Overview of advanced drug candidates
HMP's R&D activities are focused on two target therapeutic areas: autoimmune diseases and oncology. The company 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 portfolio is largely focused on novel synthetic single chemical entities.
HMP retains global rights to all compounds and drug product listed below.
HMPL-004, an oral 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 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 separate trial for Crohn’s disease (CD) of 101 patients in US and Europe also demonstrated a clear trend of efficacy with strong safety data. HMPL-004 was selected as one of the 12 finalists in Asia Innovation Awards 2011 presented by Wall Street Journal Asia.
Sulfatinib (HMPL-012) is a novel small molecule that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor (VEGF) and fibroblast growth factor receptors. A first-in-human Phase I clinical trial is underway in China. Preliminary study results indicated that Sulfatinib was well tolerated in cancer patients and exhibited a favourable pharmacokinetic profile. Key potential indications include liver, CRC, and breast cancers.
Fruquintinib (HMPL-013) is a novel small molecule compound that selectively inhibits VEGF receptors. Fruquintinib has shown highly potent inhibitory effects on multiple human tumour xenografts, including some refractory tumours such as pancreatic cancer and melanoma. The first-in-human Phase I clinical trial started in early 2011. Key potential indications include gastric, CRC, and pancreatic cancers.
Epitinib (HMPL-813) is an orally active small molecule inhibitor targeting epithelial growth factor receptor (EGFR) designed for optimal tissue distribution in order to target broader tumor types. In preclinical studies, Epitinib demonstrated excellent brain penetration and good efficacy in orthotopic brain tumor models in nude mouse, and good pharmacokinetic properties and a favorable safety profile. We obtained SFDA's approval of its Investigative New Drug ("IND") application and started the first-in-human Phase I clinical trial in October 2011. If safety, maximum tolerated dose, and preliminary efficacy against brain tumors are confirmed in clinical studies, Epitinib could become a breakthrough therapy for patients with brain tumors carrying activating EGFR mutations.
Volitinib (HMPL-504) is a potent ATP-competitive c-Met inhibitor with high selectivity over a 274-kinase panel. It demonstrated tumor growth inhibitory activity in a series of human tumor xenografts especially for those tumors with c-Met gene amplification or c-Met over-expression. IND applications of HMPL-504 have been prepared and submitted. The targeting indications may include gastric cancer and non-small cell lung cancer, as well as others with c-Met deregulation. C-Met gene amplification status and protein expression levels will be used to direct patient selection in clinical trials.
Theliatinib (HMPL-309) is an inhibitor of epidermal growth factor receptor tyrosine kinase with much improved activity against resistant mutants and a unique tissue distribution profile. We have obtained SFDA's approval of its Investigative New Drug ("IND") application. HMPL-309 will target non-small cell lung cancer.
