Clinical Development - The company has developed four clinical-stage drug candidates, with three specifically targeting cancer treatment or related complications[8]. - M701 is undergoing an Ib/II clinical trial for treating malignant pleural effusion (MPE) in China, with 24 patients recruited in the Ib phase showing preliminary efficacy[11]. - The company plans to accelerate the development of its drug candidates in 2024, focusing on M701's III phase trial and Y101D's Ib/II phase trial[17]. - The company has decided to postpone the clinical development of certain pipeline candidates to focus resources on the most promising candidates[34]. - The company anticipates holding a pre-BLA submission meeting with the Center for Drug Evaluation (CDE) in Q1 2025[28]. - The company is advancing clinical projects for pipeline products in China and globally, with the first patient enrolled in the Phase III trial of M701 for MA in March 2024[174]. - The company has completed patient recruitment for the Phase II clinical trial of M701, involving 115 patients, demonstrating good safety and efficacy in controlling MA[193]. - The first patient for the Phase III clinical trial of M701 is expected to be enrolled in March 2024, following written consent from the drug review center in February 2024[193]. - Y400, a recombinant anti-VEGF and anti-ANG2 BsAb, has initiated its Phase I clinical trial, with mid-term results indicating good safety[196]. - The IND application for Y400 was approved in April 2023, marking a significant milestone in its development[196]. - Y101D, designed to block PD-1 and PD-L1 axis and TGF-β signaling, is under development for solid tumors, showcasing potential synergistic anti-tumor activity[194]. - Y332 has commenced its Phase I clinical trial in October 2023[192]. - The company has completed patient enrollment for the Phase Ib/II trial of a combination therapy for pancreatic cancer, expected to finish by Q3 2024[192]. - The company warns that there is no guarantee of successful development and commercialization of M701, Y101D, Y332, and Y225[197]. Financial Performance - Other income for the reporting period included government grants and bank interest, totaling RMB 0.7 million, while other losses amounted to RMB 0.3 million[21]. - The company's listing expenses increased significantly from RMB 11.8 million to RMB 24.6 million due to professional fees related to the listing[23]. - The net cash inflow from investment activities was RMB 54.8 million, primarily from redeeming financial assets valued at RMB 491.0 million[25]. - Other income increased from RMB 2.6 million in the same period last year to RMB 13.0 million, primarily due to government subsidies increasing by RMB 9.7 million[39]. - Total loss and comprehensive expenses for the reporting period were RMB 191.7 million, relatively stable compared to RMB 188.9 million in the same period last year[45]. - The company reported a pre-tax loss of RMB 191.7 million, compared to a loss of RMB 188.9 million in the previous year, indicating a slight increase in losses[95]. - Basic and diluted loss per share was RMB 1.04, an improvement from RMB 1.10 in the previous year[95]. - Total operating cash outflow for the reporting period was RMB 186.0 million, compared to RMB 176.7 million in the same period last year, primarily due to a pre-tax loss of RMB 191.7 million[72]. - The company reported a net loss of RMB 191,702,000 for the year ended December 31, 2023, compared to a net loss of RMB 188,866,000 in 2022[188]. - The company reported trade and other payables of RMB 42,373,000 as of December 31, 2023, compared to RMB 33,555,000 in 2022[148]. - The company incurred listing expenses of RMB 24,629,000 in 2023, compared to RMB 11,775,000 in 2022[151]. - The company reported total non-current assets of RMB 51,523 thousand as of December 31, 2023, a decrease from RMB 63,885 thousand in 2022, representing a decline of approximately 19%[96]. - The company has unrecognized tax losses of approximately RMB 903,871,000 as of December 31, 2023, up from RMB 632,811,000 in 2022[140]. - The company has a temporary difference deductible of RMB 34,356,000 as of December 31, 2023, compared to RMB 16,256,000 in 2022[139]. Assets and Liabilities - As of December 31, 2023, current assets amounted to RMB 250.1 million, including cash and cash equivalents of RMB 196.7 million[46]. - The company's leverage ratio increased from 49.2% as of December 31, 2022, to 70.6% as of December 31, 2023, due to an increase in short-term bank borrowings[49]. - Total bank borrowings increased from RMB 76.5 million as of December 31, 2022, to RMB 89.5 million as of December 31, 2023, reflecting additional loans obtained for operational funding[73]. - The company had unutilized bank financing of RMB 160.5 million as of December 31, 2023[73]. - The total liabilities decreased to RMB 173,820 thousand in 2023 from RMB 146,960 thousand in 2022, showing an increase of approximately 18%[96]. - The company's net asset value was RMB 127,654 thousand as of December 31, 2023, down from RMB 155,882 thousand in 2022, a decrease of around 18%[96]. - Cash and cash equivalents increased from RMB 153,500,000 as of December 31, 2022, to RMB 196,700,000 as of December 31, 2023, primarily due to the redemption of investments in financial products[185]. Employee and Administrative Matters - As of December 31, 2023, the company had 123 employees, including 98 R&D personnel and 25 general and administrative staff[57]. - The company plans to recruit capable marketing professionals to enhance commercialization capabilities and expand product coverage in China[36]. - Administrative expenses increased to RMB 22.3 million, up from RMB 20.5 million in 2022, representing a rise of approximately 8.8%[95]. - The company’s administrative expenses for the year were RMB 22,311,000, showing relative stability compared to RMB 20,525,000 in the previous year[182]. - Employee welfare expenses decreased to RMB 8.8 million, accounting for 39.7% of total expenses, down from 44.4% in the previous year[68]. - Professional intermediary fees rose to RMB 5.0 million, representing 22.2% of total expenses, compared to 14.2% in the previous year[68]. Corporate Governance and Compliance - The company has established an audit committee to oversee financial reporting processes and internal control systems, ensuring compliance with listing rules[109]. - The next annual general meeting is scheduled for June 27, 2024, with notifications to be published in accordance with listing rules[111]. - The company has not been involved in any significant litigation or arbitration during the reporting period[107]. - The company is subject to new international financial reporting standards effective from January 1, 2024[118]. - The company has been certified as a high-tech enterprise in November 2023, qualifying for a preferential tax rate of 15% for three years starting from 2023[138]. Revenue and Income - The company has not generated any revenue for the years ended December 31, 2023, and 2022[103]. - Total revenue from other income was RMB 13.0 million, significantly higher than RMB 2.6 million in the previous year, marking an increase of over 400%[95]. - The company recorded government grants of RMB 11,944 thousand for the year ended December 31, 2023, significantly up from RMB 2,254 thousand in 2022, reflecting a growth of approximately 429%[104]. - Bank interest income rose to RMB 1,047 thousand in 2023 from RMB 283 thousand in 2022, marking an increase of about 270%[104]. - Total other income for the year ended December 31, 2023, was RMB 13,014,000, a significant increase of 409.4% compared to RMB 2,560,000 in 2022[176].
友芝友生物-B(02496) - 2023 - 年度业绩