Financial Performance - Total revenue for the year ended December 31, 2022, was RMB 100,063 thousand, a decrease of 9% compared to RMB 110,269 thousand in 2021[2]. - The total comprehensive loss for the year was RMB 303,596 thousand, a significant reduction of 92% from RMB 3,892,632 thousand in 2021[6]. - Adjusted total comprehensive loss was RMB 255,029 thousand, a 14% improvement compared to RMB 295,515 thousand in 2021[6]. - Gross profit for 2022 was RMB 97,478 thousand, compared to RMB 93,069 thousand in 2021, reflecting an increase of 4.3%[36]. - The company reported a net loss of RMB 303,597 thousand for the year ended December 31, 2022, significantly improved from a net loss of RMB 3,892,632 thousand in 2021[63]. - The company reported a pre-tax loss of RMB 303,597 thousand in 2022, significantly improved from a loss of RMB 3,892,632 thousand in 2021[36]. - The company recognized a one-time non-refundable advance payment of RMB 100 million from a collaboration agreement with Shanghai Jinmant Biotech for the development of CM326[75]. - The company reported a loss attributable to ordinary shareholders of RMB 308.115 million for the year ended December 31, 2022, compared to a loss of RMB 3.887 billion for the year ended December 31, 2021[85]. Research and Development - Research and development expenses increased by RMB 149,218 thousand to RMB 507,374 thousand, representing a 42% increase due to higher preclinical and clinical study costs[4]. - R&D expenses increased to RMB 507,374 thousand in 2022 from RMB 358,156 thousand in 2021, representing a rise of approximately 41.7%[63]. - The company initiated a Phase III clinical trial for CM310 in patients with moderate to severe atopic dermatitis in Q1 2022, with patient enrollment completed by November 2022[7]. - CM310 received breakthrough therapy designation for moderate to severe atopic dermatitis from the drug review center in June 2022[7]. - The company has commenced key Phase II/III clinical studies for CM310 targeting moderate asthma treatment[7]. - CM310 clinical trial applications for treating allergic rhinitis were approved by the National Medical Products Administration in July 2022 and by the FDA in August 2022[7]. - In 2022, the company initiated a Phase Ib/IIa clinical trial for CM326, focusing on safety, tolerability, and efficacy in moderate to severe atopic dermatitis patients, with patient enrollment completed by February 2023[8]. - CMG901 received FDA fast track designation and orphan drug status in April 2022 for the treatment of refractory or intolerant Claudin 18.2 positive advanced gastric cancer, with a 75% response rate observed at a dose of 2.2 mg/kg[8]. - The company completed the first patient dosing for CM313 in the treatment of systemic lupus erythematosus (SLE) in October 2022, currently in Phase Ib/IIa clinical research[9]. - CM369/ICP-B05 received approval for clinical trials in August 2022 and completed its first patient dosing in February 2023, currently in Phase I dose escalation[10]. - The company has nine clinical-stage candidates in internal development as of December 31, 2022, reflecting a strong pipeline in autoimmune and oncology therapies[11]. - The company has established a comprehensive integrated platform for biopharmaceutical development, covering all key functions from target validation to clinical development and production[11]. - The company’s product pipeline includes innovative therapies such as monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies, demonstrating market insight and scientific advancements[12]. Production and Capacity - The Chengdu new base was completed and put into operation at the end of 2022, adding a total production capacity of 16,000 liters, compliant with cGMP regulations[10]. - The company has established a cGMP-compliant production facility in Chengdu with a capacity of 1,600 liters, and a new base completed in late 2022 adds an additional 16,000 liters of capacity[27]. - The company plans to expand its cGMP-compliant production capacity to meet increasing demand for candidate drugs[35]. - The company plans to utilize RMB 240 million for leasing and purchasing new manufacturing and R&D facilities by the end of 2023[61]. Financial Position - Cash and cash equivalents, along with financial assets measured at fair value, decreased by 10% to RMB 3,175,326 thousand from RMB 3,524,579 thousand in 2021[2]. - Total assets as of December 31, 2022, were RMB 3,932,316 thousand, slightly down from RMB 3,934,455 thousand in 2021[46]. - The company’s total liabilities included interest expenses of RMB 8,397 thousand in 2022, down from RMB 11,133 thousand in 2021[79]. - The company had capital commitments of RMB 1 million for the acquisition of properties, plants, and equipment as of December 31, 2022[50]. - The company pledged equipment valued at RMB 430 million to secure its bank borrowings as of December 31, 2022[51]. - The company’s debt-to-asset ratio as of December 31, 2022, was 15%, an increase of 8% from 7% as of December 31, 2021[48]. - As of December 31, 2022, the company had no significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures[49]. Market and Strategic Initiatives - The company is focused on research and development of its core product CM310, which is defined under the listing rules[87]. - Strategic partnerships for co-development and licensing are being actively pursued to maximize the commercial value of candidate drugs globally[35]. - The company was included in the Shenzhen-Hong Kong Stock Connect and various international indices, enhancing its investor base and trading liquidity[34]. Employee and Governance - As of December 31, 2022, the company employed 613 staff, with over 240 in clinical development and operations, and over 230 in production and quality control[10]. - As of December 31, 2022, the company employed a total of 613 full-time employees, with 5 working overseas[53]. - The current board includes executive directors Bo CHEN, Changyu WANG, and Xu Gang[90]. - The board also consists of non-executive directors and independent non-executive directors[90]. Dividend and Shareholder Information - The company did not recommend a final dividend for the year ended December 31, 2022[55]. - The company did not declare or pay any dividends for the year ended December 31, 2022[84]. - The weighted average number of ordinary shares used to calculate basic and diluted loss per share increased to 261,126,555 in 2022 from 160,849,076 in 2021[85]. - Basic and diluted loss per share improved to RMB (1.18) in 2022 from RMB (24.17) in 2021[85].
康诺亚-B(02162) - 2022 - 年度业绩