CSPC PHARMA (01093): The application for the listing permit of Valsartan and Amlodipine Maleate Tablets (SYH 9056 Tablets) has been accepted by the National Medical Products Administration.

CSPC PHARMA (01093) announced that the marketing authorization application for the telmisartan maleate and amlodipine besylate tablet (SYH 9056 tablet) developed by the group has been accepted by the China National Medical Products Administration. The indication for this application is for the treatment of primary mild to moderate hypertension that is not effectively controlled by monotherapy. The product is a single compound preparation of telmisartan and amlodipine maleate (specification: 80mg/2.5mg), classified as a new drug application in the category 2.3 of chemical drug registration, with obvious clinical treatment advantages. Currently, this compound preparation is not yet marketed domestically or internationally. Amlodipine besylate (Conjupri) is the first Chinese innovative drug to receive full approval from the US Food and Drug Administration (FDA), representing the first hypertension drug from China to be marketed in the US, marking a new height for Chinese pharmaceutical companies going global. The group has breakthrough key core technologies and pioneered the preparation method of amlodipine maleate. Additionally, the group used a unique PCT patent splitting technology to split amlodipine besylate, obtaining the active ingredient - amlodipine maleate. The dosage of amlodipine maleate is only 50% of imported amlodipine, achieving the same antihypertensive effect while effectively reducing the potential adverse reactions of amlodipine, such as peripheral edema and headaches, thus increasing the safety of drug use for patients. The mechanisms of action of telmisartan and amlodipine maleate in the compound preparation complement each other, resulting in a stronger and safer antihypertensive effect when used together. Furthermore, the convenience of a single compound tablet makes medication more convenient for patients, significantly improving medication compliance and effectively controlling blood pressure. This application is based on bioequivalence studies conducted in healthy volunteers and phase III clinical research results in hypertensive patients. The results of the phase III clinical research show that in patients with primary mild to moderate hypertension who are not effectively controlled by monotherapy, the antihypertensive effect of this product is significantly better than monotherapy with amlodipine maleate or telmisartan. The treatment effect is evident after 4 weeks, stabilizes after 8 weeks, and there is no rebound effect after continuous use for 24 weeks. Additionally, the product has no added safety risks compared to monotherapy, and the occurrence rates of peripheral edema, headaches, and dizziness are much lower than historical studies on amlodipine monotherapy. Therefore, the antihypertensive effect of this product is significant, with clear advantages in safety. Based on the comprehensive advantages in efficacy, safety, and compliance, this product has significant clinical application value and is expected to become a new option for the treatment of hypertension.