在血液肿瘤领域，目前，奥布替尼在国内已获批用于四个血液瘤适应症，其中三个适应症已纳入医保， 今年4月，新增用于治疗一线 CLL/SLL，市场渗透率在不断增加。 资料显示，交易方Zenas于2024年在纳斯达克上市，是一家聚焦自身免疫性疾病领域的全球生物制药公 司，核心管线以obexelimab和奥布替尼为主，与诺诚健华的主攻方向较为契合。Zenas方面称，借助本 次交易，可以构建优势互补的均衡管线组合。 据了解，作为诺诚健华核心产品的奥布替尼，是一款中枢神经系统强渗透性BTK抑制剂，具有较高的 靶点选择性和良好的安全性。该药品早在2021年就已实现商业化，并于2022年被纳入国家医保目录。 在自身免疫性疾病领域，奥布替尼已于今年第三季度启动针对PPMS的III期临床试验，预计在2026年第 一季度启动SPMS的III期临床试验。同时，上述两项试验均获得美国 FDA及欧洲EMA的认可。此外， ITP中国III期注册临床完成患者入组，预计2026年上半年递交上市申请。 10月8日，诺诚健华披露公告称，其全资子公司与美国生物制药公司Zenas BioPharma签署一项潜在总 额超过20亿美元的全球授权许可协议。 ...

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapy [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, with 22 patients in the first part receiving daily doses of 160 mg or 320 mg of Sotorasib to assess safety and tolerability [1] - In the second part, 103 patients received the recommended daily dose of 320 mg to evaluate efficacy and safety [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] Regulatory Progress - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in MCL indications [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study (BGB-11417-302) is ongoing, with the first patient enrolled earlier this year [2]

Group 1 - The complexity of blood cancer classification presents numerous investment opportunities in various subtypes of treatment [1] - The promotion and application of emerging treatment methods such as targeted therapy, immunotherapy, and cell therapy have led to a trend in blood cancer treatment similar to chronic disease management for hypertension and diabetes [1] - The long survival cycle of blood cancer patients results in a large existing patient population, coupled with high drug treatment costs, leading to the emergence of blockbuster products and significant potential market opportunities [1]

资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 本文源自：金融界 作者：行情君 8月4日，凯信远达(CASI)盘中上涨60.5%，截至22:00，报2.07美元/股，成交2480.16万美元，总市值 3207.60万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 大事提醒： 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 ...

7月30日，凯信远达(CASI)开盘上涨2.96%，截至21:31，报1.565美元/股，成交4226.0美元，总市值 2424.60万美元。 财务数据显示，截至2025年03月31日，凯信远达收入总额624.0万美元，同比增长83.04%；归母净利 润-1075.0万美元，同比减少12.83%。 8月15日，凯信远达将披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国当地时间， 实际披露日期以公司公告为准）。 资料显示，凯信远达医药公司是一家美国纳斯达克上市的生物医药公司,致力于在血液肿瘤领域为中国 患者提供先进的疾病治疗方案。公司的总部位于美国马里兰州罗克韦尔市,在北京设有全资子公司,在无 锡与当地政府设有合资子公司及研发中心。目前公司的产品及研发管线覆盖了多发性骨髓瘤、B细胞非 霍奇金淋巴瘤、急性淋巴细胞白血病等多个疾病领域。 本文源自：金融界 作者：行情君 大事提醒： ...

Core Viewpoint - The company, DIZH Pharmaceutical (688192.SH), is set to present significant research advancements on its first-in-class drugs, GoliXitini (GoliXitini Capsules) and DZD8586, at the upcoming EHA and ICML conferences, focusing on their efficacy and safety in treating hematological malignancies [1][2]. Group 1: GoliXitini Research Findings - GoliXitini is being studied for maintenance therapy in patients with peripheral T-cell lymphoma (PTCL) who have achieved remission after first-line systemic treatment, showing potential to maintain and enhance anti-tumor efficacy with manageable safety [1] - The drug has demonstrated encouraging anti-tumor efficacy and good safety in various clinical studies, including those involving first-line treatment with the CHOP regimen for PTCL and real-world studies for relapsed/refractory T-cell large granular lymphocyte leukemia (r/rT-LGLL) [1] Group 2: DZD8586 Research Findings - DZD8586 has shown an objective response rate (ORR) of 84.2% in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously undergone multiple treatments, including those with classic BTK resistance mutations [2] - The safety profile of DZD8586 is controllable, with no observed drug-related bleeding, atrial fibrillation, or major cardiac risks in clinical settings [2] - Latest data from a Phase II clinical study of DZD8586 as a monotherapy for relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) will also be presented, indicating good anti-tumor efficacy and safety [2]

Core Insights - Nuo Cheng Jian Hua reported a revenue of 381 million yuan for Q1 2025, representing a year-on-year growth of 129.92%, with a net profit of 14 million yuan, up 109.94% year-on-year [2] - The company's gross margin improved by 5.1 percentage points to 90.5% compared to the same period last year [2] - The main driver of revenue growth is the commercialization of the drug Acalabrutinib, which generated 310 million yuan in revenue during the reporting period, an increase of 89.2% [2] Product Development - Acalabrutinib was approved for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in China on April 25, 2023, expanding its market potential [2][6] - The drug has already been included in the national medical insurance for multiple indications, which is expected to further boost sales [2] - The company is also advancing its pipeline with Tafasitamab, a CD19 monoclonal antibody, which has been approved for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) [3][9] Market Potential - CLL accounts for approximately 3% of adult leukemia cases in China, with about 7,500 new patients diagnosed annually [5] - The approval of Acalabrutinib for first-line treatment is anticipated to significantly enhance treatment options for patients and drive company growth [6] - The market for Tafasitamab is projected to exceed 1.5 billion yuan in peak sales under optimistic scenarios [10] Competitive Landscape - Acalabrutinib is positioned as a potential best-in-class BTK inhibitor, with superior selectivity and safety profile compared to existing competitors [7][8] - The company faces competition from other approved therapies targeting similar indications, particularly in the relapsed or refractory settings [6] Financial Health - Nuo Cheng Jian Hua reported a strong cash position of approximately 7.78 billion yuan as of the end of Q1 2025, which will support ongoing clinical trials and research investments [8]

Core Viewpoint - BeiGene reported a 50.2% increase in Q1 2025 revenue to 8.048 billion yuan, with a net loss of 94.503 million yuan, driven by strong sales of its self-developed products [1][2]. Revenue Growth - Q1 product revenue reached 7.985 billion yuan, up 49.9% year-on-year, primarily due to the sales growth of the self-developed drug Brukinsa® (Zebutinib) and the sales of Tislelizumab and Amgen licensed products [1]. - Global sales of Brukinsa® totaled 5.692 billion yuan in Q1, a 63.7% increase year-on-year, solidifying its leadership in the hematologic oncology field [1][2]. - Sales in the U.S. amounted to 4.041 billion yuan, reflecting a 61.9% year-on-year growth, driven by increased demand, particularly in chronic lymphocytic leukemia (CLL) indications [1]. - European sales reached 836 million yuan, up 75.4% year-on-year, attributed to market share gains across major European markets [1]. Market Position - In China, sales totaled 590 million yuan, a 43.1% increase year-on-year, maintaining a leading market share in the BTK inhibitor market [2]. - Brukinsa® has been included in the National Medical Insurance Directory for all four approved indications in China [2]. - Sales of Tislelizumab reached 1.245 billion yuan in Q1, a 19.3% increase year-on-year, driven by new indications covered by insurance and increased hospital access [2]. Clinical Development - Brukinsa® is the only BTK inhibitor with the most extensive approved indications globally and offers flexible dosing options [2]. - The clinical development program for Brukinsa® has been conducted in over 30 countries with more than 35 trials involving approximately 7,100 patients [2]. - The global Phase III ALPINE trial demonstrated sustained progression-free survival (PFS) benefits for Brukinsa® compared to ibrutinib in treating relapsed or refractory CLL/SLL patients [3]. - The company continues to advance key research projects, including the global clinical trials for Sonrotoclax, a BCL2 inhibitor, in combination with Brukinsa® for CLL and other indications [3].