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

category

GreenDiabetes/Obesity/NASH BlueOncology OrangeRare Disease PurpleOthers BBeijing Hanmi

Last updated 2020-07-08
Registration

  • Rolontis™(eflapegrastim)

    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
    Biologics License Application (BLA) filing
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
    Collaboration Partners
    Spectrum Pharmaceuticals (Code: SPI-2012)

    Zailab

Phase 3

  • efpeglenatide(LAPSExd4 Analog)

    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
    Collaboration Partners
    Sanofi (Code: SAR-439977)
    Additional Information
    Poster presentation at ADA in 2016 [download]

    Sanofi

  • Oraxol™(Paclitaxel + encequidar)

    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
    Phase 3
    Molecule Type
    Combination (small molecule)
    Technology
    ORASCOVERY™ platform (Oral Absorption Enhancing Drug Delivery Technology)
    Collaboration Partners
    Athenex

    Athenex

Phase 2

  • HM15211(LAPSTriple Agonist)

    HM15211 (LAPSTriple Agonist)
    Mechanism & Characteristic
    A long-acting glucagon, GIP and GLP-1 triple agonist; Targeting 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]

  • HM12525A(LAPSGLP/GCG)

    HM12525A (LAPSGLP/GCG)
    Synonyms
    HM12525A; 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
    Obesity
    Status
    Phase 2
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
    Additional Information
    Poster presentation at ADA in 2016 [download]

  • poziotinib(pan-HER)

    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
    Solid tumors (breast, lung cancer)
    Status
    Phase 2 (Pre-Phase 1 in CN)
    Molecule Type
    Small molecule
    Collaboration Partners
    Spectrum Pharmaceuticals in WW (except CN, KR)
    Additional Information
    Poster presentation at ASCO in 2015 [download]

    Spectrum|Luye

  • Oratecan™(irinotecan + encequidar)

    Oratecan™
    Synonyms
    Oratecan; irinotecan+encequidar; irinotecan+HM30181AK; irinotecan+HM30181AK-US
    Mechanism & Characteristic
    Irinotecan with an oral absorption enhancer (P-gp inhibitor, encequidar); A combination formulation composed of the irinotecan and the multidrug resistance (MDR) efflux pump P-glycoprotein (P-gp) inhibitor encequidar with potential antineoplastic activity having reduced side effects
    Therapeutic Area
    Oncology
    Indication
    Solid tumors (colorectal cancer, etc.)
    Status
    Phase 2
    Molecule Type
    Combination (small molecule)
    Technology
    ORASCOVERY™ platform (Oral Absorption Enhancing Drug Delivery Technology)
    Collaboration Partners
    Athenex

    Athenex

  • Oradoxel™(docetaxel + encequidar)

    Oradoxel™
    Synonyms
    Oradoxel; docetaxel+encequidar; docetaxel+HM30181AK; docetaxel+HM30181AK-US
    Mechanism & Characteristic
    Docetaxel with an oral absorption enhancer (P-gp inhibitor, encequidar); A combination formulation composed of the docetaxel and the multidrug resistance (MDR) efflux pump P-glycoprotein (P-gp) inhibitor encequidar with potential antineoplastic activity having reduced side effects
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Phase 2
    Molecule Type
    Combination (small molecule)
    Technology
    ORASCOVERY™ platform (Oral Absorption Enhancing Drug Delivery Technology)
    Collaboration Partners
    Athenex

    Athenex

  • efpegsomatropin(LAPShGH)

    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]

  • HM71224(BTK)

    HM71224 (BTK)
    Synonyms
    HM71224; 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]

  • Luminate®(ALG-1001)

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

    Allegro

Phase 1

  • HM15136(LAPSGlucagon Analog)

    HM15136 (LAPSGlucagon Analog)
    Mechanism & Characteristic
    A long-acting glucagon analog; Targeting once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    Obesity
    Status
    Phase 1
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
    Additional Information
    Poster presentation at ADA in 2017 [download]

  • HM12460A / HM12470(LAPSInsulin / LAPSInsulin Analog)

    HM12460A / HM12470
    (LAPSInsulin / LAPSInsulin Analog)
    Synonyms
    LAPS-Insulin; HM12460A / LAPS-Insulin115; HM12470; SAR440067
    Mechanism & Characteristic
    A long-acting insulin or insulin analog; Once weekly administration
    Therapeutic Area:
    Metabolic disease
    Indication
    Type 1 & 2 Diabetes
    Status
    Phase 1
    Technology
    LAPSCOVERY™ platform
    Additional Information:
    Poster presentation at ADA in 2016 [download]

  • belvarafenib(pan-RAF)

    belvarafenib (pan-RAF)
    Synonyms
    HM95573; RG6185
    Mechanism & Charactersitic
    Rapidly accelerated fibrosarcoma inhibitor; BRAF mutation & N-RAS mutation driven cancer
    Therapeutic Area
    Oncology
    Indication
    Solid tumors
    Status
    Phase 1
    Molecule Type
    Small molecule
    Collaboration Partners
    Roche/Genentech (Code: RG6185)
    Additional Information
    Poster presentation at ASCO in 2016 [download]
    Poster presentation at EORTC in 2016 [download]
    Poster presentation at AACR in 2019 [download]

    Genentech

  • PD-1/Her2 BsAb(BH2950)

    PD-1/Her2 BsAb(BH2950)
    Mechanism & Characteristic
    A bispecific antibody for targeted immuno-oncology
    Therapeutic Area
    Oncology
    Indication
    Solid Tumors
    Status
    Pre-clinical
    Molecule Type
    Bispecific antibody
    Technology
    PENTAMBODY™
    Collaboration Partners
    Innovent

    Innovent

  • FLX475

    FLX475
    Mechanism & Characteristic
    Selective oral CCR4 antagonists
    Therapeutic Area
    Oncology
    Indication
    Solid tumor and hematologic malignancy
    Status
    Phase 1
    Molecule Type
    Small molecule
    Collaboration Partners
    Rapt therapeutics

    RAPT

  • HM15136(LAPSGlucagon Analog)

    HM15136 (LAPSGlucagon Analog)
    Mechanism & Characteristic
    A long-acting glucagon analog; Targeting once weekly administration
    Therapeutic Area
    Rare disease
    Indication
    Congenital hyperinsulinism
    Status
    Phase 1
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
    Additional Information
    Poster presentation at ADA in 2017 [download]

  • Oraxol™

    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
    Rare disease
    Indication
    Angiosarcoma, Soft tissue sarcoma
    Status
    Phase 1
    Molecule Type
    Combination (small molecule)
    Technology
    ORASCOVERY™ platform (Oral Absorption Enhancing Drug Delivery Technology)
    Collaboration Partners
    Athenex

    Athenex

  • HM43239(FLT3)

    HM43239 (FLT3)
    Mechanism & Characteristic
    FMS-like tyrosine kinase 3 inhibitor
    Therapeutic Area
    Rare disease
    Indication
    Acute Myeloid Leukemia
    Status
    Phase 1
    Molecule Type
    Small molecule
    Additional Information
    Poster presentation at AACR in 2018 [download]
    Poster presentation at AACR in 2019 [download]

  • Luminate®(ALG-1001)

    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

  • HM15912(LAPSGLP-2 Analog)

    HM15912 (LAPSGLP-2 Analog)
    Mechanism & Characteristic
    Long-acting Glucagon-like peptide 2 (GLP-2) analog; Targeting once weekly administration
    Therapeutic Area
    Rare disease
    Indication
    Short bowel syndrome
    Status
    Phase 1
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform
Pre-clinical

  • HM14320(LAPSGlucagon Combo)

    HM14320(LAPSGlucagon Combo)
    Mechanism & Characteristic
    LAPS-Glucagon Derivatives and Antidiabetic Drug Complex; Once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    Obesity, NASH, Diabetes
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform

  • HM14220(LAPSInsulin Combo)

    HM14220 (LAPSInsulin Combo)
    Mechanism & Characteristic
    Combination of a long-acting insulin analog and a long-acting exendin-4 analog; Targeting once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    Type 2 Diabetes
    Status
    Pre-clinical
    Molecule Type
    Combination (biologic)
    Technology
    LAPSCOVERY™ platform
    Collaboration Partners
    Sanofi

    Sanofi

  • HM12480(LAPSInsulin 148)

    HM12480(LAPSInsulin 148)
    Mechanism & Characteristic
    A long-acting insulin analog; Once weekly administration
    Therapeutic Area
    Metabolic disease
    Indication
    Diabetes
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform

  • EZH1/2

    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

  • LSD1

    LSD1
    Mechanism & Characteristic
    Lysine-specific histone demethylase 1 inhibitor
    Therapeutic Area
    Oncology
    Indication
    Small cell lung cancer, Acute myeloid leukemia
    Status
    Pre-clinical
    Molecule Type
    Small molecule
    Additional Information
    Poster presentation at AACR in 2018 [download]
    Poster presentation at AACR in 2019 [download]

  • ADOR

    ADOR
    Mechanism & Characteristic
    Adenosine receptor antagonist
    Therapeutic Area
    Immuno-Oncology
    Indication
    Solid tumors
    Status
    Pre-clinical
    Molecule Type
    Small molecule
    Additional Information
    Poster presentation at AACR in 2019[download]

  • HM21001(GBM Stem Cell Therapy)

    HM21001 (GBM Stem Cell Therapy)
    Mechanism & Characteristic
    Glioblastoma (GBM) stem cell therapy
    Therapeutic Area
    Oncology
    Indication
    Glioblastoma
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Collaboration Partners
    Ajou University

    Ajou University Medical Center

  • Immuno-oncology BsAb(Undisclosed target)

    Immuno-oncology BsAb(Undisclosed target)
    Mechanism & Characteristic
    A bispecific antibody for targeted immuno-oncology
    Therapeutic Area
    Oncology
    Indication
    Solid Tumors
    Status
    Pre-clinical
    Molecule Type
    Bispecific antibody
    Technology
    PENTAMBODY™

    Phanes

  • PD-L1/CD47 BsAb

    PD-L1/CD47 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™

  • HM15450(Long-acting ASB)

    HM15450 (Long-acting ASB)
    Mechanism & Characteristic
    Long-acting enzyme replacement therapy (ERT); Targeting once monthly administration
    Therapeutic Area
    Rare disease
    Indication
    Mucopolysaccharidosis
    Status
    Pre-clinical
    Molecule Type
    Biologic
    Technology
    LAPSCOVERY™ platform