Following the approval of Dobutamine Hydrochloride Injection with dual specifications (20ml:250mg and 40ml:500mg), Poly Pharm.. has recently received the registration approval for consistency evaluation of Dobutamine Hydrochloride Injection (1.6ml:20mg) issued by the National Medical products Administration (NMPA). The approval of multiple specifications of the product can meet different clinical needs for medication, which is conducive to enhancing the market competitiveness of the drug, and will have a positive impact on the company's operating results.
According to the dobutamine hydrochloride injection instructions, the indication is for use as short-term supportive therapy for heart failure caused by decreased myocardial contractility in the setting of organic heart disease, including low-volume syndrome due to open-heart surgery.The usual adult dose of dobutamine is diluted in 5% dextrose solution or 0.9% sodium chloride injection and given at a drip rate of 2.5 to 10ug/kg per minute. Dobutamine Hydrochloride Injection (1.6 ml; 20 mg) allows for flexible dosing and meets the short-term supportive care needs of some patients.
Dobutamine is a sympathomimetic drug used in the treatment of heart failure and cardiogenic shock. It was developed by ELI LILLY AND CO in the United States and was approved for marketing by the FDA on July 18, 1978 (trade name: DOBUTREX®, 12.5 mg/ml, NDA No. N017820). Since then, Dobutamine Hydrochloride Injection has been approved for marketing in China, Japan, Europe and other countries.After the successful development of Poly Pharm.'s Dobutamine Hydrochloride Injection 20 ml:25 mg and 40 ml:500 mg specifications, the company successively submitted generic registration applications in the United States and China and received the approval from the U.S. Food and Drug Administration (FDA) in December 2022, and the approval of consistency evaluation from the National Medical products Administration (NMPA) in March 2023. After the successful development of the 1.6ml:20mg specification, a supplemental application for consistency evaluation in China was submitted; recently, the company received the approval for consistency evaluation from the NMPA.With the company's Dobutamine Hydrochloride Injection (specification: 1.6 ml:20mg) passing the consistency evaluation of generic injections, it enriches the product's multi-clinical application scenarios, which is conducive to the establishment of higher competitive barriers and the enhancement of the drug's competitiveness in the market and will have a positive impact on the company's operating results.In addition, Poly Pharm. also produces Dobutamine Hydrochloride API, which is an integrated variety of API and formulations.
According to data from Menet (see below for details), the domestic market for dobutamine hydrochloride injection has shown steady growth in recent years, with sales exceeding RMB 500 million in 2022, and a 5-year average annual growth rate of over 40%.
Dobutamine Hydrochloride Injection (1.6ml: 20mg), which has been approved for marketing, is a commonly used clinical content in China, which can flexibly meet all kinds of clinical therapeutic needs, has excellent clinical value and will play a great clinical role in the future.
