Service Overview Sanyou provides integrated R&D service of CAR-T antibodies Sanyou preclinical candidate (PCC) R&D service covers six major modules, including material preparation, antibody discovery, in vitro efficacy screening, antibody engineering, in vivo efficacy evaluation and quality analysis. Pre-clinical R&D (PCC-IND) involves the development of production cell lines, upstream/downstream process development, quality control, and pilot-scale production. The close connections and cooperation between various modules help customers to quickly complete the research and development of the antibody for CAR-T therapy. Service Contents Service Service Contents Client Material Deliverables (and standards) Duration CAR-T integrated project service 1. Target screening 2. Antibody discovery 3. CAR deign and construction 4. CAR plasmid construction and virus packaging 5. In vitro efficacy screening 6. In vivo efficacy evaluation Target name T cell source 1. Data reports: reports and project data packages of each stage 2. Efficacy: The candidate antibody is equivalent to or better than the control CAR-T antibody 8–12 months Staged services of CAR-T R&D Target screening 1. Antigens and family proteins 2. Control antibody 3. Overexpression cell line Target name 1. SDS-PAGE > 85% 2. ELISA identification: The activity is consistent as in the literature 3. FACS identification: The expression level is 10 times higher than the background 1 Antibody discovery 1. Screening of the human antibody library 2. Screening of the alpaca immune library Materials Deliverable lead antibodies: deliver ≥ 20 lead antibodies of unique sequences 1–2 CAR design and construction 1. Design of CARs with different functional structures 2. Customized functional transformation CAR-T design requirements CAR design strategy based on the indication 0.5 CAR plasmid construction and virus packaging 1. Construction of CAR plasmids with different structures 2. High titer production of the lentivirus packaging CAR-T cell quantity requirement 1. CAR plasmids conforming to the virus packaging 2. Virus of high titer 2–3 In vitro efficacy screening 1. Method development for 2–3 functional assays 2. 2–3 functional assays Purified antibodies 1. Deliver ≥ 3 candidate antibodies that are equivalent to or better than the control antibody in in vitro assays 2. Function screening report 1–2 In vivo efficacy evaluation 1. Method development for 2 indications 2. Candidate antibody screening by 2 models 3. PK study Candidate antibodies 1. Deliver ≥ 2 candidate antibodies that are equivalent to or better than the control antibody in the animal models 2. In vivo drug efficacy screening report 2–4 Service Highlights 1. Fast antibody discovery Various types of differentiated antibody libraries are available for high-quality, fast-speed, and cost-efficient PCC R&D. 2. Integrated R&D platforms A series of featured technology platforms make the R&D of CAR-T antibodys simple and efficient. With closely connected modules and preparation, the integrated R&D platforms enable delivery of the PCC antibodies for CAR-T within 12 months. 3. Enriched R&D experience Sanyou has developed several candidates for CAR-T and accumulated extensive R&D experience.