Randis Pharmaceutical Development Institute

What Randis Pharmaceutical Development Institute does

Randis Pharmaceutical Development Institute is a privately held Japanese pharmaceutical R&D company incorporated on February 3, 2023, and headquartered in Nagoya, Aichi Prefecture. Under Representative Director and CEO Muramatsu Naomi, it operates three distinct business lines: in-house pharmaceutical product development with a focus on cancer gene therapy; R&D support services providing outsourced powder-inhalation drug development for lung-disease programs; and consulting services around Drug Delivery System (DDS) technology. The company targets pharmaceutical developers and research organizations seeking specialized gene-therapy and inhalation-formulation capabilities, including international counterparties as signaled by the launch of an English-language corporate website.

The company's disclosed technology core is dry-powder gene delivery, applied both to its own pipeline and to client programs. Its flagship disclosed research asset is p53 Dry Gene Powder, a gene therapy candidate being developed for Malignant Pleural Mesothelioma (MPM). The R&D support line applies the same inhalation/powder-formulation expertise on a contract basis to external developers working on pulmonary indications, while the consulting line monetizes DDS advisory know-how. No patents, peer-reviewed publications, named research collaborators, or headcount figures are disclosed, so the maturity of the underlying science base is not externally verifiable.

The business model combines three revenue pathways: long-dated upside from proprietary drug development (contingent on future licensing, partnership, or commercialization milestones), fee-for-service contract R&D for powder-inhalation programs, and consulting revenue from DDS technology engagements. Pricing structures, contract terms, customer identities, and revenue figures are not publicly disclosed, and the English-language site remains largely in a 'Coming Soon' state, indicating that international commercial activity has not yet commenced. As a result, the company's near-term financial trajectory is currently unobservable from public information.

Name

Randis Pharmaceutical Development Institute

Legal name

株式会社Randis医薬開発研究所

Website

https://randis.co.jp

Company type

Private

Founded year

2023

Operating status

Operating

Short description

Randis Pharmaceutical Development Institute is a Nagoya-based Japanese pharmaceutical R&D startup founded in February 2023 that develops cancer gene therapies (including p53 Dry Gene Powder for Malignant Pleural Mesothelioma), offers powder-inhalation drug development outsourcing for lung-disease programs, and provides DDS technology consulting.

Ownership category

akta.pro rank

Product category

Pharmaceutical R&D Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)

akta.pro secondary industries

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Formulation & Preclinical CMC Support (Nonclinical) (HLAGAFAL), CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)

Keywords

• Pharmaceutical R&D services
• Cancer gene therapy
• Inhalation drug development
• Drug delivery consulting
• Contract research services

Headquarters

HQ city

Nishiku

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales, Others

Revenue model

1. Pharmaceutical R&D Services: Pharmaceutical product development and experimental equipment R&D services.
2. R&D Outsourcing Services: Contracted research and development services for third parties.
3. R&D Consulting Services: Research and development consulting services including DDS technology implementation.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Randis Pharmaceutical Development Institute conducts development of novel cancer gene therapy drugs (including a p53 Dry Gene Powder for malignant pleural mesothelioma) and provides contracted R&D services for powder inhalation formulations of low-molecular-weight compounds and nucleic acids targeting lung diseases. It also offers consulting services on Drug Delivery System (DDS) technology adoption, particularly for administration route optimization.

Product overview

Randis Pharmaceutical Development Institute operates three core business divisions: Pharmaceutical Product Developments (new cancer gene therapy drugs including p53 Dry Gene Powder), R&D Support Services (inhalation drug development contracting for lung diseases using powdered formulations), and R&D Consulting Services (DDS technology consulting for drug administration routes). The company focuses on advanced drug delivery and gene therapy research.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceutical Product Developments (医薬品開発事業) In-house development of novel cancer gene therapy drugs, including research on p53 Dry Gene Powder for malignant pleural mesothelioma (MPM). Targeted at pharmaceutical companies and research institutions seeking innovative cancer gene therapy approaches.
• R&D Support Services — Inhalation Drug Development (吸入剤開発受託事業) Contracted development of powdered inhalation formulations of low-molecular-weight compounds and nucleic acids for lung disease treatments. Supports small-lot experimental development for pharmaceutical companies and research organizations.
• R&D Consulting Services (コンサルティング事業) Development consulting for Drug Delivery System (DDS) technology implementation, with a focus on optimizing drug administration routes for pharmaceutical developers facing formulation challenges.
• p53 Dry Gene Powder Dry gene powder formulation under development for cancer gene therapy; research results announced in March 2023 showed suppression of malignant pleural mesothelioma (MPM).

Segments3 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

Scale indicators1 record

Recent moves3 records

Expansion highlights3 records

Broad incumbents

• Takara Bio Inc. Established Japanese biotech offering gene therapy CDMO services, viral vector production, and regenerative medicine products. A larger incumbent operating in the same gene therapy and nucleic acid handling domain as Randis.
• Hovione: Global CDMO with significant inhalation formulation expertise, including particle engineering for dry powder inhalers. Comparable to Randis's inhalation development service line but at substantially greater scale and with broader pharma customer base.
• CMIC Holdings: Japan's largest CRO offering pharmaceutical development, clinical operations, and CDMO services. A broad incumbent against which Randis's CRO/consulting offering competes for Japanese pharma R&D outsourcing budgets.
• Catalent: Major global pharmaceutical services company with inhalation development, soft mist, and biologic manufacturing capabilities. Broad incumbent offering overlapping inhalation and biologics services that compete with Randis's CRO offering.

Emerging players

• Aerogen: Specialist in aerosol drug delivery technology for respiratory pharmaceuticals, with a focus on vibrating mesh nebulizer platforms. Comparable to Randis's inhalation development work, though with a more device-centric and acute-care focus.
• Curalogic: Specialty drug delivery company focused on inhaled peptide and small-molecule therapies for respiratory disease. Comparable emerging player targeting the same small-lot inhalation formulation niche that Randis serves with its R&D Support Services.
• Arcturus Therapeutics: Clinical-stage nucleic acid therapeutics company developing saRNA and mRNA products, including inhaled/LNP-enabled programs. Comparable emerging player at the intersection of nucleic acid chemistry and respiratory delivery that Randis also targets.

Direct peers

• Vectura Group: Specialist inhalation drug delivery company (now part of Philip Morris International) with deep expertise in powder formulation and small-molecule/nebulized therapies. Direct peer to Randis's R&D Support Services business for lung disease inhalation development.
• Noile-Immune Biotech: Japanese clinical-stage gene therapy company focused on CAR-T and solid tumor gene-modified cell therapies. Comparable to Randis as a Japan-based, oncology-focused gene therapy developer.
• AnGes, Inc. Japanese gene therapy company that developed an MPM gene therapy candidate (MG011) using a similar intrapleural administration approach. Direct peer to Randis's p53 Dry Gene Powder program and the only publicly known Japanese peer also targeting MPM with gene therapy.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks5 records

Key highlights5 records

Customer concentration

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 Randis Pharmaceutical Development Institute