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

The first highly selective PI3Kδ inhibitor in China

SHANGHAI, CHINA - Media OutReach - 9 November 2022 - Shanghai Yingli Pharmaceutical Co., Ltd. (the "Company" or "Yingli Pharma") is pleased to announce that linperlisib, trade name因他瑞®, a novel phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, has been approved by the National Medical Products Administration (NMPA) of China on November 9 for the treatment of relapsed/refractory follicular lymphoma (R/R FL) in patients who have received 2 or more prior systemic therapies. The NDA approval validates Yingli Pharma’s strong innovation capabilities and fulfills the company’s objectives to bring new treatment options to patients and their families.

Yingli Pharma has entered into strategic partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), a leading pharmaceutical company with well-established oncology sales and marketing network, to commercialize因他瑞® in China.

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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About Yingli Pharma

Shanghai Yingli Pharmaceutical Co., Ltd. is a technologically innovative biopharmaceutical company founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark. With the Chinese government promotion of healthcare reforms, the Chinese pharmaceutical industry has gradually transformed to include the biopharmaceutical sector of innovation. The NDA approval of linperlisib is a significant milestone for this national effort and demonstrates the Company’s strong innovation capability for drug development. Yingli Pharma has established a rich and independently-developed pipeline of novel oral agents for oncology and metabolic diseases. The Company has more than ten drugs under development, including more than 100 independent intellectual property rights, with three of the investigational agents in clinical stage in China and abroad.

For more information, please see:
http://www.yl-pharma.com/