SK bioscience recognizes the importance of research ethics in the R&D process, and intends to secure it by strengthening the relevant procedures. We document the research plan, implementation, reporting, and evaluation, which provide grounds for accurate data to verify research results. This is to ensure research integrity that follows the core values of science, such as objectivity, integrity, openness, responsibility, and fairness throughout the entire research process.

We established a biosafety committee at the R&D Center to protect the health of handlers and the public from risks arising from our biological materials. The committee’s knowledge and technology help us contribute to preventing biohazards and maintaining a safe environment.

In addition, SK bioscience has been designated as a Good Clinical Laboratory Practice(GCLP) by the Ministry of Food and Drug Safety(MFDS) in pursuant to Article 34-2, Paragraph 1, Item 2 of the「 Pharmaceutical Affairs Act」and Article 35 of the「 Rules on the Safety of Drugs, Etc.」. Thus, our research activities are obliged to comply with domestic and international regulations for Good Laboratory Practice(GLP) and GCLP. Also, we get our compliance and performance, including handling of human materials(samples), regularly examined by the MFDS to maintain our GCLP status.

To improve the ethics and reliability of animal testing, we identify relevant guidelines and observe them while conducting research. We also operate a management system that monitors the external Contract Research Organizations (CROs) to ensure that they follow the equal procedures and standards.

These various activities manifest our endless efforts to comply with research ethics. By providing regular training to the researchers, we intend to stress the importance of compliance with research ethics to our researchers.

SK bioscience strengthens research data management to secure objectivity, honesty, openness, and fairness required in the entire R&D process, including research planning, proposal, execution, reporting, and evaluation. This means that all research results must be managed regardless of the success/failure so that both positive and negative factors that the research can have on society can be considered.

Research integrity for not only in-house product development but also the C(D)MO business can be key to the reliability of data that we can provide to our business partners. When it comes to joint research, research data management is integral as it indicates responsibility and integrity. Therefore, we plan to strengthen the different policies and procedures for securing research results and data in the future.

SK bioscience has organized and operates the Institutional Biosafety Committee (IBC) at the R&D Center. Their responsibilities include reviewing the guidelines and policies on research activities involving potential biohazards and preserving human and material resources and the environment.

The committee is composed of related divisions and outside members and comprehensively considers various aspects such as science, law, safety, and corporate strategies to ensure biosafety. For instance, we comply with and manage regulations on the use of biological materials (living modified organisms (LMOs), high-risk pathogens, livestock pathogens, biological agents, etc.). In addition, our company includes outside members who have no interest in the committee to ensure objectivity when conducting research.

Our IBC conducts risk assessments and approves experiments requiring biosafety management, such as genetic recombination experiments. It also reviews the safety management of LMO research facilities and makes decisions on overall research ethics by approving matters related to biosafety training, and health management, the formulation and revision of biosafety management regulations.

SK bioscience handles and manages clinical trial specimens, which are collected from clinical trial subjects upon the request of the client. We also strictly control human-derived materials such as blood, body fluids, and tissues so that they are not used for any other unintended purposes. Human-derived materials are sampled according to internal procedures by personnel who have received the necessary training and have sufficient experience.

SK bioscience has established an animal testing management system based on the ethics management process and been raising the awareness of those in charge of experimentation by providing animal experimentation ethics training.

We use animals in our research from the preclinical stage to clinical trials, including for our COVID-19 vaccine. Animal testing is a step to validate the safety and effectiveness of commercially manufactured products.

Following the MFDS guidelines for Institutional Animal Care and Use Committee(IACUC) operation, we founded the Animal Testing Ethics Committee, which is operated in compliance with the Animal Protection Act and the Laboratory Animal Act. During the biannual IACUC meetings, we review the process of using and managing experimental animals and seek advice as needed. In addition, we monitor the implementation status of Standard Operating Procedures(SOP) and applicable laws and supplement the management system with IACUC advice on deficiencies. The Animal Testing Ethics Committee also performs on-site and remote due diligence under circumstances like COVID-19 by analyzing photographs.

When deliberating and approving the animal testing plan, our IACUC Committee follows the 3R(Replacement, Reduction, Refinement) Principle. By doing so, the committee guarantees that our research considers alternatives to animal testing and ultimately respects the dignity of animal life. Also, the committee monitors animal testing processes with researchers through Post-Approval Monitoring (PAM) to improve animal welfare and ensure the reliability and transparency of experimental results.

We have been developing a corporate culture that adheres to animal testing ethics by requiring all personnel in charge of animal experimentation to complete legal training and periodic retraining on the handling of research animals as well as ethics.

All clinical trials developed and conducted by SK bioscience are carried out in compliance with all domestic and international ethical regulations. When clinical trials are domestically conducted, we obtain approval from the MFDS and when conducted overseas, we obtain approval from drug regulatory authorities/National Regulatory Agencies (NRAs) of the countries.

For international ethics regulations, we follow the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Additionally, for studies that use human derivatives or information to identify individuals, we observe the principles outlined in the Helsinki Declaration on the Ethical principles for medical research involving human subjects.

Clinical trials at SK bioscience are carried out in strict accordance with the MFDS and the detailed guidelines of each country. Toxicity is tested in advance through animal testing in the preclinical stage, and vaccine safety and efficacy(immunogenicity) are evaluated at each clinical trial stage.

We collect and submit all clinical readiness data to major regulatory authorities/NRAs such as the MFDS and the FDA. By preparing reports on material defects and sharing them with the MFDS, we maintain clinical trial transparency. In addition, information on all interventional studies conducted by us complies with national clinical trial disclosure requirements as we register and disclose it on the website operated by the National Library of Medicine (NLM).

Pursuing diversity in clinical trials is the key to successful product development. In recognition of the importance of diversity, SK bioscience strives to collect data from participants of various ethnicities, ages, and genders through global clinical trials in Korea and other countries.

SK bioscience has a system to protect the safety and rights of all clinical trial participants. Prior to the participation, we gain voluntary informed consent from the subjects who fully understand the risks and benefits involved in the trial. When we require blood samples, additional consent obtained after providing sufficient information on the purpose, amount of blood, and retention period of blood samples. Moreover, in order to protect the subjects, we have established clear standards and procedures to compensate for damages that may occur during clinical trials.

We also prepared a mechanism for the safety of subjects through the operation of Data Safety Monitoring Boards (DSMB) for clinical trials. The DSMB is comprised of independent, external experts who review and evaluate the clinical trial process, safety data, and, if necessary, critical efficacy endpoints on a regular basis. Their advice based on the evaluation results determines whether to continue, change, or discontinue a clinical trial. Overall, the DSMB plays a crucial role in protecting the safety and rights of clinical trial participants to such an extent that, in some cases, it resorts to premature termination after weighing the risks and benefits.

In our efforts to protect the safety of the subjects, we have taken measures that allow us to move to the next stage only after completing the safety review of the participants in PhaseⅠ ,Ⅱ and Ⅲ clinical trials. We also operate stricter process than usually required by international standards as we have set the monitoring period to a year.

SK bioscience conducts clinical audits to confirm whether ethical principles and standards are followed. Through audits, we ensure that the protocol and internal guidelines such as SK bioscience’s SOPs are followed. We also check compliance with international standards and laws such as the Good Clinical Practice(GCP), ICH guidelines, Institutional Review Board(IRB) regulations, and Helsinki Declaration. In addition, to secure the independence and reliability of clinical audits, we have formed and operate an independent team separate from the clinical research team.

The inspection process confirms the proper operation of the Independent Data Monitoring Committee(IDMC)1). It also includes an in-house audit of clinical trial information, data, and related documents, an on-site audit of the clinical trial institution, analysis of collected information, and reporting of inspection results. This process not only protects the rights and welfare of clinical trial subjects but realizes the principles of good deeds and justice. Consequently, we believe the system and procedures of the new drug development are improved, leading to higher-quality clinical data.

By 2023, we plan to reinforce our clinical auditing competency by developing key personnel. Since the clinical audit is an important step that influences new drug approval as well as how our new medicine is consumed by the general public, we believe our key personnel with sufficient knowledge and experience can improve the reliability of our clinical trials.

* Independent Data Monitoring Committee(IDMC): A group of independent experts outside clinical trials that evaluates the courseof trials, safety data, and, if necessary, critical efficacy endpoints.

Recently, a risk-based approach has become prevalent in the pharmaceutical and bio-industries. Clinical trial regulations have been strengthened as the risks must be identified, evaluated, and reported during the clinical trial process. As the number of our research projects conducted abroad and business partners at home and abroad grows, so does the importance of clinical trial quality assurance and management.

Under this circumstance, we plan to introduce the Electronic Quality Management System(eQMS) in 2022 to improve clinical trial quality management efficiency and accuracy. We anticipate that this system will enhance the quality of our clinical trials, reduce costs through a rapid work process using a computer system, and prepare us for the changes in the domestic and international regulations.

SK bioscience collects, evaluates, and systematically analyzes safety information through pharmacovigilance activities throughout the life cycle of pharmaceuticals to ensure safe use. We analyze the adverse events collected during the drug development phase, which includes nonclinical and clinical trials, to determine the potential risks posed by the drug and to collect and evaluate expected side effects based on data.

After marketing, we continue to collect information, such as side effects, from pharmaceutical experts who deal with biomedicine such as vaccines or our end-users to discover the issues that we did not expect during the development stage. All safety information gets compiled in a database that is used not only as data for drug risk-benefit assessments but also for various risk mitigation tools, for example, safety precautions in the attached medication guides and manuals for pharmaceutical experts/consumers.

SK bioscience conducts pharmacovigilance training once a year for all employees to ensure product quality and safety. New hires are required to complete the training within one month after joining the company. In particular, additional training is conducted for the marketing division in charge of product sales.

Since 2021, SK bioscience has been operating a new Safety Internal Reporting System (SIRS) and upgrading the Safety DB to advance the pharmacovigilance system. In addition, we completed the reorganization of the Pharmacovigilance (PV) division to optimize expertise of our PV activities.

The new SIRS allows our employees to report product abnormalities more quickly through the internal network. We will increase the accessibility of the system by having external end-users report product safety information directly without contacting our customer service. In addition, we have signed a Safety Data Exchange Agreement (SDEA) with our clients and stakeholders to exchange safety information on our products and take the necessary risk mitigation measures.

SK bioscience upgraded its pharmacovigilance system to meet the requirements of global regulatory authorities and National Regulatory Agencies (NRAs). We have created and systematically manage a database so that the information gathered during our pharmacovigilance activities can be utilized as meaningful information for safety analysis.

In 2021, we designated the PV division to be in charge of developing a drug risk management plan and risk mitigation measures, as well as conducting risk-benefit analyses based on the information collected. We can now conduct pre- and post-marketing monitoring, strengthen the expertise of each stage of pharmacovigilance, and efficiently manage the information collected at each stage.

In 2022, SK bioscience established a plan to improve its Pharmacovigilance System. The plan consists of advancing our Pharmacovigilance System Master File (PSMF) and system to European Medicines Agency (EMA) level, establishing safety signal detection procedures, and improving access to risk mitigation measures through the use of IT tools.

SK bioscience manages and guarantees the entire pharmaceutical manufacturing process, from raw material warehousing to final product shipment, in order to produce the highest-quality products with a quality-first management policy. To that end, we maintain a strict quality system in which we strive to provide products that meet both customer and legal requirements. We have secured a quality level recognized both at home and abroad by achieving the EU-GMP from the European Medicines Agency(EMA) and Korean Good Manufacturing Practice(K-GMP).

At SK bioscience, quality is the utmost priority under the strict quality management system that encompasses all stages of the product life cycle, from product development to consumer use. Our quality assurance system allows us to handle issues such as changes, deviations, and complaints to produce high-quality pharmaceuticals. Also, we perform qualification and validation of all facilities to ensure performance and functionality and verify all production processes to guarantee quality.

In this regard, we established and documented quality policies to specify essential requirements to be followed under the quality management system. With our quality policy in place, we anticipate that our quality personnel’s awareness will have increased, resulting in uncompromising quality assurance.

SK bioscience’s quality system is optimized to continuously produce, manage, and sell pharmaceuticals in a GMP environment. We documented and implemented a quality policy to ensure that all customer and legal requirements and standards for quality assurance, equipment, raw materials, manufacturing control, packaging and labeling, and test management are met.

1. The quality organization must operate independently of the production organization.
2. All employees who perform GMP must have appropriate qualifications and improve and maintain GMP level through training.
3. All-important manufacturing processes must be validated, and the quality standards established through validation must be reviewed regularly and kept up to date.
4. All the facilities and systems required for GMP must be equipped.
5. All work during the manufacturing process must be performed according to the approved method. All progress must be recorded and preserved in the manufacturing instructions and records.
6. A recall system must be established and maintained.
7. A complaint handling system must be kept in place, the cause of complaints that arise should be investigated. Appropriate measures to prevent the recurrence of the same complaints must be taken.

SK bioscience has an organizational system in place to ensure the smooth operation of the quality assurance system and GMP. Our Quality Assurance(QA) division is in charge of annual and factory quality training systems, as well as risk analysis for quality risk management and deviation and preventive action management.

Moreover, the division performs GMP-related tasks such as evaluation, monitoring, calibration, and maintenance of GMP-compliant facilities and equipment. It also oversees the general quality management tasks such as product recall notification/investigation/record storage, supplier audit, and purchase change approval.

The Quality Control(QC) division examines raw materials, intermediate process samples, and final drug substances used in pharmaceutical manufacturing to check whether the specifications have been met. In this process, physics and chemistry, microbiology, animal testing, and device analysis tests are conducted according to SOPs. To this end, it carries out test method validation and management activities to maintain the functions of the QC laboratory, such as device qualification and Computer System Validation(CSV). Finally, it monitors drug safety evaluation programs and manufacturing support facilities.

SK bioscience performs systematic quality assurance activities to diagnose and manage quality risks, and conducts trend analysis on changes.

As a company that produces vaccine raw materials and finished drugs that are temperature- and environment-sensitive, we monitor them to ensure that they are stored under suitable conditions. Also, we perform the stability test on commercialized products at least once a year to observe the quality and keep the raw materials under proper storage conditions.

SK bioscience’s quality assurance activities include GMP compliance and process management through on-site supervision of the critical processes based on product standards, manufacturing records, and guidebook. In addition, we operate the QA on the Shop Floor Policy* to monitor data integrity and process deviations in real-time.

Quality impact assessments are conducted on products being produced regularly. As a result, quality issues affecting production and quality are well resolved, and production and quality operations are continuously managed according to global GMP standards. A validated eQMS is applied to the quality assurance system, allowing for comprehensive management of deviations, changes, corrections, and prevention, as well as deviations from standards, to be tracked in real time, making records traceable.

* The QA on the Shop Floor Policy: a system that enables quality assurance personnel to participate directly in key processes to resolve or respond promptly to problems when they occur, and is operated to prevent unnecessary process deviations.

SK bioscience maintains its quality assurance capabilities by providing systematic training to employees in charge of tasks that may affect product quality.

To strengthen GMP competency, regular training is provided in accordance with the annual training plan. New hires receive basic training as well as on-the-job training that helps them acquire the necessary job competencies. Employees are evaluated on their competency during training and assigned to work once their capabilities are confirmed. We believe this ensures product quality and the seamless operation of the quality system.

In addition, for jobs that require specialized capabilities, such as quality tests and aseptic work, regular verification and qualification procedures are conducted to prevent unauthorized personnel from performing the relevant work.

Staff training consists of detailed training for each job, which are quality system operation, production procedures, hygiene and dress code, and training for changing regulations so that all employees can continue to grow and strengthen their capabilities.

By specifying its attitude toward customers in the Practice Guidelines for the Code of Ethics, SK bioscience laid the groundwork for customer-oriented management. We identify needs by listening to our customers’ diverse opinions and develop products and services based on them, which are ultimately reflected in the direction of our business activities.

SK bioscience’s Customer Satisfaction strategy is divided into the public and private markets.

• Our marketing division is in charge of domestic sales of in-house vaccines(SKYVAX), which we developed from R&D to commercialization. The division is also responsible for customer communication for outsourced product introduction, distribution, and sales.
• Each project and contract manager is in charge of customer relations in contracts that involve international organizations and government procurement. Signing a C(D)MO contract for the global COVID-19 vaccines and exporting in-house vaccines(SKYVAX) are prominent examples.

SK bioscience operates a customer service center to provide response and consultation on its products distributed to hospitals and clinics. By dispatching consulting personnel to respond to available adverse events and purchase inquiries, we aim to reduce consumer anxiety and inconvenience.

When distributing and selling vaccines, we focus on quality, safety, accuracy, and distribution through the cold chain. Our marketing strategy is to maximize customer satisfaction by delivering essential information such as safety information obtained through the BLA.

SK bioscience communicates with customers through a variety of channels. In addition to major clients and end-users, our customers include global pharmaceutical companies that import products and business partners authorized to sell our products jointly.

To communicate with key stakeholders, we hold on-line and off-line meeting led by the Steering Committee. The meetings are held based on the contractual arrangements made between each client and the company. The executives and working-level employees from each company gather to discuss major marketing plans for each product. Annual planning is carried out in accordance with the contract terms, which usually call for it every quarter or month.

At the end of each year, SK bioscience develops an annual conference promotion plan for customer support and communication for the following year. In 2021, for example, we supported 64 online and offline customer conferences with products like SKYZoster, SKYVaricella, and Boostrix. To maximize customer satisfaction, we intend to maintain support activities in 2022.

SK bioscience is conducting a customer satisfaction survey through a qualitative method that sets the scope of the regular customer satisfaction survey and reflects the survey results in the CS strategy.

SK bioscience complies with regulations for responsible marketing activities. First and foremost, our marketing policy complies with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association rules. Also, we monitor marketing activities with the help of the CP Team.

In addition, we contribute to consumer protection and fair competition by strictly regulating public relations and advertising-related activities and complying with fair trade laws. We indicate the basic principles and scope of advertisements for pharmaceuticals specifically to prevent false/exaggerated advertisements. Also, we provide detailed compliance guidelines for quasi-drug advertisements to minimize the possibility of product misuse.

When producing promotional materials used by our marketing division, we use an internal review process called the RED system. It allows us to cross-check whether there are any violations from the medical, licensing, and legal perspectives. We do not conduct any marketing or promotion that may induce prescription of off-label products.

SK bioscience puts extensive efforts to promote fair competition and responsible marketing that complies with fair trade laws. It develops marketing guidelines based on the Pharmaceutical Affairs Act and Fair Competition Regulations, conducts regular marketing personnel training, and monitors promotional activities. Not only we constantly monitor marketing and promotion activities but also engage our sales partners in fair trade compliance by receiving appropriate trade agreements from them.

SK bioscience carries out systematic and responsible marketing activities through the participation of relevant departments. To pre-check compliance with the regulations in marketing activities, marketing staff are required to plan the expenses following a consensus with CP Team. After spending, an expense report is prepared, and compliance with fair competition regulations is checked through post-monitoring.

Once violations are detected as a result of monitoring, penalty points are given and reflected in the KPI, and disciplinary action is taken according to Article 14 of the Compliance Regulations (sanctions against employees). Then, the results are notified to employees, and are reflected in individual and organizational KPIs.

In preparation for going public in 2021, SK bioscience adopted and amended security-related policies. Also, it shared eight regulations and procedures, including security management regulations, with its employees. Our information system security procedure manual designates a person in charge of information protection. It includes an integrated information protection procedure ranging from the database(DB), network, cloud, to personal information processing system security that processes sensitive information.

The company constantly adopts and revises all other information-protection-related regulations and procedures according to compliance regulations and changes in the internal work environment.

The SK bioscience information protection system aims to control the information leakage route and ensure adequate and stable corporate asset protection. In order to do so, it defines procedures as well as the roles and authorities of the employees in charge, allowing us to take the necessary security measures. Furthermore, the company conducts information protection activities that meet the standard requirements of international standards such as GMP, and strengthens the IT security control system and external data security by reflecting the ISO 27001 standards.

In 2022, we plan to acquire ISO 27001 certification, identify risk factors in information security to avoid risks, and consider purchasing insurance/reinsurance. In addition, we plan to establish a security system suitable for the progress of cloud-based internal systems and carry out various campaign activities to raise the security awareness of all employees.

The SK bioscience information protection division’s tasks are managed and supervised by C-level executives. The tasks are divided into three detailed areas which are technical security, privacy, and physical security. Each area is led by a manager, and in the case of physical security, we have allocated a manager at the HQ and L HOUSE respectively.

Going forward, we plan to hire personnel with expertise in information protection and achieve a level of management that corresponds to international standards.

By utilizing a remote security control service provided by a security specialist, SK bioscience protects its business sites from external security attacks or threats such as intrusion attempts and information leakage targeting company-wide IT systems.

The company also conducts various information protection activities to raise its employees’ awareness about internal security and information leakage. For example, we set aside one day each year for Company Security Day to conduct self-inspections of daily life security, document security status, and work equipment. We also try to create an information protection culture by sharing monthly malicious/phishing mail trends and new security threat cases via the companywide notice board.

SK bioscience conducts information protection training for new hires, employees, and employees at its business partners. In addition, it provides personal information protection training to private information handlers via an in-house security portal.

The number of cases of theft or loss of customer data (personal information, etc.) of SK bioscience has been zero so far.