KEY DISTINCTION
What we sell isn't capacity — it's industrialization with responsibility attached
A traditional contract manufacturer just delivers product — the risk and responsibility stay with the client. Seno.Bio's CDMO business runs on the medical device registrant system: the platform holds the manufacturing license and bears the corresponding manufacturing responsibility, while the client (the registrant) holds only the registration certificate. Once GLP validation is complete, there's no need to find another manufacturer, renegotiate, or hand off data — the project moves seamlessly into design transfer and production within the same platform.
Platform Credentials & Positioning
Seno.Bio's medical device CDMO industrialization platform is among the earlier movers of its kind in China, backed by state-owned capital support. Drawing on regional medical device industry resources and industrial capital over the long term, we focus on contract R&D and manufacturing built on the medical device registrant system, serving the translation and manufacturing needs of hospitals, research institutes, and innovative medical device companies.
32
products currently in contract R&D / manufacturing
6+3
registration certificates / filings
3
device categories covered by manufacturing licences — sterile implantable, active, IVD
22
hospital / research institute partnerships (9 named publicly)
SERVICE COMMITMENT · IP PROTECTION
Registrants' IP concerns, designed away at the system level
We never hold the registration certificate
The platform commits to holding only the manufacturing license, removing IP protection concerns for registrants at the root.
No competing engagements
Without the registrant's consent, the platform accepts only one registrant per product category for a set period, protecting their competitive edge.
IP stays with the registrant
Existing IP is identified and protected before the engagement begins; any new IP generated during design and process validation belongs to the registrant as well.
HOW WE COMPARE
Versus a traditional contract manufacturer or a registration-only agent
| Dimension | Typical manufacturer / registration-only agent | Seno.Bio |
|---|
| Manufacturing responsibility | Stays with the client if something goes wrong | The platform holds the licence and bears manufacturing responsibility |
| Link between safety evaluation and manufacturing | Client sources an outside lab; data changes hands between two organizations | GLP and CDMO operate inside one system; data never leaves it |
| Licensed device categories | Usually strong in one category only | Sterile implantable, active and IVD devices, all under one licence |
| Regulatory inspection record | Rarely disclosed publicly | Zero-finding registration system inspection (March 2023, disclosed) |
| Support for overseas registrants | Depends on the individual firm; rarely a structured offering | All three NMPA routes supported as a standing service |
The left-hand description is a generalisation about the market, not a claim about any named competitor.
CDMO Service Capabilities
Contract R&D and design
Full-cycle management of design planning, design inputs/outputs, and risk management, from project initiation through R&D documentation
Design-to-manufacturing transfer
Utility system validation, facility and equipment management, procurement and warehousing, and process validation/scale-up
Manufacturing license coverage
The platform holds the manufacturing license and bears the corresponding responsibility, so registrants don't need to build their own factory
Registration testing support
Coordinating product testing and retained-sample management, linking to NMPA regulatory filing and review communications
Cross-border contract manufacturing
Localized design and manufacturing for overseas registrants, covering multiple regulatory pathways — domestic manufacturing registration, import-to-domestic conversion, and licensed technology-transfer registration
Quality system development
ISO 13485 quality system consulting and implementation, supporting full lifecycle compliance
Representative Product Categories
Active devices
Ultrasound diagnostic systems, color Doppler systems, vascular stiffness monitors, surgical robot navigation consumables, microwave therapy/surgical systems, and more
Passive devices
ECMO circuit kits, oral anesthesia catheters, precision infusion sets, breast biopsy needles, orthopedic surgical positioning kits, liquid dressings, and more
IVD products
Forensic testing kits, gene mutation detection kits, infectious disease testing kits, automated sample preparation systems, and more
Registrant company names and registration certificate numbers are covered by confidentiality agreements and are not listed publicly. On the cross-border side, the platform currently has one overseas localization project in execution — dental imaging equipment for a registrant based in South Korea, with localized design and manufacturing under way and registration testing in preparation. A further four projects are in the pipeline and have not yet commenced, for registrants based in Canada, the United States and the United Kingdom, covering neuro-monitoring devices, ophthalmic surgical consumables, rehabilitation therapy equipment and regenerative medicine processing equipment. Status as of the most recent project review; pipeline projects are subject to change.
The Industrialization Path Within the Platform
GLP
GLP validation complete
Carrying a full safety data package
R&D
Contract R&D and design
Seamless in-platform transfer, no data loss
Transfer
Design-to-manufacturing transfer
Process validation and scale-up into a robust process
Testing
Registration testing support
Supporting testing/retained samples, linked to regulatory filing
Manufacture
Licensed production
Platform-licensed manufacturing, volume delivery
After manufacturing: getting the product sold
Contract manufacturing settles whether the product can be built and registered. It does not settle revenue. For a registrant without a national sales organisation in China, distribution is usually the part that actually binds.
We work with Jointown Pharmaceutical Group (SSE 600998), so devices made here and holding a registration certificate can enter an existing nationwide distribution network.
100,000+
pharmacy outlets
10,000+
county-level and above public hospitals
145
hospitals with awarded SPD supply chain projects
This stage is optional — contract manufacturing on its own is entirely normal, and many registrants have their own sales organisation.
See commercialization →
Strategic Hospital & Research Institute Partners
The platform works with the technology-transfer offices of multiple hospitals under a "contract R&D" arrangement: the hospital handles compliant in-house R&D on its medical device innovations, while the platform handles market access, sample production, and scale-up once the concept is proven. We've established translation partnerships with the following hospitals and research institutes:
Peking University Third Hospital
Peking Union Medical College Hospital, CAMS
Beijing Tongren Hospital, Capital Medical University
Beijing Jishuitan Hospital
Xuanwu Hospital, Capital Medical University
Beijing Chest Hospital, Capital Medical University
Technical Institute of Physics and Chemistry, CAS
Beijing Luhe Hospital, Capital Medical University
Beijing Plastic Surgery Hospital