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Double Materiality Matrix

Double Materiality Matrix

Identification and Analysis of Key Topics

Senhwa Biosciecnes uses the GRI standards as a reference for identifying sustainability issues. Following the four-stage process of GRI Standards 2021 for materiality assessment, the company uses the "degree of impact" as an indicator to evaluate the materiality of topics. Senhwa conducts a survey and uses a dual-impact perspective to assess the impact of key issues on the company. After distributing and collecting the surveys, a total of 9 management questionnaires and 52 stakeholder questionnaires were returned.

After analysis, Senhwa identified key material topics, selecting two major topics from each of the E, S, and G dimensions, and created a materiality matrix: Product Responsibility and Safety, Cybersecurity Protection, Talent Development, Occupational Safety, Sustainable Supply Chain, and Greenhouse Gas Management. Due to the nature of the new drug industry and innovation in research and development, Senhwa will additionally disclose this key topic.

Regarding these key topics, the company will gather important information and performance data that align with stakeholder concerns in 2024, which will be fully disclosed in the sustainability report to be published in 2025. The company will continue to strengthen its management of these topics.

Key Topic Risk Management Strategy

Environmental Risks

Energy Conservation and Carbon Reduction Challenges

Risk

External uncontrollable risks such as climate change, natural disasters, and infectious diseases.

Management Strategy

  1. Gradually introduce the TCFD framework to strengthen climate risk management.
  2. Plan to implement ISO 14064-1 by 2025 for greenhouse gas inventory, verification, and multiple energy-saving and carbon-reduction measures to mitigate the impacts of climate change.
  3. Set a greenhouse gas reduction target for the company, aiming for a 1% reduction in emissions intensity, and regularly disclose interim results.
  4. Continue carbon accounting for office electricity, water usage, and waste (collect relevant data monthly for Scope 1 and Scope 2 emissions).
  5. Implement energy-saving measures for air conditioning and lighting.

Policy Risk

Insufficient Supply Chain Resilience

Risk

Some raw materials are only produced in specific regions, so the supply chain may be affected by regional natural disasters or geopolitical risks, leading to shortages or delays, which in turn could affect product production and sales, causing severe financial and reputational losses for the company.

Management Strategy

  1. Diversification of Suppliers: Find multiple suppliers to avoid over-reliance on a single source, and establish alternative supply chains.
  2. Quality Management System: Establish a strict supplier management and quality audit system, regularly auditing and inspecting suppliers.
  3. Risk Assessment and Contingency Plans: Conduct risk assessments of the supply chain and establish contingency plans for supply chain disruptions to ensure uninterrupted production.

R&D Risks

Product Liability and Safety (Risk of Serious Side Effects / Clinical Trial Termination)

Risk

The drug may be recalled or removed from the clinical trials due to side effects or quality issues, potentially harming patient health, which could severely impact the company's reputation and finances.

Management Strategy

  1. Pharmaceutical Preparation Level
  2. Strict Clinical Trials and Quality Control: Conduct rigorous clinical trials and risk assessments before a new drug is launched to ensure product safety and efficacy.
  3. Product Recall Plan: Develop a detailed product recall plan to quickly retrieve products and minimize damage if issues are identified.
  4. Insurance Plan: Purchase product liability insurance to mitigate potential compensation liabilities.
  5. Regulatory and Production Audits: Follow regulatory updates and establish SOPs according to the quality system, conducting on-site audits to ensure compliance with relevant GXP regulations.
  1. Clinical Management Level
  2. Initial Dose Selection: Carefully select the initial dose for human trials based on preclinical trial data and design a dose escalation scheme to ensure safety.
  3. Integration of Non-clinical Trial Data: Integrate pharmacokinetic, pharmacodynamic, and safety data from non-clinical trials in the trial design to support risk assessments for human trials.
  4. Subject Selection: Choose suitable participants, considering their health status and other factors that may affect trial results.
  5. Safety Monitoring: Establish a safety monitoring system to continuously collect and analyze trial data, promptly identifying and addressing adverse reactions.
  6. Emergency Plan: Develop a detailed emergency plan to address potential emergencies during the trials, ensuring participant safety.
  7. Ethical Review: Ensure that all trial designs and procedures comply with ethical standards and are reviewed and approved by an ethics committee.

Technology Change Risk

Cybersecurity Incidents

Risk

Operational disruptions, significant financial losses, and damage to the company's reputation, potentially leading to legal issues.

Management Strategy

  1. Replace outdated firewalls with next-generation firewalls. Set up strict firewall policies, excluding unsafe domains, to prevent personnel from accessing insecure networks, and ensure cybersecurity personnel perform daily anomaly monitoring, analysis, and management.
  2. Conduct training and awareness campaigns, emphasizing that information security is the responsibility of all employees. Through continuous training, enhance employees' cybersecurity literacy and awareness.
  3. Establish control items based on the OTC (Over-the-Counter) center’s information security management guidelines. Perform annual cybersecurity risk assessments and follow the cybersecurity self-inspection checklist. Implement risk improvement plans for high-risk cybersecurity issues.
  4. Implement annual cybersecurity incident reporting and drills.
  5. Join TWCERT (Taiwan Computer Emergency Response Team) to receive the latest cybersecurity information.

Industry Risk

Talent Development and Retention Challenges

Risk

New drug development is a high-risk industry with uncertain timelines. It is challenging to cultivate and retain R&D talent.

Management Strategy

  1. Select talent with a biotechnology background and create a favorable R&D environment.
  2. Provide competitive salaries, benefits, and good promotion opportunities.
  3. Create a diverse, equal, and learning-friendivy workplace, offering employees opportunities for further education.

Other Risks

Workplace Safety Incidents

Risk

Threats to the company’s reputation and market competitiveness.

Management Strategy

  1. Developed a new Environmental, Safety, and Health Policy this year. The main content and principles include: complying with environmental protection and occupational safety regulations, full employee participation, a commitment to continuous improvement, and fostering a friendivy workplace.
  2. This year, revised the Health and Safety Work Rules (including an appendix: added guidelines for home-office occupational safety and health). These guidelines address the impact of working from home or remote work after the COVID-19 pandemic as part of workplace health and safety management. The guidelines aim to assist businesses and employees in identifying risks associated with home-office work, conducting risk assessments, providing training, and implementing preventive equipment or measures.
  3. Continue to promote and implement occupational safety and health actions and awareness programs.
  4. Invite cooperating suppliers to sign a Social Responsibility Commitment to ensure that both the company and suppliers comply with relevant legal regulations.