截至月份: 2026年3月31日 狀態: 新提交 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 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: 2026年4月1日 I. 法定/註冊股本變動 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 頁 共 10 頁 v 1.2.1 FF301 II. 已發行股份及/或庫存股份變動及足夠公眾持股量的確認 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 已發行股份（不包括庫存股份）數目 庫存股份數目 已發行股份總數 上月底結存 298,735,566 0 298,735,566 增加 / 減少 (-) 0 0 本月底結存 298,735,566 0 298,735,566 足夠公眾持股量的確認(註4) | 根據《主板上市規則》第13.32D(1)條或第19A.28D(1)條 / 《GEM上市規則》第17.37D(1)條或第25.21D(1)條，我們在此確認，就上述所列股份類別而言，截至本月 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company achieved significant revenue growth in 2025, with total revenue reaching 716 million yuan, a year-on-year increase of 67.31%. The sales revenue from the product Sipulizumab was approximately 315 million yuan, representing a 633% increase from 2024 [4][5] - The company is expected to continue its revenue growth trajectory, with projected revenues of 2.458 billion yuan in 2026, 1.624 billion yuan in 2027, and 2.224 billion yuan in 2028 [4][7] - Sipulizumab has been included in China's National Medical Insurance Drug List, enhancing its affordability and accessibility, and the company is actively expanding its product pipeline with next-generation dual antibodies [5][6] Financial Summary - The company reported a net loss of 523 million yuan in 2025, but adjusted net profit (excluding share-based payment impacts) was -495 million yuan [4] - The gross margin for 2025 was 87.7%, with a projected gross margin of 95% for the following years [7][10] - The price-to-sales (P/S) ratio is projected to be 7.4, 11.2, and 8.2 for 2026, 2027, and 2028 respectively, indicating a favorable valuation compared to historical performance [4][7]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company achieved significant revenue growth in 2025, with a total revenue of 716 million yuan, representing a year-on-year increase of 67.31%. The sales revenue from the product Siponimod (司普奇拜单抗) reached approximately 315 million yuan, a remarkable growth of 633% compared to 32 million yuan in 2024 [4][5] - The company is expected to continue its revenue growth trajectory, with projected revenues of 2.458 billion yuan in 2026, 1.624 billion yuan in 2027, and 2.224 billion yuan in 2028. This is an upward revision from previous estimates [4] - The product Siponimod has been included in China's National Medical Insurance Drug List, enhancing its affordability and accessibility, and is expected to expand into various II-type immune diseases [5] - The company has completed overseas licensing for multiple products, which will help in expanding its global market presence [6] Financial Summary - In 2025, the company reported a net loss of 523 million yuan, with an adjusted net profit of -495 million yuan. The gross margin for 2025 was 87.7%, and the net margin was -73% [7][10] - The projected earnings per share (EPS) for 2026 is 2.6 yuan, with a price-to-earnings (P/E) ratio of 23.8 times [7] - The company's total assets are expected to grow from 4.218 billion yuan in 2025 to 4.923 billion yuan in 2026, with total liabilities increasing from 1.443 billion yuan to 1.385 billion yuan in the same period [9]

Summary of Conference Call Notes Company Overview - The company discussed its performance and developments related to its products, particularly focusing on CM310 (Sikukiyu monoclonal antibody), CM512 (TSLP/IL-13 dual antibody), and CMG901 (Claudin 18.2 ADC) [2][3][4][8]. Key Points Industry and Product Performance - **CM310 (Sikukiyu monoclonal antibody)**: - Achieved sales of 310 million RMB in 2025, a 77.2% increase year-on-year [3]. - Entered the national medical insurance list in January 2026, significantly boosting hospital access [4][5]. - Expected to be available in nearly 1,000 hospitals by the end of 2026, with over 40% access achieved [5]. - **CM512 (TSLP/IL-13 dual antibody)**: - Positioned as an upgraded version of CM310, with a reduced administration frequency of 2-4 injections per year [2][8]. - Clinical data for nasal polyps expected to be read out ahead of schedule in June-July 2026 [8][16]. - **CMG901 (Claudin 18.2 ADC)**: - Licensed to AstraZeneca, with global filing for second-line gastric cancer expected in H2 2026 [2][8]. - The project has entered first-line combination therapy trials, with over 2,500 patients planned for global clinical trials [10][17]. Financial Performance - Total revenue for 2025 was 720 million RMB, a 67% increase year-on-year, with product sales contributing 310 million RMB [3][11]. - The company raised 860 million HKD through H-share placement, maintaining a cash reserve of nearly 2 billion RMB by the end of 2025 [3][11]. - R&D investment remained stable at 720 million RMB, with a net loss of 500 million RMB for 2025 [11]. Production Capacity and Cost Management - The company is expanding its production capacity with the ND4 stainless steel production line, set to be operational by March 2026, which will significantly reduce costs [6][11]. R&D Pipeline and Strategic Initiatives - The company is diversifying its R&D beyond antibody drugs, with advancements in ADC, small nucleic acids, and PROTAC platforms [7][19]. - CM336 (BCMAxCD3) has shown over 90% overall response rate (ORR) and 75% complete response (CR) in multiple myeloma, with a strategic partnership with Gilead to enhance global market access [9][12]. Future Milestones - Key R&D milestones for 2026 include: - Submission of CM310 for adolescent moderate to severe atopic dermatitis [11]. - Data readout for CM512 in nasal polyps expected in mid-2026 [11]. - Initiation of clinical trials for CM313 and CMG901 [11][17]. Market Strategy and Competitive Positioning - The company aims to leverage its first-mover advantage in the dermatology field while expanding into respiratory and nasal indications [23][24]. - CM512 is not expected to be the first approved indication; instead, the focus will be on asthma and COPD to avoid pricing pressures from a large patient population [24][25]. Clinical Data and Academic Engagement - The company plans to present key clinical data at major academic conferences in 2026, including results for CM-518 and CM-310 [27]. Patient Engagement and Market Dynamics - Following the inclusion of CM310 in the national insurance list, patient adherence (DOT) has increased, with potential for over 15 treatment cycles observed in chronic patients [28]. Conclusion The company is positioned for significant growth with a robust pipeline, strategic partnerships, and a focus on expanding its market presence while maintaining financial stability and operational efficiency.

Summary of Conference Call Records Industry Overview - The focus is on the oral GLP-1 drug "O Drug" and its related supply chain, with companies like Kanglong Chemical, WuXi AppTec, Kelun Pharmaceutical, and Chengda Pharmaceutical receiving clear orders for production [1][2] - The global biotech sector is shifting from monetary policy influences to breakthroughs in technology and patent cliffs, with expectations for a similar upward cycle as seen in 2014/2018 driven by GLP-1 products and M&A demands [1][3] - The domestic innovative drug sector is showing positive fundamentals, with business development (BD) totals reaching levels comparable to the first half of 2025, indicating a transition from losses to profitability for many companies [1][4] Key Points on "O Drug" - "O Drug" is expected to receive FDA approval for weight loss indications in April 2026, with its application submitted at the end of 2025 [2] - A head-to-head study in February 2026 showed "O Drug" outperforming oral semaglutide in reducing glycated hemoglobin and weight loss [2] - The product is currently in a pre-approval stocking phase, which is anticipated to boost API and CDMO orders for companies involved in its production [2] Market Dynamics - The current macro environment for the global biotech industry is driven by technological breakthroughs and the impending patent cliffs faced by large pharmaceutical companies, leading to increased M&A activity [3][4] - Historical data indicates that biotech indices have continued to rise even during interest rate hikes, suggesting a resilient market [4] Investment Opportunities - The investment strategy emphasizes selecting companies transitioning from biotech to biopharma, with Kangfang Biologics and Kangnuo Pharmaceutical highlighted for their expected sales growth and pipeline flexibility [1][7] - A tiered investment approach is recommended: - **Low-risk, high-certainty companies**: Kangfang, Kangnuo, and Fuhong Hanlin are expected to have significant growth potential [1][7] - **High-flexibility companies**: Companies like Junshi Biosciences and Xinlitai are noted for their potential to double or triple in value based on performance [1][7] - **Stable companies**: Companies such as Baiji Shenzhou and Xinda Biopharmaceuticals are recommended for long-term holding with expected growth of 30% to 50% [1][7] Emerging Technologies - The core focus for Chinese innovative drugs going abroad in 2026 includes dual antibodies (e.g., PD-1/VEGF) and ADCs, with significant clinical data expected to validate their market potential [6] - New technologies such as TCE dual antibodies and small nucleic acid drugs are also highlighted for their promising development and potential for international transactions [6] Conclusion - The innovative drug sector is positioned for growth, supported by favorable policies and a recovering market valuation after significant corrections in leading company stock prices [5][6]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 91.13 [8][6]. Core Insights - The company reported a revenue of RMB 716 million for 2025, representing a year-on-year increase of 67.3%, with net losses of RMB 5.23 billion and adjusted net losses of RMB 4.95 billion, which were better than the expected RMB 5.71 billion and RMB 6.79 billion respectively [1][6]. - The sales of the drug Siponimod are expected to reach RMB 750 million in 2026, driven by three major indications being included in medical insurance and a favorable pricing strategy [2][3]. - The company has a clear path for global value realization, with several key milestones expected in 2026, including the submission of BLA for CMG901 and the acceleration of CM336's global value realization due to Gilead's acquisition of Ouro [3][4]. Revenue and Profit Forecast - The revenue forecast for 2026 is adjusted to RMB 753 million, with a projected net loss of RMB 6.49 billion, improving from previous estimates [6][13]. - The company anticipates a significant increase in revenue to RMB 2.62 billion by 2028, with a projected net profit of RMB 472 million [11][13]. Pipeline and Product Development - The company has a robust pipeline with several products expected to yield data in 2026, including CM512 and CM518D1, which are anticipated to show strong efficacy and safety trends [4][5]. - The automatic injection pen for Siponimod received approval at the end of 2025, enhancing the convenience of administration compared to competitors [2][3]. Financial Health - The company reported a gross margin of approximately 87.7% for 2025, with cash reserves of RMB 1.96 billion as of the end of 2025, providing a solid financial foundation for future growth [5][6]. - The operational efficiency is expected to improve as sales scale up, with a gradual optimization of the sales expense ratio [5][6].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% in the next 6-12 months [6]. Core Insights - The company reported a revenue of 716 million yuan, a 67% increase year-on-year, with product sales from Siponimod contributing 315 million yuan and collaboration income of 402 million yuan. The net loss for the year was 523 million yuan, with adjusted net loss at 495 million yuan. R&D expenses totaled 720 million yuan, and cash reserves stood at 1.96 billion yuan as of December 31, 2025 [2]. - Siponimod is expected to see significant sales growth in 2026 as it has been included in the medical insurance directory, with three approved indications. The company anticipates rapid growth due to the advantages of insurance coverage, pricing, and exclusive indications [3]. - The year 2026 is projected to be pivotal for multiple pipelines, with key catalysts expected, including the readout of Phase III data for CMG901 in gastric cancer and submissions for various NDAs [4]. - The second business development (BD) of NewCo is expected to lead to a revaluation of pipeline value, with Gilead proposing to acquire Ouro for $2.175 billion, which could yield significant upfront and milestone payments for the company [5]. Financial Forecasts - Revenue projections for 2026-2028 are 2.871 billion yuan, 2.064 billion yuan, and 2.994 billion yuan, reflecting growth rates of 300.8%, -28.1%, and 45.0% respectively. Net profit forecasts are 1.027 billion yuan, -587 million yuan, and 272 million yuan, with corresponding EPS of 3.44 yuan, -1.96 yuan, and 0.91 yuan [6][10].

Financial Performance - Keymed Biosciences Inc. reported a revenue of RMB 716.3 million for the year ending December 31, 2025, representing a 67% increase compared to RMB 428.1 million in 2024[2]. - The cost of sales surged to RMB 88.0 million, a 622% increase from RMB 12.2 million in the previous year[2]. - The company achieved a gross profit of RMB 628.3 million, up 51% from RMB 415.9 million in 2024[2]. - The net loss for the year was RMB 522.6 million, a marginal increase of 1% from RMB 514.9 million in 2024[2]. - The company's revenue for 2025 reached RMB 716.313 million, a significant increase from RMB 428.124 million in 2024, representing a growth of approximately 67.5%[67]. - Gross profit for 2025 was RMB 628.265 million, compared to RMB 415.924 million in 2024, reflecting a gross margin improvement[67]. - The company incurred a loss before tax of RMB 520,723 thousand, compared to a loss of RMB 508,647 thousand in 2024, reflecting ongoing investment in growth[104]. - The total comprehensive loss for the year was RMB 510,251 thousand, slightly improved from RMB 513,521 thousand in the previous year[105]. Research and Development - Research and development expenses slightly decreased by 2% to RMB 723.5 million from RMB 735.2 million in 2024[2]. - The company has established a comprehensive integrated platform for drug development, covering all key functions from target validation to clinical development and production[23]. - The company is continuously recruiting talent to meet the growing demands of product commercialization, R&D, clinical, production, and operations[22]. - The company has entered into multiple licensing agreements for drug development, indicating a strategic focus on expanding its product pipeline and market presence[120][122][123]. - Research and development expenditures increased by 10% to support ongoing projects and new drug applications[144]. Product Pipeline and Clinical Trials - Keymed is advancing multiple clinical trials for its pipeline products, including CMG901/AZD0901 and CM512, with significant milestones achieved in 2025[5][7]. - CM336 achieved an objective response rate (ORR) of 95.2% and a complete response (CR) rate of 76.2% in a Phase II clinical study for relapsed or refractory multiple myeloma (RRMM) patients[11]. - CM336 received Fast Track Designation from the FDA for the treatment of autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP) on January 23, 2026[13]. - CM313 completed a Phase II clinical study evaluating its safety and efficacy in patients with primary immune thrombocytopenia[15]. - CM383 is undergoing a Phase Ib clinical study for safety and tolerability in patients with mild cognitive impairment and mild Alzheimer's disease, with patient enrollment completed by December 2025[16]. - CM350 is in the dose escalation phase of an I/II clinical study for advanced solid tumors[18]. - CM326 is advancing multiple Phase III clinical trials for various indications, including moderate to severe asthma and chronic rhinosinusitis with nasal polyps[19]. - CM355 demonstrated an overall response rate (ORR) of 82% and a complete response (CR) rate of 59% in patients with relapsed/refractory B-cell non-Hodgkin lymphoma[20]. - CM369 is in an ongoing Phase I dose escalation trial for advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma[21]. Financial Position and Assets - As of December 31, 2025, total assets were RMB 4.218 billion, up from RMB 3.767 billion in 2024, showing a growth of approximately 12%[75]. - The company's total liabilities as of December 31, 2025, were RMB 1.443 billion, compared to RMB 1.291 billion in 2024, reflecting an increase in financial obligations[75]. - The net cash flow from operating activities for 2025 was RMB 712 million, a decrease from RMB 790 million in 2024, indicating tighter cash management[76]. - The debt-to-asset ratio remained stable at 34% as of December 31, 2025, consistent with the previous year[79]. - Non-current assets totaled RMB 1,794,691,000 in 2025, up 38.0% from RMB 1,300,540,000 in 2024[106]. - Current assets decreased slightly to RMB 2,422,842,000 in 2025 from RMB 2,466,026,000 in 2024, a decline of 1.8%[106]. - The company's net asset value increased to RMB 2,774,923,000 in 2025, reflecting a growth of 12.1% from RMB 2,475,212,000 in 2024[107]. Strategic Partnerships and Agreements - Ouro Medicines signed a merger agreement with Gilead Sciences for a total transaction value of up to $2.175 billion, including an initial payment of $1.675 billion and up to $500 million in milestone payments[14]. - The company has established partnerships for the development and commercialization of candidate drugs through joint ventures and licensing arrangements[24]. - The company entered into a licensing agreement with Timberlyne Therapeutics, receiving an upfront payment of USD 25,000,000 (approximately RMB 179,233,000) in 2025[119]. - The company has established partnerships with three leading research institutions to accelerate drug development timelines[144]. Market and Growth Outlook - The company provided guidance for the next fiscal year, projecting a revenue growth of 20% and an EBITDA margin improvement of 5%[144]. - New product launches are expected to contribute an additional $50 million in revenue, with a focus on innovative biopharmaceuticals[142]. - The company is expanding its market presence in the Asia-Pacific region, targeting a 30% increase in market share by 2026[143]. - The company is exploring strategic acquisitions to enhance its product portfolio and market reach, with a budget of $100 million allocated for potential deals[142]. Employee and Operational Insights - As of December 31, 2025, the company has 1,625 full-time employees, with over 407 in the commercialization team and nearly 432 in drug discovery and clinical operations[22]. - The company has established three pilot production lines and three commercial production lines, with a total capacity of 21,800 liters; an additional stainless steel production line with a capacity of 24,000 liters has been installed and is about to be put into use[22]. - The company plans to expand its cGMP-compliant production capacity to meet the anticipated increase in demand for candidate drugs[66]. Shareholder and Governance - The board resolved not to recommend the payment of a final dividend for the year ended December 31, 2025[90]. - The annual general meeting of shareholders is scheduled for June 26, 2026[91]. - The company has established an audit committee to oversee financial reporting processes and ensure compliance with applicable accounting standards[97]. - The board has approved a share buyback program worth $20 million to enhance shareholder value[142].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Keymed Biosciences Inc. 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） （股份代號：2162） 須予披露交易 出售Ouro Medicines股權 併購事項 本公司透過其全資附屬公司一橋香港於Ouro Medicines的股本中持有約15%少數 權益，該權益於本公司的綜合財務報表中入賬為以公允價值計量且其變動計入 當期損益的金融資產。 本公司董事會（「董事會」）欣然宣佈，Ouro Medicines已知會本公司，於2026年3 月23日，買方已同意以併購方式收購Ouro Medicines。緊隨完成後，本集團將不 再持有Ouro Medicines的任何股權。併購協議規定，完成時的首付款為1,675百 萬美元（可按慣例調整），且或有里程碑付款不多於500百萬美元，總額最高可達 2,175百萬美元。 上市規則的涵義 由於併購事項的最高適用百分比率超過5%但低於25%， ...

Investment Rating - The report suggests a positive investment outlook for the innovative drug sector, highlighting potential opportunities due to upcoming clinical data and successful overseas clinical progress of pipelines [2][4]. Core Insights - The chemical products sector is experiencing significant price increases due to rising international oil prices and high overseas energy costs, particularly affecting solvent products which are difficult to stockpile [1][10]. - The raw material pharmaceutical products are expected to see price increases as upstream raw material costs rise, with downstream clients maintaining low inventory levels since April 2023, indicating a potential for sustained price increases and profit elasticity [1][10]. - The report emphasizes the importance of the PI3K/AKT/mTOR signaling pathway in cancer treatment, with renewed focus on PI3K inhibitors, particularly following Novartis's acquisition of Synnovation Therapeutics' PI3Kα inhibitor SNV4818 [34][35][36]. Summary by Sections Raw Materials - The report notes that the pharmaceutical raw material sector is poised for price increases due to rising upstream costs and low inventory levels among clients, which could lead to sustained profitability [1][10]. Pharmaceuticals - Novartis announced a $2 billion upfront payment and up to $1 billion in milestone payments to acquire Synnovation Therapeutics' PI3Kα inhibitor SNV4818, indicating a strategic focus on differentiated therapies in the HR+/HER2- breast cancer market [2][34]. Medical Devices - Innovative products in the medical device sector are expanding into international markets, with companies like MicroPort receiving CE certification for pediatric applications of their surgical robots, enhancing their global brand presence [3][11]. Biologics - The report highlights the promising results of the oral GLP-1 Aleniglipron, which showed significant weight loss in clinical trials, suggesting a shift towards oral formulations that improve patient compliance and reduce logistics costs [3][12]. Traditional Chinese Medicine - The report suggests monitoring undervalued high-dividend assets within the traditional Chinese medicine sector as companies begin to release their performance results [3][12]. Healthcare Services and Consumer Healthcare - The report discusses the upcoming release of the DRG/DIP 3.0 version by the National Healthcare Security Administration, expected to be published around July 2023, which will provide insights into the evolving healthcare payment landscape [3][12]. Investment Recommendations - The report recommends focusing on core sectors such as small nucleic acids, bispecific antibodies, and ADCs, while also identifying opportunities during earnings forecast windows and major clinical data release events [2][4].