ESG Performance & Highlights

ESG Performance & Highlights

Environmental Sustainability (E)

1. Sustainable Supply Chain

Green Supply Chain

• Completed the evaluation of new and existing suppliers, and promoted the inclusion of ESG sustainability evaluation items in the future.
• Completed the checklist for the supplier ESG sustainability evaluation items.

2. Greenhouse Gas Inventory

Carbon Inventory

Continually track carbon inventory for office electricity, water usage, and waste (monthly data collection for Scope 1 and Scope 2).

Unit: ML	Water Source Type	Water Usage by Different Plant Locations	Water Usage in Water-Stressed Areas	Total Water Usage
2022	Tap Water			0.8620
2023	Tap Water			1.6390
2024	Tap Water			1.5050

Metric Tons	Waste Item	2022	2023	2024
General Business Waste
Total		9.702	9.826	--

Energy Saving Measures

Air Conditioning

• Independently set up areas and operate based on actual demand for on/off control.
• Regularly outsource to professional companies for cleaning and maintenance of air conditioning equipment to ensure optimal performance and air quality.

Lighting

• Gradually replace lighting equipment with more energy-efficient alternatives to reduce energy consumption.
• Promote the habit of turning off lights when not in use.

Friendivy Workplace (S)

1. Talent Development

New Employee Training

New employee training includes introducing the company's organizational structure, rules and regulations, office safety and environmental maintenance, information software tools, job content, and workflows. It provides the necessary resources and support to help new employees integrate into the company quickly.

Ongoing

On-the-job Training

This training improves employees' professional skills and helps them achieve work goals through experiential learning, ensuring mastery of essential skills and knowledge.

Ongoing

Quality Policy / SOP Training

The quality policy scope and structure provided in the quality manual are integrated into the organization, planning, implementation, recording, and evaluation of clinical trials and new drug R&D activities to achieve continuous improvement, ensure product safety, efficacy, reliability, and patient safety, and support data quality for regulatory submissions.

Ongoing

Professional Training Courses

Continuously enhancing employees' professional knowledge and work skills, encouraging them to participate in external training courses to improve work capabilities, productivity, and meet the company's needs for innovation and development.

Includes courses related to regulations for each unit, ongoing professional development for each unit, clinical trial courses for new drugs, new drug development courses, pharmaceutical manufacturing courses, etc.

Human Rights Awareness Training

Implement the company's labor rights and gender equality policies related to human rights governance.

Implemented on November 14, 2024.

Business Integrity Awareness Training

Implement the company's business integrity policy guidelines.

Implemented on October 18, 2024.

2. Occupational Safety and Health

New Environmental Safety and Health Policy

To ensure the safety and health of employees and protect the environment, while enhancing the occupational safety and health awareness of all employees, preventing disasters, and aiming for sustainable development of the company.

A new Environmental Safety and Health Policy was established this year. Key contents and principles include: compliance with environmental protection and occupational safety and health regulations, participation of all employees, commitment to continuous improvement, and a friendly workplace.

Addition of Home Safety and Occupational Safety Guidelines

To ensure the safety and health of employees and protect the environment, while enhancing the occupational safety and health awareness of all employees, preventing disasters, and aiming for sustainable development of the company.

This year, the safety and health work regulations were revised (Appendix added: home office occupational safety and health reference guidelines). This guideline aims to provide companies and employees with hazard identification, risk assessment, and training related to home office work, and adopt preventive equipment or measures, responding to the norm of remote work or telecommuting post-COVID for workplace epidemic prevention and management.

Updating Occupational Safety Regulations

Compliant with regulatory requirements.

The administrative department assigned colleagues to complete 35 hours of safety education training for Level B Occupational Safety and Health Supervisors to obtain certification, ensuring a safe workplace.

Employee Occupational Safety and Health Awareness

Irregular safety and health awareness campaigns are conducted annually via email, including topics on workplace physical and mental health, flu prevention measures, the impact and prevention of prolonged sitting, and fire prevention in electrical equipment. Occupational safety-related videos are also shared for employees to view.

Occupational safety-related actions and awareness were communicated via email on December 16.

Supplier Commitment

Irregular safety and health awareness campaigns are conducted annually via email, including topics on workplace physical and mental health, flu prevention measures, the impact and prevention of prolonged sitting, and fire prevention in electrical equipment. Occupational safety-related videos are also shared for employees to view.

In addition to establishing a comprehensive occupational safety management system within the company, we also invite our suppliers to sign a social responsibility commitment letter, ensuring that both the company and its suppliers comply with relevant legal regulations.

Transparent Governance (G)

1. Product Responsibility and Safety

Strengthening the R&D Team

This year, we recruited two colleagues with expertise in new drug formulation (including difficult formulations) and the production and registration of generic drugs, strengthening our team.

New Dosage Form Research and Development

To explore novel drug mechanisms, we invest in the research and development of dosage forms that can be used in clinical trials and future market launches, using QTPP as the basis for product lifecycle planning, and following guidelines from ICH, US FDA, TFDA, etc.

Ensuring Medication Safety

For clinical medications, each batch has a complete stability plan to ensure the safety and efficacy of the drug.

Preclinical Testing

As the ultimate goal of drugs is to be used for human treatment, our team invests in human resources and resources for various tests, including pharmacokinetics (PK)/pharmacodynamics (PD) testing and drug toxicity tests. This ensures that preliminary safety and efficacy data are available before the drug enters the clinical phase in humans.

Clinical Execution Quality

• This year, we completed training for dedicated personnel in charge of Safety Management. Additionally, two employees have completed the Drug Safety eLearning Program from the Drug Information Association (DIA).
• In clinical trial design, we integrate non-clinical pharmacokinetics, pharmacodynamics, and safety data to support the risk assessment for human trials. We also design dose escalation schemes to ensure the optimal dosage.

Safety Monitoring and Emergency Plans

• In ongoing clinical trials, whether sponsored by our company or investigator-initiated (IIT) trials, a safety management plan has been developed, or relevant regulations have been outlined according to contract terms. Trial teams provide regular reports every one to six months on adverse reactions, including a list of serious adverse reactions, for the company's Chief Medical Officer (CMO) and Safety Specialists to conduct timely drug safety and risk-benefit assessments.
• In accordance with FDA and TFDA regulations, if new safety findings pose significant risks to research participants, immediate notification will be sent to the investigators and regulatory authorities, and the Investigator Brochure (IB) will be updated. In 2023, there were no safety issues that required expedited reporting or any new safety findings that posed significant risks to participants in clinical trials.

Responsible Safety Risk Assessment

In compliance with ICH and FDA regulations, our company writes a Development Safety Update Report (DSUR) each year, consolidating clinical trial efficacy and safety data, integrating past and ongoing trial data, and evaluating efficacy and safety from the past year. This process is reviewed by department heads, including regulatory, pharmaceutical, preclinical, clinical, and medical affairs departments, and a comprehensive risk-benefit assessment is submitted to the FDA.

2. Cybersecurity Protection

Strengthening Cybersecurity Protection

We regularly perform information security risk assessments to strengthen information security management and enhance technology, such as updating antivirus software to the latest version, upgrading computer operating system versions to improve security levels, performing routine antivirus code updates, and conducting system restore drills.

Cybersecurity Regulation Updates

Cybersecurity personnel attend external training sessions periodically to stay updated with the latest cybersecurity regulations and trends.

Internal Cybersecurity Awareness

 

• To prevent cyber-attacks and avoid cybersecurity incidents, we have implemented network security protection and multi-factor authentication. We continuously conduct internal cybersecurity awareness campaigns, covering topics such as social engineering and online fraud prevention, password usage principles, backup practices, and case studies of industry cybersecurity incidents, to enhance employees' information security awareness.
• This year, employees completed a total of 24 hours of cybersecurity education and training.