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.

All Pipeline

New Drug Development Status

Registration
  • Rolontis® (eflapegrastim) Chemotherapy-induced neutropenia

    Rolontis® (eflapegrastim)
    Synonyms
    Rolontis; eflapegrastim (rINN/USAN); HM10460A; SPI-2012; LAPS-GCSF Analog
    Mechanism & Characteristic
    A long-acting Granulocyte-Colony Stimulating Factor (G-CSF) analog; Every three weeks administration
    Therapeutic Area
    Oncology
    Indication
    Chemotherapy-induced neutropenia
    Status
    Korea : MFDS Approva
    US : FDA Biologics License Application (BLA) filed
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Collaboration Partners
    Spectrum Pharmaceuticals

    Zailab

  • poziotinib (pan-HER) HER2 exon 20–mutated NSCLC (2nd-line therapy)

    poziotinib (pan-HER)
    Synonyms
    poziotinib (rINN); HM781-36B; HM781-36
    Mechanism & Characteristic
    A pan-HER inhibitor that irreversibly blocks signaling through the HER family of tyrosine-kinase receptors including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), as well as HER receptor mutations
    Therapeutic Area
    Oncology
    Indication
    HER2 exon 20–mutated NSCLC
    Status
    New Drug Application(NDA) filed
    Molecule Type
    Small molecule
    Collaboration Partners
    Spectrum Pharmaceuticals in WW (except CN, KR)
    Additional Information
    Poster presentation at ASCO in 2015 [download]

    Spectrum|Luye

  • Oraxol® (paclitaxel + encequidar) Solid tumors (breast cancer)

    Oraxol®
    Synonyms
    Oraxol; paclitaxel+encequidar; paclitaxel+HM30181AK; paclitaxel+HM30181AK-US
    Mechanism & Characteristic
    A combination formulation composed of the taxane compound paclitaxel and the multidrug resistance (MDR) efflux pump P-glycoprotein (P-gp) inhibitor encequidar, with potential antineoplastic activity expecting reduced side effects and low neurotoxicity
    Therapeutic Area
    Oncology
    Indication
    Solid tumors (breast cancer)
    Status
    Marketing Authorisation Application (MAA) filied
    Molecule Type
    Combination (small molecule)
    Technology
    ORASCOVERY platform (Oral Absorption Enhancing Drug Delivery Technology)
    Collaboration Partners
    Athenex

    Athenex

Phase 3
  • efpeglenatide (LAPSExd4 Analog) Diabetes

    efpeglenatide (LAPSExd4 Analog)
    Synonyms
    efpeglenatide (rINN); HM11260C; SAR-439977; LAPS-Exd4 Analog; LAPS-Exendin-4 Analog; LAPS-CA-Exd4; LAPS-CA-Exendin-4 Analog; langlenatide
    Mechanism & Characteristic
    A long-acting exendin-4 analog as a Glucagon-like peptide-1 (GLP-1) receptor agonist; Superior blood glucose lowering efficacy via less GLP-1R desensitization; Once weekly~monthly administration (best-in-class potential)
    Therapeutic Area
    Metabolic disease
    Indication
    Diabetes
    Status
    Phase 3
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Additional Information
    Poster presentation at ADA in 2016 [download]
    Oral presentation at ADA in 2021 [download]
Phase 2
  • efinopegdutide (LAPSGLP/GCG) NASH

    efinopegdutide (LAPSGLP/GCG)
    Synonyms
    efinopegdutide(rINN/USAN); HM12525A;MK-6024;LAPS-GLP/GCG; LAPS-GLP-1/GCG; LAPS-OXM
    Mechanism & Charactersitic
    A long-acting GLP-1 & glucagon dual receptor agonist; Improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity; Once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    NASH
    Status
    Phase 2
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Collaboration Partners
    MSD
    Additional Information
    Poster presentation at ADA in 2016 [download]

    MSD

  • HM15211 (LAPSTriple Agonist) NASH

    HM15211 (LAPSTriple Agonist)
    Mechanism & Characteristic
    A long-acting glucagon, GIP and GLP-1 triple agonist; once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    NASH
    Status
    Phase 2
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Additional Information
    Poster presentation at EASD in 2018 [download]
    Oral presentation at EASD in 2018 [download]
    Poster presentation at ADA in 2018 [download]
  • belvarafenib (pan-RAF) BRAF mutant/fusion solid tumor ②-B

    belvarafenib (pan-RAF)
    Synonyms
    HM95573; RG6185; GDC-5573
    Mechanism & Characteristic
    Rapidly accelerated fibrosarcoma inhibitor; BRAF mutation & N-RAS mutation driven cancer
    Therapeutic Area
    Oncology
    Indication
    BRAF class II mutant/fusion-positive tumor
    BRAF class III mutant-positive tumor
    Status
    Phase 2
    - TAPISTRY Platform Study (NCT04589845)
    Molecule Type
    Small molecule
    Collaboration Partners
    Genentech

    ROCHE

  • poziotinib (pan-HER) NSCLC (1st-line therapy)

    poziotinib (pan-HER)
    Synonyms
    poziotinib; HM781-36B; HM781-36
    Mechanism & Characteristic
    A pan-HER inhibitor that irreversibly blocks signaling through the HER family of tyrosine-kinase receptors including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), as well as HER receptor mutations
    Therapeutic Area
    Oncology
    Indication
    NSCLC (1st-line therapy)
    Status
    Phase 2
    Molecule Type
    Small molecule
    Collaboration Partners
    Spectrum Pharmaceuticals

    SPECTRUM

  • FLX475 (CCR4 Antagonist) Solid tumors

    FLX475 (CCR4)
    Mechanism & Characteristic
    Selective oral CCR4 antagonists
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Phase 2
    Molecule Type
    Small molecule
    Collaboration Partners
    Rapt therapeutics

    MSD

    RAPT

  • HM15136 (LAPSGlucagon Analog) Congenital hyperinsulinism

    HM15136 (LAPSGlucagon Analog)
    Mechanism & Characteristic
    A long-acting glucagon analog; once weekly administration
    Therapeutic Area
    Rare disease
    Indication
    Congenital hyperinsulinism
    Status
    Phase 2
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Additional Information
    Poster presentation at ADA in 2017 [download]
  • HM15912 (LAPSGLP-2 Analog) Short bowel syndrome

    HM15912 (LAPSGLP-2 Analog)
    Mechanism & Characteristic
    Long-acting Glucagon-like peptide 2 (GLP-2) analog; Once monthly administration
    Therapeutic Area
    Rare disease
    Indication
    Short bowel syndrome
    Status
    Phase 2
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
  • efpegsomatropin (LAPShGH) Growth hormone deficiency

    efpegsomatropin (LAPShGH)
    Synonyms
    efpegsomatropin (rINN); HM10560A; LAPS-hGH; LAPS-rhGH
    Mechanism & Characteristic
    A long-acting recombinant human growth hormone; Once weekly administration
    Therapeutic Area
    Rare disease
    Indication
    Growth hormone deficiency
    Status
    Phase 2
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Additional Information
    Poster presentation at ENDO in 2015 [download]
  • Luminate® (ALG-1001) Dry age-related macular degeneration

    Luminate® (ALG-1001)
    Synonyms
    Luminate; ALG-1001
    Mechanism & Charactersitic
    Integrin modulator; Anti-angiogenesis and vitreolysis
    Therapeutic Area
    Ophthalmologic disease
    Indication
    Dry age-related macular degeneration
    Status
    Phase 2
    Molecule Type
    Small molecule (peptide)
    Collaboration Partners
    Allegro ophthalmics

    AffaMed

    Allegro

  • poseltinib (BTK) Autoimmune disease

    poseltinib (BTK)
    Synonyms
    poseltinib; LY3337641
    Mechanism & Charactersitic
    Bruton's tyrosine kinase inhibitor
    Therapeutic Area
    Autoimmune disease
    Status
    Phase 2 (began in August 2016 in patients with rheumatoid arthritis)
    Molecule Type
    Small molecule
    Additional Information
    Poster presentation at EULAR in 2015 [download]
Phase 1
  • HM12470 (LAPSInsulin Analog) Diabetes

    HM12470 (LAPSInsulin Analog)
    Synonyms
    LAPS-Insulin115; HM12470; SAR440067
    Mechanism & Characteristic
    A long-acting insulin or insulin analog; Once weekly administration
    Therapeutic Area:
    Metabolic disease
    Indication
    Diabetes
    Status
    Phase 1
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Additional Information:
    Poster presentation at ADA in 2016 [download]
  • Rolontis® (eflapegrastim) Chemotherapy-induced neutropenia ①-A

    Rolontis® (eflapegrastim)
    Synonyms
    Rolontis; eflapegrastim (rINN/USAN); HM10460A; SPI-2012; LAPS-GCSF Analog
    Mechanism & Characteristic
    A long-acting Granulocyte-Colony Stimulating Factor (G-CSF) analog; Every three weeks administration
    Therapeutic Area:
    Oncology
    Indication
    Chemotherapy-induced neutropenia, Same-day administration
    Status
    Phase 1
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
    Collaboration Partners
    Spectrum Pharmaceuticals

    Spectrum

  • belvarafenib (pan-RAF) Solid tumors (melanoma) ②-A

    belvarafenib (pan-RAF)
    Synonyms
    HM95573; RG6185; GDC-5573
    Mechanism & Charactersitic
    Rapidly accelerated fibrosarcoma inhibitor; BRAF mutation & N-RAS mutation driven cancer
    Therapeutic Area
    Oncology
    Indication
    Solid tumors (melanoma)
    Status
    Phase 1
    - Monotherapy and combination
    Molecule Type
    Small molecule
    Collaboration Partners
    Genentech

    Genentech

  • BH2950 (PD-1/HER2 BsAb) Solid tumors

    BH2950 (PD-1/HER2 BsAb)
    Mechanism & Characteristic
    A bispecific antibody for targeted immuno-oncology
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Phase 1
    Molecule Type
    Bispecific antibody
    Technology
    PENTAMBODY
    Collaboration Partners
    Innovent

    Innovent

  • HM43239 (MKI) Acute myeloid leukemia

    HM43239 (MKI)
    Mechanism & Characteristic
    Myeloid kinome inhibitor such as FLT3(FMS-like tyrosine kinase 3) and SYK(spleen tyrosine kinase)
    Therapeutic Area
    Rare disease
    Indication
    Acute myeloid leukemia
    Status
    Phase 1
    Molecule Type
    Small molecule
    Collaboration Partners
    Aptose

    APTOSE

  • Luminate® (ALG-1001) Retinitis pigmentosa

    Luminate® (ALG-1001)
    Synonyms
    Luminate; ALG-1001
    Mechanism & Charactersitic
    Integrin modulator; Anti-angiogenesis and vitreolysis
    Therapeutic Area
    Rare disease
    Indication
    Retinitis pigmentosa
    Status
    Phase 1
    Molecule Type
    Small molecule (peptide)
    Collaboration Partners
    Allegro ophthalmics

    Allegro

Pre-clinical
  • HM15136 + efpeglenatide (LAPSGlucagon Combo) Obesity/Metabolic disease

    HM15136 + efpeglenatide
    (LAPSGlucagon Combo)
    Mechanism & Characteristic
    Combination of HM15136 and efpeglenatide; Once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    Obesity/Metabolic disease
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
  • HM12470 + efpeglenatide (LAPSInsulin Combo) Diabetes

    HM12470 + efpeglenatide
    (LAPSInsulin Combo)
    Mechanism & Characteristic
    Combination of HM12470 and efpeglenatide; Once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    Diabetes
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY platform
  • HM97662 (EZH1/2) Solid tumors / Hematologic cancers

    HM97662 (EZH1/2)
    Mechanism & Characteristic
    Enhancer of zeste homolog 1/2 dual inhibitor
    Therapeutic Area
    Oncology
    Indication
    Solid tumors / Hematologic cancers
    Status
    Pre-clinical
    Molecule Type
    Small molecule
    Additional Information
    Poster presentation at AACR in 2021 [download]
  • HM99462 (SOS1) Solid tumors

    HM99462 (SOS1)
    Mechanism & Characteristic
    Son of sevenless homolog 1 inhibitor
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Pre-clinical
    Molecule Type
    Small molecule
  • HM16390 (LAPSIL-2 Analog) Solid tumors

    HM16390 (LAPSIL-2 Analog)
    Mechanism & Characteristic
    A long-acting IL-2 analog
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
  • BH3120 (PD-L1/4-1BB BsAb) Solid tumors

    BH3120 (PD-L1/4-1BB BsAb)
    Mechanism & Characteristic
    A bispecific antibody for targeted immuno-oncology
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Pre-clinical
    Molecule Type
    Bispecific antibody
    Technology
    PENTAMBODY
    Additional Information
    Poster presentation at AACR in 2022[download]
  • HM15211 (LAPSTriple Agonist) Idiopathic pulmonary fibrosis

    HM15211 (LAPSTriple Agonist)
    Mechanism & Characteristic
    A long-acting glucagon, GIP and GLP-1 triple agonist
    Therapeutic Area
    Rare disease
    Indication
    Idiopathic pulmonary fibrosis
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
  • HM15450 (Long-acting ASB) Mucopolysaccharidosis

    HM15450 (Long-acting ASB)
    Mechanism & Characteristic
    Long-acting Arylsulfatase B
    Therapeutic Area
    Rare disease
    Indication
    Mucopolysaccharidosis
    Status
    Pre-clinical
    Molecule Type
    Biologic
  • HM15421 (Long-acting GLA) Fabry disease

    HM15421 (Long-acting GLA)
    Mechanism & Characteristic
    Long-acting alpha-galactosidase
    Therapeutic Area
    Rare disease
    Indication
    Fabry disease
    Status
    Pre-clinical
    Molecule Type
    Biologic
  • ①-A : Same-day administration
  • ②-A : Belvarafenib monotherapy and combination therapy
  • ②-B : TAPISTRY Platform Study (NCT04589845)

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