其三，港股生物医药板块2026年将有重要亮点。 短期港股波动根源：存款搬家 最近1个多月的港股走势让许多朋友很是困惑，一方面美元指数重新跌破100（自11月下旬跌穿100后持续于100楼下徘 徊），对于采用联系汇率的香港资本市场显然是一大利好，但另一方面恒生指数同期表现却畏缩不前，头部科技企业 集中的恒生科技指数更是出现了较大幅度的回调（恒指及科指今年开局两周以来仅稍稍反攻上月的颓势，微升3.34% 及3.04%）。 与之所对应的乃是生物医药板块的"大爆发"，如进入2026年后映恩生物(09606.HK)涨幅已经一度超过20%，信达生物 (01801.HK)开局以来亦一度升更一成，行业中小规模企业的李氏大药厂(00950.HK)亦曾见半成涨幅。 站在2026年初这个时点，我们不妨重新梳理对港股的分析框架，以展望2026年的香港资本市场。 本文核心观点： 其一，近期港股的波动主要源自存款搬家导致的流动性收缩，不会改变中后期向好的趋势； 其二，上述风险将随着新任美联储主席的撬动而得到缓释； 在此之前我们将"离岸人民币"视为港股流动性的锚，从而产生"离岸人民币升值——市场买入人民币抛港币——港币流 动性充盈——资本 ...

Group 1 - The core viewpoint of the news is that China Biologic Products Holdings (01177.HK) has seen significant insider buying from its executive director, demonstrating confidence in the company's long-term growth potential [1] - Executive Vice President Xie Xin purchased 1 million shares at an average price of HKD 6.4068 per share, totaling approximately HKD 6.4068 million, increasing his total holdings to 361 million shares, representing 1.92% of the company [1] - This marks Xie Xin's third purchase since July 2025, with previous acquisitions in July and August 2025 at average prices of HKD 6.47 and HKD 7.36 per share, respectively, indicating a total investment of over HKD 20 million in the past six months [1] Group 2 - The company announced that its innovative drug pipeline has achieved significant milestones since December last year, including the approval of the breast cancer drug Kemosil Capsules, the first global CDK2/4/6 inhibitor [2] - The oral GLP-1 receptor agonist TQF3250 for weight loss has received clinical application approvals from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) [2] - The TYK2/JAK1 inhibitor TQH3906 has shown positive progress in Phase II clinical trials for plaque psoriasis, and the ROCK2 inhibitor TDI01 has enrolled its first patient in a Phase III clinical trial for idiopathic pulmonary fibrosis, marking it as the first globally to enter this stage [2]

Group 1 - The core point of the news is that China Biologic Products (01177.HK) has seen significant insider buying from its executive director, demonstrating confidence in the company's long-term development [1] - Executive Vice President Xie Xin purchased 1 million shares at an average price of HKD 6.4068 per share, totaling approximately HKD 6.4068 million, increasing his holdings to 361 million shares, representing 1.92% of the company [1] - This marks Xie Xin's third purchase since July 2025, with previous purchases made at average prices of HKD 6.47 and HKD 7.36, indicating a total investment of over HKD 20 million in the past six months [1] Group 2 - The mid-year report for 2025 indicates that China Biologic Products' innovative transformation is showing significant results, with expectations that revenue from innovative products will exceed 50% of total revenue [2] - The company has achieved several milestones since December last year, including the approval of the breast cancer innovative drug Kemosil capsules, which is the world's first CDK2/4/6 inhibitor [2] - Other notable advancements include the clinical application approvals for the oral GLP-1 receptor agonist TQF3250 for weight loss by both the NMPA and FDA, and positive progress in the phase II clinical trial of the TYK2/JAK1 inhibitor TQH3906 for plaque psoriasis [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].

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 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].