sanofi Winthrop Industrie SA和Sanofi-Aventis Recherche & Developpement在中国大陆开展临床三期试验，用于治疗重症肌无力。（CTR20220329） 2022年03月10日，由赛诺菲在德国和美国开展临床一期试验，用于治疗肾功能不全。（NCT05282030） 2021年12月20日，由赛诺菲（中国）投资有限公司、Sanofi Winthrop Industrie SA和Sanofi-Aventis Recherche & Developpement在巴西、加拿大和德国等国家和地区开展临床三期试验，用于治疗重症肌无力。（CTR20220329） 2021年12月03日，由赛诺菲在加拿大、匈牙利和意大利等国家和地区开展临床三期试验，用于治疗重症肌无力。（NCT05132569） 2021年11月03日，由Koneksa Health Inc开展临床前研究试验。（https://www.prnewswire.com/news-releases/koneksa-broadens-multi-year-cns-research-collaboration-with-sanofi-301415238.html） 2021年04月15日，由National Institute Of Neurological Disorders And Stroke在美国开展临床二期试验，用于治疗多发性硬化。（NCT04742400） 2021年02月23日，由赛诺菲（中国）投资有限公司、Sanofi-Aventis Recherche & Developpement和美国健赞公司在中国香港、中国台湾和中国大陆等国家和地区开展临床三期试验，用于治疗多发性硬化。（CTR20240417; CTR20210060; CTR20202631; CTR20210121） 2020年10月23日，由赛诺菲（中国）投资有限公司、Sanofi-Aventis Recherche & Developpement和美国健赞公司在奥地利、白俄罗斯和保加利亚等国家和地区开展临床三期试验，用于治疗多发性硬化。（CTR20240417; CTR20210060） 2020年08月13日，由赛诺菲在阿根廷、澳大利亚和奥地利等国家和地区开展临床三期试验，用于治疗慢性进行性多发性硬化。（NCT04458051; NCT06372145） 2020年06月30日，由赛诺菲在奥地利、白俄罗斯和保加利亚等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT06372145; NCT04410978） 2020年06月11日，由赛诺菲在阿根廷、比利时和巴西等国家和地区开展临床三期试验，用于治疗多发性硬化。（NCT06372145; NCT04410978; NCT04410991） 2020年05月18日，由赛诺菲在美国开展临床一期试验，用于治疗多发性硬化。（NCT06106074; NCT06064539） 2019年11月13日，由赛诺菲在英国开展临床一期试验，用于治疗多发性硬化。（NCT04171310） 2019年03月29日，由赛诺菲在加拿大、爱沙尼亚和法国等国家和地区开展临床二期试验，用于治疗多发性硬化。（NCT03996291; NCT03889639） 11、临床试验 登记号 试验标题 试验药 适应症 原始适应症 申办/合作机构 试验状态 试验分期 开始日期 完成日期 国家/地区 NCT07526597 Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors 托莱布替尼 慢性淋巴细胞白血病 | 小淋巴细胞淋巴瘤 Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma Lineberger Comprehensive Cancer Center Not yet recruiting 临床2期 2026-05-01 2032-06-01 美国 NCT07120633 The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients Anti-CD19 CAR-T (The Affiliated Hospital of Xuzhou Medical University) | 托莱布替尼 慢性淋巴细胞白血病 | 小淋巴细胞淋巴瘤 CLL | CAR-T Cell Therapy | SLL 徐州医科大学附属医院 Recruiting N/A 2025-09-01 2028-09-01 中国 NCT06372145 An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis 托莱布替尼 (片剂, 口服) 原发性进行性多发性硬化 | 继发进展型多发性硬化 | 复发性多发性硬化 Relapsing Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple Sclerosis Sanofi Active, not recruiting 临床3期 2024-04-16 2029-04-30 美国 | 中国香港 | 捷克 | 泰国 | 葡萄牙 | 希腊 | 瑞典 | 韩国 | 荷兰 | 拉脱维亚 | 奥地利 | 中国 | 土耳其 | 波兰 | 巴西 | 斯洛伐克 | 塞尔维亚共和国 | 立陶宛 | 法国 | 智利 | 保加利亚 | 克罗地亚 | 哥伦比亚 | 阿根廷 | 罗马尼亚 | 匈牙利 | 日本 | 乌克兰 | 英国 | 瑞士 | 西班牙 | 印度 | 加拿大 | 比利时 | 挪威 | 中国台湾 | 芬兰 | 丹麦 | 南非 | 墨西哥 | 意大利 | 以色列 | 澳大利亚 | 德国 | 爱沙尼亚 NCT06106074 A Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants 托莱布替尼 (片剂, 口服) 多发性硬化症 Multiple Sclerosis Sanofi Completed 临床1期 2020-08-10 2022-05-23 美国 NCT06064539 A Phase 1, Single-center, Open-label, Two-cohort, Two-period, One-sequence, Two Treatment, Drug-drug Interaction Study of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Subjects 吉非罗齐 (片剂, 口服) | 利福平 (片剂, 口服) | 托莱布替尼 (片剂, 口服) 多发性硬化症 Multiple Sclerosis Sanofi Completed 临床1期 2020-05-18 2020-07-08 美国 NCT05283915 An Open-label Phase 1, Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Dose in Adult Participants With Mild Hepatic Impairment, and in Matched Participants With Normal Hepatic Function 托莱布替尼 (薄膜包衣片, 口服) 肝功能不全 Hepatic Function Abnormal Sanofi Completed 临床1期 2022-03-18 2022-05-24 美国 NCT05282030 An Open-label, Multi-center Phase 1 Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Oral Dose in Participants With Renal Impairment and in Matched Participants With Normal Renal Function. 托莱布替尼 (薄膜包衣片, 口服) 肾功能不全 Renal Impairment Sanofi Completed 临床1期 2022-03-10 2022-08-02 美国 | 德国 ChiCTR2200055554 An Open, Single-Center Clinical Observation Study to Assess the Efficacy and Safety of The Thiotepa for Primary Central Nervous System Lymphoma (PCNSL) Patients 卡莫司汀 | 托莱布替尼 | 甲氨蝶呤 | 利妥昔单抗 | 塞替派 原发性中枢神经系统淋巴瘤 Primary central nervous system lymphoma/Central?high?risk?of?diffuse?large?B-cell?lymphoma 兰州大学第二医院 Recruiting 临床2期 2022-04-01 2024-04-04 中国 NCT05132569 A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG) 托莱布替尼 (薄膜包衣片, 口服) 重症肌无力 Myasthenia Gravis Sanofi Terminated 临床3期 2021-12-03 2023-02-21 加拿大 | 匈牙利 | 美国 | 日本 | 中国 | 波兰 | 英国 | 意大利 | 西班牙 NCT04978779 An Open-label, Multicenter Phase 1/1b Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP152 Monotherapy or Combination Therapy in Subjects With High-risk Chronic Lymphocytic Leukemia or Richter Syndrome Enitociclib (静脉注射) | 托莱布替尼 染色体易位 | 复发性非霍奇金淋巴瘤 | 难治性慢性淋巴细胞白血病 | 里氏综合症 Relapsed Non Hodgkin Lymphoma | Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Richter Syndrome | MYC Amplification | MYC Overexpression | MYC Translocation Vincerx Pharma, Inc. Terminated 临床1期 2021-12-16 2023-05-26 美国 | 波兰 NCT04742400 A Phase 2 Clinical Trial of Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis 托莱布替尼 (口服) 多发性硬化症 Multiple Sclerosis National Institute of Neurological Disorders & Stroke Active, not recruiting 临床2期 2021-04-15 2025-12-31 美国 NCT04458051 A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS) 托莱布替尼 (薄膜包衣片, 口服) 原发性进行性多发性硬化 Primary Progressive Multiple Sclerosis Sanofi Completed 临床3期 2020-08-13 2025-11-14 捷克 | 美国 | 泰国 | 葡萄牙 | 俄罗斯 | 希腊 | 瑞典 | 荷兰 | 拉脱维亚 | 奥地利 | 中国 | 土耳其 | 波兰 | 巴西 | 塞尔维亚共和国 | 法国 | 智利 | 保加利亚 | 克罗地亚 | 哥伦比亚 | 阿根廷 | 罗马尼亚 | 匈牙利 | 日本 | 乌克兰 | 英国 | 白俄罗斯 | 西班牙 | 印度 | 加拿大 | 比利时 | 挪威 | 丹麦 | 南非 | 墨西哥 | 意大利 | 以色列 | 澳大利亚 | 秘鲁 | 德国 | 爱沙尼亚 NCT04411641 A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis 托莱布替尼 (薄膜包衣片, 口服) 继发进展型多发性硬化 Non-relapsing Secondary Progressive Multiple Sclerosis Sanofi Completed 临床3期 2020-09-24 2024-08-29 俄罗斯 | 捷克 | 美国 | 葡萄牙 | 希腊 | 荷兰 | 奥地利 | 中国 | 波兰 | 立陶宛 | 法国 | 保加利亚 | 阿根廷 | 罗马尼亚 | 匈牙利 | 日本 | 乌克兰 | 英国 | 白俄罗斯 | 西班牙 | 印度 | 加拿大 | 土耳其 | 比利时 | 挪威 | 芬兰 | 丹麦 | 意大利 | 以色列 | 澳大利亚 | 德国 NCT04410978 A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis 托莱布替尼 (片剂, 口服) 复发性多发性硬化 Relapsing Multiple Sclerosis Sanofi Completed 临床3期 2020-06-30 2024-07-15 俄罗斯 | 罗马尼亚 | 中国香港 | 捷克 | 美国 | 日本 | 乌克兰 | 白俄罗斯 | 西班牙 | 加拿大 | 瑞典 | 奥地利 | 土耳其 | 中国 | 中国台湾 | 芬兰 | 波兰 | 丹麦 | 墨西哥 | 意大利 | 立陶宛 | 保加利亚 | 德国 | 爱沙尼亚 NCT04171310 An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects 托莱布替尼 多发性硬化症 Multiple Sclerosis Sanofi Completed 临床1期 2019-11-13 2019-12-30 英国 KCT0004309 A Phase 1, single-center, randomized, double-blind, placebo-controlled, incomplete block, 3-period crossover, single-dose escalation study to determine the safety, tolerability and pharmacokinetics of orally administered SAR442168 tablet in healthy East Asian (Japanese / Chinese / Korean) male subjects 托莱布替尼 神经系统疾病 Diseases of the nervous system Sanofi-Aventis Korea Co., Ltd. Completed 临床1期 2019-08-13 - 韩国 NCT03996291 Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis 托莱布替尼 复发性多发性硬化 Relapsing Multiple Sclerosis Sanofi Completed 临床2期 2019-09-23 2024-11-26 加拿大 | 荷兰 | 捷克 | 美国 | 乌克兰 | 法国 | 西班牙 | 俄罗斯 | 爱沙尼亚 NCT03889639 A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis 托莱布替尼 复发性多发性硬化 Relapsing Multiple Sclerosis Sanofi Completed 临床2期 2019-03-29 2020-01-02 加拿大 | 荷兰 | 捷克 | 美国 | 乌克兰 | 斯洛伐克 | 法国 | 西班牙 | 俄罗斯 | 爱沙尼亚 ACTRN12618001523291 A Phase 1, Randomized, Open-Label Study of the Relative Bioavailability and Effect of Food on the Pharmacokinetics of a Novel Formulation of PRN2246 Compared to a Reference Formulation in Healthy Adult Participants 托莱布替尼 多发性硬化症 | 神经系统疾病 Immune-mediated neurologic disorders | Immune-mediated neurologic disorders | Neurological - Multiple sclerosis Clinical Network Services Pty Ltd. Completed 临床1期 2018-10-14 2018-11-09 澳大利亚 ACTRN12617001457336 A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered PRN2246 in Healthy Volunteers 托莱布替尼 神经系统疾病 Immune-mediated neurologic disorders Clinical Network Services Pty Ltd. Recruiting 临床1期 2017-10-17 - - 12、临床结果 标题 登记号 来源 分期 适应症 评价人数 用药方案 结果 评价 发布日期 申办/合作机构 主要研究药物 来源链接 Synapse链接 TP53 aberrant Mantle Cell Lymphoma treated with first-line systemic therapy: A real-world analysis of outcomes in 120 patients treated in the United Kingdom - ASH N/A 套细胞淋巴瘤 120 High intensity ICT (rituximab + high dose cytarabine based) CR = 45.0 %  不佳 2025-12-06 University Hospital Southampton NHS Foundation Trust | Barts Health NHS Trust | Blackpool Teaching Hospitals NHS Foundation Trust | South Tees Hospitals NHS Foundation Trust | Nottingham University Hospitals Nhs Trust | University College London Hospitals NHS Foundation Trust - https://meetings-api.hematology.org/api/abstract/vmpreview/300472 https://synapse.zhihuiya.com/clinical-result-detail/82ed9a2825328852205ea4ee592a5358 TP53 aberrant Mantle Cell Lymphoma treated with first-line systemic therapy: A real-world analysis of outcomes in 120 patients treated in the United Kingdom - ASH N/A 套细胞淋巴瘤 120 Intermediate intensity ICT (R-CHOP/R- Bendamustine/R-BAC/VR-CAP) FFS(1st line) = 8.9 Month ( 3.8 ~ 14.0) 不佳 2025-12-06 University Hospital Southampton NHS Foundation Trust | Barts Health NHS Trust | Blackpool Teaching Hospitals NHS Foundation Trust | South Tees Hospitals NHS Foundation Trust | Nottingham University Hospitals Nhs Trust | University College London Hospitals NHS Foundation Trust - https://meetings-api.hematology.org/api/abstract/vmpreview/300472 https://synapse.zhihuiya.com/clinical-result-detail/82ed9a2825328852205ea4ee592a5358 Real-world outcomes of younger patients with chronic lymphocytic leukemia treated with first-line BTK inhibitor or BCL2 inhibitor therapy - ASH N/A 慢性淋巴细胞白血病 426 BTKi (ibrutinib, acalabrutinib, or zanubrutinib) mDoT = 20.7 Month  积极 2025-12-06 University of Utah Spencer Fox Eccles School of Medicine - https://meetings-api.hematology.org/api/abstract/vmpreview/300991 https://synapse.zhihuiya.com/clinical-result-detail/a335842a820a8a504d2a223a038ea2e2 Real-world outcomes of younger patients with chronic lymphocytic leukemia treated with first-line BTK inhibitor or BCL2 inhibitor therapy - ASH N/A 慢性淋巴细胞白血病 426 BCL2i (venetoclax ± rituximab or obinutuzumab) mDoT = 11.9 Month  积极 2025-12-06 University of Utah Spencer Fox Eccles School of Medicine - https://meetings-api.hematology.org/api/abstract/vmpreview/300991 https://synapse.zhihuiya.com/clinical-result-detail/a335842a820a8a504d2a223a038ea2e2 Outcomes of patients with Richter transformation (RT) treated with frontline chemoimmunotherapy (CIT) and BTK inhibitor (BTKi) - ASH N/A 里氏综合症 56 CIT+BTKi ORR = 62.5 %  积极 2025-12-06 University of California - https://meetings-api.hematology.org/api/abstract/vmpreview/291372 https://synapse.zhihuiya.com/clinical-result-detail/a25243a9e42aee422543ad5522aa24d3 Outcomes of patients with Richter transformation (RT) treated with frontline chemoimmunotherapy (CIT) and BTK inhibitor (BTKi) - ASH N/A 里氏综合症 56 CIT-only CR = 58.3 %  积极 2025-12-06 University of California - https://meetings-api.hematology.org/api/abstract/vmpreview/291372 https://synapse.zhihuiya.com/clinical-result-detail/a25243a9e42aee422543ad5522aa24d3 Upfront continuous BTK inhibitor (BTKi) versus time-limited venetoclax-BTKi combinations in CLL across IGHV subgroups: Results of an indirect analysis - ASH N/A 慢性淋巴细胞白血病 2037 continuous BTKi therapy PFS(four-year): Δ = 0.5(95.0% CI, -4.8 ~ 5.8), P-Value = 0.85 积极 2025-12-06 - 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/291473 https://synapse.zhihuiya.com/clinical-result-detail/00482ea9a5ae42545259ea22de2249e5 Upfront continuous BTK inhibitor (BTKi) versus time-limited venetoclax-BTKi combinations in CLL across IGHV subgroups: Results of an indirect analysis - ASH N/A 慢性淋巴细胞白血病 2037 TL venetoclax-BTKi regimens PFS(four-year): Δ = 0.5(95.0% CI, -4.8 ~ 5.8), P-Value = 0.85 积极 2025-12-06 - 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/291473 https://synapse.zhihuiya.com/clinical-result-detail/00482ea9a5ae42545259ea22de2249e5 Comparison of infections in patients with chronic lymphocytic leukemia (CLL) treated with BTKi versus venetoclax obinutuzumab in first line therapy - ASH N/A 慢性淋巴细胞白血病 3178 BTKi (ibrutinib, zanubrutinib, or acalabrutinib) 菌血症 = 8.1 %  不佳 2025-12-06 Roswell Park Comprehensive Cancer Center 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/290555 https://synapse.zhihuiya.com/clinical-result-detail/59525e99a0325ad52ad42ed5382a22aa Comparison of infections in patients with chronic lymphocytic leukemia (CLL) treated with BTKi versus venetoclax obinutuzumab in first line therapy - ASH N/A 慢性淋巴细胞白血病 3178 VenObin (venetoclax & obinutuzumab) 菌血症 = 4.8 %  不佳 2025-12-06 Roswell Park Comprehensive Cancer Center 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/290555 https://synapse.zhihuiya.com/clinical-result-detail/59525e99a0325ad52ad42ed5382a22aa Characteristics, treatment outcomes, and prognostic analysis of 118 cases of lymphoplasmacytic lymphoma/Waldenström macroglobulinemia - ASH N/A 淋巴浆细胞性淋巴瘤 | 巨球蛋白血症 101 BTKi (Bruton Tyrosine kinase inhibitor, Ibrutinib 140mg QD, or Zanubrutinib 160mg BID) CRR = 100.0 %  积极 2025-12-06 - 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/302249 https://synapse.zhihuiya.com/clinical-result-detail/e82a5e2894a082a8408a8e89ade32804 Characteristics, treatment outcomes, and prognostic analysis of 118 cases of lymphoplasmacytic lymphoma/Waldenström macroglobulinemia - ASH N/A 淋巴浆细胞性淋巴瘤 | 巨球蛋白血症 101 VD (Bortezomib 1.3mg/m2,d1,8,15, Dexamethasone, 20mg, d1,2,8,9,15,16,22,23) mOS = NR   积极 2025-12-06 - 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/302249 https://synapse.zhihuiya.com/clinical-result-detail/e82a5e2894a082a8408a8e89ade32804 Progression of disease within 36 months (POD36) of starting first-line targeted therapy independently predicts poor overall survival in patients with chronic lymphocytic leukemia (CLL) - ASH N/A 慢性淋巴细胞白血病 787 BTKi +/- CD20mAb mOS = not reached   积极 2025-12-06 Mayo Clinic 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/292616 https://synapse.zhihuiya.com/clinical-result-detail/0a582a8e8e4e82d002a88403ea958e22 Progression of disease within 36 months (POD36) of starting first-line targeted therapy independently predicts poor overall survival in patients with chronic lymphocytic leukemia (CLL) - ASH N/A 慢性淋巴细胞白血病 787 BCL2i + CD20mAb mOS = not reached   积极 2025-12-06 Mayo Clinic 托莱布替尼 https://meetings-api.hematology.org/api/abstract/vmpreview/292616 https://synapse.zhihuiya.com/clinical-result-detail/0a582a8e8e4e82d002a88403ea958e22 Real-world comparison of treatment outcomes between BCL2i and 2nd generation BTKi therapy in first-line CLL patients - ASH N/A 慢性淋巴细胞白血病 3844 Second-generation BTKi Event-free probability(30-month) = 70.0 %  积极 2025-12-06 - 维奈克拉 | 奥妥珠单抗 https://meetings-api.hematology.org/api/abstract/vmpreview/297011 https://synapse.zhihuiya.com/clinical-result-detail/02e232eea4d0a32325242482e5588a3e Real-world comparison of treatment outcomes between BCL2i and 2nd generation BTKi therapy in first-line CLL patients - ASH N/A 慢性淋巴细胞白血病 3844 V+O Event-free probability(30-month) = 83.0 %  积极 2025-12-06 - 维奈克拉 | 奥妥珠单抗 https://meetings-api.hematology.org/api/abstract/vmpreview/297011 https://synapse.zhihuiya.com/clinical-result-detail/02e232eea4d0a32325242482e5588a3e A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis NCT04410978 CTgov 临床3期 复发性多发性硬化 974 Teriflunomide(Teriflunomide 14 mg) Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses = 0.122 relapses per participant year (95%CI, 0.100 ~ 0.150) - 2025-06-18 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT04410978 https://synapse.zhihuiya.com/clinical-result-detail/aa855a8320d22a542424eaa85889e239 A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis NCT04410978 CTgov 临床3期 复发性多发性硬化 974 Tolebrutinib(Tolebrutinib 60 mg) Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses = 0.130 relapses per participant year (95%CI, 0.108 ~ 0.156) - 2025-06-18 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT04410978 https://synapse.zhihuiya.com/clinical-result-detail/aa855a8320d22a542424eaa85889e239 A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis NCT04411641 CTgov 临床3期 继发进展型多发性硬化 1131 placebo+tolebrutinib(DB: Placebo) Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS)(Median) = 11.97 Month (Full Range, 0.5 ~ 39.1) - 2025-06-18 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT04411641 https://synapse.zhihuiya.com/clinical-result-detail/888e2aed428e888334e855ae28d4894e A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis NCT04411641 CTgov 临床3期 继发进展型多发性硬化 1131 Tolebrutinib(DB: Tolebrutinib 60 mg) Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS)(Median) = 12.04 Month (Full Range, 2.8 ~ 37.4) - 2025-06-18 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT04411641 https://synapse.zhihuiya.com/clinical-result-detail/888e2aed428e888334e855ae28d4894e A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis NCT04410991 CTgov 临床3期 复发性多发性硬化 899 Teriflunomide(Teriflunomide 14 mg) Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses = 0.109 relapses per participant year (95%CI, 0.088 ~ 0.134) - 2025-06-18 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT04410991 https://synapse.zhihuiya.com/clinical-result-detail/e23e3a42323d22a53223aa0422482855 A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis NCT04410991 CTgov 临床3期 复发性多发性硬化 899 Tolebrutinib(Tolebrutinib 60 mg) Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses = 0.108 relapses per participant year (95%CI, 0.089 ~ 0.131) - 2025-06-18 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT04410991 https://synapse.zhihuiya.com/clinical-result-detail/e23e3a42323d22a53223aa0422482855 Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis NCT04411641 Pubmed 临床3期 继发进展型多发性硬化 1131 Tolebrutinib 60 mg once daily SAE = 15.0 %  积极 2025-05-15 Sanofi 托莱布替尼 https://pubmed.ncbi.nlm.nih.gov/40202696/ | https://doi.org/10.1056/nejmoa2415988 https://synapse.zhihuiya.com/clinical-result-detail/3e22028925a888a52224a2d5d5528253 Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis NCT04411641 Pubmed 临床3期 继发进展型多发性硬化 1131 Placebo SAE = 10.4 %  积极 2025-05-15 Sanofi 托莱布替尼 https://pubmed.ncbi.nlm.nih.gov/40202696/ | https://doi.org/10.1056/nejmoa2415988 https://synapse.zhihuiya.com/clinical-result-detail/3e22028925a888a52224a2d5d5528253 LONG-TERM OUTCOMES IN WALDENSTRÖM MACROGLOBULINEMIA (WM) PATIENTS WHO DISCONTINUE BRUTON'S TYROSINE KINASE INHIBITOR (BTKI) THERAPY - EHA N/A 巨球蛋白血症 153 BTKi Adverse Event: AE = AEs leading to therapy discontinuation were reported in 44% of patients who discontinued 1st BTKi therapy   - 2025-05-14 MD Anderson Cancer Center Orlando - https://library.ehaweb.org/eha/2025/eha2025-congress/4160964/karan.chohan.long-term.outcomes.in.waldenstrm.macroglobulinemia.28wm29.patients.html https://synapse.zhihuiya.com/clinical-result-detail/208240a8e89254aa20a22ee38e22592e LONG-TERM OUTCOMES IN WALDENSTRÖM MACROGLOBULINEMIA (WM) PATIENTS WHO DISCONTINUE BRUTON'S TYROSINE KINASE INHIBITOR (BTKI) THERAPY - EHA N/A 巨球蛋白血症 153 Alternate BTKi-based regimen Adverse Event: AE = AEs leading to therapy discontinuation were reported in 44% of patients who discontinued 1st BTKi therapy   - 2025-05-14 MD Anderson Cancer Center Orlando - https://library.ehaweb.org/eha/2025/eha2025-congress/4160964/karan.chohan.long-term.outcomes.in.waldenstrm.macroglobulinemia.28wm29.patients.html https://synapse.zhihuiya.com/clinical-result-detail/208240a8e89254aa20a22ee38e22592e Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis NCT04410991 | NCT04410978 Pubmed 临床3期 复发性多发性硬化 - Tolebrutinib 60 mg once dailyTolebrutinib 60 mg once dailyTolebrutinib 60 mg once daily ARR(GEMINI 1) = 0.13 Unit  不佳 2025-04-08 Sanofi 托莱布替尼 https://pubmed.ncbi.nlm.nih.gov/40202623/ | https://doi.org/10.1056/nejmoa2415985 https://synapse.zhihuiya.com/clinical-result-detail/ee2e48dd088d98eee2e8e28590d2dd3a Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis NCT04410991 | NCT04410978 Pubmed 临床3期 复发性多发性硬化 - Teriflunomide 14 mg once daily ARR(GEMINI 1) = 0.12 Unit  不佳 2025-04-08 Sanofi 托莱布替尼 https://pubmed.ncbi.nlm.nih.gov/40202623/ | https://doi.org/10.1056/nejmoa2415985 https://synapse.zhihuiya.com/clinical-result-detail/ee2e48dd088d98eee2e8e28590d2dd3a 4392Clinical Outcomes of Lymphoplasmacytic Lymphoma / Waldenstrom Macroglobulinemia (LPL/WM) in the Targeted Therapy Era: A US Multicenter Retrospective Analysis - ASH N/A 淋巴浆细胞性淋巴瘤 | 巨球蛋白血症 - Chemo-immunotherapy (CIT) ORR = 68 %  - 2024-12-09 University of Arkansas for Medical Sciences | The Ohio State University | Hematology/Oncology Associates of Central New York PC | Taussig Cancer Institute | H. Lee Moffitt Cancer Center & Research Institute, Inc. | The Fox Chase Cancer Center | Roswell Park Comprehensive Cancer Center - https://ash.confex.com/ash/2024/webprogram/Paper199278.html https://synapse.zhihuiya.com/clinical-result-detail/e95288a9eeee22482e8d2ee54345ea54 4392Clinical Outcomes of Lymphoplasmacytic Lymphoma / Waldenstrom Macroglobulinemia (LPL/WM) in the Targeted Therapy Era: A US Multicenter Retrospective Analysis - ASH N/A 淋巴浆细胞性淋巴瘤 | 巨球蛋白血症 - Rituximab (R) ORR = 34 %  - 2024-12-09 University of Arkansas for Medical Sciences | The Ohio State University | Hematology/Oncology Associates of Central New York PC | Taussig Cancer Institute | H. Lee Moffitt Cancer Center & Research Institute, Inc. | The Fox Chase Cancer Center | Roswell Park Comprehensive Cancer Center - https://ash.confex.com/ash/2024/webprogram/Paper199278.html https://synapse.zhihuiya.com/clinical-result-detail/e95288a9eeee22482e8d2ee54345ea54 5109Real-World Risk of Major Bleeding Events in BTKi-Treated Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) - ASH N/A 慢性淋巴细胞白血病 | 小淋巴细胞淋巴瘤 - BTKi 大出血 = 6.5 %  - 2024-12-09 AstraZeneca AS | University of Pittsburgh Medical Center | AstraZeneca, Inc. | AstraZeneca PLC 托莱布替尼 https://ash.confex.com/ash/2024/webprogram/Paper198681.html https://synapse.zhihuiya.com/clinical-result-detail/ae2d228884d5da5ad4e4e5ea202205aa 5109Real-World Risk of Major Bleeding Events in BTKi-Treated Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) - ASH N/A 慢性淋巴细胞白血病 | 小淋巴细胞淋巴瘤 - Anticoagulant/Antiplatelet 大出血 = 5.2 %  - 2024-12-09 AstraZeneca AS | University of Pittsburgh Medical Center | AstraZeneca, Inc. | AstraZeneca PLC 托莱布替尼 https://ash.confex.com/ash/2024/webprogram/Paper198681.html https://synapse.zhihuiya.com/clinical-result-detail/ae2d228884d5da5ad4e4e5ea202205aa 5105Real-World Bleeding Risk, Outcomes and Treatment Patterns of Patients with CLL/SLL Receiving BTKi with or without Prescription Anticoagulants or Antiplatelets - ASH N/A 小淋巴细胞淋巴瘤 - BTKi (Ibrutinib) Adverse Event: Bleeding events = A quarter of all pts experienced a non-fatal bleed, resulting in <15% of the pts discontinuing and >50% pts interrupting their BTKi tx   - 2024-12-09 AstraZeneca AS | University of Pittsburgh Medical Center 托莱布替尼 https://ash.confex.com/ash/2024/webprogram/Paper198724.html https://synapse.zhihuiya.com/clinical-result-detail/ae58994a2802282ea9438ea3a3e3558d 5105Real-World Bleeding Risk, Outcomes and Treatment Patterns of Patients with CLL/SLL Receiving BTKi with or without Prescription Anticoagulants or Antiplatelets - ASH N/A 小淋巴细胞淋巴瘤 - Prescription Anticoagulants or Antiplatelets Adverse Event: Bleeding events = A quarter of all pts experienced a non-fatal bleed, resulting in <15% of the pts discontinuing and >50% pts interrupting their BTKi tx   - 2024-12-09 AstraZeneca AS | University of Pittsburgh Medical Center 托莱布替尼 https://ash.confex.com/ash/2024/webprogram/Paper198724.html https://synapse.zhihuiya.com/clinical-result-detail/ae58994a2802282ea9438ea3a3e3558d 1654Real World Treatment Outcomes in the First Line Management of Waldenström Macroglobulinemia from the Global Patient Derived Data Registry, Whimsical - ASH N/A 巨球蛋白血症 - Bendamustine and Rituximab (BR) TTNT = not reached Year  - 2024-12-07 The University of Texas MD Anderson Cancer Center | Cancer Center | Concord Repatriation General Hospital | University College London Hospitals NHS Foundation Trust | Brown University - https://ash.confex.com/ash/2024/webprogram/Paper202820.html https://synapse.zhihuiya.com/clinical-result-detail/902a52ddde822294e850e4222250e34e 1654Real World Treatment Outcomes in the First Line Management of Waldenström Macroglobulinemia from the Global Patient Derived Data Registry, Whimsical - ASH N/A 巨球蛋白血症 - Bruton Tyrosine-Kinase inhibitors (BTKi) TTNT = 8.9 Year  - 2024-12-07 The University of Texas MD Anderson Cancer Center | Cancer Center | Concord Repatriation General Hospital | University College London Hospitals NHS Foundation Trust | Brown University - https://ash.confex.com/ash/2024/webprogram/Paper202820.html https://synapse.zhihuiya.com/clinical-result-detail/902a52ddde822294e850e4222250e34e Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study NCT04410978，NCT04410991 - - 多发性硬化症 1872 Tolebrutinib 复合终点 = 0.12   不佳 2024-09-20 Sanofi 托莱布替尼 https://pipelinereview.com/tolebrutinib-demonstrated-a-31-delay-in-time-to-onset-of-confirmed-disability-progression-in-non-relapsing-secondary-progressive-multiple-sclerosis-phase-3-study/ https://synapse.zhihuiya.com/clinical-result-detail/0a2da8292ed452e4835202e5552a38e2 Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study NCT04410978，NCT04410991 - - 多发性硬化症 1872 特立氟胺 复合终点 = 0.12   不佳 2024-09-20 Sanofi 托莱布替尼 https://pipelinereview.com/tolebrutinib-demonstrated-a-31-delay-in-time-to-onset-of-confirmed-disability-progression-in-non-relapsing-secondary-progressive-multiple-sclerosis-phase-3-study/ https://synapse.zhihuiya.com/clinical-result-detail/0a2da8292ed452e4835202e5552a38e2 CLL-495 Treatment Characteristics and Outcomes of Patients With Chronic/Small Lymphocytic Leukemia (CLL) Treated With Venetoclax and Bruton Tyrosine Kinase Inhibitor (BTKi) Combination Therapies - SOHO N/A 慢性淋巴细胞白血病 - Venetoclax+BTKi ORR = 90.4 %  - 2024-09-04 Analysis Group, Inc. | Nottingham University Hospitals Nhs Trust | AbbVie, Inc. 维奈克拉 https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(24)01287-4/fulltext https://synapse.zhihuiya.com/clinical-result-detail/ee229de282da3052eee92e5a5e52a248 CLL-495 Treatment Characteristics and Outcomes of Patients With Chronic/Small Lymphocytic Leukemia (CLL) Treated With Venetoclax and Bruton Tyrosine Kinase Inhibitor (BTKi) Combination Therapies - SOHO N/A 慢性淋巴细胞白血病 - Venetoclax+ibrutinib-based ORR = 94.9 %  - 2024-09-04 Analysis Group, Inc. | Nottingham University Hospitals Nhs Trust | AbbVie, Inc. 维奈克拉 https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(24)01287-4/fulltext https://synapse.zhihuiya.com/clinical-result-detail/ee229de282da3052eee92e5a5e52a248 Sanofi’s investigational BTK inhibitor tolebrutinib shows promise in phase 3 MS study NCT04411641 NEWS 临床3期 继发进展型多发性硬化 - Tolebrutinib CDP: HR = 0.69(95% CI, 0.55 ~ 0.88), P-Value = 0.0026 达到 积极 2024-09-02 Sanofi 托莱布替尼 https://pmlive.com/pharma_news/sanofis-investigational-btk-inhibitor-tolebrutinib-shows-promise-in-phase-3-ms-study/ https://synapse.zhihuiya.com/clinical-result-detail/8a8e5245402e280e3a52053a35dd55d2 Sanofi’s investigational BTK inhibitor tolebrutinib shows promise in phase 3 MS study NCT04411641 NEWS 临床3期 继发进展型多发性硬化 - placebo CDP: HR = 0.69(95% CI, 0.55 ~ 0.88), P-Value = 0.0026 达到 积极 2024-09-02 Sanofi 托莱布替尼 https://pmlive.com/pharma_news/sanofis-investigational-btk-inhibitor-tolebrutinib-shows-promise-in-phase-3-ms-study/ https://synapse.zhihuiya.com/clinical-result-detail/8a8e5245402e280e3a52053a35dd55d2 Real-world risk of bleeding events in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) treated with BTKi. - ASCO N/A 慢性淋巴细胞白血病 2091 Ibrutinib 出血 = 26.6 %  积极 2024-05-24 AstraZeneca PLC 托莱布替尼 https://meetings.asco.org/abstracts-presentations/239180 https://synapse.zhihuiya.com/clinical-result-detail/5d02988ea5382a850202d22ae4052d45 Real-world risk of bleeding events in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) treated with BTKi. - ASCO N/A 慢性淋巴细胞白血病 2091 Acalabrutinib 出血 = 26.6 %  积极 2024-05-24 AstraZeneca PLC 托莱布替尼 https://meetings.asco.org/abstracts-presentations/239180 https://synapse.zhihuiya.com/clinical-result-detail/5d02988ea5382a850202d22ae4052d45 REAL-WORLD FIRST LINE CHRONIC LYMPHOCYTIC LEUKEMIA TREATMENT IN GERMANY IN THE ERA OF TARGETED AGENTS - EHA N/A 慢性淋巴细胞白血病 481 BTKi-based treatment Aberration of TP53 = 29% %  - 2024-05-14 - - https://library.ehaweb.org/eha/2024/eha2024-congress/419932/zuzana.dostalova.real-world.first.line.chronic.lymphocytic.leukemia.treatment.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2552%2Aot_id%3D29194%2Amarker%3D5100%2Afeatured%3D18527 https://synapse.zhihuiya.com/clinical-result-detail/0588589a22a92455a42e222a205e5852 REAL-WORLD FIRST LINE CHRONIC LYMPHOCYTIC LEUKEMIA TREATMENT IN GERMANY IN THE ERA OF TARGETED AGENTS - EHA N/A 慢性淋巴细胞白血病 481 VEN-based treatment Aberration of TP53 = 29% %  - 2024-05-14 - - https://library.ehaweb.org/eha/2024/eha2024-congress/419932/zuzana.dostalova.real-world.first.line.chronic.lymphocytic.leukemia.treatment.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2552%2Aot_id%3D29194%2Amarker%3D5100%2Afeatured%3D18527 https://synapse.zhihuiya.com/clinical-result-detail/0588589a22a92455a42e222a205e5852 TIME TO NEXT TREATMENT AFTER FIRST-LINE TREATMENT WITH TIME-LIMITED TARGETED AGENTS: A POOLED ANALYSIS OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TREATED WITHIN CLINICAL TRIALS OF THE GCLLSG - EHA N/A 慢性淋巴细胞白血病 - anti-CD20+BCL2i-based regimen Median TTNT = not reached Month  积极 2024-05-14 - - https://library.ehaweb.org/eha/2024/eha2024-congress/420722/nadine.kutsch.time.to.next.treatment.after.first-line.treatment.with.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2552%2Aot_id%3D29194%2Amarker%3D5101%2Afeatured%3D18527 https://synapse.zhihuiya.com/clinical-result-detail/29820558a2d5e255ea02a5aa5582a5a9 TIME TO NEXT TREATMENT AFTER FIRST-LINE TREATMENT WITH TIME-LIMITED TARGETED AGENTS: A POOLED ANALYSIS OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TREATED WITHIN CLINICAL TRIALS OF THE GCLLSG - EHA N/A 慢性淋巴细胞白血病 - anti-CD20+BTKi-based regimen Median TTNT = not reached Month  积极 2024-05-14 - - https://library.ehaweb.org/eha/2024/eha2024-congress/420722/nadine.kutsch.time.to.next.treatment.after.first-line.treatment.with.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2552%2Aot_id%3D29194%2Amarker%3D5101%2Afeatured%3D18527 https://synapse.zhihuiya.com/clinical-result-detail/29820558a2d5e255ea02a5aa5582a5a9 A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG) NCT05132569 CTgov 临床3期 重症肌无力 6 placebo+tolebrutinib(DB Period: Placebo) DB Period: Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 12(Mean) = -2.0 Point  - 2024-04-08 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT05132569 https://synapse.zhihuiya.com/clinical-result-detail/99aa223ad23aa2ea942de2dade2e09d2 A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG) NCT05132569 CTgov 临床3期 重症肌无力 6 Tolebrutinib(DB Period: Tolebrutinib) DB Period: Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 12(Mean) = -1.7 Point  - 2024-04-08 Sanofi 托莱布替尼 https://clinicaltrials.gov/ct2/show/results/NCT05132569 https://synapse.zhihuiya.com/clinical-result-detail/99aa223ad23aa2ea942de2dade2e09d2 4644  Outcomes and Treatment Sequences of Therapies with BCL2- and BTK Inhibitors in Chronic Lymphocytic Leukemia (CLL): An Analysis of Patient Data within the German CLL Study Group (GCLLSG) Registry - ASH N/A 慢性淋巴细胞白血病 - Venetoclax-based regimen mEFS = 31.8 Month  - 2023-12-11 - - https://ash.confex.com/ash/2023/webprogram/Paper185741.html https://synapse.zhihuiya.com/clinical-result-detail/2d85825de834832ed0d544455aa28a32 4644  Outcomes and Treatment Sequences of Therapies with BCL2- and BTK Inhibitors in Chronic Lymphocytic Leukemia (CLL): An Analysis of Patient Data within the German CLL Study Group (GCLLSG) Registry - ASH N/A 慢性淋巴细胞白血病 - BTKi-based regimen mEFS = 23.2 Month  - 2023-12-11 - - https://ash.confex.com/ash/2023/webprogram/Paper185741.html https://synapse.zhihuiya.com/clinical-result-detail/2d85825de834832ed0d544455aa28a32 3276  Clinical Outcomes with Venetoclax-Based Treatment Regimens in Patients with Chronic Lymphocytic Leukemia (CLL) - ASH N/A 慢性淋巴细胞白血病 155 First-line therapy with venetoclax + obinutuzumab mOS = 54.6 Month  - 2023-12-10 Mayo Clinic 维奈克拉 https://ash.confex.com/ash/2023/webprogram/Paper183007.html https://synapse.zhihuiya.com/clinical-result-detail/20aee328ae580a2a23a890d2425ed528 3276  Clinical Outcomes with Venetoclax-Based Treatment Regimens in Patients with Chronic Lymphocytic Leukemia (CLL) - ASH N/A 慢性淋巴细胞白血病 155 Relapsed/BTKi-naïve venetoclax-treated patients Median TFS = 26.9 Month  - 2023-12-10 Mayo Clinic 维奈克拉 https://ash.confex.com/ash/2023/webprogram/Paper183007.html https://synapse.zhihuiya.com/clinical-result-detail/20aee328ae580a2a23a890d2425ed528 1678  Impact of the Current Treatments on the Survival of Patients with Mantle Cell Lymphoma (MCL): A Real-Life Study on Behalf of the Spanish Group of Lymphoma (GELTAMO) - ASH N/A 套细胞淋巴瘤 505 HiDAC (high-dose cytarabine or HiDAC-based) CR = 78.4 %  - 2023-12-09 - - https://ash.confex.com/ash/2023/webprogram/Paper186101.html https://synapse.zhihuiya.com/clinical-result-detail/a5ad0eda59489822898a2a80ae225a45 1678  Impact of the Current Treatments on the Survival of Patients with Mantle Cell Lymphoma (MCL): A Real-Life Study on Behalf of the Spanish Group of Lymphoma (GELTAMO) - ASH N/A 套细胞淋巴瘤 505 BTKi (BTK inhibitors) CR/CRh = 60.8 %  - 2023-12-09 - - https://ash.confex.com/ash/2023/webprogram/Paper186101.html https://synapse.zhihuiya.com/clinical-result-detail/a5ad0eda59489822898a2a80ae225a45 1907  Comparison of Venetoclax Based Treatments for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia - ASH N/A 慢性淋巴细胞白血病 98 Venetoclax monotherapy MRD = 66.7 %  - 2023-12-09 - 维奈克拉 https://ash.confex.com/ash/2023/webprogram/Paper188129.html https://synapse.zhihuiya.com/clinical-result-detail/22d2028849855a534e3e922e9282828e 1907  Comparison of Venetoclax Based Treatments for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia - ASH N/A 慢性淋巴细胞白血病 98 Venetoclax + rituximab MRD = 82.4 %  - 2023-12-09 - 维奈克拉 https://ash.confex.com/ash/2023/webprogram/Paper188129.html https://synapse.zhihuiya.com/clinical-result-detail/22d2028849855a534e3e922e9282828e MRI Outcomes from the Long-term Extension Study of Tolebrutinib in Participants with Relapsing Multiple Sclerosis: 3-Year Results NCT03996291 ECTRIMS 临床2期 复发性多发性硬化 125 5/60 mg New Gd-enhancing T1 lesions = 0.5 count  - 2023-09-30 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/epub/10.1177/13524585231196194 https://synapse.zhihuiya.com/clinical-result-detail/28229353ead20de54e550ad805d24a52 MRI Outcomes from the Long-term Extension Study of Tolebrutinib in Participants with Relapsing Multiple Sclerosis: 3-Year Results NCT03996291 ECTRIMS 临床2期 复发性多发性硬化 125 15/60 mg New Gd-enhancing T1 lesions = 0.48 count  - 2023-09-30 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/epub/10.1177/13524585231196194 https://synapse.zhihuiya.com/clinical-result-detail/28229353ead20de54e550ad805d24a52 Baseline Characteristics in the Tolebrutinib Phase 3 Non-Relapsing Secondary Progressive Multiple Sclerosis (nrSPMS) HERCULES Clinical Trial NCT04411641 ECTRIMS 临床3期 继发进展型多发性硬化 - Tolebrutinib 60 mg T2 lesion volume = 18.8 cm3 (mean±SD, 14.4) - 2023-09-30 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/epub/10.1177/13524585231196195 https://synapse.zhihuiya.com/clinical-result-detail/e0204828248a85582aae98583a5a45a8 Baseline Characteristics in theTolebrutinib Phase 3 Relapsing MultipleSclerosis GEMINI 1 and 2 Trials NCT04410978 | NCT04410991 EAN 临床3期 复发性多发性硬化 - Tolebrutinib 60 mg Time since diagnosis = 4.7 Year  积极 2023-06-28 Sanofi 托莱布替尼 https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.15950 https://synapse.zhihuiya.com/clinical-result-detail/8422e4a8e55e8232a22a22eedad82a29 Baseline Characteristics in theTolebrutinib Phase 3 Relapsing MultipleSclerosis GEMINI 1 and 2 Trials NCT04410978 | NCT04410991 EAN 临床3期 复发性多发性硬化 - Teriflunomide 14 mg Time since diagnosis = 3.8 Year  积极 2023-06-28 Sanofi 托莱布替尼 https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.15950 https://synapse.zhihuiya.com/clinical-result-detail/8422e4a8e55e8232a22a22eedad82a29 HARNESSING BTKI THERAPY BY CDK4/6I CONTROL OF T CELL SURVEILLANCE - ICML 临床1期 - 27 Palbociclib CR rate = 42 %  积极 2023-06-09 Weill Cornell Medicine 托莱布替尼 https://onlinelibrary.wiley.com/doi/10.1002/hon.3163_120 https://synapse.zhihuiya.com/clinical-result-detail/ee22d38228a528e485a55e8ea59a8da8 REAL-WORLD TREATMENT AND OUTCOMES OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING FIRST-LINE (1L) THERAPY IN THE NOVEL AGENT ERA: AN INTERNATIONAL STUDY - EHA N/A - - Anti-CD20 monotherapy mPFS = 23 Month  - 2023-06-08 - - - https://synapse.zhihuiya.com/clinical-result-detail/8842e52d8eedde0502e9a28d8e540e03 REAL-WORLD TREATMENT AND OUTCOMES OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING FIRST-LINE (1L) THERAPY IN THE NOVEL AGENT ERA: AN INTERNATIONAL STUDY - EHA N/A - - BTKi-based therapy mPFS = 51 Month  - 2023-06-08 - - - https://synapse.zhihuiya.com/clinical-result-detail/8842e52d8eedde0502e9a28d8e540e03 Safety and Clinical Efficacy Outcomes From the Long-term Extension Study of Tolebrutinib in Participants With Relapsing Multiple Sclerosis: 2.5-Year Results (S16.010) NCT03889639 AAN 临床2期 复发性多发性硬化 107 Tolebrutinib 60 mg/day Adverse Event: COVID-19 = 24.8% [31/125]   积极 2023-04-25 Sanofi 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.0000000000202287 https://synapse.zhihuiya.com/clinical-result-detail/80e020050a3e882323ea35d45d2de228 Comparative CNS Pharmacology of Tolebrutinib Versus Other BTK Inhibitor Candidates for Treating MS (S46.007) - AAN 临床3期 多发性硬化症 - Tolebrutinib CSF exposure = 4.8 ng/mL (kp, uu CSF, 0.40) 积极 2023-04-25 TMed Holdings, Inc. | Neurology First | Bcb Ltd 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.0000000000203897 https://synapse.zhihuiya.com/clinical-result-detail/929ea348544e555a3a2982e4a2492285 Comparative CNS Pharmacology of Tolebrutinib Versus Other BTK Inhibitor Candidates for Treating MS (S46.007) - AAN 临床3期 多发性硬化症 - Evobrutinib CSF exposure = 3.2 ng/mL (kp, uu CSF, 0.13) 积极 2023-04-25 TMed Holdings, Inc. | Neurology First | Bcb Ltd 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.0000000000203897 https://synapse.zhihuiya.com/clinical-result-detail/929ea348544e555a3a2982e4a2492285 MRI, Efficacy, and Safety of Tolebrutinib in Patients with Highly Active Disease (HAD): 2-Year Data from the Phase 2b Long-term Safety (LTS) Study (P6-3.017) NCT03889639 AAN 临床2期 - 61 Tolebrutinib 60mg Adverse Event: TEAEs = Most common treatment-emergent adverse events (TEAEs) were COVID-19, nasopharyngitis, headache, and upper respiratory tract infection   - 2023-04-25 Sanofi 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.0000000000202143 https://synapse.zhihuiya.com/clinical-result-detail/40929aad5a23ea95558220e2a39ee5de MRI outcomes from the long-term extension study of tolebrutinib in patients with relapsing multiple sclerosis: 2-year results NCT03889639 ECTRIMS 临床2期 复发性多发性硬化 125 Tolebrutinib 5 mg/day T2 lesion volume change = 0.38 cm3  积极 2022-10-12 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/epub/10.1177/13524585221123687 https://synapse.zhihuiya.com/clinical-result-detail/932de853229ae0a5389d3e88e9a4a552 MRI, efficacy, and safety of tolebrutinib in patients with highly active disease (HAD): 2-year data from the phase 2b Long-term safety (LTS) Study NCT03889639 ECTRIMS 临床2期 - 61 Tolebrutinib 60 mg/day Adverse Event: COVID-19 = 20%   - 2022-10-12 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/epub/10.1177/13524585221123687 https://synapse.zhihuiya.com/clinical-result-detail/983dd55498e29ae32d08a5a2ea909583 CLL-461 Humoral Response to COVID-19 Vaccine: A Challenge in CLL - SOHO N/A 新型冠状病毒感染 | 慢性淋巴细胞白血病 - Patients on active therapy SCR = 20.5 %  - 2022-10-01 Laboratories at Bonfils Clinical Laboratory, Inc. - https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(22)01348-9/fulltext https://synapse.zhihuiya.com/clinical-result-detail/aad82980a92e2d02e828d8d2959e5ee2 CLL-461 Humoral Response to COVID-19 Vaccine: A Challenge in CLL - SOHO N/A 新型冠状病毒感染 | 慢性淋巴细胞白血病 - BTKi treatment Antibody response rate = 19.7 %  - 2022-10-01 Laboratories at Bonfils Clinical Laboratory, Inc. - https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(22)01348-9/fulltext https://synapse.zhihuiya.com/clinical-result-detail/aad82980a92e2d02e828d8d2959e5ee2 CLL-105 Cumulative Incidence of Grade 3 or Higher Infections in Patients With CLL/SLL Treated With BTKi-Based Regimens - SOHO N/A 小淋巴细胞淋巴瘤 - BTKi-based regimens Grade 3 or higher infections = 19.86 % ( 16.03 ~ 23.98) - 2022-10-01 - 伊布替尼 | 阿可替尼 | 泽布替尼 https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(22)01321-0/fulltext https://synapse.zhihuiya.com/clinical-result-detail/d558930482d2a934a802255322405292 CLL-105 Cumulative Incidence of Grade 3 or Higher Infections in Patients With CLL/SLL Treated With BTKi-Based Regimens - SOHO N/A 小淋巴细胞淋巴瘤 - Monotherapy with BTKi Grade 3 or higher infections = 20.7 % ( 16.48 ~ 25.26) - 2022-10-01 - 伊布替尼 | 阿可替尼 | 泽布替尼 https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(22)01321-0/fulltext https://synapse.zhihuiya.com/clinical-result-detail/d558930482d2a934a802255322405292 Characteristics and Outcomes of COVID-19 Cases from the Long-term Extension Study of Tolebrutinib in Patients with Relapsing MS NCT03996291 ACTRIMS 临床2期 新型冠状病毒感染 | 复发性多发性硬化 130 Tolebrutinib Adverse Event: COVID-19 cases = COVID-19 cases were mild (n=11) or moderate (n=9). Three of the moderate COVID-19 cases were considered serious, of which 2 were hospitalized (female aged 55 years and male aged 57 years). All patients recovered (one patient was still recovering at cut-off), and all patients remained in the study. Tolebrutinib was interrupted temporarily in 4 patients while the remaining 16 patients continued tolebrutinib uninterrupted during their infection. Only 1 fully vaccinated patient (female, aged 56 years; vaccinated with BNT162b2) contracted COVID-19.   积极 2022-05-16 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/full/10.1177/13524585221094745 https://synapse.zhihuiya.com/clinical-result-detail/e828a5d9220aa228ee2282e5853955a9 MRI, Safety, and Efficacy Outcomes in Patients with Relapsing MS: 18-month Results from the Long-term Extension Study of Tolebrutinib NCT03889639 ACTRIMS 临床2期 复发性多发性硬化 129 Tolebrutinib 5 mg/day Adverse Event: COVID-19 = 12.8% [16/125]   积极 2022-05-16 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/full/10.1177/13524585221094745 https://synapse.zhihuiya.com/clinical-result-detail/28a5e9d022a2e00442d309e08e485858 MRI, Safety, and Efficacy Outcomes in Patients with Relapsing MS: 18-month Results from the Long-term Extension Study of Tolebrutinib NCT03889639 ACTRIMS 临床2期 复发性多发性硬化 129 Tolebrutinib 15 mg/day Adverse Event: COVID-19 = 12.8% [16/125]   积极 2022-05-16 Sanofi 托莱布替尼 https://journals.sagepub.com/doi/full/10.1177/13524585221094745 https://synapse.zhihuiya.com/clinical-result-detail/28a5e9d022a2e00442d309e08e485858 TREATMENT SEQUENCES AND OUTCOMES OF PATIENTS WITH CLL TREATED WITH TARGETED AGENTS IN REAL-WORLD SETTINGS - EHA N/A 慢性淋巴细胞白血病 - 1L CT/CIT 1L tx use = 48.8 %  - 2022-05-12 Analysis Group, Inc. | Nottingham University Hospitals Nhs Trust | AbbVie, Inc. - https://library.ehaweb.org/eha/2022/eha2022-congress/357533/anthony.r.mato.treatment.sequences.and.outcomes.of.patients.with.cll.treated.html https://synapse.zhihuiya.com/clinical-result-detail/4e0a52e2ed453a28d2a3520e0a40a355 TREATMENT SEQUENCES AND OUTCOMES OF PATIENTS WITH CLL TREATED WITH TARGETED AGENTS IN REAL-WORLD SETTINGS - EHA N/A 慢性淋巴细胞白血病 - 1L targeted agent 1L tx use = 40.6 %  - 2022-05-12 Analysis Group, Inc. | Nottingham University Hospitals Nhs Trust | AbbVie, Inc. - https://library.ehaweb.org/eha/2022/eha2022-congress/357533/anthony.r.mato.treatment.sequences.and.outcomes.of.patients.with.cll.treated.html https://synapse.zhihuiya.com/clinical-result-detail/4e0a52e2ed453a28d2a3520e0a40a355 MRI Outcomes from the Long-term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis: 18-Month Results (P1-1.Virtual) NCT03996291 AAN 临床2期 复发性多发性硬化 125 Tolebrutinib 5 mg SEL volume = 441 mm^3 ( 69 ~ 630) 积极 2022-05-03 Sanofi 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.98.18_supplement.2577 https://synapse.zhihuiya.com/clinical-result-detail/52905d302a222e982a83223e5e505ee3 MRI Outcomes from the Long-term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis: 18-Month Results (P1-1.Virtual) NCT03996291 AAN 临床2期 复发性多发性硬化 125 Tolebrutinib 15 mg SEL volume = 468 mm^3 ( 102 ~ 1317) 积极 2022-05-03 Sanofi 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.98.18_supplement.2577 https://synapse.zhihuiya.com/clinical-result-detail/52905d302a222e982a83223e5e505ee3 New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021  NCT03996291 GlobeNewswire 临床2期 多发性硬化症 125 Tolebrutinib ARR(treated with 60mg) = 0.17 Point (95%CI, 0.10 ~ 0.29) 积极 2021-10-13 Sanofi 托莱布替尼 https://www.globenewswire.com/news-release/2021/10/13/2313117/0/en/New-long-term-data-reinforcing-promising-safety-and-efficacy-profile-of-brain-penetrant-tolebrutinib-presented-at-ECTRIMS-2021.html https://synapse.zhihuiya.com/clinical-result-detail/23ee208333242e22285252e0458305e4 MCL-041: Outcomes for Recurrent Mantle Cell Lymphoma Post-BTK Inhibitor Therapy in Japan: An Administrative Database Study - SOHO N/A 复发性套细胞淋巴瘤 - Post-BTKi Therapy Adverse Event: anti-infectives = 52% vs 32%   - 2021-09-01 Eli Lilly & Co. | Kindai University Faculty of Medicine | Eli Lilly Japan KK - https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(21)01918-2/fulltext https://synapse.zhihuiya.com/clinical-result-detail/8e0de82888a05882a55ed2a3e34e5852 Efficacy and Safety of Tolebrutinib in Patients With Highly Active Relapsing MS: Subgroup Analysis of the Phase 2b Study (2260) NCT03889639 AAN 临床2期 复发性多发性硬化 130 Tolebrutinib 5 mg New Gd-enhancing lesions = 0.82 Lesion  - 2021-04-13 Sanofi 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.96.15_supplement.2260 https://synapse.zhihuiya.com/clinical-result-detail/2503e0328aee0352254a89adae90d898 Efficacy and Safety of Tolebrutinib in Patients With Highly Active Relapsing MS: Subgroup Analysis of the Phase 2b Study (2260) NCT03889639 AAN 临床2期 复发性多发性硬化 130 Tolebrutinib 15 mg New Gd-enhancing lesions = 0.5 Lesion  - 2021-04-13 Sanofi 托莱布替尼 https://www.neurology.org/doi/full/10.1212/WNL.96.15_supplement.2260 https://synapse.zhihuiya.com/clinical-result-detail/2503e0328aee0352254a89adae90d898 Efficacy and safety outcomes in patientswith relapsing forms of MS treatedwith the CNS-Penetrating BTK inhibitorSAR442168: results from thephase 2b trial NCT03889639 EAN 临床2期 复发-缓解型多发性硬化 130 SAR442168 5mg Time since MS diagnosis = 5.6 Year  - 2020-05-22 Sanofi 托莱布替尼 https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.14306 https://synapse.zhihuiya.com/clinical-result-detail/e2ade43e28d985025034e8044a222da5 Efficacy and safety outcomes in patientswith relapsing forms of MS treatedwith the CNS-Penetrating BTK inhibitorSAR442168: results from thephase 2b trial NCT03889639 EAN 临床2期 复发-缓解型多发性硬化 130 SAR442168 15mg Time since MS diagnosis = 5.6 Year  - 2020-05-22 Sanofi 托莱布替尼 https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.14306 https://synapse.zhihuiya.com/clinical-result-detail/e2ade43e28d985025034e8044a222da5