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IDEAS...MATTER

HTI U.S. / GLOBAL CLINICAL STUDIES


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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).
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-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). 
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). 

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).

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).

OUR R&D ENGINE


Hengrui has 11 R&D centers across China, U.S. and Japan, with over 3,200 dedicated scientists and researchers around the world.
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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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LEARN MORE ABOUT ETERNITY
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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