Penehyclidine

In response to clinical demands such as perioperative glandular secretion inhibition and organophosphorus poisoning detoxification, the selective anticholinergic drug penehyclidine has combined advantages in efficacy and safety. This drug is a highly selective M cholinergic receptor antagonist, which can specifically act on M1 and M3 receptors and has low affinity for cardiac M2 receptors. While inhibiting glandular secretion in the respiratory tract and digestive tract, it is not prone to cause common adverse reactions of traditional anticholinergic drugs such as tachycardia and urinary retention. At present, it has been widely used in pre-anesthesia medication, emergency treatment of organophosphorus poisoning, and airway secretion control in patients with chronic obstructive pulmonary disease, covering multiple applicable groups including adults and children.

The domestic penehyclidine market has maintained steady growth in recent years. In 2023, the overall market size exceeded 1.2 billion yuan, with a compound annual growth rate of around 8%. As a specialized drug developed independently in China, its competitive landscape is highly concentrated, with leading enterprises accounting for more than 90% of the market share. With the improvement of perioperative medication specifications and the sinking of the organophosphorus poisoning emergency system, there is still room for further release of demand in the primary market.

The original research enterprise of penehyclidine is Chengdu Lisite Pharmaceutical Co., Ltd., with the brand name "Changtuoning", and the core compound patent expired in 2022. At present, the originally researched formulations approved for marketing in China are mainly injections, with conventional specifications including 1ml:0.5mg, 1ml:1mg and 2ml:2mg, which have been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration. As of now, the CDE API Registration Platform has 3 penehyclidine API registration entries including that of the original research enterprise, among which 2 are in "A" status and can be used for associated review. The domestic approved preparation varieties are mainly injections, and inhalants are in the clinical declaration stage. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO can provide a complete set of impurity reference standards for penehyclidine API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the whole process of API R&D, quality research and declaration.