Zhi Tong Cai Jing·2025-09-15 10:28Group 1 - The core point of the news is that Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, received approval from the National Medical Products Administration for a new indication of the drug FCN-437c (brand name: Fuzhuoning) for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1] - The newly approved indication allows the drug to be used in combination with aromatase inhibitors as initial endocrine therapy [1] - The drug is an innovative small molecule CDK4/6 inhibitor with independent intellectual property rights, classified as a new structure oral medication [1] Group 2 - The drug had previously received approval for another indication for HR-positive, HER2-negative recurrent or metastatic breast cancer patients who have progressed after prior endocrine therapy, which was approved for market entry in China by May 2025 [1] - As of August 2025, the cumulative R&D investment for this drug is approximately RMB 617 million (unaudited) [1] - According to IQVIA MIDAS™ data, global sales of CDK4/6 inhibitors are projected to be around $14.912 billion in 2024, indicating a strong market potential for the newly approved indication [2]