证券日报网讯 12月25日，华兰生物在互动平台回答投资者提问时表示，公司参股公司开展创新药和生 物类似药的研发、生产。贝伐珠单抗已于2024年11月取得药品注册证书，开始正式生产和销售；利妥昔 单抗、地舒单抗分别于2024年11月、2025年12月完成临床研究并递交药品注册上市许可申请并被受理； 阿达木单抗、曲妥珠单抗、伊匹木单抗、帕尼单抗、重组抗Claudin18.2全人源单克隆抗体注射液、重组 抗PD-L1和TGF-β双功能融合蛋白注射液、重组抗BCMA和CD3双特异性抗体注射液等已取得临床批 件，正在开展相关临床研究，为公司培育新的利润增长点，丰富公司的产品梯队。 （文章来源：证券日报） ...

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]

2025年，对百时美施贵宝（BMS）中国而言，是承前启后的关键之年。 如果说四十多年前，这家最早进入中国市场的来自美国的跨国药企，"看好"的是中国巨大的市场潜力； 那么今天，其在中国的战略重心已经从"开拓市场"转向"共建生态"。 百时美施贵宝副总裁、新任中国总经理钱江指出，BMS对中国的"看好"始终不变，但"看好"的内核已经 发生更迭。"今天，我们看好中国市场，不再仅仅把它视作为一个'销售市场'，而是将其定位为一个我 们能够与之'共同创新的生态系统'。在这里，双向赋能是路径，双向创新是目标。" 作为一位深耕医药行业近三十年的实干型领导者，钱江于2025年7月就任这一职位。他的履新本身就是 BMS与中国创新生态"双向赋能"的例证 —— 他曾任联拓生物首席商业官兼中国总经理。在BMS从联拓 生物获得在中国和其他亚洲市场开发和商业化全球首创心肌肌球蛋白抑制剂独家权利的合作过程中，双 方不仅达成了交易，也实现了人才与创新的互联、互通和互赢。 从"看好市场"到"看好市场且看好创新"，BMS早在2020年就前瞻性地在中国提出了公司的"中国2030战 略"。在这一"十年长期战略"行至半程之际，钱江为BMS中国团队明确了三件 ...

Core Viewpoint - Bristol-Myers Squibb (BMS) has shifted its perspective on the Chinese market from merely a sales opportunity to a collaborative innovation ecosystem, emphasizing mutual empowerment and innovation as key goals [2][3]. Group 1: Strategic Focus - The year 2025 is identified as a pivotal year for BMS in China, marking a transition from market expansion to ecosystem co-creation [2]. - BMS's "China 2030 Strategy," initiated in 2020, aims to maintain robust performance, integrate and lead innovation ecosystems, and enhance talent development [3]. - The three strategic focuses of performance, innovation, and talent are interrelated, forming a cohesive framework for BMS's operations in China [4]. Group 2: Performance as a Foundation - Performance encompasses not only commercial success but also the synchronization of Phase III clinical trials and new drug registrations with global standards [6]. - BMS has accelerated the introduction of innovative drugs in China, focusing on areas with unmet medical needs, including several first-in-class and best-in-class therapies [6]. - The company has successfully integrated five innovative products into the national medical insurance directory within a year of their launch, showcasing a new speed in market access [6][8]. Group 3: Innovation as an Engine - BMS aims to transition from being an innovator's "importer" to a leader within China's innovation ecosystem, emphasizing the importance of collaboration with local partners [11]. - The selection of partnerships is guided by strategic alignment with BMS's core disease areas and the potential for long-term value creation [12]. Group 4: Talent as a Bridge - BMS is building a talent pool that understands both the Chinese market and global dynamics, essential for executing its "China 2030 Strategy" [14]. - The company encourages cross-regional and cross-functional experiences to enhance employees' global perspectives while being rooted in local market needs [14]. Group 5: Long-term Vision - BMS remains committed to a patient-centered approach and innovation as its core competitive advantage, with a strong belief in the resilience and potential of the Chinese market [15].

Core Insights - Company announced the completion of the first patient dosing in a Phase 1 clinical trial for HLX13, a biosimilar of ipilimumab, for the treatment of unresectable hepatocellular carcinoma (HCC) in China [1] - The trial is a multicenter, randomized, double-blind, parallel-controlled study aimed at evaluating the pharmacokinetics, safety, efficacy, and immunogenicity of HLX13 compared to the original drug YERVOY® in previously untreated advanced HCC patients [1][2] - HLX13 is also being developed for multiple indications including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The global sales of ipilimumab are projected to be approximately $2.873 billion in 2024 [3] Group 1 - HLX13 is a biosimilar of ipilimumab, designed to enhance immune response by blocking CTLA-4, thereby targeting tumors [2] - The Phase 1 trial involves a 1:1 random allocation of participants to receive either HLX13 or YERVOY® combined with OPDIVO® treatment [1] - The primary endpoint of the trial is the area under the concentration-time curve (AUC) from dosing to 21 days post-administration [1] Group 2 - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023 [2] - The company has entered into a licensing agreement with Sandoz AG for the commercialization of HLX13 in the U.S. and select European regions, Japan, Australia, and Canada [2] - The sales figure for ipilimumab indicates a significant market potential for HLX13 as a biosimilar in the oncology sector [3]

Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients, and plans to conduct an international multi-center clinical trial in the U.S. [1] Group 1 - HLX13 is a biosimilar of ipilimumab, targeting multiple cancers including melanoma, renal cell carcinoma, colorectal cancer, HCC, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The mechanism of HLX13 involves blocking CTLA-4 to enhance immune response against tumors [2] - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023, and further approvals for other cancers were granted in November 2023 [2] Group 2 - In April 2025, the company signed a licensing agreement with Sandoz AG, granting exclusive rights for the commercialization of HLX13 in the U.S., certain European regions, Japan, Australia, and Canada [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four drugs, indicating a significant advancement in its oncology pipeline [1][2][3][4] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiaries have been granted clinical trial approval for SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, and Apatinib mesylate tablets [1][2][3][4] - SHR-8068 is a fully human anti-CTLA-4 monoclonal antibody aimed at enhancing anti-tumor immune effects, with a cumulative R&D investment of approximately 214 million yuan [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in March 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 887 million yuan [2] - Bevacizumab injection, a humanized anti-VEGF monoclonal antibody, was approved in June 2021, with a cumulative R&D investment of around 345 million yuan [3] - Apatinib mesylate tablets have been approved for three indications, with a cumulative R&D investment of approximately 587 million yuan [4] Group 2: Market Potential and Competitors - The global sales of similar products for SHR-8068, including Ipilimumab and Tremelimumab, are projected to be approximately 3.271 billion USD in 2024 [1] - The combined global sales for Adebali's competitors, Atezolizumab, Avelumab, and Durvalumab, are estimated to be around 9.648 billion USD in 2024 [2] - Bevacizumab's global sales are projected to be about 5.655 billion USD in 2024 [3] - The global sales for Apatinib's competitors, including Sorafenib, Sunitinib, and Pazopanib, are expected to total approximately 543 million USD in 2024 [4]

Core Viewpoint - The personalized neoantigen vaccine developed by Dana-Farber Cancer Institute shows significant potential in inducing strong immunity in melanoma patients, although its immunogenicity still requires enhancement [1][2]. Group 1 - The study published in the journal Cell highlights the development of a multi-adjuvant personalized neoantigen vaccine that effectively stimulates immunity in melanoma patients [1][2]. - The research involved testing a long peptide vaccine on 10 melanoma patients, utilizing two adjuvants, Montanide and poly-ICLC, in conjunction with local injection of Ipilimumab and systemic use of Nivolumab [4]. - Among the 9 patients who completed vaccination, the personalized vaccines induced ex vivo T cell responses targeting most neoantigens, with 6 patients generating ex vivo CD8+ T cell responses [5]. Group 2 - Key findings of the study include the ability of most neoantigens to induce ex vivo T cell responses, including CD8+ cell responses [8]. - The vaccine induced dynamic changes in myeloid cell populations at the injection site [8]. - The neoantigen vaccination reshaped the T cell receptor repertoire specific to tumors beyond anti-PD-1 treatment, revealing vaccine-specific tumor-infiltrating lymphocytes (TIL) through TCR reconstruction and antigen screening [8].

Core Viewpoint - Immune checkpoint inhibitors (ICIs) have transformed the treatment of various solid tumors, but resistance remains a significant challenge, particularly in advanced and recurrent ovarian cancer, where response rates to single-agent PD-1/PD-L1 inhibitors are only 5%-15% [2][3] Group 1: Research Findings - A study published in Nature by a team from MD Anderson Cancer Center found that patients with PPP2R1A gene mutations had significantly improved survival after receiving combined anti-PD-1/PD-L1 and anti-CTLA-4 immunotherapy compared to those with wild-type PPP2R1A [3][6] - The presence of PPP2R1A mutations enhances tumor response to immunotherapy, and this finding was validated across various cancer types in clinical cohorts [3][9] - In recurrent ovarian cancer, dual targeting of PD-1/PD-L1 and CTLA-4 showed a response rate of 31.4% compared to 12.2% for single-agent PD-1 therapy, indicating a potential benefit for patients with ovarian clear cell carcinoma (OCCC) [5][6] Group 2: Clinical Implications - The study suggests that targeting PPP2R1A could represent an effective strategy to improve outcomes for cancer patients undergoing immunotherapy [9] - Enhanced immune cell infiltration and signaling pathways were observed in tumors with PPP2R1A mutations, indicating a more favorable immune environment for treatment [8] - The research team is conducting prospective trials to explore the efficacy of dual immune checkpoint blockade in OCCC patients, particularly those with platinum-resistant disease [5][6]

Group 1: Financial Performance - In Q1 2025, the company achieved revenue of 867.61 million yuan, a year-on-year increase of 10.2% [3] - Net profit attributable to shareholders was 313.14 million yuan, up 19.62% compared to the same period last year [3] - Net profit excluding non-recurring gains and losses decreased by 35.35% to 299.74 million yuan [3] Group 2: Market Dynamics - The supply of blood products in China is relatively insufficient compared to Europe and the US, indicating significant growth potential in the domestic market [3] - The import volume of human albumin is expected to account for 68% of total approvals in 2024, creating competitive pressure on domestic products [3] - The company’s main product prices remained stable in Q1 2025 compared to the previous year [3] Group 3: Product Development - The company has begun generating sales revenue from Bevacizumab since Q1 2025, following its registration in late 2024 [4] - Several new products are expected to be launched in the next 1-3 years, including Rituximab, which is currently under review [4] Group 4: Operational Efficiency - The company plans to enhance operational efficiency through improved management, increased investment in information technology, and a focus on quality management [4] - In 2024, the company aims to increase plasma collection by enhancing recruitment efforts and upgrading management systems [6] Group 5: Dividend Policy - The company has distributed a total of 5.34 billion yuan in dividends since its listing, with a payout ratio of 30% of net profit planned for 2024-2026 [5] - The dividend amount is 8.52 times the financing amount of 626 million yuan [5] Group 6: Industry Trends - The blood products industry is experiencing consolidation, with the top five companies holding 80%-85% of the market share globally [6] - The company is open to participating in mergers and acquisitions if suitable opportunities arise [6] Group 7: Vaccine Market Strategy - The company plans to adjust the price of its quadrivalent influenza vaccine to enhance market competitiveness [6] - Despite a decline in overall vaccine industry revenue, the company maintains the highest market share and vaccination rates [6]