英力制药宣布与FDA成功召开2期结束会议，并获批林珀利西用于治疗复发和/或难治性外周T细胞淋巴瘤的全球多中心3期注册研究设计-动脉网

Yingli Pharma Announces Successful End-of-Phase 2 Meeting with FDA and Clearance of Global Multi-center Phase 3 Registration Study Design of Linperlisib for the Treatment of Relapsed and/or Refractory Peripheral T-cell Lymphoma

CISION 等信源发布 2025-04-01 22:00

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可切换为仅中文

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SAN FRANCISCO

旧金山

，

April 1, 2025

2025年4月1日

/PRNewswire/ -- Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians' choice of standard of care for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL).

/PRNewswire/ -- 上海英利制药有限公司（英利药业），一家致力于开发用于癌症、代谢和免疫疾病的口服小分子药物的临床阶段生物技术公司，今日宣布已获得美国食品药品监督管理局（FDA）的批准，将启动一项全球注册的3期临床研究，评估林珀利西布与医生选择的标准疗法相比，用于治疗复发/难治性（R/R）外周T细胞淋巴瘤（PTCL）的效果。

FDA's approval of the pivotal Phase 3 protocol follows a successful Type B End-of-Phase 2 meeting, during which Yingli Pharma discussed the overall development program and regulatory path. The Phase 3 study is planned to commence during the second quarter of 2025. Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3Kδ) developed by Yingli Pharma..

FDA批准了关键的III期试验方案，此前Yingli Pharma在2型二期结束会议（Type B End-of-Phase 2 meeting）上成功讨论了整体开发计划和监管路径。III期研究计划于2025年第二季度开始。Linperlisib是一种由Yingli Pharma开发的强效口服小分子PI3激酶（PI3Kδ）δ亚型抑制剂。

'This is a major milestone for linperlisib.', said

“这是linperlisib的一个重要里程碑。”，表示

Michael Hui

许冠文

, Chairman and Chief Executive Officer of Yingli Pharma, 'We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL.'.

英利制药董事长兼首席执行官表示：“我们非常高兴林普利塞已进入全球关键研究阶段，并获得FDA的认可。我们将继续履行使命，满足全球患者的未竟临床需求，并加快推进林普利塞的临床开发项目，为R/R PTCL患者带来更多治疗选择。”

In this Phase 3 study, linperlisib will be evaluated versus physicians' choice of standard of care in R/R PTCL patients who have received one or more prior systemic therapies. The Phase 3 study will open enrollment in the U.S. and other countries.

在这一 III 期研究中，将针对接受过一种或多种先前系统治疗的 R/R PTCL 患者，评估 linperlisib 与医生选择的标准治疗方案的疗效。III 期研究将在美国和其他国家开放招募。

About linperlisib

关于林佩利西布

Linperlisib is a next-generation highly selective PI3Kδ inhibitor with a well-tolerated and differentiated safety profile as indicated from clinical trials in follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies. In

Linperlisib是一种下一代高选择性PI3Kδ抑制剂，在滤泡性淋巴瘤（FL）、T细胞淋巴瘤及其他血液和实体肿瘤研究的临床试验中显示出良好耐受性和差异化的安全性。

November 2022

2022年11月

, linperlisib was approved in

，linperlisib 获得批准在

China

中国

for the treatment of adult patients with R/R FL. Also in 2022, linperlisib received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma and T-Cell Lymphoma. To date, over 6000 patients have been treated with linperlisib in clinical studies and post market approval with consistent and well-tolerated safety profile..

用于治疗成人R/R FL患者。同样在2022年，林普利西布获得了美国食品药品监督管理局（FDA）针对FL、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤和T细胞淋巴瘤的孤儿药资格认定。迄今为止，在临床研究和上市后批准中，已有超过6000名患者接受了林普利西布治疗，其安全特性始终如一且耐受性良好。

Linperlisib has been studied in three clinical trials in R/R PTCL in

林普利塞已在三项针对R/R PTCL的临床试验中进行了研究。

China

中国

, U.S. and

，美国和

Europe

欧洲

, with greater than 165 R/R PTCL patients treated. Collectively, these studies have demonstrated a high objective response rate, high complete response rate, promising progression free survival, overall survival, and a very manageable safety profile through the ongoing evaluations. Overall, Chinese, U.S.

，已治疗超过165名R/R PTCL患者。总体而言，这些研究展示了高的客观缓解率、完全缓解率、无进展生存期和整体生存率，并且通过持续评估显示出非常可控的安全性。总体上，中国、美国。

and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial..

并且欧洲R/R PTCL患者表现出相似的疗效和耐受性，为全球注册试验奠定了坚实的基础。

About Yingli Pharma

关于英利制药

Yingli Pharma is a clinical stage biopharmaceutical company founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark. The company is dedicated to serving unmet medical needs of patients and focuses on discovery and development of therapy for cancer, metabolic and immune diseases.

英里制药是一家临床阶段的生物制药公司，成立于2011年，位于上海张江创新园国家生物医药产业基地。该公司致力于满足患者的未满足医疗需求，专注于发现和开发针对癌症、代谢和免疫疾病的治疗方法。

Yingli Pharma is advancing a portfolio of drugs through clinical development, including panRAS, TGFβR1 oral small molecule inhibitors in oncology, and URAT1 and HIPK2 inhibitors in metabolic and immune diseases. Linperlisib, the company's first drug candidate was awarded NMPA Breakthrough Therapy status in .

英力药业正在推进一系列药物的临床开发，包括泛RAS、TGFβR1口服小分子抑制剂在肿瘤学领域的应用，以及URAT1和HIPK2抑制剂在代谢和免疫疾病中的应用。该公司的首个候选药物Linperlisib获得了NMPA突破性疗法认定。

China

中国

, making Yingli Pharma the second pharmaceutical company in

，使英利制药成为第二家在

China

中国

and the first in

并且是第一个在

Shanghai

上海

to receive this recognition.