Etilefrine

Orthostatic hypotension and hypotensive circulatory disorders caused by insufficient sympathetic excitability have long been a clinical pain point of inadequate precision in drug selection. Etilefrine, as a sympathomimetic amine vasopressor, directly activates α-adrenergic receptors and simultaneously promotes the release of norepinephrine from sympathetic nerve endings, which can mildly and persistently increase systolic and diastolic blood pressure, and improve symptoms such as dizziness and fatigue caused by insufficient peripheral circulatory perfusion. It is mainly used for the symptomatic treatment of essential hypotension, orthostatic hypotension and hypotensive states associated with diseases, and is suitable for hypotensive people of all ages without severe organic cardiovascular diseases. Compared with similar vasopressors, it has the characteristics of less impact on heart rate and lower incidence of adverse reactions, which is more suitable for long-term maintenance treatment.At present, the overall domestic etilefrine market is still in the stage of clinical cognition improvement. The number of patients with relevant indications exceeds 20 million, but the penetration rate of existing clinical medication is less than 3%. In 2023, the domestic market size of relevant preparations was approximately 120 million yuan, and the compound annual growth rate in the past three years has remained at around 18%. In terms of the competitive landscape, imported preparations still dominate at present, and the number of approved generic domestic preparations is extremely small. On the API side, large-scale domestic supply has not yet been achieved in China, and most preparation enterprises rely on imported raw materials. With the improvement of the recommendation level of this variety in clinical guidelines, the market size is expected to exceed 300 million yuan in the next 3-5 years.The original research enterprise of etilefrine is Boehringer Ingelheim of Germany, and the original brand name is Effortil. The core compound patents of etilefrine in major global markets all expired before 2000. The original dosage form marketed in China is mainly tablets with a specification of 25 mg per tablet, and this original product has been included in the China Listed Drug Catalogue as a reference preparation. At present, no domestic enterprise has obtained the A status registration number of etilefrine API. Only 2 enterprises have submitted API DMF registrations which are under the review stage. The only preparations approved for marketing in China are the original imported varieties, and no generic drugs have been approved yet. (Data as of September 2024, please refer to the official CDE website for the latest information)CATO can provide a full set of etilefrine impurity reference standards, covering all dimensions of process impurities and degradation impurities. Most products are available in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research, and generic drug consistency evaluation.

目前国内依替福林整体市场仍处于临床认知提升阶段，相关适应症患病人群超2000万，但现有临床用药渗透率不足3%，2023年国内相关制剂市场规模约1.2亿元，近三年年复合增长率保持在18%左右。竞争格局方面目前仍以进口制剂主导，国产仿制制剂获批数量极少，原料药端国内尚未实现规模化国产供应，多数制剂企业依赖进口原料，随着临床指南对该品种推荐等级提升，未来3-5年市场规模有望突破3亿元。

依替福林原研企业为德国Boehringer Ingelheim，原研商品名为Effortil，其核心化合物专利在全球主要市场已在2000年前全部到期，国内上市的原研剂型主要为片剂，规格为25mg/片，该原研品已被列入中国上市药品目录集作为参比制剂。目前国内尚未有企业获得依替福林原料药的A状态登记号，仅2家企业提交了原料药DMF登记处于审评阶段，国内获批上市的制剂仅原研进口品种，尚未有仿制药获批。（数据截至2024年9月，最新请以CDE官网为准）

CATO/佳途科技可提供依替福林全套杂质标准品，覆盖工艺杂质、降解杂质全维度，大部分产品可现货供应，现货产品16:00前下单即可当天发货，所有标准品均符合中国药典、FDA等多法规体系合规要求，可充分满足原料药研发、质量研究、仿制药一致性评价等不同场景的使用需求。