Pilocarpine

Glaucoma is the world's leading irreversible blinding eye disease. In clinical practice, the long-term control of both angle-closure and open-angle glaucoma relies on intraocular pressure regulating drugs, and pilocarpine is a classic representative of this type of treatment. As a cholinergic M receptor agonist, it can contract the pupillary sphincter, open the chamber angle, promote the expansion of trabecular meshwork space, and accelerate the discharge of aqueous humor to rapidly reduce intraocular pressure. It is not only the first-line emergency medication for acute attacks of angle-closure glaucoma, but also can be combined with other intraocular pressure lowering drugs for the long-term maintenance treatment of open-angle glaucoma, and can also relieve the symptoms of mydriasis after ophthalmic surgery. The applicable population covers glaucoma patients of all age groups and some postoperative rehabilitation groups.The global market size of anti-glaucoma drugs was approximately USD 7.2 billion in 2023, among which cholinergic drugs account for about 8%. As a basic drug in this category, pilocarpine has a stable annual market growth rate of 3.2%. In the domestic market, this variety has been included in the National Essential Drug List. In 2022, the winning bid price in provincial centralized procurement decreased by an average of 47% compared with the previous round, and the accessibility at the primary level has been greatly improved. At present, there are 12 preparation enterprises approved for production in China, and the supply of API is mainly dominated by domestic local enterprises, with a relatively fragmented market competition pattern.The original research enterprise of pilocarpine is Alcon, and the original brand name is Isopto Carpine. The core compound patent expired globally in 1990. At present, the mainstream dosage form is eye drops, and common specifications include 1% (5ml:50mg) and 2% (5ml:100mg). The original research product has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. According to the domestic API registration platform, there are currently 6 approved registration numbers (A status) for pilocarpine API, a total of 11 domestic enterprises have been approved for the production of domestic eye drops, and the original research eye drops have also been approved for import in China. (Data as of June 2024, please refer to the official website of CDE for the latest information)In response to the R&D and production quality control requirements related to pilocarpine, CATO provides a full set of impurity reference standards for this API. Most of the products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of enterprises in various scenarios such as impurity research and quality standard establishment.

全球抗青光眼药物市场规模2023年约为72亿美元，其中拟胆碱类药物占比约8%，毛果芸香碱作为该类别中的基础用药，年市场增速稳定在3.2%。国内市场中，该品种已纳入国家基本药物目录，2022年省级集采中标价格较前一轮平均下降47%，基层可及性大幅提升，目前国内获批生产的制剂企业共12家，原料药供应以国内本土企业为主，市场竞争格局较为分散。

毛果芸香碱的原研企业为爱尔康公司，原研商品名为Isopto Carpine，核心化合物专利已于1990年全球到期。目前主流剂型为滴眼液，常见规格包括1%（5ml:50mg）、2%（5ml:100mg），原研产品已列入FDA参比制剂目录，同时也被纳入中国《化学药品参比制剂目录》。国内原料药登记平台显示，目前共有6条毛果芸香碱原料药获批登记号（A状态），国产滴眼剂获批企业共11家，原研滴眼剂也已在国内获批进口。（数据截至2024年6月，最新请以CDE官网为准）

针对毛果芸香碱相关的研发与生产质控需求，CATO/佳途科技提供该API全套杂质标准品，绝大部分产品可现货供应，现货订单16:00前下单即可当日发出，所有产品均符合中国药典、FDA等多法规体系合规要求，可充分满足企业杂质研究、质量标准建立等各类场景需求。