Annual Inspection Report for the Experimental Animal License of the Suzhou Area, China (Jiangsu) Pilot Free Trade Zone

Unit Name  
(Legal Entity)

Shengshi Taikang Biopharmaceutical Technology (Suzhou) Co., Ltd.

Legal  
Representative

Ding Juping

Unit Address

No. 218 Xinghu Street, Suzhou Industrial Park

Unit Website

https://www.cgenetech.com.cn

Laboratory animals  
The unit's supervisory authority

Department of Biology

Department Head and Landline Phone

Lu Qin, 18951119020

Laboratory animals  
Regarding qualifications

None

Is it located within the park premises? (Situated in science parks, high-tech zones, incubators, etc.)

Yes, Suzhou Area of the Free Trade Zone

Does the organization qualify as a high-tech enterprise?

£ is (year obtained:         Year) ■No

Management Compliance Status

Is there any violation of research integrity?

□ Yes ■ No

Is there any violation of safe production practices?

□ Yes ■ No

Whether you have been listed on the credit blacklist by the relevant authorities

□ Yes ■ No

Are there any actions that violate the "Implementation Measures for Strengthening In-Process and Post-Event Supervision of Administrative Licensing for Laboratory Animals (Trial)"?

£ is (specifically:             , Category: □ Criticism and Education □ Order for Rectification □ Minor Dishonesty □ Moderate Dishonesty □ Serious Dishonesty
■No

Mid- and Post-Event Supervision  
Content Self-Review Status

Changes to License Basic Information

(1) Promptly update the organization’s registration information, including the unit name, legal representative, facility address, and other relevant details.

□ is the specific change details:           
□ No ■ No changes this year

(2) Promptly update permit information such as facility environment, animal species, and facility area.

□ is the specific change details:                 
□ No ■ No changes this year

(3) Apply for license renewal by the specified deadline.

□ Yes, renewal license number:                 
□ No ■ No continuation this year

Implementation Status of Basic Systems

(1) Develop management systems and standard operating procedures, and revise them promptly.

■ Yes □ No

(2) Complete original records related to the production of laboratory animals (including personnel entry/exit, disinfection, temperature and humidity, pressure differentials, strain preservation, breeding, and operation of hardware equipment, etc.).

■ Yes □ No

(3) Develop a biosafety emergency response plan, equip essential emergency supplies, and publicly display contact information for reporting incidents involving laboratory animals as well as emergency procedures in prominent locations.

■ Yes □ No

Management Team and Staffing Information

(1) Promptly appoint a new head for the laboratory animal management and ethics committee.

□ Yes □ No ■No changes this year

(2) Promptly update the biosafety emergency contact and facility liaison.

□ Yes □ No ■No changes this year

Facility Usage and Environmental Quality Control Status

(1) Promptly file a record if facilities are temporarily out of use or have not conducted animal experimentation activities for more than 6 months.

■ Yes □ No

(2) Regular environmental testing of the laboratory animal facilities, with complete original records of all relevant tests.

■ Yes □ No

Animal Quality, Control, and Welfare Assurance Measures

(1) Regular quality inspections of animals, with complete original records for relevant tests (limited to production facilities only).

□ Yes □ No

(2) Harmlessly dispose of animal carcasses and waste materials, with complete documentation.

■ Yes □ No

(3) Promptly submit data to the national and provincial laboratory animal management systems.

■ Yes □ No

(4) Conduct experimental animal welfare and ethics reviews in a standardized manner.

■ Yes □ No

Other situations

(1) Produce and sell, as well as purchase and use, laboratory animals that come with valid quality certificates—all in accordance with laws and regulations.

■ Yes □ No

(2) Applications for science and technology awards and participation in science and technology projects must adhere to standards for laboratory animal research and ensure complete documentation.

£ is □ No ■ Not applicable

(3) Are there any instances of outsourcing or subcontracting animal testing?

□ Yes, subcontracted to a qualified organization with a subcontracting agreement (contract) ■ No

(4) Do the quality of laboratory animal cages and equipment meet relevant standards? Are the frames stable and secure, with smooth, even surfaces free from cracks or leaks?

■ Yes □ No

Biological Safety Management Status

(Biosecurity management systems and staff training, preparation and implementation of emergency plans, as well as emergency drills)
Shengshi Taikang has established a comprehensive biosafety management system and conducts regular training sessions for relevant personnel. An emergency response plan has also been put in place. The company promptly updates the contact persons responsible for reporting and managing biosafety emergencies, and actively carries out biosafety-related activities under the supervision and guidance of its internal safety officers—proactively addressing potential risks to ensure that no safety incidents or liabilities occur.

Laboratory animal personnel

Personnel
Total count
 6   Person

Classified by nature
(People)

Technical personnel

Management personnel

Animal caretakers

Veterinarian

3

1

1

1

Categorized by educational level
(People)

Doctor

Master's degree

Bachelor

Junior college

0

2

2

1

Number of times employees participated in skills training and continuing education

5

Employee Health Checkups (Persons)

4

Level of innovation

Undertake
Government
Scientific research
Project

Conducting scientific research using laboratory animals
Project

Apply at the provincial level or above    /       Item

Experimental Animal Research Project

Apply at the provincial level or above     /      Item

Source

Quantity
(Item)

Funding
Funding
(Ten thousand yuan)

Source

Quantity
(Item)

Funding
Funding
(Ten thousand yuan)

Country

/

/

Country

/

/

Provincial

/

/

Provincial

/

/

City-level

/

/

City-level

/

/

Other

/

/

Other

/

/

Total

/

/

Total

/

/

Experiment
Animals
Related
Award-winning
Situation

Award Name

Issuing Department

Award Level

/

/

/

/

/

/

Experiment
Animals
Related
Standard
Develop
Situation

Application   /   Item             

Application for Standard Name, Type, and Department         /                 

Project Approval    /  Item

Project Approval Standard Name

Types of standards (National Standard, Local Standard, Industry Standard, Enterprise Standard)

Project Approval Department

/

/

        /

/

/

        /

Experiment
Animals
Related
Paper
Situation

International   /   Article
Domestic   /   Article

Representative Paper Title
(No more than 3 articles)

Publication Venue

First author

/

/

/

/

/

/

/

/

/

This year, achievements with significant scientific or industry impact related to laboratory animals (limited to 3 entries, each within 500 words).

/

Animal production status

License
Certificate Number

Facilities
Address
(Precise to building name, floor, and orientation)

Facilities
Environment (Normal/Barrier)

Total area
(m²)

Housing Area
(m²)

Auxiliary Zone
(m²)

Animal breeds

Quality
Level

Actual production and breeding volume
(Only)

Internal Supply

Animal usage status

To ensure the smooth operation of the animal facility, routine inspections of the facility's housing environment, quality checks on pressure vessel sterilization, and calibration of instruments and equipment are conducted as scheduled. Qualified experimental animals are used exclusively, and thorough measures are taken to safely dispose of animal carcasses, medical waste, bedding materials, and other related废弃物. Additionally, comprehensive pre-employment training is provided for researchers, while technical staff receive enhanced skills development to refine their operational techniques, ultimately boosting their awareness of both animal welfare ethics and biosafety protocols. In 2022, as the number of research projects expanded, so did the demand for experimental animals; consequently, the facility added an additional IVC system to accommodate the growing needs.
Quantity
(Only)

To ensure the smooth operation of the animal facility, routine inspections of the facility's housing environment, quality checks on pressure vessel sterilization, and calibration of instruments and equipment are conducted as scheduled. Qualified experimental animals are used exclusively, and thorough measures are taken to safely dispose of animal carcasses, medical waste, bedding materials, and other related废弃物. Additionally, comprehensive pre-employment training is provided for researchers, while technical staff receive enhanced skills development to refine their operational techniques, ultimately boosting their awareness of both animal welfare ethics and biosafety protocols. In 2022, as the number of research projects expanded, so did the demand for experimental animals; consequently, the facility added an additional IVC system to accommodate the growing needs.
Income
(Ten thousand yuan)

Export Quantity (Units Only)

Outbound Sales
Income
(Ten thousand yuan)

Issue Certificate(s) (Quantity: ___)

Within the province

Out of province

Overseas

National
System

Provincial-level
System

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

Total

/

/

/

Total

/

/

/

/

/

/

/

/

/

Animal usage情况

Internally
Services

Supporting scientific research projects
(Item)

Supporting teaching
(Course Hours)

Cultivating talent
(People)

License
Certificate Number

Facility Address
(Precise to building name, floor, and orientation)

Facilities
Environment
(Ordinary/Barrier)

Total area
(m²)

Housing Area
(m²)

Auxiliary Zone
(m²)

Animals
Variety

Quality
Level

Actual usage
(Only)

Animal-derived (only)

Self-produced

Outsourced

Total

6

100

4

SYXK (From Suzhou) 2021-0001

Northwest side of C19-301, Phase I, Bio-Nano Park, Xinghu Street, Suzhou Industrial Park

Barrier

100

33.7

66.3

NCG

SPF

30

0

30

BALB/c-nude

SPF

206

0

206

To the outside
Services

Number of contracts

Contract
Transaction volume
(Ten thousand yuan)

Technology
Transaction volume
(Ten thousand yuan)

NOD-Scid

SPF

24

0

24

C57BL/6J

SPF

15

0

15

B-hGLP-1R

SPF

55

0

55

Total

/

/

/

NOG

SPF

506

0

506

ICR

SPF

108

0

108

C57BL/6N

SPF

120

35

85

Lewis

SPF

319

0

319

SD

SPF

354

0

354

Total

100

33.7

66.3

Total

1737

35

1702

License-issuing entity  
Annual Work Summary  
(Within 1000 words, additional pages may be attached.)

It primarily includes: (1) the institution's management of laboratory animals (such as its management system, institutional framework, safety protocols, ethical review processes, and financial investments and supporting measures); (2) the annual construction and operational status of the animal facilities, as well as their role in supporting the institution or broader industry development; and (3) any existing challenges along with relevant recommendations.
Shengshi Taikang Experimental Animal Facility is located in Suzhou Free Trade Zone and is under the jurisdiction of the Ministry of Biology. The primary function of the facility is to support the breeding of research animals for our company’s scientific experiments. The Ministry of Biology and the Quality Department regularly review and promptly update the management systems related to experimental animals.
To ensure the smooth operation of the animal facility, routine inspections of the facility's housing environment, quality checks on pressure vessel sterilization, and calibration of instruments and equipment are conducted as scheduled. Qualified experimental animals are used exclusively, and thorough measures are taken to safely dispose of animal carcasses, medical waste, bedding materials, and other related废弃物. Additionally, comprehensive pre-employment training is provided for researchers, while technical staff receive enhanced skills development to refine their operational techniques, ultimately boosting their awareness of both animal welfare ethics and biosafety protocols. In 2022, as the number of research projects expanded, so did the demand for experimental animals; consequently, the facility added an additional IVC system to accommodate the growing needs.
The facility's sterilizer has a smaller capacity and slightly lower sterilization efficiency, making it in need of improvement.

License-issuing entity  
Opinion

The information provided above is accurate.

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