파이프라인
한미약품은 축적된 연구 개발 기술력을 바탕으로 비만 및 대사성 질환, 항암, 희귀질환 치료제 분야에서
다양한 혁신신약을 개발하고 있습니다.

주요 파이프라인 소개

한미약품과 인류의 건강을 위한 창조와 혁신 그리고 도전 정신을 함께 할 파트너사를 찾습니다.

efocipegtrutide (LAPSTriple agonist)

OVERVIEW

Efocipegtrutide is a long-acting glucagon, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1) triple full agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY)

The physiological effects mediated by optimal activation of multiple incretin receptors, Glucagon, GIP, and GLP-1 receptors, could provide an improved therapeutic efficacy in subjects with non-alcoholic steatohepatitis (NASH) and fibrosis compared to any single targeting medications via simultaneously affecting liver fat accumulation, inflammation, and fibrogenesis - the hallmark of NASH.

In nonclinical studies, remarkable reduction in liver fat content and robust improvement in liver inflammation and fibrosis were observed in various animal models of NASH and/or liver fibrosis. Based on these results, we prioritized clinical development of efocipegtrutide as a novel therapeutic medication for NASH/fibrosis. Recently, phase 2b clinical study is being investigated in biopsy-confirmed NASH subjects with fibrosis. The FDA granted fast track designation to efocipegtrutide for the treatment of NASH.

In addition, potential benefit in diverse fibrotic diseases of high unmet medical needs is being investigated for efocipegtrutide’s indication expansion. Based on promising nonclinical study results, efocipegtrutide received orphan drug designation from the FDA and EMA for the treatment of idiopathic pulmonary fibrosis (IPF), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC).
Glucagon/GIP/
GLP-1 triple agonism
  • Maximal efficacy for liver fat removal by three combined mode of action (energy intake, β-oxidation, and de novo lipogenesis)
  • Maximal efficacy for Improvement of liver inflammation by multiple incretin action in cooperation with favorable liver targeting
  • Direct down-regulation of hepatic stellate cell activation
Ultra-long duration of action
  • Extended duration of action by LAPSCOVERY
  • Targeting first-in-class weekly Glucagon/GIP/GLP-1 triple agonist

CLINICAL DEVELOPMENT

A phase 1 and 2a study was completed (NCT03374241, NCT03744182).
A phase 2b study with biopsy-confirmed NASH subjects are currently ongoing in US and Korea (NCT04505436).

PUBLICATIONS

Improvement of liver fibrosis by a novel long acting glucagon/GIP/GLP-1 triple agonist, efocipegtrutide (HM15211) in carbon tetrachloride-induced mouse model of liver injury and fibrosis
Poster, European Association for the Study of the Liver (EASL) Congress, 2023
Anti-inflammatory and anti-fibrotic effects by simultaneous activation of glucagon, GIP, and GLP-1 of efocipegtrutide (HM15211) in thioacetamide-induced mouse model of liver injury and fibrosis
Poster, European Association for the Study of the Liver (EASL) Congress, 2023
Anti-fibrotic and mortality reduction potential of a novel long-acting glucagon/GIP/GLP-1 triple agonist (HM15211) in preclinical models of idiopathic pulmonary fibrosis
Poster, American Thoracic Society (ATS) International conference, 2023
Anti-inflammatory and anti-fibrotic effects of a novel long-acting Glucagon/GIP/GLP-1 triple agonist, HM15211, in TAA induced mouse model of liver injury and fibrosis
Oral presentation, European association for the study of diabetes (EASD) 58th Annual meeting, 2022
Anti-fibrotic potential of a novel long-acting Glucagon/GIP/GLP-1 triple agonist (HM15211) in preclinical models of idiopathic pulmonary fibrosis
Oral presentation, European association for the study of diabetes (EASD) 58th Annual meeting, 2022
Direct Anti-inflammatory and Anti-fibrotic Effects of a Novel Long-acting Glucagon/GIP/GLP-1 Triple Agonist, HM15211, in TAA-induced Mouse Model of Liver Injuary and Fibrosis
Poster, American diabetes association (ADA) 82nd Scientific sessions, 2022
Anti-fibrotic potential of a novel long-acting Glucagon/GIP/GLP-1 triple agonist (HM15211) in preclinical models of fibrosis
Poster, American diabetes association (ADA) 81st Scientific sessions, 2021
Multi-target engagement effect of a novel long-acting Glucagon/GIP/GLP-1 triple agonist (HM15211) in animal model of NASH
Oral presentation, European association for the study of diabetes (EASD) 57th Annual meeting, 2021
Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211)in CDHFD-induced NASH and fibrosis mice
Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist, exhibits anti-inflammatory and –fibrotic effects in AMLN/TAA induced liver inflammation and fibrosis mice
Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
Anti-fibrotic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in BDL-induced liver fibrosis mice
Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
Effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a NASH and liver fibrosis animal models
Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
Effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a dyslipidemia animal models
Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
Neuroprotective effects of HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
A double-blinded, placebo controlled, single ascending dose study for safety, tolerability, pharmacokinetics, and pharmacodynamics after subcutaneous administration of novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in healthy obese subjects
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Effect of HM15211, a novel long-Acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a dyslipidemia animal model
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a NASH and fibrosis animal model
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Novel combination of GLP-1/GIP/Glucagon triple agonist (HM15211) and once-weekly basal insulin offers improved glucose lowering and weight loss in a diabetic animal model
Poster, European association for the study of diabetes (EASD) 54th Annual meeting, 2018
Bone protective effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in the obese-osteoporosis rodent model
Poster, European association for the study of diabetes (EASD) 54th Annual meeting, 2018
Neuroprotective effects of HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
Oral presentation, European association for the study of diabetes (EASD) 54th Annual meeting, 2018
Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in NASH and fibrosis animal models
Oral presentation, American diabetes association (ADA) 78th Scientific sessions, 2018
Neuroprotective effects of HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
Poster, American diabetes association (ADA) 78th Scientific sessions, 2018
Effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a NASH and fibrosis animal model
Poster, American diabetes association (ADA) 78th Scientific sessions, 2018
Bone protective effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in an animal model
Poster, American diabetes association (ADA) 78th Scientific sessions, 2018
Novel combination of a long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) and once-weekly basal insulin (HM12460A) offers improved glucose lowering and weight loss in a diabetic animal model
Oral presentation, American diabetes association (ADA) 78th Scientific sessions, 2018
Neuroprotective effects of HM15211, a novel long-acting GLP-1/Glucagon/GIP tri-agonist in the MPTP Parkinson's disease mouse model
Poster, European association for the study of diabetes (EASD) 53rd Annual meeting, 2017
Potent body weight loss, and therapeutic efficacy in a NASH animal model by a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211)
Oral presentation, European association for the study of diabetes (EASD) 53rd Annual meeting, 2017
Potent body weight loss and efficacy in a NASH animal model by a novel long-acting GLP-1/Glucagon/GIP triple-agonist (HM15211)
Poster, American diabetes association (ADA) 77th Scientific sessions, 2017
Neuroprotective effects of HM15211, a novel long-acting GLP-1/Glucagon/GIP triple agonist in the MPTP Parkinson's disease mouse model
Poster, American diabetes association (ADA) 77th Scientific sessions, 2017