Cheng Yi Pharmaceutical: Dobutamine Hydrochloride Injection Passes Consistency Evaluation

Shanghai Securities News - China Securities Network News: On September 13, Cheng Yi Pharmaceutical (Stock Code: 603811) issued an announcement regarding the company's drug passing the generic drug consistency evaluation. The announcement shows that the company recently received the "Approval Notice for Supplementary Drug Application" approved and issued by the National Medical Products Administration (NMPA), and its Dobutamine Hydrochloride Injection has passed the consistency evaluation of generic drug quality and efficacy. The drug is available in two specifications, 2ml:20mg and 5ml:100mg, both of which have been approved.

Dobutamine Hydrochloride Injection is mainly used for short-term supportive treatment of heart failure caused by organic heart disease and low cardiac output syndrome after cardiac surgery. The company obtained the "Drug Registration Approval" for Dobutamine Hydrochloride Injection (2ml:20mg) approved and issued by the NMPA in September 2002. In July 2024, it submitted an application for consistency evaluation of domestically produced drugs for this product to the Center for Drug Evaluation (CDE) of the NMPA, along with an application to add the 5ml:100mg specification. The application was accepted on July 23, 2024, and recently, both specifications have obtained the approval for passing the generic drug consistency evaluation. As of the disclosure date of the announcement, according to Yaozhi.com, there are a total of 31 manufacturers (including Cheng Yi Pharmaceutical) whose Dobutamine Hydrochloride Injection has passed the NMPA consistency evaluation. This drug has been included in the 10th batch of the National Drug Centralized Procurement Catalogue, with 8 winning bidders in total.

The announcement indicates that the company has invested a total of approximately 5.3752 million yuan in R&D for the consistency evaluation of this drug.

This progress reflects the company's continuous R&D capabilities and policy response capabilities in the field of chemical drug preparations, providing strong support for its competition in the centralized procurement market. (Jin Lulu)

Source: China Securities Network