Core Viewpoint - China Biopharmaceutical has submitted a new indication application for its CDK2/4/6 inhibitor TQB3616 in combination with Fulvestrant for previously untreated HR+/HER2- locally advanced or metastatic breast cancer to the CDE, which has been accepted [1][2] Group 1: Clinical Research and Development - TQB3616-III-02 (NCT04523272) is a randomized, double-blind, parallel-controlled, multi-center Phase III clinical study aimed at evaluating the efficacy and safety of TQB3616 combined with Fulvestrant compared to placebo plus Fulvestrant in previously untreated HR+/HER2- advanced breast cancer patients [1] - The study has achieved its primary endpoint, with detailed data to be presented at an upcoming international academic conference [1] Group 2: Market Potential and Guidelines - Breast cancer is the most common malignant tumor among women, with HR+/HER2- breast cancer accounting for approximately 65%-70% of all breast cancer cases [1] - About 4%-6% of breast cancer patients are diagnosed at an advanced stage, and even early-stage patients have a 30%-40% chance of progressing to advanced disease despite standard adjuvant therapy [1] - The CSCO Breast Cancer Guidelines (2025 edition) recommend CDK4/6 inhibitors in combination with endocrine therapy for first-line treatment of HR+/HER2- advanced breast cancer [1]

Core Viewpoint - The company has submitted a new indication application for its self-developed CDK2/4/6 inhibitor TQB3616 in combination with Fulvestrant for previously untreated HR-positive, HER2-negative locally advanced or metastatic breast cancer to the National Medical Products Administration of China, which has been accepted [1] Group 1 - The application for the first-line indication further confirms the broad potential of this combination therapy in different treatment stages of advanced breast cancer [1] - The study has achieved its primary endpoint, with detailed data expected to be presented at an upcoming international academic conference [1]