Carbetocin

Cesarean section and postpartum hemorrhage are clinical risks that receive key attention in the global obstetric field, and there is an urgent clinical demand for oxytocics with fast onset and long-lasting effect. Carbetocin is a synthetic long-acting oxytocin analogue. It rapidly induces tonic uterine contraction by selectively agonizing oxytocin receptors on uterine smooth muscle, and its duration of action can reach 1 hour, which is much longer than that of ordinary oxytocin. Its indications are mainly for the prevention of uterine atony and postpartum hemorrhage after cesarean section under epidural or lumbar anesthesia, and it can also be used for the prevention of postpartum hemorrhage in some high-risk parturients with natural delivery. It is currently a first-line uterine contraction management drug in obstetric clinical practice.Public data show that in recent years, the domestic market size of carbetocin has been stable at more than 1.5 billion yuan, with an annual compound growth rate of about 8%. With the implementation of the three-child policy and the improvement of obstetric safety guarantee standards, the market demand still has room for continuous growth. In terms of the competitive landscape, the original research product once occupied a dominant position for a long time. With the advancement of the consistency evaluation of generic drugs, generic drugs from a number of domestic pharmaceutical companies have been approved for marketing, and this variety has been included in the centralized procurement of many provinces. After centralized procurement, the price has dropped by more than 70%, the terminal accessibility has been greatly improved, and the market share of generic drugs has exceeded 60%.The original research enterprise of carbetocin is Ferring Pharmaceuticals, and the original research trade name is Duratocin. The expiration time of its core compound patent in major markets such as Europe and the United States is 2012, and the compound patent in China also expired in 2012. The main dosage form approved for the original research is injection, with the specification of 1ml:100μg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are more than 30 registration numbers of carbetocin API in China, among which more than 20 are in A status and can be used for associated review. More than 15 domestic enterprises have obtained approval for the marketing of carbetocin injection. (Data as of September 2024, please refer to the official website of CDE for the latest information)CATO provides a full set of impurity reference standards for carbetocin API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D needs of pharmaceutical enterprises related to impurity research, quality standard establishment and consistency evaluation.

公开数据显示，近年国内卡贝缩宫素市场规模稳定在15亿元以上，年复合增长率保持8%左右，随着三孩政策落地及产科安全保障标准提升，市场需求仍有持续上升空间。竞争格局方面，原研产品曾长期占据主导地位，随着仿制药一致性评价推进，已有多家国内药企的仿制药获批上市，且该品种已被纳入多省份集采，集采后价格降幅超70%，终端可及性大幅提升，仿制药市场占比已超过60%。

卡贝缩宫素原研企业为辉凌制药，原研商品名为巧特欣，其核心化合物专利在欧洲、美国等主要市场的到期时间为2012年，中国境内化合物专利同样于2012年到期。原研获批的主要剂型为注射液，规格为1ml:100μg，已被列入中国《化学药品参比制剂目录》，同时收载于FDA参比制剂目录。截至目前，中国境内已有超过30条卡贝缩宫素原料药登记号，其中超过20条为A状态，可关联审评使用，国内已有超过15家企业的卡贝缩宫素注射液获批上市。（数据截至2024年9月，最新请以CDE官网为准）

CATO/佳途科技提供卡贝缩宫素API全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，符合中国药典、FDA等多法规合规要求，可充分满足药企的杂质研究、质量标准建立及一致性评价相关研发需求。