Initiation of HMPL-523 Clinical Trials in Hematological Cancer in China

Shanghai: Tuesday, January 10, 2017: Hutchison MediPharma Limited (“HMP”) today announces that it has initiated a Phase I trial of its novel spleen tyrosine kinase (“Syk”) inhibitor, HMPL-523, in patients with hematological malignancies in China.  The first patient was dosed on December 27, 2016.  This study complements the ongoing Phase I trial in patients in Australia with hematological malignancies, which is expected to complete dose-escalation in the first half of 2017.

Syk, a non-receptor type of tyrosine kinase, plays a pivotal role in the regulation of the B-cell receptor (BCR) signaling pathway, which regulates proliferation, differentiation and survival of B lymphocytes.  The abnormal activation of BCR signaling is closely related to transformation and development of B-cell lymphoma.  Data from a recent pre-clinical study investigating the in vitro and in vivo anti-tumor activities of HMPL-523 was presented at the annual meeting of the American Society of Hematology held in San Diego, CA on December 5, 2016.  The presentation is available.

Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02857998.

Clinical development in immunology

HMPL-523 is also being studied in immunological indications.  Clinical data for HMPL-523 in a Phase I dose-escalating study in healthy volunteers in Australia was recently presented at the 2016 annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals, which was held in November 2016.  The detailed poster presentation can be viewed at www.hmplglobal.com.  The Company plans to initiate proof-of-concept clinical trials in the United States in 2017.

About B-cell signaling

The BCR signaling pathway regulates proliferation, differentiation and survival of B lymphocytes, a major cellular component of the immune system.  The abnormal activation of BCR signaling is closely related to transformation and development of hematological cancers (i.e. B-cell malignancies), including lymphoma and leukemia, as well as autoimmune diseases, such as rheumatoid arthritis.  Targeted BCR signaling therapies, including monoclonal antibodies and small molecules, have been proven to be clinically effective for the treatment of B-cell malignancies, leading to scientific and commercial success.

Syk is a key protein involved in the BCR signaling pathway.