AKESO(HK:09926)2023-04-27 14:16Drug Development and Innovation - The company has developed over 30 innovative drug products targeting major diseases, with 17 of them currently in clinical stages, including two internationally first-in-class bispecific antibody drugs[2]. - The company aims to become a leading global biopharmaceutical enterprise by developing innovative drugs that are either first-in-class or best-in-class therapies[2]. - The company has established an end-to-end drug development platform (ACE platform) that integrates drug discovery and development functions, including target validation and CMC production process development[2]. - The company has successfully developed Tetrabody technology to address three major CMC challenges in the development and production of bispecific antibodies[2]. - The company is focused on creating affordable innovative antibody drugs for global patients[2]. - The company has a strong pipeline for treating cancer, autoimmune diseases, inflammation, and metabolic diseases[2]. - The company is committed to high-efficiency and innovative R&D to enhance its drug development capabilities[2]. - The company expects to submit multiple new drug applications to NMPA in 2023, including for the treatment of EGFR mutation NSCLC and severe psoriasis[16]. - The company plans to accelerate the clinical development and market launch of 3-4 new drug varieties in China and overseas within the next three years[17]. - The company aims to leverage breakthrough therapy designations for its key products to expedite development and approval processes[36]. Financial Performance - The market sales revenue for the year ended December 31, 2022, was RMB 1,104.4 million, a 422% increase from RMB 211.6 million in 2021[18]. - Total revenue for the year ended December 31, 2022, was RMB 837.7 million, compared to RMB 225.6 million in 2021, reflecting a growth of 270%[70]. - The gross profit for the year ended December 31, 2022, was RMB 743.5 million, up 283% from RMB 194.4 million in 2021[71]. - The company reported a net loss of RMB 1,422.2 million for the year ended December 31, 2022, compared to a net loss of RMB 1,258.1 million in 2021[79]. - The company’s other income and net gains for the year ended December 31, 2022, were RMB 158.6 million, a 36% increase from RMB 116.3 million in 2021[71]. - The company had a total employee count of 2,341 as of December 31, 2022, an increase from 1,865 in the previous year[59]. - The total employee cost for the reporting period was RMB 624.1 million, up from RMB 536.7 million in 2021, reflecting a year-over-year increase of approximately 16.3%[139]. Regulatory and Market Expansion - The company has received regulatory approvals for its products from various international health authorities, including the FDA and EMA[6]. - The company is actively exploring market expansion opportunities and potential mergers and acquisitions to enhance its competitive position[2]. - The company has initiated plans for a listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board to enhance funding for new drug development[17]. - The company is exploring strategic partnerships for co-development and licensing of products both in China and globally[66]. Clinical Trials and Research - The company has 17 independently developed new drug products in clinical research, with 6 in critical Phase III trials[14]. - The company is currently conducting clinical trials for multiple indications, including 1L gastric/gastroesophageal adenocarcinoma and advanced solid tumors, with patient enrollment completed for several studies[36]. - The company has achieved clinical endpoints for several products, including Inusi for primary hypercholesterolemia and mixed dyslipidemia, and AK102 for heterozygous familial hypercholesterolemia[38]. - The company advanced two preclinical candidates into clinical stages in 2022, demonstrating its commitment to expanding its oncology pipeline[46]. - The company published 26 significant research findings in international academic conferences or journals in 2022, showcasing its innovative capabilities in drug development and clinical research[34]. Corporate Governance and Compliance - The company emphasizes the importance of corporate governance and compliance with listing rules to maintain investor confidence[9]. - The company has established compliance policies and procedures to ensure adherence to applicable laws and regulations[138]. - The independent non-executive directors have reviewed the exclusive sales agreements and procurement agreements, confirming that the terms are fair and reasonable[159]. - The auditor has issued an unqualified opinion regarding the continuing connected transactions, confirming compliance with the relevant Listing Rules[160]. Strategic Partnerships and Agreements - The company entered into a licensing agreement with Summit Therapeutics for the development and commercialization of Ivorosi (AK112), receiving an upfront payment of USD 500 million and potential total transaction value of up to USD 5 billion[30]. - The exclusive sales agreement allows the subsidiary Tianqing Kangfang to authorize Lianyungang Zhengda Tianqing as the sole sales entity for monoclonal antibody products in China, with a fixed sales fee rate of no less than 35%[144][146]. - The company has established a strategic partnership with Zhengda Tianqing, which holds a 50% equity interest in Tianqing Kangfang, enhancing its market position and operational capabilities[150]. Employee Relations and Sustainability - The company is committed to environmental sustainability and adheres to relevant environmental protection laws and regulations[137]. - The company has maintained stable employee relations without any significant strikes or labor disputes during the reporting period[139]. - The company has implemented competitive compensation packages to retain employees, including salaries, discretionary bonuses, and benefits[139]. - The company’s commitment to training programs aims to enhance employee knowledge and skills, contributing to overall organizational growth[139].