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Yaohai BioPharma Overview

Yaohai Bio-Pharma is the first and largest biologics CRDMO (Contract Research, Development and Manufacturing Organization) focusing on microbial expression systems in China. It provides customized end-to-end solutions from DNA design and synthesis, microbial strain engineering and construction to drug substance manufacturing in GMP or non-GMP level and products fill & finish across diversified modalities, such as recombinant proteins, peptides and polypeptides, enzymes, single-domain antibodies (sdAbs), plasmid DNA and mRNA, glyco-polymers, virus-like particles (VLPs), to meet global customers

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Yaohai BioPharma Overview

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  1. Yaohai BioPharma

  2. About Us ◆ Founded in 2010, located in China Medical City ◆ The 1stand Largest microbial CRDMO, end-to-end solution provider in China ◆ 500 team members Services: ◆ Focus on recombinant proteins, peptides/polypeptides, enzymes, antibody fragments and single-domain antibodies (sdAbs), plasmid DNA and mRNA, China Medical City glyco-polymers, virus-like particles (VLPs) ◆ Meet global customers’ clinical and commercial needs in biological drugs, biosimilars, vaccines and diagnostics for human and animal health, aesthetic medicine Advantages : ◆cGMP Production Platform 7500+L ◆The Largest GMP-level Plasmid Supplier in China ◆Explosion-proof Facilities (High Potency Manufacturing Suite) ◆Bio-safety Level 2 (BSL-2) Lab for CDO ◆Allowing Customer PM/Technical Personnel to Be Stationed On-site

  3. Global Market CDMO Market Growth Rate by Region (2022-2027) Source: Mordor Intelligence Global CDMO Market By Cell Line Type $Million (2022) Source: www.psmarketresearch.com >50% 20-30%

  4. Position In The Industry The First and Largest CRDMO in Microbial Expression System Revenue in 5 years (USD, million) in China. 1 1 11.1 CAGR89% 7.63 3.89 3.20 Top 1 Number of serviced projects Top 1 Scale of 1.04 production capacity (7500+L） 2017 2018 2019 2020 2021

  5. Facilities G29 10, 000 m², in Production DS Workshop III：50-100L, DS Workshop IV：50-500L, DS Workshop V：50-200-500-2000L, DP Workshop II, Quality Control Center G27 8, 000 m², in Production DS Workshop I：50-500L, DS Workshop II：50-200-1000-2000L DP Workshop I FDA/EU Industrialization Standard Beijing Branch Process Development Center Nucleic Acid Drugs and Single-domain Antibodies CRO/CDO Quality Research Service

  6. Technical Capabilities Yaohai Bio-Pharma (Yaohai) concentrates on three principal technology areas: recombinant proteins, nucleic acid drugs and single-domain antibodies. Yaohai assists global biotech and pharmaceutical companies with all processes from R&D to commercial production, such as strain construction, analytical method development, process development, stability research, IND production for Phase I-III, registration & application, commercial manufacturing to serve customers with solutions for the whole process from Pre-IND to commercial production. Yaohai is engaged in providing efficient and feasible CDMO services and solutions to customers and facilitate the R&D of new drugs. Recombinant Protein Nucleic Acid Drug Single-domain Antibody (sdAb) End-to-end CDMO service platform for Focusing on the use of plasmid and mRNA, Global expression platform recombinant protein/polypeptide drugs accelerating the progress from R&D to clinical application Well experienced and equipped with LNP

  7. Expression Systems Yeast E. coli Tailor Constructed Strains Pichia pastoris, Hansenula polymorpha, Saccharomyces cerevisiae, etc. K-12 strains & derivatives (DH1, DH5α, RV308, W3110, MG1655, JM109, BW25113…) B strains (BL21, BL21(DE3), BL21(DE3) pLysS, BL21(DE3) Rosetta…) Other microbe/microbiota/microbiome provided by customers, such as customized protease-deficient engineered bacteria Yaohai has an integrated service platform from R&R to cGMP manufacturing to produce recombinant proteins, plasmids, and antibody fragments with expression systems of E.coli, yeast and customer-supplied or in-house engineered microbial strains.

  8. Service System ONE-STOP CRDMO Quality Management CTO CRO CDO CMO Microbial Strain Engineerin g and Constructi on Lab-scale Process Development & Optimization Commerci alized Productio n Selection of Nucleic Acid Drugs & Single- domain Antibodies GMP Quality Manag ement Process Scale-up &Optimiz ation Sample Production in Phase I/II/III Analytical Method Develop ment Registration & Application Quality Standard Research IND Applic ation Verific ation Stability Research Microbial Strain Engineering and Construction/Strain Bank Construction Process Development & Optimization Customized R&D Services Registration & Application Production in Phase I~III Commercial- ized Production IND Batches

  9. Cooperated Projects US-CN application 7 EU-CN application 1 AUS-CN application 2 CAN-CN application 1 Based on project phase Based on project type Recombinant antibody 7% IND 32% Recombinant peptide 3% Vaccine 8% Nanobodies 8% Recombinant protein 55% CircRNA 2% mRNA 8% Phase I 9% Pre-IND 53% DNA plasmid 9% Phase II 4% Recombinant protein CircRNA Recombinant peptide DNA plasmid Nanobodies Recombinant antibody mRNA Vaccine Phase III, 3%

  10. Core Services Strain Construction & Strain Bank Establishment Process Development & Optimization GMP Compliance Scale-up Production Method Development & Quality Control Strain construction Fermentation scale-up & Quality standards research Fermentation process ➢ ➢ ➢ ➢ GMP secondary strain library development & optimization production Method development & validation ➢ ➢ (WCB+MCB) establishment Purification scale-up & Sample commissioned testing Purification process ➢ ➢ ➢ development & optimization production Stability & compatibility ➢ Preparation production Preparation process research ➢ ➢ development & optimization Preparation of standards ➢ Related product preparation ➢

  11. Filling and Finishing Specification Range Maximum Output Workshop Equipment Dosage Form Filling speed: 1500m² Aseptic Pre-filled injectables Annual production: 2ml vial 160~300 vials/min, preparation workshop in Lyophilized powder injections 10 million injection (vials) 10ml vial 140~200 vials/min 1-25mL accordance with GMP Eye drops 5 million lyophilized Lyophilization capacity: requirements for Any Oral solutions powder for injection (vials) 2ml 37800 vials (4200 * 9 layers) Modalities (biologics, Inhalation formulations 10ml 20043 vials (2227 * 9 layers) vaccines, chemicals…)

  12. Equipment For Process Development 1 2 3 1 –Sartorius BIOSTAT C Full- automatic Bioreactor-30L 2 –Quadruple Fermentation System Made by Bioengineering AG -7L 3 – GE AKTA System 4 –BIO RAD Gel Imaging System 5 – qPCR Made by ThermoFisher 4 5 6 6 –SCIEX Capillary Electrophoresis;

  13. Equipment For Drug Substance Automatic buffer Configuration/storage system Fermentation system 00 L Disc centrifuge High pressure homogenizer Explosion-proof facilities/ RP system Sterility Isolator Hollow fiber system

  14. Equipment For QC HPLC Agilent 1260 Molecular Devices iD3 HPLC Thermo (U3000/Vanquish) QPCR ABI QuantStudio5 GC Agilent 8890

  15. Strategic Planning CRDMO Integration CDMO Aesthetic Medicine ◆ Extend service chain ◆ Based on the microbiology expression and cultivation ◆ Form CRO/CDMO integration ◆ Raw material and CDMO service integration ◆ Promote the comprehensive competitive ◆ Give full play to the comprehensive advantages of talent and advantage of technology and scale microbial track

  16. Website: https://www.yaohai-bio.com.cn/ Yaohai will live up to your trust！ Email: BD@yaohaibio.cn SERVE WITH HEART, CREATE THE FUTURE TOGETHER

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