^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    CDK2/4/6 inhibitor

    Related drugs:
    27d
    A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy. (clinicaltrials.gov)
    P2, N=98, Recruiting, Fudan University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • HER-2 expression • HER-2 negative + ER positive
    |
    fulvestrant • Saitanxin (culmerciclib)
    2ms
    Culmerciclib: First Approval. (PubMed, Drugs)
    The drug received its first approval in China on 9 December 2025 for use in combination with fulvestrant in adults with HR+/HER2- advanced or metastatic breast cancer whose disease has progressed after endocrine therapy. This article summarizes the milestones in the development of culmerciclib leading to this first approval.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • Saitanxin (culmerciclib)
    3ms
    A single-arm, phase II, exploratory study of neoadjuvant treatment with Kudosil combined with Culmerciclib and dual-targeted therapy of trastuzumab and pertuzumab in HR+, HER2+ breast cancer (ChiCTR2600121242)
    P2, N=28, Recruiting, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital); The First Affiliated Hospital of Nanjing Medical U
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • letrozole • Saitanxin (culmerciclib)
    3ms
    TQB3616-III-03: Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer (clinicaltrials.gov)
    P3, N=1946, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • Saitanxin (culmerciclib)
    3ms
    TQB3616-ALTN-II-01: A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=21, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=126 --> 21 | Recruiting --> Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial termination
    |
    Focus V (anlotinib) • irinotecan • Saitanxin (culmerciclib)
    3ms
    TQB3616-I-0001: A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics (clinicaltrials.gov)
    P1, N=40, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown status --> Completed | N=30 --> 40
    Trial completion • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Saitanxin (culmerciclib)
    3ms
    TQB3616-II-04: Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    fulvestrant • Saitanxin (culmerciclib)
    3ms
    TQB3616-III-01: TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail (clinicaltrials.gov)
    P3, N=293, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • Saitanxin (culmerciclib)
    3ms
    TQB3616-II-01: A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=122, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Saitanxin (culmerciclib)
    5ms
    A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer (clinicaltrials.gov)
    P1/2, N=285, Recruiting, Genentech, Inc. | Trial completion date: Jul 2030 --> Aug 2028 | Trial primary completion date: Jul 2030 --> Aug 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • giredestrant (RG6171) • RG6794
    7ms
    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. (PubMed, Signal Transduct Target Ther)
    In conclusion, this randomized clinical trial met its primary outcome. Culmerciclib plus fulvestrant is well tolerated and leads to a significant gain in PFS of pretreated HR-positive HER2-negative ABC patients.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Saitanxin (culmerciclib)
    7ms
    Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=8, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=75 --> 8 | Trial completion date: Apr 2027 --> Nov 2025 | Recruiting --> Terminated | Trial primary completion date: Apr 2027 --> Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    fulvestrant • Saitanxin (culmerciclib)