Clinical Development - The company received IND approval from the National Medical Products Administration in March 2023 for the ATG-022 treatment for advanced or metastatic solid tumors [26]. - The first patient in Australia was dosed in the CLINCH trial in March 2023, followed by the first patient in mainland China in May 2023 [27][28]. - ATG-022 received orphan drug designation from the FDA for the treatment of gastric cancer and pancreatic cancer in May 2023 [27]. - Preliminary clinical data from the CLINCH trial showed complete response (CR) and partial response (PR) in 2 out of 7 gastric cancer patients [30]. - The clinical pipeline demonstrated promising early results, with four global assets showing positive outcomes in Phase I dose escalation studies [45]. - ATG-008, an mTORC1/2 inhibitor, achieved an objective response rate (ORR) of 53.3% in cervical cancer patients who had not previously used immune checkpoint inhibitors (ICIs) [51]. - ATG-101, a bispecific antibody, showed promising results with partial responses in metastatic colorectal cancer patients, indicating potential for further development [51]. - The first patient in the PERFORM trial for ATG-031 was dosed in December 2023 [119]. - The company received FDA IND approval for ATG-031 to initiate Phase I trials for advanced solid tumors or B-NHL patients in May 2023 [119]. - The first patient was dosed in the I phase study of ATG-017 (ERK1/2 inhibitor) for advanced solid tumors and hematologic malignancies in July 2023 [146]. - Early data from the I phase trial of ATG-101 (a novel PD-L1/4-1BB bispecific antibody) showed partial response in a patient with metastatic colon adenocarcinoma, with ongoing trials in mainland China, Australia, and the US [147]. - The first patient was dosed in July 2023 in mainland China for the I phase trial of ATG-037 (CD73 inhibitor) as monotherapy and in combination with a PD-1 antibody for locally advanced or metastatic solid tumors [148]. - In May 2023, the company announced the latest results of the I/II phase TORCH-2 study for Onatasertib (ATG-008), which were subsequently presented at the ASCO 2023 conference [144]. - The open-label Phase II study of Eltanexor (ATG-016) for high-risk myelodysplastic syndromes was completed in mainland China [145]. Financial Performance - The company reported a cash balance of RMB 1.188 billion, ensuring funding for future drug development pipelines without the need for additional financing [54]. - The company has a 10-year validity period for its 2022 Restricted Share Unit Plan, with approximately 7.5 years remaining [16]. - The company has adopted a dividend policy without a preset payout ratio, considering financial performance, cash flow, and future operations when deciding on dividends [157]. - The company anticipates achieving significant clinical data for each project in its product portfolio and advancing at least one new project into the clinical stage in 2024 [169]. Corporate Governance - The company has adopted the principles and code provisions of the Corporate Governance Code as the basis for its corporate governance practices [33]. - The board consists of seven members, including three executive directors, one non-executive director, and three independent non-executive directors [36]. - The board held six meetings during the fiscal year ending December 31, 2023, exceeding the minimum requirement of four regular meetings per year [86]. - The company aims to maintain at least 10% female representation on the board, currently achieved with one female director among seven members [99]. - The board has delegated the responsibility of selecting and appointing directors to the nomination and corporate governance committee [103]. - The company has established procedures for identifying, handling, and disclosing inside information, including annual reviews of the insider information disclosure policy [93]. - The board is responsible for ensuring effective internal controls to safeguard shareholder investments, with policies in place for ongoing risk identification and assessment [90]. - The board consists of at least one-third independent non-executive directors, aligning with the company's diversity policy [102]. - The nomination and corporate governance committee evaluates the independence of non-executive directors based on criteria outlined in the listing rules [105]. - The company has implemented measures to ensure compliance with corporate governance codes and regularly reviews its governance policies [97]. - The board has reviewed the effectiveness of the risk management and internal control systems and deemed them effective and adequate [117]. Strategic Partnerships and Market Expansion - The commercial business achieved three key milestones, including the commercial partnership for the drug Xivio® in China and its inclusion in the national medical insurance catalog [53]. - The company is focused on expanding the regulatory and reimbursement approval scope for Xivio® in the Asia-Pacific region, aiming for increased market potential [53]. - In August 2023, the company entered a commercialization agreement with Hansoh Pharmaceutical for the drug Xivivo® (Selinexor) in mainland China, with a maximum upfront payment of RMB 200 million, including RMB 100 million upon signing [56]. - Xivivo® (Selinexor) was included in the National Medical Insurance Catalog (2023 version) effective January 1, 2024, for treating adult patients with relapsed/refractory multiple myeloma (rrMM) who have received at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody [56]. - In May 2023, the company submitted a New Drug Application (NDA) for Xivivo® (Selinexor) to the Indonesian Food and Drug Authority for treating rrMM and relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) [57]. - In June 2023, Xivivo® (Selinexor) was included in the Pharmaceutical Benefits Scheme (PBS) in Australia for treating adult patients with rrMM who have received at least one prior treatment [57]. - In July 2023, the Hong Kong Department of Health approved the NDA for Xivivo® (Selinexor) for treating adult patients with rrMM who have undergone at least four prior treatments and experienced disease progression [57]. - The company will continue to record revenue from Selinexor sales in mainland China while Hansoh Pharmaceutical will charge service fees [125]. Risk Management and Compliance - The company has established a comprehensive risk management policy to identify, assess, and monitor key risks related to its strategic objectives [112]. - The company has established a strict anti-corruption policy for personnel with external communication functions to ensure compliance with promotional and advertising regulations [140]. - The company has set up an internal audit function, risk management, and internal control systems deemed appropriate for its business operations [140]. - The company has not identified any significant uncertainties that may affect its ability to continue as a going concern [118]. Environmental, Social, and Governance (ESG) - The company emphasizes a corporate culture focused on employee development, workplace safety, and sustainability [32]. - The company has established a management framework for environmental, social, and governance (ESG) strategies, with the board fully responsible for the sustainability strategy and reporting [191]. - A total of HKD 5 million has been deposited as green deposits to support eligible green projects, including green buildings and renewable energy initiatives [200]. - The company plans to establish several ESG-related goals and conduct progress reviews to enhance its sustainability efforts based on actual business conditions [191]. - The company encourages shareholders to provide email addresses for timely and effective communication [170]. - The company received recognition as one of the "Top 10 Most Growth-Oriented Antibody Drug Enterprises" at the 2023 China Biopharmaceutical Innovation Cooperation Conference [190]. - The company aims to maintain strategic thinking with a strong emphasis on quality, integrity, and financial standards in its operations [169].
德琪医药-B(06996) - 2023 - 年度财报