A PORTFOLIO OF DIFFERENTIATED ASSETS
ONCOLOGY
PYROTINIB - A HER2 TYROSINE KINASE INHIBITOR
Pyrotinib (SHR-1258) is a novel, irreversible pan-HER2 tyrosine kinase inhibitor. Pyrotinib is currently in phase 1 cohort expansion studies in the US for the treatment of patients with HER2 over expression metastatic breast cancer, HER2-mutant non-small cell lung cancer (NSCLC), and patients with other solid tumors with activating HER2 alteration (e.g., mutation, amplification). A marketing application for pyrotinib for metastatic breast cancer was submitted in China in 2017. The phase 1 clinical study for pyrotinib in the US is listed on clinicaltrials.gov (NCT02500199).
Pyrotinib (SHR-1258) is a novel, irreversible pan-HER2 tyrosine kinase inhibitor. Pyrotinib is currently in phase 1 cohort expansion studies in the US for the treatment of patients with HER2 over expression metastatic breast cancer, HER2-mutant non-small cell lung cancer (NSCLC), and patients with other solid tumors with activating HER2 alteration (e.g., mutation, amplification). A marketing application for pyrotinib for metastatic breast cancer was submitted in China in 2017. The phase 1 clinical study for pyrotinib in the US is listed on clinicaltrials.gov (NCT02500199).
HTI-1066 - C-MET ANTIBODY DRUG CONJUGATE
SHR-A1403 (also known as HTI-1066) is an antibody-drug conjugate (ADC) comprised of a proprietary anti-c-Met antibody conjugated to a proprietary payload that has the potential for increased specificity compared with monomethyl auristatin F (MMAF), a payload used in other ADCs. The target for HTI-1066 is c-Met, also called tyrosine-protein kinase Met or hepatocyte growth factor receptor (HGFR), a receptor tyrosine kinase (RTK) that is important in tumor growth, metastasis, and angiogenesis of many human malignancies, including liver, stomach, colorectal, lung, and breast cancers. The phase 1 clinical study for HTI-1066 in the US is listed on clinicaltrials.gov (NCT03398720).
SHR-A1403 (also known as HTI-1066) is an antibody-drug conjugate (ADC) comprised of a proprietary anti-c-Met antibody conjugated to a proprietary payload that has the potential for increased specificity compared with monomethyl auristatin F (MMAF), a payload used in other ADCs. The target for HTI-1066 is c-Met, also called tyrosine-protein kinase Met or hepatocyte growth factor receptor (HGFR), a receptor tyrosine kinase (RTK) that is important in tumor growth, metastasis, and angiogenesis of many human malignancies, including liver, stomach, colorectal, lung, and breast cancers. The phase 1 clinical study for HTI-1066 in the US is listed on clinicaltrials.gov (NCT03398720).
SHR-1316 - PD-L1 ANTIBODY
SHR-1316 is a fully humanized monoclonal antibody against programmed cell death ligand 1 (PD-L1, CD274) that blocks the interaction of PD-L1 on cancer cells with its receptor PD-1 on T cells. SHR-1316 is under investigation as an immuno-oncology agent. Hengrui Therapeutics, Inc. (HTI) filed an IND for the initial clinical study with SHR-1316 with US FDA. This phase 1 clinical study with SHR-1316 is being conducted at clinical trial sites in Australia and is listed on clinicaltrials.gov (NCT03133247).
SHR-1316 is a fully humanized monoclonal antibody against programmed cell death ligand 1 (PD-L1, CD274) that blocks the interaction of PD-L1 on cancer cells with its receptor PD-1 on T cells. SHR-1316 is under investigation as an immuno-oncology agent. Hengrui Therapeutics, Inc. (HTI) filed an IND for the initial clinical study with SHR-1316 with US FDA. This phase 1 clinical study with SHR-1316 is being conducted at clinical trial sites in Australia and is listed on clinicaltrials.gov (NCT03133247).
HTI-1090 - IDO INHIBITOR
HTI-1090 (also referred as SHR-9146) is an orally bioavailable, highly potent, novel small-molecule IDO1/TDO dual inhibitor. The tryptophan (Trp) to kynurenine (Kyn) metabolic pathway, driven by the rate-limiting enzymes indoleamine- 2,3-dioxygenase (IDO) and tryptophan-2,3-dioxygenase (TDO) is a key regulator of immune tolerance in both innate and adaptive immunity. Tryptophan depletion and tryptophan metabolites lead to inhibition of effector T cells and activation of suppressive Tregs, so blockade of the IDO/TDO pathway could potentially reverse cancer-induced immunosuppression. Hengrui Therapeutics, Inc. (HTI) filed an IND for the initial clinical study with HTI-1090 with US FDA. This phase 1 clinical study with HTI-1090 is being conducted at clinical trial sites in Australia and is listed on clinicaltrials.gov (NCT03208959).
HTI-1090 (also referred as SHR-9146) is an orally bioavailable, highly potent, novel small-molecule IDO1/TDO dual inhibitor. The tryptophan (Trp) to kynurenine (Kyn) metabolic pathway, driven by the rate-limiting enzymes indoleamine- 2,3-dioxygenase (IDO) and tryptophan-2,3-dioxygenase (TDO) is a key regulator of immune tolerance in both innate and adaptive immunity. Tryptophan depletion and tryptophan metabolites lead to inhibition of effector T cells and activation of suppressive Tregs, so blockade of the IDO/TDO pathway could potentially reverse cancer-induced immunosuppression. Hengrui Therapeutics, Inc. (HTI) filed an IND for the initial clinical study with HTI-1090 with US FDA. This phase 1 clinical study with HTI-1090 is being conducted at clinical trial sites in Australia and is listed on clinicaltrials.gov (NCT03208959).
METABOLIC
HTI-2088 - GLP-1 PEPTIDE
HTI-2088 is a synthetic analog of GLP-1 (glucagon-like peptide-1) which is an incretin to promote glucose-induced insulin secretion. HTI-2088 is an oral tablet dosage form being developed for the treatment of type 2 diabetes. A double-blind, placebo-controlled, single-dose study in healthy volunteers with HTI-2088 was completed in the US. The phase 1 clinical study for HTI-2088 is listed on clinicaltrials.gov (NCT03203811).
HTI-2088 is a synthetic analog of GLP-1 (glucagon-like peptide-1) which is an incretin to promote glucose-induced insulin secretion. HTI-2088 is an oral tablet dosage form being developed for the treatment of type 2 diabetes. A double-blind, placebo-controlled, single-dose study in healthy volunteers with HTI-2088 was completed in the US. The phase 1 clinical study for HTI-2088 is listed on clinicaltrials.gov (NCT03203811).
AUTOIMMUNE
SHR-1314 - IL-17 ANTIBODY
SHR-1314 is a humanized IgG1 monoclonal antibody antagonist of IL-17A. SHR-1314 binds selectively to IL-17A and inhibits its interaction with IL-17R, resulting in blockade of downstream inflammatory signal transduction. The phase 2 multi-national clinical study for SHR-1314 in patients with psoriasis is listed on clinicaltrials.gov (NCT03463187).
SHR-1314 is a humanized IgG1 monoclonal antibody antagonist of IL-17A. SHR-1314 binds selectively to IL-17A and inhibits its interaction with IL-17R, resulting in blockade of downstream inflammatory signal transduction. The phase 2 multi-national clinical study for SHR-1314 in patients with psoriasis is listed on clinicaltrials.gov (NCT03463187).
OUR R&D ENGINE
Hengrui has 7 R&D centers across China, U.S. and Japan, with over 2,100 dedicated scientists and researchers around the world.
SHANGHAI, CHINA - INNOVATIVE DRUG RESEARCH & DISCOVERY
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LIANYUNGANG, CHINA - CMC, MANUFACTURING, AND PRODUCT REGISTRATIONS
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CHENGDU, CHINA - HIGH POTENCY SMALL MOLECULES, HORMONAL THERAPIES, AND CONTRAST AGENTS
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JAPAN - HIGH VALUE FORMULATIONS AND REGULATORY AFFAIRS
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PRINCETON, US - INNOVATIVE SMALL MOLECULE DISCOVERY
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SHANGHAI MEDICAL CENTER, CHINA - INNOVATIVE DRUGS CLINICAL DEVELOPMENT AND FILINGS
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NANJING, CHINA - DOWNSTREAM SELECTION OF DRUG CANDIDATES, SALTS, CRYSTAL FORMS, AND FORMULATIONS
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Eternity Biosciences, Inc., located in New Jersey, was founded in 2009 by Jiangsu Hengrui Medicine. Its mission is to deliver high value drug candidates for critical medical needs with first- or best-in-class potential. Examples of its research and discovery include targeted oncology therapies such as EZH2, BRAF, MEK, and BTK inhibitors.
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