The first imitation of 5 varieties was released, and the anti-epileptic life-saving drug of "one medicine is hard to find" has finally arrived

On September 19, the State Food and Drug Administration released the latest drug approval documents
.

A total of 29 varieties and 43 product specifications in this batch have passed / been deemed to have passed the consistency evaluation, of which 5 varieties are the first imitation evaluation: Hunan Kelun Pharmaceutical's ceftriaxone sodium for injection/sodium chloride injection (imitation class 3), Shutaishen Biopharmaceutical's compound polyethylene glycol (3350) electrolyte powder (imitation class 3), Jiangxi Yiyou Pharmaceutical's bromide hexanexin granules (imitation class 3), Hainan Simcere Pharmaceutical's edoxaban tablets (imitation class 4), Yichang Renfu Pharmaceutical's chlorbazon tablets (imitation category
。

The details of the evaluated varieties are as follows:

#01

Keren Pharmaceutical - Ceftriaxone sodium / sodium chloride injection for injection

Ceftriaxone sodium is a third-generation long-acting and broad-spectrum cephalosporin developed by Roche, which has the advantages
of long half-life, strong tissue penetration and small toxicity and side effects compared with other third-generation cephalosporins.

Ceftriaxone sodium / sodium chloride injection for injection (trade name: heyisone) is the second powder double-chamber bag product approved by Kelun Pharmaceutical after the injection of ceftazidine/5% glucose injection, and it is also the first ceftriaxone powder double-chamber bag product in China
.

(Source: Intranet)

According to the data of the rice intranet, ceftriaxone sodium is more than 100 million varieties, in recent years, the terminal sales of domestic sample hospitals have exceeded 400 million, and the sales volume in 2021 is 450 million yuan, due to the impact of collection, sales in 2022 have declined, and H1 is only 71.

Shutaishen Biopharma - Compound Polyethylene Glycol (3350) Electrolyte Dispersion

The indications for compound polyethylene glycol electrolyte dispersion are "for the treatment of functional constipation; It is used for preoperative bowel cleansing preparation, enteroscopy and other intestinal cleansing preparation
before examination.

There are many clinical studies that show that polyethylene glycol drugs have a clear effect on constipation and fecal impaction in adults and children, and have good
safety.

#03

Jiangxi Yiyou Pharmaceutical - Bromhexin hydrochloride granules

The original research of bromhexin is Boehringer Ingelheim, which was launched in Europe in 1963, mainly in Germany, France and Spain
.

Bromhexine hydrochloride granules are mainly used for acute bronchitis, chronic bronchitis, tuberculosis, pneumoconiosis, and expectorant
after surgery.

At present, domestic bromhexixin hydrochloride has tablets, injections and other dosage forms, and injections are the main sales dosage forms, accounting for more than 90% of
sales.

Intranet data shows that in 2021, the terminal sales of domestic sample hospitals will be about 180 million yuan
.

#04

Hainan Simcere Pharmaceutical - Edoxaban toluenesulfonate tablets

Edoxaban reversible factor X.

In December 2018, the original research products entered the domestic market and entered the national medical insurance catalogue (Class B)
through negotiations in December 2020.

The first three total of edoxaban toluene sulfonate tablets have performed well recently, according to the data of the Intranet, the terminal sales of H1 domestic sample hospitals in 2022 were 35.

#05

Yichang Renfu Pharmaceutical - Chlorbachan tablets

Clobachan is a long-acting benzodiazepine with a pharmacological effect similar to diazepam, with anxiolytic and anticonvulsant effects
.

In 2011, the U.

In recent years, the demand for this life-saving drug for children has become increasingly large, many parents have to buy through gray channels, "drug trafficking for children" incident has attracted much attention, and later the Food and Drug Administration has also issued some policies to temporarily import chlorbajan
.
Renfu Pharmaceutical declared clinical treatment in November 2020, which lasted nearly two years and was finally approved for listing, and the "life-saving drug" of the children finally landed
.
After the listing of Chloropazhan, Renfu Pharmaceutical will continue to consolidate its leading position
as a central nervous system drug.

In addition, Renfu Pharmaceutical also applied for a clinical trial of chlorobachan oral suspension on August 16, and Renfu may want to monopolize this field
.