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

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References

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