Acute heart failure drug Shuangding Pharmaceutical's Operinone Hydrochloride Injection was approved for marketing

On April 13, the official website of the State Food and Drug Administration showed that Shenyang Shuangding Pharmaceutical Co.
, Ltd.
was approved to market Operinone Hydrochloride Injection, which was reported to be a third-class generic drug, becoming the first company to pass the evaluation of this product
.
Prior to this, Oprinon Hydrochloride Injection was the exclusive variety of Zhitong Bio.
In 2020, the terminal sales of public medical institutions in China exceeded 50 million yuan, and the trend was increasing year by year
.
Operinone hydrochloride injection is clinically used for the treatment of acute heart failure.
The drug was developed by Eisai and was first marketed in Japan in 1996
.
Before the approval of Shenyang Shuangding Pharmaceutical's products, only the first generic drug of Hebei Aierhaitai Pharmaceuticals (Zhitong Bio) was listed on the domestic market for Operinone Hydrochloride Injection
.
According to the data of Minet.
com, in 2020, the sales of terminal Oprinone hydrochloride injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) exceeded 50 million yuan.
Under the influence of the epidemic Still achieving a growth of 26.
58%, sales in the first half of 2021 increased by 21.
74% year-on-year
.
The sales situation of terminal Operinone hydrochloride injection in Chinese public medical institutions (unit: RMB 10,000) Source: Minet In the listing application, the products of Shenyang Shuangding Pharmaceutical have been approved for production and deemed to have been reviewed, which is the first in China.
The products of Sichang Pharmaceutical, Jichuan Pharmaceutical, Bainuo Pharmaceutical, Hengsheng Pharmaceutical, Sinopharm Group and other enterprises are still under review.
In addition, Hebei Aierhaitai Pharmaceutical has submitted a supplementary application for consistency evaluation and is currently under review
.
Source: Minet.
com MED2.
0 China Drug Evaluation Database Shenyang Shuangding Pharmaceutical's Operinone Hydrochloride Injection was approved for production and was the first to pass the review, which will change the product Market monopoly pattern to enhance market competitiveness
.
Shenyang Shuangding Pharmaceutical's existing products are mainly concentrated in the treatment fields of cardio-cerebral blood, anti-tuberculosis, orthopedics, hepatitis, etc.
, including Operinone hydrochloride injection, the company has launched a total of 39 drugs, of which 27 are proprietary Chinese medicines.
12 are chemical drugs, among which Kudiezi injection, rifampicin injection and other varieties have achieved terminal sales of over 100 million yuan in China's public medical institutions in 2020
.
Source: Minet database, NMPA official website, etc.
Note: The statistics are as of April 13.
If there are any omissions, please correct me!