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， ...

中证报中证网讯(记者傅苏颖)12月11日，中国生物制药宣布，下属企业正大天晴自主研发的CDK2/4/6抑 制剂库莫西利胶囊(商品名：赛坦欣)获批上市，用于既往内分泌经治的HR+/HER2-局部晚期或转移性乳 腺癌。中国生物制药正在不断拓展库莫西利的适应证范围，包括联合氟维司群一线治疗HR+/HER2-晚 期乳腺癌、HR+早期乳腺癌辅助治疗等方面都已经取得了重要进展。 乳腺癌治疗药物市场规模不断增长，成为全球创新药物竞争最为密集的领域之一。中国生物制药布局了 乳腺癌领域HER2阳性(HER2+)、HER2低表达、HR阳性(HR+/HER2-)以及三阴性乳腺癌(TNBC)等全分 子分型；在治疗周期上，中国生物制药系统性的覆盖了从辅助治疗，一线、二线及以上，到新辅助的全 线治疗场景，力求为更多患者提供新的治疗选择。在HR+/HER2-领域，除了库莫西利，还差异化布局 了TQB2102(HER2双抗ADC)、TQB3126(ER-PROTAC)、TQB3202(PI3Kα)等产品。 与此同时，中国生物制药已全面布局乳腺癌主流基石药物，包括已上市的晴可依(氟维司群注射液)、晴 维时(依维莫司片)、赛妥(注射用曲妥珠单抗 ...

Core Insights - The Chinese biopharmaceutical industry has achieved significant international recognition and growth, transitioning from a follower to a key contributor in the global market during the "14th Five-Year Plan" period [1][5]. Group 1: International Collaborations and Financial Milestones - In just two days, Chinese innovative drugs secured five major international deals, with several transactions exceeding $1 billion, including a $16.4 billion collaboration between Shenzhen Pruijun Biopharmaceutical Co., Ltd. and Gilead Sciences' Kite Pharma [1]. - The total value of China's innovative drug licensing agreements reached nearly $66 billion in the first half of 2025, surpassing the entire 2024 total of $51.9 billion [5]. Group 2: Technological Advancements in Drug Development - The integration of artificial intelligence and other cutting-edge technologies has transformed drug development in China, allowing for a more precise and efficient approach [2][3]. - China's share of new drug research and development has exceeded 20% globally, positioning the country as the second-largest in new drug development [2]. Group 3: Clinical Trials and International Recognition - Chinese innovative drugs are increasingly being presented at international academic conferences, demonstrating their clinical trial results that directly compete with global leading drugs [4]. - The development of new drugs such as the CDK2/4/6 inhibitor by Zhengda Tianqing Pharmaceutical Group has showcased China's capability to produce competitive therapies on the international stage [4]. Group 4: Investment in Research and Development - Chinese biopharmaceutical companies are significantly increasing their R&D investments, with some companies reporting annual R&D expenditures exceeding 4 billion yuan [4]. - The focus on original innovation and translational medicine is driving the industry towards achieving globally competitive products [5].

Core Insights - The Chinese biopharmaceutical industry is experiencing significant growth, with multiple large international deals being signed in a short period, indicating a shift from quantity to quality in innovation [1][6] - The integration of advanced technologies such as artificial intelligence and virtual cells is transforming drug development processes, allowing for more efficient and targeted research [2][3] - Chinese innovative drugs are gaining international recognition, with an increasing number of clinical trials presented at global academic conferences, showcasing their competitive efficacy against established global drugs [4][5] Group 1: International Collaborations - Shenzhen Pruijun Biopharmaceutical Co., Ltd. signed a collaboration with Gilead Sciences' Kite Pharma for in vivo editing therapy, with a potential total deal value of $1.64 billion [1] - Hansoh Pharmaceutical Group reached a licensing agreement with Roche for a targeted antibody-drug conjugate, with a potential total deal value of $1.53 billion [1] - The total value of China's innovative drug licensing agreements in the first half of 2025 is estimated to be nearly $66 billion, surpassing the total for the entire year of 2024 [6] Group 2: Technological Advancements - The Chinese biopharmaceutical industry is leveraging artificial intelligence and other cutting-edge technologies to enhance drug development, aiming to reduce traditional research timelines by 90% [2] - The establishment of digital twins and drug models for cancer patients is facilitating innovative research and accelerating new drug development [2][3] - The integration of AI, quantitative simulation, and high-throughput screening is improving research efficiency and enabling breakthroughs in drug delivery systems [3] Group 3: Clinical Recognition - The Chinese innovative drug, Moxilib Capsule, was presented at the 2025 European Society for Medical Oncology annual meeting, highlighting its clinical data [4] - Chinese drugs are increasingly participating in head-to-head trials against global leaders, demonstrating superior efficacy in various cancer treatments [4] - The focus on source innovation and disease mechanism-based research is leading to significant international achievements in the biopharmaceutical sector [5]

Core Insights - China Biopharmaceutical announced the interim analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules, presented at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy for HR+/HER2- advanced breast cancer [1] Group 1 - Kumosili is a novel oral CDK2/4/6 inhibitor with varying degrees of inhibition on CDK2, CDK4, and CDK6, showing strong selectivity against CDK4, which may help delay clinical resistance and reduce bone marrow suppression [2] - The China National Medical Products Administration (NMPA) accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer in July 2024, with a second indication application expected in July 2025 [2] - The company is actively advancing a Phase III clinical trial for Kumosili in adjuvant therapy for breast cancer, having completed patient enrollment, with plans to submit a marketing application in the next two years [2] Group 2 - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Core Insights - China Biologic Products (01177) announced the mid-analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules (CDK2/4/6 inhibitor), for first-line treatment of HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy in HR+/HER2- advanced breast cancer [1] - Kumosili shows selective inhibition of CDK4 kinase, which may help delay clinical resistance and reduce bone marrow suppression, potentially positioning it as a Best-in-Class therapy [1] Regulatory Developments - The Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer, expected to be reviewed by July 2024 [2] - A second indication for initial endocrine treatment in HR+/HER2- locally advanced or metastatic breast cancer is also under review, with an expected decision by July 2025 [2] - The company is advancing a Phase III clinical trial for Kumosili in adjuvant therapy, with all participants enrolled and a marketing application anticipated within the next two years [2] Market Potential - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Investment Rating - The industry is rated as "Positive" for the next 12 months, indicating an expected increase in performance relative to the CSI 300 index [7][71][82]. Core Insights - The report highlights a concentrated period of semi-annual performance forecasts, suggesting a focus on pipeline realization, performance growth, and business collaborations in innovative drugs and related industry chains [7][70]. - Recent policy adjustments by the National Medical Insurance Administration are expected to catalyze innovation and development within the industry [14]. - Notable acquisitions and drug approvals, such as Merck's $10 billion acquisition of Verona and the approval of new drugs like the Bcl-2 inhibitor by Ascentage Pharma, are significant developments [2][27][14]. Industry Data - As of July 10, 2025, the SW pharmaceutical industry has a TTM price-to-earnings ratio of 28.55, with a valuation premium of 144% compared to the CSI 300 index [5][61]. - The report notes a general upward trend in various sub-sectors, with the medical services sector leading at a 1.56% increase [5][54]. - The report also provides insights into the pricing trends of raw materials, such as vitamins and traditional Chinese medicine, indicating fluctuations and year-on-year changes [15][17]. Company Announcements - Ascentage Pharma's Bcl-2 inhibitor has received conditional approval from the NMPA for treating chronic lymphocytic leukemia [27]. - WuXi AppTec anticipates a revenue increase of approximately 20.64% for the first half of 2025, with a significant net profit growth of about 44.43% [28]. - Gan & Lee Pharmaceuticals expects a net profit increase of 100.73% to 114.12% for the same period [29].

Major Events - QianShi International (00381) subsidiary FuLao Investment signed a memorandum of understanding with Yanji Municipal Government for potential cooperation in digital economy-related businesses in Hong Kong [1] - Stone Pharmaceutical Group (02005) obtained production registration approval for potassium chloride and sodium chloride injection (500ml and 250ml) [1] - Basilea Pharmaceutica (02616) received approval from the National Medical Products Administration for the domestic production registration application of Prujita® (Pralsetinib capsules) [1] - United BioPharma (03933) received FDA approval for new drug clinical trials for UBT37034 injection [1] - China National Pharmaceutical Group (01177) had the application for the new indication of Kumosil capsules for first-line treatment of breast cancer accepted [1] - Oceanwide Holdings (08476) applied to the Stock Exchange for a transfer listing to the main board [1] Financial Data - Kaison Holdings (00102) reported a loss attributable to shareholders of approximately HKD 740 million for 2023, a shift from profit to loss year-on-year [1] - JiaoGe Friends Holdings (01450) achieved a cumulative GMV of approximately CNY 6.98 billion in the first half of the year, a year-on-year increase of approximately 17.11% [1] - Sunny Optical Technology (02382) reported a smartphone lens shipment of approximately 95.056 million units in June, a month-on-month decrease of 3.1% and a year-on-year decrease of 12.7% [1] - Fast Retailing (06288) announced a profit attributable to the parent company of JPY 339.099 billion for the first three quarters, a year-on-year increase of 8.4% [1] - Jianye Real Estate (00832) reported a total property contract sales of CNY 4.44 billion in the first half of the year, a year-on-year decrease of 1.2% [1] - China Lilang (01234) reported a mid-to-high single-digit year-on-year growth in retail sales of "LILANZ" products in the first half of the year [1]

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]