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

Last updated 2022-07-02

BIO
Research
Area
Project Indication Preclinical Clinical Licensing
Phase 1 Phase 2 Phase 3 Registration
BIO

Rolontis®(eflapegrastim)

Every three weeks administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Spectrum

Chemotherapy-induced
neutropenia

complete

complete

complete

complete

complete

Spectrum

efpeglenatideLAPSExd4 Analog

Once weekly~monthly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration
Diabetes

complete

complete

complete

complete

uncompleted

none

efinopegdutide(LAPSGLP/GCG)

Once weekly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

NASH

complete

complete

On going

uncompleted

uncompleted

MSD

HM15211(LAPSTriple Agonist)

Once weekly administration (Glucagon/GIP/GLP-1)

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

NASH

complete

complete

On going

uncompleted

uncompleted

none

HM15136(LAPSGlucagon Analog)

Once weekly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Congenital hyperinsulinism

complete

complete

On going

uncompleted

uncompleted

none

HM15912(LAPSGLP-2 Analog)

Once monthly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Short bowel syndrome

complete

complete

On going

uncompleted

uncompleted

none

efpegsomatropin(LAPShGH)

Once weekly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Growth hormone
deficiency

complete

complete

complete

uncompleted

uncompleted

none

Rolontis®(eflapegrastim)

Every three weeks administration

Same-day administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Spectrum

Chemotherapy-induced
neutropenia

complete

On going

uncompleted

uncompleted

uncompleted

Spectrum

HM12470(LAPSInsulin Analog)

Once weekly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Diabetes

complete

complete

uncompleted

uncompleted

uncompleted

none

HM15211(LAPSTriple Agonist)

Once weekly administration (Glucagon/GIP/GLP-1)

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Idiopathic pulmonary fibrosis

complete

uncompleted

uncompleted

uncompleted

uncompleted

none

LAPSGlucagon Combo(HM15136 + efpeglenatide)

Once weekly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Obesity

complete

uncompleted

uncompleted

uncompleted

uncompleted

none

LAPSInsulin Combo(HM12470 + efpeglenatide)

Once weekly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration
Diabetes

complete

uncompleted

uncompleted

uncompleted

uncompleted

none

HM15450(Long-acting ASB)

Once monthly administration

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Mucopolysaccharidosis

complete

uncompleted

uncompleted

uncompleted

uncompleted

none

HM15421(Long-acting GLA)

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Fabry disease

complete

uncompleted

uncompleted

uncompleted

uncompleted

none

HM16390(LAPSIL-2 Analog)

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Solid tumors

complete

uncompleted

uncompleted

uncompleted

uncompleted

none

NCE
Research
area
Project Indication Preclinical Clinical Licensing
Phase 1 Phase 2 Phase 3 Registration
NCE

poziotinib(pan-HER)

pan-HER inhibitor for multi-targeted anti-cancer drug

second-line therapy

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Spectrum

HER2 exon 20–mutated NSCLC

complete

complete

complete

complete

complete

Spectrum

Oraxol®(paclitaxel + encequidar)

Oral paclitaxel

encequidar: Oral absorption enhancer

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Athenex

Solid tumors
(breast cancer)

complete

complete

complete

complete

complete

Athenex

poziotinib(pan-HER)

pan-HER inhibitor for multi-targeted anti-cancer drug

first-line therapy

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Spectrum

NSCLC

complete

complete

on going

uncompleted

none

Spectrum

Luminate®(ALG-1001)

Integrin modulator

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

RAPT AffaMed

Dry age-related mascular degeneration

complete

complete

on going

uncompleted

none

Allegro AffaMed

poseltinib(BTK)

Bruton's tyrosine kinase inhibitor

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration
Autoimmune
disease

complete

complete

on going

uncompleted

none

none

FLX475(CCR4)

Selective oral CCR4 antagonists

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

RAPT MSD

Solid tumors

complete

complete

on going

uncompleted

none

RAPT MSD

belvarafenib(pan-RAF)

pan-RAF inhibitor

TAPISTRY Platform Study (NCT04589845)

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Roche

BRAF mutant/fusion tumor

complete

complete

on going

uncompleted

none

Roche

belvarafenib(pan-RAF)

pan-RAF inhibitor

Monotherapy and combination

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Genentech

Solid tumors
(melanoma)

complete

Phase 1 ongoing

uncompleted

uncompleted

none

Genentech

HM43239(MKI)

Myeloid kinome inhibitor such as FLT3(FMS-like tyrosine kinase 3) and SYK(Spleen tyrosine kinase)

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

APTOSE

Acute myeloid leukemia

complete

Phase 1 ongoing

uncompleted

uncompleted

none

APTOSE

Luminate® (ALG-1001)

Integrin modulator

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

Allegro

Retinitis pigmentosa

complete

Phase 1 ongoing

uncompleted

uncompleted

none

Allegro

HM97662 (EZH1/2)

Enhancer of zeste homolog 1/2 dual inhibitor

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Solid tumors, Hematologic cancers

ongoing

uncompleted

uncompleted

uncompleted

none

none

HM99462 (SOS1)

Son of sevenless homolog 1 inhibitor

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Solid tumors

completed

uncompleted

uncompleted

uncompleted

none

none

BIO
Beijing Hanmi’s New Drug Pipeline
BIO

BH2950(PD-1/HER2 BsAb)

A bispecific antibody for targeted immuno-oncology

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

INNOVENT

Solid tumors

completed

On going

uncompleted

uncompleted

none

INNOVENT

BH3120 (PD-L1/4-1BB BsAb)

A bispecific antibody for targeted immuno-oncology

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Registration

none

Solid tumors

ongoing

uncompleted

uncompleted

uncompleted

none

none