Overview on Advanced Drug Candidates
Hutchison MediPharma's R&D activities are focused on two target therapeutic areas: autoimmune disorders and oncology. Hutchison MediPharma has several promising anti-inflammatory and anti-cancer drug candidates in various stages of clinical trials and a pipeline of early stage discovery projects. The discovery portfolio largely focuses on novel synthetic single chemical entities.
HMPL-004, Hutchison MediPharma’s leading drug candidate is an orally botanical product that acts on multiple targets in the pathogenesis of inflammatory bowel disease. To date HMPL-004 has completed three clinical studies, including two recently completed global phase II clinical trials. A 223-patient global Phase IIb trial for the treatment of ulcerative colitis (“UC”) clearly succeeded in meeting all its endpoints, including its primary efficacy endpoint of clinical response with a decrease in rectal bleeding, alongside an excellent safety profile. A 101-patient global Phase II trial for the treatment of Crohn’s disease (“CD”) demonstrated strong efficacy with an outstanding safety profile.
HMPL-011 is a novel, first-in-class oral cytokine modulator that controls the production of pro-inflammatory cytokines and advanced into clinical development for autoimmune diseases, including rheumatoid arthritis and psoriasis. It has shown good efficacy in animal models of a variety of inflammatory disorders. The first-in-human Phase I clinical trial was initiated in Australia in October 2009 and is expected to report results in the first half of 2010.
HMPL-012 (Sulfatinib) is a novel, orally active VEGFR/FGFR inhibitor. Sulfatinib demonstrated broad-spectrum anti-tumor activity via oral dosing against a variety of human tumors in xenograft models. Its unique kinase profile provides a promising opportunity and potential therapeutic differentiation against existing products on the market. An IND application was submitted in May 2009 to the Chinese State Food and Drug Administration (SFDA) and is currently under review.
HMPL-013 (Fruqintinib) is a novel small molecule VEGFR inhibitor. It is differentiated from HMPL-012 and other marketed drugs in this class by its kinase selectivity in vitro and superior potency in vivo against a variety of human xenografts. An IND application was submitted in August 2009 to SFDA and is currently under review.
HMPL-813 is a highly potent and selective EGFR tyrosine kinase inhibitor. HMPL-813 demonstrated anti-tumor activity against a variety of human tumors in xenograft models. The candidate was selected in 2009 and the IND-enabling evaluations are in progress. The IND application to SFDA is planned for the first half of 2010.
HMPL-309 is the second EGFR inhibitor selected in 2009. It has much improved activity against resistant mutants. HMPL-309 has a unique tissue distribution profile ideal for solid tumors, including possibly brain tumors.
HMPL-342 is a novel IKKb inhibitor that controls the production of pro-inflammatory cytokines for asthma/COPD and other autoimmune disease. Hutchison Medipharma retains global rights to HMPL-342.
