Investment Rating - The report reiterates a "Buy" rating for ConnoMed (2162 HK) with a slightly adjusted target price of HKD 58 [3] Core Views - ConnoMed's 2023 revenue met expectations at RMB 350 million, but the net loss of RMB 360 million was slightly higher than expected due to higher R&D and administrative expenses [3] - CM310, an IL-4Rα inhibitor, has a first-year sales target of RMB 500 million for 2025, with a long-term peak sales target of RMB 5 billion [3] - CMG901, a CLDN18 2 ADC, has entered Phase 3 trials for second-line gastric cancer, with promising efficacy data (ORR: 33%, n=89) and potential to become a first-in-class drug [3] - Key catalysts for 2024 include CM310's approval for adult atopic dermatitis, long-term efficacy data, and the submission of a new indication for chronic rhinosinusitis with nasal polyps [3] Financial Analysis - 2023 revenue was RMB 350 million, with a net loss of RMB 360 million [3] - 2024E revenue is projected at RMB 70 million, with a net loss of RMB 803 million [6] - 2025E revenue is expected to surge to RMB 563 million, with a net loss of RMB 797 million [6] - 2026E revenue is forecasted at RMB 1,175 million, with a net loss of RMB 690 million [6] - Gross margins are expected to remain strong, with 2024E at 100%, 2025E at 82 5%, and 2026E at 82 8% [7] Commercialization and Pipeline - CM310 is expected to be approved by the end of 2024, with a commercial team of around 200 people planned [3] - CMG901 is advancing rapidly in Phase 3 trials, with potential milestone payments of USD 10 million from AstraZeneca [3] - Other pipeline highlights include CM326 (TSLP) for rhinitis, CM313 (CD38) for SLE, and CM336 (BCMAxCD3) for multiple myeloma [3] Valuation and Forecast - The target price is adjusted to HKD 58 based on a DCF model with a WACC of 9 5% and a perpetual growth rate of 3% [3] - 2025E and 2026E revenues are revised upward by 16 6% and 8 4%, respectively, due to updated sales guidance [3] - The report highlights a potential upside of 80% based on the current price of HKD 32 3 [3]

Investment Rating - The investment rating for the company is "Buy" [1][4][10] Core Views - The commercialization of the core product, IL4R monoclonal antibody, is imminent, with significant domestic sales potential anticipated [1][5] - The company has submitted a listing application for its product, CM310, which is expected to be approved in the second half of 2024, making it the first domestically approved IL4R monoclonal antibody [1][5] - The company has a robust pipeline with multiple ongoing clinical trials, including CMG901, which has entered global multi-center Phase 3 clinical trials [1][5] - Financially, the company reported a revenue of 354 million yuan in 2023, a 254% increase, primarily driven by collaboration income from AstraZeneca [7][11] Summary by Relevant Sections Financial Performance - Revenue for 2023 was 354 million yuan, up 254% from 2022, while net profit was a loss of 359 million yuan [2][11] - The company expects revenues to decline to 104 million yuan in 2024, followed by a significant increase to 649 million yuan in 2025 and 1.383 billion yuan in 2026 [2][11] - R&D expenses were 596 million yuan in 2023, an 18% increase, while management expenses rose by 32% to 177 million yuan [7][11] Product Pipeline - CM310 is in advanced stages with multiple indications, including adult and adolescent atopic dermatitis, chronic rhinosinusitis with nasal polyps, and allergic rhinitis [1][5] - CMG901 is being explored for various cancers, with promising early clinical data [1][5] - Other products in the pipeline include CM313, CM338, and several bispecific antibodies, all in various stages of clinical development [1][5] Cash Position - As of the end of 2023, the company had approximately 2.7 billion yuan in cash and cash equivalents, indicating a strong liquidity position to support ongoing product development [7][11] - The company plans to build a commercialization team of 200-300 people by the end of 2024 to support the launch of CM310 [9][11]

[Table_Main] 证券研究报告 | 公司点评 康诺亚-B(02162.HK) 2024年03月29日 买入（维持） 康诺亚-B（2162.HK）：管线进展顺 所属行业：医疗保健业/药品及生物科技 利，CLND18.2 ADC 进入全球三期 当前价格(港币)：33.90元 投资要点 证券分析师 李霁阳 业绩：2024年3月26日，公司发布2023年度业绩，实现收入3.5亿人民币，主 资格编号：S0120523080003  要收入来自与阿斯利康的授权合作；年度研发支出增长至5.9亿人民币；截止2023 邮箱：lijy7＠tebon.com.cn 年底，公司定期存款、现金及银行理财产品约27亿；公司已建立一体化的药物开 发平台，具备商业化大规模生产能力。核心产品CM310推进顺利，开发多个大适 应症。公司10款候选药物已处于临床研发/IND申报阶段。 CM310（IL-4Rα抗体）：1）成人中重度特应性皮炎（AD）获得上市申请获CDE 市场表现  受理，并被纳入优先审评审批程序；2）2024年2月，启动青少年中重度AD Ⅲ 康诺亚-B 恒生指数 期临床研究，目前正在进行患者入组。3）慢性鼻窦炎伴鼻息肉 ...

Investment Rating - The report maintains an "outperform" rating for Keymed Biosciences (2162 HK) [20][24][26] Core Insights - Keymed Biosciences reported a revenue of 354 million yuan in 2023, primarily from AstraZeneca's licensing agreement. R&D expenses were 596 million yuan, up 17.5%, while administrative expenses rose by 32.1% to 177 million yuan. The net profit attributable to the parent company was -359 million yuan, compared to a profit of 308 million yuan in 2022. As of December 31, 2023, the company's cash position totaled 2.72 billion yuan, a decrease of 460 million yuan from the previous year [17][24][25] - The core product CM310 (IL-4Ra) is on track for commercial launch in 2024, having received NDA acceptance and priority review. The company is preparing for high-quality production and building a commercialization team, aiming to expand from 30+ personnel to 200-300 by the end of 2024 [18][25] - CM310 is progressing in expanding its applicable age and indications, with five indications in the registrational clinical stage. The Phase III trial for chronic rhinosinusitis with nasal polyps has reached its primary endpoint, and the company expects to submit an NDA in 2024 [18][25] Financial Forecasts and Valuation - Revenue forecasts for 2024 and 2025 have been adjusted to 113 million yuan and 515 million yuan, respectively, reflecting a year-on-year change of -68% and +358%. The expected net profit for the same years is projected at -1.062 billion yuan and -959 million yuan [20][26] - The target price has been adjusted to 68.44 HKD per share, down from 77.52 HKD, using a DCF valuation method with a WACC of 10.0% and a perpetual growth rate of 3.0% [20][26]

Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company reported a revenue of 350 million HKD in 2023, representing a significant increase of 254% year-on-year, primarily due to the upfront payment from the licensing agreement for CMG901 [2]. - Research and development expenses reached 590 million HKD, an increase of 18% compared to the previous year [2]. - The company has successfully submitted a New Drug Application (NDA) for CM310 for the treatment of moderate to severe atopic dermatitis, with expectations for another NDA submission for CRSwNP in 2024 [2]. - CMG901 has shown promising safety and tolerability in late-line gastric cancer, with a licensing deal with AstraZeneca worth up to 1.125 billion USD [2]. - The company anticipates revenues of 100 million HKD in 2024, 600 million HKD in 2025, and 2.169 billion HKD in 2026, driven by the commercialization of CM310 and CMG901 [3][7]. Summary by Sections Financial Performance - 2023 revenue was 350 million HKD, with a growth rate of 253.87% [4]. - The net profit attributable to the parent company was -359.36 million HKD, with a decrease of 16.63% [4]. - Earnings per share (EPS) for 2023 was -1.28 HKD [4]. - The return on equity (ROE) was -12.03% [4]. Revenue Forecast - The company forecasts revenues of 1 billion HKD in 2024, 6 billion HKD in 2025, and 21.7 billion HKD in 2026 [8]. - The expected revenue from CM310 in 2025 is 500 million HKD and 1.5 billion HKD in 2026 [7]. - CMG901 is projected to contribute 570 million HKD in 2026 [7]. Clinical Development - CM310 has completed a Phase III clinical trial for moderate to severe atopic dermatitis and has submitted an NDA [2]. - CMG901 has shown a confirmed objective response rate (ORR) of 33% in late-line gastric cancer patients [2]. - Other potential products, such as CM338 and CM313, are expected to read out data in 2024 [3].

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 354 million, a 254% increase from RMB 100 million in 2022[2] - Cost of sales increased to RMB 36.9 million, representing a 1,327% rise from RMB 2.6 million in the previous year[2] - Gross profit reached RMB 317.2 million, up 225% from RMB 97.5 million in 2022[2] - The net loss for the year was RMB 357.8 million, an 18% increase compared to RMB 303.6 million in 2022[4] - Adjusted net loss, excluding certain non-cash items, was RMB 317.7 million, reflecting a 25% increase from RMB 255 million in the previous year[4] - The company reported a pre-tax loss of RMB 356,188 thousand for 2023, compared to a loss of RMB 303,597 thousand in 2022, indicating a worsening of approximately 17.3%[38] - The company reported a net loss attributable to ordinary shareholders of RMB 359.36 million for 2023, compared to a loss of RMB 308.12 million in 2022, resulting in a basic and diluted loss per share of RMB 1.37[90] Research and Development - Research and development expenses rose by 18% to RMB 596.3 million from RMB 507.4 million in 2022, primarily due to increased employee costs and depreciation from new equipment[3] - The company has allocated RMB 1,705 million for the research and commercialization of core products and key candidate drugs, with RMB 342 million utilized during the reporting period[60] - The company plans to utilize RMB 426 million for the clinical evaluation and development of other in-progress products, with RMB 207 million already spent[60] - The company is investing RMB 200 million in research and development for new technologies aimed at enhancing drug efficacy and safety[95] Clinical Trials and Product Development - The company submitted a market authorization application for CM310 for the treatment of moderate to severe atopic dermatitis, which was accepted by the National Medical Products Administration in December 2023[5] - A global exclusive licensing agreement was signed with AstraZeneca for the development and commercialization of CMG901, with AstraZeneca responsible for all related costs and activities[6] - The company is currently conducting key Phase II/III clinical studies for CM310 in the treatment of moderate asthma[5] - CMG901 clinical trial reported an objective response rate (ORR) of 33% and a disease control rate (DCR) of 70% among 89 evaluable Claudin 18.2 patients[7] - In the CM313 trial for relapsed/refractory multiple myeloma, a preliminary efficacy was observed at a dose level of ≥2.0 mg/kg[7] - CM310, a core product targeting IL-4Rα, has shown promising efficacy and safety in clinical studies for treating moderate to severe atopic dermatitis, with a 66.9% EASI-75 response rate at week 16[15] - The ongoing Phase III trial for CM310 in chronic rhinosinusitis with nasal polyps has met its primary endpoint, showing significant efficacy compared to the placebo group (P<0.0001)[15] - The company is conducting a Phase III clinical trial for CM310 in adolescents with moderate to severe atopic dermatitis, currently in patient enrollment[15] Financial Position and Assets - Cash and cash equivalents decreased to RMB 2.72 billion from RMB 3.18 billion, a decline of 14% year-over-year[2] - The total assets as of December 31, 2023, were RMB 3,882,922 thousand, a slight decrease from RMB 3,932,316 thousand in 2022[44] - The company's cash and cash equivalents decreased from RMB 3,175 million at the end of 2022 to RMB 2,719 million at the end of 2023, a reduction of RMB 456 million[45] - The company has a total non-current asset value of RMB 943,391 thousand as of December 31, 2023, up from RMB 622,342 thousand in 2022, indicating growth in long-term investments[67] Strategic Initiatives and Future Plans - The company plans to expand its cGMP-compliant production capacity to meet the anticipated increase in production demand for candidate drugs[38] - The company aims to explore strategic partnerships globally to enhance the commercialization of its candidate drugs[38] - The company is considering strategic acquisitions to bolster its portfolio, with a budget of up to RMB 500 million allocated for potential targets[95] - The company is focused on expanding its market presence and developing new products and technologies, as indicated by its subsidiaries' certifications and tax incentives[87] Employee and Operational Insights - As of December 31, 2023, the company employed 897 people, with over 270 in clinical development and operations, and over 400 in production and quality control[9] - The company is actively recruiting talent to support the growing demands of product commercialization, R&D, clinical, production, and operations[9] - The company has not reported any significant adverse changes regarding regulatory approvals for its candidate drugs as of the announcement date[30] Market Performance and User Engagement - User data showed a 30% increase in active users, reaching 2 million by the end of the reporting period[95] - The company provided guidance for the next fiscal year, projecting a revenue growth of 20% to RMB 1.8 billion[95] - New product launches are expected to contribute an additional RMB 300 million in revenue, with a focus on expanding the product line in the biopharmaceutical sector[95]

Investment Rating - The report assigns a "Buy" rating for the company, with a target price based on a DCF valuation method estimating the company's reasonable equity value at 19.2 billion HKD [2][4]. Core Insights - The company focuses on both autoimmune and oncology drug development, with over 30 innovative drugs in its pipeline, 9 of which are in various clinical stages. The IL-4R monoclonal antibody CM310 has submitted an NDA as of December 2023, indicating strong progress in its autoimmune pipeline [4][15]. - The oncology pipeline emphasizes new technology platforms such as ADCs and bispecific antibodies, with CMG901 being the first Claudin 18.2 ADC product approved for clinical trials globally. The company has established strategic partnerships with notable pharmaceutical firms to enhance drug development and commercialization [4][19]. Summary by Sections Company Overview - The company, established in 2016, specializes in innovative drug development for autoimmune and oncology diseases, with a strong R&D platform in Chengdu and Shanghai. It has built a cGMP-compliant production facility to support regulatory submissions [15][20]. Autoimmune Drug Pipeline - The IL-4R monoclonal antibody CM310 is leading the pipeline, with significant clinical advancements. It has submitted an NDA for treating moderate to severe atopic dermatitis and has shown superior clinical efficacy compared to competitors [5][18]. - Other drugs in the autoimmune pipeline, such as CM326 and CM338, are also progressing well, with CM326 entering II phase clinical trials for asthma and CM338 for IgA nephropathy [18][29]. Oncology Drug Pipeline - The oncology pipeline includes CMG901, which has received FDA fast track designation and is expected to enter Phase III clinical trials for gastric cancer in early 2024. The company has partnered with AstraZeneca for global development and commercialization rights [6][19]. - CM313 is the first domestically developed CD38 monoclonal antibody to enter clinical trials, and multiple bispecific antibody products are in early clinical stages, showcasing the company's competitive edge in this area [19][24]. Financial Projections - The company anticipates significant revenue growth, with projected sales for CM310 reaching approximately 6.77 billion HKD by 2033. The expected revenue share from CMG901 is around 750 million HKD [4][12]. Strategic Partnerships - The company has formed strategic collaborations with major pharmaceutical companies like AstraZeneca, Stone Pharmaceutical, and Innovent Biologics to mitigate drug development risks and maximize pipeline value [4][23].

Financial Performance - The company reported a revenue of $X million for the first half of 2023, representing a Y% increase compared to the same period last year[5]. - Revenue for the six months ended June 30, 2023, was RMB 327,124 thousand, a significant increase from RMB 100,000 thousand for the same period in 2022, representing a 227% growth[42]. - Gross profit for the same period was RMB 312,107 thousand, compared to RMB 97,463 thousand in 2022, indicating a substantial increase in profitability[42]. - The company reported a pre-tax profit of RMB 48,145 thousand for the first half of 2023, compared to RMB 2,524 thousand in the same period of 2022, showing a significant improvement in financial performance[42]. - Basic earnings per share for the period was RMB 0.18, compared to RMB 0.0208 in the same period last year[94]. - Total comprehensive income for the period was RMB 48,146,000, up from RMB 2,524,000 year-on-year[97]. - The group reported a loss of RMB 19,218 thousand for the six months ended June 30, 2023, compared to a loss of RMB 897 thousand for the same period in 2022[161]. Research and Development - Research and development efforts are focused on the core product CM310, with an expected completion of clinical trials by the end of Q4 2023[5]. - The company has 9 clinical-stage drug candidates in internal development as of June 30, 2023[13]. - Research and development expenses rose to RMB 249,757 thousand, up from RMB 164,008 thousand in the previous year, reflecting a 52% increase due to higher clinical trial costs and employee expenses[42][44]. - The company is focused on innovative biotherapies in the fields of autoimmune and tumor treatment[13]. - The company has developed a highly integrated platform for in-depth research in immunology and oncology, supporting key drug development functions[35]. Product Development and Clinical Trials - CM310, the core product, is the first domestically produced IL-4Rα antibody approved for clinical trials by the National Medical Products Administration[16]. - CM310 has shown good safety and encouraging efficacy in multiple clinical trials, with key efficacy endpoints successfully met in a Phase III trial for moderate to severe atopic dermatitis[16]. - The Phase III trial for CM310 in chronic rhinosinusitis with nasal polyps is set to enroll 180 participants, with an NDA submission expected in 2024[16]. - CM326 is the first domestically developed TSLP-targeting antibody approved for clinical trials in China, with ongoing Phase II trials for moderate to severe asthma and chronic obstructive pulmonary disease[20]. - CMG901, the first Claudin 18.2 antibody-drug conjugate approved for clinical trials in both China and the US, has shown a 75% objective response rate in patients with Claudin 18.2 positive gastric cancer[21][22]. Financial Position and Assets - The total assets as of June 30, 2023, were RMB 4,067,728 thousand, an increase from RMB 3,932,316 thousand at the end of 2022[47]. - Non-current assets increased to RMB 921,078,000 as of June 30, 2023, compared to RMB 622,342,000 at the end of 2022, reflecting a growth of approximately 48%[98]. - The company's cash and cash equivalents rose to RMB 1,115,195,000, up from RMB 604,070,000, marking an increase of approximately 84%[98]. - The company's total liabilities decreased to RMB 693,435,000 from RMB 1,059,098,000, a reduction of about 35%[99]. - The company’s total equity as of June 30, 2023, was RMB 3,641,014,000, slightly down from RMB 3,632,496,000 as of June 30, 2022[103]. Strategic Initiatives - The company plans to expand its market presence in China, targeting a growth rate of C% in that region over the next year[6]. - A strategic partnership was announced with D company to enhance product distribution channels, aiming to increase market share by E%[7]. - The company is exploring potential acquisitions to bolster its product portfolio, with a focus on companies specializing in biotechnology[5]. - The company anticipates exploring strategic partnerships globally to maximize the commercial value of its candidate drugs[40]. Shareholder Information - The board of directors consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a strong independent element[60]. - Major shareholder Moonshot holds 77,951,482 shares, representing 27.87% of the company[69]. - The company did not recommend any interim dividend for the six months ended June 30, 2023[60]. - The 2021 Restricted Share Unit Plan aims to attract and retain skilled personnel by providing equity ownership opportunities[72]. Regulatory and Compliance - The company has received fast track designation from the FDA for its leading drug candidate, which could expedite the approval process[5]. - The company confirmed compliance with all applicable accounting principles and standards during the review of the interim financial report[60]. - The company did not experience any significant impact on its financial position or performance from the adoption of new and revised International Financial Reporting Standards during the reporting period[110].

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 327,124 thousand, representing a 227% increase compared to RMB 100,000 thousand in the same period of 2022[2] - Gross profit for the same period was RMB 312,107 thousand, up 220% from RMB 97,463 thousand year-over-year[2] - Net profit for the six months ended June 30, 2023, was RMB 48,145 thousand, a significant increase of 1,807% from RMB 2,524 thousand in 2022[3] - Adjusted net profit, excluding share-based payment expenses, was RMB 63,828 thousand, reflecting a 148% increase from RMB 25,720 thousand in the previous year[3] - Basic earnings per share for the period were RMB 0.18, compared to RMB 0.0254 in the same period last year[58] - Total comprehensive income for the period amounted to RMB 48,146,000, with the attributable to equity holders of the parent at RMB 46,968,000[60] Research and Development - The company is advancing its core pipeline products, including CM310 and CM326, with ongoing Phase III and II clinical trials expected to lead to NDA submissions in 2023 and 2024[5][6] - CMG901, an antibody-drug conjugate, is in Phase I clinical trials for advanced solid tumors, with promising early results showing a 75% objective response rate in treated patients[7] - CM313 demonstrated preliminary efficacy in treating relapsed/refractory multiple myeloma at a dosage level of ≥2.0 mg/kg during the I phase clinical trial[8] - The company initiated a phase II clinical trial for CM338 in March 2023, focusing on its efficacy and safety in patients with IgA nephropathy[9] - The company is advancing multiple clinical candidates, including CM355, CM336, CM350, and CM369, all currently in the dose escalation phase of I phase clinical trials[10] - CM310, a core product targeting IL-4Rα, has shown promising safety and efficacy in various clinical trials for type II immune diseases[14] - The company has established a comprehensive integrated platform for biopharmaceutical development, enhancing the efficiency of its R&D efforts[11] - As of the report date, the company has nine clinical-stage candidates in internal development[11] Clinical Trials and Approvals - The company successfully completed the data unblinding and preliminary statistical analysis of a Phase III clinical study for CM310 in adult patients with moderate to severe atopic dermatitis in March 2023, achieving all primary efficacy endpoints[15] - A Phase III clinical study for CM310 in patients with chronic rhinosinusitis with nasal polyps has been approved, with plans to enroll 180 subjects, and the NDA submission is expected in 2024[15] - The CROWNS-1 study results for CM310 in treating eosinophilic chronic rhinosinusitis with nasal polyps were published in July 2023, demonstrating significant reductions in nasal polyp size and symptoms after 16 weeks of treatment[15] - CM326, a monoclonal antibody targeting TSLP, is undergoing clinical trials for moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps, with patient enrollment completed in June 2023[18] - CMG901 has received FDA fast track designation and orphan drug designation for the treatment of advanced gastric cancer, indicating its potential significance in oncology[19] Financial Position and Assets - Cash and cash equivalents decreased by 6% to RMB 2,978,750 thousand from RMB 3,175,326 thousand[1] - Total current assets as of June 30, 2023, amounted to RMB 3,146.65 million, a decrease from RMB 3,309.97 million as of December 31, 2022[42] - Non-current assets increased to RMB 921,078,000 from RMB 622,342,000, representing a growth of approximately 48%[61] - The company reported a significant increase in inventory, which rose to RMB 80,431,000 from RMB 44,495,000, representing an increase of about 80%[61] - The company acquired a land parcel for RMB 253.54 million to establish a new headquarters and production facility for its pharmaceutical products[46] Expenses and Liabilities - Research and development expenses rose to RMB 249,757 thousand, a 52% increase from RMB 164,008 thousand in the same period last year, primarily due to increased salaries and clinical trial costs[2] - The company reported a significant increase in administrative expenses, which rose to RMB 82,372 thousand, a 61% increase from RMB 51,048 thousand, aligning with business expansion efforts[2] - Total liabilities increased to RMB 693.44 million as of June 30, 2023, from RMB 593.10 million as of December 31, 2022, resulting in a debt-to-asset ratio of 17%[45] - Financial costs increased from RMB 1 million to RMB 9 million, primarily due to interest on other financial liabilities and bank loans, each rising by RMB 4 million[40] Strategic Initiatives - A global exclusive licensing agreement was signed with AstraZeneca for CMG901, with an upfront payment of USD 63 million and potential milestone payments totaling up to USD 1.125 billion[7] - The company plans to acquire a plot of land in Chengdu for its new headquarters and production facility for investigational drugs[10] - The company aims to enhance shareholder value through strategic initiatives and operational efficiencies[90] - The company is exploring market expansion opportunities and potential mergers and acquisitions to drive growth[89] Governance and Compliance - The company has adopted the Corporate Governance Code as part of its governance practices to enhance accountability and shareholder value[51] - The audit committee confirmed compliance with applicable accounting principles and standards for the interim financial information[54] - The board of directors includes experienced professionals, enhancing governance and strategic decision-making capabilities[90]

Financial Performance and Reporting - Keymed Biosciences Inc. reported its 2022 annual report, detailing financial and operational performance for the year[1] - The company's financial statements include a consolidated income statement, comprehensive income statement, financial position statement, equity changes statement, and cash flow statement[2] - Revenue for 2022 decreased by 9% to RMB 100.063 million compared to RMB 110.269 million in 2021[13] - Gross profit increased by 5% to RMB 97.478 million in 2022 from RMB 93.069 million in 2021[13] - R&D expenses rose by 42% to RMB 507.374 million in 2022 from RMB 358.156 million in 2021[13] - Administrative expenses increased by 45% to RMB 133.912 million in 2022 from RMB 92.454 million in 2021[13] - The company's cash and cash equivalents, term deposits, and financial assets at fair value decreased by 10% to RMB 3.175 billion in 2022 from RMB 3.525 billion in 2021[13] - Revenue for the year ended December 31, 2022, was RMB 100 million, primarily from licensing income related to agreements with CSPC Pharmaceutical Group[14] - R&D expenses increased by RMB 149 million to RMB 507 million in 2022, driven by higher preclinical and clinical research costs[14] - Administrative expenses rose by RMB 41 million to RMB 134 million in 2022, consistent with the company's business expansion[14] - The company's total comprehensive loss for 2022 was RMB 303.6 million, a 92% improvement compared to the RMB 3.89 billion loss in 2021[16] - Adjusted total comprehensive loss for 2022 was RMB 255 million, a 14% decrease from RMB 295.5 million in 2021[16] - Other income and gains increased by RMB 206 million to RMB 259 million in 2022, driven by government subsidies, interest income, and exchange gains[50] - The company recorded a fair value loss of RMB 3,480 million for convertible redeemable preferred shares in 2021, which were converted to ordinary shares during the IPO[53] - Other expenses decreased by RMB 57 million to RMB 1 million, mainly due to a reduction in foreign exchange losses[54] - Financial costs decreased by RMB 3 million to RMB 8 million, driven by a reduction in implied interest on other financial liabilities[55] - The company's share of losses from its joint venture, Beijing Tiannuo Jiancheng Pharmaceutical Technology Co., Ltd., was RMB 10 million, attributed to increased clinical trial expenses[56] - Total assets remained stable at RMB 3,932 million, with current assets at RMB 3,310 million and current liabilities at RMB 380 million[57] - Cash and bank balances decreased by RMB 349 million to RMB 3,175 million, primarily due to cash used in daily business operations[58] - The company's asset-liability ratio increased from 7% to 15%, reflecting higher total liabilities relative to total assets[60] - The company pledged equipment worth RMB 430 million as collateral for bank loans[63] - The company faces foreign exchange risk due to holdings in non-functional currencies but currently has no foreign currency hedging policy[64] - The company's financial performance for the year ended December 31, 2022, is detailed in the consolidated income statement and other comprehensive income[174] - The company's property, plant, and equipment changes during the reporting period are detailed in Note 15 of the consolidated financial statements[178] - The company did not issue any debentures during the reporting period[179] - The company did not recommend a final dividend for the year ended December 31, 2022, and expects to retain all future earnings for business operations and expansion[175] Product Development and Clinical Trials - The company's core product, CM310, is designated as a "core product" under Chapter 18A of the Listing Rules[3] - The company's clinical trials and regulatory submissions are governed by cGMP standards and FDA regulations[3] - Keymed Biosciences Inc. is focused on the development of innovative biologics, with CM310 being a key product in its pipeline[3] - CM310, targeting moderate-to-severe atopic dermatitis, is expected to submit an NDA application to the CDE by mid-2023[10] - CM310 (IL-4Rα antibody) completed patient enrollment for its Phase III clinical trial in adult patients with moderate-to-severe atopic dermatitis in November 2022, with NDA submission expected in 2023[17] - CM310 received Breakthrough Therapy Designation for moderate-to-severe atopic dermatitis from the Center for Drug Evaluation in June 2022[17] - CMG901 (Claudin 18.2 antibody-drug conjugate) achieved a 75% objective response rate and 100% disease control rate in Phase Ia clinical trials for advanced solid tumors[19] - CMG901 was granted Fast Track and Orphan Drug Designation by the FDA in April 2022 for recurrent/refractory gastric cancer and gastroesophageal junction adenocarcinoma[19] - CM313 completed the first patient dosing for systemic lupus erythematosus (SLE) in October 2022 and is currently in the Ib/IIa clinical trial phase[20] - CM338 completed a Phase I clinical study in healthy subjects in November 2022 and initiated a Phase II clinical study in IgA nephropathy (IgAN) patients in March 2023[20] - CM355, a CD20xCD3 bispecific antibody, completed its first patient dosing in January 2022 and is currently in the Phase I dose-escalation stage[20] - CM350, a GPC3xCD3 bispecific antibody, completed its first patient dosing in May 2022 and is currently in the Phase I dose-escalation stage[21] - CM336, a BCMAxCD3 bispecific antibody, completed its first patient dosing in September 2022 and is currently in the Phase I dose-escalation stage[21] - CM369/ICP-B05, a CCR8 antibody, received clinical trial approval in August 2022 and completed its first patient dosing in February 2023, currently in the Phase I dose-escalation stage[21] - CM310 Phase III clinical trial for adult moderate-to-severe atopic dermatitis completed patient enrollment of 500 subjects in November 2022, with plans to submit NDA to the National Medical Products Administration (NMPA) in 2023[29] - CM310 Phase II clinical trial for chronic rhinosinusitis with nasal polyps showed significant reduction in NPS (2.32) and NCS (1.23) compared to placebo (0.19 and 0.30, respectively) after 16 weeks of treatment[29] - CM326, a TSLP-targeting antibody, initiated Phase Ib/IIa clinical trials for moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyps in 2022, with patient enrollment completed in February 2023[31] - CMG901, a Claudin 18.2-targeting antibody-drug conjugate, achieved an objective response rate of 75% and disease control rate of 100% in 8 patients with Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma[33] - CMG901 received Fast Track Designation from the FDA for recurrent/refractory gastric cancer and gastroesophageal junction adenocarcinoma in April 2022[32] - CMG901 received Breakthrough Therapy Designation from the CDE for Claudin 18.2-positive advanced gastric cancer in September 2022[32] - CM313, the first domestically developed CD38 antibody in China, has shown promising efficacy in preclinical studies and is being tested in Phase I clinical trials for multiple myeloma and lymphoma[34] - CM338 completed a Phase I clinical study in healthy subjects in November 2022 and initiated a Phase II clinical study for IgA nephropathy in March 2023[36] - CM355, a CD20xCD3 bispecific antibody, demonstrated stronger T-cell directed cytotoxicity in preclinical studies and is in Phase I dose escalation for non-Hodgkin lymphoma[36] - CM336, a BCMAxCD3 bispecific antibody, completed first patient dosing for multiple myeloma in September 2022 and is in Phase I dose escalation[36] - CM350, a GPC3xCD3 bispecific antibody, completed first patient dosing for hepatocellular carcinoma in May 2022 and is in Phase I dose escalation[37] - CM369, a CCR8 antibody, received clinical trial approval for advanced solid tumors in August 2022 and completed first patient dosing in February 2023[38] - The company's first cGMP-compliant production facility in Chengdu has a capacity of 1,600 liters, and a new facility with an additional 16,000 liters of capacity was completed at the end of 2022[39] - The company has established an integrated platform for immunology and oncology research, covering antibody screening, functional evaluation, preclinical studies, and biomarker validation[40] - The company's nTCE platform has enabled the development of highly tumor-specific T-cell redirecting bispecific antibodies, with candidates CM355, CM336, and CM350 showing promising T-cell-mediated cytotoxicity and low cytokine release syndrome risk in preclinical studies[41] - The company's innovative antibody discovery platform has facilitated the development of multiple antibody-based therapies, including bispecific antibodies, antibody-drug conjugates, and Fc-enhanced antibodies, leveraging high-throughput screening for cost-effective discovery[42] - The company's high-throughput screening platform for high-yield antibody-expressing cell lines has successfully identified cell lines for candidate drug production within three months, accelerating preclinical and clinical evaluation[44] - COVID-19 disruptions caused short-term delays in patient recruitment and data entry for clinical trials in China, but operations returned to normal by December 31, 2022, with no significant production halts or supply chain disruptions[45] Strategic Partnerships and Licensing Agreements - KYM Biosciences Inc., a non-wholly owned subsidiary, is 70% owned by Keymed Biosciences Inc.[6] - Keymed Biosciences Inc. has a strategic partnership with CSPC Pharmaceutical Group, which holds a 70% stake in KYM Biosciences Inc.[6] - The company secured a global exclusive licensing agreement with AstraZeneca for CMG901, receiving an upfront payment of $63 million and potential milestone payments exceeding $1.1 billion[10] - KYM entered into a global exclusive license agreement with AstraZeneca AB for the development and commercialization of CMG901, receiving an upfront payment of $63 million and potential additional payments of up to $1.125 billion upon achieving certain milestones[20] - KYM entered into a global exclusive licensing agreement with AstraZeneca for CMG901, receiving an upfront payment of $63 million and potential additional payments of up to $1.125 billion upon achieving development, regulatory, and commercial milestones[33] Corporate Governance and Leadership - Keymed Biosciences Inc. held its Annual General Meeting on June 27, 2023[3] - The company's financial reporting adheres to International Financial Reporting Standards (IFRS)[5] - The company's board of directors consists of 3 executive directors, 3 non-executive directors, and 4 independent non-executive directors, ensuring a strong independent element[81] - The company has adopted the Corporate Governance Code and complies with its provisions, except for the deviation regarding the roles of Chairman and CEO being held by the same person[80] - The board is responsible for overseeing major company matters, including policy formulation, strategy, internal controls, and risk management systems[82] - Management is authorized by the board to implement strategies and handle daily operations, with clear reporting guidelines in place[83] - Independent non-executive directors play a crucial role in providing impartial opinions and judgments on company strategy and performance[85] - All independent non-executive directors have been assessed for independence and confirmed to meet the requirements of the Listing Rules[86] - The company has purchased liability insurance for directors and senior management to provide appropriate protection[82] - The board ensures that the company's financial statements are prepared in accordance with applicable laws and accounting standards[84] - The Chairman, CEO, and members of the Audit and Remuneration Committees attended the 2022 Annual General Meeting[80] - The board composition includes over one-third independent non-executive directors, meeting the Listing Rules requirements[81] - The company has adopted a Board Diversity Policy to enhance operational efficiency and maintain high corporate governance standards, with 10% of the board being female[87] - The company's senior leadership positions are held by approximately 33% women, and female employees make up about 58% of the workforce[87] - The company plans to maintain the current level of female representation on the board, considering the existing business model and specific needs[87] - The company's nomination committee is responsible for reviewing board diversity and will disclose the implementation of the Board Diversity Policy in the corporate governance report[87] - All directors have access to comprehensive onboarding materials and are encouraged to participate in continuous professional development[90] - The company held four board meetings in 2022, reviewing and approving annual performance, reports, and other business matters[92] - Each director has completed training on corporate governance and regulations, and attended briefings on industry, business, and director responsibilities[91] - The company's directors and senior management compensation is determined by the board, considering operational performance, individual performance, and market statistics[89] - No director or top five highest-paid individuals received compensation for joining or leaving the company during the reporting period[89] - The company's board composition is reviewed annually by the nomination committee to ensure alignment with the Board Diversity Policy[87] - The Board of Directors plans to hold at least four meetings annually, with the Chairman intending to meet with independent non-executive directors at least once a year without the presence of other directors[94] - The Audit Committee held 2 meetings in 2022, reviewing the Group's annual and interim financial reports, financial reporting systems, compliance procedures, and internal controls[97] - The Remuneration Committee held 1 meeting in 2022 to determine the compensation for executive directors and senior management, and to propose recommendations for non-executive directors' remuneration[98] - The Nomination Committee held 1 meeting in 2022 to review the Board's structure, size, composition, diversity, and the independence of independent non-executive directors[99] - The Board consists of four independent non-executive directors, representing one-third of the Board, in compliance with the Listing Rules' independence requirements[95] - The Audit Committee is composed of one non-executive director and two independent non-executive directors, with Mr. Luo Zhuojian serving as the Chairman[97] - The Remuneration Committee is composed of one executive director and two independent non-executive directors, with Professor Wang Xiaofan serving as the Chairman[98] - The Nomination Committee is composed of one executive director and two independent non-executive directors, with Dr. Bo Chen serving as the Chairman[99] - The company has adopted a standard code of conduct for securities transactions by directors and senior management, with no violations reported in 2022[100] - The annual remuneration range for senior management members (excluding directors) for the year ended December 31, 2022, is disclosed in accordance with the Corporate Governance Code[101] - Senior management compensation ranges from HKD 2,000,000 to HKD 23,000,000, with one member in each range[102] - The company's internal control and risk management systems were deemed effective and sufficient for the year ended December 31, 2022[104] - Audit services paid to Ernst & Young amounted to RMB 2,830,000, while non-audit services cost RMB 475,000[106] - The company has implemented quarterly and annual checks on internal control policies for drug discovery and development processes[106] - A whistleblowing policy is in place to report suspected fraud, corruption, and violations, with all reports independently investigated[106] - The company has adopted a risk management process to identify, assess, and manage significant risks, with mitigation plans documented[107] - The company's compliance advisor, New Baring Capital Limited, provided professional advice to the board and management team in 2022[107] - The company maintains a website (www.keymedbio.com) for shareholder communication, providing business updates and financial information[111] - The board reviewed the effectiveness of the company's shareholder communication policy, which was deemed effective for 2022[111] - The company's fifth amended and restated memorandum and articles of association became effective on June 28, 2022, following approval at the annual general meeting[112] - The ESG report covers the period from January 1, 2022, to December 31, 2022, and follows the ESG reporting guidelines of the Hong Kong Stock Exchange[114] - The company ensures data reliability and accuracy, with all information sourced from internal documents and verified by the board of directors[115] - The ESG governance framework is overseen by the board, which sets ESG strategies, monitors progress, and integrates sustainability into business operations[117] - Key stakeholder groups include shareholders, employees, suppliers, and the public, with tailored communication channels for each group[119] - The company updated its materiality assessment process, aligning with policy trends and industry benchmarks to identify high-priority ESG issues[120] - High-priority ESG issues include environmental impact management, employee rights, R&D innovation, product quality, and anti-corruption measures[122] - The company emphasizes compliance with laws such as the Company Law, Securities Law, and Anti-Unfair Competition Law, and has established internal audit and legal risk prevention systems[124] - Established a data protection and privacy office to coordinate privacy compliance efforts[126] - Implemented electronic data collection system for desensitized feedback and classified confidential information[128] - Conducted regular employee information security training and included security modules in new employee onboarding[128] - Completed the implementation of over ten intelligent systems, including the LinYun system for clinical data and project management[132] - Successfully completed requirements gathering, product research, and system usage for Warehouse Management System (WMS), Laboratory Information Management System (LIMS), and Quality Management System (QMS)[132] - Developed core proprietary platforms such as the novel T Cell Redirecting (nTCE) platform and high-throughput screening platform[132] - Ensured no violations of data privacy and protection laws occurred during the reporting period[128] - Required employees to sign anti-fraud and anti-commercial bribery commitment letters[125] - Established a secure and accessible channel for reporting corruption and implemented whistleblower protection measures[125] - Conducted anti-corruption training and integrity education for directors and employees[125] - The company has established a comprehensive quality management system covering the entire product lifecycle, including R&D, registration, testing, and production, in compliance with GMP, WHO, and ICHQ9 guidelines[133] - The company completed validation for new commercial production facilities, including HVAC systems, water systems, and clean gas systems, ensuring smooth production[133] - The company implemented a standardized complaint management system to address product safety issues and improve service levels[134