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Regenerative Medicine
The therapy exists.
The access does not.
Allogeneic stem cell therapy developed and clinically tested in Korea, brought into Malaysia and ASEAN through a licensed local venture — with the manufacturing, regulatory pathway and clinical partnership arranged before the first patient.
Business Opportunity
The delay is structural, not scientific.
Advanced cell therapy reaches Southeast Asia years after it is proven elsewhere. The delay is rarely about evidence. It is about who will register the product, who will manufacture it to GMP in-country, and who will train the clinicians.
Malaysia has moved ahead of that curve. The national regulator has published a dedicated registration pathway for cell and gene therapy products, and the country already carries substantial regional medical travel volume and hospital capacity. The regulatory door is open in a way it is not everywhere in the region.
What is missing is the vehicle — an entity that holds the licence, the manufacturing arrangement and the clinical relationship at once, so that a therapy arrives fully compliant rather than as an unregulated pilot.
A defined regulatory pathway
Malaysia's National Pharmaceutical Regulatory Agency publishes guidance for the registration of cell and gene therapy products — a defined route rather than a one-off exception.
Regional demand already concentrated
Malaysia draws significant cross-border medical travel. A therapy registered here is reachable by a regional patient population, not only a domestic one.
Allogeneic changes the economics
An off-the-shelf allogeneic product can be manufactured in batches and held in inventory. That is what makes local manufacturing and distribution viable at all.
Proposed Solution
Proven platform.
Local venture.
JSY is working with Mirae Cell Bio, a Korean regenerative medicine company founded by Prof. Park Se-Pill, to bring its allogeneic stem cell platform into Malaysia through a licensed local venture.
The core technology is MMSC — clinical-grade allogeneic mesenchymal stem cells derived from embryonic stem cells. Because it is allogeneic rather than patient-derived, it can be produced under GMP in batches and supplied as a product, which is what makes registration, manufacturing and distribution structurable as a business.
Technology Partner
Mirae Cell Bio Co., Ltd.
A Korean regenerative medicine company operating a GMP cell therapy manufacturing facility in Seoul with ISO 9001 and ISO 14001 certification, alongside CDMO and CMO services.
Founder
Prof. Park Se-Pill
- Founder and Chairman, Mirae Cell Bio
- Professor, Jeju National University, and Director of its Stem Cell Research Center
- Established a frozen-embryo-derived human embryonic stem cell line (US patent granted)
- Produced cloned pigs carrying human Alzheimer's disease genes (US patent granted)
- Advisor, Korea Research Institute of Bioscience and Biotechnology
- 157 SCI-level papers published and 32 patents registered
Lead indication — interstitial cystitis
A severe inflammatory bladder condition with unexplained tissue damage, in which more than 90% of patients are female and existing treatment options are limited. Mirae Cell Bio's MMSC therapy has completed a Phase 1/2a clinical trial in Korea.
Phase 1/2a Clinical Trial · Korea, 2022–2023
Completed, with results reported.
interstitial cystitis
completed
treatment group
placebo group
The trial was conducted at Asan Medical Center in Seoul between 2022 and 2023. No serious adverse events related to the investigational product were observed. In the treatment group, Hunner lesions were reduced or in complete remission in 8 of 12 evaluated patients.
These are results from a Phase 1/2a trial conducted in Korea. They are reported here as the basis for the localisation proposal and do not constitute a claim of approval, efficacy or availability in Malaysia or any other market.
Beyond the Lead Indication
One platform, four therapeutic areas.
The same allogeneic cell platform underpins a pipeline across four areas. Registering the first indication establishes the manufacturing and regulatory base the others follow through.
Voiding dysfunction
Urinary disorders, including the lead interstitial cystitis programme.
Neurological disorders
Brain and central nervous system indications.
Autoimmune skin disorders
Autoimmune dermatological conditions.
Musculoskeletal disorders
Musculoskeletal degeneration and injury.
Separately from the therapeutic pipeline, Mirae Cell Bio produces transgenic pigs expressing the APP, TAU and PS1 genes together — a model used to evaluate the efficacy of Alzheimer's disease drug candidates. It is a research service rather than a therapy, and it is relevant to Malaysia as a route for pharmaceutical partners in the region to access preclinical evaluation capability without building it.
JSY's Role
We bring the licence in and we hold the venture.
JSY is not a distributor and not a clinic operator. We introduce the technology into Malaysia, structure the licensed local venture that carries it, and take an equity position in that venture.
Cell therapy fails on localisation more often than on science. Registration, GMP manufacturing, cold chain, clinician training and reimbursement each sit with a different counterparty. Our role is to hold them together under one shareholding so that no single gap stalls the whole programme.
Technology Introduction
We negotiate the licence and technology transfer terms with the technology owner, scoped to Malaysia and the wider ASEAN market.
Regulatory & Clinical Pathway
We coordinate the registration route with the national regulator and align hospital and investigator partners so that clinical and regulatory work proceeds on one timeline.
Manufacturing Localisation
We structure the manufacturing arrangement — imported product first, local GMP capacity as volume justifies it — including CDMO options with the technology owner.
Equity Participation & Governance
We subscribe for equity in the local venture and hold board representation, with capital committed against regulatory and clinical milestones.
Project Structure
One licensed venture, four counterparties.
Mirae Cell Bio
Licenses the MMSC platform and supplies product, technology transfer and CDMO capability from its Korean GMP facility.
JSY Asset Holdings
Negotiates the licence, structures the local venture, subscribes for equity and holds board representation.
Local Licensed Company
Malaysian entity holding the registration, the manufacturing arrangement and the clinical relationships.
Hospitals & Patients
Accredited hospitals and specialists delivering the therapy to domestic and regional patients.
Registration before revenue
The regulatory pathway is cleared before commercial commitments are made. No treatment is offered ahead of registration.
Import first, localise later
Product is supplied from the existing GMP facility while volume is established; local manufacturing follows demand rather than preceding it.
Indication by indication
The first indication establishes the regulatory and manufacturing base. The remaining pipeline follows through the same channel.
Partnership
Who we are looking to work with.
The localisation programme is being structured now. Clinical, regulatory and manufacturing partners engaging at this stage help define the pathway rather than inherit it.
Hospitals & clinical investigators
Accredited centres and specialists in urology, neurology, dermatology and musculoskeletal medicine interested in local clinical work and in delivering the therapy once registered.
Manufacturing & CDMO partners
GMP cell therapy manufacturing operators in Malaysia and the region, for local production as volume justifies it.
Pharmaceutical & research partners
Companies and institutions seeking preclinical evaluation capability, including access to the Alzheimer's disease transgenic model, without building it in-house.
Investors & healthcare groups
Healthcare investors and hospital groups seeking exposure to a licensed regenerative medicine platform with an existing clinical dataset behind it.
Contact
Start with your role in the pathway.
Whether you are a hospital, a manufacturer, a research group or an investor, tell us where you sit and what you would need to participate. We will come back with how the structure would accommodate it.
Or write directly — contact@jsy-asset-holdings.com