Core Viewpoint - Mirxes Holding Company Limited has successfully passed the Hong Kong Stock Exchange hearing and is set to launch its global offering, aiming for a listing on May 23, 2025 [1][2] Group 1: IPO Details - Mirxes plans to issue 46.62 million shares, with 90% allocated for international offering and 10% for Hong Kong public offering, raising approximately HKD 1.086 billion [1] - The offering price is set at HKD 23.30 per share, with a minimum subscription of 100 shares [1] - Two investors have committed to purchasing shares worth approximately USD 57.92 million (around HKD 449 million), including Beijing Xunrui and Evergreen Gate [1] Group 2: Company Overview - Founded in 2014 and headquartered in Singapore, Mirxes specializes in microRNA (miRNA) technology for disease screening and diagnostic solutions [2] - The company has one core product, GASTROClear™, and two other commercialized products, LUNGClear™ and Fortitude™, along with six candidates in preclinical stages [2] - GASTROClear™ is the first and only approved blood-based miRNA diagnostic product for gastric cancer screening, having received regulatory approval in Singapore and breakthrough device designation from the FDA [2] Group 3: Financial Performance - Despite having commercialized products, Mirxes is currently operating at a loss, with revenues of USD 17.76 million, USD 24.18 million, and USD 20.28 million from 2022 to 2024, respectively [3] - The company reported losses of USD 56.20 million, USD 69.57 million, and USD 92.21 million during the same period [3] - Operating expenses, including sales, distribution, and administrative costs, are on the rise, with total expenses projected to increase significantly [3] Group 4: Use of Proceeds - The net proceeds from the IPO, estimated at HKD 881 million, will be allocated as follows: 51% for the development and commercialization of GASTROClear™, 24% for ongoing and planned R&D, 15% for enhancing operational capabilities, and 10% for working capital and general corporate purposes [4]

Financial Data and Key Metrics Changes - The company reported $47 million in revenue for Q1 2025, exceeding expectations and showing a growth of over $4 million from Q4 2024 [6][27] - GAAP net loss before noncontrolling interests was $53 million for Q1 2025, compared to a loss of $23 million in Q1 2024 [27] - Adjusted EBITDA was negative $11 million for Q1 2025, down from a positive $8 million in Q1 2024 [28] - Basic and diluted EPS for Q1 was a loss of $0.21 per share, compared to a loss of $0.09 per share in Q1 2024 [30] Business Line Data and Key Metrics Changes - The Nucleic Acid Production (NAP) segment generated $29 million in revenue for Q1 2025, an increase of $1 million from Q4 2024 [6] - The Biologics Safety Testing (BST) segment reported $18 million in revenue for Q1 2025, up $3 million from Q4 2024 and flat compared to Q1 2024 [6][35] - The adjusted EBITDA margin for the BST segment was 70%, indicating strong performance [35] Market Data and Key Metrics Changes - Revenue by customer type in Q1 was 29% from biopharma, 28% from life science and diagnostics, 6% from academia, 7% from CDMO, and 30% through distributors [7] - Revenue by geography was 62% from North America, 15% from EMEA, 15% from Asia Pacific, and 8% from China [7] Company Strategy and Development Direction - The company is focused on a return to growth strategy and building a diversified franchise as a life science tool provider and clinical partner [10] - The strategy includes vertical integration in the NAP segment to enhance quality, speed, and cost efficiency [8] - The company aims to expand its product and service portfolio to drive long-term sustainable growth [10] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges of transitioning from a COVID-driven revenue model to a more diversified business [39] - The company is closely monitoring trade dynamics and working to mitigate potential impacts from tariffs [39] - The cash position of $285 million is seen as sufficient to manage the reset period while focusing on long-term growth [40] Other Important Information - The company plans to publish its 2024 sustainability report, highlighting its commitment to sustainability and long-term strategic objectives [25] - The integration of recent acquisitions is progressing well, enhancing operational capabilities and supply chain control [32] Q&A Session Summary Question: Focus areas for new trials and reasons for discontinuation - Management noted that while preclinical programs were flat, clinical programs showed growth, indicating a focus on later-stage projects due to funding conservatism [44][46] Question: Drivers of incremental demand in the next 12-18 months - Incremental demand is expected from clinical progression, new business wins, and the transition from bulk reagent supply to comprehensive service offerings [48] Question: Opportunities for market share due to U.S. manufacturing - The company sees potential for market share growth as interest in U.S.-based manufacturing increases, particularly in the mRNA space [51][54] Question: Impact of U.S. policy changes on customer buying patterns - Customers are experiencing mixed impacts from government funding changes, with some securing long-term funding while others delay decisions [60] Question: Government work and exposure - The company has no direct government work currently, with past contracts fulfilled, but remains open to future opportunities [66] Question: Seasonality in BST revenue - Q1 is typically a high point for BST revenue, influenced by manufacturing cycles and strong performance in China [70][72]

智通财经APP获悉，据港交所5月12日披露，觅瑞集团(Mirxes Holding Company Limited)通过港交所主板上市聆讯，中 金公司、建银国际为其联席保荐人。 GASTROClearTM市场机会巨大。中国、日本、东南亚及美国胃癌筛查市场规模由2019年的130亿美元增长至2023年 的152亿美元，复合年增长率为4.1%。预计将于2028年增长至212亿美元，并于2033年进一步增长至254亿美元，2023 年至 2028年及2028年至2033年的复合年增长率分别为6.8%及3.7%。 在精准多组学业务细分分部，觅瑞集团专注于为生物制药公司、政府机构以及学术及临床机构提供复杂的、以 miRNA为中心的多组学检测解决方案。此外，公司亦与的合作伙伴合作开发下一代高复杂性诊断应用，以发现各种 疾病以生物标志物形式呈现的新型生物性关连特征，帮助发现候选疗法。该等活动支持公司为临床客户及合作伙伴 开发全面的知识产权及诊断解决方案产品组合，使公司能够在癌症医疗行业保持竞争力。 财务方面，2022年、2023年及2024年，觅瑞集团实现收益分别约为美元1775.9万元、2418.5万元、2028.27万 ...

核心产品GASTROClear™是全球市场上唯一一款获批准进行胃癌筛查的分子诊断IVD产 品。 本文为IPO早知道原创 作者｜ Stone Jin 微信公众号｜ipozaozhidao 据 IPO早知道消息， Mirxes Holding Company Limited （以下简称 "觅瑞"）日前通过港交所聆 讯并于5月12日披露通过聆讯后的资料集，中金公司和建银国际担任联席保荐人。 成立于 2014年 的觅瑞作为 一家微小核糖核酸（「 miRNA」）技术公司，致力于使疾病筛查诊断 解决方案在亚洲关键市场（包括新加坡及中国）触手可及。 截至 2025 年 5 月 7 日 ， 觅 瑞 有 一 种 核 心 产 品 ( 即 GASTROClear™) 、 两 种 其 他 商 业 化 产 品 (即 LungClear™ 及 Fortitude™) 以 及 六 种 处 于 临 床 前 阶 段 的 候 选 产 品 。 其 中 ， 核 心 产 品 GASTROClear™ 是 一个由 12种miRNA生物 标志物 组成的用于胃癌筛查的基于血液的 miRNA检 测组 ，其已于 2019年5月获得新加坡卫生科学局的C类体外诊断 ...

弗若斯特沙利文数据显示，中国、日本、东南亚及美国的胃癌筛查市场规模已从2019年的130亿美元增 至2023年的152亿美元，预计到2033年将突破250亿美元。这一增长背后，是各国医保政策从"治 病"向"防病"的战略转型。 当多数企业仍在实验室阶段徘徊时，Mirxes觅瑞（以下简称"觅瑞"）已率先实现技术破壁。尤其2024年 诺贝尔生理学或医学奖花落miRNA领域，更为觅瑞带来爆发契机。其核心产品GASTROClearTM作为全 球首款获批的miRNA胃癌早筛试剂盒，与传统筛查手段相比，成为一种无创、具有成本效益、更易获 得且便捷的选择，表现出卓越的性能优势。 作为全球少数实现miRNA早筛产品商业化的企业，2025年5月，觅瑞已向中国港交所再次提交IPO申 请。在港股18A上市企业中，明确以早筛为核心业务或拥有成熟早筛产品的企业较少，其中觅瑞的 miRNA技术独特性显著。 在资本与技术双轮驱动下，前景可期的觅瑞野心更不止于胃癌——其多癌种早筛管线也已蓄势待发。觅 瑞在招股书中透露，在中国、美国及日本的扩张最终将由早期检测试剂盒产品引领。尽管提供实验室自 研检测（LDT）服务可以提升品牌知名度并迅速在新市场 ...

雷递网 雷建平 5月7日 | | | | 截至12月51日上午反 | | | | | --- | --- | --- | --- | --- | --- | --- | | | 2022年 | | 2023年 | | 2024年 | | | | | 估收益 | | 估收益 | | 佔收益 | | | 美元 | 百分比 | 美元 | 白分比 | 美元 | 百分比 | | 收益 | 17.758.971 | 100.0 | 24.185.013 | 100.0 | 20.282,675 | 100.0 | | 銷售成本 | (8,432,593) | (47.5) | (10,603,016) | (43.8) | (11,395,665) | (56.2) | | 毛利 | 9,326,378 | 52.5 | 13,581,997 | 56.2 | 8,887,010 | 43.8 | | 其他收入及 | | | | | | | | 其他收益／(虧損) | 2.333.802 | 13.1 | 726,163 | 3.0 | (6,318,319) | (31.2) | | 銷售及分銷開支 | (13,586 ...

BioNTech (BNTX) Q1 2025 Earnings Call May 05, 2025 08:00 AM ET Company Participants Michael Horowicz - Director - IRUgur Sahin - Co-Founder, CEO & Chair of the Management BoardÖzlem Türeci - Co-Founder, Chief Medical Officer & Member of Management BoardJens Holstein - CFORyan Richardson - Chief Strategy OfficerAkash Tewari - Managing DirectorCory Kasimov - Senior Managing DirectorMohit Bansal - Managing DirectorKarina Rabayeva - VP - Biotech Equity ResearchHarry Gillis - Vice President - Pharmaceuticals Equ ...

Core Insights - Recently, Yuyuan Pharmaceutical achieved a breakthrough in new drug development with its mRNA vaccine YKYY025 for respiratory syncytial virus (RSV) receiving clinical trial approval from the National Medical Products Administration (NMPA) in China, following prior approval from the FDA in the United States, showcasing the company's strong innovation capabilities and international competitiveness [1][3] Group 1: Innovation in mRNA Vaccine Development - Yuyuan Pharmaceutical's subsidiary, Hangzhou Tianlong Pharmaceutical, has successfully submitted clinical trial applications for multiple mRNA vaccines, including YKYY026 for shingles, which has also been accepted by the NMPA [3] - The company has received clinical approvals for its broad-spectrum anti-coronavirus peptide YKYY017 aerosol inhalation and long-acting lipid-lowering nucleic acid drug YKYY015 in both China and the U.S. [3] - Yuyuan's proprietary nucleic acid delivery system has been granted patents in multiple countries, including the U.S., Japan, and Israel, establishing a solid foundation for its mRNA vaccine and nucleic acid drug development [3] Group 2: Comprehensive R&D Platform - The company has built a complete platform system for nucleic acid drug development, covering target discovery, high-throughput screening, process development, and quality control, which is rare among domestic pharmaceutical companies [4] - Yuyuan Pharmaceutical has multiple innovative products nearing commercialization, with three class 1 innovative drugs receiving acceptance for market application, and its peptide drug YKYY017 entering phase III clinical trials [4] - The anti-liver cancer antisense oligonucleotide drug CT102 has completed phase IIa clinical trials, indicating a strong pipeline that could provide new treatment options for patients and drive future growth for the company [4]

据招股书披露，瑞博生物成立于2007年，是研究和开发小核酸药物、尤其专注于siRNA疗法的全球领军 者，也是最早涉足该领域的开拓者之一。公司致力于率先开发创新疗法，以彻底改变亟需解决的疾病治 疗方式，这些疾病包括心血管、代谢类、肾脏和肝脏疾病。 瑞博生物在招股书中称，公司已建立自主研发的技术平台，涵盖小核酸药物开发的所有关键方面，从药 物递送、化学修饰、多靶点药物设计到模型引导的药物开发和生产，实现从早期研究到商业化的全生命 周期支持。这种整合和可扩展的方法已通过瑞博生物的小核酸候选药物管线进行验证，并继续推动企业 药物开发过程的创新和效率。 21世纪经济报道记者 唐唯珂 广州报道 4月25日，苏州瑞博生物技术股份有限公司（以下简称"瑞博生物"）正式向港交所递交主板上市申请， 联席保荐人为中金公司与花旗银行。 这是继2021年科创板终止审核后，这家中国小核酸药物企业的又一重大资本动作。公司曾于2020年12月 29日申报科创板并获受理，在经过一轮问询与回复后撤回申报材料，2021年5月21日被上交所终止。 凭借全球领先的siRNA（小干扰RNA）技术平台及丰富的临床管线，瑞博生物在小核酸药物领域积累了 深厚的 ...

全球范围内首家且唯一一家获得分子胃癌筛查IVD产品监管批准的公司。 本文为IPO早知道原创 作者｜Stone Jin 微信公众号｜ipozaozhidao 据 IPO 早 知 道 消 息 ， 中 国 证 监 会 国 际 合 作 司 于 2025 年 1 月 24 日 披 露 了 《 关 于 Mirxes Holding Company Limited（觅瑞集团控股有限公司，以下简称"觅瑞"）境外发行上市备案通知书》。 成立于2014年的觅瑞作为一家起源于新加坡的微小核糖核酸("miRNA")技术公司，中国总部在浙江 安吉，专注于在全球范围内普及疾病筛查诊断解决方案。 截至2024年10月31日，觅瑞拥有一种核心产品(即GASTROClear™)、两种其他商业化产品(即 LungClear™及Fortitude™)以及六种处于临床前阶段的候选产品。 其中，觅瑞的核心产品GASTROClear™为一个由12种miRNA生物标志物组成的用于胃癌筛查的基 于血液的miRNA检测组，其已于2019年5月获得新加坡卫生科学局的C类体外诊断证书后成功商业 化。 根据弗若斯特沙利文的资料，觅瑞是开发及商业化用于癌症及其他疾病 ...