美国FDA授予迪哲医药的百利替尼快速通道资格，用于治疗复发/难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤-动脉网

The U.S. FDA Granted Fast Track Designation to Dizal's Birelentinib for Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

CISION 等信源发布 2025-08-06 19:02

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Birelentinib

贝瑞替尼

(DZD8586)

received Fast Track Designation from the U.S. FDA for relapsed/refractory CLL/SLL

获得美国FDA授予的复发/难治性CLL/SLL快速通道资格

Supporting data from a pooled analysis of phase I/II studies of birelentinib showed an objective response rate of 84.2% in heavily pretreated CLL/SLL patients

对一期/二期研究的汇总分析的支持数据表明，birelentinib 在经过重度预处理的 CLL/SLL 患者中的客观缓解率为 84.2%。

SHANGHAI

上海

，

Aug. 6, 2025

2025年8月6日

/PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its Birelentinib

/PRNewswire/ -- 致力于开发治疗癌症和免疫疾病新药的生物制药公司迪哲（SSE:688192）宣布，美国食品药品监督管理局（FDA）已授予其Birelentinib快速通道资格。

(DZD8586)

for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

用于治疗接受过至少两种前期治疗（包括BTK抑制剂和BCL-2抑制剂）的复发/难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成年患者。

Patients with CLL/SLL treated with a BTK inhibitor or a BCL-2 inhibitor often relapse or progress due to two major resistance mechanisms: BTK C481X mutations and BTK-independent activation of BCR signaling pathway. No targeted therapy currently addresses both mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging anti-tumor activity in early CLL/SLL clinical studies, mutation-mediated resistance has already been reported, and degrader-associated toxicities may limit their long-term clinical application..

接受BTK抑制剂或BCL-2抑制剂治疗的CLL/SLL患者常因两种主要耐药机制而复发或进展：BTK C481X突变和BTK非依赖性BCR信号通路的激活。目前尚无针对性疗法能够同时解决这两种机制，这构成了一个紧迫的临床挑战。尽管BTK降解剂在早期CLL/SLL临床研究中显示出令人鼓舞的抗肿瘤活性，但已有报道称突变介导的耐药性出现，且降解剂相关的毒性可能限制其长期临床应用。

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration. It has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting both BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-cell non-Hodgkin lymphomas (B-NHLs)..

Birelentinib是一种首创的、非共价的LYN/BTK双重抑制剂，具有完全的血脑屏障（BBB）渗透能力。它对其他TEC家族激酶（TEC、ITK、TXK和BMX）具有高选择性。通过同时靶向BTK和LYN，它能够阻断BTK依赖性和非依赖性的BCR信号通路，有效抑制B细胞非霍奇金淋巴瘤（B-NHLs）的肿瘤生长。

The Fast Track Designation is supported by data from a pooled analysis of two phase I/II studies of birelentinib in CLL/SLL patients previously treated with covalent/non-covalent BTK inhibitors and BTK degraders. The results were presented at 2025 European Hematology Association (EHA) Annual Congress and featured in oral presentations at both the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML)..

快速通道资格得到了来自两项I/II期研究的汇总分析数据的支持，这些研究针对之前接受过共价/非共价BTK抑制剂和BTK降解剂治疗的CLL/SLL患者使用birelentinib。研究结果在2025年欧洲血液学协会（EHA）年会上公布，并在2025年美国临床肿瘤学会（ASCO）年会以及第18届恶性淋巴瘤国际会议（ICML）上进行了口头报告。

Birelentinib demonstrated significant anti-tumor efficacy in heavily pretreated CLL/SLL patients with an objective response rate (ORR) of 84.2%, with a good safety profile. Tumor responses were observed irrespective of prior treatment with covalent/non-covalent BTK inhibitors, BTK degraders, or BCL-2 inhibitors, including in patients harboring classic BTK resistance mutations (C481X) as well as other BTK mutations, such as kinase-dead mutations.

Birelentinib 在经过多线治疗的 CLL/SLL 患者中显示出显著的抗肿瘤效力，客观缓解率（ORR）达到 84.2%，且安全性良好。无论患者之前是否接受过共价/非共价 BTK 抑制剂、BTK 降解剂或 BCL-2 抑制剂的治疗，均观察到肿瘤缓解，包括携带经典 BTK 耐药突变（C481X）以及其他 BTK 突变（如激酶失活突变）的患者。

Responses were durable, with an estimated 9-month duration of response (DOR) rate of 83.3%..

反应持久，估计9个月的反应持续时间（DOR）率为83.3%。

'The granting of Fast Track Designation underscores the U.S. FDA's recognition of birelentinib's potential to address an unmet medical need in patients with CLL/SLL,' said Dr. Xiaolin Zhang, CEO of Dizal. 'We look forward to working closely with the FDA to accelerate the global clinical development of birelentinib and bring this treatment option to patients as quickly as possible.'.

“授予快速通道资格体现了美国FDA对birelentinib在满足CLL/SLL患者未竟医疗需求方面潜力的认可，”迪哲医药首席执行官张晓林博士表示，“我们期待与FDA紧密合作，加速birelentinib的全球临床开发，尽快将这一治疗选择带给患者。”

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs for serious conditions that address unmet medical needs. The designation enables for frequent FDA interactions and may allow for rolling revie, priority review, or accelerated approval if criteria are met..

快速通道资格是FDA设立的一个项目，旨在促进针对未满足医疗需求的严重疾病的药物开发，并加快其审查进程。该资格允许与FDA频繁互动，并且如果符合标准，可能允许滚动审评、优先审评或加速批准。

About Birelentinib

关于Birelentinib

(DZD8586)

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

Birelentinib 是一种首创的、非共价的LYN/BTK双重抑制剂，具有完全的血脑屏障（BBB）渗透能力，被设计为B细胞非霍奇金淋巴瘤（B-NHL）的潜在治疗选择。

While Bruton's Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge.

虽然布鲁顿酪氨酸激酶（BTK）抑制剂已被批准用于治疗B-NHL，但耐药性可能通过两种主要机制产生：BTK C481X突变和BTK非依赖性BCR信号通路激活。目前尚无针对这两种耐药机制的靶向疗法，构成了亟待解决的临床挑战。

Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application. .

尽管BTK降解剂在早期临床研究中显示出令人鼓舞的疗效，但已报告了与突变相关的耐药性，且降解剂相关的毒性可能影响长期临床应用。

Birelentinib has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. In clinical studies, birelentinib exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL..

Birelentinib对其他TEC家族激酶（TEC、ITK、TXK和BMX）具有高选择性。通过靶向BTK和LYN，它阻断了BTK依赖性和非依赖性BCR信号通路，有效抑制了B-NHL在细胞系和动物模型中的肿瘤生长。在临床研究中，birelentinib表现出良好的药代动力学特性、良好的中枢神经系统（CNS）渗透性、完全阻断BCR信号传导，并在B-NHL患者中显示出令人鼓舞的抗肿瘤疗效，同时具有良好的安全性和耐受性。

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor..

2025年8月，birelentinib获得美国FDA授予的快速通道资格，用于治疗至少接受过两线既往治疗（包括BTK抑制剂和BCL-2抑制剂）的复发/难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成年患者。

About Dizal

关于Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide.

迪哲是一家生物医药公司，致力于发现、开发和商业化用于治疗癌症和免疫疾病的差异化疗法。公司旨在开发首创和突破性的新药，进一步满足全球未被满足的医疗需求。

Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and .

植根于转化科学和分子设计，它已经建立了具有国际竞争力的产品组合，在全球关键研究中拥有多个资产，以及两个领先的资产：ZEGFROVY，已在美国和其他地区获得批准。

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Forward-Looking Statements

前瞻性声明

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', and 'intend' and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。与迪哲相关的“预期”、“相信”、“估计”、“预计”和“意图”等词语及类似表达旨在识别某些前瞻性陈述。

Dizal does not intend to update these forward-looking statements regularly..

Dizal 并不打算定期更新这些前瞻性声明。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict.

这些前瞻性陈述是基于迪哲管理层在作出这些陈述时对未来事件的现有信念、假设、期望、估计、预测和理解。这些陈述并非对未来发展的保证，且受风险、不确定性和其他因素的影响，其中一些因素超出迪哲的控制范围并且难以预测。

Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions..

因此，由于我们业务、迪哲竞争环境以及政治、经济、法律和社会条件的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息存在重大差异。

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

Dizal、董事及Dizal的员工(a)不承担纠正或更新本网站所包含的前瞻性声明的义务；且(b)不对任何前瞻性声明未能实现或被证明不正确承担责任。

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