Delivered Work

What we have actually delivered
devices and drug GLP–CRO, by category and pathway

Client names are under NDA. Everything else — device category, classification, pathway, and drug GLP–CRO service scope — is here.

WHY NO COMPANY NAMES

Registrant and sponsor company names, registration certificate numbers and GLP study reports are covered by confidentiality agreements with our clients and are not published. What is published below — device category, classification, pathway, and drug GLP–CRO service scope — is enough to tell you whether we have done work like yours.

Domestic contract R&D and manufacturing

32 products currently in contract R&D and manufacturing. Registration certificates and filings obtained on behalf of registrants to date cover the following:

Device categoryProductsClassification
Active devicesUltrasound diagnostic systems (handheld and colour Doppler)Class II
Active devicesMicrowave therapy / surgical systemsClass III
Sterile single-use devicesOrthopaedic surgical positioning kitClass II
Sterile single-use devicesOral anaesthesia catheterClass III
Ophthalmic observation devicesInverting lens, non-contact wide-angle fundus observation lens, non-contact fundus lensClass I (filing)
Broader manufacturing scopeECMO circuit kits, precision infusion sets, breast biopsy needles, liquid dressings, surgical robot navigation consumablesClass II / III
IVD productsForensic testing kits, gene mutation detection kits, infectious disease testing kits, automated sample preparation systemsClass II / III

Cross-border localization for overseas registrants

One project in execution, four in the pipeline. Status as of the most recent project review; pipeline projects have not yet commenced and are subject to change.

StageDevice categoryRegistrant based inRegulatory pathwayCurrent status
In executionDental / maxillofacial cone-beam CT imagingSouth KoreaImport-to-domestic conversionLocalized design and manufacturing under way; registration testing in preparation
PipelineCerebral oximetry & blood flow monitoringCanadaDomestic manufacturing registrationNot yet commenced
PipelineOphthalmic surgical consumables (vitrectomy probe)United StatesImport-to-domestic conversionNot yet commenced
PipelineInfrared therapy deviceCanadaDomestic manufacturing registration (Class II)Not yet commenced
PipelineRegenerative medicine — autologous adipose tissue processingUnited KingdomDomestic manufacturing registrationNot yet commenced

If your situation resembles any row above, the Entering China page sets out which regulatory pathway applies and what each one requires.

Translational partnerships

22 partnerships with tertiary hospitals and research institutes. Under these arrangements the hospital conducts compliant in-house R&D on its device innovations, and the platform takes on market access, sample production and scale-up once the concept is proven. Named partners are listed on the Partners page.

Drug GLP–CRO delivered through GLP-accredited CRO partnership

Beyond devices, the platform delivers preclinical drug research through a deep partnership with a GLP-accredited CRO. Seno.Bio contracts with the client; the CRO’s GLP-accredited centres carry out the work under joint-name laboratories.

Service areaWhat the CRO partner deliversAccreditations
Nonclinical safety evaluationGLP toxicology, safety pharmacology, PK/ADME, general and specialised toxicology, pathologyNMPA 10 GLP accreditations, OECD GLP, AAALAC
Pharmacology & efficacyPharmacological efficacy, animal models, AI-driven and organoid early drug screeningNMPA, OECD GLP, AAALAC
Antibody discovery & developmentAntibody discovery, ADC internalisation antibodies, CAR-T/NK, antibody characterisationNMPA, OECD GLP
Central laboratoryBiological sample analysis, clinical Phase I, pharmacovigilance, companion diagnosticsGCP, GLP, CAP, ISO 15189, A2LA
Radiopharmaceutical CRDMORadiopharmaceutical integrated production R&D platformNMPA, OECD GLP, AAALAC

Specialty platforms include radiopharmaceuticals, ophthalmology, inhalation, CNS/neurological, cell & gene therapy, PROTAC/ADC/mRNA. Global footprint: Beijing functional lab, four GLP bases in Gu’an/Suzhou/Shenzhen/Wuxi, plus US node. See how the drug path works with us →

Multi-omics front-end enhancement with SinoGenoMax

Before entering the GLP phase, multi-omics profiling from SinoGenoMax — National Human Genome Center (North) — sharpens target and biomarker selection. Better-defined hypotheses enter preclinical work, so fewer studies are wasted on the wrong question.

Transcriptomics
Gene-expression profiling for target and biomarker selection
Metagenomics
Microbiome profiling for biomarker and mechanism discovery
Methylation
Epigenetic profiling for biomarker and companion-diagnostic development
Liquid biopsy
ctDNA and circulating-biomarker profiling for patient stratification

See how multi-omics fits the GLP chain →

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