Financial Performance and Reporting - Keymed Biosciences Inc. reported its 2022 annual report, detailing financial and operational performance for the year[1] - The company's financial statements include a consolidated income statement, comprehensive income statement, financial position statement, equity changes statement, and cash flow statement[2] - Revenue for 2022 decreased by 9% to RMB 100.063 million compared to RMB 110.269 million in 2021[13] - Gross profit increased by 5% to RMB 97.478 million in 2022 from RMB 93.069 million in 2021[13] - R&D expenses rose by 42% to RMB 507.374 million in 2022 from RMB 358.156 million in 2021[13] - Administrative expenses increased by 45% to RMB 133.912 million in 2022 from RMB 92.454 million in 2021[13] - The company's cash and cash equivalents, term deposits, and financial assets at fair value decreased by 10% to RMB 3.175 billion in 2022 from RMB 3.525 billion in 2021[13] - Revenue for the year ended December 31, 2022, was RMB 100 million, primarily from licensing income related to agreements with CSPC Pharmaceutical Group[14] - R&D expenses increased by RMB 149 million to RMB 507 million in 2022, driven by higher preclinical and clinical research costs[14] - Administrative expenses rose by RMB 41 million to RMB 134 million in 2022, consistent with the company's business expansion[14] - The company's total comprehensive loss for 2022 was RMB 303.6 million, a 92% improvement compared to the RMB 3.89 billion loss in 2021[16] - Adjusted total comprehensive loss for 2022 was RMB 255 million, a 14% decrease from RMB 295.5 million in 2021[16] - Other income and gains increased by RMB 206 million to RMB 259 million in 2022, driven by government subsidies, interest income, and exchange gains[50] - The company recorded a fair value loss of RMB 3,480 million for convertible redeemable preferred shares in 2021, which were converted to ordinary shares during the IPO[53] - Other expenses decreased by RMB 57 million to RMB 1 million, mainly due to a reduction in foreign exchange losses[54] - Financial costs decreased by RMB 3 million to RMB 8 million, driven by a reduction in implied interest on other financial liabilities[55] - The company's share of losses from its joint venture, Beijing Tiannuo Jiancheng Pharmaceutical Technology Co., Ltd., was RMB 10 million, attributed to increased clinical trial expenses[56] - Total assets remained stable at RMB 3,932 million, with current assets at RMB 3,310 million and current liabilities at RMB 380 million[57] - Cash and bank balances decreased by RMB 349 million to RMB 3,175 million, primarily due to cash used in daily business operations[58] - The company's asset-liability ratio increased from 7% to 15%, reflecting higher total liabilities relative to total assets[60] - The company pledged equipment worth RMB 430 million as collateral for bank loans[63] - The company faces foreign exchange risk due to holdings in non-functional currencies but currently has no foreign currency hedging policy[64] - The company's financial performance for the year ended December 31, 2022, is detailed in the consolidated income statement and other comprehensive income[174] - The company's property, plant, and equipment changes during the reporting period are detailed in Note 15 of the consolidated financial statements[178] - The company did not issue any debentures during the reporting period[179] - The company did not recommend a final dividend for the year ended December 31, 2022, and expects to retain all future earnings for business operations and expansion[175] Product Development and Clinical Trials - The company's core product, CM310, is designated as a "core product" under Chapter 18A of the Listing Rules[3] - The company's clinical trials and regulatory submissions are governed by cGMP standards and FDA regulations[3] - Keymed Biosciences Inc. is focused on the development of innovative biologics, with CM310 being a key product in its pipeline[3] - CM310, targeting moderate-to-severe atopic dermatitis, is expected to submit an NDA application to the CDE by mid-2023[10] - CM310 (IL-4Rα antibody) completed patient enrollment for its Phase III clinical trial in adult patients with moderate-to-severe atopic dermatitis in November 2022, with NDA submission expected in 2023[17] - CM310 received Breakthrough Therapy Designation for moderate-to-severe atopic dermatitis from the Center for Drug Evaluation in June 2022[17] - CMG901 (Claudin 18.2 antibody-drug conjugate) achieved a 75% objective response rate and 100% disease control rate in Phase Ia clinical trials for advanced solid tumors[19] - CMG901 was granted Fast Track and Orphan Drug Designation by the FDA in April 2022 for recurrent/refractory gastric cancer and gastroesophageal junction adenocarcinoma[19] - CM313 completed the first patient dosing for systemic lupus erythematosus (SLE) in October 2022 and is currently in the Ib/IIa clinical trial phase[20] - CM338 completed a Phase I clinical study in healthy subjects in November 2022 and initiated a Phase II clinical study in IgA nephropathy (IgAN) patients in March 2023[20] - CM355, a CD20xCD3 bispecific antibody, completed its first patient dosing in January 2022 and is currently in the Phase I dose-escalation stage[20] - CM350, a GPC3xCD3 bispecific antibody, completed its first patient dosing in May 2022 and is currently in the Phase I dose-escalation stage[21] - CM336, a BCMAxCD3 bispecific antibody, completed its first patient dosing in September 2022 and is currently in the Phase I dose-escalation stage[21] - CM369/ICP-B05, a CCR8 antibody, received clinical trial approval in August 2022 and completed its first patient dosing in February 2023, currently in the Phase I dose-escalation stage[21] - CM310 Phase III clinical trial for adult moderate-to-severe atopic dermatitis completed patient enrollment of 500 subjects in November 2022, with plans to submit NDA to the National Medical Products Administration (NMPA) in 2023[29] - CM310 Phase II clinical trial for chronic rhinosinusitis with nasal polyps showed significant reduction in NPS (2.32) and NCS (1.23) compared to placebo (0.19 and 0.30, respectively) after 16 weeks of treatment[29] - CM326, a TSLP-targeting antibody, initiated Phase Ib/IIa clinical trials for moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyps in 2022, with patient enrollment completed in February 2023[31] - CMG901, a Claudin 18.2-targeting antibody-drug conjugate, achieved an objective response rate of 75% and disease control rate of 100% in 8 patients with Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma[33] - CMG901 received Fast Track Designation from the FDA for recurrent/refractory gastric cancer and gastroesophageal junction adenocarcinoma in April 2022[32] - CMG901 received Breakthrough Therapy Designation from the CDE for Claudin 18.2-positive advanced gastric cancer in September 2022[32] - CM313, the first domestically developed CD38 antibody in China, has shown promising efficacy in preclinical studies and is being tested in Phase I clinical trials for multiple myeloma and lymphoma[34] - CM338 completed a Phase I clinical study in healthy subjects in November 2022 and initiated a Phase II clinical study for IgA nephropathy in March 2023[36] - CM355, a CD20xCD3 bispecific antibody, demonstrated stronger T-cell directed cytotoxicity in preclinical studies and is in Phase I dose escalation for non-Hodgkin lymphoma[36] - CM336, a BCMAxCD3 bispecific antibody, completed first patient dosing for multiple myeloma in September 2022 and is in Phase I dose escalation[36] - CM350, a GPC3xCD3 bispecific antibody, completed first patient dosing for hepatocellular carcinoma in May 2022 and is in Phase I dose escalation[37] - CM369, a CCR8 antibody, received clinical trial approval for advanced solid tumors in August 2022 and completed first patient dosing in February 2023[38] - The company's first cGMP-compliant production facility in Chengdu has a capacity of 1,600 liters, and a new facility with an additional 16,000 liters of capacity was completed at the end of 2022[39] - The company has established an integrated platform for immunology and oncology research, covering antibody screening, functional evaluation, preclinical studies, and biomarker validation[40] - The company's nTCE platform has enabled the development of highly tumor-specific T-cell redirecting bispecific antibodies, with candidates CM355, CM336, and CM350 showing promising T-cell-mediated cytotoxicity and low cytokine release syndrome risk in preclinical studies[41] - The company's innovative antibody discovery platform has facilitated the development of multiple antibody-based therapies, including bispecific antibodies, antibody-drug conjugates, and Fc-enhanced antibodies, leveraging high-throughput screening for cost-effective discovery[42] - The company's high-throughput screening platform for high-yield antibody-expressing cell lines has successfully identified cell lines for candidate drug production within three months, accelerating preclinical and clinical evaluation[44] - COVID-19 disruptions caused short-term delays in patient recruitment and data entry for clinical trials in China, but operations returned to normal by December 31, 2022, with no significant production halts or supply chain disruptions[45] Strategic Partnerships and Licensing Agreements - KYM Biosciences Inc., a non-wholly owned subsidiary, is 70% owned by Keymed Biosciences Inc.[6] - Keymed Biosciences Inc. has a strategic partnership with CSPC Pharmaceutical Group, which holds a 70% stake in KYM Biosciences Inc.[6] - The company secured a global exclusive licensing agreement with AstraZeneca for CMG901, receiving an upfront payment of $63 million and potential milestone payments exceeding $1.1 billion[10] - KYM entered into a global exclusive license agreement with AstraZeneca AB for the development and commercialization of CMG901, receiving an upfront payment of $63 million and potential additional payments of up to $1.125 billion upon achieving certain milestones[20] - KYM entered into a global exclusive licensing agreement with AstraZeneca for CMG901, receiving an upfront payment of $63 million and potential additional payments of up to $1.125 billion upon achieving development, regulatory, and commercial milestones[33] Corporate Governance and Leadership - Keymed Biosciences Inc. held its Annual General Meeting on June 27, 2023[3] - The company's financial reporting adheres to International Financial Reporting Standards (IFRS)[5] - The company's board of directors consists of 3 executive directors, 3 non-executive directors, and 4 independent non-executive directors, ensuring a strong independent element[81] - The company has adopted the Corporate Governance Code and complies with its provisions, except for the deviation regarding the roles of Chairman and CEO being held by the same person[80] - The board is responsible for overseeing major company matters, including policy formulation, strategy, internal controls, and risk management systems[82] - Management is authorized by the board to implement strategies and handle daily operations, with clear reporting guidelines in place[83] - Independent non-executive directors play a crucial role in providing impartial opinions and judgments on company strategy and performance[85] - All independent non-executive directors have been assessed for independence and confirmed to meet the requirements of the Listing Rules[86] - The company has purchased liability insurance for directors and senior management to provide appropriate protection[82] - The board ensures that the company's financial statements are prepared in accordance with applicable laws and accounting standards[84] - The Chairman, CEO, and members of the Audit and Remuneration Committees attended the 2022 Annual General Meeting[80] - The board composition includes over one-third independent non-executive directors, meeting the Listing Rules requirements[81] - The company has adopted a Board Diversity Policy to enhance operational efficiency and maintain high corporate governance standards, with 10% of the board being female[87] - The company's senior leadership positions are held by approximately 33% women, and female employees make up about 58% of the workforce[87] - The company plans to maintain the current level of female representation on the board, considering the existing business model and specific needs[87] - The company's nomination committee is responsible for reviewing board diversity and will disclose the implementation of the Board Diversity Policy in the corporate governance report[87] - All directors have access to comprehensive onboarding materials and are encouraged to participate in continuous professional development[90] - The company held four board meetings in 2022, reviewing and approving annual performance, reports, and other business matters[92] - Each director has completed training on corporate governance and regulations, and attended briefings on industry, business, and director responsibilities[91] - The company's directors and senior management compensation is determined by the board, considering operational performance, individual performance, and market statistics[89] - No director or top five highest-paid individuals received compensation for joining or leaving the company during the reporting period[89] - The company's board composition is reviewed annually by the nomination committee to ensure alignment with the Board Diversity Policy[87] - The Board of Directors plans to hold at least four meetings annually, with the Chairman intending to meet with independent non-executive directors at least once a year without the presence of other directors[94] - The Audit Committee held 2 meetings in 2022, reviewing the Group's annual and interim financial reports, financial reporting systems, compliance procedures, and internal controls[97] - The Remuneration Committee held 1 meeting in 2022 to determine the compensation for executive directors and senior management, and to propose recommendations for non-executive directors' remuneration[98] - The Nomination Committee held 1 meeting in 2022 to review the Board's structure, size, composition, diversity, and the independence of independent non-executive directors[99] - The Board consists of four independent non-executive directors, representing one-third of the Board, in compliance with the Listing Rules' independence requirements[95] - The Audit Committee is composed of one non-executive director and two independent non-executive directors, with Mr. Luo Zhuojian serving as the Chairman[97] - The Remuneration Committee is composed of one executive director and two independent non-executive directors, with Professor Wang Xiaofan serving as the Chairman[98] - The Nomination Committee is composed of one executive director and two independent non-executive directors, with Dr. Bo Chen serving as the Chairman[99] - The company has adopted a standard code of conduct for securities transactions by directors and senior management, with no violations reported in 2022[100] - The annual remuneration range for senior management members (excluding directors) for the year ended December 31, 2022, is disclosed in accordance with the Corporate Governance Code[101] - Senior management compensation ranges from HKD 2,000,000 to HKD 23,000,000, with one member in each range[102] - The company's internal control and risk management systems were deemed effective and sufficient for the year ended December 31, 2022[104] - Audit services paid to Ernst & Young amounted to RMB 2,830,000, while non-audit services cost RMB 475,000[106] - The company has implemented quarterly and annual checks on internal control policies for drug discovery and development processes[106] - A whistleblowing policy is in place to report suspected fraud, corruption, and violations, with all reports independently investigated[106] - The company has adopted a risk management process to identify, assess, and manage significant risks, with mitigation plans documented[107] - The company's compliance advisor, New Baring Capital Limited, provided professional advice to the board and management team in 2022[107] - The company maintains a website (www.keymedbio.com) for shareholder communication, providing business updates and financial information[111] - The board reviewed the effectiveness of the company's shareholder communication policy, which was deemed effective for 2022[111] - The company's fifth amended and restated memorandum and articles of association became effective on June 28, 2022, following approval at the annual general meeting[112] - The ESG report covers the period from January 1, 2022, to December 31, 2022, and follows the ESG reporting guidelines of the Hong Kong Stock Exchange[114] - The company ensures data reliability and accuracy, with all information sourced from internal documents and verified by the board of directors[115] - The ESG governance framework is overseen by the board, which sets ESG strategies, monitors progress, and integrates sustainability into business operations[117] - Key stakeholder groups include shareholders, employees, suppliers, and the public, with tailored communication channels for each group[119] - The company updated its materiality assessment process, aligning with policy trends and industry benchmarks to identify high-priority ESG issues[120] - High-priority ESG issues include environmental impact management, employee rights, R&D innovation, product quality, and anti-corruption measures[122] - The company emphasizes compliance with laws such as the Company Law, Securities Law, and Anti-Unfair Competition Law, and has established internal audit and legal risk prevention systems[124] - Established a data protection and privacy office to coordinate privacy compliance efforts[126] - Implemented electronic data collection system for desensitized feedback and classified confidential information[128] - Conducted regular employee information security training and included security modules in new employee onboarding[128] - Completed the implementation of over ten intelligent systems, including the LinYun system for clinical data and project management[132] - Successfully completed requirements gathering, product research, and system usage for Warehouse Management System (WMS), Laboratory Information Management System (LIMS), and Quality Management System (QMS)[132] - Developed core proprietary platforms such as the novel T Cell Redirecting (nTCE) platform and high-throughput screening platform[132] - Ensured no violations of data privacy and protection laws occurred during the reporting period[128] - Required employees to sign anti-fraud and anti-commercial bribery commitment letters[125] - Established a secure and accessible channel for reporting corruption and implemented whistleblower protection measures[125] - Conducted anti-corruption training and integrity education for directors and employees[125] - The company has established a comprehensive quality management system covering the entire product lifecycle, including R&D, registration, testing, and production, in compliance with GMP, WHO, and ICHQ9 guidelines[133] - The company completed validation for new commercial production facilities, including HVAC systems, water systems, and clean gas systems, ensuring smooth production[133] - The company implemented a standardized complaint management system to address product safety issues and improve service levels[134

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致之任何損失承擔任何責任。 Keymed Biosciences Inc. 康諾亞生物醫藥科技有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2162） 截至2022年12月31日止年度之年度業績公告 | --- | --- | --- | --- | --- | |----------------------------------------------------------------------------|--------------------------------|----------------------------------|------------------------|------------| | | | | | | | 財務摘要 | 2022 年 人民幣千元 | 2021 年 人民幣千元 | 變動 人民幣千元 | 同比變動 % | | 收入 | 100,063 | 110,269 | (1 ...