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Service Overviews

Based on ”Super-trillion Innovative Antibody Discovery Platform” and “Integrated Innovative Antibody Drug Preclinical R&D Platforms”. Sanyou Bio provides integrated pre-clinical candidate (PCC) drug R&D services.

The solutions include drug-target validation, material preparation, antibody generation, in vitro efficacy evaluation, antibody engineering, in vivo efficacy assessment and other on-demand studies to ensure the delivery of PCC antibody drugs with promising developability potential.


Service Overview Based on ”Super-trillion Innovative Antibody Discovery Platform” and “Integrated Innovative Antibody Drug Preclinical R&D Platforms”.Sanyou Bio provides integrated pre-clinical candidate (PCC) drug R&D services. The solutions include drug-target validation, material preparation, antibody generation, in vitro efficacy evaluation, antibody engineering, in vivo efficacy assessment and other on-demand studies to ensure the delivery of PCC antibody drugs with promising developability potential. Service Contents Service Type Service Contents Provided by Clients Deliverables and Standards Timeline (month) PCC Projects 1. material preparation 2. antibody discovery 3. antibody humanization 4. antibody affinity maturation 5. in vitro efficacy screening 6. in vivo efficacy screening 1. Target Information 2. R&D requirements 1.Data reports: stage reports and project data reports 2.Deliverables: 2-3 candidate antibodies with activities comparable or superior to control antibodies 8-12 Drug PCC Development Stages Breakdown Material Preparation 1. human/monkey/mouse antigens, receptor/ligand and family proteins 2. control antibodies 3. human/monkey/mouse antigen expressing cell lines Target Information 1. SDS-PAGE>85% 2. ELISA:activity is consistent as in the literature 3. FACS:expression level 10 times higher than the background 1 Antibody Discovery 1. mouse immune library 2. alpaca immune library 3. fully human library Materials 1. Delivery of lead antibodies: delivery of ≥20 monoclonal lead antibodies with human-monkey cross-reactivity 1-2 In Vitro Efficacy Screening 1. method development of the required assays 2. in vitro screening of the candidate antibodies Purified and Qualified Antibodies 1. Functional screening: delivery of ≥3 antibody molecules with activities comparable or superior to control antibodies 2. Data report: in vitro functional screening data reports 1-2 Antibody Humanization 1. humanization design 2. plasmid construction, expression and purification 3. antibody function validation and drug developability assessment Candidate Antibody Sequences 1. Humanness rate: degree of humanization>90% 2. Antibody characterization: activities of the humanized antibody is similar to or superior to that of the parental antibody 3. Data report: humanization data reports 1 Affinity Maturation 1. library construction strategy development 2. library construction and screening 3. antibody function validation and drug developability assessment Candidate Antibody Sequences 1. Affinity: the affinity of the engineered antibody is 5-20 times better than that of the parental 2. In vitro efficacy: the in vitro efficacy of the candidate antibody is significantly better than that of the parent 3. Data report: antibody affinity maturation reports 2 In Vivo Efficacy Screening 1. method development of the required models 2. in vivo screening of the candidate antibodies 3. pharmacokinetic analysis Candidate Antibodies 1. In vivo screening: delivery of ≥2 antibody candidates with in vivo activities comparable or superior to the control antibodies 2. Data report: in vivo drug efficacy screening data reports 2-4 Service Highlights 1. Integrated Solutions All-in-one solutions include target validation, material preparation, antibody discovery, in vitro efficacy evaluation, antibody engineering, in vivo efficacy assessment and other on-demand studies. 2. Super-trillion Antibody Libraries with the support of large-capacity antibody libraries (7×1012),thusands of lead molecules can be obtained for conventional drug targets, and potential lead molecules can be derived from multiple layers of screening. 3. Experienced in R&D Our team has more than 100 successful PCC development experience with various disease targets, which guarantees the success of project development. 4. Comprehensive Validations The candidate molecules are fully verified by affinity, specificity, drug efficacy in vivo and in vitro, and exploitability to ensure the quality. 5. Solid Scientific Foundation Supported by more than 50 scientists,we provide value-added services for the project by completing target research and project recommendation. 6. Industry-leading Expert Team Well-established and reliable services provided by nearly 300 experienced scientists in the R&D team. 7. Extensive Successful Cases Successfully project deliveries to more than 300 global pharmaceutical companies with 80% repeated orders. 8. Client-oriented Business Model Diverse and flexible business models are generated following client-oriented and result-oriented principles. Case Presentations As of February 2022, Sanyou has experiences of nearly 100 drug PCC development covering various antibody formats and indications. The above chart shows the number of PCC projects completed annually by Sanyou in the recent years, where 68 PCC projects are expected to be completed in 2022. The above chart shows the formats of the PCC antibodies that Sanyou has completed, including monoclonal antibodies, bi-specific antibodies, tri-specific antibodies and ADC. The above chart shows a variety of indications of targets that are under development by Sanyou, which focus on oncology and autoimmunity, meanwhile cover infection, ophthalmology and metabolism. Last

Service Contents

Service

Service Details

Client Provides

Deliverables and Standards

Time

PCC projects

1. Material preparation

2. Antibody generation

3. Antibody humanization

4. Antibody affinity maturation

5. In vitro efficacy screening

6. In vivo efficacy screening

1. Target information

2. R&D requirements

1. Data reports: Stage reports and project data reports

2. Deliverables: 2-3 candidate antibodies with activities comparable or superior to control antibodies

8-12

Drug PCC Development Stages

Material preparation

1. Human/monkey/mouse antigens, receptor/ligand and family proteins
2. Control antibodies
3. Human/monkey/mouse antigen expressing cell lines

Target information

1. SDS-PAGE>85%
2. ELISA:Activity is consistent as in the literature
3. FACS:Expression level 10 times higher than the background

1

Antibody generation

1. Mouse immune library
2. Alpaca immune library
3. Fully human library

Materials

1. Delivery of lead antibodies: Delivery of ≥20 monoclonal lead antibodies with human-monkey cross-reactivity

1-2

In vitro efficacy screening 1. Method development of the required assays
2. In vitro screening of the candidate antibodies

Purified and qualified antibodies

1. Functional screening: Delivery of ≥3 antibody molecules with activities comparable or superior to control antibodies
2. Data report: In vitro functional screening data reports

1-2

Antibody humanization

1. Humanization design

2. Plasmid construction, expression and purification

3. Antibody function validation and drug developability assessment

Candidate antibody sequences

1. Humanization degree >90%
2. Antibody characterization: Activities of the humanized antibody is similar to or superior to that of the parental antibody
3. Data report: Humanization data reports

1

Affinity maturation

1. Library construction strategy development

2. Library construction and screening

3. Antibody function validation and drug developability assessment

Candidate antibody sequences

1. Affinity: The affinity of the engineered antibody is 5-20 times better than that of the parental
2. In vitro efficacy: The in vitro efficacy of the candidate antibody is significantly better that of the parental antibody
3. Data report: Antibody affinity maturation reports

2

In vivo efficacy screening 1. Method development of the required models
2. In vivo screening of the candidate antibodies

3. Pharmacokinetic analysis

Candidate antibodies

1. In vivo screening: Delivery of ≥2 antibody candidates with in vitro activities comparable or superior to the control antibodies
2. Data report: In vivo drug efficacy screening data reports

2-4


Service Highlights
  • 1. Integrated Solutions
    1. All-in-one solutions include target validation, material preparation, antibody generation, in vitro efficacy evaluation, antibody engineering, in vivo efficacy assessment and other on-demand studies.
  • 2. Super-trillion Antibody Libraries
    1. with the support of large-capacity antibody libraries (7×1012), lead molecules can be obtained for conventional drug targets, and potential lead molecules can be further obtained from multiple layers of screening.
  • 3. Experienced in R&D
    1. Our team has more than 100 successful pre-PPC or PCC development experience on various disease targets, which guarantees the success of PCC molecule development.
  • 4. Comprehensive Validations
    1. The candidate molecules are fully verified by affinity, specificity, drug efficacy in vivo and in vitro, and 12.developability to ensure the quality.
  • 5. Solid Scientific Foundation
    1. Supported by more than 50 scientists,we provide value-added services for the project by completing target investigation and recommendation.
  • 6. Industry-leading Expert Team
    1. Well-established and reliable services provided by nearly 300 experienced scientists in the R&D team.
  • 7. Extensive Successful Cases
    1. Successfully project deliveries to more than 300 global pharmaceutical companies with 80% repeated orders.
  • 8. Client-oriented Business Model
    1. Diverse and flexible business models are generated following client-oriented and result-oriented principles.

Case Studies

As of February 2022, Sanyou has accumulated experience of nearly 100 drug PCC development project, covering various antibody formats and indications.



The above chart shows the number of PCC projects completed annually by Sanyou in the recent years, where 68 PCC projects are expected to be completed in 2022.



The above chart shows the formats of the PCC antibodies that Sanyou has completed, including monoclonal antibodies, bi-specific antibodies, tri-specific antibodies and ADC.



The above figure shows the indication types of the targets currently under research by Sanyou Bio. Focusing on majorly oncology and autoimmunity, infection, ophthalmology and metabolism are also covered.