Product Development and Clinical Trials - Keymed Biosciences reported a significant focus on the development of its core product, CM310, which is defined as a designated "core product" under the listing rules[13] - Keymed Biosciences is actively pursuing clinical trial applications in both China and the United States, reflecting its commitment to advancing its research and development efforts[14] - The company has ten drug candidates in clinical trial application and clinical stages, with five in clinical stages and two accepted by the National Medical Products Administration for clinical trial applications[20] - CM310, the core product, is the first domestically produced IL-4Rα antibody approved for clinical trials, showing promising efficacy and safety in various allergic diseases[22] - CM326 is the first domestically produced TSLP-targeting antibody approved for clinical trials in China, with potential applications in chronic obstructive pulmonary disease and various allergic diseases[23] - The company plans to initiate Phase III studies for CM310 in mid-2022 and submit a New Drug Application (NDA) to the National Medical Products Administration in 2023[22] - The company has received approval for Phase II clinical trials for CM310 targeting moderate to severe asthma and plans to submit clinical trial applications for moderate to severe atopic dermatitis in children and adolescents[22] - CMG901 is the first Claudin 18.2 antibody-drug conjugate approved for clinical trials in China and the US, targeting solid tumors with high selectivity and broad expression[24] - CM313 is the first domestically produced CD38 antibody approved for clinical trials in China, showing promising efficacy in treating relapsed/refractory multiple myeloma and lymphomas[25] - CM355 is a bispecific antibody targeting CD20 and CD3 for treating relapsed/refractory non-Hodgkin lymphoma, with a clinical trial application submitted and accepted in July 2021[30] - CM336 is a bispecific antibody targeting BCMA and CD3 for multiple myeloma, with plans to submit a clinical trial application in 2021[31] - CM350 is a bispecific antibody targeting GPC3 and CD3 for solid tumors, with a clinical trial application planned for submission in 2021[32] - CM352 is a monoclonal antibody for various solid and hematological tumors, currently in preclinical safety evaluation, with plans for a clinical trial application in 2021[33] Research and Development - The company is committed to adhering to cGMP standards to ensure the quality and safety of its products, which includes establishing a robust quality management system[13] - The company has established a comprehensive integrated platform covering all key functions of biopharmaceutical development, enabling cost-effective and rapid discovery and development of innovative therapies[19] - The integrated platform allows the company to advance a diverse pipeline of innovative and differentiated antibody therapies, including monoclonal antibodies and bispecific antibodies[19] - The company aims to leverage its internal drug discovery and development capabilities through partnerships with other pharmaceutical and biotech companies[19] - The company is focused on developing therapies for autoimmune and tumor treatment areas, with multiple candidates targeting key pathways in these diseases[21] - The company has established a highly integrated platform for in-depth research in immunology and oncology, supporting key drug development functions including antibody screening and preclinical studies[35] - The nTCE platform enables the development of highly tumor-specific bispecific T cell redirecting antibodies, with candidates CM355 submitted for clinical trial application and CM336 and CM350 entering the clinical trial application stage[36] Financial Performance - For the six months ended June 30, 2021, the company reported a total revenue of RMB 21,425,000, compared to RMB 8,492,000 for the same period in 2020, representing an increase of 152.5%[77] - The net loss attributable to ordinary shareholders for the same period was RMB 3,630,431,000, compared to a loss of RMB 35,486,000 in 2020, indicating a significant increase in losses[77] - The company reported a total comprehensive loss of RMB 3,630,431 thousand for the six months ended June 30, 2021, compared to a loss of RMB 35,486 thousand for the same period in 2020, indicating a substantial increase in losses[81] - The company recorded a net loss before tax of RMB 3,399,789,000 for the six months ended June 30, 2021, compared to a loss of RMB 11,148,000 in the same period of 2020[93] - The company’s total liabilities included RMB 4,625,724,000 in net debt as of June 30, 2021[87] - The company’s total financial liabilities were RMB 164,070,000 as of June 30, 2021, down from RMB 181,354,000 as of December 31, 2020, reflecting a reduction in financial obligations[153] Shareholder Information - The company issued 58,264,500 shares at HKD 53.3 per share, raising approximately HKD 2,942.0 million after underwriting fees and expenses[64] - An additional 8,739,500 shares were issued at the same price, raising approximately HKD 446.7 million after commissions and other issuance expenses[64] - Bo Chen holds 77,812,482 shares, representing 27.82% of the company, and an additional 17,976,153 shares through a trust, representing 6.43%[66] - Major shareholders include Moonshot with 27.82% and Eagle Hero with 6.43%[69] - The company has established a trust for managing the restricted share unit plan, indicating a structured approach to employee incentives and retention[72] - The company has granted 4,538,197 restricted share units to eligible employees as of June 30, 2021, under the restricted share unit plan approved on April 5, 2021[140] Governance and Compliance - Keymed's board of directors includes experienced professionals, ensuring strong governance and strategic oversight[17] - The board consists of three executive directors, four non-executive directors, and four independent non-executive directors, ensuring a strong independent element[61] - The audit committee is composed of two independent non-executive directors and one non-executive director, overseeing financial reporting and internal controls[64] - The company has complied with the Corporate Governance Code since its listing date[61] - The external auditor confirmed no significant issues were found in the interim financial data reviewed[64] Operational Updates - The company has not experienced significant adverse effects on its business or financial condition due to the COVID-19 pandemic, with normal patient recruitment and clinical trial data input restored by June 30, 2021[40] - The company plans to expand its cGMP-compliant production capacity, with a new commercial-scale production facility expected to begin operations in 2022, adding 16,000 liters of additional capacity[41] - The company has established a cGMP-compliant production facility in Chengdu with a total capacity of 1,600 liters to ensure high-quality antibody drug supply for clinical studies[34] Cash Flow and Investments - As of June 30, 2021, cash and bank balances increased to RMB 833.6 million from RMB 199.4 million as of December 31, 2020, primarily due to cash inflow from Series C financing[53] - The net cash used in operating activities for the six months ended June 30, 2021, was RMB 84.8 million, an increase from RMB 79.8 million in the same period of 2020, driven by business expansion and accelerated clinical trial progress[53] - The company raised RMB 872,111 thousand from the issuance of preferred shares during the financing activities for the six months ended June 30, 2021, compared to RMB 3,475 thousand in the same period of the previous year[85] - The total cash and cash equivalents at the end of the period were RMB 833,609 thousand, a significant increase from RMB 163,138 thousand at the end of the previous period[85] Employee Compensation and Expenses - R&D expenses rose from RMB 399 million to RMB 1,911 million, with employee compensation accounting for RMB 1,172 million, representing 61.3% of total R&D expenses[44] - For the six months ended June 30, 2021, employee compensation amounted to RMB 11,287,000, representing 42.1% of total administrative expenses, a significant increase from RMB 2,386,000 (31.1%) in the same period of 2020[48] - The total compensation for key management personnel was RMB 99,010,000 for the six months ended June 30, 2021, compared to RMB 2,505,000 for the same period in 2020, showing a dramatic increase[149] Future Outlook - The company plans to continue its market expansion and product development strategies, although specific future projections were not detailed in the report[74] - The company is actively exploring strategic partnerships for co-development and licensing to maximize the commercial value of its drug candidates[41]
康诺亚-B(02162) - 2021 - 中期财报