On November 9, 2022, Shanghai Yingli Pharmaceutical Co., Ltd. (hereinafter referred to as "YL-Pharma") announced that the Class 1 anti-cancer new drug linperlisib has been approved for marketing by the China National Medical Products Administration (NMPA) for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), under the trade name Yin Tai Rui^®. As a professional imaging CRO company in China, Union Image provided full independent imaging assessment (Independent Review Committee, IRC) services for the clinical study of this drug to aid in the smooth approval of the new drug.

Screenshot source: webpage of NMPA

According to the Chinese Guidelines for the Diagnosis and Treatment of Lymphoma (2022 Edition), in 2020, there were 92,834 new cases of non-Hodgkin lymphoma (NHL) in China, with the incidence and mortality rates of NHL in men ranking tenth among all malignant tumors. FL is one of the most common types of NHL, accounting for 10-20% of all NHL cases. Twenty percent of FL patients experience disease progression within two years after first-line therapy¹; for some relapsed and refractory patients, subsequent treatment options are very limited, indicating an unmet medical need in this field. In recent years, the development of novel targeted therapies, including PI3Kδ inhibitors, has advanced precision treatment in the field of lymphoma and brought hope to patients with relapsed and refractory lymphoma.

In the linperlisib clinical study project, Union Image, based on its independently developed digital imaging evaluation system (U-ORBIT^®), leveraging the dynamic and efficient project management capabilities of its professional team, provided the sponsor with full-process services including remote image data upload, image data quality control, image review and evaluation, medical auditing, and data export, successfully responding to the urgency of delivery. By fully meeting the requirements in terms of science, quality, and timelines, and providing accurate and compliant independent evaluation results, it accelerated the progress of the product's marketing application and received unanimous recognition and praise from colleagues at YL-Pharma.

Since its establishment in 2017, Union Image has accumulated rich clinical research experience in the field of oncology, can proceed from clinical needs, stand in the sponsor's perspective, plan and integrate resources, and help clients succeed. In the future, Union Image will continue to leverage its professional advantages and capabilities, providing scientific, professional, and efficient independent imaging evaluation solutions for more new oncology drugs, helping to accelerate the development of innovative drugs, and contributing Union Image's strength to human life and health!

About Union Image

Shanghai Union Image Technology Co., Ltd. is a third-party independent imaging evaluation CRO, providing third-party independent imaging evaluation services for clinical research of oncology drugs, ensuring the objectivity and scientific validity of trial results, accelerating the process of clinical studies and registration approvals, and assisting new drugs to market.

Union Image was established in December 2017, headquartered in Shanghai, and is a wholly-owned subsidiary of Shanghai UnionClin Co., Ltd.

Source:

1.Fischer T, Zing NPC, Chiattone CS, Federico M, Luminari S. Transformed follicular lymphoma. Ann Hematol 2018; 97(1): 17-29.