Saitanxin (culmerciclib) / Sino Biopharm - LARVOL DELTA

Neoadjuvant Culmerciclib Combined With Endocrine Therapy for HR-Positive HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Culmerciclib plus fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer: A phase III trial (CULMINATE-2) (ESMO 2025) - P3 | "Conclusions Adding Culm to Ful demonstrated a significant PFS benefit in HR+/HER2- ABC, with manageable toxicities. Culm is the first CDK2/4/6 inhibitor to show survival benefit with Ful in both pretreated and untreated HR+/HER2- ABC, positioning this combination as a promising therapeutic strategy and potentially the leading treatment among CDK inhibitors."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Shengjing Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Culmerciclib in HR+/HER2+ Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER

Phase II Clinical Trial of TQB3616 Capsules Combined with Aromatase Inhibitor in HR-positive, HER2-negative Advanced Breast Cancer (ChiCTR) - P2 | N=60 | Completed | Sponsor: Liaoning Cancer Hospital & Institute; Liaoning Cancer Hospital & Institute

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

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 | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

TAYLOR-002: Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Sino Biopharmaceutical Limited…announces that data from a Phase II clinical trial of culmerciclib 'CDK2/4/6 inhibitor;…was presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (HKEXnews) - "As of April 15, 2026, 35 patients were enrolled, with a median follow-up of 10.8 months....Among 34 evaluable patients, the culmerciclib combination regimen demonstrated potent antitumor activity. The confirmed ORR was 32.4% (95% CI: 17.4–50.5, p < 0.0001), meeting the primary endpoint. The DCR was 88.2% (95% CI: 72.6–96.7), and the CBR was 82.4% (95% CI: 65.5–93.2). Median time to response (TTR) was 3.7 months. Notably, median PFS and median duration of response (DoR) have not yet been reached, with a 10-month PFS rate of 61.8% (95% CI: 42.3–76.4), suggesting sustained disease control."

P2 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Culmerciclib (CDK2/4/6 inhibitor) plus fulvestrant in HR+/HER2− advanced breast cancer after progression on CDK4/6i: Preliminary results from a phase II trial. (ASCO 2026) - P2 | "All pts had received prior CDK4/6i +ET (AI and/or SERM) therapies, prior CDK4/6i was 68.6% palbociclib, 28.6% dalpiciclib, and 8.6% ribociclib (2 pts with dual CDK4/6i); 28.6% had received prior two lines endocrine therapy, also 37.1% had received prior chemotherapy for metastatic disease. Culm combined with Ful demonstrated promising antitumor activity in HR+/HER2- ABC after progression on previous CDK4/6i + ET, offering a potential targeted therapeutic strategy for this population (NCT06702618)."

Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

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 • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Sino Biopharmaceutical Limited…announces that culmerciclib capsule 'CDK2/4/6 inhibitor'…in combination with fulvestrant, has received approval for marketing from the…NMPA of China for the initial endocrine therapy for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer (HKEXnews) - "The approval of this new indication is primarily based on data from the CULMINATE-2 study. This study is the first Phase III trial worldwide which demonstrates positive results for the combination of CDK2/4/6 inhibitor and endocrine therapy as the first-line treatment for HR-positive/HER2-negative advanced breast cancer..."

China approval • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

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 (ChiCTR) - P2 | N=28 | Recruiting | Sponsor: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital); The First Affiliated Hospital of Nanjing Medical U

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

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 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

TQB3616-I-0001: A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown status ➔ Completed | N=30 ➔ 40

Enrollment change • Trial completion • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

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 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

TQB3616-II-01: A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=122 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 | Sponsor: 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 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

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) - P3 | "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 • Journal • P3 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Sino Biopharmaceutical Limited announced that its self-developed drug, culmerciclib capsule, has been approved by the China National Medical Products Administration for marketing. (TipRanks) - "This innovative drug, used in combination with fulvestrant, targets HR-positive, HER2-negative advanced breast cancer, showing significant efficacy in clinical trials by prolonging progression-free survival and improving response rates with a tolerable safety profile."

China approval • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

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 | Sponsor: 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 primary completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

TQB3616-II-03: TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma (clinicaltrials.gov) - P2 | N=26 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=118 ➔ 26 | Trial completion date: Dec 2024 ➔ Sep 2025 | Not yet recruiting ➔ Terminated; 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 • Liposarcoma • Oncology • Sarcoma • Solid Tumor

PHASE III STUDY RESULTS OF CULMERCICLIB IN COMBINATION WITH FULVESTRANT FOR FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER WAS PRESENTED AT ESMO 2025 (HKEXnews) - "The primary endpoint was median progression-free survival (PFS) as assessed by investigators (INV): NR (not yet reached) vs 20.2 months in the study group versus the control group, with a 44% reduction in the risk of disease progression/death (HR=0.56, P=0.0004). The secondary endpoint was median PFS as assessed by the Independent Review Committee (IRC): NR (not yet reached) vs 22.0 months in the study group versus the control group, with a 60% reduction in risk of disease progression/death (HR=0.40, P<0.0001)."

P3 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer