Investment Rating - The investment rating for the company is "Buy" and is maintained [5][6]. Core Insights - The company reported a total revenue of 354 million CNY for the year 2023, which includes collaboration income generated from the authorization to AZ. The adjusted net loss for 2023 was 318 million CNY, compared to a loss of 255 million CNY in the previous year. The total R&D expenditure for 2023 was 596 million CNY, up from 507 million CNY in 2022 [5][6]. - The core product CM310 has submitted a marketing application for adult moderate to severe atopic dermatitis and has been accepted, marking the company’s entry into a new commercialization cycle. The product has shown promising efficacy data in clinical trials [5][6]. - The company has also made progress with CMG901, which has demonstrated potential in treating gastric and gastroesophageal junction cancers, and has received orphan drug designation and fast track designation from the FDA [6]. Summary by Sections Financial Performance - In 2023, the company achieved a revenue of 354 million CNY, with an adjusted loss of 318 million CNY and R&D expenses of 596 million CNY [5][6]. Product Pipeline - CM310 has completed its Phase III clinical trials for adult moderate to severe atopic dermatitis, achieving an EASI-75 responder rate of 66.9% and an IGA 0/1 rate of 44.2%. The product is also undergoing trials for chronic rhinosinusitis with nasal polyps and has initiated studies for adolescent atopic dermatitis and seasonal allergic rhinitis [5][6]. - CMG901 has shown a confirmed objective response rate of 33% in patients with Claudin 18.2 positive gastric and gastroesophageal junction cancers, with a disease control rate of 70% [6]. Future Outlook - The company is expected to incur net losses of 768 million CNY, 633 million CNY, and 239 million CNY for the years 2024 to 2026, respectively, with corresponding EPS of -2.75, -2.26, and -0.85 CNY [6].

Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Insights - The core product CM310 for moderate to severe AD has submitted its NDA and is expected to be approved by the end of 2024, becoming the first domestically produced IL-4R monoclonal antibody [2][3]. - The company reported a revenue of 354 million in 2023, a 254% increase, primarily driven by upfront payments from the licensing of CMG901 to AstraZeneca [2]. - Adjusted net loss for the year was 318 million, with R&D expenses amounting to 596 million, reflecting an 18% increase due to rising employee costs and depreciation of new equipment [2]. - Cash and cash equivalents totaled 2.719 billion as of December 31, 2023, a decrease of 456 million from the end of 2022, indicating high capital utilization [2]. Financial Summary - Revenue projections for 2024 and 2025 have been revised down to 156 million and 526 million respectively, from previous estimates of 231 million and 697 million [2]. - The new revenue forecast for 2026 is set at 1.441 billion [2]. - The company is expected to initiate commercialization of CM310 in 2025 following its anticipated approval [2]. Clinical Development - CM310's Phase III trial data presented at EADV in October 2023 showed significant efficacy, with 66.9% of patients achieving EASI-75 compared to 25.8% in the control group [2]. - The company plans to start a Phase III double-blind trial for adolescents with moderate to severe AD in February 2024 [2]. - CMG901 has shown promising early data, with an overall response rate of 33% in a recent study, and is currently undergoing multiple Phase II clinical trials [2]. Pipeline Progress - The company has multiple products in its pipeline, including CM313 for ITP and CM326 for AD and asthma, both showing promising early results [2]. - The clinical data for CM350, CM355, and CM336 are also progressing steadily [2].

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].