Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Insights - The report highlights the promising data from CTLA-4 drugs, suggesting potential investment opportunities in related areas [3][5] - The pharmaceutical index experienced a slight decline of 0.14% from December 15 to December 19, 2025, but showed a relative outperformance of 0.14% against the CSI 300 index [5] - The report emphasizes the importance of innovative drugs as a key investment theme for 2026, with a focus on companies that are expected to show clear performance trends and potential reversals in operations [5][41] Summary by Sections 1. CTLA-4 Target - CTLA-4 is identified as a significant immune checkpoint that can inhibit T cell activation, presenting potential value in cancer immunotherapy [8][9] - The CTLA-4 monoclonal antibody Gotistobart shows promising clinical trial results for squamous non-small cell lung cancer (sqNSCLC) patients who are resistant to immunotherapy [14][15] - Gotistobart's innovative mechanism targets Treg cells in the tumor microenvironment, potentially leading to a new paradigm in tumor immunotherapy [20][24] 2. Industry Perspective - The report maintains that innovative drugs should be the main focus for the year, while also considering manufacturing exports and aging-related consumption as relatively undervalued assets [25][41] - The pharmaceutical index has shown a year-to-date increase of 14.49%, with a notable number of stocks experiencing significant gains [25][26] - The report suggests that the Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs opening new growth avenues for companies [41][42] 3. Investment Recommendations - Recommended stocks include innovative drug companies such as Xinyi Tai, Zai Jian Pharmaceutical, and others, as well as companies in the medical device sector [5][45] - The report advises focusing on companies with strong performance trends and those expected to benefit from the aging population and outpatient consumption [42][44] - The report also highlights the potential of AI in the pharmaceutical sector, suggesting that related stocks may perform well in the coming years [42][44]

港股止跌，整个早盘都维持在中轴附近窄幅盘整，大消费和科技小幅收红，互联网和医疗走了和寂寞。 大消费探底回升后震荡上行，截止午盘小涨0.32%。其中李宁都在4.37%，申洲国际上涨2.26%，石药集 团、老铺黄金、药明生物、泡泡玛特等股涨幅均在1%上方；创科实业、小鹏汽车、地平线等股逆势绿 盘。 科技股开盘一直围绕中轴盘整，截止午盘小涨0.14%。其中美团上涨1.21%，京东集团、阿里巴巴、腾 讯控股、中芯国际等股均小幅收涨；比亚迪股份、网易等股逆势小跌。 恒生医疗走了个寂寞，其中石药集团上涨1.9%，药明生物上涨1.68%，百济神州、信达生物、三生制药 等股均小幅收涨；康方生物、中国生物、京东健康、翰森制药等股均小幅收跌。 内容只是个人观点，仅供参考，不作为投资依据！欢迎关注交流，互相学习、共同探讨！ ...

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 1.91% on December 16, with a trading volume of 1.078 billion yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of December 15, 2024, the fund's total shares reached 10.425 billion, with a total size of 8.174 billion yuan, reflecting a significant increase in shares and size compared to the previous year [1] Fund Performance - The fund manager, Ma Jun, has achieved a return of 64.28% since taking over management on January 3, 2024 [2] - The fund's performance benchmark is the National Index of Hong Kong Innovative Drugs, adjusted for valuation exchange rates [1] Holdings Overview - Major holdings in the fund include: - BeiGene (10.62% holding, market value 817 million yuan) - CanSino Biologics (10.55% holding, market value 812 million yuan) - Innovent Biologics (10.21% holding, market value 786 million yuan) - China National Pharmaceutical Group (9.62% holding, market value 741 million yuan) - CSPC Pharmaceutical Group (7.56% holding, market value 583 million yuan) [2]

中国生物制药(01177.HK)公布，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。 本文源自：金融界AI电报 ...

Group 1 - The core point of the news is that China National Pharmaceutical Group has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Kumosili Capsule (brand name: Saitanxin), for use in combination with Fulvestrant to treat hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer patients who have previously undergone endocrine therapy [1][2] - Kumosili is a world-first triple inhibitor targeting CDK2/4/6, showing varying degrees of inhibition on CDK2, CDK4, and CDK6 kinases, with a strong selective inhibition capability on CDK4 kinase [1] - The unique mechanism of action of Kumosili helps delay the resistance issues associated with CDK4/6 inhibitors in clinical settings and reduces the risk of bone marrow suppression [1] Group 2 - In the pivotal Phase III clinical trial (TQB3616-III-01), the combination of Kumosili and Fulvestrant demonstrated encouraging efficacy, with a median progression-free survival (mPFS) of 16.62 months, significantly extending the mPFS by 9.16 months compared to the Fulvestrant group (7.46 months), and reducing the risk of disease progression or death by 64% (HR=0.36, p<0.0001) [2] - The objective response rate (ORR) significantly improved to 40.21% compared to 12.12% in the Fulvestrant group (p<0.0001) [2] - The most common treatment-related adverse events (TRAEs) were mostly grade 1-2 and manageable; grade 3 or higher hematological toxicities, such as bone marrow suppression, were low; no TRAEs led to treatment discontinuation or death, indicating overall safety and tolerability [2] - In addition to the approved second-line treatment indication, a first-line HR+/HER2- breast cancer indication for Kumosili in combination with Fulvestrant has been submitted to NMPA for approval in July 2025, and the Phase III clinical trial for its adjuvant treatment indication has completed patient enrollment, with gradual approvals expected in the next two years [2]

Core Viewpoint - China Biologic Products (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Kumosily, for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer patients who have experienced disease progression after endocrine therapy [1][2]. Group 1: Drug Approval and Mechanism - Kumosily is a globally first-in-class triple inhibitor targeting CDK2/4/6, showing selective inhibition of CDK4 kinase, which helps delay resistance to CDK4/6 inhibitors and reduces the risk of bone marrow suppression [1]. - The drug has been approved for use in combination with Fulvestrant for second-line treatment [1]. Group 2: Clinical Trial Results - In the pivotal Phase III clinical trial (TQB3616-III-01), the combination of Kumosily and Fulvestrant demonstrated a median progression-free survival (mPFS) of 16.62 months, significantly extending the mPFS by 9.16 months compared to the Fulvestrant group (7.46 months) [2]. - The risk of disease progression or death was reduced by 64% (HR=0.36, p<0.0001), and the objective response rate (ORR) increased significantly to 40.21% compared to 12.12% (p<0.0001) [2]. - Most treatment-related adverse events (TRAEs) were manageable and of grade 1-2, with minimal grade ≥3 hematological toxicity, and no TRAEs leading to treatment discontinuation or death [2]. Group 3: Future Development and Pipeline - Besides the approved second-line indication, a first-line application for HR+/HER2- breast cancer has been submitted to NMPA, with expectations for approval by July 2025 [3]. - The company has completed patient enrollment for the Phase III clinical trial for the adjuvant treatment indication, aiming for gradual approvals in the next two years [3]. - The company is focused on the breast cancer field, developing a pipeline that covers all molecular subtypes, including HR-positive, HER2-positive, low HER2 expression, and triple-negative breast cancer, with a comprehensive treatment strategy from new adjuvant to later lines [3].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 「庫莫西利膠囊」獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團自 主研發的國家1類創新藥庫莫西利膠囊 (商品名：賽坦欣®) 已獲得中國國家藥品監督管理局 (NMPA) 的上市批准，用於與氟維司群聯合治療既往接受內分泌治療後出現疾病進展的激素受體 (HR) 陽性、 人表皮生長因子受體2 (HER2) 陰性的局部晚期或轉移性乳腺癌患者。 參考文獻： 承董事會命 庫莫西利是全球首創的同時靶向CDK2/4/6的三重抑制劑，對CDK2、CDK4、CDK6激酶有不同程度 的抑制效果，且對CDK4激酶有較強的選擇性抑制能力。基於其獨特的作用機制，庫莫西利不僅有助 於延緩臨床中CDK4/6抑制劑的耐藥問題，還可以減輕骨髓抑制風險[1]。 在關鍵I ...

Core Viewpoint - The approval of the first global CDK2/4/6 inhibitor, Kumosiliz, by China National Pharmaceutical Group's subsidiary, marks a significant advancement in targeted therapy for HR+/HER2- advanced or metastatic breast cancer in China, positioning the country in the international arena of breast cancer treatment [1][4]. Group 1: Product Approval and Efficacy - Kumosiliz's approval is based on the CULMINATE-1 study, which demonstrated significant improvement in median progression-free survival (PFS) when combined with Fulvestrant compared to Fulvestrant alone, reducing the risk of disease progression or death in HR+/HER2- advanced breast cancer [1][2]. - The unique molecular design of Kumosiliz allows for precise targeting of CDK4 while enhancing binding to CDK2, with a weaker inhibitory effect on CDK6, thereby reducing the risk of bone marrow suppression associated with traditional CDK4/6 inhibitors [1]. Group 2: Market Potential and Strategic Positioning - Analysts have identified Kumosiliz as a potential "blockbuster" drug, with peak sales in China projected to exceed 2 billion yuan [3]. - China National Pharmaceutical Group is expanding Kumosiliz's indications, including first-line treatment for HR+/HER2- advanced breast cancer and adjuvant therapy for HR+ early breast cancer, indicating a strategic approach to capture a larger market share [3]. - The breast cancer treatment market is rapidly growing, and the company is not relying solely on Kumosiliz but is also developing a comprehensive portfolio of therapies across various breast cancer subtypes and treatment stages [3][4]. Group 3: Comprehensive Product Portfolio - The company has established a robust portfolio of foundational drugs for breast cancer, including already marketed products such as Fulvestrant injection and Trastuzumab injection, positioning itself to leverage the launch of Kumosiliz [4]. - With the launch of Kumosiliz, the company is expected to transition from a single product focus to a cluster of breakthrough products in the breast cancer treatment space, supported by a full-spectrum product matrix covering all molecular subtypes and treatment cycles [4].

Core Viewpoint - China National Pharmaceutical Group announced that its subsidiary, Chengdu Tianqing, received approval for the CDK2/4/6 inhibitor, Kemosir Capsule (brand name: Saitanxin), for the treatment of HR+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine therapy [1] Group 1: Product Development and Market Position - The company is expanding the indications for Kemosir, including first-line treatment for HR+/HER2- advanced breast cancer in combination with Fulvestrant and adjuvant therapy for HR+ early breast cancer [1] - The breast cancer treatment market is growing, becoming one of the most competitive areas for innovative drugs globally [1] - The company has established a comprehensive portfolio in the breast cancer field, covering various molecular subtypes such as HER2 positive (HER2+), low HER2 expression, HR positive (HR+/HER2-), and triple-negative breast cancer (TNBC) [1] Group 2: Comprehensive Treatment Coverage - The company systematically covers the entire treatment cycle for breast cancer, including adjuvant therapy, first-line, second-line, and neoadjuvant treatment scenarios, aiming to provide new treatment options for more patients [1] - In addition to Kemosir in the HR+/HER2- field, the company has differentiated products such as TQB2102 (HER2 dual antibody ADC), TQB3126 (ER-PROTAC), and TQB3202 (PI3Kα) [1] - The company has fully established a portfolio of mainstream foundational drugs for breast cancer, including already marketed products such as Qingkeyi (Fulvestrant injection), Qingweishi (Everolimus tablets), Saituo (Trastuzumab injection), Paletan (Pertuzumab injection), and Qingweiyi (Palbociclib capsules) [2]

Core Viewpoint - The innovation drug sector in China is experiencing significant growth due to favorable policy developments, with the introduction of new drug listings in the national medical insurance catalog and commercial insurance, providing a stable policy outlook for innovative drug companies [1][2]. Group 1: Industry Trends - The China Hong Kong Stock Connect Innovation Drug Index increased by 0.30% as of December 11, 2025, with notable gains from companies such as Zhaoyan New Drug (+4.15%) and Rongchang Bio (+2.85%) [1]. - The national medical insurance catalog for 2025 successfully added 114 new drugs, including 50 innovative drugs, achieving a historical high success rate of 88% [1]. - The introduction of dual catalogs for medical insurance and commercial insurance is expected to directly benefit innovative drug companies, indicating a positive industry outlook [1]. Group 2: Market Opportunities - The top ten weighted stocks in the China Hong Kong Stock Connect Innovation Drug Index account for 72.68% of the index, highlighting the concentration of investment in leading innovative drug companies [2]. - The Harvest Innovation Drug ETF (520970) closely tracks the index, providing investors with access to leading companies involved in drug research, development, and production [2]. - Investors without stock accounts can leverage the Hong Kong Stock Connect Innovation Drug ETF linked fund (024700) to capitalize on the growth opportunities in the innovative drug sector [2].