乳腺癌是全球最常见的恶性肿瘤之一，2022年全球新发患者数量超过230万例。其中，HR+/HER2-乳腺 癌约占全部乳腺癌的65%-70%，是乳腺癌中最常见的亚型。约4%-6%的乳腺癌患者初诊即为晚期，而早 期患者即使接受标准辅助治疗，仍有30%-40%会进展至晚期，存在显著的未满足临床需求。 除本次获批的二线治疗适应症外，库莫西利联合氟维司群用于一线HR+/HER2-乳腺癌适应症已于2025 年7月向NMPA递交上市申请，其辅助治疗适应症的Ⅲ期临床试验已完成全部患者入组，有望在未来两 年逐步获批上市。 格隆汇12月12日丨中国生物制药(01177.HK)宣布，集团自主研发的国家1类创新药库莫西利胶囊 (商品 名：赛坦欣®) 已获得中国国家药品监督管理局 (NMPA)的上市批准，用于与氟维司群联合治疗既往接 受内分泌治疗后出现疾病进展的激素受体 (HR) 阳性、人表皮生长因子受体2 (HER2) 阴性的局部晚期或 转移性乳腺癌患者。 库莫西利是全球首创的同时靶向CDK2/4/6的三重抑制剂，对CDK2、CDK4、CDK6激酶有不同程度的抑 制效果，且对CDK4激酶有较强的选择性抑制能力。基于其独特的作用机制， ...

该适应症的获批主要基于CULMINATE-1研究，显示库莫西利联合氟维司群较氟维司群取得了显著的中 位无进展生存期(PFS)改善，大幅降低了HR+/HER2-晚期乳腺癌疾病进展或死亡风险。 乳腺癌已成为全球及中国女性群体中的"第一大癌种"，HR+/HER2-乳腺癌是最主要的亚型。对于晚期 HR+乳腺癌，国内外指南目前均推荐CDK4/6抑制剂作为治疗选择，但CDK4/6抑制剂本身的耐药问题、 骨髓抑制问题也亟待解决。 作为新一代CDK2/4/6抑制剂，库莫西利独特分子结构设计：既能精准靶向抑制CDK4，又能显著增强对 CDK2的结合能力，同时对CDK6的抑制作用较弱，能有效降低骨髓抑制的用药风险。临床前数据显 示，库莫西利对CDK2、CDK4的抑制活性显著优于传统CDK4/6抑制剂。 库莫西利此次获批主要基于CULMINATE-1研究，该研究充分验证了产品的疗效与安全性。安全性方 面，库莫西利联合氟维司群组治疗相关不良事件(TRAEs)多为1-2级，较传统CDK4/6抑制剂具有更低的 骨髓抑制风险，为长期治疗的依从性提供了有效保障。 有券商在近期报告中将库莫西利列为潜在的"重磅炸弹"药物，仅在中国的峰值销售额便 ...

智通财经APP讯，复星医药(600196.SH)发布公告，近日，公司控股子公司上海复宏汉霖生物技术股份 有限公司及其控股子公司(以下合称"复宏汉霖")收到国家药品监督管理局关于同意HLX22(即重组人源化 抗HER2单克隆抗体注射液)联合注射用HLX87(即靶向HER2抗体偶联药物)于中国境内开展如下临床试 验的批准：(1)用于HER2阳性乳腺癌(BC)一线治疗的Ⅱ/Ⅲ期临床试验;(2)用于HER2阳性乳腺癌新辅助治 疗(BC neo)的Ⅱ/Ⅲ期临床试验。复宏汉霖拟于条件具备后于中国境内开展上述相关临床研究。 ...

许可产品(枸橼酸伏维西利胶囊)作为CDK4/6抑制剂，已获批用于HR+、HER2–的乳腺癌治疗。许可产 品契合公司在乳腺癌领域的商业化布局，与公司现有的其他乳腺癌管线产品具有商业协同性。引进许可 产品有助于丰富公司管线，以及有助于借助集团现有的乳腺癌商业化团队和资源提升集团未来收入规 模。 格隆汇12月3日丨复宏汉霖(02696.HK)公告，于2025年12月3日，公司与奥鸿药业订立合作协议，据此， 奥鸿药业同意授予集团于区域内及领域内商业化运营许可产品的独家许可权。合作协议乃于双方在2025 年8月7日订立合作备忘录(作为上市规则项下符合最低豁免水平的交易)后订立，集团已据合作备忘录获 得截至双方正式签署合作协议之日期间的过渡期内，许可产品于中国境内的独家商业化运营权利，合作 备忘录亦约定双方将于有关条件具备后订立正式协议。合作备忘录已被合作协议所取代，并于2025年12 月3日自动终止。 ...

许可产品(枸橼酸伏维西利胶囊)作为CDK4/6抑制剂，已获批用于HR+、 HER2–的乳腺癌治疗。许可产 品契合公司在乳腺癌领域的商业化布局，与公司现有的其他乳腺癌管线产品具有商业协同性。引进许可 产品有助于丰富公司管线，以及有助于借助集团现有的乳腺癌商业化团队和资源提升集团未来收入规 模。 智通财经APP讯，复宏汉霖(02696)公布，于2025年12月3日，公司与奥鸿药业订立合作协议，据此，奥 鸿药业同意授予集团于区域内及领域内商业化运营许可产品的独家许可权。合作协议乃于双方在2025年 8月7日订立合作备忘录(作为上市规则项下符合最低豁免水平的交易)后订立，集团已据合作备忘录获得 截至双方正式签署合作协议的日期间的过渡期内，许可产品于中国境内的独家商业化运营权利，合作备 忘录亦约定双方将于有关条件具备后订立正式协议。合作备忘录已被合作协议所取代，并于2025年12月 3日自动终止。 ...

Core Insights - Breast cancer has become one of the most common malignant tumors threatening women's health in China, making its prevention and treatment crucial for family well-being [1] Group 1: Event Overview - A discussion titled "Breaking the Deadlock in Breast Cancer Treatment in China" will be held on November 17, 2025, featuring prominent experts in the field [1] - The event will be broadcasted from 14:00 to 15:00, inviting viewers to engage with the topic [1] Group 2: Guest Profiles - Xu Binghe, an academician of the Chinese Academy of Engineering and a leading oncologist, is known for his research in clinical diagnosis, treatment, and the development of new anti-cancer drugs, particularly in molecular typing and personalized treatment for breast cancer [5] - Hao Jihui, a chief physician and doctoral supervisor, serves as the president of Tianjin Medical University and the director of Tianjin Medical University Cancer Hospital, with significant contributions to clinical research in malignant tumors [5] Group 3: Viewing Information - The event can be accessed through the People's Good Doctor App, where users can find the program on the homepage [6] - Additionally, viewers can follow the People's Health public WeChat account for more health-related content and instructions on accessing the app [8]

Core Insights - The 2025 European Society for Medical Oncology (ESMO) annual meeting will take place in Germany from October 17 to 21, where several significant oral reports from domestic innovative pharmaceutical companies are expected to be disclosed [1] - China National Pharmaceutical Group is set to present key data on its CDK2/4/6 inhibitor, Kumosili, and HER2 dual-target ADC, TQB2102, highlighting its comprehensive coverage in the breast cancer treatment landscape [1] Industry Overview - Breast cancer is the second most common cancer globally, following lung cancer, and has the highest incidence and mortality rates among women [1] - The breast cancer market is highly competitive, particularly in the HR+/HER2- subtype, which accounts for approximately 65%-70% of all breast cancer cases [2] - The global market for CDK4/6 inhibitors is projected to approach $13 billion by 2024, with ongoing growth driven by products from Pfizer, Eli Lilly, and Novartis [2] Company Developments - Kumosili capsules, a new generation CDK2/4/6 inhibitor, are expected to receive approval for second-line treatment of HR+/HER2- locally advanced or metastatic breast cancer by the end of this year [3] - The company is also advancing its clinical trials for Kumosili in first-line and adjuvant settings, aiming for comprehensive coverage across treatment lines [3] - TQB2102, another product from China National Pharmaceutical Group, will present phase Ib clinical data for HER2-positive recurrent/metastatic breast cancer at ESMO [3] Competitive Landscape - The ADC market for HER2-positive breast cancer is evolving, with significant sales from existing products like DS-8201, which reached $3.8 billion last year and is projected to peak at $10 billion [4] - TQB2102 has been optimized in terms of target binding, toxin load, and payload compared to DS-8201, and has been recognized as a breakthrough therapy for multiple indications [4] - The company has a diverse pipeline covering various cancer types, including breast, colorectal, lung, bile duct, and gastric cancers, with several indications entering phase III clinical trials [4]

Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has received clinical approval for its core product, Tinengotinib (TT-00420), in combination with Fulvestrant for the treatment of HR+/HER2- recurrent or metastatic breast cancer that has failed previous treatments [1] Group 1: Clinical Trial Details - The clinical trial is a Phase II, open-label, multi-center study evaluating the safety, efficacy, and pharmacokinetics of Tinengotinib combined with Fulvestrant in patients with HR+/HER2- recurrent or metastatic breast cancer [1] - The trial has received clinical implicit approval from the National Medical Products Administration of China as of September 10, 2025 [1] Group 2: Early Research Results - Early clinical research results indicate that Tinengotinib as a monotherapy shows promising clinical effects in HR+/HER2- breast cancer patients who have undergone multiple treatments, including endocrine therapy, CDK4/6 inhibitors, and chemotherapy [1] - Preclinical studies suggest that the combination of Tinengotinib and Fulvestrant exhibits pharmacological synergy against endocrine-resistant breast cancer cells [1] Group 3: Potential Impact - The clinical treatment strategy involving Tinengotinib in combination with Fulvestrant may provide a new breakthrough in the treatment of breast cancer patients who have developed resistance to endocrine therapy [1]

Core Viewpoint - The company has received clinical approval for its core product, Tinengotinib, in combination with Fulvestrant, for the treatment of HR+/HER2- recurrent or metastatic breast cancer that has failed previous treatments [1] Group 1: Clinical Trial Details - The clinical trial is a Phase II, open-label, multi-center study conducted in China, evaluating the safety, efficacy, and pharmacokinetics of Tinengotinib combined with Fulvestrant in patients with HR+/HER2- breast cancer [1] - The trial received clinical implicit approval from the National Medical Products Administration of China on September 10, 2025 [1] Group 2: Early Research Findings - Early clinical research results indicate that Tinengotinib as a monotherapy shows promising clinical effects in HR+/HER2- breast cancer patients who have undergone multiple treatments, including endocrine therapy, CDK4/6 inhibitors, and chemotherapy [1] - Preclinical studies suggest that the combination of Tinengotinib and Fulvestrant exhibits pharmacological synergy against endocrine-resistant breast cancer cells [1] Group 3: Potential Impact - The clinical treatment strategy involving Tinengotinib and Fulvestrant may provide a new breakthrough in the treatment of breast cancer patients who have developed resistance to endocrine therapy [1]

Core Viewpoint - Eli Lilly's drug Verzenio has shown significant progress in late-stage clinical trials, improving overall survival rates for specific breast cancer patients [1] Group 1: Clinical Trial Results - The global Phase III monarchE trial included over 5,500 high-risk early breast cancer patients who are hormone receptor-positive (HR+), HER2-negative, and lymph node-positive [1] - Verzenio, when used in combination with endocrine therapy, demonstrated statistically significant and clinically meaningful improvements in overall survival compared to endocrine therapy alone [1] - The drug also showed sustained benefits in key research metrics such as invasive disease-free survival, which was the primary endpoint of the monarchE trial [1] Group 2: Company Statements and Future Plans - Jacob Van Naarden, head of Eli Lilly's oncology division, emphasized the importance of the data in establishing Verzenio as a standard treatment for high-risk lymph node-positive patients [1] - The company plans to present detailed research findings at an upcoming medical conference and submit the paper for peer review in a prestigious academic journal [1] - Eli Lilly will also engage with major global regulatory agencies to communicate the results [1]