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].

Financial Performance - KeyMed Biosciences reported a revenue of $XX million for the first half of 2022, representing a YY% increase compared to the same period last year[21]. - The company reported revenue of RMB 100 million for the six months ended June 30, 2022, compared to no revenue in the same period of 2021[48]. - Gross profit for the same period was RMB 97.463 million, with a sales cost of RMB 2.537 million[48]. - Other income and gains increased significantly from RMB 21.425 million in the six months ended June 30, 2021, to RMB 130.259 million in the same period of 2022, primarily due to foreign exchange gains and interest income[50]. - The company reported a profit before tax of RMB 2.524 million, a significant recovery from a loss of RMB 3.630 billion in the same period last year[88]. - The company reported a profit attributable to ordinary shareholders of RMB 5,454,000 for the six months ended June 30, 2022, compared to a loss of RMB 3,628,500,000 for the same period in 2021[118]. Research and Development - The company is investing heavily in R&D, allocating $AA million towards the development of new therapies and technologies, aiming for a BB% increase in R&D output[21]. - KeyMed has established strategic partnerships with leading CROs to enhance its clinical trial capabilities, which is expected to reduce time-to-market for new products by CC%[21]. - The company has developed multiple bispecific T cell engagers (nTCE) that have shown promising T cell-mediated cytotoxicity effects in preclinical studies, with candidates CM355, CM336, and CM350 entering clinical trials[40]. - The innovative antibody discovery platform has enabled the development of various drug candidates, including bispecific antibodies and antibody-drug conjugates, enhancing therapeutic efficacy and specificity[41]. Product Development and Clinical Trials - The company has 9 clinical-stage drug candidates as of June 30, 2022, focusing on innovative biotherapies for autoimmune and tumor treatments[22]. - CM310, the core product, is the first domestically produced IL-4Rα antibody approved for clinical trials, targeting IL-4 and IL-13 signaling pathways, with potential applications in various II-type immune diseases[26]. - A Phase III clinical study for CM310 in adult patients with moderate to severe atopic dermatitis is planned to enroll 500 participants, with a primary endpoint of achieving EASI-75 after 16 weeks of treatment[26]. - CM310 has received breakthrough therapy designation from the regulatory authority for treating moderate to severe atopic dermatitis, which will expedite its development process[26]. - The Phase II clinical trial for CM310 in patients with chronic rhinosinusitis with nasal polyps included 56 participants, showing significant improvements in nasal polyp scores and nasal congestion scores compared to the placebo group[26]. - CM326, a TSLP-targeting antibody, is the first domestically produced TSLP antibody approved for clinical trials in China, with potential applications in treating various allergic diseases[30]. - The company has initiated a Phase Ib/IIa clinical trial for CM326 in patients with moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps[30]. Market Expansion and Strategic Initiatives - KeyMed is actively expanding its market presence, with plans to enter new geographical regions and increase its distribution network by ZZ% over the next year[21]. - The company anticipates a revenue growth forecast of DD% for the next fiscal year, driven by the launch of new products and market expansion initiatives[21]. - The company is exploring potential M&A opportunities to bolster its product pipeline and enhance competitive positioning in the market[21]. Financial Position and Cash Flow - Total current assets as of June 30, 2022, were RMB 3,559,896 thousand, a slight decrease from RMB 3,581,949 thousand as of December 31, 2021[58]. - Cash and bank balances decreased from RMB 3,471 million to RMB 3,319 million, primarily due to cash outflows from daily operations[59]. - The net cash used in operating activities increased from RMB 8.5 million to RMB 16.5 million, driven by business expansion and accelerated clinical trial progress[59]. - The asset-liability ratio increased from 7% to 11% as of June 30, 2022[61]. - The company’s total cash and cash equivalents amounted to RMB 3,546,202,000 as of June 30, 2022, compared to RMB 1,520,619,000 as of December 31, 2021[154]. Corporate Governance and Compliance - The company is committed to maintaining compliance with cGMP standards, ensuring high-quality production processes and product integrity[15]. - The audit committee confirmed compliance with applicable accounting principles and standards for the financial reporting period[71]. - The company has adopted the Corporate Governance Code to ensure high standards of corporate governance[69]. Shareholder Information - As of June 30, 2022, Dr. Bo Chen holds a controlled corporation interest of 77,924,482 shares, representing 27.86% of the company's total shares[79]. - Major shareholders include Moonshot with 27.86% and HH KNY Holdings Limited with 9.26% of the shares[82]. - The total number of shares held by major shareholders indicates a significant concentration of ownership within a few entities[82].

Financial Performance - KeyMed Biosciences reported a significant increase in revenue, achieving a total of $XX million for the fiscal year 2021, representing a YY% growth compared to the previous year[2]. - In 2021, the company generated revenue of RMB 110,269,000, with a gross profit of RMB 93,069,000[12]. - Revenue for the year ended December 31, 2021, was RMB 1,103 million, primarily from collaboration income related to licenses granted to CSPC Pharmaceutical Group and Innovent Biologics[13]. - The company reported a total comprehensive loss of RMB 3,892,632,000 for the year, compared to RMB 818,848,000 in 2020[12]. - The fair value loss of convertible redeemable preferred shares increased by RMB 2,783.8 million to RMB 3,480.3 million, primarily due to the company's valuation increase after the IPO on July 8, 2021[13]. - The company reported a total loss for the year of RMB 3,892.6 million, compared to a loss of RMB 818.8 million in the previous year[45]. Research and Development - The company emphasized its commitment to R&D, allocating CC% of its revenue towards research initiatives to innovate and improve product offerings[2]. - Research and development expenses increased significantly to RMB 358,156,000 from RMB 127,400,000 in 2020, indicating a focus on innovation[12]. - The core pipeline product CM310 successfully completed a Phase IIb clinical study for moderate to severe atopic dermatitis, with encouraging efficacy and safety data[9]. - The company has established nine clinical-stage drug candidates, reflecting its market insights and cutting-edge scientific discoveries[25]. - CM310 (IL-4Rα antibody) completed Phase Ib/IIa clinical study and initiated Phase IIb clinical study with 120 participants, data unblinding completed by November 2021[17]. - The company plans to advance Phase III clinical trials for CM310 and other pipeline products, while continuously recruiting talent for R&D and commercialization[10]. Market Expansion and Strategy - KeyMed Biosciences provided an optimistic outlook for 2022, projecting a revenue increase of BB% driven by new product launches and market expansion strategies[2]. - The management discussed plans for expanding into international markets, particularly targeting regions with high unmet medical needs[2]. - The company is exploring strategic partnerships and potential acquisitions to enhance its market presence and accelerate growth in the biopharmaceutical sector[2]. - A strategic alliance was formed with CSPC Pharmaceutical Group to co-develop products for respiratory diseases in China[23]. - The company is focusing on market expansion, targeting D new regions for growth in the upcoming year[69]. Corporate Governance - The company aims to enhance its corporate governance practices in line with the latest regulatory requirements to ensure transparency and accountability[2]. - The company has adopted the Corporate Governance Code as per the Listing Rules, committing to high standards of corporate governance to protect shareholder interests[76]. - The board consists of three executive directors, four non-executive directors, and four independent non-executive directors, ensuring a balanced composition for effective governance[77]. - The company has appointed experienced independent non-executive directors to enhance governance and oversight[71]. - The company has a strong emphasis on internal controls and risk management, with the board responsible for overseeing all significant matters, including policy formulation and performance monitoring[78]. Sustainability and ESG Initiatives - KeyMed is focused on sustainability initiatives, aiming to reduce its environmental impact by EE% over the next five years[2]. - The company emphasizes the importance of training employees regularly as part of its internal control measures[98]. - The company is committed to maintaining high standards of corporate governance and actively incorporates ESG factors into daily decision-making processes[113]. - The company has established an ESG management framework to oversee the implementation of ESG-related goals and strategies[114]. - The company emphasizes communication with stakeholders to understand their expectations regarding ESG initiatives and sustainable development goals[115]. Employee and Talent Management - The company expanded its team to 325 employees by the end of 2021, enhancing its clinical development and operational capabilities[10]. - The employee count at the end of the reporting period was 325, with a turnover rate of 10.71%[137]. - The company has implemented a talent protection plan to enhance employee retention and satisfaction[141]. - Training participation rate was 100%, with 45.54% of male employees and 54.46% of female employees receiving training[144]. - The company has established a comprehensive occupational health and safety management system to mitigate workplace risks[145]. Production and Operational Efficiency - KeyMed's operational efficiency improved, with a reduction in production costs by DD%, contributing to better profit margins[2]. - A new production facility in Chengdu is expected to begin trial operations by mid-2022, providing a capacity of 16,000 liters to support commercialization[10]. - The first production line at the Chengdu facility is expected to commence trial operations in mid-2022, complying with cGMP regulations[22]. - The company has established a comprehensive quality management system covering quality assurance, quality control, production management, logistics management, and personnel management[125]. Financial Management - The company has a commitment to maintaining a high level of corporate governance, having complied with the Corporate Governance Code since its listing[76]. - The company has not issued any debt securities during the reporting period[171]. - The company has not retained any profits as distributable reserves under International Financial Reporting Standards as of December 31, 2021[171]. - The company has confirmed compliance with a non-competition agreement from its controlling shareholder, with no new business opportunities received during the reporting period[188].

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]