What Kringle Pharma does

Kringle Pharma, Inc. (TYO: 4884) is a late clinical-stage Japanese biopharmaceutical company founded in 2001 in Osaka and listed on the Tokyo Stock Exchange Growth Market since December 2020. The company develops recombinant human hepatocyte growth factor (HGF) protein therapeutics under the international nonproprietary name Oremepermin Alfa (KP-100) for intractable diseases with no effective pharmacological treatment. HGF is a 692-amino-acid endogenous protein with tissue-protective, regenerative, and anti-fibrotic activities, and Kringle Pharma is the only company globally with the capability to mass-produce GMP-compliant, pharmaceutical-grade HGF for clinical use. The pipeline comprises four indications: KP-100IT (intrathecal) for acute phase spinal cord injury, with Phase III enrollment completed in April 2023 and orphan drug designations in Japan (2019) and the United States (2025); KP-100LI (intracordal) for vocal fold scar, currently in Phase III; KP-100 (intrathecal) for amyotrophic lateral sclerosis, with Phase II completed and additional biomarker analysis underway with Tohoku University; and KP-100 (intravenous) for acute kidney injury, with Phase I completed.

The business model is a hybrid of independent Japanese commercialization and partnered international/secondary-indication development. Kringle Pharma intends to hold the Japanese manufacturing and marketing license for KP-100IT, supply Maruishi Pharmaceutical (capital and business alliance from August 2020) for marketing and promotion to emergency hospitals, and use TOHO HOLDINGS (2020 alliance) for nationwide distribution, capturing product supply revenue plus milestones and royalties. Claris Biotherapeutics (license and supply agreement, 2020) purchases HGF API for ophthalmic Phase I/II trials in the U.S. and Canada, and ReproCell distributes research-grade HGF globally. Kringle Pharma is currently pre-revenue, with FY2025 R&D expenses of ¥680 million, a ¥64 million stated capital base, 17 employees, and a 61.5% equity ratio; its near-term value driver is the Japanese approval and launch of KP-100IT, supported by a 10-year re-examination period extension and Japan/U.S. orphan exclusivity. A U.S. subsidiary (Kringle Pharma USA, Inc.) was established in November 2025 to pursue IND filing, secure U.S. government grants, and accelerate business development for the SCI program.

Name

Kringle Pharma

Legal name

クリングルファーマ株式会社

Website

https://kringle-pharma.com

Company type

Public

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

Kringle Pharma is a late clinical-stage Japanese biopharmaceutical company that develops recombinant human HGF (hepatocyte growth factor) protein therapeutics, branded Oremepermin Alfa (KP-100), for intractable diseases including acute spinal cord injury, vocal fold scar, ALS, and acute kidney injury.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Specialty Injectable & Infusion Therapies (Cross-therapeutic) (HLAIACAO)

Keywords

• Biopharmaceutical drug development
• Regenerative medicine therapeutics
• Recombinant protein therapeutics
• Rare disease drug development
• Hepatocyte growth factor protein

Headquarters

HQ city

Osaka

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Others

Revenue model

1. Product sales (post-approval): Revenue from sales of HGF-based medicines upon obtaining manufacturing and marketing approval. For acute phase spinal cord injury, Kringle Pharma will hold the manufacturing and marketing license, receive product supply revenue plus milestone and royalty payments from Maruishi Pharmaceutical. The company aims to maximize earnings over the medium to long term through in-house product sales.
2. Development milestones: Development milestone payments received from Maruishi Pharmaceutical at the time of application for manufacturing and marketing approval, at drug price listing, and at approval of additional indications. Sales milestone revenue when sales achieve certain annual thresholds.
3. API supply to Claris Biotherapeutics: Supply of recombinant human HGF protein as active pharmaceutical ingredient to Claris Biotherapeutics (US), which is conducting clinical trials for ophthalmic diseases. Claris pays for the supplied API.
4. Research reagent HGF supply: Supply of research-grade HGF protein globally through reprocell (株式会社リプロセル). This is a separate commercial stream for non-clinical research use.
5. Future royalties from partnerships: Royalty income from future pharmaceutical partners (currently being sought for ALS and acute kidney injury pipelines). Royalties calculated as a percentage of annual sales after product launch.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Kringle Pharma is a late clinical-stage biopharmaceutical company that develops and manufactures recombinant human hepatocyte growth factor (HGF) protein therapeutics (INN: Oremepermin Alfa, development code KP-100) for intractable diseases. Its core platform is a GMP-compliant, pharmaceutical-grade HGF protein manufacturing system, with multiple route-of-administration formulations targeting acute spinal cord injury (KP-100IT), vocal fold scar (KP-100LI), ALS, and acute kidney injury. The company also supplies HGF active pharmaceutical ingredient to partner Claris Biotherapeutics for ophthalmic indications and sells research-grade HGF protein globally via ReproCell.

Product overview

Kringle Pharma is a late clinical-stage biopharmaceutical company developing recombinant human HGF (hepatocyte growth factor) protein therapeutics. The company operates a hybrid business model combining in-house development with partnerships. The core product platform is Oremepermin Alfa (KP-100), a first-in-class regenerative medicine candidate that has progressed through multiple clinical-stage pipelines: KP-100IT for acute spinal cord injury (Phase III completed), KP-100LI for vocal fold scar (Phase III ongoing), KP-100 for ALS (Phase II completed), and KP-100 for acute kidney injury (Phase I completed). Kringle Pharma supplies recombinant human HGF API to partner Claris Biotherapeutics for ophthalmic applications.

Differentiator

Problem solved

Functional benefit

Products and services

• KP-100IT (Oremepermin Alfa) for acute spinal cord injury Recombinant human HGF (hepatocyte growth factor) protein therapeutic (INN: Oremepermin Alfa) administered intrathecally to patients with acute phase cervical spinal cord injury (AIS grade A) within 72 hours post-injury. Phase III study completed; orphan drug designation granted in Japan (2019) and the United States (2025).
• KP-100LI (Oremepermin Alfa) for vocal fold scar Recombinant human HGF protein formulation administered via intracordal injection to treat vocal fold scar and fibrosis causing voice disorders. Phase III study with 65 subjects is ongoing as of November 2025, with enrollment nearly complete.
• KP-100 (Oremepermin Alfa) for ALS Recombinant human HGF protein therapeutic administered intrathecally to patients with amyotrophic lateral sclerosis (ALS). Phase II study completed with additional biomarker analysis being conducted with Tohoku University; partner search ongoing.
• KP-100 for acute kidney injury Recombinant human HGF protein therapeutic administered intravenously to patients with acute kidney injury. Phase I studies completed with safety confirmed; partner search for Phase II development ongoing.
• Recombinant human HGF protein API supply to Claris Biotherapeutics Supply of recombinant human HGF protein as active pharmaceutical ingredient (API) to Claris Biotherapeutics for clinical use in ophthalmic indications including neurotrophic keratitis, limbal stem cell deficiency, and corneal scarring in the US and Canada.
• Research-grade recombinant human HGF protein (via ReproCell) Supply of research-grade recombinant human HGF protein globally through ReproCell (株式会社リプロセル) as a distributor for non-clinical research use, providing a separate commercial stream from clinical API supply.

Quantifiable outcome

• In Phase I/II study for acute spinal cord injury: 26.7% (4/15) of patients with complete paralysis (Frankel A) improved to C1 incomplete paralysis with KP-100IT vs. 6.3% (1/16) in placebo group — indicating dramatic improvement in the treatment group.
• +4 more outcomes

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Kringle Pharma USA, Inc. (US Subsidiary)coreOthers · 1 October 2025Kringle Pharma established Kringle Pharma USA, Inc. as a US subsidiary in October/November 2025 to accelerate its spinal cord injury program. The subsidiary's purposes include: (1) securing US government/public institution grants for development expenses; (2) accelerating business development and partnering activities in the US; (3) accelerating IND preparation activities for US clinical trials.
• Tohoku UniversitycoreStrategic or Co-development Partner · 1 April 2024Joint research collaboration with Tohoku University (April 2024 to September 2025) to conduct additional biomarker analysis of the ALS Phase II clinical trial data. Measures biomarkers of neurodegeneration and neuroinflammation to evaluate efficacy of HGF administration in ALS patients. Measurement completed; data analysis in progress.
• Keio University School of MedicinecoreStrategic or Co-development Partner · 1 February 2021Joint research agreement signed in February 2021 with Keio University School of Medicine, aiming to develop advanced therapies using HGF and other technologies (including iPS cells) for the treatment of spinal cord injury. Joint patents filed for chronic spinal cord injury (2022) and combination therapy using HGF and iPS cells (2022). Results published in Biomaterials journal (2023). Key researchers: Prof. Hideyuki Okano and Prof. Masaya Nakamura.
• Maruishi Pharmaceutical Co., Ltd.coreChannel Partner/ Reseller/ Distributor · 1 August 2020Capital and business alliance established in August 2020 with Maruishi Pharmaceutical to build marketing and promotion network for KP-100IT for treating acute phase spinal cord injury. Maruishi is a specialty pharmaceutical company in emergency medicine with a nationwide sales force covering most emergency hospitals in Japan. Kringle Pharma receives product supply revenue, development milestones, and royalty payments from Maruishi.
• TOHO HOLDINGS CO., LTD.coreChannel Partner/ Reseller/ Distributor · 1 January 2020Capital and business alliance established in 2020 with TOHO HOLDINGS for distribution of HGF-based drugs in Japan for acute phase spinal cord injury. TOHO HOLDINGS handles wholesale distribution to emergency hospitals throughout Japan as part of the supply chain. Kringle Pharma receives distribution-related revenue.
• Claris Biotherapeutics, Inc. (US)coreOEM/ Whitelabel/ Licensing Partner · 1 January 2020License and supply agreement signed in 2020 with Claris Biotherapeutics (US). Kringle Pharma supplies recombinant human HGF protein as API, and Claris conducts Phase I/II study for neurotrophic keratitis in the US. In 2023, collaboration began to increase efficiency and scale up HGF production to meet growing global demand. Claris has also initiated Phase I trials for limbal stem cell deficiency and corneal scarring.
• Rogosin Institute (US)minorStrategic or Co-development PartnerCollaborated with Rogosin Institute (nephrology clinic in the US) for Phase I clinical trials of HGF protein for kidney disease. Rogosin provided clinical trial support for early studies in chronic kidney disease patients as a proxy for the more unstable acute kidney injury patient population.
• 株式会社リプロセル (ReproCell)minorChannel Partner/ Reseller/ DistributorKringle Pharma supplies research-grade HGF protein globally through ReproCell as a distributor for non-clinical research reagent use. This represents a separate commercial stream from clinical API supply to Claris Biotherapeutics.

Scale indicators9 records

Recent moves9 records

Expansion highlights7 records

Broad incumbents

• Daiichi Sankyo: Large Japanese pharma with neurology, rare disease, and specialty pharma franchises. Comparable as a potential strategic acquirer/partner for Kringle given its scale, regulatory expertise, and presence across both Japan and the US — particularly relevant as Kringle weighs out-licensing or BD options for ALS and AKI programs.
• Sumitomo Pharma (formerly Sumitomo Dainippon Pharma): Japanese large-cap pharma with established CNS franchise including treatments for ALS and a regenerative medicine pipeline. Comparable as a broad incumbent in the same Japanese CNS market that Kringle plans to enter, and as a potential BD partner or competitor for any of Kringle's neurodegeneration assets.
• Rohto Pharmaceutical: Japanese specialty pharma with regenerative medicine and ophthalmology activities. Comparable as a domestic Japanese partner/distribution channel for HGF-based ophthalmology or specialty indications, and as a broader incumbent in the rare-disease specialty pharma segment Kringle targets.

Emerging players

• Pharmicell: Korean cell therapy company commercializing stem-cell-based regenerative medicines. Comparable as a regional regenerative medicine peer pursuing similar orphan/neurologic indications and as a model for how a small-cap Asian biotech transitions from clinical development to commercial supply.
• Cytokinetics: US clinical-stage biotech developing muscle-directed therapeutics for ALS (reldesemtiv) and other neuromuscular diseases. Comparable as an emerging ALS competitor with a different mechanism but similar orphan-drug economics and similar Phase II/III-stage risk profile to Kringle's intrathecal HGF ALS program.
• Claris Biotherapeutics: US emerging biotech using recombinant human HGF supplied by Kringle Pharma for ophthalmology indications including neurotrophic keratitis. Comparable as a co-developer in the broader HGF ecosystem (the API originates from Kringle's GMP platform) and as a near-term indicator of how HGF protein behaves in additional indications beyond spinal cord injury.

Direct peers

• BrainStorm Cell Therapeutics: Clinical-stage biotech developing NurOwn, an autologous stem cell therapy for ALS. Direct comparable on (i) ALS indication overlap and (ii) regenerative/biologic modality aiming to modify motor neuron disease progression, paralleling Kringle's neurotrophic mechanism via intrathecal HGF delivery.
• Lineage Cell Therapeutics: Clinical-stage cell therapy company developing oligodendrocyte progenitor cell therapies for acute spinal cord injury. The most directly comparable US-listed biotech pursuing a regenerative approach to the same lead indication Kringle is targeting with intrathecal KP-100IT.
• Helixmith (formerly ViroMed): Korean biotech developing Engensis (donor fibroblast-derived neurotrophic factor gene therapy) for diabetic neuropathy and SCI. Closely comparable because it is a neurotrophic-factor biologic for overlapping SCI and peripheral nerve indications, and is the most likely head-to-head competitor if it advances in acute SCI.
• Mitsubishi Tanabe Pharma (subsidiary of Mitsubishi Chemical Group): Japanese specialty pharma that developed and markets Radicava (edaravone) for ALS, the dominant approved ALS therapy in the US/Japan. Directly comparable to Kringle Pharma because it competes in the same ALS patient population that Kringle's intrathecal HGF program targets and represents the established incumbent against which any HGF ALS data will be benchmarked.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors28 records

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M&A

Investments

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Frequently asked questions about Kringle Pharma