HONG KONG, CHINA – 13 August 2018 – Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), announced that its innovative in-house developed oncology drug pirotinib has commenced into Phase II Clinical testing in China following the completion of a Phase I clinical trial in three renowned cancer research centres in the United States.

Pirotinib is a novel, irreversible, pan-epidermal growth factor receptor (“EGFR”) tyrosine kinase inhibitor (TKI). EGFR mutations can ‘drive’ the growth of various types of malignancies including cancers of the lung, stomach, and oesophagus.

Pan-EGFR TKIs are used for the treatment of several types of cancers, including non-small cell lung cancer (NSCLC) which is the leading cause of cancer mortality and morbidity in China. Preclinical in vitro and in vivo tests have demonstrated that pirotinib is able to suppress the growth of NSCLC-cells with EGFR-mutations irresponsive to other targeted therapies available.

The Phase II study, led by Professor Wu Yilong, Chairman of the Chinese Society of Lung Cancer and standing member of the Chinese Society of Clinical Oncology (CSCO), has just commenced and the first study subjects have enrolled prior to this announcement.

A Phase III Clinical Trial is scheduled to commence in the second half of 2019.