Enfuvirtide

GLP-1减肥药概念的火热行情从2023年持续烧到了2024年，以诺和诺德和礼来为主导的两大强者，手握司美格鲁肽和替尔泊肽，一路高歌猛进，稳坐全球制药企业市值前两位。 而在国内，有这样一家企业，深耕多肽领域20余年，2024年上半年多肽原料药出口同比增长97.51%，这就是圣诺生物。 近来，圣诺生物在资本的关注下经历了市值“过山车”。冷静过后，要如何看待多肽龙头圣诺生物？ 专注多肽20余年 与很多“跟风”上马多肽项目的国内企业不同，成立于2001年的圣诺生物，是国内最早一批多肽研发生产企业。董事长兼首席科学家文永均是国内最早研究多肽药物领域的专家之一，曾主持开发了国内第一个经国家批准并取得新药证书的多肽药物胸腺五肽，并主持完成胸腺法新的国内首仿。 2021年，圣诺生物登陆A股科创板后，业绩始终保持稳健增长。2021年-2023年，营业收入分别为3.87亿元、3.96亿元及4.35亿元；归母净利润分别为6125万元、6449万元及7034万元。 从2023年四季度开始，圣诺生物业绩明显提速。2024年，在政府补贴减少的情况下，净利润增长8.14%，扣除非经常损益后，净利润增长达到106.6%，自我造血能力得到充分加强。 推动圣诺生物业绩增长的是其三大核心业务，分别是多肽创新药CDMO服务、多肽制剂业务以及多肽原料药业务。 在多肽CDMO领域，圣诺生物凭借多肽合成和修饰核心技术优势，先后为山东鲁抗、山西锦波、派格生物、百奥泰制药、江苏普莱、哈尔滨医大药业、众生睿创等新药研发企业和科研机构提供了40余个项目的多肽创新药药学CDMO服务，其中2个品种获批上市进入商业化阶段，1个进入申报生产阶段，20个进入临床试验阶段。 得益于越来越多的产品进入商业化或临床试验后期，圣诺生物2024年上半年定制生产业务实现营收1046.8万元，同比增长3.74倍。 在多肽制剂产品方面，圣诺生物挑选在国内外具有较大市场容量及较强市场竞争力的多肽仿制药品种进行研发，开发的10个多肽制剂品种在国内取得了14个生产批件，产品涵盖免疫系统疾病、肿瘤、心血管、慢性乙肝、糖尿病及产科疾病等多肽药物发挥重要作用的领域。 2023年6月，多肽制剂产品注射用生长抑素、注射用阿托西班集采中标后快速放量，制剂销售收入大幅增长，从去年同期的6378万元，增长至9456万元，同比增长48.3%，占总营收的比例达47.5%。 图1 2024年上半年圣诺生物营收情况 图片来源：圣诺生物半年报 虽然制剂业务收入占比最高，但在圣诺生物的三大核心业务中，原料药业务才是更具增长潜力的。 多肽原料药“水涨船高” 近年来，随着多肽药物技术的飞速发展，全球多肽药物市场规模不断扩大，根据Frost&Sullivan的统计及预测，全球市场规模从2016年的568亿美元上涨到2020年的628亿美元，预计到2030年将达到1418亿美元。 图2 全球多肽市场规模 图片来源：华安证券 得益于多肽药物市场持续扩容，上游原料药需求急剧提升。根据Polypeptide官网显示，2020年全球多肽原料药市场规模达18亿美元，其中65%采用外包服务（2020-2025年复合增速有望达10%）。其中，中国多肽原料药注册数量快速增长，截至2023年底，中国NMPA共批准80件多肽药物上市，占全球批准上市多肽药物数量43%。 虽然多肽药物具有高活性、低剂量、低毒性等优点，但同样存在生产成本高、给药不便的缺点。多肽药物规模化生产难度较大，部分大品种原料药国际市场每千克高达25万-50万美元。 目前多肽合成的方法中，固相合成是生产的主流方法，但固相合成工艺具有较高的技术壁垒。尤其是GLP-1药物使用的长链多肽原料药，合成过程往往需要经过几十个步骤，合成难度大、收率低，且多肽药物对于纯度的要求较高，各环节的工艺技术、质量控制以及生产成本控制都有较高的技术门槛。 圣诺生物经过多年的技术积累，逐渐掌握了长链肽偶联技术、单硫环肽规模化生产技术、多对二硫环肽合成技术、片段缩合技术、聚乙二醇化修饰技术、脂肪酸修饰技术等多项多肽合成和修饰类核心技术，并解决了多个多肽原料药品种规模化生产的技术瓶颈。 在原料药品种方面，拥有19个自主研发的多肽类原料药品种。在国内市场，取得14个品种多肽原料药生产批件或激活备案，其中恩夫韦肽、卡贝缩宫素为国内首仿品种；在国外市场，比伐芦定、依替巴肽、利拉鲁肽等10个品种获得美国DMF备案。 目前，圣诺生物原料药产品已销往欧美、韩国等国家和地区，与费森尤斯（Fresenius）、Masung、DAEHAN、华源沙赛、海南中和、上药第一生化、扬子江等众多国内外知名制药企业建立了合作关系。 2024年上半年，圣诺生物原料药收入5683万元，同比增长11.2%，其中原料药境外销售比去年同期增加97.51%，成为其利润增长的主要驱动力之一。 下半场怎么打？ 近日，礼来官宣其GLP-1产品替尔泊肽也在中国获批减重适应症，诺和诺德的司美格鲁肽和礼来替尔泊肽的竞争趋于白热化。 数据显示，2023年司美格鲁肽收入211.58亿美元，位居全球畅销创新药第二，2024年一季度继续保持两位数的增长速度达到61亿美元，以此趋势，有望在2024年登顶药王宝座。 而礼来的替尔泊肽在2022年获批降糖适应症后，2023年销量就达到了51.63亿美元。2023年底，替尔泊肽获批减重适应症，2024年一季度销售收入就达到了23.24亿美元，同比增长308.8%，成为有史以来爬坡放量速度最快的药物之一。 而国内GLP-1的竞争也日趋激烈，全球在研GLP-1药物有近280款，其中来自中国药企的有115款。GLP-1药物的超预期增长，也开启了上游原料药及CDMO产能大战。 现阶段产能成为限制多肽药物销售放量的关键因素，诺和诺德及礼来分别投入超百亿美元加速布局自有产能。根据中金公司分析，考虑到投产节奏，多肽原料药优质产能供不应求的局面将维持到至少2026年。 图3 诺和诺德扩产情况 图片来源：国盛证券 为抓住市场发展机遇，圣诺生物加快在建工程项目实施进度。2024年上半年，“年产395千克多肽原料药生产线项目”“制剂产业化技术改造项目”和“多肽创新药CDMO、原料药产业化项目”主体建设已完成并进入设备调试阶段，随着未来产能逐渐释放，有望带动业绩持续增长。 此外，为提升多肽药物研发能力及优化生产工艺，圣诺生物持续加大研发投入。2024年上半年，研发投入2439万元，同比增长56.39%。募投项目“工程技术中心升级项目”顺利结项，有效确保未来3-5年研发工作的顺利开展。 结语 相对于国内的GLP-1创新药、仿制药研发热潮，处在产业链上游的原料药及CDMO可以更早享受到市场扩张带来的红利，并且随着未来专利到期，仿制药上市，相关原料药的供应需求必将大幅增加。圣诺生物占据先发优势，但能否将先发优势转化为长久的竞争优势，值得持续关注。 参考资料 1.圣诺生物招股书、年报、半年报 2.《圣诺生物(688117)：深耕多肽领域，多业务板块放量在即》，华安证券研究，2024年05月08日 3.《多肽原料药景气度持续上行！》，制药网，2024年08月01日 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 史蒂文 转载开白 | 马老师 18996384680（同微信） 商务合作 | 王存星 19922864877（同微信）  阅读原文，是受欢迎的文章哦

WUPPERTAL, Germany--( BUSINESS WIRE )-- AiCuris Anti-infective Cures AG announced today the appointment of Cynthia Wat, MD as Chief Medical Officer, effective July 1, 2024. Dr. Wat is a highly accomplished pharmaceutical physician with over 25 years of experience in delivering novel treatments to patients with infectious diseases. Her proven track record of designing and executing successful clinical development strategies from early to late-stage development and through market licensure, will benefit the company as it prepares to advance its Phase 3 product candidate pritelivir towards market authorization. Pritelivir is AiCuris’ innovative therapeutic candidate inhibiting HSV replication which is currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. As part of her role, Dr. Wat will be responsible for the management and global development of AiCuris' clinical pipeline of innovative therapeutic candidates aiming to improve the lives of immune compromised patients. AiCuris also provided an update on further leadership team changes. Holger Zimmermann, PhD, has stepped down from his position as Chief Research and Development Officer to pursue other opportunities. Dr. Zimmermann was part of the spin-out in 2006 which became AiCuris, served as AiCuris CEO from 2015 to April 2023 and was key contributor in the discovery and development of letermovir which was out-licensed to MSD in 2012 and is currently marketed as PREVYMIS ® . “As we complete patient enrollment in our pivotal Phase 3 study with pritelivir in the first half of 2025, Cynthia’s extensive experience in product filing and negotiating with global health authorities will be vital to rapidly and successfully position our lead candidate for commercialization,” said Larry Edwards, CEO of AiCuris . “I am looking forward to working with Cynthia as we continue to execute on our mission of providing multiple therapeutic solutions for immunocompromised patients in a more efficient and effective manner. On behalf of the AiCuris team, I also would like to sincerely thank Holger for his invaluable support since the inception of the company and his contributions over the years. We wish him all the best for his future endeavors.” “Joining AiCuris presents a unique opportunity to rapidly and effectively deliver innovative therapies to immunocompromised individuals. The company is one of the few private biotech companies that successfully developed a commercial-stage drug that is improving the lives of thousands of seriously ill patients. Its differentiated pipeline candidates hold the potential to deliver substantial value and life-saving treatments to vulnerable patient populations where simple infections can pose serious threats. I am eager to contribute to these efforts together with the AiCuris team and to expedite the path toward product approval, ensuring that critical medical needs are met and that vulnerable patients receive the care they urgently require,” added Cynthia Wat, MD . Cynthia Wat joins AiCuris from her most recent position as a Pharmaceutical Consultant and Director at ID Pharma Consultancy Ltd. With more than 25 years of extensive global drug development experience, she has held leadership and managerial roles for licensed products Fuzeon ® , Pegasys ® , and Tamiflu ® at Roche that included pivotal registration trials and multiple filing activities. As a recognized expert in infectious diseases and hepatitis, Dr. Wat has a proven track record for creating and successfully implementing novel clinical trial designs and clinical development strategies for chronic Hepatitis B, COVID-19, and other respiratory viruses and is experienced in a broad range of modalities, small molecules, biologics, RNA therapeutics including antisense oligonucleotides and predictive biomarker research. Additionally, she is a strong collaborator with health authorities, and has provided recommendations to NICE and other regulators in her role at the Faculty of Pharmaceutical Medicine. Dr. Wat holds a Bachelor of Medicine, Bachelor of Surgery (MBBS) from St. Mary's Hospital Medical School, Imperial College, London, a Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine (FPM) and is a Member of the Royal College of Physicians (MRCP). About AiCuris AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS ® , marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.