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

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]