Group 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]

Core Insights - 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 treating HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1][2] - The drug is an innovative small molecule CDK4/6 inhibitor with independent intellectual property rights, classified as a major new drug creation project in China since 2018 [1] - The cumulative R&D investment for this drug reached approximately RMB 617 million (unaudited) as of August 2025 [1] Market Impact - The approval of the new indication is expected to enhance the market competitiveness of the drug and provide more treatment options for breast cancer patients in China [2] - Global sales of CDK4/6 inhibitors are projected to be approximately $14.912 billion in 2024 [2]

Core Viewpoint - Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, received approval from the National Medical Products Administration for new indications of two drugs, indicating a positive development in the company's product pipeline and potential market expansion [1] Group 1: Drug Approvals - The drug citric acid vorinostat capsules (brand name: Fuzhuoning) received approval for a new indication to be used in combination with aromatase inhibitors as initial endocrine therapy for adult patients with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer [1] - The drug famotidine injection also received approval for its indication to treat upper gastrointestinal bleeding caused by peptic ulcers and other non-tumor-related conditions, excluding esophageal and gastric variceal bleeding [1]

Core Viewpoint - Fosun Pharma (600196.SH) announced that its subsidiary, Jinzhou Aohong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a new indication for the drug FCN-437c (commercial name: Fuzhuoning), which is a CDK4/6 inhibitor for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1] Group 1 - The newly approved indication is for use in combination with aromatase inhibitors as initial endocrine therapy [1] - The drug is an innovative small molecule with independent intellectual property rights owned by the group [1] - FCN-437c was included in the national "Major New Drug Creation" science and technology major project in 2018 [1]