Pegcetacoplan

如何在龙头光环下找到生存之道？ 当前，CDMO行业呈现“头部集中、细分突围、分化加剧”的竞争格局。像具备产能储备+连续流技术+全球化布局+寡核苷酸协同能力的平台型巨头药明康德占据了主要市场份额。 据相关统计数据，从2024年~2025H1，美国FDA批准的40款小分子药物中，有8款由药明康德业务平台服务。一方面说明药明康德作为头部CDMO的价值，短期内在全球市场难以被替代；另一方面，腰部CDMO企业想与其正面竞争也困难重重。 值得注意的是，不管是以凯莱英、九洲药业为代表的、营收规模维持在30亿元左右的技术专长型企业；还是诺泰生物、圣诺生物、泰德医药等聚焦细分赛道的专家型企业，都选择了聚焦多肽CDMO这条业务线，并以超行业平均增速实现弯道超车，构成行业“高增长阵营”。 行业龙头靠平台与产能统治了核心市场，但细分领域的技术壁垒为有技术积累的企业留下突围窗口。未来CDMO行业的竞争或将从单纯的成本优势竞争，演变到围绕技术深度展开，多肽CDMO的发展已经初步展示了行业格局的新变化。 01 多肽助推业绩起飞 GLP-1的扩张，带飞了多肽CDMO行业。 据华福证券数据，2025年Q1~Q3，CXO板块收入同比增长12%，归母净利润同比增加58%，聚焦到2025Q3，收入同比增加10%，归母净利润同比增加51%。特别是CDMO龙头企业药明康德，在2025年前三季度业务在手订单同比增长41%，显示出良好增长态势，但真正值得关注的，是除药明之外的其他CDMO，他们的向上发展才是行业持续复苏的写照。 医药细分板块业绩表现，图源华福证券 值得注意的是，多肽业务成为部分CDMO企业主要的增长驱动力。 如凯莱英在2025年前三季度，实现营业总收入46.3亿元，同比增长11.82%，可其中小分子CDMO业务收入基本持平，多肽、寡核苷酸、ADC等增量业务板块收入同比增长72%，而以多肽为代表的化学大分子业务收入更是同比增长超150%。与此同时，新业务订单保持双位数增长，从下半年待交付的订单分布看，Q4交付规模将显著高于Q3，预计全年营业收入将实现13%~15%增长。 圣诺生物前三季度业绩同比增长54%，实现归母净利润同比增长123%，业绩攀升的主因也是因为多肽业务的快速增长。诺泰生物的增长同样依托多肽业务，2025前三季度实现营业收入15.27亿元，同比增长22%，归母净利润同比增长27%。还有专注于多肽业务的泰德医药，在报告期内也实现了项目数的大幅增长。 当然，这一切都离不开GLP-1药物在全球的快速放量，据企业2025年第三季度财报数据显示，诺和诺德核心产品司美格鲁肽三大品牌药物前三季度合计销售约254亿美元，竞争对手礼来的替尔泊肽前三季度销售约248亿美元，仅两大巨头就占据了超500亿美元的市场。 有了巨头打样，近几年全球众多药企纷纷加入GLP-1赛道进行竞争，他们的加入不仅使全球多肽市场规模迅速扩大，同样让多肽CDMO行业得以快速发展，国内CDMO行业稳稳接住了这波风口。只是由于有药明康德这家巨头的存在，使得其他企业的光芒被其掩盖。 对于这些竞争者来说，如何在龙头压制下找到自身发展路径，对于行业的良性发展至关重要。 02 产能之外的突围策略 规模红利正在远去，技术溢价助推多肽CDMO赛道兴起。 过去，中国CDMO企业凭借大力扩产，形成规模优势参与全球竞争；近几年，随着各种新兴疗法的兴起，各类FIC药物的数量呈现逐年上升的态势。同时，新疗法也面临复杂工艺开发、规模化生产优化等技术问题亟待解决，市场需求的转变也推动了中国CDMO行业的从规模化红利向技术溢价转型，企业的产能并非多建工厂就能解决，而是要在技术源头进行突破，这就对企业提出了更高的要求。 多肽正是CDMO行业向细分化、专业化发展过程中，逐渐走入成熟期的细分赛道。 中国生物医药发展生命周期，图源沙利文 近年来，凯莱英将以多肽为代表的化学大分子CDMO作为重点发展的新兴业务，并依托其在小分子CDMO领域积累的技术、客户和质量体系优势，向多肽等化学大分子领域进行能力延伸和横向拓展。 不管是传统固相多肽合成技术上的持续打磨优化、还是攻克液相多肽合成技术后成功实现复杂多肽序列的高效液相合成、以及通过生物发酵合成精准调控多肽的表达与分泌，从而实现数种生物活性多肽的工业化生产、还有化学酶促多肽合成等路径，凯莱英都已走通。 此外，凯莱英在连续流反应技术（CFCT）方面的深厚积累也被应用于多肽合成过程，有助于提升收率、纯度和生产安全性，并且针对多肽未来的发展方向，布局了环肽合成技术。 另一方面，凭借在小分子CDMO领域与全球顶级制药公司积累的良好口碑和合作关系，凯莱英积极将合作延伸至多肽等新兴领域，目前其多肽业务增长驱动更多来自海外大制药公司。同时，凯莱英预计在2025年下半年到2026年，多肽业务来源将逐渐变为海外为主。 多肽项目进入中后期后对产能需求较高，经过前期大规模扩张， 目前凯莱英产能利用率还在爬坡阶段。由于在多肽减重领域共服务了十几个分子，近半数处于临床2和3期，预计明年部分项目将进入工艺性能确认阶段，产能需求还将持续增加。根据中报披露，企业2025年底多肽固相合成总产能达44000L，并且已启动第三栋多肽厂房的建设工作。 当然，像凯莱英这样能力全面的CDMO企业并不太多，对于其他竞争者，找到适合自己的垂直细分路线才更为重要。 如圣诺生物以API+制剂一体化为核心布局，覆盖多肽原料药研发、生产及制剂开发全流程。在多肽合成与修饰技术上，圣诺生物拥有长链肽偶联技术、单硫环肽规模化生产技术（其硫环肽合成纯度高达95%，远超行业均值）、多对二硫环肽合成技术、聚乙二醇化修饰等。 正是有了这些积累，使得企业可以在多肽药研产业链上贯穿多肽CDMO、多肽原料药和多肽制剂三端业务。更为重要的是，GLP-1业务目前占比仅有30%左右，企业并未将多肽业务固定在代谢疾病领域，在目前服务的40多个项目中，不乏全球TOP10药企的早期研发项目，涉及抗肿瘤、抗感染等领域。 这种合作不仅带来了稳定的收入，更让企业在多肽领域广阔的空间中肆意开拓，如能陪伴潜在重磅品种成长，还能反哺原料药业务。此外，圣诺生物还将其多肽技术拓展到医美领域，其美容肽产品按照欧盟EFfCI GMP规范生产，覆盖抗皱紧致、舒缓修护、美白淡斑、眼周护理、生发防脱等80多个产品。 还有突破长链多肽药物规模化大生产技术瓶颈，成功建立了基于固液融合的多肽规模化生产技术平台，具备侧链化学修饰多肽、长链修饰多肽数公斤级大生产能力的诺泰生物，能在司美格鲁肽、替尔泊肽等品种实现单批次超10公斤量产能力。 正是有了这些技术突破，才有产能的建设，自多肽创新药CDMO106车间于2024年底投产后，107车间、108车间也在2025年上半年陆续投入运营。此外，年产395千克多肽原料药生产线项目也已顺利投产。也就是说，凭借生产工艺的突破，诺泰能够为多肽创新药和仿制药提供从工艺路线设计，到工艺验证和质量研究，以及药物研发及商业化生产的全链条定制服务，覆盖从药物发现、临床前研究，到临床试验和上市销售的完整药物开发周期。 专注于多肽CDMO业务的泰德医药凭借其成熟且高效的多肽API规模化生产技术，在多肽药物设计、修饰、合成等关键环节表现出色，且在长链肽及复杂修饰肽领域中积累了大量生产案例，目前合成新分子的平均成功率超过99.95%，具备多个100千克级订单的并行处理能力。 此外，泰德医药还建立了PeptiConjuX（多肽偶联药物平台）和PeptiNuclide LinkTech（放射性核素偶联药物平台）两大特色技术平台，并合成了约1900种多肽前体分子，为创新药研发提供了关键资源。这些积累有助于复杂分子的开发，协助客户解决产品纯化和杂质消除等关键技术难题，并获得了吉利德的认可。 还有CDMO订单数量增速超20%的九洲药业，今年以来，多肽业务引入新客户20多家，新签合同金额近千万美元，并已完成十多个项目的交付工作。吸引他们的，是九洲药业多肽合成技术平台包含固相合成、液相合成、固液相结合以及原创的非经典固相合成技术。 目前，九洲药业已成功合成了最长可达78个氨基酸的蛋白片段，远超当前热门GLP-1药物（如替尔泊肽39个氨基酸、司美格鲁肽31个氨基酸）的长度，展示了处理高难度项目的技术实力。 综合来看，在多肽CDMO业务的发展上，企业们根据自身的技术特点打造了差异化优势。像凯莱英利用规模和平台效应，快速完成技术平移和产能扩张；诺泰生物、圣诺生物这类企业则在于深耕特定技术环节形成的壁垒；而泰德医药的独特优势在于其前端CRO服务带来的项目源头优势和高度国际化的运营能力。 只是，作为成熟期的多肽业务是否还能持续带来收入呢？ 03 多肽的风还能吹多久 多肽仍有潜力，但比拼“内功”的时代已经到来。 当前多肽CDMO的繁荣主要由GLP-1药物（司美格鲁肽、替尔泊肽）减重适应症的商业化爆发驱动，这一潜力已在业绩端得到充分验证。尽管GLP-1商业化潜力逐步兑现，但后续多肽药物或仍有多元化增长动力，这主要来自技术迭代和适应症拓展。 首先是多肽技术路径的创新，例如多靶点多肽药物的强势崛起，包括已经进入临床3期的礼来Retatrutide（GLP-1/GIP/GCGR三靶点，减重效率较单靶点提升30%~50%），已经获批上市的全球首个GLP-1/GCGR双靶点激动剂信达生物的玛仕度肽，还有罗氏押注的兼具减重和肌肉保护作用的Amylin胰淀素多肽，以及安进选择的超长效GLP-1受体激动剂与GIP受体拮抗剂结合的双靶点减肥药MariTide。 随着普通多肽产能逐渐普及，下一阶段的竞争还将转向长链肽、复杂修饰肽（如具有稳定环状结构和高靶点亲和力的环肽药物），还有多肽药物偶联策略（包括肽-药物偶联物PDC、肽-寡核苷酸偶联技术POC）等更高技术壁垒的领域。更为重要的是，AI辅助药物设计将在PDC、环肽药物发现中发挥重要作用。 适应症方面，多肽疗法呈现多线发展态势。除了GLP-1药物拓展MASH适应症外，多肽疗法也在癌症领域取得进展，如PDS Biotechnology开发的多肽疫苗PDS0101联合K药的临床2期中，使HPV16阳性复发或转移性头颈鳞状细胞癌患者中位总生存期达39.3个月。还有Elicio开发的靶向突变KRAS的多肽疫苗ELI-002，也在临床1期中取得胰腺癌和结直肠癌患者的死亡风险降低77%，复发风险降低88%的结果。 此外，强生与Protagonist联合开发的用于治疗银屑病的口服多肽疗法icotrokinra也已向FDA递交NDA申请；默沙东的口服大环肽enlicitide decanoate在3期试验中能显著降低高胆固醇血症患者的低密度脂蛋白胆固醇水平。在罕见病领域，Apellis的双环肽疗法Empaveli、Stealth Bio的多肽疗法Forzinity也获得了FDA的批准。 总的来看，多肽药物已成为治疗多种疾病的重要研发方向，在多个领域为患者带来了全新的治疗方案。与传统的小分子药物相比，多肽药物更为复杂，对生产过程的多个环节提出了更高要求，因而对CDMO的要求会越来越高。 当前竞争虽然还是围绕GLP-1等热门靶点的产能和交付能力展开，但需求结构正在发生变化。由于在欧、美、日等市场，司美格鲁肽的核心专利保护要等到2031年，很多CDMO还在囤积产能，如若在这个过程中忽略了技术的积累与行业发展的变化，当产能过剩、研发能力滞后、市场需求波动等问题出现后，没有准备的企业或将被直接波及。 当市场从短缺走向过剩，当竞争从增量市场转向存量争夺，企业的核心竞争力必然会发生变化。 多肽不仅是CDMO行业的“现在”，仍可能是“未来”，但行业价值将从单纯的产能规模转向技术创新和生态构建。相关企业只有专注复杂工艺、在早期与项目绑定和适应症开拓，才能在下一代多肽药物浪潮中持续获益。 *封面图片来源：神笔PRO 如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。 近 期 推 荐 声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。 动脉网，未来医疗服务平台

WALTHAM, Mass., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced data from a post hoc analysis of the GALE extension study following five years of continuous treatment with SYFOVRE® (pegcetacoplan injection), the leading treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The results demonstrate that both every-other-month and monthly SYFOVRE delayed GA lesion growth by approximately 1.5 years in patients with nonsubfoveal GA when compared to sham/projected sham. “I’m very encouraged by these long-term results, which show that early and continuous treatment with SYFOVRE can meaningfully delay the progression of GA,” said Dilsher Dhoot, M.D., California Retina Consultants. “Importantly, these data indicate that SYFOVRE alters the natural course of this disease, which causes irreversible vision loss and profoundly impacts patients’ daily lives.” “These five-year results underscore the transformative and durable impact of targeting C3 with SYFOVRE to delay the progression of GA,” said Caroline Baumal, M.D., chief medical officer, Apellis. “With the most extensive data set in GA, our broad clinical and real-world experience has greatly advanced the retina community’s understanding of this devastating disease and reinforced Apellis’ leadership.” The safety profile of SYFOVRE through five years remained consistent with previously reported data. Detailed results will be presented at a future medical meeting. About the GALE Long-Term Extension Study GALE (n=792) is a Phase 3, multicenter, open-label, extension study to evaluate the long-term efficacy and safety of SYFOVRE® (pegcetacoplan injection) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The objectives of the study are to evaluate the long-term incidence and severity of ocular and systemic treatment emergent adverse events as well as change in the total area of GA lesions as measured by fundus autofluorescence. More than 80 percent of participants who completed the OAKS and DERBY studies entered the GALE study. Patients included in the 5-year GALE lesion growth reduction analyses were in the SYFOVRE treatment arms through Month 24 in the OAKS and DERBY studies and remained on the same regimen in GALE. Sham-treated patients in the Phase 3 OAKS and DERBY studies were eligible to transition to SYFOVRE treatment in GALE after Month 24, so a projected sham arm was used to estimate the growth of GA lesions without treatment between Months 24 and 60. The projected sham arm is based on the observed linear growth of GA lesions over two years and was validated by a fellow eye analysis. It was estimated as the average 12-month mean rate of change in the OAKS and DERBY sham arms through Month 24. About the Phase 3 OAKS and DERBY Studies OAKS (n=637) and DERBY (n=621) were Phase 3, multicenter, randomized, double-masked, sham-controlled studies that compared the efficacy and safety of SYFOVRE® (pegcetacoplan injection) with sham injections across a broad and heterogenous population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month SYFOVRE in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence. In these studies at 24 months, both every-other-month and monthly SYFOVRE reduced GA lesion growth with increasing effects over time and a well-demonstrated safety profile. About SYFOVRE® (pegcetacoplan injection) SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration. About Geographic Atrophy (GA) Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3 U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection) CONTRAINDICATIONS SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred. WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. Neovascular AMD In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. Intraocular Inflammation In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Increased Intraocular Pressure Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. Please see full Prescribing Information for more information. About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on LinkedIn and X. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the data analyses reported in this release indicate an apparent positive effect that is greater than the actual positive effect, and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2025 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contact: Tracy Vineis media@apellis.com 617.420.4839 Investor Contact: Eva Stroynowski ir@apellis.com 617.938.6229 1Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580. 2Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116. 3Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174. A graph accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/4b4f80eb-9369-4c1f-8754-5dccbe0b4553