HUYABIO Development Compounds

HUYABIO International identifies a select subset of promising early stage compounds from its product portfolio and positions them for development in markets worldwide. HUYABIO seeks opportunities in therapeutic areas with significant market potential and unmet medical need, where the compound has a competitive advantage, strong patent position worldwide, and a clear clinical development path.

The company is currently developing a number of programs, including the next generation oncology drug HBI-8000, the novel anti-arrhythmic HBI-3000, the small molecule with regenerative properties for myocardial infarction HBI-3800, the novel SHP2 inhibitor for solid tumors HBI-2376, and the novel epigenetic target for myelodysplastic syndrome and acute myeloid leukemia HBI-ONC.

Product Target Indications Territory IND FIH POC REG MKT


ATL Japan
Regulatory Approval Received


PTCL Korea, Japan
Regulatory Submission


1L Melanoma Worldwide
Nivo Combo Registration Trial


2L Lung Cancer Worldwide
Nivo Combo POC Achieved


Solid Tumors Worldwide


MDS/AML Worldwide


Atrial Fibrillation Worldwide
Phase 2


Post-MI Worldwide
Drug Phase
HBI-8000 Phase 2
HBI-3000 Phase 1
HBI-3800 Pre-Clinical
Drug Phase
HBI-8000 Phase 2
HBI-3000 Phase 1
HBI-3800 Pre-Clinical

* Combination Therapy

About HBI-8000

The novel epigenetic drug, HBI-8000, a member of the benzamide class of histone deacetylase inhibitors (HDACIs), alters histone structure to control the expression of many genes necessary to the growth of cancer cells. This activity is responsible for HBI-8000’s single agent activity against certain lymphomas. In addition, the drug also controls the nuclear transport of a key protein involved in tumor immunity and the tumor microenvironment, modulates the tumor microenvironment, and alters innate and adaptive immunity, leading to increased cancer cell death. Evidence suggests that the mechanism of action of selective HDACI, such as HBI-8000, increases the therapeutic efficacy in combination with other anti-cancer agents such as checkpoint inhibitors.

HUYABIO International is developing HBI-8000, the first approved, oral class I selective HDACI. The company was the first to leverage the Tripartite Agreement between China, Japan and South Korea, to use Chinese clinical data for a path for accelerated development of this drug in lymphoma, using clinical results from the Japanese Pharmaceutical and Medical Devices Agency. HUYABIO has submitted applications for the approval of HBI-8000 as monotherapy for the treatment of patients with relapsed refractory peripheral T-cell lymphoma (PTCL) and adult T-cell lymphoma (ATL) in Japan under Orphan Drug Designation.

Leveraging its immunomodulatory properties, HUYABIO is also conducting a multi-national Phase III trial of HBI-8000 in combination with nivolumab to establish the safety and efficacy of HBI-8000 for the treatment of melanoma in patients naïve to checkpoint therapy. HUYABIO will pursue additional trials for HBI-8000 in combination with checkpoint inhibitors and other anti-cancer therapeutics with the aim of meeting unmet medical needs in oncology.

About HBI-2376

SHP2 is an attractive target in oncology drug development due to its bidirectional role in both tumor growth promotion and T-cell inactivation. Its key features include being selected from five leading SHP2 assets in the HUYABIO R&D Engine, being the potentially best-in-class SHP2 inhibitor, demonstrating immune-modulatory activity as well as efficacy in EGFR or KRAS mutant cancer cell lines, and superior potency and efficacy compared to Novartis TNO-155.

HBI-2376 has broad indications in EGFR/KRAS mutant tumors such as head and neck squamous cell carcinoma (HNSCS) and non-small cell lung cancer (NSCLC), colorectal cancer and in IO (immuno-oncology). It also shows great synergy in combination with EGFR/KRAS inhibitors as well as checkpoint inhibitors anti-PD1, anti-PD-L1 and anti-CTLA4 antibodies.


HBI-ONC is an in-licensed novel epigenetic target identified from the HUYABIO R&D Engine. It is an epigenetic inhibitor and is capitalizing on HUYABIO expertise with epigenetic drugs.

About HBI-3000

HBI-3000 is a multi-ion channel blocker in development for the treatment of cardiac arrhythmias. Anti-arrhythmic drugs are used to treat patients with atrial fibrillation (AF), a serious condition that affects more than 3.5 million patients in the US and 30 million patients worldwide. There is a significant need for safer and more effective pharmacological interventions to treat AF, as current treatments have poor safety and efficacy profiles and the alternative, electrical cardioversion, has poor patient acceptance and requires patient sedation.

HBI-3000 has a unique ion channel profile (INa-Peak, INa-Late, ICa,L and IKr, as well as some activity at Ito and IKur) and does not pose a pro-arrhythmic risk in preclinical models. The drug’s preclinical pharmacology also supports the potential of HBI-3000 to restore sinus rhythm in AF. This profile makes HBI-3000 a promising antiarrhythmic candidate for clinical development.

A Phase I randomized, double-blind, placebo-controlled, serial cohort dose escalation study of HBI-3000 has been completed in the UK and the results were published at the American Heart Association conference in November 2019. (See link to AHA poster here.)

A second Phase I study to examine HBI-3000 metabolism and potential effects on contractility is underway in Australia, and a Phase II dose escalation study to evaluate the efficacy of HBI-3000 to convert patients in acute AF has been initiated in New Zealand.

About HBI-3800

HBI-3800 is a small molecule with unique preclinical activity in regenerating cardiac muscle cells, or cardiomyocytes, damaged by ischemia. Coronary artery disease is the leading cause of death in the US and many other countries. Treatment of patients after a myocardial infarction, or heart attack, currently involves drugs to improve blood flow. However, no therapy in current development appears to lead to regeneration of heart muscle tissue. In animal models of myocardial infarction, HBI-3800 stimulates stem cell differentiation into functional cardiomyocytes, replacing and remodeling the myocardium with new functional tissue. This potentially revolutionary agent has several promising uses, including treatment of the consequences of myocardial infarction, improving global heart function and preventing chronic heart failure.

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