Nitto BioPharma

What Nitto BioPharma does

Nitto BioPharma, Inc. (NBPI) is a clinical-stage biotechnology company founded in 2016 in San Diego, California, operating as a wholly-owned subsidiary of Nitto Denko Corporation, a Japanese diversified conglomerate with over a century of operating history. The company focuses on nucleic acid drug delivery, built around a proprietary Lipid Nanoparticle (LNP) platform covering more than 15 lipid families and over 1,000 patented or patent-pending lipid structures. The technology targets delivery of siRNA, miRNA, mRNA, circular RNA, DNA, and gene-editing cargo (Cas9 + gRNA) to specific organs (liver, lung, kidney) and cells via passive and active targeting mechanisms, with biodegradable formulations validated in human clinical trials. Key technical differentiators include receptor-targeting ligand functionality, antibody-functionalized LNP architectures (with peer-reviewed data on selective CD8+ delivery and in vivo CAR-T generation), piperidine-based ionizable lipids for cold-chain stability (shelf life ≥36 months at 2-8°C to -20°C), and proprietary lyophilization processes that eliminate the need for filtration or premedication.

The company monetizes primarily through a licensing and partnering model. Its three revenue streams are (1) DDS platform licensing, where partners gain access to lipid IP, material transfer, and LNP optimization under structured agreements (CDA → feasibility → CLA → co-development), (2) out-licensing of clinical-stage pipeline assets, and (3) co-development partnerships with upfront and milestone payments during IND-enabling work. Pricing is not publicly disclosed and is customized per partnership. Customers are pharmaceutical and biotechnology companies developing nucleic acid therapeutics, with NBPI also offering CMC, manufacturing, and regulatory support across US, European, and Japanese authorities. The lead clinical asset, NBF-006, is an siRNA-LNP targeting GSTP for KRAS-driven non-small cell lung cancer, currently in Phase 1/2 trials. The company has no independent capital-raising history, with funding flowing through its parent; its growth is signaled through sustained scientific publication output (2024-2026), heavy presence across the global partnering conference circuit (Bio International, JPM Healthcare, RNA Leaders Congress, ESGCT, BIO Japan), and deliberate expansion into Asia-Pacific markets including Taiwan and Japan.

Name

Nitto BioPharma

Legal name

Nitto BioPharma, Inc.

Website

https://nittobiopharma.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

51–100 employees

Short description

Nitto BioPharma is a clinical-stage biotechnology subsidiary of Japan's Nitto Denko Corporation, developing proprietary lipid nanoparticle drug delivery systems for nucleic acid therapeutics (siRNA, mRNA, gene-editing) and licensing the platform to pharmaceutical partners.

Ownership category

akta.pro rank

Product category

Drug Delivery Solutions / Nucleic Acid Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro industry

PRIMARYHLAAADAD

RNA Delivery Technologies (LNPs, polymers, conjugates incl. GalNAc, peptides, exosomes)

Healthcare & Life Sciences/Biotechnology & Biologics/RNA Therapeutics (mRNA, siRNA, ASO)

SECONDARYHLAAADAB

siRNA Therapeutics (gene silencing)

Healthcare & Life Sciences/Biotechnology & Biologics/RNA Therapeutics (mRNA, siRNA, ASO)

SECONDARYHLAAACAC

Non-viral Gene Delivery & Gene Therapy (LNP, polymers, electroporation, physical methods)

Healthcare & Life Sciences/Biotechnology & Biologics/Gene Therapy (AAV/lentiviral/other vectors)

SECONDARYHLAIALAD

CMC & Pharmaceutical Development (Formulation/Process/Analytical Development)

Healthcare & Life Sciences/Pharmaceuticals/Pharmaceutical Research and Development

SECONDARYHLAAACAN

Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream)

Healthcare & Life Sciences/Biotechnology & Biologics/Gene Therapy (AAV/lentiviral/other vectors)

SECONDARYHLAAADAG

RNA Therapeutics Platforms & Design (sequence design, target ID/validation, AI/bioinformatics)

Healthcare & Life Sciences/Biotechnology & Biologics/RNA Therapeutics (mRNA, siRNA, ASO)

Keywords

• Lipid nanoparticle delivery
• Nucleic acid therapeutics
• Drug delivery solutions
• RNAi drug development
• Clinical-stage biotechnology

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. DDS Platform Licensing: Licensing of proprietary Drug Delivery Solutions (DDS) platform including lipid IP, lipid material transfer, LNP material transfer, and LNP optimization. IP is licensed as a bundle to enable turnkey LNP solutions for partners. Revenue generated through technical access fees, upfront payments, milestone payments, and royalties.
2. Pipeline Asset Out-licensing: Nitto has a pipeline of siRNA therapeutics for KRAS Cancers and fibrotic diseases in Phase 1 and Phase 2 clinical trials. The company seeks to out-license and partner these clinical assets along with additional preclinical programs through collaboration and licensing agreements.
3. Co-Development Partnerships: Execution of product development combining partner API with Nitto LNP, including IND-enabling development activities. Revenue generated through upfront and milestone payments during clinical development.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Nitto BioPharma develops and licenses a proprietary Lipid Nanoparticle (LNP) Drug Delivery Solutions (DDS) platform — built on more than 15 lipid families and over 1,000 proprietary lipids — for the passive and active targeted delivery of nucleic acid therapeutics (siRNA, miRNA, mRNA, circular RNA, DNA, and gene-editing cargo) to organs such as the liver, lung, and kidney. The platform is paired with a clinical-stage pipeline led by NBF-006, an siRNA-LNP therapeutic for KRAS-driven NSCLC, and is commercialized via licensing and co-development agreements with pharmaceutical and biotechnology partners.

Product overview

Nitto BioPharma operates as a clinical-stage biotechnology company with a Drug Delivery Solutions (DDS) platform centered on proprietary lipid nanoparticle (LNP) technology. The core offering consists of biodegradable LNPs designed for passive or active targeting to specific organs and cells, enabling delivery of various nucleic acid cargo types including mRNA, siRNA, miRNA, DNA, and gene-editing components. The platform includes over 1000 proprietary lipids across more than 15 lipid families. The lead clinical asset NBF-006 is an siRNA-based LNP therapeutic for KRAS-driven NSCLC. Nitto offers their technology through DDS Platform Licensing and Program Development Services, which include IND-enabling studies, CMC support, and regulatory guidance. A key differentiator is their LNP Lyophilization Technology enabling drug product stability.

Differentiator

Problem solved

Functional benefit

Products and services

• Lipid Nanoparticle (LNP) Delivery System

Quantifiable outcome

• Statistically significant higher distribution of NBF-006 to lungs and tumor compared with liver in in vivo studies
• +2 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered minor and core.

• Development Center for Biotechnology (DCB)minorGTM or Marketing Partner · 21 June 2026Co-organized the 2026 Taiwan Biotech Forum with GeneOnline and Biocom, gathering US and Taiwan experts to discuss precision medicine innovations. Nitto BioPharma presented its lipid nanoparticle delivery system at this forum.
• GeneOnlineminorGTM or Marketing Partner · 21 June 2026Co-organized the 2026 Taiwan Biotech Forum with DCB and Biocom, providing a platform for Nitto BioPharma to showcase its LNP delivery technology alongside other precision medicine innovations.
• BiocomminorGTM or Marketing Partner · 21 June 2026Co-organized the 2026 Taiwan Biotech Forum, which featured Nitto BioPharma's lipid nanoparticle delivery system presentation alongside other biotech innovations.
• Nitto Denko Corporation (Parent Company)coreOthersNitto BioPharma is a wholly-owned subsidiary of Nitto Denko Corporation, headquartered in Osaka, Japan. The company was established in 2016 as an independent center of excellence within the Nitto Group to pioneer research and develop new growth engines in the life sciences domain. NBPI leverages Nitto's long-standing success, corporate philosophy ('Innovation for Customers', 'Creating Wonders'), and multi-disciplinary global team.
• Nitto AveciaminorOthersSister company within the Nitto Group offering pharmaceutical contract manufacturing services, representing part of Nitto's global technology ecosystem.
• Nitto Avecia Pharma ServicesminorOthersSister company offering pharmaceutical services within the Nitto Group network, providing contract development and manufacturing capabilities.
• Nitto Denko Technical CorpminorOthersSister company within the Nitto Group serving as part of the global technology portfolio under the Nitto umbrella.
• Kinovate Life SciencesminorOthersSister company within the Nitto Group operating as part of the broader Nitto global technologies network.

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Acuitas Therapeutics: Acuitas is a private LNP delivery specialist that licenses its ionizable lipid technology to major partners including Pfizer (Comirnaty) and BioNTech. It is the most direct comparable to NBPI given its licensing-first business model and focus on LNP delivery for nucleic acid therapeutics.
• Genevant Sciences: Genevant is a lipid nanoparticle delivery platform company with a similar licensing and partnered asset model. Comparable because it focuses on siRNA, mRNA, and gene-editing cargo delivery through proprietary LNPs, addressing the same customer segments as NBPI.
• Arcturus Therapeutics: Arcturus develops self-amplifying mRNA and conventional mRNA therapeutics enabled by its LNP delivery technology. Comparable because it combines proprietary LNP formulations with internal nucleic acid therapeutic assets targeting rare diseases and infectious disease, overlapping NBPI's siRNA-LNP and mRNA-LNP capabilities.
• Arbutus Biopharma: Arbutus is a clinical-stage biopharmaceutical company with proprietary LNP and GalNAc delivery technologies for RNA therapeutics, primarily in HBV and oncology. It is comparable to NBPI as a delivery-platform company with clinical assets in oncology and infectious disease.
• Precision Nanosystems (Cytiva): Precision Nanosystems, now part of Cytiva, provides LNP formulation tools, lipid libraries, and development services for nucleic acid therapeutics. Comparable to NBPI's lipid library and CMC/program development capabilities.

Emerging players

• Kernal Biologics: Kernal Biologics is an emerging mRNA therapeutics company developing selective mRNA-LNP delivery to specific immune cells and hematopoietic stem cells. Comparable as a clinical-stage competitor in the targeted LNP delivery space, with particular overlap to NBPI's antibody-functionalized LNP work.

Broad incumbents

• Moderna: Moderna operates one of the largest proprietary LNP-mRNA platforms with internalized delivery R&D and a broad clinical pipeline. Comparable as a major incumbent in nucleic acid delivery, though it does not license its LNP platform externally, positioning NBPI as a potential partner or alternative for partners not aligned with Moderna.
• BioNTech: BioNTech is a leading mRNA therapeutics company with proprietary LNP capabilities and a broad pipeline spanning oncology, infectious disease, and rare diseases. Comparable as a broad incumbent in LNP-based nucleic acid delivery with internalized delivery R&D.
• Alnylam Pharmaceuticals: Alnylam is the established leader in siRNA therapeutics with proprietary GalNAc and LNP delivery technologies and multiple approved products. Comparable as a nucleic acid therapeutics incumbent with internal delivery capabilities, though primarily GalNAc-focused for liver delivery.
• Ionis Pharmaceuticals: Ionis is an established RNA-targeted therapeutics company with multiple approved antisense oligonucleotide (ASO) drugs and a broad pipeline. Comparable as a broad incumbent in nucleic acid therapeutics with internal delivery and targeting expertise.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/nitto-biopharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nitto BioPharma