R&D

Pipeline

The hero of the global First-in Class is Hanmi Pharmaceutical.
Hanmi Pharmaceutical is developing in the areas of anti-cancer,
obesity, diabetes, and rare diseases.

Focused Pipeline

Overview

HM15136 is a long-acting Glucagon analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY). The physiological effects of glucagon receptor agonism (suppression of food intake, increased energy expenditure, and improved lipid metabolism) suggest superior weight loss efficacy in subjects with obesity. In preclinical studies, we observed a remarkable weight loss effect and improved lipid profile.

Additionally, GCGR agonism for glucose homeostasis by increasing glycogenolysis and gluconeogenesis suggests a novel therapeutic option in patients with various chronic hypoglycemic diseases such as congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric surgery (PBS). In preclinical studies with insulin-induced hypoglycemic model, chronic treatment of HM15136 provided a stable euglycemic profile. Based on the result, HM15136 was granted FDA and EMA orphan drug designation for the treatment CHI.

  1. Glucagon agonism (for obesity)
    • Body weigh loss via food intake inhibition, increased energy expenditure, and lipid metabolism
    • Improved insulin resistance by weight loss (lipid profile)
  2. Glucagon agonism (for chronic hypoglycemic disease)
    • Sustained glycogenolysis
    • Sustained gluconeogenesis
  3. Weekly injection by application of LAPS technology
    • Extended duration of action via vascular endothelium recycling without effector functions (ADCC and CDC)
    • Targeting first-in-class weekly Glucagon agonist

Clinical Development

A phase 1, first in human (FIH), single ascending dose (SAD) study was completed (NCT04032782), safe and tolerable profiles were confirmed in healthy subjects. We are currently conducting the phase 1b in US, Multiple ascending dose (MAD) trial of HM15136 in obese subjects with or without T2DM (NCT04167553).

Publications
Potent weight loss effects and mechanism of a novel long-acting Glucagon analog, HM15136, in animal models
Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
Beneficial effects of a novel long-acting glucagon analog, HM15136, on obesity and obesity related metabolic disorders in animal models
Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
A double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long-acting glucagon analogue, in healthy subjects
Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
Sustained Glucagon effect on blood glucose and improvements of insulin resistance mediated by a novel long-acting Glucagon analogue, HM15136, in animal models
Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
Potential of a novel long-acting Glucagon analogue, HM15136, for the treatment of obesity
Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
Potential of a novel long-acting Glucagon analog, HM15136, for the treatment of obesity
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Potent weight loss mechanism by a novel long-acting Glucagon analog, HM15136, in animal models
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Sustained Glucagon effect on blood glucose and improvements of insulin resistance mediated by a novel long-acting Glucagon analog, HM15136, in animal models
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
Therapeutic potential of novel combination of a long-acting Glucagon analog (HM15136) and antidiabetic drugs for the treatment of obesity
Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
A novel long-acting Glucagon analog (HM15136) offers favorable stability, PK/PD, and therapeutic potentials in CHI (congenital hyperinsulinism) animal model
Poster, European association for the study of diabetes (EASD) 53rd Annual meeting, 2017
A novel long-acting Glucagon analog (HM15136) offers favorable stability, PK, and therapeutic potentials in congenital hyperinsulinism animal model
Poster, American diabetes association (ADA) 77th Scientific sessions, 2017
Press Releases
[38th J.P. Morgan healthcare conference] Hanmi, ready to lead global pharmaceutical market with innovative R&D pipeline
Hanmi announces FDA orphan drug designation for LAPSGlucagon analog
[36th J.P. Morgan healthcare conference] Hanmi seeks global expansion with innovative drugs for NASH, rare diseases and targeted anti-cancer drugs