Drugs / Culmerciclib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | progesterone-receptor positive breast cancer | 2024-07-18 | “7月18日，正大天晴自主研发的1类创新药库莫西利胶囊（Culmerciclib，TQB3616）联合氟维司群注射液（商标名：晴可依），已向国家药监局药品审评中心（CDE）递交新药上市申请并获受理” cttq.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07796880 | Sep 2026 → Sep 2028 expected | hormone receptor-positive breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07795424 | Sep 2026 → Mar 2028 expected | HER2 positive breast carcinoma | Shengjing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07666555 | Jun 2026 → Jun 2028 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07616453 | May 2026 → May 2028 expected | hormone receptor-positive breast cancer | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-06 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 库莫西利一线治疗乳腺癌获批上市！中国生物制药推动CDK治疗迈入新阶段 cttq.com ↗
5月6日，国家药品监督管理局（NMPA）官网显示，中国生物制药（1177.HK）核心企业正大天晴自主研发的库莫西利胶囊（赛坦欣®）第2个适应症获批上市，联合氟维司群用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或转移性乳腺癌患者的初始内分泌治疗。 |
| 2025-12-12 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 全球首个！CDK2/4/6抑制剂库莫西利（赛坦欣®）获批上市，重塑乳腺癌治疗格局 cttq.com ↗
12月11日，全球首个CDK2/4/6抑制剂库莫西利胶囊（赛坦欣®）收到了国家药品监督管理局（NMPA）颁发的药品注册批件，联合氟维司群，用于既往接受内分泌经治的激素受体阳性、人表皮生长因子受体2阴性的（HR+/HER2-）局部晚期或转移性乳腺癌患者。 |
| 2024-07-19 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴乳腺癌领域1类新药库莫西利上市申请获受理 cttq.com ↗
7月18日，正大天晴自主研发的1类创新药库莫西利胶囊（Culmerciclib，TQB3616）联合氟维司群注射液（商标名：晴可依），已向国家药监局药品审评中心（CDE）递交新药上市申请并获受理，用于既往内分泌经治的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌的治疗。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-06 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 库莫西利一线治疗乳腺癌获批上市！中国生物制药推动CDK治疗迈入新阶段 cttq.com ↗ |
| 2025-12-12 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 全球首个！CDK2/4/6抑制剂库莫西利（赛坦欣®）获批上市，重塑乳腺癌治疗格局 cttq.com ↗ |
| 2024-07-19 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴乳腺癌领域1类新药库莫西利上市申请获受理 cttq.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Culmerciclib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07616453 ↗ |
| Known as | TQB3616 | “Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial.” PMID 41413016 ↗ Dec 2025 |
| Action | Inhibit | “CDK2/4/6 inhibitor” NCT07616453 ↗ |
| Route | Oral | “culmerciclib 180 mg orally once daily” NCT07795424 ↗ |
| Target | CDK2 | “CDK2/4/6 inhibitor” NCT07616453 ↗ |