On September 15, 2025, an innovative small-molecule CDK4/6 inhibitor ——New Indication for Citrate Fuvexil Capsules Approved by China's National Medical Products Administration (NMPA)，In combination with aromatase inhibitors, used forHR-positive, HER2-negative locally advanced or metastatic breast cancer in premenopausal, perimenopausal, and postmenopausal womenInitial Endocrine Therapy for Female Patients.This is an important step for volasertib in the field of breast cancer treatment following its initial approval in May 2025.

It not only further refines the initial treatment landscape for HR-positive, HER2-negative advanced breast cancer, but also provides patients at different menopausal stages with more precise and tailored new treatment options – from now on, more women troubled by advanced breast cancer will no longer be restricted by their menopausal status and can access targeted solutions more quickly, adding tangible confidence and hope in the fight against the disease!

▲Screenshot source“NMPA”

Citrate Fuvorxil Capsules (Futoning®, FCN-437c) is an innovative small-molecule CDK4/6 inhibitor developed by Jinzhou Aohong Pharmaceutical, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Its mechanism of action involves inhibiting the cell cycle progression and blocking the transition of cells from the G1 phase to the S phase—effectively slowing down the proliferation rate of cancer cells while inducing apoptosis in tumor cells, ultimately achieving the goal of controlling tumor progression.

Previously, on May 29, 2025, the drug was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with...Hormone receptor (HR) positive, human epidermal growth factor 2 (HER2) negative recurrent or metastatic breast cancer with disease progression after prior endocrine therapy。

And just today (September 15, 2025), the new indication for this drug has been approved again: in combination with aromatase inhibitors, as the initial endocrine therapy for premenopausal, perimenopausal, and postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

At the 2022 San Antonio Breast Cancer Symposium (SABCS), significant efficacy data from the Phase II clinical study (NCT05004142) of the innovative CDK4/6 inhibitor Fuvixil (FCN-437c) was announced.

This study enrolled a total of 67 patients with HR+, HER2- advanced breast cancer (ABC), who were divided into two groups based on their status and treatment regimen: one group consisted of postmenopausal patients (Cohort 1, including first-line or second-line treatment, using the vorvixil + fulvestrant regimen), and the other group consisted of premenopausal patients (Cohort 2, all first-line treatment, using the vorvixil + letrozole + goserelin regimen). The median follow-up time was 12.8 months.

Results: Per-protocol SetAmong 27 patients in China, partial response (PR) was achieved, with an objective response rate (ORR) of 40.9%.（95%CI：29.0-53.7）；The 12-month progression-free survival rate (PFS) was 67.7%.（95%CI：29.0-53.7），The 12-month overall survival (OS) rate reached 95.9%.（95%CI：84.5-99.0），6-Month Duration of Response (DOR) Rate is 96.0%（95%CI：74.8-99.4）。

Subgroup data further validates efficacy:Cohort 1 (n=35)11 patients achieved PR, with an ORR of 31.4%.（95%CI：16.9-49.3%），Median Progression-Free Survival (mPFS) was 12.9 months（95%CI：9.2-NR），6-month DOR rate is 100%；In Cohort 2 (n=31), 16 patients achieved PR, with an ORR of 51.6%.（95%CI：33.1%-69.9%）。

▲Data Source“AACR”

In summary, Fuvorixilib (FCN-437c) combined with fulvestrant, or in combination with letrozole plus goserelin, demonstrated favorable anti-tumor activity and safety in patients with HR+, HER2- advanced breast cancer (ABC), with good patient tolerability.

Believe that after seeing the data above, patients with HER2-positive breast cancer or other solid tumors must have ignited new hope! The good news is that currently, China is conducting multiple clinical studies targeting breast cancer. A large number of patients have successfully joined the treatment program for this new anti-cancer drug through the Global Cancer Doctors Network's new drug recruitment center!

Application Process

Patients who wish to apply for clinical trials of new anti-cancer drugs need to compile their recent pathology reports, genetic test reports, and other relevant materials, then submit them to the Medical Department of Global Cancer Doctors Network (you can directly call the Medical Department at 4006667998 or send the documents to doctor.huang@globecancer.com, leaving contact information in the email) for an initial evaluation.

Our experts will provide you with a comprehensive analysis and interpretation of the test report. We will contact you by phone within one working day to recommend a medication plan and match suitable patients for clinical trial projects. Note: As a leading platform for cancer patients in China, Global Cancer Doctors Network promises to keep all participants' personal information confidential and ensure compliance with national laws and regulations related to clinical research throughout the process.

In recent years, significant progress has been made in the treatment of breast cancer, reversing the survival period for patients with advanced stages. In addition to the content summarized above, more new drugs are currently under development. If you are not satisfied with the current treatment options or would like to learn more about new anti-cancer drugs/technologies for breast cancer, you can submit your treatment history, recent pathology examination reports, discharge summaries, etc., toMedical Department of Global Cancer Doctors Network (400-666-7998), conduct a preliminary assessment.