枸橼酸伏维西利胶囊(复妥宁)
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复宏汉霖联手奥鸿药业推进复妥宁®商业化进程
Zheng Quan Shi Bao Wang· 2025-12-03 15:57
人民财讯12月3日电,12月3日晚,复宏汉霖公告,公司与奥鸿药业宣布就创新型小分子CDK4/6抑制剂 枸橼酸伏维西利胶囊(商品名复妥宁)达成合作,加速其商业化进程。复妥宁已在中国获批,用于内分 泌初始或者既往接受内分泌治疗后进展的局部晚期或者转移性的激素受体(HR)阳性、人表皮生长因 子2(HER2)阴性的乳腺癌患者。复妥宁由奥鸿药业开发,复宏汉霖拥有其在中国的商业化独占许可和 权利。 (原标题:复宏汉霖联手奥鸿药业推进复妥宁®商业化进程) ...
复宏汉霖联手奥鸿药业推进复妥宁 商业化进程
Zheng Quan Shi Bao Wang· 2025-12-03 15:33
人民财讯12月3日电,12月3日晚,复宏汉霖公告,公司与奥鸿药业宣布就创新型小分子CDK4/6抑制剂 枸橼酸伏维西利胶囊(商品名复妥宁)达成合作,加速其商业化进程。复妥宁已在中国获批,用于内分泌 初始或者既往接受内分泌治疗后进展的局部晚期或者转移性的激素受体(HR)阳性、人表皮生长因子 2(HER2)阴性的乳腺癌患者。复妥宁由奥鸿药业开发,复宏汉霖拥有其在中国的商业化独占许可和权 利。 ...
复星医药:枸橼酸伏维西利胶囊新增适应症的药品注册申请获国家药监局批准
Zhi Tong Cai Jing· 2025-09-15 10:28
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]
复星医药(02196):枸橼酸伏维西利胶囊新增适应症的药品注册申请获国家药监局批准
智通财经网· 2025-09-15 09:57
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]
复星医药:控股子公司药品枸橼酸伏维西利胶囊等获注册批准
Zheng Quan Shi Bao Wang· 2025-09-15 09:05
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]
复星医药:枸橼酸伏维西利胶囊新增适应症药品注册申请获批
Zhi Tong Cai Jing· 2025-09-15 08:51
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]