每经记者｜许立波 每经编辑｜董兴生 6月30日，云顶新耀（HK01952，股价62.2港元，市值203亿港元）股价上涨8.74%，近7个交易日累计上涨28.6%。 在近日举行的mRNA创新技术平台研发日活动上，云顶新耀展示了mRNA（信使核糖核酸）技术平台和自身免疫疾病领域的三款产品，分别是通用型现货肿 瘤治疗性疫苗EVM14、个性化肿瘤治疗性疫苗EVM16，以及自体生成CAR-T（嵌合抗原受体T细胞免疫疗法）项目。 "我们已与全球Top 20药企广泛建立接洽，BD（商务拓展）策略聚焦通过国际伙伴资源推动创新药全球布局。"云顶新耀首席执行官罗永庆表示，公司在BD 方面"有选择权"，能够等待一个好的时间点以追求最大的回报。 据云顶新耀透露，EVM14全球多中心I期临床试验（EVM14 C101）即将启动，预计于2025年第三季度完成首例患者入组。云顶新耀嘉善工厂已于今年6月9 日顺利放行首批GMP临床试验样品，预计将于8月中旬运抵美国各临床研究中心。 mRNA平台已成国际药企关注焦点 云顶新耀曾是mRNA新冠疫苗大军中的一员。2021年9月，云顶新耀与Providence签订许可协议，引进了mRNA新冠疫苗，但 ...

宠物医药：突破从 0 到 1，何以从 1 至 1020260629 摘要 中国宠物药品市场增长迅速，年复合增长率达 22%，需求具有刚性，贯 穿宠物生命周期。宠物老龄化加速，七岁以上老年犬占比显著提升，推 动老年病用药需求增加，养宠意识提升也增强了消费意愿。 宠物临床用药面临供给瓶颈，尤其老年病用药紧缺，长期依赖进口。行 业探索人药转化，发布《宠物临床急需使用的人用药品目录》以缓解供 需矛盾，并加速研发创新，突破慢性疾病、肿瘤等特效药研发。 国产企业在核心疫苗领域取得进展，如猫三联疫苗。瑞普生物推出国内 首个获批上市的猫三联疫苗瑞苗舒，截至 2025 年 6 月，共有 11 款国 产猫三联疫苗上市，逐步打破外资垄断。 宠物疫苗市场空间广阔，国产替代加速。国内强制免疫狂犬疫苗市场份 额约为 30-40 亿元，猫三联和犬联两种核心疫苗分别约 20 亿元左右规 模。国产企业逐步突破，形成技术集权效应。 国产猫三联疫苗在毒株匹配性和价格方面具有优势。国产疫苗毒株更适 合国内猫咪，且价格通常比进口疫苗低 20%左右，推动国产替代。 Q&A 当前我国宠物药品市场的主要特征是什么？ 我国宠物药品市场的主要特征包括需求爆发和 ...

近年来，创新药支持政策不断加码，从去年国务院审议通过《全链条支持创新药发展实施方案》，到本 月国家药监局发布的《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》，都在持续 为创新药研发注入强心剂。 在政策东风下，中国创新药企出海交易正呈现井喷态势，医药魔方数据显示，仅2025年第一季度，中国 创新药"License-out"（授权许可）交易金额已达369.29亿美元，一批拥有强劲自研实力的创新药企正在 吸引全球生物医药产业的目光。 日前，云顶新耀（01952.HK）的一则公告在创新药领域激起涟漪：公司宣布将于6月27日举办2025云顶 新耀mRNA创新技术平台研发日。 这是云顶新耀首次举办mRNA技术平台研发日，此次对自研实力的集中展示不仅标志着这家曾经 以"License-in"（授权引进）为人熟知的企业，完成了向创新药企的战略转身，更预示着其自研mRNA平 台已初具规模，正迎来价值释放的收获期。同时，这也是中国创新药行业从"跟跑"到"领跑"的一个缩 影。 而支撑这一创新平台走向世界的，是其日益稳固的商业化基础。成立7年以来，云顶新耀成功引进了耐 赋康®（布地奈德肠溶胶囊）、依嘉®（注射用依拉环 ...

智通财经APP获悉，美国监管机构已批准mRNA疫苗领域领军者Moderna(MRNA.US)旗下的一款疫苗产 品用于预防更多成年人群体罹患常见呼吸道疾病，这可能显示出特朗普政府对于mRNA疫苗技术的抵制 有所缓和。此项批准将帮助 Moderna 瞄准更大规模市场，因为其竞争对手辉瑞已获准向60岁以下高风 险人群出售其RSV疫苗，葛兰素史克已获准向50至59岁高风险人群出售RSV疫苗。 Moderna 在一份声明中表示，该公司可向60岁以下、感染呼吸道合胞病毒(RSV)风险较高的成年人销售 这款疫苗产品。据了解，美国食品药品监督管理局(FDA)去年已批准该疫苗用于60岁及以上人群，这也 意味着为Moderna在其mRNA新冠疫苗之后带来了第二款mRNA疫苗产品。 自那以后，Moderna 的RSV疫苗产品一直难以获得广泛采用。此次针对更年轻成人的新增批准，将帮助 该公司面向更大规模的疫苗市场。其竞争对手辉瑞公司(PFE.US)此前已获准向60岁以下高风险患病人群 出售RSV疫苗;另一RSV疫苗竞争对手葛兰素史克公司也已获准向50至59岁这一范围的高风险人群销售 RSV疫苗产品。 今年4月，美国FDA关键顾问小组 ...

BioNTech SE BNTX on Thursday agreed to acquire CureVac N.V. CVAC in an all-stock transaction.According to the agreement, shareholders can exchange CureVac shares for around $5.46 in BioNTech ADSs. This equates, roughly, to an equity value of $1.25 billion.The consideration is subject to a collar mechanism. If the 10-day volume weighted average price of the BioNTech ADSs ending on the fifth business day before the offer’s closing exceeds $126.55, the exchange ratio would be 0.04318. If the VWAP is lower than ...

Moderna (MRNA) FY Conference June 11, 2025 08:40 AM ET Speaker0 So much for joining us. Really pleased to have Stephane Benzel, CEO of Moderna, with us. Maybe just start here, Stephane. You know, in the context of the current environment, both from a COVID demand and regulatory standpoint and the overall health care policy that we're seeing flow through from HHS and FDA and then there's the drug pricing dynamics. But just walk us through today where Moderna's business stands from a revenue and expenses stan ...

Moderna (MRNA) FY 2025 Conference May 29, 2025 10:00 AM ET Speaker0 Sure. Speaker1 Fantastic. So I am thrilled to be here today with Stephane Pansell from Moderna. My name is Courtney Breen. I am The U. S. Biopharma Analyst here at Bernstein. Before we dive into the Q and A, I will give Stephane the opportunity to give us some context to where Moderna is at, and then we'll dive in. I've got a long, long list of questions, and we I'm sure we won't get through all. For as a reminder, and I think if you have a ...

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]

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]