致：香港交易及結算所有限公司 公司名稱: 康諾亞生物醫藥科技有限公司（於開曼群島註冊成立的有限公司） 呈交日期: 2025年9月2日 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02162 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,000,000 | USD | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： ...

Core Viewpoint - 康诺亚生物 reported a significant revenue increase of 812% year-on-year for the first half of 2025, driven by the rapid sales growth of its drug,司普奇拜单抗, and supported by substantial cash reserves and strategic investments in R&D and commercialization [1][2]. Group 1: Financial Performance - In the first half of 2025, the company achieved a revenue of 4.99 billion yuan, with a year-on-year growth of 812% [1]. - The sales net revenue of 司普奇拜单抗 reached approximately 1.7 billion yuan [1]. - R&D investment amounted to 3.60 billion yuan, reflecting a year-on-year increase of 9% [1]. Group 2: R&D and Product Pipeline - The company has over 50 products in development, with more than 10 in clinical stages, including 5 bispecific antibodies and 2 ADC drugs [2]. - 司普奇拜单抗 is the first domestically developed IL-4Rα antibody approved for multiple indications, including atopic dermatitis and chronic rhinosinusitis with nasal polyps [2]. - CM512 is the world's first long-acting dual blocker (TSLP×IL-13) currently in Phase II trials for asthma and COPD [2]. Group 3: Strategic Investments and Collaborations - The company raised approximately 8.64 billion HKD through placement and subscription transactions, allocating funds for key pipeline R&D and commercialization efforts [1]. - In the first half of 2025, the company completed 5 global collaboration events, including exclusive licensing agreements for CM313 and CM355 [3]. - CMG901, an ADC, has been granted exclusive global rights to AstraZeneca for research and commercialization, with ongoing clinical studies for various cancers [2][3]. Group 4: Market Expansion - The company is diversifying its technology platforms to explore chronic disease markets, including areas such as oncology and neurodegenerative diseases [1][2]. - The company is actively pursuing global market opportunities, with several products having obtained overseas IND approvals [3].

Group 1 - The Hong Kong innovative drug sector continues to rise, with the Hang Seng Innovative Drug Index up by 3.0% as of 10:48, and notable gains in stocks such as Innovent Biologics up over 6%, CanSino Biologics and CSPC Pharmaceutical Group up over 5% [1] - The Hang Seng Innovative Drug ETF (159316) has seen a trading volume exceeding 400 million yuan, with net inflows for four consecutive trading days, bringing its latest scale to 1.8 billion yuan [1] - The National Healthcare Security Administration has officially announced the preliminary review list of drugs for the 2025 medical insurance and commercial insurance innovative drug directory, featuring new drugs including the "million-dollar cancer drug" CAR-T products and several "first and only in the world" products [1] Group 2 - CITIC Securities anticipates a significant increase in innovative drug catalyst events in September, and the recent technology switch has alleviated the short-term speculative money previously accumulated in the sector, suggesting that innovative drugs may continue to rise after this adjustment [1] - The Hang Seng Innovative Drug Index has officially adjusted to exclude contract research organizations (CROs), achieving a "100% purity" index that more accurately reflects the overall performance of China's innovative drug companies [1] - Backtesting indicates that since the index's launch on July 10, 2023, the annualized return and Sharpe ratio have improved after excluding CROs, making the Hang Seng Innovative Drug ETF (159316) the only product tracking this index, aiding investors in precisely positioning themselves for opportunities in the innovative drug industry [1]

Investment Rating - The investment rating for the company is "Buy" and is maintained [7]. Core Insights - The company reported a significant increase in revenue, achieving 499 million CNY in the first half of 2025, representing a year-on-year growth of 812%. R&D investment was 360 million CNY, up 9% year-on-year [2][4]. - The company is expanding its technological platforms to tap into the blue ocean market for chronic diseases, moving from antibody platforms to oligonucleotide and PROTAC small molecule platforms [7]. - The company has a diverse pipeline with over 50 products in development, including 10 in clinical stages, and is focusing on high-potential BIC iterative molecules [7]. - The company is exploring multiple models for global expansion, having completed five global cooperation events in the first half of 2025 [7]. - Profit forecasts indicate that the company will have a net loss of 550 million CNY in 2025, a reduced loss of 214 million CNY in 2026, and a profit of 224 million CNY in 2027, with corresponding EPS of -1.84 CNY, -0.72 CNY, and 0.75 CNY [7]. Summary by Sections Financial Performance - In the first half of 2025, the company achieved revenue of 499 million CNY, a year-on-year increase of 812%, with R&D investment at 360 million CNY, up 9% [2][4]. Product Development - The company is advancing its product pipeline with over 50 products in development, including 10 in clinical stages, and is focusing on innovative therapies for various chronic diseases and cancers [7]. Market Strategy - The company is actively pursuing global partnerships and has made significant progress in its international expansion efforts, including obtaining overseas INDs for several products [7]. Profitability Outlook - The company expects to incur net losses in the coming years, with projections of -550 million CNY in 2025, -214 million CNY in 2026, and a return to profitability in 2027 with a net profit of 224 million CNY [7].

Core Viewpoint - The company reported a narrower net loss in 1H25 than expected, maintaining a "Buy" rating and raising the target price to HKD 77 [1][5] Financial Performance - In 1H25, the company achieved revenue of RMB 499 million, representing an increase of 812.1% year-over-year, with product revenue of RMB 169 million and collaboration revenue of RMB 329 million, which increased by 502.6% year-over-year [2] - The net loss attributable to the parent company narrowed to RMB 78.84 million from RMB 337 million in 1H24, better than expectations due to higher collaboration revenue and improved gross margin on product sales [2] - Cash on hand reached RMB 2.8 billion as of June 30, 2025, up from RMB 2.16 billion at the end of 2024, aided by a successful placement in the Hong Kong market [2] Product Development and Sales - CM310 achieved sales of RMB 169 million in the first half of the year, with the company maintaining its first-year sales target of RMB 500 million [3] - The commercial team for CM310 has expanded to over 360 members, covering more than 1,400 hospitals across 30 provinces [3] - The company is optimistic about including multiple indications of CM310 in national health insurance, particularly for atopic dermatitis and nasal polyps [3] Pipeline and R&D - CM512, a next-generation dual antibody drug, is being prioritized for development, with a long half-life supporting less frequent dosing [4] - The company is advancing clinical trials for CM512 in multiple indications, including asthma and chronic rhinosinusitis with nasal polyps, with rapid progress in domestic clinical trials [4] Valuation and Outlook - The company revised its estimates for net losses in 2025, 2026, and 2027 to RMB 570 million, RMB 560 million, and RMB 420 million, respectively, due to improved gross margin forecasts [5] - A DCF valuation model yielded a new target price of HKD 77, reflecting the company's robust early pipeline [5]

Core Viewpoint - The company reported a revenue of 499 million yuan and a net profit of -79 million yuan for the first half of 2025, with promising developments in its core product, IL-4R monoclonal antibody, and ongoing clinical trials for multiple early-stage pipelines [1][2]. Group 1: Financial Performance - The company achieved a revenue of 499 million yuan in the first half of 2025 [1]. - The net profit for the same period was -79 million yuan [1]. Group 2: Product Development - The IL-4R monoclonal antibody, Siponimod, has successfully advanced in commercialization, generating sales of 170 million yuan in the first half of 2025 [1]. - The product has been approved for three indications: moderate to severe atopic dermatitis, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis [1]. - The product has passed the review for inclusion in the 2025 medical insurance drug list, with future negotiations expected to enhance market sales [1]. Group 3: Clinical Pipeline - The company is advancing multiple differentiated early-stage pipelines, including: - TSLP×IL-13 bispecific antibody CM512 in Phase 2 clinical trials for moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps [2]. - CDH17 ADC CM518D1 in Phase 1/2 clinical trials for advanced solid tumors [2]. - BCMA×CD3 bispecific antibody CM336 in Phase 1/2 clinical trials for relapsed or refractory multiple myeloma [2]. - CD38 antibody in Phase 2 clinical trials for primary immune thrombocytopenia and IgA nephropathy [2]. - Aβ protofibril antibody CM383 in Phase 1b clinical trials for mild cognitive impairment and mild Alzheimer's disease [2]. Group 4: Investment Outlook - The company is projected to generate revenues of 750 million yuan, 1.11 billion yuan, and 2.08 billion yuan for the years 2025, 2026, and 2027, respectively [2]. - Expected net profits for the same years are -440 million yuan, -410 million yuan, and 80 million yuan [2]. - Given the potential for product volume growth and a rich clinical development pipeline, the company has a favorable outlook, with an initial investment rating of Buy-A and a target price of 78.83 HKD based on the DCF model [2].

Core Viewpoint - The company reported a significant increase in revenue for the first half of 2025, achieving 499 million yuan, a year-on-year increase of 812%, primarily driven by the commercialization of its product, Sipuqibai monoclonal antibody [1][2] Group 1: Financial Performance - The company's revenue from drug sales was approximately 170 million yuan, while income from external collaborations was about 330 million yuan [1] - The net profit attributable to the parent company, excluding non-recurring items, was -79 million yuan [1] - The forecast for the net profit for 2025 has been adjusted to -624 million yuan, up from the previous estimate of -737 million yuan [2] Group 2: Product Development and Market Position - Sipuqibai monoclonal antibody is the first IL-4Rα antibody drug in China for treating chronic rhinosinusitis with nasal polyps and the first globally for seasonal allergic rhinitis, addressing unmet medical needs [1] - The company is focusing on the field of type 2 inflammatory diseases and has built a specialized sales team for autoimmune diseases [1] - The commercialization team has expanded to over 360 members and the drug is now available in over 30 provinces and 240 cities, covering more than 1,400 hospitals [1] Group 3: Pipeline and Future Prospects - The company is advancing multiple clinical trials for its pipeline products, including CM512 for moderate to severe allergic diseases and CMG901 for advanced gastric cancer [2] - The company is also conducting clinical studies for CM313, a humanized monoclonal antibody targeting CD38, in various autoimmune diseases [2] - The company maintains a "buy" rating based on the rapid sales growth of its core product and the broad pipeline coverage [2]

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company has experienced rapid sales growth of its flagship product, Siponimod, with a revenue increase of 807.96% year-on-year in H1 2025, reaching 499 million yuan. The net profit attributable to shareholders was -78.84 million yuan [7] - The revenue forecast for 2025-2027 has been revised upwards, with expected revenues of 800 million, 1.01 billion, and 1.62 billion yuan respectively, compared to previous estimates of 467 million and 1.003 billion yuan [7] - The company is actively expanding its product pipeline with next-generation dual antibodies, which are currently in various stages of clinical trials [8] Financial Summary - In H1 2025, the company achieved a revenue of 499 million yuan, with a year-on-year growth of 807.96%. The net profit attributable to shareholders was -78.84 million yuan [7] - The projected revenues for 2025, 2026, and 2027 are 800 million, 1.01 billion, and 1.62 billion yuan respectively, with year-on-year growth rates of 87.0%, 26.2%, and 60.4% [10] - The company’s gross margin is expected to remain high at around 95% for the forecast period [10] Product Development and Market Expansion - Siponimod is rapidly gaining traction in the market, with sales of approximately 169 million yuan in H1 2025, driven by its indications for moderate to severe atopic dermatitis, chronic sinusitis with nasal polyps, and seasonal allergic rhinitis [8] - The company has successfully completed overseas licensing for multiple products, generating 329 million yuan in revenue from product collaborations and licensing in H1 2025 [9]

Investment Rating - The investment rating for the company is "Outperform the Market" [4][17]. Core Views - The sales of Siponimod have experienced rapid growth, with revenue reaching 499 million yuan in the first half of 2025, representing an increase of 812%. The sales of Siponimod alone accounted for 169 million yuan [7][17]. - The company reported a loss of 79 million yuan in the first half of 2025, an improvement from a loss of 337 million yuan in the same period last year. Research and development expenses increased by 9% to 360 million yuan, while sales expenses surged by 492% to 138 million yuan [7][17]. - The company has approximately 2.8 billion yuan in cash as of mid-2025 [7]. Summary by Sections Sales Growth and Product Pipeline - Siponimod was approved for market launch in September 2024 and has received approval for three indications: atopic dermatitis, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis. The unique indications in the nasal category are exclusive to China, which is expected to drive sales growth [13][17]. - Ongoing clinical trials for additional indications, including nodular prurigo and atopic dermatitis in adolescents and children, are in Phase 3 [13]. Future Revenue Projections - The revenue forecast for the company has been revised upwards due to successful licensing transactions, with expected revenues of 827 million yuan, 1.095 billion yuan, and 2.046 billion yuan for 2025, 2026, and 2027, respectively [17]. - The projected net profit for the parent company is expected to improve to -490 million yuan in 2025, -576 million yuan in 2026, and a profit of 53 million yuan in 2027 [17]. Clinical Development Progress - The company’s pipeline includes CMG901 (CLDN18.2 ADC), which has been licensed to AZ and is currently undergoing global registration clinical trials. Other candidates like CM512 (TSLPxIL13 bispecific antibody) are in Phase 2 trials for various indications [2][13].

Investment Rating - The report maintains a "Buy" rating for the company and raises the target price to HKD 77.0, indicating a potential upside of 16% from the current price of HKD 66.5 [2][5][7]. Core Insights - The company's net loss attributable to shareholders for the first half of 2025 was better than expected, with revenue reaching RMB 499 million, a year-on-year increase of 812.1%. Product revenue was RMB 169 million, while collaboration revenue was RMB 329 million, up 502.6% year-on-year [5][7]. - The company is focusing on the commercialization of CM310 and preparing for national medical insurance negotiations, with confidence in multiple indications being included in the insurance scheme [5][7]. - The next-generation core pipeline drug, CM512, is being prioritized for development, showing promising safety and efficacy in preclinical studies [5][7]. Financial Performance - For 1H25, the company reported a net loss of RMB 78.84 million, significantly reduced from RMB 337 million in 1H24, primarily due to better-than-expected collaboration revenue and improved gross margins [5][7]. - The company’s cash position improved to RMB 2.8 billion as of June 30, 2025, up from RMB 2.16 billion at the end of 2024, aided by a successful placement in June [5][7]. - Revenue projections for the upcoming years show significant growth, with expected revenues of RMB 823 million in 2025, RMB 1.5 billion in 2026, and RMB 2.3 billion in 2027, reflecting year-on-year growth rates of 92%, 82%, and 54% respectively [7][9].