21世纪经济报道记者季媛媛 淋巴瘤是严重威胁人类健康的血液肿瘤之一，在众多类型中，滤泡性淋巴瘤（FL）是最常见的惰性淋 巴瘤。 近年来，随着我国人口老龄化的加剧及诊断水平的提高，滤泡性淋巴瘤的发病率呈逐年上升趋势。尽管 滤泡性淋巴瘤被称为"惰性"淋巴瘤，但其极易复发和难以治愈的特性为治疗带来极大挑战。 近期，第67届美国血液学会（ASH）年会落下帷幕。作为全球血液学领域的风向标，大会公布了淋巴瘤 领域的多项重磅进展。借此契机，中国女医师协会血液学分会主任委员、浙江大学医学院附属第一医院 血液科主任医师金洁教授在接受21世纪经济报道记者采访时表示，近年来滤泡性淋巴瘤的治疗进展颇为 显著。例如，抗体类药物中已有人源化单克隆抗体应用于临床，这一成果虽已问世一段时间，但仍属重 要治疗进展。此外，CD3/CD20双特异性抗体药物、CAR-T治疗（嵌合抗原受体T细胞免疫疗法）、 BTK抑制剂等靶向药物等新方案也相继涌现，使得临床可依据患者自身诉求及疾病整体状况，为其选择 适宜的治疗方式。 "这些新药在不同临床场景下切实提升了治疗效果，也为患者提供了新的选择。部分患者因惧怕化疗副 作用且经济条件允许，此时可直接推荐更合适的 ...

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） ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ （来源：医学界） 转自：医学界 重症肌无力（MG）是一种由自身抗体介导、获得性的神经肌肉接头（NMJ）疾病，其核心特征是骨骼 肌无力和易疲劳性[1]。当肌无力症状超出眼外肌范围，累及到球部（如吞咽、构音）、四肢和躯干肌 肉时，即称为全身型重症肌无力（ MG），gMG约占所有MG病例的85%，是MG中最常见的亚型[2]。 此类患者在临床上常常面临哪些治疗困境？随着当前研究进展又有哪些破局之法？针对这些问题，医学 界有幸邀请到首都医科大学宣武医院笪宇威教授就gMG治疗困境、MG指南更新及gMG治疗新策略等方 面进行了深度分享。 起效慢、不良反应明显：传统治疗方案局限凸显靶向治疗需求 针对gMG治疗困境，笪宇威教授指出，尽管大部分患者在常规非特异性免疫治疗（激素和非激素类免 疫抑制剂）下可明显改善症状，但这些药物存在明显的局限性。首当其冲的是长期口服糖皮质激素所带 来的不良反应，激素治疗的并发症会进一步增加疾病治疗的负担，同时有10%~20%的患者对常规免疫 治疗药物反应有限，不能耐受药物不良反应或存在激素禁忌症的患者会陷入治疗困境，从而发展 ...

Core Viewpoint - Fuhong Hanlin (复宏汉霖) is positioned as a leading player in the biosimilar drug market in China, focusing on hematological malignancies, solid tumors, and autoimmune diseases, with a strong emphasis on international collaboration and product commercialization [1][2] Group 1: Business Performance - In 2023, the company achieved profitability with projected revenue of 5.724 billion yuan in 2024, representing a 6% year-on-year growth, and a net profit of 815 million yuan, reflecting a 50% increase compared to the previous year [2] - The company is expected to enter a high-growth phase in overseas business by 2025, with overseas product profits projected to grow over 200% in the first half of 2025 [2] Group 2: Product Pipeline and R&D - HLX43, a potential BICPD-L1ADC, is under clinical development for multiple indications including lung cancer and gastric cancer, showing significant efficacy in clinical trials with an overall response rate (ORR) of 33.3% for squamous NSCLC and 48.6% for non-squamous NSCLC [3] - HLX22, in combination with trastuzumab, has shown improved efficacy and safety in treating HER2-positive gastric/gastroesophageal junction cancer, with ongoing global Phase III trials [3] - The company is also advancing the development of Surulitinib, which aims to replace postoperative chemotherapy in gastric cancer with immunotherapy, having met primary clinical endpoints [3] Group 3: Market Strategy and Valuation - The company has established a global presence with its biosimilar products, which are key drivers of revenue growth, and is considering implementing full circulation of H-shares to enhance liquidity [4] - The projected net profits for 2025-2027 are estimated at 823 million, 744 million, and 1.129 billion yuan respectively, with corresponding price-to-earnings ratios of 39, 43, and 28, suggesting a total market valuation between 52.1 billion and 67.9 billion yuan [4]

Summary of the Conference Call for Ascentage Pharma Company Overview - **Company**: Ascentage Pharma - **Focus**: Development of innovative therapies for hematological malignancies and solid tumors Key Points from the Conference Call Clinical Data and Drug Development - **Lisatoclax**: - Achieved a 63% overall response rate (ORR) in patients with relapsed/refractory Chronic Lymphocytic Leukemia (CLL) [2][5] - Notable safety profile with low incidence of severe adverse events [5] - Approved in July 2025, demonstrating rapid development within 11 years [3] - **Orebacitinib (耐立克)**: - In first-line treatment for Ph+ Acute Lymphoblastic Leukemia (ALL), achieved a 64% MRD-negative complete response rate (CRR) at 3 months, outperforming the Falcon Trial [2][9] - In second-line treatment, both Major Molecular Response (MMR) and CRR rates improved over time, especially in patients previously treated with dasatinib or nilotinib [10] - **FGFR Rearrangement in Hematological Malignancies**: - Research led by Professor Chen Shulin showed significant responses in patients with rare FGFR rearrangements, with 5 achieving complete molecular remission [12] - **EED Inhibitors**: - Showed potential in models of anemia and multiple myeloma, with effects comparable or superior to Forcan's drugs [2][14] - Ongoing Phase I clinical trials for multiple indications [2] Regulatory and Market Position - **Global Clinical Trials**: - Significant progress in global registration trials, with multiple studies receiving FDA and EMA approvals [8] - Focus on addressing unmet clinical needs in MDS, with potential to be the first approved BCL-2 selective inhibitor for MDS [8] - **Competitive Landscape**: - Ascentage Pharma has established a strong position in the BCL-2 inhibitor market, with ongoing trials in AML and MDS [21][22] - Plans to consolidate market position through monotherapy and combination therapies [22] Future Directions - **ALL Treatment Plans**: - Advancing the combination of Orebacitinib and 2,575 for ALL, exploring chemotherapy-free options [20] - **MDS and MM Developments**: - Continued focus on MDS with plans for registration studies and addressing challenges in treatment [17][23] - BCL-2 inhibitors remain a key strategy for high-risk MDS treatment [18] - **EED Inhibitor Development**: - Despite challenges, Ascentage Pharma is leading in EED inhibitor research, with promising early results in anemia treatment [24][26] Additional Insights - **Safety and Efficacy**: - Lisatoclax demonstrated a low incidence of tumor lysis syndrome (TIS), attributed to its short half-life and effective preventive measures [16] - **Market Potential**: - The anemia market is considered larger than the lymphoma market, with ongoing research into various anemia types [26] - **Collaboration and Innovation**: - Emphasis on innovative clinical trials and collaborations to meet the needs of hematological cancer patients globally [28] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Ascentage Pharma's advancements in drug development, regulatory achievements, and strategic positioning in the market.

Core Viewpoint - The recent downturn in the Hong Kong innovative drug market has shifted investor focus towards the core value of pharmaceutical companies, with Fuhong Hanlin being a notable beneficiary of this trend, experiencing significant stock price increases and financial returns [1][2][3]. Group 1: Company Overview - Fuhong Hanlin, established in 2010, initially focused on developing biosimilars targeting blockbuster original drugs, covering areas such as oncology and autoimmune diseases [2]. - The company has achieved substantial financial returns early on, with total revenue of 2.8 billion yuan and a net profit of 390 million yuan in the first half of this year [3]. Group 2: Product Pipeline and Strategy - Fuhong Hanlin is shifting its focus towards innovative drugs as its biosimilar business matures, which is seen as a crucial path for overcoming growth ceilings [5]. - The company’s core innovative drug pipeline includes the PD-1 drug, H drug, which has shown promising results in clinical trials for gastric cancer and is expected to generate significant global sales [7][8]. Group 3: Market Expansion and Clinical Development - H drug is projected to reach global sales of 5 billion USD, with a focus on expanding into the U.S. market after initial approvals in Southeast Asia and the EU [8][9]. - The company aims to establish a clinical development capability that spans from clinical trials to product registration and GMP production, enhancing its competitiveness in the U.S. market [9]. Group 4: Innovative Approaches and Future Directions - Fuhong Hanlin is exploring differentiated indications based on clinical needs, particularly in areas where competitors have failed, such as perioperative treatment for gastric cancer [10][11]. - The company emphasizes the importance of addressing unmet clinical needs and adapting to regulatory environments to successfully penetrate local markets [12]. Group 5: Research and Development Investments - Fuhong Hanlin is investing heavily in its research pipeline, including a PD-L1 ADC drug, HLX43, which aims to address limitations of existing therapies and has shown promising early clinical results [14][15]. - The company is also developing HLX22 for HER2-positive advanced gastric cancer, with significant investment aimed at improving patient outcomes and expanding market potential [16].

Summary of the Conference Call for 福翁翰林 Company Overview - 福翁翰林 has nearly 50 high-quality product pipelines, including established products like Rituximab, Trastuzumab, and Bevacizumab, which are entering a growth phase, supporting revenue and profit margin increases [2][3][6] - The company has launched four commercialized biosimilars, including Rituximab and Trastuzumab, with projected revenue of 7.013 billion RMB by 2027 [3][15] Key Products and Developments - **Helix 43**: A PD-L1 ADC asset with global Best in Class potential, it is the second PD-L1 ADC to enter clinical trials globally and the first in China. Phase I clinical data shows an ORR of 36.8% and a DCR of 100% in brain metastasis patients [2][5][9] - **Helix 22**: An innovative HER2 monoclonal antibody recognized as an orphan drug by the FDA and Europe for gastric cancer treatment. Phase II clinical data shows a 24-month PFS rate of 54.8% and an ORR of 87.1% [2][11] - **斯鲁利单抗**: The first PD-1 monoclonal antibody approved for extensive small cell lung cancer, with global revenue reaching 1.3 billion RMB by 2024, covering 40 countries [2][12][13] - **Combination Trials**: 斯鲁利单抗 combined with Bevacizumab and chemotherapy in a Phase III trial for first-line colorectal cancer shows significant survival extension and good safety data [2][14] Clinical Trials and Market Potential - 福翁翰林 is conducting over 30 clinical trials covering 19 products, with potential for international licensing [3][5] - The company is in the internationalization 2.0 phase, with a comprehensive pipeline including protein drugs, ADCs, and small molecules targeting oncology and autoimmune diseases [6][7] Financial Performance and Future Outlook - The company has shown good financial health with revenue growth supported by commercialized products and effective cost control, leading to stable cash flow [6][7] - Plans for full circulation of Hong Kong stocks are expected to enhance liquidity and attract more capital market opportunities [4][6] Competitive Landscape - The global biosimilar market is projected to grow significantly, with 福翁翰林 positioned to capitalize on this trend through its established products and ongoing clinical developments [15][16] International Collaboration - 福翁翰林 utilizes a License out model to expand its international market presence and collaborates with high-quality partners to enhance its product offerings [16][17] Conclusion - 福翁翰林's strong R&D capabilities, mature commercialized products, and robust financial performance position it for continued rapid growth in the biopharmaceutical industry [6][7]

Core Insights - The company reported a total operating revenue of 1.798 billion yuan for H1 2025, representing an 8.8% year-on-year increase, and a net profit attributable to shareholders of 516 million yuan, up 17.19% [1] - The blood products segment showed steady growth with revenue of 1.737 billion yuan in H1 2025, a 7.57% increase, and a gross margin of 51.69% [1][2] - The vaccine segment achieved significant growth with a revenue of 57 million yuan, a 92.63% increase, despite challenges from price reductions and fluctuating vaccination rates [2] - The company demonstrated improved profitability with a net profit margin of 28.69%, up 2.06 percentage points year-on-year, and announced a mid-year dividend plan of 5 yuan per 10 shares, totaling approximately 914 million yuan [3] Financial Performance - H1 2025 total operating revenue: 1.798 billion yuan, up 8.8% [1] - H1 2025 net profit attributable to shareholders: 516 million yuan, up 17.19% [1] - H1 2025 gross margin for blood products: 51.69%, up 1.59 percentage points [1] - H1 2025 net profit margin: 28.69%, up 2.06 percentage points [3] Segment Performance - Blood products revenue: 1.737 billion yuan in H1 2025, up 7.57% [1] - Vaccine revenue: 57 million yuan in H1 2025, up 92.63% [2] - Clinical progress in vaccines includes completion of Phase III for certain products and ongoing clinical trials for others [2] Future Outlook - The company expects steady growth in plasma collection due to the operational commencement of the Fengdu plasma collection station and the upcoming peak collection season [1] - Earnings per share (EPS) projections for 2025-2027 are 0.71 yuan, 0.76 yuan, and 0.80 yuan respectively [4]

Investment Rating - The report maintains a "Recommended" rating for Hualan Biological (002007.SZ) [8] Core Views - The blood products segment shows steady growth, with the number of plasma stations and average plasma collection volume leading the industry [5] - The vaccine segment, particularly rabies vaccines, has seen significant revenue growth, while the launch of biosimilars is expected to contribute additional revenue [6] - The company has adjusted its profit forecasts for 2025-2026 and added a new forecast for 2027, estimating net profit attributable to shareholders at 12.45 billion, 14.76 billion, and 16.78 billion respectively [8] Summary by Sections Company Overview - Hualan Biological operates in the pharmaceutical industry, with a total market capitalization of 32.2 billion yuan and a total share capital of 1,827 million shares [1] Financial Performance - In the first half of 2025, the company achieved revenue of 1.798 billion yuan (yoy +8.80%) and a net profit of 516 million yuan (yoy +17.19%) [4] - The blood products segment generated revenue of 1.737 billion yuan (yoy +7.57%), with a gross margin of 51.69% [5] Future Projections - Revenue projections for 2024A, 2025E, 2026E, and 2027E are 4.379 billion, 4.945 billion, 5.529 billion, and 6.095 billion respectively, with corresponding net profit estimates of 1.088 billion, 1.245 billion, 1.476 billion, and 1.678 billion [7][9] - The company anticipates a gradual increase in gross margin from 61.4% in 2024 to 62.1% in 2027 [10] Investment Considerations - The report highlights the potential for accelerated growth due to the upcoming launches of biosimilars by the subsidiary Hualan Gene [8]

Core Insights - Lunan Pharmaceutical Group has been recognized as the top company in the "Top 100 Innovative Private Enterprises" list for four consecutive years, showcasing its strong commitment to innovation in the pharmaceutical industry [1] - The company has accumulated over 2,800 patent authorizations and maintained a research and development investment intensity of over 10% for five consecutive years, establishing a robust innovation moat [1] Group 1: Innovation and Research - Lunan Pharmaceutical initiated a national key laboratory restructuring plan to integrate traditional Chinese medicine with modern pharmaceutical practices, overcoming industry challenges [2] - The company successfully developed a domestic culture medium that significantly reduced costs from 150 RMB per liter to 10 RMB, enabling the launch of a CD20 monoclonal antibody injection and breaking a 20-year foreign monopoly [3] - Lunan has established a research network with five national and eleven provincial platforms, collaborating with over 100 top global universities, resulting in an average of one new patent every three days [3] Group 2: Talent Strategy - The company employs a dual strategy of attracting global talent while cultivating local talent, ensuring a sustainable talent ecosystem [4] - The "Shennong Plan" and "Excellent Engineer Class" are key initiatives for recruiting top-tier talent, with competitive compensation packages and comprehensive research support [5] - The average age of the R&D team is 32, reflecting a youthful and dynamic workforce capable of handling over 40 clinical studies for new drugs [6] Group 3: Strategic Collaboration and Industry Impact - Lunan's innovation strategy has evolved from individual technological breakthroughs to a comprehensive restructuring of the industry chain, exemplified by the successful launch of the rituximab project [7] - The company has shared its breakthroughs in culture medium technology with eight local pharmaceutical companies, leading to an 18% reduction in overall production costs in Shandong [7] - Lunan Pharmaceutical has submitted over 40 active pharmaceutical ingredient registration applications in the U.S. and has 72 formulations approved in 129 countries, positioning its products prominently in international markets [8]