Hutchison Pharmaceutical's Solopinib China Phase III patient enrollment was completed

According to the news released by Hehuang Pharma on January 5, the phase II clinical trial of Hutchison Pharmaceutical's innovative drug Solopinib for the treatment of patients infected with severe/critical novel coronavirus (COVID-19) was achieved on January 4, 2023 in Huashan Hospital, affiliated to Fudan University in Shanghai.

Solopinib (formerly known as HMPL-523) is a novel, researchable and selective small molecule oral splenic tyrosine kinase ("Syk") inhibitor independently developed by Hutchison Pharmaceutical. Syk, a key protein in the B-cell receptor and Fc receptor signaling pathway, is a well-established therapeutic target for autoimmune diseases and various subtypes of B-cell lymphoma. By inhibiting the release of cytokines and inflammatory factors, increasing protection of vital organs, and avoiding the failure of multiple organs, Syk inhibitors have the potential to help mitigate the harmful effects of excessive immune responses caused by coronavirus infection.

As the only phase III clinical phase Syk inhibitor in China, the phase III clinical trial of solopinib for the treatment of immune thrombocytopenia is underway in China, and was included in the breakthrough therapy drug variety by the National Medical Products Administration of China in January 2022. Solopinib has also been studied in China, the United States and Europe for the treatment of warm antibody autoimmune hemolytic anemia, indolent non-Hodgkin lymphoma, and various subtypes of B-cell malignancies. Solopinib has shown good safety and clinical efficacy data in clinical studies so far, and a large number of research data support the further clinical development of solpinib in the treatment of new crown infection, which is expected to become a new optimized treatment for severe/critically ill new crown patients.

The study was led by Professor Zhang Wenhong, Director of the Department of Infectious Diseases, Huashan Hospital Affiliated to Fudan University, National Center for Infectious Diseases. At the recent project kick-off meeting, Professor Zhang Wenhong introduced the development characteristics and trends of the current national epidemic to the participating experts and representatives, hoping that through the rapid promotion of this clinical program, focus on protecting vulnerable groups under the epidemic, benefit patients, and more effectively play the positive role of innovative drugs in the new stage of epidemic prevention and control from "infection prevention" to "health and severe disease prevention".