Yingli Pharma Announces NMPA Approval of New Anti-cancer Drug Linperlisib

A safe and effective treatment choice for FL patients

Linperlisib is a next generation phosphoinositide 3-kinase delta (PI3Kδ) inhibitor independently developed by the Company. PI3Kδ plays a key role in the tumor immune cell proliferation and survival, making it a potent target for non-Hodgkins lymphomas. Treatment options for R/R FL patients, a major form of non-Hodgkins lymphoma, are extremely limited in China. In 2020, linperlisib was awarded NMPA Breakthrough Therapy status for the treatment of R/R FL in China. In addition, it received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic lymphocytic leukemia/ small lymphocytic lymphoma and T cell lymphoma.

In the pivotal R/R FL Phase II clinical trial in China, linperlisib-treated patients had an 79.8% overall response rate, a 96.6% disease control rate, a median Time to Response of 1.9 months, a median Progression Free Survival of 13.4 months, Duration of Response of 12.3 months and a 91.4% overall survival rate at 12 months¹. Linperlisib was well-tolerated with a differentiated and manageable safety profile, with low immune-mediated toxicities. In the linperlisib-treated patient safety dataset of the pivotal study, the most common (>15%) non-hematologic treatment related adverse events (TRAE) (Any Grade/ Grade≥3) were hypertriglyceridemia (25%/3%), ALT elevation (19%/2%), AST elevation (15%/2%), diarrhea (15%/2%), and pneumonia (15%/15%). The most common (>5%) hematologic TRAEs (Grade≥3) were neutropenia (15%), leukocytopenia (5%), and lymphocytopenia (5%).

“We are pleased to provide a new treatment option for patients with R/R FL with the approval of linperlisib. As linperlisib is the first innovative drug independently developed by Yingli Pharma, the NDA approval is a significant milestone”, said Dr. Xu Zusheng, General Manager and President of R&D of Yingli Pharma, “We would like to thank the patients, clinicians, and scientists for their generosity and great effort in the clinical development of linperlisib. It is a convenient once daily oral drug which demonstrated favorable safety, promising efficacy and great patient compliance. Yingli Pharma looks forward to in-depth collaboration with Hengrui Pharma to bring forth a full commercialization of 因他瑞® and extend the clinical development into additional indications.”

Dr. Lianshan Zhang, Deputy General Manager and President of Global R&D of Hengrui Pharma, said, " We are delighted with the NDA approval of linperlisib (因他瑞) for R/R FL. This approval is an important step for Hengrui Pharm to build a strong hematology franchise with an enriched pipeline. As Hengrui Pharma focuses on patient-centered R&D and innovation, we will continue to evaluate new indications for linperlisib, and combinations with the company's existing products to potentially benefit more patients.”

1. Lugui Qiu et al. 2022EHA.Abstract 1119

Hashtag: #YingliPharma

The issuer is solely responsible for the content of this announcement.