Technology name
Last update: Mar 2025LAPSCOVERY (Long Acting Protein / Peptide Discovery Platform Technology)
Developer(s)
Sponsor(s)
Not specified
Type of technology
aglycosylated Fc based particles
Administration route
Intravenous, Subcutaneous, Intramuscular
Development state and regulatory approval
efocipegtrutide (GLP-1 triple agonist )
Phase II
Efocipegtrutide Fast Track designation and orphan drug status for the treatment of nonalcoholic steatohepatitis (MASH).
Description
LAPSCOVERY is a long-acting platform technology designed to extend the half-life of biologics administered systemically. The API (therapeutic proteins) is fused with aglycosylated Fc fragments, which enhances the pharmacokinetics of the API. The monomeric Fc fragments help to reduce receptor-mediated clearance, thereby delaying renal filtration and prolonging the therapeutic effect.
Developer(s)
Hanmi Pharmaceutical
Hanmi Pharmaceutical Ltd., founded in 1973 in South Korea, is a leading R&D-driven company specializing in innovative drug development. It pioneers platform technologies like LAPSCOVERY for long-acting biologics and ORASCOVERY for oral chemotherapeutics. Hanmi collaborates with global firms, including Sanofi, Eli Lilly, and Genentech, advancing oncology, diabetes, and rare disease treatments.
Technology highlight
1. The flexible linker minimizes loss of intrinsic activity 2. Highest bioavailability reduces dose level 3. Low Immunogenicity 4. Minimal Loss of activity 5. Increased cellular solubility 6. No loss of neonatal Fc receptor (FcRn) binding
Illustration(s)
Technology main components
1. Two Aglycolated Fc Fragments 2. Carrier (e.g., Ethylene vinyl acetate) 3. Non-peptide biocompatible polymer (Linker) 4. Excipients—lactose , dextrose , sucrose , sorbitol, mannitol , xylitol , erythritol , maltitol , starch , acacia rubber, alginate , gelatin , calcium phosphate , calcium silicate , cellulose , methyl cellulose , microcrystalline cellulose , polyvinylpyrrolidone, water , methyl hydroxybenzoate , propyl hydroxybenzoate , talc , magnesium stearate , mineral oil , etc. 5. Fillers, anti-coagulant , lubricants, humectants, flavoring agents, preservatives, etc.
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Safety, Efficacy and Evidence Summary
In the phase 3 clinical trial evaluating once-weekly efpeglenatide, the most frequently reported adverse events were mild to moderate gastrointestinal symptoms, including diarrhea, vomiting, and constipation. Treatment-emergent adverse events (TEAEs) occurred in 78.4–83.8% of patients in the treatment group, with two cases of diabetic retinopathy being reported. Serious TEAEs were observed in 9–11% of the patient population.
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APIs compatibility profile
LAPSCOVERY specially focuses on protein-based small molecules designed to target epidermal growth factor receptors (EGFR), including HER2 and HER4, with compounds such as poziotinib,Tuspetinib.
LAPSCOVERY targets a diverse range of proteins, including insulin homologues, human growth hormone, GLP-1 agonists, glucagon, granulocyte colony-stimulating factor, interleukins, and bispecific antibodies.
Not provided
Not provided
50-75 wt%
2 different APIs : Not provided
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Not provided
Scale-up and manufacturing prospects
Hanmi has a bio plant in Pyeongtaek for the LAPSCOVERY-based biologics occupying a 4,600 m² area.
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Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
Single-dose prefilled syringe
Additional features
- Drug-eluting
- At least 1 year shelf life
Upon reaching the target site, the aglycosylated Fc-bound API is released via the detachment of the flexible PEG linker. Once freed, the API binds to its target receptor, eliciting its therapeutic effect through agonistic or antagonistic activity. This monomeric complex partially reduces receptor-mediated clearance and renal filtration. Due to this mechanism, the activity of the API is prolonged.
The prefilled injection of efpeglenatide (LAPScovery formulation) typically uses a 29-gauge needle for subcutaneous administration.
LASPSCOVERY formulation in its prefilled pen or vial is stable for up to 24 months when stored under the recommended refrigeration condition
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. It can be stored at room temperature (up to 30°C/86°F) for a maximum of 14 days.
Therapeutic area(s)
- Diabetes
- Other(s) : "Obesity/ metabolic disorders and rare diseases"
- Oncology
Not provided
Potential associated API(s)
- efpegerglucagon (glucagon analog)
- efpeglenatide (exendin-4 analog)
- efocipegtrutide (GLP-1 triple agonist )
- HM16390 (IL-2 analog)
- efpegsomatropin (human growth hormone (hGh) analog)
- sonefpeglutide (Glucagon-like peptide-2 (GLP-2) analogue)
Use of technology
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
Weekly, Monthly
Targeted user groups
- Adults
- Older Adults
- All
Unspecified
Unspecified
Unspecified
Not provided
efpegerglucagon (glucagon analog)
Glucagon Analog
Phase II
Not provided
Congenital Hyperinsulinism (CHI)
2 years and older
Once weekly
Efpegerglucagon received orphan drug designation from the FDA, EMA, and MFDS for the treatment of CHI
efpeglenatide (exendin-4 analog)
Exendin-4 Analog
Phase III
Type 2 Diabetes
< 18 years and older
Once weekly
Not provided
efocipegtrutide (GLP-1 triple agonist )
GLP-1 triple agonist
Phase II
nonalcoholic steatohepatitis (MASH)
Adults ≥ 18 to ≤ 70 years
Once weekly
Efocipegtrutide Fast Track designation and orphan drug status for the treatment of nonalcoholic steatohepatitis (MASH).
HM16390 (IL-2 analog)
Interleukin Analogues
Phase I
Advanced or Metastatic Solid Tumors
Not provided
Not provided
Not provided
efpegsomatropin (human growth hormone (hGh) analog)
Somatotropin receptor agonists
Phase II
Not provided
Somatotropin deficiency
Not provided
Not provided
Not provided
sonefpeglutide (Glucagon-like peptide-2 (GLP-2) analogue)
GLP-2 analog
Phase II
Short Bowel Syndrome-associated Intestinal Failure
Not provided
Once monthly
Not provided
Composition for treating diabetes comprising long-acting insulin conjugate and long-acting insulinotropic peptide conjugate
The present invention relates to an anti-cancer pharmaceutical composition comprising an interferon alpha or a polymer congugate thereof and use thereof in the treatment of cancer by co-administration with anti-cancer agents. The interferon alpha conjugate of the present invention shows a longer in vivo half-life and a more excellent anti-cancer activity than the conventional interferon alpha, and in particular, its co-administration with an anti-cancer agent such as gemcitabine has synergistic inhibitory effects on cancer cell growth and proliferation so as to exhibit a remarkably excellent anti-cancer activity. Further, the anti-cancer pharmaceutical composition of the present invention has excellent in vivo half-life and anti-cancer activity to greatly reduce administration frequency. C
WO2013036032
Formulation
Hanmi Science Co Ltd
Not provided
June 1, 2032
Granted: AU, EP (BE, CH, FR, IT, LI), JP, MX, RU, US Pending: CA, CN Not in force: BR
Long-acting glucagon conjugate and pharmaceutical composition comprising the same for the prevention and treatment of obesity
Disclosed is a novel long-acting glucagon conjugate in which glucagon or its derivative is covalently linked to a polymer carrier via a non-peptide linker, and a pharmaceutical composition comprising the same as an effective ingredient useful for the prevention and treatment of obesity. Since the long-acting glucagon conjugate of the present invention shows improved in vivo durability and stability, when used in combination with an anti-obesity drug, it is possible to induce synergistic effects on the loss of body weight and decrease in food intake without causing any side-effects such as fluctuation in blood glucose level. Accordingly, the long-acting peptide conjugate of the present invention is very effective for the prevention and treatment of obesity.
WO2012011752
Compound
Hanmi Science Co Ltd
Not provided
September 21, 2031
Granted: EP (DE, FR, GB), JP, KR, US Pending: AR
Protein conjugate comprising polypetide drug, aglycosylated IgG4 Fc fragment, and PEG linker
Disclosed are a protein conjugate with improved in vivo duration and stability and the use thereof. The protein conjugate includes a physiologically active polypeptide, a non-peptide polymer and an immunoglobulin Fc fragment. Since the three components are covalently linked, the protein conjugate has extended in vivo duration and enhanced stability for the physiologically active polypeptide. The protein conjugate maintains the in vivo activity at relatively high levels and remarkably increases the serum half-life for the physiologically active polypeptide, with less risk of inducing undesirable immune responses. Thus, the protein conjugate is useful for developing long-acting formulations of various polypeptide drugs.
WO2005047336
Compound
HANMI PHARMACEUTICAL. CO., LTD.
Not provided
November 13, 2024
Expired
