safetyHealthEnvironmentManagementManufacturing operations shall be in compliance with the legal requirements of Safety, Health, and Environment. All domestic legal requirements shall be satisfied while the international rules and regulations shall be adhered to, as applicable. CEO President,Dr. Tae Han Kim Safety Preventing Accidents Continuous Improvement in the Safety Management System (PDCA) Process Risk AssessmentWe prevent accidents such as fire, explosion, and leaks by managing potential hazards and operational problems that are analyzed regularly based on the risks of the process. Management Work RiskWe carry out voluntary preliminary inspections and safety management systems through work permit systems for dangerous work by analyzing the risk of each work situation. Work MonitoringWe consistently monitor our business sites to keep them safe by constantly checking and improving the production sites and laboratories. Annual Safety Evaluation of Each DepartmentWe practice evaluation systems for the continuous improvement by comprehensively reviewing the safety management status of each division in terms of safety, hygiene, environment, and chemical substances periodically. Identification of Potential RiskIdentification of Potential RiskWe have established a health and safety culture in the organization for which all of our employees participate by taking the appropriate measures of reporting and identifying any potential risks, analyzing the causes and establishing the measures to prevent a recurrence. Emergency Response DrillWe have established various scenarios and conduct annual emergency response training in order to efficiently and systematically respond to the emergency circumstances of human and material resources. Safety Culture Annual Assessment of the Safety Culture (Assessment → Analysis → SHE Annual Plan) Emphasis on Safety Culture from the managementAll our employees strive to strengthen and cultivate a health and safety culture along with the continuous care and support of the management. Safety Awareness TrainingWe annually conduct and analyze safety culture evaluations, and associate the measures of vulnerabilities found with attitude enhancement training to share with all employees. Safety CampaignWe confirm that all employees are aware of the importance of contributing to a health and safety culture by not only implementing legal issues but also organizing a safety campaign on traffic and public security to establish a better safety culture. Safety CommunicationWe are strengthening our organizational communication by exchanging large and small safety issues through monthly health and safety meetings, safety talks & TBM. Safety ChampionWe motivate our employees to display a keen interest in safety issues by selecting a Safety Champion. The Safety Champion is selected across the departments, and these individuals who have achieved excellent safety standards will be awarded. Safety EventWe motivate our employees to display a keen interest in safety issues by selecting a Safety Champion. The Safety Champion is selected across the departments, and these individuals who have achieved excellent safety standards will be awarded. Health Health Enhancement for Our Employees Health Check-Up and Follow-UpWe conduct annual health check-ups on the health status of our employees and conduct any necessary follow-up management through the affiliated hospitals. Musculoskeletal System Harmful Factors ManagementWe conduct research on the harmful factors of musculoskeletal disorders and deliver a program for the prevention of musculoskeletal disorders to achieve a better working environment. Operation of Mental Health ClinicWe operate a variety of programs for mental health to prevent any mental health issues and mental health related accidents occurring for our valued employees. Industrial Hygiene Management Work Environment AssessmentWe continue to make the essential efforts to create healthy workplaces by measuring the exposure levels of harmful facto

leadershipmanufacturing are decreasing, and new innovative types of medicines are being developed to help millions suffering from devastating diseases. Our vision is to become the most competitive CDMO and offer a significant increase in available capacity, quality, and innovation. This will allow our client partners to provide valuable biological medicines to their patients both cost-effectively and on time. To realize this vision, we have built a unique continual processing platform for the manufacturing of biopharmaceutical products with quality and utional excellence in compliance with global regulatory bodies including the FDA, EMA, PMDA, and MFDS. We pride ourselves in delivering superior customer satisfaction through better quality, superior service, and compliance. Based on Samsung’s principles of Quality First and a track record for excellence in plant design, construction, operations, and ution, our competitiveness surpasses that of our rivals without sacrificing quality, regulatory compliance, or our business ethics. While continuing to implement current industry best practices, we strive together with our clients to set higher standards for biopharmaceutical manufacturing. Our operations are designed to fully comply with international regulatory and cGMP requirements and are overseen by our Quality Division. Our advanced facilities are able to manufacture biological products from early development through commercial supply stages. Furthermore, our experienced people provide expertise in cell line development, culture, purification, analytical testing, aseptic filling, and packaging. Our diverse capabilities, manufacturing scale, and flexibility represent a truly integrated one-stop service that meets all our clients’ needs. We will continue expanding our facilities and capabilities to meet growing market demand. As a global company, we pledge to continue Samsung’s legacy of excellence by combining our business, manufacturing, and engineering expertise, to bring innovation and progress to today’s biopharmaceutical industry. Sincerely yours, Dr. Tae Han KimPresident & CEO, Samsung BioLogics Key utives UTIVE VICE PRESIDENTKyusung Lee, Ph.D.Dr. Kyusung Lee is utive Vice President in charge of Contract Manufacturing Operation 1 of Samsung BioLogics. Prior to joining Samsung in 2010, Dr. Lee held various leadership positions in biopharmaceutical companies in the U.S. Dr. Lee began his career with Miller Brewing Company in 1991 as a biochemical engineer. He led the production team for Amoco BioProducts Corporation from 1992 to 1995 and was responsible for the technology transfer of a full scale biotechnology process, after which Dr. Lee moved to Merck & Co. During his tenure at Merck from 1995 to 2005, Dr. Lee participated in the design, construction, start-up, technology transfer, and commercial operation of biologics and pharmaceutical manufacturing facilities. From 2005 to 2010, Dr. Lee assumed responsibilities for technology transfer activities for Bristol-Myers Squibb Co.'s CMO programs. Dr. Lee holds a doctoral degree in chemical engineering from Purdue University. UTIVE VICE PRESIDENTJohn RimJohn Rim is utive Vice President in charge of Contract Manufacturing Operations 2 comprising the newest plant within Samsung BioLogics. Prior to joining Samsung BioLogics in 2015, Mr. Park held various technical and operational positions, as well as business development management leadership positions in biopharmaceutical companies in the U.S. Mr. Park began his career in 1989 with ALZA Corporation, a subsidiary of J & J, as a chemical engineer where he participated and led process and product development, technology transfer, validation and commercialization of several OROS products. He then worked in Technical & Alliance Management at Watson Pharmaceuticals. Transitioning to Merck as a Change Agent/Six Sigma Project Manager, Mr. Park then managed the Operational Excellence projects related to process improvements, cost savings and qua

historyManufacturing Partnership with CytoDynMar. 2019 Development Partnership with EutilexOCT. 2018 AEO CertificationOCT. 2018 Plant 3 cGMP ReadyJul. 2018 First DP Approval by FDAJul. 2018 Manufacturing Partnership with UCBJUN. 2018 Development Partnership with GI InnovationJUN. 2018 First Approval of Plant 1 by Health CanadaApl. 2018 ISO 22301 Certification (BCMS)DEC. 2017 First Approval of Plant 2 by EMANOV. 2017 Plant 3 Mechanical CompletionOCT. 2017 MOU for Strategic Alliance with MerckSEP. 2017 First Approval of Plant 2 by FDAJUL. 2017 Manufacturing Partnership with Sun PharmaMAY. 2017 First Approval of Plant 1 by PMDASamsung’s Innovative DesignPLANT 2 The Largest Single Plant5X Scale (DS 15,000L + DP Fill/Finish)Total Capacity - 152,000L (10x15,000L / 2x1,000L)Construction - 29 months to cGMP ready2016NOV. 2016 Samsung BioLogics IPO on KOSPINOV. 2016 First Approval of Plant 1 by EMAFED. 2016 Plant 2 DS cGMP ReadyNOV. 2015 First Approval of Plant 1 by FDANOV. 2015 Plant 3 Construction StartedOCT. 2015 Plant 1 PLI ApprovalFEB. 2015 Plant 2 mechanical CompletionAPR. 2014 Manufacturing Partnership with BMS2011-2013Standard DesignPLANT 1 Industry StandardIndustry Average Scale (DS 30,000L + DP Fill/Finish)Total Capacity - 30,000L (6x5,000L)Construction - 25 months to cGMP ready2013OCT. 2013 Manufacturing Partnership with RocheSEP. 2013 Plant 2 Construction StartedAug. 2013 Plant 1 DP cGMP ReadyJul. 2013 Manufacturing Partnership with BMS JUN. 2013 Plant 1 DS cGMP ReadyJUL. 2012 Plant 1 Mechanical CompletionMAY. 2011 Plant 1 Construction StartedAPR. 2011 Foundation of Samsung BioLogics

Drug ProductManufacturing. Samsung BioLogics’ dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production. Global Health Authority approvals for Plant 1 by the FDA, EMA, NAVISA, COFERIS, MOIT and TITICK. FILL & FINISHSamsung BioLogics DevelopmentSamsung BioLogics provides Formulation services for Drug Product Fill and Finish. Formulations can be completed from both single use systems or hard pipe systems. Additionally, we provide optimized type formulations while securing stability and effectiveness for the customer within the time they need. We are also fulfilling customer satisfaction through development service that considers even the permitted articles following the relevant formulations. Core EquipmentSmall scale lyoDown Flow BoothDSCKarl FisherFreeze Dryer MicroscopeManual Filler (Peristaltic Type)Specialized CapabilityBiopharmaceuticalsMonoclonal antibodiesFusion proteinsBispecific antibodiesPackaging (Vials)ProteinsPeptidesFormulation process optimization based on QbDFormulation DevelopmentFormulation DevelopmentThawEquipmentFreeze/Thaw skid for cryovesselsFreeze/Thaw skid for cryobagsCapacity/CapabilityControlled freezing and thawingMax. capacity : 1 tank per stationTemperature range : -70ºC to 40ºCThawThawFormulationPlant 1EquipmentExcipient and formulation vesselsCapacity/CapabilityExcipient vessel capacity : 20L to 3,000LFormulation vessel capacity : 20L to 1,500LpH and temperature controlWeight controlCIP/SIP of excipient and formulation vesselsSingle use solutions capabilitiesPlant 2EquipmentExcipient and formulation vesselsCapacity/CapabilityExcipient vessel capacity : 200L to 2,000LFormulation vessel capacity : 200L to 2,500LpH and temperature controlWeight controlCIP/SIP of excipient and formulation vesselsSingle use solutions capabilitiesVial Preparation and FillingPlant 1EquipmentWashing, depyrogenation, vial fillingStoppering, capping, transfer to lyoCapacity/CapabilityActive RABSFilling rate : up to 12,000 vials/hrFilling operation range : 0.1 ~ 100mlPump types : piston and peristalticCIP/SIP of vial filling machine2mL to 50mL vial sizeGRADE A over sealingAdaptable process to include single use or fixed systemsInline IPC capability (non-destructive testing)Plant 2EquipmentWashing, depyrogenation, vial fillingStoppering, cappingCapacity/CapabilityActive RABS, Piston & Peristatic PumpMax. capacity : 300 vials/min (based on 10ml vial)Filling operation range : 0.1ml to 100ml100% weight check systemCIP/SIP of vial filling machineGRADE A over sealing (enclosed RABS)Adaptable process to include single use or fixed systemsVial Preparation and FillingVial Preparation and FillingInspectionManual InspectionEquipmentManual inspection BoothsCapacity/CapabilityComprehensive visual inspection programOperators' manual inspection qualificationProduct type : liquid, high viscosity, and lyophilizedDefect classification library and qualification programs developed for all product typesVial cap printing capabilities availableSemi Automatic and Automated InspectionEquipmentAutomated inspection lineCapacity/CapabilityLine speed : 12,000 vials/hr (20R vial)Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc.InspectionInspectionPackagingEquipmentManual bulk packagingCapacity/CapabilityLine speed : 18,000 vials/hr (30mm diameter vial)Pakaging type : labeler, cartoner, overwrapperLaser carton print systemAutomatic weight check unit between cartoner and overwrapperPackagingLYOPHILIZATIONEquipmentTwo(2) lyophilizersCapacity/CapabilityMax. loading capacity : 32,000 vials (10ml) per lyoIce load capacity : 300kgShelf area : 16.7 ㎡Automatic loading and unloading system with RABSLyophilizationLyophilizationLyophilization Cycle Development and Commercial ScalabilityLyophilized product design Product characterization Thermal characterization of product (Tg, Tg’, Teu,Tc)Characterization of freezing step

DevelopmentManufacturingcGMP DS Stability Study6.cGMP DP ManufacturingcGMP DP Stability Study7. IND Filing Support Timeline – Speed to IND Timeline of Cell Line development to DS productionYear Month Construction CLD to IND Filing : ~ 18 MonthCLD to DS Production : ~ 12 Month DS to IND Filing Semi-fast -2M Vector Construction -1M Year 1 1M Cell Line Development 2M 3M 4M Process Development- Upstream- Downstream- Formulation- Anaytical Method 5M 6M Non GMP DS (Tox.)- Non GMP DS Stability- Non GMP DP Stability- Interim Reference Stadard Qualification 7M 8M Analytical Method Transfer to QC 9M 10M Virus Clearance Study 11M cGMP Clinical DS- Lot Release- cGMP DS Stability 12M Year 2 13M GMP DS Characterization 14M 15M cGMP DP- Lot Release- cGMP DS Stability Regulatory Documentation16M 17M 18M CELL LINE DEVELOPMENT Right Start, and Better Quality At Samsung BioLogics, we provide high-quality mammalian cell line development for a variety of antibodies and proteins using the CHOZN platform. Along with Samsung BioLogics’ specialized cell line development know-how, our experts have extensive experience of molecule development including difficult-to-handle products and are capable of delivering robust, high-yield single cell clone to our clients. Cell Line Development Platform Process 1,2 : 1st screeing - Screen and rank potential clones into 5 pools3 : Single Cell Cloning - Support monoclonial process4 : 2nd screening - Screen and rank of top 10 subclones6 : Top 3 RCB - Screen and rank of top 10 subclones6 : Stability Study - Assess stable maintanance of titer and product qualtiy6.5 : Fed-Batch - Assess stable maintanance of titer and product qualtiy UPSTREAM PROCESS DEVELOPMENT Samsung BioLogics has a highly skillful development R&D team with dedicated focus on advanced development services. With our sophisticated platform development process, our team provides Process Development services utilizing Quality by Design (QbD) approach. Upstream Process Development Flow Molecule information / cell bank transferBasal Media Screening in shake flaskFeed Media Screening in shake flaskProcess Optimization In Ambr 15™Process verification run in 2L STR DOWNSTREAM PROCESS DEVELOPMENT Samsung BioLogics offers our established downstream process development platform developed by our highly experienced scientists. Together with our insights in bioprocess and manufacturing, we are capable of developing a customized, optimal and efficient process resulting in high yield manufacture in a timely manner. Downstream Process Development Flow Preparation for DSP Development Virus Inactivation Process Development Filter Preocess Development Process verification run in AKRA ANALYTICAL METHOD DEVELOPMENT Analytical Method Development Analytical Method Development - Quantity- Impurities- Identity- Potency- Glycan profile- Excipient- Purity & Heterogeneity Extended characterization & comparability studies - Primary strucure- High order structure- Biological activity Analytical Support - In-process analysis for USP and DSP development CMP Facilities Small Scale Manufacturing – CMP 1 & CMP 2 As the world’s largest CDMO, we offer multiple cGMP manufacturing facilities to meet the diverse scales of our clients’ demands. The CMP Facility has the same best-in-class characteristics and equipment as our large-scale capacity. CMP1-STAINLESS STEEL BIOREACTORS Flask CultureBrx 1x20(N-1) - 20L (nominal volume) wave bioreactorBrx 1x30(N-1) - 40L (w.v) seed bioreactorBrx 1x40(N-1) - 200L (w.v) seed bioreactorBrx 1xY0(N) - 1,000L (w.v) production bioreactor CMP2-SINGLE-USE BIOREACTORS Flask Culture20L - (nominal volume) Single use bioreactor50L (w.v) - seed bioreactor200L (w.v) - seed bioreactor1,000L (w.v) - producti

QUALITY CONTROLManufacturing, Quality & Compliance, and Analytical Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes. Analytical Testing Capabilities Across the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release as well as stability. Our QC team is capable of performing analytical test method transfers from client laboratories and performing the required method validation, qualification, or verification, according to the ICH Q2 (R1) guidelines in order to satisfy the requirements of the U.S. FDA, EMA, and PMDA. Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of: ChemicalTesting 1. pH, Osmolality, Protein Content (A280), Appearance2. Water content3. Identification by FT-IR4. Impurity / Purity by HPLC BiochemicalTesting 1. Enzyme-Linked Immunosorbent Assay (ELISA)2. Polymerase Chain Reaction (PCR)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based Assays MicrobiologicalTesting 1. Microbial Limit (Bioburden)2. Endotoxin3. Microbial Identification4. Sterility Stability Program Capabilities We maintain a controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and the accelerated conditions of temperature and/or light. Environmental and Clean Utility Monitoring Through our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that the controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable particulates, Settle Plates, and Contact Plates. Clean Utilities Monitoring includes the testing for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.