Pipeline | 黑料门 Group

Pipeline

As of Aug 29, 2025

Ethical Pharmaceuticals

Stage	Name	Type	Efficacy Classification	Notes
Launched (Japan, South Korea) Approved(Taiwan,Thailand)	ME3208 (Belumosudil)	Oral	Chronic Graft Versus Host Disease	Product name (Japan, South Korea): REZUROCK Tablets (Japan: Launched on May 22, 2024, South Korea: Launched in November 2024) Partnership: Romeck Pharma, LLC Distribution (South Korea): SANOFI-AVENTIS KOREA CO., LTD.
Launched (EU, UK) Approved (The U.S.)^* Filed (Overseas)^* Phase Ⅰ (Japan)	DMB-3115 (Ustekinumab Biosimilar)	Injection	Plaque psoriasis/Psoriatic arthritis/Crohn's disease/Ulcerative colitis (Biosimilar)	Product name (EU, UK): IMULDOSA(launched starting January 2025) * Co-development: Dong-A ST Co., Ltd. (South Korea) / Out-license: Intas Pharmaceuticals Ltd. (India)
Phase Ⅲ (Japan, Overseas)	HBI-8000 (Tucidinostat)	Oral	Unresectable or metastatic melanoma	Co-development: HUYABIO International, LLC (The U.S.) Multi-Regional Clinical Trials
Phase Ⅲ (Japan, Overseas)	OP0595 (Nacubactam)	Injection	尾-lactamase inhibitor	Discovered in-house Multi-Regional Clinical Trials
Phase Ⅲ (Japan)	KD-380 (Immune globulin 10% liquid)	Injection	Induction and maintenance therapy for patients with chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) (Human plasma-derived products)
Phase Ⅲ (Japan)	KD-416 (Blood coagulation factor X agent)	Injection	Suppression of bleeding tendency in blood coagulation factor X deficiency (Human plasma-derived products)	Discovered in-house
Phase Ⅱ (Overseas)	ME3183	Oral	Psoriasis/Selective PDE4 inhibitor	Discovered in-house
Phase Ⅰb / Ⅱ (Japan)	HBI-8000 (Tucidinostat)	Oral	Relapsed or refractory B-cell non-Hodgkin's lymphoma	In-license: HUYABIO International, LLC (The U.S.) Multi-Regional Clinical Trials

Human Vaccines

Stage	Name	Target Disease	Notes
Launched (Japan)	KOSTAIVE	Self-amplifying mRNA vaccine against COVID-19 (18 years old or older), 16 dose vial	Partnership: CSL Seqirus (The U.S.) * Partial change approved on September 13, 2024 (Omicron strain JN.1)
Approved (Japan)	KOSTAIVE	Self-amplifying mRNA vaccine against COVID-19 (18 years old or older), 2 dose vial	Partnership: CSL Seqirus (The U.S.)
Phase Ⅲ (Japan)	KOSTAIVE	Self-amplifying mRNA vaccine against COVID-19 (12-17 years old, Omicron strain JN.1)	Partnership: CSL Seqirus (The U.S.)
Phase Ⅲ (Japan)	KD-414	Inactivated vaccine against COVID-19 (Adults^*, Original strain)	Multi-Regional Clinical Trials * 18-40 years old
Phase Ⅲ (Japan)	KD-414	Inactivated vaccine against COVID-19 (Pediatric^*, Original strain)	* 6 months - 11 years old
Phase Ⅲ (Japan)	KD-414	Inactivated vaccine against COVID-19 (Pediatric^*, Omicron strain)	* 6 months - 12 years old
Phase Ⅱ (Japan)	KD2-396	Hexavalent vaccine against diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b, and Hepatitis B virus (Six-in-one combination vaccine)
Phase Ⅱ (Overseas)	KD-382	Live attenuated tetravalent vaccine against dengue fever

Veterinary Drugs

Stage	Name	Efficacy Classification	Notes
Launched (Japan)	ME4137	Injectable antibacterial drug for cattle	Product name: FORCYL (Launched on May 27, 2024)
Launched (Japan)	ME4137	Injectable antibacterial drug for swine	Product name: FORCYL S (Launched on January 6, 2025)
Approved (Japan)	KD-412	Vaccine for cattle	Discovered in-house
Approved (Japan)	MD-22-3002	Anti-inflammatory drug for cattle, swine and horse
Under development	ME4305	Antibacterial drug for cattle	Discovered in-house
Under development	MD-22-1001-1	Injectable antibacterial drug for cattle
Under development	ME4406	Feed Additive	Discovered in-house

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黑料门 Seika Pharma Co., Ltd.

Based in Japan, we are a leading developer and manufacturer of antibacterial drugs, vaccines and biotech solutions, with a history of over 75 years.

Location

Headquarters: 2-4-16 Kyobashi, Chuo-ku, Tokyo104-8002 Japan