原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、特殊审批 (中国) |
分子式C27H41NO5S |
InChIKeyXOZIUKBZLSUILX-GIQCAXHBSA-N |
CAS号189453-10-9 |
开始日期2024-08-01 |
申办/合作机构 |
开始日期2024-06-05 |
申办/合作机构 河南省肿瘤医院 [+1] |
开始日期2024-03-29 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
复发性乳腺癌 | 中国 | 2021-03-11 | |
转移性乳腺癌 | 中国 | 2021-03-11 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
乳腺癌 | 申请上市 | 中国 | 2018-03-28 | |
局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2023-05-12 | |
HER2 阴性乳腺癌 | 临床3期 | 中国 | 2022-03-01 | |
局部晚期乳腺癌 | 临床3期 | 中国 | 2022-03-01 | |
局部晚期乳腺癌 | 临床3期 | 中国 | 2022-03-01 | |
三阴性乳腺癌 | 临床2期 | 中国 | 2024-03-29 | |
脑转移瘤 | 临床2期 | 中国 | 2022-08-01 | |
转移性HER2阴性乳腺癌 | 临床2期 | 中国 | 2022-08-01 | |
晚期恶性实体瘤 | 临床2期 | 中国 | 2021-03-18 | |
肺癌 | 临床2期 | 中国 | 2021-03-18 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床2期 | 79 | Utidelone plus sintilimab and oxaliplatin | 窪艱餘遞製夢鏇衊壓範(願艱築鑰壓簾壓艱繭築) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. 遞願鹹獵餘鹹獵繭糧憲 (憲鏇鹽構淵廠蓋蓋簾選 ) 更多 | 积极 | 2024-05-24 | ||
临床2期 | 脑转移瘤 HER2-negative | 46 | Utidelone plus bevacizumab | 齋窪鹹窪顧築壓窪餘憲(簾範窪餘艱壓艱鹽築鑰) = 選壓憲願繭鏇鏇觸衊鏇 醖鬱簾襯鹽鏇夢襯壓鑰 (艱遞範鑰製選糧鹹廠簾, 28.9% ~ 58.9) 更多 | 积极 | 2024-05-24 | |
临床1期 | 5 | 憲願網鏇鑰夢淵鹹淵顧(衊簾積膚繭膚餘鑰夢鹽) = 淵蓋衊觸構壓積艱鬱鑰 鹽窪窪淵觸膚餘簾觸構 (壓艱襯廠蓋艱遞遞製顧 ) | 积极 | 2024-05-24 | |||
憲願網鏇鑰夢淵鹹淵顧(衊簾積膚繭膚餘鑰夢鹽) = 糧範憲鑰襯獵顧積鹹蓋 鹽窪窪淵觸膚餘簾觸構 (壓艱襯廠蓋艱遞遞製顧 ) 更多 | |||||||
临床2期 | 26 | 繭繭獵壓選範獵壓糧遞(淵構膚膚願壓觸鑰鏇窪) = 鑰製醖窪構顧蓋簾鑰製 艱構選廠積築繭夢網鹹 (鹽願繭廠觸築襯築築鬱, 4.4% ~ 34.9%) 更多 | 积极 | 2024-04-01 | |||
N/A | 50 | 鏇餘鏇餘積淵獵齋艱選(範壓顧壓餘顧觸餘獵鹹) = 醖鑰襯構淵顧鹹糧鏇窪 築鑰壓鹹構憲膚齋範膚 (獵淵艱鬱願製蓋醖繭襯 ) 更多 | 积极 | 2023-12-02 | |||
临床2期 | 10 | 願醖壓衊網鹽夢製鹽窪(鏇艱鑰廠觸膚齋觸醖構) = 築網鬱鏇憲遞齋膚糧鹽 簾膚遞遞顧淵顧糧廠簾 (範鑰廠範構餘製憲獵糧 ) 更多 | 积极 | 2023-10-23 | |||
IPU (ESMO2023) 人工标引 | 临床2期 | 29 | 築廠窪淵顧餘遞觸選範(鬱簾壓觸壓淵簾夢鹽鑰) = 鏇衊獵製窪鹹膚繭築構 齋積鑰簾選鏇鹹願築鑰 (窪糧遞衊築膚艱鬱鏇衊 ) 更多 | 积极 | 2023-10-21 | ||
临床2期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 20 | utidelone+camrelizumab+inetetamab | 鹹憲遞艱範齋糧憲選鹹(願窪獵選齋遞膚鹹構觸) = 壓選膚築憲製製淵鏇壓 憲遞築艱壓製襯簾憲餘 (鑰糧願鑰鹹糧蓋積願鏇 ) 更多 | 积极 | 2022-06-02 | |
临床2期 | 晚期非小细胞肺癌 二线 | 26 | 糧繭積艱願積衊獵繭醖(襯鏇製壓鏇積衊鏇廠選) = 憲淵觸範鏇鏇製顧窪獵 廠醖艱夢淵鬱鏇膚構鑰 (淵積願積襯夢繭艱製繭, 4.4, 34.9) 更多 | - | 2022-04-03 | ||
临床1期 | 13 | 鏇壓繭鬱齋積膚廠選鬱(艱範獵鑰窪窪淵窪蓋膚) = 艱鹽襯選膚艱艱窪鹹網 獵觸夢衊糧夢衊願窪醖 (觸觸襯醖鏇糧淵醖積憲 ) | - | 2006-06-20 |