Mabwell(SH:688062)2025-04-28 09:50Financial Performance - The company's revenue for Q1 2025 was ¥44,788,452.49, representing a decrease of 33.70% compared to ¥67,555,138.51 in the same period last year[4] - The net profit attributable to shareholders was -¥291,728,135.28, worsening from -¥205,658,524.39 year-on-year[4] - The basic and diluted earnings per share were both -¥0.73, compared to -¥0.51 in the same period last year[4] - The net loss for Q1 2025 was CNY 292,457,640.37, compared to a net loss of CNY 206,210,666.06 in Q1 2024, indicating a worsening of 41.8%[27] - The company recorded a negative comprehensive income of CNY 292,498,768.44 for Q1 2025, compared to a negative comprehensive income of CNY 206,087,581.46 in Q1 2024[27] - The total comprehensive income attributable to minority shareholders for Q1 2025 was -729,505.09 RMB, compared to -552,141.67 RMB in Q1 2024, indicating a decline[29] Research and Development - Research and development (R&D) expenses totaled ¥208,545,133.67, an increase of 14.49% from ¥182,152,879.71 in the previous year[4] - R&D expenses accounted for 465.62% of revenue, up by 195.98 percentage points from 269.64% in the previous year[5] - The company continues to invest heavily in clinical trials for multiple research projects, contributing to high R&D expenses[8] - The company is focusing on differentiated innovation in R&D, achieving notable results in its pipeline[12] Clinical Trials and Product Development - The company has 16 core products in various stages, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases[11] - The innovative drug 9MW2821 has been included in the breakthrough therapy list by the National Medical Products Administration, targeting advanced urinary tract cancer[12] - Clinical trials for 9MW2821 have enrolled over 800 patients, with three key Phase III trials currently ongoing[12] - The company’s 9MW1911 drug for chronic obstructive pulmonary disease (COPD) has completed the enrollment of 80 patients in Phase Ib/IIa trials and is in the follow-up stage[14] - The company is preparing for a larger sample size Phase II clinical trial for 9MW1911, which is the first drug of its kind to enter clinical trials in China[14] - The company has received clinical trial approval for JS207, aimed at treating advanced solid tumors[12] - The clinical safety and efficacy of 9MW2821 have been validated, with significant potential in treating various cancers[12] - The company’s innovative drug 9MW3011 for treating Polycythemia Vera (PV) has completed the first patient enrollment in an open-label Ib phase clinical study, with plans for a phase II study in the US in the first half of 2025[15] - 9MW3011 is the first targeted TMPRSS6 monoclonal antibody for PV treatment globally, with 78% of patients unable to control hematocrit levels and a significant thrombotic event rate of 34-41%[15] - The company’s product 1MW5011 for osteoarthritis is in phase II clinical trials, with advantages over existing intra-articular therapies, including oral administration and better long-term treatment compliance[17] - The company’s antibody-drug conjugate 7MW3711 has received clinical trial approval for a multi-center study in advanced solid tumors, expected to start in April 2025[17] - The company’s biosimilar drug 9MW0813 has submitted a pre-NDA communication request to the National Medical Products Administration, with a formal NDA submission planned for 2025[17] Financial Position - The total assets at the end of the reporting period were ¥4,191,356,415.53, a decrease of 1.97% from ¥4,275,508,853.05 at the end of the previous year[5] - The equity attributable to shareholders decreased by 18.59% to ¥1,277,151,626.39 from ¥1,568,877,364.27 at the end of the previous year[5] - Total liabilities increased to CNY 2,928,033,610.17, up from CNY 2,719,730,804.72, representing a growth of 7.7%[24] - The company's equity attributable to shareholders decreased to CNY 1,277,151,626.39 from CNY 1,568,877,364.27, a decline of 18.6%[24] - The cash and cash equivalents decreased to CNY 80,860,527.91 from CNY 86,293,283.11, a drop of 6.0%[23] - The company reported cash and cash equivalents of approximately CNY 1.12 billion, a slight decrease from CNY 1.19 billion at the end of 2024[22] Cash Flow - The net cash flow from operating activities was -¥216,616,741.17, an improvement from -¥330,596,938.03 in the same period last year[4] - Cash inflows from operating activities in Q1 2025 totaled 59,382,060.81 RMB, down 34.4% from 90,544,176.33 RMB in Q1 2024[30] - Cash outflows from operating activities in Q1 2025 were 275,998,801.98 RMB, a decrease of 34.5% compared to 421,141,114.36 RMB in Q1 2024[30] - Cash inflows from investing activities in Q1 2025 were 32,155,778.45 RMB, down 70.2% from 107,716,644.21 RMB in Q1 2024[31] - The net cash flow from investing activities for Q1 2025 was -54,977,359.47 RMB, an improvement from -175,788,921.01 RMB in Q1 2024[31] - Cash inflows from financing activities in Q1 2025 amounted to 751,840,000.00 RMB, a decrease of 44.6% from 1,360,160,000.00 RMB in Q1 2024[31] - The net cash flow from financing activities for Q1 2025 was 181,132,528.98 RMB, down 68.9% from 584,440,756.11 RMB in Q1 2024[31] - The ending cash and cash equivalents balance for Q1 2025 was 1,136,965,756.42 RMB, compared to 1,721,702,106.25 RMB at the end of Q1 2024, indicating a decrease of 33.9%[31] Market Presence and Strategy - The company has shipped a total of 418,088 units of its product Mai Li Shu® and has established access in 1,986 hospitals across 30 provinces[19] - The company’s product Mai Wei Jian® was approved for market on March 29, 2024, with 14,320 units shipped by the end of the reporting period[19] - The company has received a drug production license from the Shanghai Municipal Drug Administration, enhancing its capabilities as a marketing authorization holder[20] - The company is actively integrating AI technology into its biopharmaceutical development, partnering with leading AI firms to improve research efficiency[19] - The company is actively expanding its market presence in oncology and respiratory diseases, with a strong emphasis on innovative therapies[12]