By Fineline Cube China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for its Category 1 gastric acid blocker, X842. The targeted indication for this innovative drug is reflux esophagitis (RE), a condition affecting a significant number of patients globally.
X842: Next-Generation P-CAB
X842 is a next-generation potassium ion competitive acid blocker (P-CAB) that offers several advantages over existing treatments. It features rapid onset of action, strong and durable acid suppression, and a low incidence of adverse reactions. These characteristics make X842 a promising candidate for the treatment of reflux esophagitis, where effective and safe acid control is crucial.
Licensing Deal and Market Potential
Shanghai Pharmaceuticals has entered into a licensing deal with compatriot firm Guizhou Sinorda Biotechnology Co., Ltd. Through this agreement, Shanghai Pharmaceuticals has secured exclusive manufacturing and sales rights to X842 for Greater China, including mainland China, Hong Kong, Macau, and Taiwan. This strategic move positions the company to capitalize on the growing market demand for effective treatments for reflux esophagitis.
Global P-CAB Landscape
Other firms with P-CABs approved globally include Yuhan Corporation’s revaprazan, Takeda’s vonoprazan, HK inno.N Corporation’s tegoprazan, and Daewoong Pharmaceutical Co., Ltd’s fexuprazan. Takeda’s vonoprazan was the first P-CAB approved in China in May 2020 for the treatment of adult RE. Tegoprazan, which was approved for marketing in China in April 2022 to treat RE, is owned by Luoxin Pharma in terms of rights in China. The acceptance of X842 for review by the NMPA marks a significant step forward in the development of this class of drugs in China.-Fineline Info & Tech