2026-05-06_库莫西利一线乳腺癌获批
- 来源: 公告/披露原始TXT转换
- 日期: 2026-05-06
- 涉及公司: 中国生物制药
- 涉及主题: 2026-05-06 库莫西利一线乳腺癌获批
- 一句话摘要: 由同目录 TXT/HTML 原始文件转换生成的 Markdown 主阅读版,原始文件保留作备份;具体内容以正文为准。
- 来源文件:
sources/filings/中国生物制药/2026-05-06_库莫西利一线乳腺癌获批.txt - 转换日期: 2026-05-12
- 类型: TXT/HTML 转 Markdown 主阅读版
- 说明: 本文件由同目录 TXT/HTML 轻量转换生成;原始文件保留作备份。
1
ҁ
፠༈ഃʫ
ዄОபf
ʮ̡
ၣ१jwww.sbpgroup.com
΅ᇜj1177
Іᗴʮѓ
Глᇭᚾ CDK2/4/6ᐕԪ໗ᐖอቇᏐसᐏҭɪ̹
ʮ̡ ͉ʮ̡᙮ʮ̡୕၈ ͉ණྠ ԫึ ԫึбd͉ණ
ʮ̡ ͍ɽ˂౹1Глᇭᚾ
CDK2/4/6ؚ®္ຖ၍ଣ҅(NMPA)ݯ
ዧ९ա (HR)Ϊɿա 2 (HER2)٫
ୋ2 ධቇᏐसf
CULMINATE-2ࡈCDK2/4/6ҵՓኒᑌΥ
HR+/HER2-2025໕
ኪึ(ESMO)ࠅLBA)ϣʮ̺ [1]j
• ͛πಂ(mPFS)މNR ͊༺Ց
vs. 20.2Э44% HR=0.56d p=0.0004ᝈᇠ༆ଟ(ORR)ܵ
ග(DOR)ࣩ
ٙPFSᐏूf
2
• ᗫʔԄԫ (TRAEs)މ1-2၍ଣi ≥3ߤ
೯͛ଟස 20.3%ᐕ˟ˢԷස 3.5%̙છ˲
၍ଣf
໕ᆯfՉʕdHR+/HER2-ԭ
ٙ65%-70% [2] f ʕᑗґ໕ᆯኪึ(CSCO)2025 ഃ ᛆ
પᑥCDK4/6މHR+/HER2-ࣩ[3,4] f್Ͼdʥ
Ϟ30%-40%ᖹ [5]f
ٙCDK2/4/6ҵՓኒdஷཀ੶ʷ࿁CDK2 ձCDK4Э࿁
CDK6͟CDK2ၾ
̻ፅ [6]f
ٙ࢝HR+/HER2-Ԫ໗ᐖቇᏐसdʊ
2025ϋ 12˜ᐏNMPAॶɝ CSCO2026
HR+/HER2-ٙIII ಂᑗґ༊᜕͍ίආ
ع
ᐕ፯f
Ը๕j
[1] Erwei song, et al. Culmerciclib plus fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer cancer: A
phase 3 trial (CULMINATE-2), ESMO 2025 LBA25.
[2] ڡ.Бषኪᒈැʿԣછ઼ͪj2018–2022జѓ ༆ᛘ[J]. ʕ౷̮ਿ
ᓾၾᑗґᕏႦd2024, 31(07): 796-802.
[3] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline). Breast
Cancer, version 5. 2023[EB/OL]. [2024-01-12].
[4] ึdᇜഹ. یܸ2025[M]. ٟو.
[5] Abu-Khalaf, M.M., Alex Hodge, K., Hatzis, C. et al. AKT/mTOR signaling modulates resistance to endocrine therapy
and CDK4/6 inhibition in metastatic breast cancers. npj Precis. Onc. 7, 18 (2023).
3
[6] Xu Z, Liu Y, Song B, et al. Discovery and preclinical evaluations of TQB3616, a novel CDK4-biased inhibitor.
Bioorganic & Medicinal Chemistry Letters 2024; 107.
ԫึն
ʮ̡
ࢩ
ᑽՉᆗ
ಥdɚཧɚʬϋʞ˜ʬ˚
ᆗ
ɾ
ɻeੵኁ˃͛ʿҽಊᔼ͛f