Aflibercept

截至目前，吉利德、安进、Vertex、再生元和渤健均已公开业绩，详情如下： 一、Vertex Vertex是美国市值最高的biotech公司之一，于2月10日公布了2024年的业绩。Vertex全年营收110.2亿美元，同比增长11.67%；净亏损5.36亿美元，主要由收购Alpine导致。 2023年以来，Vertex的喜讯不断，一是Trikafta和Kalydeco的拓展适应症申请获得了FDA批准，二是全球首个基因编辑疗法Casgevy（exagamglogene autotemcel）获得了FDA批准，三是治疗一型糖尿病的干细胞疗法的临床研究取得了显著性进展，四是新一代CF三复方制剂Vanza（vanzacaftor+替扎卡托+氘代依伐卡托）和全新机制的非阿片类止痛药suzetrigine相继成功完成了临床试验，五是IgA肾炎新药povetacicept获得了积极的临床试验数据……在这些捷报的冲击下，Vertex的股价屡创新高，市值一度逼近1400亿美元，成为全球市值第二高的biotech巨头（仅次于安进）。 总营收：110.2亿美元，药品销售额：110.2亿美元，净利润：-5.36亿美元，研发投入：36.3亿美元；市值：1210亿美元 二、安进 Amgen是全球最大的biotech公司，于2月4日公布了2024年业绩。Amgen在2024年的总营收为334亿美元，其中药品销售额320.26亿美元，在全球制药巨头排名中，位于第十三位。由于Amgen在去年收购了Horizon，导致销售额大幅上涨，但净利润同比下跌至40.9亿美元。 近年来，Amgen的多个看家品种面临专利悬崖，为了稳住大盘，该公司开启了买买买的模式，为了稳住大盘，Bradway在2020-2024年又相继收购了Five Prime（19亿美元）、Teneobio（25亿美元）、Horizon（278亿美元）等公司，获得了bemarituzumab、teprotumumab等产品，并布局了罕见病治疗。虽然大规模的兼并让安进的营收重回增长，但也带来了巨大的债务压力——2022-2024年的平均负债率（总负债/总资产）高达94%。 总营收：334.24亿美元，药品销售额：320.26亿美元，净利润：40.9亿美元，研发投入：50.9亿美元；市值：1593亿美元 三、吉利德 吉利德是全球市值第三高的biotech公司，于2月11日公布了2024年的业绩。该公司在报告期内的总营收为287.54亿美元，其中产品销售额286.10亿美元，在全球制药巨头排名中位居第十五位。净利润4.8亿美元，相比去年同期大幅下降。 由于艾滋病治疗市场趋于成熟和丙肝治疗市场的快速萎缩，吉利德不得不产品管线多样化。近年来，由于不惜血本地管线扩张，吉利德的负债率居高不下，2017-2024年的平均负债率高达67%，2020年更是高达73%，加之抗肿瘤药和免疫抑制剂的销售表现不理想，导致投资回报水平较低，净资产增长缓慢，自2016年以来，市值一直处于低位。 总营收：287.54亿美元，药品销售额：286.10亿美元，净利润：4.8亿美元，研发投入：59.07亿美元；市值：1198亿美元 四、再生元 再生元在2月4日公布了2024年业绩，全年营收增长8%至142亿美元，净利润增长12%至44.13亿美元。再生元的收入主要来自EYLEA（阿柏西普），虽然该产品的美国销售额增长1%达59.68亿美元（美国以外由拜耳销售）。Libtayo是再生元的第二大产品，并且在全球范围内拥有销售权益，2024年同比增长41%至12.17亿美元。除此以外，再生元还在美国销售Praluent、Evkeeza和Inmazeb，2024年的销售额分别为2.42亿美元、1.26亿美元和0.76亿美元（美国以外由赛诺菲销售） 总营收：142.02亿美元，药品销售额：76.29亿美元，净利润：44.13亿美元，研发投入：51.32亿美元；市值：728亿美元 五、渤健 2月12日，渤健发布了财务报告，2024年的总营收为96.75亿美元，同比下降2%，净利润为16.32亿美元，同比增长5亿美元。近年来，渤健表现出创新乏力，多个畅销多发性药物面临专利悬崖，销售额和股价均出现了大幅下跌。 总营收：96.75亿美元，药品销售额：72.14亿美元，净利润：16.32亿美元，研发投入：20.42亿美元；市值：191亿美元 与制药巨头一样，biotech公司发展到一定规模也会出现创新乏力。一是biotech公司的性质决定了他们都是从单一的前沿性技术起家，而每一种技术、每一个靶点可衍生出的药物是有限的，一旦技术、靶点的价值被充分发掘，biotech公司也必须像制药巨头一样，布局新的技术赛道，这意味着科学家要进行跨领域研究，也涉及知识、技术方面的移动壁垒，甚至还可能出现路径依赖和夜郎自大的现象；二则随着公司的规模不断扩大，流程也会变长，出现组织灵活度降低的现象。因此，为了解决创新乏力，他们也需要强强合并或持续不断地收购规模更小的biotech公司，以实现研发赛道的多样化。 药事纵横投稿须知：稿费已上调，欢迎投稿

Multiple subcutaneous doses safe and well-tolerated >69% reduction in anti-VEGF intravitreal (IVT) treatment burden in study eyes >67% reduction in anti-VEGF IVT treatment in fellow eyes of bilateral disease patients Maintenance of BCVA and reduction of CST in these previously treated patients Migaldendranib therapy obviates or reduces the need for more invasive in-the-eye injections Feb. 10, 2025 -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation, today announced positive Phase 2 data for Migaldendranib (MGB; D-4517.2), a novel subcutaneously (subQ) administered nanomedicine treatment for retinal diseases. SubQ administered MGB selectively targets and reduces fluid production in the retina of both eyes to reduce the need for therapies that remove the fluid after an injection in the eye. Over 50 subjects have been treated to date across three clinical trials. The interim results of the chronic subQ MGB dosing Phase 2 study for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) were presented at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting on February 8, 2025. The data were presented by Michael Singer, M.D., Clinical Professor of Ophthalmology at the University of Texas Health Science Center San Antonio and Director of Clinical Research at Medical Center Ophthalmology San Antonio. The ongoing Phase 2 study includes 25 patients (16 wet AMD and 9 DME), previously treated with anti-VEGF IVT injections, and is evaluating the novel, proprietary nanomedicine, MGB, which is subcutaneously administered every 2 or 4 weeks for up to 40 weeks after a single intravitreal injection of aflibercept (2 mg) at Day 1 (Baseline). "These results suggest that subcutaneous MGB could potentially offer patients a more convenient at-home treatment option while maintaining disease control and significantly reducing IVT injection burden," said Dr. Singer. "The bilateral treatment effect is particularly encouraging for patients with disease in both eyes." In subjects completing 24 weeks of treatment at this interim analysis, key findings included: 69.2% and 76.5% reduction in anti-VEGF treatment burden for wet AMD and DME study eyes, respectively, versus 24 weeks prior to screening Maintenance of mean central subfield thickness (CST) and best corrected visual acuity (BCVA) in wet AMD study eyes Modest decreases in CST (-69.1 microns) with modest increases in BCVA (+4.5 ETDRS letters) in DME study eyes Similar effects observed in fellow eyes, which did not receive an anti-VEGF IVT at Day 1 (Baseline), with 66.7% and 94.7% reduction in treatment burden for wet AMD and DME subjects, respectively, with bilateral disease versus 24 weeks prior to screening Generally safe and well-tolerated with no treatment-related ocular adverse events reported "These promising results highlight our dedication to developing innovative therapies for wet AMD and DME,” said Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics. “For subjects who have completed 24 weeks of treatment, there has been a significant reduction in the need for supplemental intravitreal aflibercept. Migaldendranib has the potential to be administered at home subcutaneously once per month to reduce the production of fluid in the retina, reducing the need for injections of anti-VEGF in the eye. These results substantially reduce treatment burden for patients, especially those with bilateral disease, leading to less office visits. We are encouraged by these findings and look forward to continuing our development efforts to bring this promising therapy to market." Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care across ophthalmology, neurology, and inflammation. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. The content above comes from the network. if any infringement, please contact us to modify.