【"十四五"答卷·创新驱动产业蝶变】 短短两天，国产创新药物就开出了5张出海大单，其中多个交易总金额超10亿美元。10月16日，深 圳普瑞金生物药业股份有限公司与美国吉利德科学公司旗下细胞疗法公司Kite Pharma就体内原位编辑 疗法达成合作，交易潜在总金额达16.4亿美元；17日，翰森制药集团有限公司与瑞士罗氏集团就靶向抗 体偶联创新药物达成许可协议，交易潜在总金额达15.3亿美元……前沿领域、创新靶点、国际大单，中 国生物医药产业的创新实力不仅获得国际认可，也得到跨国大药企的信任与垂青。 生物医药产业里从不缺乏新赛道。"十四五"期间，我国生物医药产业精准把握技术革命与需求升级 契机，构建起创新引领的产业发展格局，在纳米载体、抗体偶联药物等多个新赛道逐浪潮头。 研发实力，国际认可 10月17日，中国1类新药库莫西利胶囊在2025年欧洲肿瘤内科学会年会上发布了临床数据报告。这 一新型细胞周期依赖性激酶（CDK2/4/6）抑制剂由正大天晴药业集团股份有限公司自主研制。 近年来，登上国际学术大会报告台的中国新药临床试验不断增加，通过临床试验直接对标国际明星 药物的中国创新药也不断以硬核数据证明实力。安罗替尼联 ...

"十四五"期间，国产创新药获批上市数量稳步上升，出海交易屡爆大单，完成了从"量的积累"到"质的 飞跃"的深刻蝶变。生物医药产业创新生态持续完善，全球竞争力显著提升，不仅成为经济高质量发展 的"硬核"增长极，更在国际生物医药舞台上实现了从"跟跑者"到"关键贡献者"的转变。 把握机遇，逐浪潮头 短短两天，国产创新药物就开出了5张出海大单，其中多个交易总金额超10亿美元。10月16日，深圳普 瑞金生物药业股份有限公司与美国吉利德科学公司旗下细胞疗法公司Kite Pharma就体内原位编辑疗法 达成合作，交易潜在总金额达16.4亿美元；17日，翰森制药集团有限公司与瑞士罗氏集团就靶向抗体偶 联创新药物达成许可协议，交易潜在总金额达15.3亿美元……前沿领域、创新靶点、国际大单，中国生 物医药产业的创新实力不仅获得国际认可，也得到跨国大药企的信任与垂青。 10月17日，中国1类新药库莫西利胶囊在2025年欧洲肿瘤内科学会年会上发布了临床数据报告。这一新 型细胞周期依赖性激酶（CDK2/4/6）抑制剂由正大天晴药业集团股份有限公司自主研制。 近年来，登上国际学术大会报告台的中国新药临床试验不断增加，通过临床试验直接对标国 ...

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]