At the beginning of Feb 2025, Jiudian Hongyang's API trimebutine maleate (Y20230000418) officially received the marketing approval from the CDE, and its registration status was successfully changed to "A".

Trimebutine maleate is a drug used to treat the symptoms of irritable bowel syndrome (IBS). It has a bidirectional regulatory effect of excitation and inhibition on gastrointestinal motility. It can treat both diarrhea and constipation. It is the earliest antispasmodic drug that directly acts on gastrointestinal smooth muscle. In the past, drugs with gastrointestinal motility-promoting effects (such as domperidone, etc.) or antispasmodics were generally used to treat such diseases, but sometimes it was difficult to achieve satisfactory results. In particular, when the gastrointestinal smooth muscle shows alternating contraction enhancement and weakening, the therapeutic effect of drugs with unidirectional regulatory effects is not ideal. Trimebutine maleate has obvious advantages in this regard. When the digestive tract is in a low-motility state, it can inhibit the cell membrane potassium ion channel and produce depolarization, thereby exciting the gastrointestinal smooth muscle and restoring the gastrointestinal motility to normal; when the digestive tract is in a state of motility excitement, it can act on cholinergic neurons to inhibit the release of acetylcholine, thereby inhibiting excessive gastrointestinal motility and regulating the disordered gastrointestinal function. In addition, trimebutine can also excite opioid receptors and promote the release of gastrointestinal peptides, thereby inhibiting gastrointestinal pain nerve reflexes, relieving abdominal pain, and also playing a certain antiemetic role. It is clinically used to treat loss of appetite, nausea, vomiting, belching, abdominal distension, abdominal pain, diarrhea, constipation, etc.

With the improvement of people's living standards, changes in dietary structure, accelerated pace of life, and increased pressure, more and more people have suffered from gastrointestinal diseases such as stomach discomfort, bloating, and loss of appetite in recent years. According to statistics, the incidence of gastrointestinal dysfunction in my country is currently around 10%. According to the MinEnet database, trimebutine maleate has always been the top 1 oral product in the terminal synthetic spasmolytic and anticholinergic drug market in China's public medical institutions, with sales exceeding 500 million yuan in 2023.

The successful approval of trimebutine maleate API has enriched our digestive system product line, further enhancing our core competitiveness, solidifying our company's advantageous position, and continuously contributing to improve performance, and bring more and broader cooperation opportunities to Jiudian Hongyang.