Possible next steps to accelerating SBE R&D.

BackgroundProgress in snakebite envenoming (SBE) therapeutics has suffered from a critical lack of data on the research and development (R&D) landscape. A database characterising this information would be a powerful tool for coordinating and accelerating SBE R&D. To address this need, we aimed to identify and categorise all active investigational candidates in development for SBE and all available or marketed products.Methodology/Principal findingsIn this landscape study, publicly available data and literature were reviewed to canvas the state of the SBE therapeutics market and research pipeline by identifying, characterising, and validating all investigational drug and biologic candidates with direct action on snake venom toxins, and all products available or marketed from 2015 to 2022. We identified 127 marketed products and 196 candidates in the pipeline, describing a very homogenous market of similar but geographically bespoke products and a diverse but immature pipeline, as most investigational candidates are at an early stage of development, with only eight candidates in clinical development.Conclusions/SignificanceFurther investment and research is needed to address the shortfalls in products already on the market and to accelerate R&D for new therapeutics. This should be accompanied by efforts to converge on shared priorities and reshape the current SBE R&D ecosystem to ensure translation of innovation and access.研究背景 蛇伤中毒（snakebite envenoming, SBE）治疗领域的研发进展长期受制于研发（research and development, R&D）格局相关数据的严重匮乏。构建一套收录此类信息的数据库，将成为协调并加速SBE治疗药物研发的有力工具。为填补这一数据空白，本研究旨在识别并分类所有针对SBE的在研活性候选药物，以及所有已上市或可获取的相关产品。 研究方法与主要研究结果 本项研发格局研究通过梳理公开数据与文献，对2015年至2022年间所有直接作用于蛇毒毒素的在研化学药物与生物制剂候选物（investigational drug and biologic candidates），以及所有已上市或可获取的SBE治疗产品进行识别、特征刻画与验证，以此全面描绘当前SBE治疗药物的市场现状与研发管线。本次研究共识别出127款上市产品与196个在研管线候选物，结果显示当前市场同质化程度较高，产品虽核心属性相似但均为地域定制化产品；而研发管线则呈现多样化但尚不成熟的特征——绝大多数在研候选物处于早期研发阶段，仅8个候选物进入临床研发阶段。 研究结论与意义 当前仍需加大投入与研究力度，以弥补现有上市产品的短板，并加速新型治疗药物的研发进程。与此同时，应致力于凝聚共同研发优先级，重塑当前SBE治疗药物研发生态系统，以确保创新成果的转化与可及性。