Compliance and Certifications - The company has achieved compliance with GMP standards and possesses commercialization capabilities[1] - The company has received NMPA GMP certification for its self-developed products, ensuring commercial production capabilities[5] - The company has received NMPA GMP certification for its monoclonal antibody production line, ensuring compliance with quality standards[75] Research and Development - The global R&D center, covering an area of 25,000 square meters, is set to be operational in the second half of 2023, marking a significant milestone in the company's global industrial layout[6] - The company has a strong focus on R&D and production of renewable energy solutions, as indicated by the previous roles of its executives in related industries[33] - The company is focused on developing and commercializing innovative oncology drugs, with a pipeline that includes monoclonal antibodies (mAb) and antibody-drug conjugates (ADC)[140] Production and Operational Achievements - The company completed 100% of production project deliveries in 2022, gaining market trust and high recognition from customers despite challenges posed by the pandemic[10] - The company has established a leading "end-to-end" ADC industrialization platform to enhance its CDMO business scale and market competitiveness[11] - The company has successfully completed multiple batches of clinical production and process validation for ADC drugs and CDMO projects[5] - The company has equipped its production lines with advanced technology, including a fully automated filling line for monoclonal antibodies, maximizing production efficiency[5] - The company has achieved a monoclonal antibody production scale of over 20,000L, equipped with commercial, pilot, and small-scale production lines[75] - The ADC (Antibody-Drug Conjugate) production facility has a capacity of up to 500L, with multiple batches of ADC drugs completed for clinical production and process validation, meeting GMP standards[76] - The formulation production capacity exceeds 18,000 bottles per hour for filling, with freeze-dried product capacity exceeding 50,000 bottles per batch[77] Corporate Governance - The company has adopted the corporate governance code as a foundation for its governance practices, ensuring accountability, transparency, fairness, and risk management[38] - The board believes that high standards of corporate governance are essential for protecting shareholder interests and enhancing corporate value[38] - The company has established a clear separation of roles between the Chairman and the CEO to enhance governance[43] - The board consists of seven members, including two executive directors, two non-executive directors, and three independent non-executive directors as of December 31, 2022[41] - The board has maintained compliance with listing rules by having at least three independent non-executive directors, representing one-third of the board members[46] - The board consists of three independent non-executive directors, accounting for 42.9% of the board[55] - The company has implemented strict guidelines for employee trading of securities to prevent insider trading[41] Risk Management and Compliance - The company confirmed its responsibility for the effectiveness of risk management and internal control systems, which are designed to manage, not eliminate, risks to achieving business objectives[105] - The audit and related party transaction committee has assisted the board in overseeing the design, implementation, and monitoring of risk management and internal control systems[108] - The company has established a risk governance framework to identify, assess, resolve, monitor, and communicate key risks, including strategic, financial, operational, and compliance risks[105] - The company has established a whistleblowing procedure to allow employees to confidentially express concerns regarding financial reporting and internal controls[113] - The company has conducted annual self-assessments to ensure compliance with control policies across various departments[111] Leadership and Management - The company appointed Dr. Pan Zhiwei as Vice President of CMC (Chemistry, Manufacturing, and Controls) in March 2023, responsible for process development and project management[33] - Ms. Xiao Ben joined the company in January 2022 and was appointed as Chief Financial Officer in October 2022, overseeing financial management and investment matters[33] - The company has expanded its leadership team with experienced professionals from various sectors, enhancing its strategic capabilities[33] - The leadership team has extensive experience in the biopharmaceutical and biotechnology sectors, which is crucial for the company's growth strategy[33] - The strategic appointments reflect the company's commitment to strengthening its operational and financial management capabilities[33] Environmental, Social, and Governance (ESG) - The company is focused on enhancing its ESG governance standards and integrating ESG concepts into its regular management practices[10] - The strategic and ESG committee consists of five members, including Mr. Fu Shan as the chairman, overseeing the implementation and evaluation of significant changes in ESG projects[21] - The company aims to review its long-term strategic development plans and provide recommendations to the board regarding ESG-related issues[21] - The company is focused on assessing its environmental and social impacts while monitoring international and Chinese ESG trends to identify potential business opportunities and risks[21] - The company has implemented ESG policies to ensure sustainability and compliance with applicable laws and regulations[93] Financial Performance - The company reported a net loss for the year ending December 31, 2022, with specific figures detailed in the comprehensive loss statement on page 82 of the annual report[141] - The company has no plans to pay any cash dividends in the foreseeable future, as it intends to retain all available funds for business development[131] - For the year ended December 31, 2022, revenue from the group's top five customers accounted for less than 30% of total revenue[152] - As of December 31, 2022, purchases from the group's top five suppliers represented 46% of total procurement costs, with the largest supplier accounting for 21%[156] Shareholder and Stakeholder Engagement - The company has maintained regular communication with shareholders through various channels, including annual general meetings and social media platforms[117] - The company emphasizes effective communication with shareholders to strengthen investor relations and understanding of its business performance and strategies[128] Diversity and Inclusion - The board consists of 5 male directors and 2 female directors, achieving a gender diversity ratio of 29% female and 71% male[86] - The senior management team has a gender diversity ratio of 53% female and 47% male, with 9 female and 8 male members[88] - The overall employee gender ratio is 53% female and 47% male, comprising 229 female and 202 male employees[88] - The company has adopted a Board Diversity Policy to enhance diversity at the board level, considering factors such as gender, age, and professional qualifications[85] Compensation and Incentives - The company’s compensation policy for executives is based on skills, knowledge, responsibilities, and company performance, with performance bonuses included[41] - The group has established a compensation committee responsible for developing compensation policies for all directors, senior management, and employees[152] - The group has implemented an employee stock option plan since 2013 to incentivize and reward employees[153] - The group has adopted a restricted share incentive plan in 2020 to further motivate employees[153] Audit and Financial Oversight - The Audit and Related Party Transactions Committee held four meetings during the year ended December 31, 2022, to review and approve interim and annual financial performance and reports[79] - The external auditor's fees for the year ended December 31, 2022, totaled RMB 3,230,000, with RMB 3,200,000 for audit services and RMB 30,000 for non-audit services[114]
东曜药业(01875) - 2022 - 年度财报