Centre for Regenerative Medicine and Health (CRMH), HKISI, CAS

What Centre for Regenerative Medicine and Health (CRMH), HKISI, CAS does

Centre for Regenerative Medicine and Health (CRMH) is a research and development institution under the Hong Kong Institute of Science & Innovation of the Chinese Academy of Sciences (CAS), established in 2020 at Hong Kong Science Park under the Hong Kong SAR Government's InnoHK initiative. It is the first CAS regenerative medicine R&D center in Hong Kong and operates three interconnected research programs: Cell Therapy, Organ and Tissue Regeneration, and Drug Discovery, supported by the Guangzhou Institutes of Biomedicine and Health (GIBH). CRMH's core technology platform spans human pluripotent stem cell (hPSC) interspecies chimerism, MAP2K6-driven chromatin remodeling, large-scale generation of IL-12 secreting engineered macrophages (iMac_IL12) for solid tumor immunotherapy, intestinal aging biomarker discovery with NAD+ reversal strategies, and small-molecule drug design based on neural plasticity mechanisms.

CRMH's most advanced commercial asset is Neu-001, a first-in-class small-molecule amblyopia drug jointly developed with City University of Hong Kong, which received FDA IND approval in December 2024 (the first chemical drug to achieve this under InnoHK), completed Phase I in 2025, and advanced to Phase IIa in July 2026 with approximately 30 patients across multiple clinical centers. An affiliated program — Orelabrutinib (GZD824), a third-generation BCR-ABL inhibitor for TKI-resistant CML — was approved by China NMPA in November 2021, validating the underlying drug development capabilities. CRMH does not generate commercial product revenue; its operations are funded through CAS institutional support and Hong Kong SAR Government InnoHK grants, with outputs disseminated via scientific journals (Nature Communications, Cell Stem Cell, Molecular Cancer), annual symposia, licensing to industry partners (e.g., Guangzhou Shunjian Biomedicine Technology for Orelabrutinib commercialization), and academic collaborations with HKU, CUHK, HKUST, CityU, Max Planck Institute, and Westlake University.

Name

Centre for Regenerative Medicine and Health (CRMH), HKISI, CAS

Legal name

Centre for Regenerative Medicine and Health, Hong Kong Institute of Science & Innovation, Chinese Academy of Sciences

Website

https://crmh-cas.org.hk

Company type

Private

Founded year

2021

Operating status

Operating

Short description

CRMH is a CAS-affiliated, InnoHK-funded regenerative medicine research institute in Hong Kong Science Park operating Cell Therapy, Organ/Tissue Regeneration, and Drug Discovery programs, with lead candidate Neu-001 in Phase IIa trials for amblyopia.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Research

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (54171), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Preclinical CROs (Discovery/Pharmacology/DMPK) (HLAGAAAB)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Regenerative medicine research
• Stem cell therapy
• Drug discovery
• Cell therapy research
• Tissue regeneration

Headquarters

HQ city

Hong Kong

HQ country

Hong Kong SAR China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure

Revenue model

1. Research funding and grants: As a research institute under the Chinese Academy of Sciences supported by the InnoHK initiative of the Hong Kong SAR Government, CRMH operates primarily through government research funding, institutional grants, and InnoHK support. Revenue is derived from national and regional government research programs rather than commercial product sales.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

CRMH is a non-profit research institute that conducts high-level scientific and innovative technology research in regenerative medicine and health, operating three core programs — Cell Therapy, Organ and Tissue Regeneration, and Drug Discovery. The institute advances first-in-class drug candidates (including Neu-001 for amblyopia, which progressed from FDA IND approval in December 2024 through Phase I in 2025 into Phase IIa in 2026) and translates scientific discoveries into clinical applications through partnerships with universities, hospitals, and pharmaceutical companies in Hong Kong, Mainland China, and internationally.

Product overview

CRMH operates as a unified research and development institution under three interconnected research programs: Cell Therapy, Organ and Tissue Regeneration, and Drug Discovery. The Drug Discovery program is the most advanced, having produced Neu-001, a first-in-class small-molecule drug candidate for amblyopia that has progressed through FDA IND approval and into Phase IIa clinical trials. The institution leverages InnoHK platform support to translate scientific discoveries from these three research streams into clinical applications, with translation services facilitating industry partnerships.

Differentiator

Problem solved

Functional benefit

Products and services

• Cell Therapy Research Program Core research program focused on developing cell-based therapies for regenerative medicine applications, including human pluripotent stem cell (hPSC) technology and large-scale generation of engineered macrophages for cancer therapy. Targets academic collaborators and translational partners.
• Organ and Tissue Regeneration Research Program Core research program focused on organ and tissue regeneration techniques and therapies, including discovery of intestinal aging biomarkers and mtDNA mutation patterns and development of NAD+ precursor supplementation strategies. Targets academic and medical research collaborators.
• Drug Discovery Research Program Core research program dedicated to drug discovery and development, including the pioneering Neu-001 amblyopia treatment. Conducts small-molecule drug design based on neural plasticity and develops CNS, musculoskeletal, and orphan disease therapeutics. Targets pharmaceutical partners and licensees.
• Neu-001 First-in-class small-molecule drug candidate for amblyopia (lazy eye) treatment, developed jointly by CRMH and City University of Hong Kong. Activates neural plasticity within the visual cortex to treat amblyopia. FDA IND approved December 2024; Phase I completed 2025; Phase IIa initiated 2026 with approximately 30 patients across multiple clinical centers.
• Translation Services Services supporting the translation of research discoveries into clinical applications, including industry partnerships (e.g., NeuDirection for CNS drug development) and licensing arrangements for drug candidates. Targets pharmaceutical and biomedical companies seeking to develop CRMH-discovered therapeutics.

Quantifiable outcome

• Neu-001 (first-in-class amblyopia drug) received FDA IND approval (December 2024) and completed Phase I clinical trial, entering Phase IIa with ~30 patients (2026). Phase Ia planned to enroll 53 healthy adults across 8 dose cohorts.
• +2 more outcomes

Named customers2 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• City University of Hong Kong (CityU)coreStrategic or Co-development Partner · 17 December 2024CRMH and CityU jointly developed Neu-001, a first-in-class small-molecule drug for amblyopia treatment. CRMH's Micky Tortorella team and CityU's He Jufang team collaborated on development. Neu-001 received FDA IND approval in December 2024 (first InnoHK chemical drug to achieve this milestone) and entered Phase I dosing at Shanghai General Hospital (August 2025), progressing to Phase IIa (2026).
• The University of Hong Kong (HKU)coreStrategic or Co-development PartnerHKU is a key partner university of CRMH. Professor Liu Pengtao from HKU delivered the keynote at CRMH's inaugural annual academic conference (December 2021). CRMH aims to conduct world-class collaborative biomedical research with HKU and other regional institutions.
• The Chinese University of Hong Kong (CUHK)coreStrategic or Co-development PartnerCUHK is a key partner university hosting the 4th Annual Meeting of Max Planck-GIBH Joint Center and CUHK-MPI-GIBH-CRMH Joint Forum on Stem Cells and Molecular Medicine (November-December 2023). CRMH collaborates with CUHK on stem cell and regenerative medicine research.
• The Hong Kong University of Science and Technology (HKUST)coreStrategic or Co-development PartnerHKUST is listed as a key partner university of CRMH, collaborating on biomedical research initiatives within the InnoHK platform and Greater Bay Area biomedical ecosystem.
• The Fifth Affiliated Hospital of Guangzhou Medical UniversityminorStrategic or Co-development PartnerListed as a partner institution of CRMH, supporting regional biomedical collaborations in the Greater Bay Area for clinical research and translation.
• Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences (GIBH)coreStrategic or Co-development PartnerGIBH is the supporting institution for CRMH. Both institutions share scientific leadership (Professor Pan Guangjin serves as Director of both GIBH and CRMH). Joint research programs include cell therapy, organ regeneration, drug discovery, and co-organize the annual Guangzhou International Symposium on Stem Cells and Regenerative Medicine.
• NeuDirection / 神瞻醫藥minorStrategic or Co-development PartnerDisplayed on CRMH Translation page as a collaboration partner developing small molecule and peptide drugs targeting unexplored GPCRs in the brain for rare and neglected CNS diseases, as well as drugs for skeletal and brain diseases.
• Max Planck Institute (MPI)coreStrategic or Co-development PartnerMPI collaborates with GIBH and CRMH through the Max Planck-GIBH Joint Center for Regenerative Biomedicine. Joint annual meetings are held with CUHK and CRMH participation. Collaborative research in stem cells and molecular medicine.
• Hong Kong Science Park (HKSTP)coreImplementation/ SI/ Consulting PartnerCRMH is located within Hong Kong Science Park. HKSTP provides operational infrastructure and support. CEO Albert Wong attended the Neu-001 FDA IND approval press conference.
• Shanghai General Hospital (上海市第一人民医院)coreStrategic or Co-development PartnerShanghai General Hospital conducted the first Phase I clinical trial dosing for Neu-001 in August 2025 (53 healthy adult subjects, 8 dose cohorts). This is the first-in-human study for CRMH's lead drug candidate.
• Westlake UniversityminorStrategic or Co-development PartnerProfessor Pei Duanqing (西湖大學) from Westlake University collaborated with CRMH scientist Micky D. Tortorella and GIBH on a first-of-its-kind discovery published in Molecular Cancer (IF=37, April 2024) on oncogenic nuclear condensate reshaping.
• Guangzhou Shunjian Biomedicine Technology CompanyminorOEM/ Whitelabel/ Licensing PartnerLicensed orelabrutinib (GZD824/Olverembatinib) from GIBH for further development and industrialization after the drug received NMPA approval in November 2021. The development process took approximately 13 years from R&D to approval.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Others

• Westlake University: Chinese research university collaborating with CRMH on oncogenic condensate biology research published in Molecular Cancer (IF=37). Comparable as a peer scientific institution with stem cell, regenerative medicine, and biomedical research programs.

Emerging players

• Hutchmed (China): Hong Kong-headquartered innovator developing novel small-molecule oncology drugs with global clinical and commercial reach. Comparable as a Greater Bay Area-headquartered organization advancing China-discovered candidates through FDA and global trials.
• Innovent Biologics: Chinese biotech with a deep pipeline of innovative biologics and small molecules in oncology and other areas. Comparable as a Chinese-headquartered organization translating novel modalities from discovery to multi-region approval.
• Junshi Biosciences: Chinese biotech focused on immuno-oncology including cell therapy and antibody platforms. Comparable to CRMH's iMac_IL12 engineered macrophage oncology program as a developer of novel cancer immunotherapy modalities.

Broad incumbents

• WuXi AppTec: China-headquartered global CRO/CDMO spanning discovery through clinical development. Comparable end-to-end drug development services and similar customer base of biotech innovators advancing novel molecules.
• Tigermed: Largest Chinese clinical CRO running Phase I-IV trials across therapeutic areas, including ophthalmology. Comparable operational model for executing multi-center clinical trials of the type CRMH is running for Neu-001.

Direct peers

• Shanghai Institute of Materia Medica (SIMM), CAS: CAS-affiliated drug discovery institute with a similar model of basic research feeding into small-molecule drug development. Closely comparable in mission, scale, and translational pipeline orientation.
• Shenzhen Institute of Advanced Technology (SIAT), CAS: CAS research institute based in the Greater Bay Area with overlapping biomedical, stem cell, and translational research programs. Comparable in institutional positioning and regional collaboration model.
• RIKEN Center for Developmental Biology: Japanese national research institute conducting world-class stem cell, regenerative medicine, and developmental biology research with translational pipelines. Comparable as a publicly funded research institute advancing cell therapy toward clinical application.
• Guangzhou Institutes of Biomedicine and Health (GIBH): CAS research institute that serves as CRMH's direct supporting institution and shares scientific leadership. Conducts parallel regenerative medicine, stem cell, and drug discovery research, and produced the NMPA-approved Orelabrutinib.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Centre for Regenerative Medicine and Health (CRMH), HKISI, CAS