An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Bosutinib Tablets 100 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with Bosulif (bosutinib) 100 mg, Manufactured and Packed by: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee, Freiburg, Germany, Imported by: Pfizer Brasil Ltda. Rodovia Presidente Castelo Branco, nº32501, km 32.5 CEP 06696-000 – Itapevi – SP, in healthy adult, human subjects under fed condition.

开始日期2025-01-31

申办/合作机构

Sun Pharmaceutical Industries Ltd.

NCT06297161

/ RecruitingN/A

Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF

The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.
This study is seeking for participants who are:
1. Patients who are being treated* or will be treated with Bosulif according to it's local product document under routine clinical practice (*Patients who initiated Bosulif treatment within one year before consent)
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.
The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.

开始日期2025-01-20

申办/合作机构

Pfizer Inc.

CTIS2024-516511-24-00

/ Active, not recruiting临床4期

A Patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: RODEO study

开始日期2024-11-14

申办/合作机构-

100 项与伯舒替尼相关的临床结果

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100 项与伯舒替尼相关的转化医学

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100 项与伯舒替尼相关的专利（医药）

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1,469

项与伯舒替尼相关的文献（医药）

2026-12-31·Future Science OA

Multi-omics analysis identified SPRR2D as a potential biomarker for tumor prognosis and immune microenvironment infiltration: a pan-cancer perspective

Article

作者: Shi, Yuan-Xiang

BACKGROUND:

Clarification of the molecular mechanism of malignant tumor progression, identification of the key signaling pathways and molecules involved in the processes of invasion and metastasis, and identification of new targets and strategies for effective tumor treatment are extremely important for scientific research and clinical application prospects.

METHODS:

Based on large-sample data mining, we first evaluated the expression and mutation profiles of SPRR family genes across cancers and then focused on the molecular functions of SPRR2D across cancers.

RESULTS:

Multi-omics experiments revealed that SPRR2D is significantly overexpressed in various tumors, especially in LUSC. ROC curve analysis revealed that SPRR2D demonstrated significant diagnostic efficacy across cancers. Cox regression analysis revealed that the expression of SPRR2D was associated with the survival time of patients with various tumors. Moreover, the expression of SPRR2D is closely related to tumor immune infiltration. GDSC data analysis revealed that the expression levels of SPRR1A, SPRR1B, SPRR2A, SPRR3, and SPRR2D are negatively correlated with the sensitivity to gefitinib, trametinib, bosutinib, afatinib, lapatinib, and erlotinib.

CONCLUSIONS:

From a multi-omics perspective, it was revealed that SPRR2D plays a significant role in regulating tumorigenesis and drug sensitivity in tumors.

2026-06-01·Endocrinologia Diabetes y Nutricion

Gastrointestinal toxicity in the treatment of hematological tumors. Influence on nutritional status

Article

作者: Botella Romero, Francisco ; Díaz Jordán, Bolívar Luis ; García Malpartida, Katherine ; Alonso Domínguez, Teresa ; González Medina, José ; Serna Muñoz, María José ; Civera Andrés, Miguel ; Torres Jiménez, Williana M

INTRODUCTION:

Hematologic neoplasms (lymphomas, leukemias, and myelomas) represent approximately 10% of all tumors. Antineoplastic treatments, including chemotherapy, targeted therapies, and immunotherapy, generate gastrointestinal toxicity that impacts therapeutic efficacy and nutritional status, establishing a vicious cycle of malnutrition and toxicity.

MATERIALS AND METHODS:

A narrative review was conducted using a literature search of the electronic databases PubMed, Embase, UpToDate, and Medscape for chemotherapy, targeted therapies, and immunotherapy used in lymphomas, leukemias, and multiple myeloma. The frequencies of gastrointestinal adverse effects (diarrhea, nausea/vomiting, mucositis), as well as those of grade ≥3, were analyzed.

RESULTS:

The results are presented in tables showing the commonly used drugs along with the probability of experiencing gastrointestinal adverse effects. In acute lymphoblastic leukemia, therapies such as Tisa-Cel and Brexu-Cel, with or without cytotoxic agents, cause gastrointestinal toxicity in almost all patients. In acute myeloid leukemia, most drugs produce nausea and vomiting, while diarrhea and mucositis are less frequent (30%). In chronic lymphocytic leukemia, diarrhea is prominent with targeted therapies (ibrutinib [42%], idelalisib [47%]). In chronic myeloid leukemia, bosutinib causes the highest rate of gastrointestinal intolerance (68%). In non-Hodgkin lymphoma, most combinations induce nausea/vomiting (>90%). Regarding multiple myeloma, gastrointestinal effects are generally low, with the exception of some immunotherapies (selinexor, elranatamab, elotuzumab).

DISCUSSION:

Diarrhea, nausea, vomiting, and mucositis are common complications, with diverse mechanisms depending on the drug. These toxicities directly impact nutritional status and quality of life, potentially requiring modifications to treatments.

CONCLUSIONS:

Understanding the frequency and severity of gastrointestinal side effects of drugs used to treat hematological malignancies can facilitate early diagnosis and medical-nutritional management, which can be key to reducing malnutrition and improving clinical outcomes in hematological tumors.

2026-05-01·CANCER LETTERS

A MUC1-ALIX complex regulates extracellular vesicle cargo loading with activated SRC to enhance pancreatic cancer progression

Article

作者: Triplett, Aleata A ; O'Connell, Kelly A ; Caffrey, Thomas C ; Hu, Tuo ; Grandgenett, Paul M ; Le, Phong ; Baniya, Amina ; Hoagstrom, Kristine V ; Huang, Ying ; Jensen-Smith, Heather C ; Wragge, Jacob ; McAndrews, Kyle L ; Singh, Pankaj K ; Mundry, Clara S ; Hollingsworth, Michael A

Extracellular vesicles (EVs) are critical mediators of intercellular communication in the tumor microenvironment and play an essential role in tumor growth and metastasis. MUC1 has been identified in tumor cell-derived EVs, but its function in that context has not been well investigated. We show that MUC1 is highly enriched in EVs derived from pancreatic cancer cell lines and patient tumors but not normal pancreas. Pretreatment of mice with tumor derived MUC1 positive EVs promoted tumor cell growth and metastasis in vivo. MUC1 positive EVs enhanced tumor cell growth, motility and invasion in vitro. Proteomic profiling revealed that MUC1-positive EVs contain protein cargo distinct from MUC1-negative EVs, which implicates MUC1 in selective EV cargo regulation. We demonstrate that the cytoplasmic tail of MUC1 expressed in pancreatic cancer cells interacts with programmed cell death 6-interacting protein (ALIX) and influences EV biogenesis and loading of specific oncogenic cargo (Phospho_Tyr416-Src) that are known to associate with MUC1. EVs from SRC inhibitor Bosutinib treated cells showed reduced effects on cell viability, migration, and invasion of MUC1 knockout cells as compared to EVs from untreated cells. Thus, MUC1-positive EVs containing activated Src promoted tumor cell proliferation and in vivo tumor growth, migration, and metastasis of orthotopic pancreatic cancer cells. Collectively, our findings identify a previously unrecognized role for MUC1 in influencing EV composition and function: influencing loading of oncogenic protein cargoes into EVs. Our data highlight a novel mechanism controlling tumor-specific EV cargo loading and demonstrate that oncogenic cargo in MUC1-associated EVs contributes to pancreatic cancer progression.

178

项与伯舒替尼相关的新闻（医药）

2026-06-21

·WockHarDT

渐冻症（ALS）：不是绝症，而是需要科学面对的罕见病

一、什么是渐冻症？权威定义与核心特征渐冻症医学全称肌萎缩侧索硬化（ALS），是一种进行性、致命性的运动神经元病，核心病变为大脑、脑干、脊髓中的运动神经元渐进性死亡，导致肌肉失去神经支配，逐渐无力、萎缩、僵硬，最终全身瘫痪，但意识、思维、感觉始终清醒。权威依据• 国内标准：《肌萎缩侧索硬化诊断和治疗中国专家共识2022》（中华医学会神经病学分会，《中华神经科杂志》2022年6月）。• 国际标准：1994年El Escorial标准、2020年Gold Coast标准，全球通用诊断框架。• 流行病学：我国发病率1.62/10万，患病率2.98/10万，每年新增约2.4万例；高发于40-70岁中年男性，男女比例1.5:1；确诊后平均生存期3-5年，最终多因呼吸肌麻痹、呼吸衰竭离世。• 历史溯源：1869年法国神经学家让-马丁·夏科首次系统描述，又称“夏科病”；美国以棒球运动员卢·格里克命名“卢·格里克病”；2018年纳入中国首批罕见病目录。二、病因：遗传仅10%，90%为散发性（非遗传病）1. 家族性ALS（占比5%-10%，常染色体显性遗传）• 权威基因（美国NIH神经疾病与卒中研究所NINDS、《Nature Genetics》2024）：◦ C9orf72：最常见，占家族性病例25%-40%，少数散发病例也携带此突变。◦ SOD1：第二常见，占12%-20%，编码抗氧化酶，突变后致神经元损伤。◦ 其他：TARDBP、FUS、SPTLC1（儿童型）等十余种基因。2. 散发性ALS（占比90%，多因素叠加致病）• 核心机制（《Brain》2025、科普中国2026）：◦ 异常蛋白蓄积：TDP-43、SOD1蛋白错误折叠，形成毒性聚集物。◦ 线粒体功能障碍：神经元能量供应衰竭。◦ 谷氨酸兴奋性毒性：神经递质过量，过度刺激神经元致死亡。◦ 神经炎症：小胶质细胞异常激活，攻击自身神经元。• 环境诱因（《中华神经科杂志》2022共识）：长期接触重金属（铝、铅）、化学毒物；吸烟、酗酒、高强度体力劳动；病毒感染（HIV、朊病毒）；自身免疫异常。结论渐冻症不是典型遗传病，仅5%-10%家族性病例与基因直接相关；90%散发性病例是遗传背景+环境诱因+细胞损伤机制共同作用的结果。三、病情发展：从“肉跳无力”到“呼吸衰竭”，分阶段进展1. 早期（1-2年，易误诊）• 症状：轻微无力、肉跳（肌束震颤）、易疲劳、精细动作笨拙（如扣纽扣、写字困难）；可伴肌肉痉挛、麻木。• 分型：◦ 肢体起病型（80%）：先累及四肢，从单侧手指或脚趾开始，逐渐蔓延至全身。◦ 延髓起病型（20%）：早期出现说话含糊、吞咽困难、饮水呛咳，进展更快，生存期更短。• 误诊率：高达70%，常被误诊为颈椎病、腰椎病、脑卒中、周围神经病。2. 中期（2-4年，明显残疾）• 症状：肌肉明显萎缩、无力加重、肢体僵硬（痉挛）、行走困难、易跌倒；吞咽困难、构音障碍加重，需流食；呼吸肌开始受累，活动后气短。• 体征：上运动神经元受损（反射亢进、病理征阳性）；下运动神经元受损（肌肉萎缩、肌束震颤）。3. 晚期（4年以上，全身瘫痪）• 症状：四肢完全瘫痪、卧床不起、无法说话、吞咽完全丧失，需鼻饲；呼吸肌严重麻痹，静息时呼吸困难，依赖呼吸机；最终因呼吸衰竭、肺部感染、营养不良离世。• 权威评估：常用ALSFRS-R评分（满分48分），每下降1分提示功能恶化，可预测生存期。四、治疗：无法治愈，但可延缓进展、改善生活质量（权威方案）1. 药物治疗（《中国ALS共识2022》、FDA/EMA批准）• 利鲁唑（Riluzole）：唯一经典药物，1994年法国获批，机制为抑制谷氨酸释放、稳定钠通道；用法50mg 每日2次口服；可延长生存期3-6个月，延缓呼吸功能衰退；不良反应：疲乏、恶心、肝功能异常，需定期查肝功能。• 依达拉奉（Edaravone）：自由基清除剂，2017年日本获批，2019年中国获批；机制为清除氧化应激产物、保护神经元；适用发病<2年、病情较轻患者；静脉制剂：14天注射+14天休息为1周期；口服混悬液已上市，方便居家用药。• 托夫生（Tofersen）：2023年FDA批准，全球首个基因靶向药，反义寡核苷酸（ASO），靶向SOD1突变；用于SOD1突变型ALS；鞘内注射，可显著降低脑脊液SOD1蛋白水平、延缓运动功能衰退。2. 综合支持治疗（共识核心推荐，决定生活质量与生存期）• 呼吸支持：早期无创通气（双水平正压通气BiPAP），尽早使用，改善缺氧、延长生存期；晚期呼吸衰竭时行气管切开有创通气。• 营养管理：吞咽困难时尽早胃造瘘（PEG），保证营养摄入，避免营养不良；高蛋白、高热量饮食，每日热量2500-3000kcal。• 康复与护理：适度康复训练，维持关节活动度、预防肌肉挛缩；心理支持，缓解焦虑抑郁；预防压疮、肺部感染、深静脉血栓。五、未来治疗趋势：基因治疗、早期诊断、新药研发（国际前沿）1. 基因治疗（精准靶向，突破瓶颈）• ASO药物：除托夫生外，针对C9orf72、TARDBP的ASO药物已进入Ⅱ/Ⅲ期临床试验（《Nature Medicine》2025）。• 基因编辑：CRISPR-Cas9技术修复SOD1、C9orf72突变，动物实验显著延缓病情，2026年启动Ⅰ期临床（《Science》2026）。2. 早期诊断（提前5-10年，干预窗口前移）• 血液生物标志物：约翰霍普金斯大学2025年发表于《Nature Medicine》的研究，发现血液蛋白标志物组合，准确率>98%，可在症状出现前5-10年检出，为早期干预提供可能。• 影像学标志物：头颅/脊髓MRI检测运动皮层萎缩、脊髓信号异常，联合肌电图，缩短确诊时间至6个月内（Gold Coast标准，2020）。3. 新药研发（多靶点、老药新用）• 创新药物：针对TDP-43蛋白聚集、线粒体修复、神经保护的小分子药物，10余种进入Ⅲ期临床（《Frontiers in Neuroscience》2024）。• 老药新用：已获批药物（如抗癌药Bosutinib、抗炎药Baricitinib）用于ALS治疗，快速推进临床，降低研发成本与周期。4. 细胞治疗（修复神经元，再生医学希望）• 干细胞移植：间充质干细胞（MSC）、神经干细胞移植，动物实验显示保护运动神经元、促进神经修复，2026年国内启动Ⅱ期临床（中华医学会2026）。六、总结：科学认识，积极面对渐冻症是罕见、进行性、无法治愈但可有效管理的神经系统疾病，遗传≠致病，90%为散发性；病情分早中晚三期，早期易误诊，早诊断、早治疗是关键；目前利鲁唑、依达拉奉、托夫生为核心药物，配合呼吸、营养、康复支持，可显著改善生活质量、延长生存期；未来基因治疗、早期诊断、细胞治疗将带来新突破。权威信息来源1. 《肌萎缩侧索硬化诊断和治疗中国专家共识2022》，中华医学会神经病学分会，《中华神经科杂志》2022年6月。2. 美国NIH神经疾病与卒中研究所（NINDS）ALS指南（2025）。3. 《Nature Medicine》《Brain》《Science》等国际权威期刊2024-2026年研究。4. 央视网《够科普》（2025）、科普中国（2026）。往期精选：不止尘肺病！八大行业高发职业病对照表，打工人自查保命三万元入刑背后：治理的终点，不该是从业者的集体焦虑 AI重塑法医侦查：精准作案画像，破解悬案侦破难题

上市批准临床结果

2026-06-20

·元戊医学

²⁰²⁶/₆.₂₁ 世界渐冻人日 | 破冰2026：iPSC细胞与基因靶向治疗重塑ALS生命防线！

· 2026.6.21· 每年的6月21日是“世界渐冻人日”。1997年，由“渐冻人”协会国际联盟选定这一日期，后在2000年于丹麦举行的国际病友大会上正式确立。他们的大脑清醒如昨，灵魂却被困在逐渐僵硬的躯壳里；他们能清晰感知每一次呼吸的艰难，连抬手擦泪都成为奢望；他们看着自己一点点“冻住”，从指尖蔓延至全身，最终连呼吸都需要机器维持。今天，6月21日，世界渐冻人日。让我们一起走近这个被称为“超级绝症”的疾病，走近那些在绝望中依然坚守的生命。 01 渐冻症渐冻症的医学名称是肌萎缩侧索硬化症（ALS），是一种目前尚无法治愈、进行性的致死性神经退行性疾病。它会攻击大脑和脊髓中负责控制肌肉运动的神经细胞，导致肌肉逐渐无力、萎缩，最终影响吞咽、说话和呼吸功能。患者的智力、记忆和感知能力基本不受影响，他们就像被慢慢冰封的人，清醒地看着自己走向死亡。这也是为什么渐冻症被称为“世界上最残忍的疾病”。发病率：全球年发病率约为每10万人1.5-2.7例（患病率约为每10万人4-6例）。我国现存患者约6-10万人，每年新增约2.3万例。发病年龄：多在40-60岁之间。平均生存期：确诊后仅2-5年。病因：至今不明，仅约5%-10%与遗传因素相关（家族性ALS），其余为散发性。 ALS的病理核心是上、下运动神经元进行性退化。在ALS中，因TDP-43、FUS蛋白异常聚集，C9ORF72、SOD1等基因突变，以及氧化应激等因素，两类神经元逐渐受损。上运动神经元损伤引发肌肉痉挛、腱反射亢进，下运动神经元损伤导致肌肉萎缩、肌束颤动，最终因神经冲动传导中断和肌肉失养，使患者丧失行走、说话、吞咽等自主运动能力。 ALS患者受损运动神经元导致肌肉收缩功能丧失左：正常神经细胞；右：ALS患者受损神经细胞 02 科学破冰：干细胞治疗带来新曙光尽管目前ALS仍然无法被完全治愈，但医学领域从未停止探索的脚步。国内外已上市的利鲁唑和依达拉奉等药物，能够在一定程度上延缓疾病发展，延长患者生存期。利鲁唑作为ALS患者的基本用药，早在20世纪90年代就已投入使用；依达拉奉作为抗氧化小分子药物，2017年经国家药监局批准在国内上市，后续还推出了舌下片等更便于患者使用的剂型。全球首个针对SOD1基因突变型ALS的对因治疗药物——托夫生注射液（Tofersen/Qalsody）已于2025年6月在中国商业上市，2026年1月纳入珠海市“大爱无疆”项目罕见病自费药补偿（据既往政策，1万元以上、30万元以内部分可报销90%，具体以官方文件为准）。这款药物标志着我国部分渐冻症患者（约2%，即SOD1突变携带者）的治疗迈入了精准医疗阶段。此外，针对ALS的细胞与基因治疗等前沿研究也在积极推进，为攻克这一难题带来新的曙光。 1 间充质干细胞（MSC）治疗ALS NurOwn®，由以色列BrainStorm公司开发，是一种在体外定向分化出能分泌神经营养因子（NTF）的MSC-NTF细胞，通过鞘内注射递送。这是全球首个申请上市的ALS干细胞疗法，2014年获得FDA快速通道产品认定。临床试验： Phase 2（2016年发表，NCT02017912）：共纳入48例ALS患者（治疗组36例，安慰剂组12例），总体未达到主要终点，但在基线ALSFRS-R≥35的轻症患者亚组中观察到功能保留的信号，安全性良好。 Phase 3（NCT03280056，2022年发表）： 189例患者随机分组，主要终点未达到统计学显著性（治疗组应答率33% vs 安慰剂组28%，p=0.45），疗效证据不足。 FDA审查： 2021年、2022年两次拒绝生物制品许可申请（BLA）；2023年咨询委员会以17票反对、1票赞成、1票弃权的结果反对批准。 2026年最新动态： BrainStorm公司继续推进NurOwn的3b期ENDURANCE研究，计划招募约200名早期ALS患者。该研究采用24周随机双盲安慰剂对照+24周开放标签扩展设计，主要终点为ALSFRS-R评分变化。公司披露扩展访问计划（EAP）中10例患者有50%仍存活，预估平均生存期约84个月（历史数据显示仅约20%患者能达到5年生存期）。图片来源：Brainstorm官网 Neuronata-R®（lenzumestrocel），韩国CorestemChemon公司开发。2025年5月，其III期ALSummit试验在缓慢进展型患者亚组中显示显著疗效——12个月后ALSFRS-R评分31.2 vs 安慰剂组26.4（p=0.001），且NfL水平下降。据2025年12月报道，公司计划2026年第三季度向美国FDA提交生物制品许可申请（BLA），并已入选美国NSF支持的再生医学创新引擎。 2026年1月，北京协和医院发表多中心临床研究结果，126例ALS患者接受脐带MSC重复治疗后，平均生存期延长至48个月，显著高于对照组的32个月。该研究为目前国内最大规模的MSC治疗ALS多中心临床数据，证实重复输注脐带MSC具有良好的安全性，并可能通过调节神经炎症微环境、促进神经营养因子分泌等机制，显著延缓疾病进展、延长患者生存期。 2026年4月，上海交通大学医学院附属瑞金医院在《自然·医学》（Nature Medicine）发表重要研究，证实MSC联合神经营养因子纳米粒鞘内递送可显著提高治疗效果。研究团队利用纳米技术将神经营养因子（如BDNF、GDNF）包裹于生物相容性纳米粒中，与MSC共同经鞘内注射递送。研究发现，纳米粒可实现神经营养因子的缓释与靶向递送，而移植的干细胞可随脑脊液迁移并定位于脊髓与脑实质损伤区域，形成“细胞+因子”的协同修复网络。该策略在动物模型中显著改善了运动神经元存活率，并已进入早期临床转化阶段，为优化MSC治疗方案提供了全新思路。 2 诱导多能干细胞（iPSC）治疗ALS XS-228注射液，士泽生物医药（苏州/上海）有限公司自主研发的全球首款通用型iPSC衍生亚型神经前体细胞注射液，采用先进的细胞重编程和分化技术。通过将体细胞重编程为多能干细胞，再定向分化为特定的神经前体细胞，该疗法有望实现对ALS患者神经系统的修复和再生。 XS-228具备独特的作用机制——原位替代与重建（分化为功能性运动神经元）、微环境重塑（分泌BDNF、GDNF等神经营养因子）、免疫刹车（分泌抗炎因子）。作为“现货型”异体通用细胞治疗方案，具有可扩展性强、成本效益高等优势，无需依赖患者自体细胞，可实现标准化生产与即时供应。来源：士泽生物官网 2026年6月，《自然》子刊发表综述指出，基于诱导多能干细胞（iPSC）的肌萎缩侧索硬化症（ALS）药物发现已从实验室技术成熟为经过临床测试的平台。该综述系统回顾了iPSC技术在神经退行性疾病药物研发中的进展，明确指出iPSC模型已成为连接基础研究与临床试验的关键桥梁。日本庆应义塾大学利用患者iPSC筛选出的ropinirole（罗匹尼罗），以及京都大学通过iPSC平台筛选出的bosutinib（博舒替尼），均已推进至临床试验阶段。 ropinirole（罗匹尼罗）：由庆应义塾大学团队负责，临床试验编号UMIN000034954，属于I/IIa期随机对照试验，时间跨度为2018年至2021年。 bosutinib（博舒替尼）：由京都大学团队推动，临床试验编号UMIN000036295，属于I/II期开放标签试验，时间跨度为2019年至2024年。 3 基因治疗ALS SNUG01注射液，神济昌华（北京）生物科技有限公司研发，全球首款以TRIM72为靶点的基因治疗药物。以重组腺相关病毒9型（rAAV9）为载体，通过鞘内注射将人源TRIM72基因精准递送至神经元。核心优势：与仅针对特定基因突变型ALS的疗法不同，SNUG01凭借多维度神经保护机制，有望覆盖占患者总数约90%的散发型ALS（sALS）患者，为目前无有效治疗手段的这一庞大群体提供潜在解决方案。2025年3月获美国FDA临床试验许可，2025年6月获FDA孤儿药资格认定，2025年8月获中国NMPA临床试验默示许可，已正式进入中美国际多中心临床试验（MRCT）阶段。来源：神济昌华官网 03 结语近年来，干细胞疗法与基因治疗在ALS领域的研究已取得了重大突破，从基础科研到临床转化的层层推进，干细胞治疗正从“探索性尝试”加速迈向“循证医学验证”与“规模化临床落地”。然而，不同干细胞类型（MSC、iPSC衍生细胞等）的最佳给药方案、长期安全性、疗效持久性以及个体化治疗策略仍需更多高质量随机对照试验来证实。我们期待随着研究的深入，干细胞与基因治疗能在ALS治疗的舞台上大展身手，让生命免于“渐冻”，还ALS患者一个健康美好的未来！

2026-06-13

·Business Wire

Dr. Reddy’s Announces the First-to-Market Launch of Bosutinib Tablets 400mg, a Generic Equivalent of Bosulif ® , in the United States

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the first-to-market launch of Bosutinib Tablets 400mg, a generic equivalent of Bosulif®, in the United States, expanding its oncology portfolio and reinforcing its commitment to improving patient access to affordable, high-quality medicines. Dr. Reddy’s has collaborated with MSN Laboratories Private Limited (“MSN”), a leading pharmaceutical company in India, on this product. Dr. Reddy’s holds the exclusive marketing rights for the product in the United States. MSN is responsible for the development and manufacturing of the product. Bosutinib Tablets (400mg) was a first-to-file product and is eligible for 180-days of generic drug exclusivity for this strength, in the U.S. Milan Kalawadia, CEO- North America, Dr. Reddy’s Laboratories, Inc. said: “This launch highlights our commitment to leading with timely market entry for high-priority therapies while broadening access for both patients and healthcare providers. With this launch, we remain focused on strengthening our oncology portfolio and partnering across the healthcare system to ensure that critical treatments are both accessible and affordable.” Bharat Reddy, Executive Director, MSN Laboratories added: “The successful development and commercialization of Bosutinib Tablets demonstrates MSN’s strong scientific, regulatory, and manufacturing capabilities in complex oncology products. We remain committed to delivering high-quality, affordable medicines globally through efficient development and reliable manufacturing excellence.” The Bosulif® brand (400mg) had U.S. sales of approximately $253.8 million for the latest 12-month period ended April 2026, according to IQVIA National Sales Perspectives data. Bosulif® is a registered trademark of Wyeth LLC. RDY-0626-887 ………………………………………………………………………………………………………………………………………………………………………………………………………… About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com. About MSN Laboratories: MSN Laboratories is a research-driven pharmaceutical company with integrated capabilities across APIs and finished dosage formulations. The company is recognized for its strong expertise in product development, regulatory execution, and world-class manufacturing infrastructure with USFDA approved facilities in Hyderabad, India and in New Jersey, USA. MSN serves global markets with a focus on quality, affordability, and operational excellence across multiple therapeutic segments, including oncology. ……………………………………………………………………………………………………………………………………………………… Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2025. The company assumes no obligation to update any information contained herein.

上市批准

100 项与伯舒替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09728	伯舒替尼	L01XE14	DB06616

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性粒细胞性白血病	日本	Pfizer Japan, Inc.	2014-09-26
动脉导管未闭	澳大利亚	Pfizer Australia Pty Ltd.	2014-04-29
加速期费城染色体阳性慢性粒细胞白血病	欧盟	Pfizer Europe MA EEIG	2013-03-27
加速期费城染色体阳性慢性粒细胞白血病	冰岛	Pfizer Europe MA EEIG	2013-03-27
加速期费城染色体阳性慢性粒细胞白血病	列支敦士登	Pfizer Europe MA EEIG	2013-03-27
加速期费城染色体阳性慢性粒细胞白血病	挪威	Pfizer Europe MA EEIG	2013-03-27
急变期费城染色体阳性慢性粒细胞白血病	欧盟	Pfizer Europe MA EEIG	2013-03-27
急变期费城染色体阳性慢性粒细胞白血病	冰岛	Pfizer Europe MA EEIG	2013-03-27
急变期费城染色体阳性慢性粒细胞白血病	列支敦士登	Pfizer Europe MA EEIG	2013-03-27
急变期费城染色体阳性慢性粒细胞白血病	挪威	Pfizer Europe MA EEIG	2013-03-27
慢性期费城染色体阳性慢性粒细胞白血病	欧盟	Pfizer Europe MA EEIG	2013-03-27
慢性期费城染色体阳性慢性粒细胞白血病	冰岛	Pfizer Europe MA EEIG	2013-03-27
慢性期费城染色体阳性慢性粒细胞白血病	列支敦士登	Pfizer Europe MA EEIG	2013-03-27
慢性期费城染色体阳性慢性粒细胞白血病	挪威	Pfizer Europe MA EEIG	2013-03-27
费城染色体阳性慢性粒细胞白血病	美国	PF Prism CV	2012-09-04

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适应症	最高研发状态	国家/地区	公司	日期
慢性期慢性髓性白血病	临床3期	美国	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	澳大利亚	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	比利时	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	加拿大	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	捷克	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	丹麦	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	芬兰	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	法国	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	德国	Pfizer Inc.	2014-07-15
慢性期慢性髓性白血病	临床3期	匈牙利	Pfizer Inc.	2014-07-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AACR2026	N/A	慢性粒细胞性白血病	291	Ponatinib	膚繭襯襯醖選構餘夢醖(願顧鹽積觸襯鹹窪廠範) = 窪築築鏇簾壓簾鹹醖膚蓋壓構廠簾蓋築膚醖願 (鹽廠範艱積願艱艱簾夢 )	积极	2026-04-21
				Bosutinib	鏇壓窪製蓋觸齋鑰膚繭(範鏇繭壓顧範憲積餘齋) = 餘壓築膚積衊醖膚淵醖鹹鹹鑰獵觸夢鬱衊蓋廠 (繭獵遞夢膚簾蓋網蓋齋 ) 更多
NCT04258943 (ITCC-054/COG-AAML1921, EHA2025)	临床2期	诺里病 BCR::ABL1	30	Bosutinib 300 mg/m2 QD	衊顧糧窪鹹簾鑰鏇繭願(獵獵淵窪獵餘願網壓簾) = 壓簾選齋壓蓋餘願膚簾襯選顧積範膚鏇艱製範 (遞遞網壓遞膚鬱鏇襯淵, 90 ~ 100%) 更多	积极	2025-05-14
NCT03205267 (Bodo Trial (CML-VII-study of the German CML Study Group), ASH2024)	临床2期	慢性期慢性髓性白血病二线	45	Bosutinib	獵艱艱簾鏇憲衊網網遞(憲獵壓構鏇憲網夢憲窪) = All pts had ≥1 any grade treatment emergent adverse event (TEAE), occuring a median of 15 days after starting bosutinib (range: 1 - 225 days) 網顧鹹夢觸窪艱遞繭獵 (餘積積範窪廠襯鑰鹹鑰 ) 更多	积极	2024-12-07
				Nilotinib
NCT04916769 (CTgov)	临床1期	-	18	Bosutinib (Bosutinib 500 mg Capsule Contents + Applesauce 45 mL)	鹽觸遞餘醖鏇範襯繭鑰(製窪顧遞鑰餘艱膚淵憲) = 觸構艱鹽醖鹹網憲糧窪襯簾範膚窪願繭觸積衊 (構糧蓋鹽壓築鏇糧簾網, 28) 更多	-	2024-11-07
				Bosutinib (Bosutinib 500 mg Capsule Contents + Yogurt 45 mL)	鹽觸遞餘醖鏇範襯繭鑰(製窪顧遞鑰餘艱膚淵憲) = 鹽憲繭艱醖觸鏇網艱鏇襯簾範膚窪願繭觸積衊 (構糧蓋鹽壓築鏇糧簾網, 23) 更多
NCT02228382 (BYOND, Pubmed \| Leukemia) 人工标引	临床4期	慢性粒细胞性白血病 Philadelphia Chromosome	163	Bosutinib 500 mg QD	願廠齋蓋觸簾遞蓋網鑰(膚構壓構構蓋願鑰艱餘) = 夢膚衊積製網夢願積鑰糧獵憲鬱鹽鬱夢鹹範製 (獵製糧願糧襯夢顧糧鏇, 63.9 ~ 78.9) 更多	积极	2024-10-01
NCT05032690 (CTgov)	临床1期	-	32	Bosutinib (Treatment A: Bosutinib 1*100 mg Capsule Fed)	顧選壓範鏇構選願遞製(獵繭構繭製衊繭鑰餘廠) = 窪鏇襯淵觸襯餘衊壓窪觸獵網壓襯構襯鹽鏇夢 (蓋壓艱構製顧膚鬱齋鑰, 32) 更多	-	2024-09-20
				Bosutinib (Treatment B: Bosutinib 4*25 mg Capsule Fed)	顧選壓範鏇構選願遞製(獵繭構繭製衊繭鑰餘廠) = 齋鏇膚膚選鹹蓋繭獵衊觸獵網壓襯構襯鹽鏇夢 (蓋壓艱構製顧膚鬱齋鑰, 39) 更多
NCT02228382 (BYOND, Pubmed) 人工标引	临床4期	费城染色体阳性慢性粒细胞白血病 Philadelphia chromosome-positive	156	Bosutinib500mg once daily	淵襯鏇網鹽窪鬱蓋顧遞(齋衊遞蓋糧襯選築艱選) = 蓋醖衊網簾鑰窪積夢鏇廠蓋顧糧衊窪網築醖鑰 (醖鏇廠積鹽鬱遞窪齋醖 ) 更多	积极	2024-04-01
				Bosutinib 500mg once daily (dasatinib/nilotinib-resistant)	淵襯鏇網鹽窪鬱蓋顧遞(齋衊遞蓋糧襯選築艱選) = 餘製壓艱膚廠醖選鹹願廠蓋顧糧衊窪網築醖鑰 (醖鏇廠積鹽鬱遞窪齋醖 ) 更多
NCT04793399 (CTgov)	临床1/2期	慢性期慢性髓性白血病 \| 慢性白血病 \| 费城染色体阳性慢性粒细胞白血病	9	Atezolizumab+Bosutinib	繭膚鹹選襯餘憲窪鏇鏇 = 築襯糧製簾窪鑰顧築選蓋夢網鬱齋積齋製窪願 (壓製選壓糧廠構鏇繭鏇, 鹽鹽積憲鹽窪鏇遞憲鹽 ~ 窪餘餘構夢鑰鏇壓獵願) 更多	-	2024-03-12
NCT04258943 (ITCC054 \| COG AAML1921, Pubmed) 人工标引	临床1期	慢性期慢性髓性白血病 EGFR T790M	27	Bosutinib 300-400 mg/m2 once daily	廠鏇齋顧築範繭鑰壓醖(糧構餘糧網繭選壓願廠) = 憲鑰積觸蓋夢糧觸淵網築醖積簾繭夢壓淵膚襯 (觸窪壓膚淵構簾廠窪鬱 )	积极	2024-03-01
				Bosutinib 300 mg/m2 once daily	壓襯壓願衊製積顧鹽獵(選繭窪鹽顧餘遞鑰窪製) = 淵遞憲窪願製夢夢觸齋衊廠膚夢壓餘鑰衊簾鬱 (鏇觸鹽鬱願齋願網壓鏇 ) 更多
BOGI trial (ASH2023)	临床2期	费城染色体阳性慢性粒细胞白血病	35	Bosutinib 200 mg	憲繭顧窪簾顧鬱遞鬱願(鹹糧窪繭築製齋獵築獵) = 遞艱蓋艱醖觸廠鏇顧繭顧選鹹遞製醖艱願衊糧 (鑰鹹願遞窪觸窪夢廠鏇 ) 更多	-	2023-12-10