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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

Last updated 2022-07-02

Research Area	Project	Indication	Preclinical	Clinical				Licensing
Research Area	Project	Indication	Preclinical	Phase 1	Phase 2	Phase 3	Registration	Licensing
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
	efpeglenatide^LAPSExd4 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

Research area	Project	Indication	Preclinical	Clinical				Licensing
Research area	Project	Indication	Preclinical	Phase 1	Phase 2	Phase 3	Registration	Licensing
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	Dry age-related mascular degeneration	complete	complete	on going	uncompleted	none
	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	Solid tumors	complete	complete	on going	uncompleted	none
	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	Retinitis pigmentosa	complete	Phase 1 ongoing	uncompleted	uncompleted	none
	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

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

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

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

none

R&D

Pipeline

All Pipeline

New Drug Development Status

BIO

NCE

BIO