Pipeline

Ethical Pharmaceuticals

*The stage icons indicate the development status of each pipeline. "Ⅰ", "Ⅱ" and "Ⅲ" denote the Phases 1-3 of clinical trials, "F" denotes the submission of a marketing authorization application, and "A" denotes the receipt of marketing authorization.

*In this document, the ® and ™ symbols have been omitted.

Ethical Pharmaceuticals

Therapeutic Area	Product Name/Development Code (generic name)	Therapeutic Category/Indication	Stage	Notes
Infectious diseases	OP0595 (Nacubactam)	Infections caused by Gram-negative bacteria suspected of being resistant to carbapenem (β-lactamase inhibitor)	Japan Overseas	Discovered in-house
Infectious diseases	KOSTAIVE	Self-amplifying mRNA vaccine against COVID-19 (12-17 years old)	Japan	Partnership: CSL Seqirus (The U.S.)
Infectious diseases	KD-414	Inactivated vaccine against COVID-19 (Pediatric)	Japan
Infectious diseases	KD2-396	Hexavalent vaccine against diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b, and Hepatitis B virus (Six-in-one combination vaccine)	Japan
Infectious diseases	KD-382	Live attenuated tetravalent vaccine against dengue fever	Overseas
Hematology / Oncology	LASERPHYRIN/ME2906(Talaporfin sodium)	Cervical Intraepithelial Neoplasia (CIN)(Photodynamic Therapy)	Japan
Hematology / Oncology	HIYASTA/HBI-8000 (Tucidinostat)	Unresectable or metastatic melanoma (HDAC inhibitor)	Overseas	Co-development: HUYABIO International, LLC (The U.S.)
		Relapsed or refractory B-cell non-Hodgkin's lymphoma (HDAC inhibitor)	Overseas	In-license: HUYABIO International, LLC (The U.S.)
Hematology / Oncology	KD-380(Immunoglobulin 10% liquid)	Induction and maintenance therapy for patients with chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) (Human plasma-derived products)	Japan
Hematology / Oncology	KD-416(Blood coagulation factor X agent)	Suppression of bleeding tendency in blood coagulation factor X deficiency (Human plasma-derived products)	Japan	Discovered in-house
Immune and Inflammatory diseases	REZUROCK/ME3208 (Belumosudil)	Chronic Graft Versus Host Disease/Selective ROCK2 inhibitor	Overseas	Approved (South Korea, Taiwan, Thailand)
		Chronic Graft Versus Host Disease (Pediatric)/Selective ROCK2 inhibitor	Japan
		Chronic Lung Allograft Dysfunction/Selective ROCK2 inhibitor	Japan
Immune and Inflammatory diseases	IMULDOSA/DMB-3115 (Ustekinumab Biosimilar)	Plaque psoriasis/Psoriatic arthritis/Crohn's disease/Ulcerative colitis (Biosimilar)	Overseas Japan	Co-development: Dong-A ST Co., Ltd. (South Korea) / Out-license: Intas Pharmaceuticals Ltd. (India)
Immune and Inflammatory diseases	ME3183	Psoriasis/Selective PDE4 inhibitor	Overseas	Discovered in-house (Reviewing development plan in light of market environment)
		Palmoplantar pustulosis/Selective PDE4 inhibitor	Overseas	Discovered in-house (Orphan Medicinal Product Designation by the European Commission)
Immune and Inflammatory diseases	ME3241	Autoimmune disorders (Anti-PD-1 agonist antibody)	Overseas	Joint research ：The Foundation for Biomedical Research and Innovation at Kobe

Veterinary Drugs