FF301 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12月31日 狀態: 新提交 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1月5日 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 | ...

Investment Rating - The report maintains an "Outperform" rating for the industry [7] Core Insights - The pharmaceutical sector experienced a significant rebound in 2025, driven by innovation, and is expected to reach new highs in 2026 [4][17] - The A-share market saw a 12.9% increase year-to-date, while the H-share market surged by 57% [18] - The report emphasizes the importance of tracking macroeconomic conditions and the potential for valuation recovery in the consumer healthcare sector [4][24] Market Review - The CITIC Pharmaceutical Index fell by 2.0% in the week of December 29, 2025, to January 2, 2026, underperforming the CSI 300 Index by 1.4 percentage points [3][32] - Year-to-date, the CITIC Pharmaceutical Index has risen by 12.9%, lagging behind the CSI 300 Index by 4.8 percentage points [32] - The top-performing stocks for the week included Duorui Pharmaceutical (+15.9%) and Mailland (+10.3%) [47] Sector Performance - The report highlights significant sector differentiation, with the medical services sector (including CXO and innovative supply chains) showing the highest growth, exceeding 50% [24] - The quarterly performance showed a strong start in Q1, followed by fluctuations in Q2 and Q4 due to various market catalysts [27] Investment Strategy - The report suggests focusing on innovative drugs, particularly those with revenue and performance exceeding expectations, as well as companies benefiting from technological advancements [5][4] - Specific stocks recommended for January include Kangfang Biotech, WuXi AppTec, and Aidi Pharmaceutical [5][4]

Investment Rating - The report does not explicitly state an investment rating for the interleukin industry Core Insights - The interleukin family consists of various cytokines that play significant roles in immune regulation, inflammation, and cancer, with many related drugs and clinical pipelines in development [4][5] - The IL-12 and IL-23 cytokines are crucial in immune modulation and have become important therapeutic targets for autoimmune diseases such as psoriasis and Crohn's disease [9][10] - The market for IL-4Rα drugs in allergic diseases is expanding, with two main drugs approved in China for treating allergic asthma and other conditions [16] - IL-1β inhibitors are gaining traction in gout treatment, with a notable increase in patient numbers projected for high uric acid levels and gout by 2030 [23][25] - Artificial intelligence is enhancing drug development processes across various stages, significantly reducing the time required for drug discovery and optimization [31][32] Summary by Sections Interleukin Family Overview - The interleukin family includes multiple members categorized into several groups, each with distinct roles in immune response and disease [3][4] - Key interleukins such as IL-1, IL-2, IL-6, IL-10, and IL-17 are involved in autoimmune and inflammatory diseases, with existing drugs and clinical pipelines targeting these cytokines [5] Market Status of IL-12/IL-23 - Several drugs targeting IL-12 and IL-23 have been approved for treating autoimmune diseases, with notable examples including Ustekinumab and Guselkumab [8][10] - The first fully human monoclonal antibody targeting IL-12/IL-23, Iroquois, is set to launch in 2025 for moderate to severe plaque psoriasis [10] IL-4 in Allergic Diseases - Two IL-4Rα drugs have been approved in China for allergic diseases, with Dupilumab included in the national medical insurance list [16] - The report outlines ongoing clinical trials for additional IL-4Rα therapies targeting various allergic conditions [17] IL-1β Inhibitors in Gout Treatment - The report highlights the increasing prevalence of high uric acid and gout, with projections indicating significant growth in patient numbers by 2030 [21][23] - The first IL-1β monoclonal antibody, Canakinumab, has been approved for gout treatment, with a projected global sales figure of $1.5 billion by 2024 [25] Role of Artificial Intelligence in Drug Development - AI is transforming drug discovery by streamlining processes and improving efficiency, reducing the time for lead compound optimization from approximately 65 months to 30 months [32] - The integration of AI in drug development enhances the accuracy of personalized medicine and accelerates the identification of effective drug candidates [31][32]

Group 1 - Hong Kong biopharmaceutical stocks weakened during trading on December 30, with Genscript Biotech falling nearly 4% [1] - Fuhong Hanlin declined by nearly 3%, while Kelun-Biotech dropped over 2% [1] - Other stocks such as CanSino Biologics, Rongchang Biologics, and Kanyin Biologics also experienced declines of over 1.5% [1]

Summary of the Conference Call for 康诺亚 Company Overview - 康诺亚 is focused on developing monoclonal antibodies and other innovative therapies, with a strong emphasis on addressing chronic diseases such as asthma, chronic rhinosinusitis, and atopic dermatitis. Key Points Industry and Market Position - 康诺亚's four non-competitive monoclonal antibody has been included in the medical insurance directory, expected to be priced lower than Dupilumab, providing a competitive market entry advantage [2][3] - The market for type 2 inflammatory response treatments is significant, with Dupilumab projected to reach $14 billion in sales by 2024, indicating substantial market potential for 康诺亚's products [5] Product Pipeline and Clinical Development - **四不击败单抗**: Currently the first domestically produced IL-4R monoclonal antibody, has expanded to treat adult atopic dermatitis, chronic rhinosinusitis with nasal polyps, and allergic asthma, with plans for further indications [2][5] - **CM512 (IL-13/TSLP Dual Antibody)**: Phase I data shows significant improvement in IC90, advancing to Phase II trials for chronic rhinosinusitis, asthma, and COPD, with data expected in 2026 [2][3] - **CMG901 (Claudin 18.2 ADC)**: Leading global progress, expected to complete Phase III trials for second-line gastric cancer by mid-2026 and submit NDA applications [2][4] Sales and Revenue Projections - Sales for the four non-competitive monoclonal antibody are projected to reach RMB 3 billion for the year, with a rapid increase expected in the following year [2][3] - Sales forecasts for the monoclonal antibody are RMB 330 million in 2025, RMB 905 million in 2026, and RMB 1.627 billion in 2027 [10] Competitive Advantages - 康诺亚's products have unique advantages in treating chronic rhinosinusitis and allergic rhinitis, with the latter being the only approved drug in China for this indication [7] - The company holds a 1-2 year exclusive period in the domestic market for atopic dermatitis, allowing for accelerated market share capture [5][6] Future Growth and Risks - The adjustment of the medical insurance directory in 2026 is expected to enhance market access and drive sales growth [10] - The DCF valuation model estimates the company's market value at RMB 22.9 billion, indicating a potential 50% upside from current levels, but risks remain if R&D progress does not meet expectations [10] Emerging Technologies - 康诺亚 is actively exploring new technology platforms such as small nucleic acids and PROTAC, which are expected to enrich the product pipeline and enhance commercialization opportunities [2][4] Additional Insights - The company is well-positioned in the respiratory disease market, with approximately 46 million asthma patients and nearly 100 million COPD patients in China, indicating a large potential patient base [8] - The unique selling propositions of 康诺亚's products, including longer half-lives and specific targeting of chronic conditions, are expected to attract a significant patient population [8][9]

Investment Rating - The report does not explicitly state an investment rating for the biopharmaceutical industry, but it suggests a positive outlook based on upcoming catalysts and potential drug approvals. Core Insights - The biopharmaceutical sector is expected to see significant developments in 2026, with multiple domestic drugs anticipated to report key clinical data. This includes drugs from companies like Betta Pharmaceuticals, Hutchison China MediTech, and CanSino Biologics, which are expected to read out critical clinical data in 2026 [3][21]. - The report emphasizes that the long-term theme for the innovative drug sector is international expansion, with several sub-themes to focus on, including overseas business development (BD) licensing, key clinical trials, and unexpected overseas sales growth [3][18]. Summary by Sections Weekly New Drug Market Review - From December 22 to December 28, 2025, the top five gainers in the new drug sector were Dongyao Pharmaceutical (+23.15%), Beihai Kangcheng (+19.27%), Junshengtai (+16.41%), Shiyao Group (+6.95%), and Ailis (+5.78%). The top five losers were Gakos (-16.11%), Jiahe Biotech (-10.29%), Laika Pharmaceuticals (-9.33%), Yunding Xinyao (-8.98%), and Yongtai Biotech (-6.94%) [1][14]. Weekly Focused Stocks - The report suggests focusing on several stocks with high overseas expansion potential, including: 1. Companies with MNC certification and high overseas volume certainty: Sanofi, United Pharmaceuticals, and Kelun-Biotech. 2. Companies with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and InnoCare Pharma. 3. Potential heavyweights for overseas MNC licensing: Junshi Biosciences, Shiyao Group, and Yifang Biotech. 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat loss and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18]. Weekly New Drug Approval & Acceptance Status - This week, 23 new drug or new indication applications were approved in China, and 10 new drug or new indication applications were accepted [4][19]. Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 99 new drug clinical applications were approved, and 64 new drug clinical applications were accepted [5][24]. Key Domestic Market Events - Notable events include: 1. Xiansheng Zhaoming announced a global exclusive licensing agreement with Ipsen for an ADC drug, potentially worth up to $1.06 billion. 2. He Yu Pharmaceuticals received approval for its CSF-1R selective small molecule inhibitor. 3. Tongyi Pharmaceuticals announced a licensing agreement for a peptide conjugate drug for prostate cancer, with potential payments totaling around $2 billion [10]. Key Overseas Market Events - Significant overseas events include: 1. Novo Nordisk received FDA approval for a 25mg oral semaglutide tablet for weight loss. 2. Sanofi announced a cash acquisition agreement for Dynavax Technologies Corporation, valued at approximately $2.2 billion. 3. Agios Pharmaceuticals announced FDA approval for an oral PK activator for treating α or β thalassemia in adult patients [11].

Investment Rating - The report suggests a positive investment outlook for the medical device sector, particularly in brain-computer interface devices, which are expected to see accelerated commercialization due to supportive policies [1][3]. Core Insights - Recent policies have significantly increased support for innovation in medical devices, with the National Medical Products Administration actively promoting faster market entry for brain-computer interface devices, indicating a diverse application landscape and substantial future potential [1][3]. - The pharmaceutical sector is witnessing positive developments, such as GSK's approval of mepolizumab for a new indication in COPD patients, marking it as the first monthly administered biologic in China, which is expected to reduce the annual incidence of severe exacerbations significantly [1][32]. - The report highlights the approval of Wegovy® tablets in the U.S. for weight management, emphasizing its potential impact on the market as the first oral GLP-1 receptor agonist for this purpose [37][40]. Summary by Sections Pharmaceutical Sector - Mepolizumab has been approved for COPD treatment in China, with a monthly dosing schedule, targeting a significant patient population [1][32]. - The A/H share innovation drug sector maintains high activity levels, with new drug approvals and cross-border transactions remaining robust [16][28]. Biologics - Wegovy® tablets have been approved in the U.S. for weight management, showing similar weight loss efficacy to its injectable counterpart, with a significant portion of participants achieving substantial weight loss [37][40]. CXO and Pharmaceutical Supply Chain - The CXO sector continues to show upward momentum, supported by a stable order backlog, with November financing levels slightly above the annual average [44][46]. Medical Devices - The centralized procurement process for high-value medical consumables is progressing steadily, with high selection rates in multiple rounds of bidding, indicating a favorable environment for leading domestic companies [2][52]. Retail Pharmacy - The industry is undergoing a consolidation phase, with leading companies expected to benefit from increased market share through mergers and acquisitions [2][3]. Medical Services and Consumer Healthcare - Aier Eye Hospital's acquisition of 39 institutions for 960 million yuan strengthens its market position, with the acquired entities showing signs of financial recovery [2][3].

Core Viewpoint - The report from Guojin Securities highlights the promising pipeline of Connoa-B (02162), with its core product, Supacibab, already approved for market. The company is expanding its clinical trials for CM512 (TSLP/IL-13 bispecific antibody) and expects to submit an NDA for CMG901 in the U.S. by 2026. The company has a robust pipeline and is well-positioned for growth, receiving a "Buy" rating with a target price of HKD 83.29 [1]. Group 1: Product Pipeline and Market Potential - Supacibab is the first domestically produced IL-4R monoclonal antibody, providing a significant first-mover advantage. It targets various type II inflammatory diseases, with expectations for rapid market uptake post-2026 when it enters the national medical insurance directory [1]. - The global sales of Dupilumab, a competing IL-4R monoclonal antibody, exceeded USD 14 billion in 2024, indicating a strong market potential for Supacibab, which has already been approved for three indications [1]. - Sales projections for Supacibab are estimated at CNY 0.36 billion in 2024, CNY 1.69 billion in the first half of 2025, and expected to reach CNY 3.31 billion, CNY 9.05 billion, and CNY 16.27 billion from 2025 to 2027 [1]. Group 2: Clinical Development and Competitive Landscape - CM512 is currently in Phase II clinical trials and is positioned as the second globally in development, with significant differentiation advantages in the respiratory market. It targets asthma and COPD, with potential approval by 2029 [2]. - CMG901, a Claudin 18.2 ADC, has been licensed to AstraZeneca and is the fastest progressing globally. It is expected to complete Phase III trials for second-line gastric cancer by 2026 and submit for market approval, with potential milestone payments and royalties for the company [2]. Group 3: Financial Projections and Valuation - The company is projected to achieve revenues of CNY 6.61 billion, CNY 12.55 billion, and CNY 20.64 billion for the years 2025, 2026, and 2027, reflecting year-on-year growth rates of 54%, 90%, and 65% respectively [3]. - The net profit forecast shows a loss of CNY 5.13 billion in 2025, narrowing to a loss of CNY 2.97 billion in 2026, before turning to a profit of CNY 2.01 billion in 2027, with corresponding EPS of -1.72, -0.99, and 0.67 [3]. - A DCF valuation method has been applied, resulting in a target price of HKD 83.29, with an initial "Buy" rating assigned [3].

Core Viewpoint - The report from Guojin Securities highlights the promising pipeline of Connoa-B (02162), with its core product, Supqi Baidankang, already approved for market release. The company is advancing multiple Phase II clinical trials for CM512 (TSLP/IL-13 bispecific antibody) and expects to submit an NDA for CMG901 to the FDA by 2026, indicating a strong growth potential and robust pipeline [1]. Group 1: Product Pipeline and Market Potential - Supqi Baidankang is the first domestically produced IL-4R monoclonal antibody, which is expected to gain rapid market traction after being included in the national medical insurance directory by December 2025, with anticipated sales of 0.36 million, 1.69 million, 3.31 million, 9.05 million, and 16.27 million yuan from 2024 to 2027 [1][3]. - CM512 (TSLP/IL-13 bispecific antibody) is currently in Phase II clinical trials and is positioned as the second globally in development, targeting a broad respiratory market with significant potential, expected to be approved by 2029 [2]. - CMG901 (Claudin 18.2 ADC) has been licensed to AstraZeneca and is the fastest progressing globally, with expectations to complete Phase III clinical trials for second-line gastric cancer by 2026 and potentially launch in 2027, which could yield milestone revenues and royalties for the company [2]. Group 2: Financial Projections and Valuation - The company is projected to achieve revenues of 661 million, 1.255 billion, and 2.064 billion yuan for the years 2025, 2026, and 2027, reflecting year-on-year growth rates of 54%, 90%, and 65% respectively, with a turnaround to profitability expected in 2027 [3]. - The estimated earnings per share (EPS) are projected to be -1.72, -0.99, and 0.67 yuan for the years 2025, 2026, and 2027, indicating a path towards profitability [3]. - Based on a DCF valuation method, the target price is set at 83.29 HKD, with an initial "buy" rating assigned [3].

Core Viewpoint - The probability of IPO failure for companies like Maijizhi Bio, which have not yet entered the hearing stage after submitting their applications to the Hong Kong Stock Exchange, is increasing, with the company expressing concerns about the successful development and commercialization of its core product MG-K10 [1][4]. Company Overview - Maijizhi Bio, established in 2016, focuses on clinical-stage biopharmaceuticals for allergic and autoimmune diseases, with a pipeline of eight innovative candidates, the most advanced being the long-acting anti-IL-4Rα antibody MG-K10 [2][4]. - The company has partnered with Kangzhe Pharmaceutical, granting them exclusive commercialization rights for MG-K10, which reflects Maijizhi Bio's challenges in independently navigating a competitive market [2]. Market Potential - The global market for atopic dermatitis drugs is projected to grow from $14.2 billion in 2023 to $29.1 billion by 2032, with the Chinese market expected to increase from 8.4 billion RMB to 46.4 billion RMB [3]. - The IL-4Rα space in China is highly competitive, with multiple companies, including Sanofi and Kangzhe, already having products on the market or in advanced clinical stages [3]. Intellectual Property Challenges - Maijizhi Bio faces significant intellectual property challenges, particularly from its former parent company, Sanofi, which has initiated legal actions regarding patents related to MG-K10 [5][6]. - The company has previously lost a patent dispute to Sanofi, which raises concerns about the stability of its core patents and the potential impact on MG-K10's commercialization [7]. Financial Situation - Since its inception, Maijizhi Bio has operated without product revenue, relying on financing to sustain operations, with reported revenues of 8.72 million RMB, 24,000 RMB, and 0 RMB for 2023 and the first quarter of 2025 [8][9]. - The company has incurred significant losses, with net losses of 253 million RMB, 178 million RMB, and 27 million RMB for the same periods, and a cumulative loss exceeding 808 million RMB as of March 2025 [9]. - Cash flow is a critical concern, with only 70.78 million RMB in cash and equivalents as of March 31, 2025, and estimated costs of 500 to 600 million RMB needed to complete clinical trials and registration for MG-K10 [9]. Financing and Investment - Maijizhi Bio has successfully raised over 700 million RMB through multiple financing rounds since its establishment, achieving a post-investment valuation of 2.64 billion RMB after the Pre-IPO round in 2025 [10]. - Some early investors have begun to exit, with significant share transfers occurring prior to the company's IPO application, indicating potential investor concerns about the company's future [10].