On September 13, Chengyi PharmaceuticalAn announcement was released regarding the company's drug passing the generic drug consistency evaluation. The announcement revealed that the company recently received the "Notice of Approval of Supplementary Drug Application" from the National Medical Products Administration (NMPA). The company's dobutamine hydrochloride injection has passed the generic drug quality and efficacy consistency evaluation. The drug is available in two strengths: 2ml: 20mg and 5ml: 100mg, both of which have been approved.

Dobutamine hydrochloride injection is primarily used for the short-term supportive treatment of heart failure caused by organic heart disease and post-cardiac surgery low-output syndrome. The company received the Drug Registration Approval for dobutamine hydrochloride injection (2ml:20mg) from the National Medical Products Administration (NMPA) in September 2002. In July 2024, the company submitted an application for domestic production consistency evaluation of the drug to the NMPA's Center for Drug Evaluation, also seeking an additional 5ml:100mg strength. The application was accepted on July 23, 2024, and both applications recently passed the generic drug consistency evaluation. As of the date of this announcement, according to Yaozhi.com, 31 manufacturers of dobutamine hydrochloride injection, including Chengyi Pharmaceutical , have passed the NMPA's consistency evaluation. The drug has been included in the tenth batch of the National Drug Procurement Catalog, with eight companies receiving the winning bid.

The announcement shows that the company's cumulative R&D investment in the consistency evaluation of this drug is approximately 5.3752 million yuan.

This progress reflects the company's continuous R&D capabilities and policy responsiveness in the field of chemical preparations, and provides strong support for its competition in the centralized procurement market.

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