Drugs / TQB3616
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 | “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 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06662773 | Nov 2024 → Mar 2025 overdue | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06149611 | Jan → Jun 2024 | breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05344729 | Jul → Aug 2021 | breast carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03850873 | May 2019 → Sep 2021 | breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06851442 | May → Nov 2025 | breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06202261 | Apr 2023 → Dec 2026 expected | breast carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05139082 | Nov 2021 → Oct 2023 | digestive system neoplasm | Peking University | Unknown | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06702618 | Feb 2025 → Jun 2026 overdue | breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05496569 | Aug 2022 → Jun 2024 | dedifferentiated liposarcoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05156450 | Jan 2022 → Oct 2023 | castration-resistant prostate carcinoma | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04924192 | Aug 2021 → Sep 2022 | lung carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04796623 | Feb 2021 → May 2024 | hormone receptor-positive breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05780567 | Mar 2023 → Dec 2026 expected | breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05365178 | Jul 2022 → Jul 2025 overdue | hormone receptor-positive breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05375461 | Mar 2022 → Jan 2024 | hormone receptor-positive breast cancer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-03-25 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 从二线到一线治疗晚期乳腺癌，库莫西利联合氟维司群又一适应症将申报上市 cttq.com ↗
库莫西利胶囊（TQB3616）联合氟维司群注射液用于既往未经治疗的HR阳性、HER2阴性（HR+/HER2-）局部晚期或转移性乳腺癌的Ⅲ期临床试验（TQB3616-Ⅲ-02）取得阳性结果。 |
| 2024-08-30 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 乳腺癌1类新药库莫西利III期研究入选全国临床肿瘤学大会口头报告 cttq.com ↗
研究显示，相较于对照组，库莫西利联合氟维司群可显著降低HR+/HER2-晚期乳腺癌患者的疾病进展或死亡风险，同时改善客观缓解率（ORR）、CBR（临床获益率）、OS（总生存期）等次要终点。 |
| 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 |
|---|---|---|
| 2025-03-25 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 从二线到一线治疗晚期乳腺癌，库莫西利联合氟维司群又一适应症将申报上市 cttq.com ↗ |
| 2024-08-30 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 乳腺癌1类新药库莫西利III期研究入选全国临床肿瘤学大会口头报告 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 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TQB3616 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05139082 ↗ |
| Known as | culmerciclib | “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 | “TQB3616 may work in cancer by stopping cancer cells from multiplying.” NCT03850873 ↗ |
| Modality | Small molecule | “TQB3616 capsule is a small molecule oral drug” NCT05344729 ↗ |
| Route | Oral | “TQB3616 is taken by mouth daily.” NCT03850873 ↗ |
| Target | CDK4 | “A CDK4/6 kinase inhibitor” NCT04924192 ↗ |