Climate Change Data

科濟藥業控股有限公司 CARSGEN THERAPEUTICS HOLDINGS LIMITED

Climate Impact & Sustainability Data (2022, 2023)

Reporting Period: 2022

Environmental Metrics

Total Carbon Emissions:17,179.52 tCO2e
Scope 1 Emissions:5,031.79 tCO2e
Scope 2 Emissions:12,147.73 tCO2e
Total Energy Consumption:26,406.92 MWh
Water Consumption:76,102 tons
Waste Generated:24.9 tons (hazardous), 12.70 tons (non-hazardous)

ESG Focus Areas

  • Product quality and safety
  • Privacy and information protection
  • Product R&D and innovation
  • Health accessibility and clinical experiment safety
  • Climate change

Environmental Achievements

  • Upgrading and renovation of the wastewater treatment facility, including operation optimization, upgrading of the automatic dosing system and upgrading of the online monitoring system
  • Implemented a “green office” campaign to reduce the carbon footprint

Social Achievements

  • CARsgen Immune Cell R&D Team was granted “2022 National Worker Pioneer”
  • Launched international talent reservation – management trainee program
  • Provided special allowances to employees who stuck to their positions during the pandemic lockdown
  • Implemented an employee equity incentive plan

Governance Achievements

  • Established ESG working groups to plan and implement the Company’s ESG management policies
  • Formulated and issued the Compliance Management Policy to systematically advance compliance management
  • Established an Audit Committee, a Remuneration Committee and a Nomination and Corporate Governance Committee

Climate Goals & Targets

Environmental Challenges

  • COVID-19 pandemic impact on patient enrollment, patient visits and monitor’s hospital visits
  • Global supply chain constraints impacting procurement and delivery of materials
  • Potential impact of the COVID-19 pandemic on the construction, commissioning, qualification and validation of the U.S. CGMP manufacturing facility
Mitigation Strategies
  • Conducted clinical trials at multiple institutions located in different areas, cities, and countries
  • Implemented a set of COVID-19 prevention and control measures
  • Adopted an integrated project delivery approach for the RTP Manufacturing Facility to shorten construction turnaround time and improve cost effectiveness

Supply Chain Management

Supplier Audits: 48 related suppliers reviewed

Responsible Procurement
  • Supplier Management Policy
  • Procurement and Bidding Procedures
  • Indirect Procurement Management Policy
  • Material Inventory Coding Management Process

Climate-Related Risks & Opportunities

Physical Risks
  • extreme weather accidents such as typhoons and storms

Reporting Standards

Frameworks Used: Appendix 27 Environmental, Social and Governance Reporting Guide to the Main Board Listing Rules of Stock Exchange of Hong Kong Limited

Awards & Recognition

  • 2022 National Worker Pioneer
  • Top Ten Pioneer Companies in Drug Innovation of the Year
  • Top Ten Drug Innovation Scientists of the Year
  • High-value Patent Operation Competition: Patent Operation Investment Value Award
  • China’s Top 100 Innovative Pharmaceutical Companies Award

Reporting Period: 2023

Environmental Metrics

Total Carbon Emissions:15,327.77 tCO2e
Scope 1 Emissions:3,639.12 tCO2e
Scope 2 Emissions:11,688.65 tCO2e
Total Energy Consumption:27,642.52 MWh
Water Consumption:90,040 tons
Waste Generated:152.33 tons

ESG Focus Areas

  • Product quality and safety
  • Privacy and information protection
  • Product R&D and innovation
  • Health accessibility and clinical experiment safety
  • Business ethics
  • Employee rights protection
  • Occupational health and safety

Environmental Achievements

  • Saved approximately 150,000 KWH of electricity throughout the year by adopting various energy-saving measures.
  • Saved about 1,100 tons of water a year by retrofitting the hot water closed circulation system and increasing preventive maintenance of the chilled water circulation system.

Social Achievements

  • Continued investment in talent development, including new hire orientation training, performance management workshops, English training, job rotations, and overseas assignments.
  • Launched various employee engagement activities, including tourism groups, birthday parties, women’s care activities, and public welfare lectures.
  • Donated more than RMB30,000 worth of winter supplies to the Xiadawu Township School in Qinghai Province.
  • Organized 14 employees to participate in unpaid blood donation activities.
  • 15 employees participated in apheresis activities and donated their immune cells to cancer research.

Governance Achievements

  • Established a sound ESG governance system, integrating sustainable development into business strategies and daily operations.
  • Developed a well-established stakeholder communication mechanism.
  • Conducted a materiality assessment to identify key areas of ESG practice.
  • Revised and optimized quality management system documents and management processes.
  • Passed the GMP compliance on-site inspection.
  • Formulated and introduced the Post-marketing Spontaneous Adverse Event Reporting Management Procedure.
  • Revised and optimized Quality Complaint Management Procedures.
  • Revised the Anti-Bribery and Anti-Corruption Management Policy.
  • Improved information security management system.

Climate Goals & Targets

Environmental Challenges

  • FDA placed a clinical hold on zevor-cel, satricabtagene autoleucel and CT071 due to CMC observations related to the RTP Manufacturing Facility in Durham, North Carolina.
  • Significant net losses and net operating cash outflows since inception.
  • Need for additional capital to meet operating cash requirements.
  • Limited operating history.
  • Competition in the rapidly changing biopharmaceutical industry.
  • Lengthy and expensive clinical development process with uncertain outcome.
  • Extensive government regulation.
  • Complex manufacturing process for cell therapies.
  • Limited market opportunities for product candidates.
  • Limited marketing and sales organization.
  • Potential for product liability claims.
  • Limited intellectual property protection.
Mitigation Strategies
  • Conducting a thorough review and taking comprehensive actions to enhance CGMP compliance and collaborating closely with the FDA to resolve issues.
  • Exploring equity and debt financing options.
  • Building vertically integrated manufacturing capabilities.
  • Establishing marketing and sales capabilities.
  • Obtaining and maintaining adequate patent and other intellectual property protection.
  • Implementing comprehensive risk management policies.
  • Developing innovative technology platforms to address challenges in CAR T-cell therapies.
  • Collaborating with Huadong Medicine for commercialization of zevor-cel in mainland China.
  • Collaborating with Moderna to investigate CT041 in combination with an mRNA cancer vaccine.
  • Implementing Corrective and Preventive Actions (CAPAs) plan.

Supply Chain Management

Supplier Audits: 18 related suppliers reviewed

Responsible Procurement
  • Supplier Management Policy
  • Procurement and Bidding Procedures
  • Indirect Procurement Management Policy
  • Material Inventory Coding Management Process
  • Supplier Compliance Notice
  • Confidentiality Agreement
  • Integrity Co-construction Agreement
  • Green procurement practices

Climate-Related Risks & Opportunities

Physical Risks
  • Increased severity and frequency of extreme weather events
  • Disruption of supply chain transport routes
  • Increased operating costs due to increased temperatures
  • Additional subsidies and insurance costs
Transition Risks
  • Increased environmental compliance costs
  • Increased investment in new technologies
  • Increased input costs
  • Responding to stakeholders’ expectations
Opportunities
  • Increased demand for energy efficiency and low-carbon products and services
  • Improve the efficiency of resource use
  • Reduce operating costs by enhancing the stability and reliability of business operations

Reporting Standards

Frameworks Used: Appendix C2 Environmental, Social and Governance Reporting Guide to the Main Board Listing Rules of Stock Exchange of Hong Kong Limited

Awards & Recognition

  • Shanghai ‘Specialized, Refinement, Differential and Innovation’ SMEs (2023-2025)
  • Top 10 Innovative Companies of the Year
  • Top 10 Innovative Research Teams of the Year
  • Innovative SME
  • 2023 Synthetic Biology Industry Value Gold Ranking Top 36
  • Top 100 Innovative Pharmaceutical Enterprises in China
  • Top 10 Innovative Pharmaceutical Enterprises of 2023