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SAN FRANCISCO, April 1, 2025 /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). 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.
"This is a major milestone for linperlisib.", said Michael Hui, 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."
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.
About linperlisib
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 November 2022, linperlisib was approved in China 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.
Linperlisib has been studied in three clinical trials in R/R PTCL in China, U.S. and Europe, 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. and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial.
About Yingli Pharma
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. 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 China, making Yingli Pharma the second pharmaceutical company in China and the first in Shanghai to receive this recognition.
For more information, please see:
http://www.yl-pharma.com/
CONTACT: Wendy Xiong, MD , Email : [email protected], Phone : 669-842-3439
