Securities code: Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) securities abbreviation: Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) Announcement No.: 2022008
Wanbangde Pharmaceutical Holding Group Co.Ltd(002082)
Announcement on the first wholly-owned subsidiary to pass the consistency evaluation of phloroglucinol injection
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
On March 1, 2022, Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) (hereinafter referred to as "the company"), a wholly-owned subsidiary of Wanbangde Pharmaceutical Holding Group Co.Ltd(002082) Pharmaceutical Group Co., Ltd., received the notice of approval of supplementary drug application (Notice No.: 2022b00839) from the State Drug Administration on phloroglucinol injection (hereinafter referred to as "the product"). The main contents are announced as follows:
1、 Basic information of approval notice
Generic name of drug: phloroglucinol injection
English name / Latin name: chlorolucinol injection
Dosage form: injection
Registration category: Chemicals
Specification: 4ml; 40mg
Drug registration Standard No.: ybh01972022
Original drug approval No.: gyzz h20057779
Approval conclusion: according to the drug administration law of the people's Republic of China and the opinions of the State Council on reforming the evaluation and approval system of drugs and medical devices (GF [2015] No. 44) According to the provisions of the announcement on matters related to the evaluation of the quality and efficacy consistency of generic drugs (No. 100 in 2017) and the announcement of the State Food and Drug Administration on the evaluation of the quality and efficacy consistency of generic drugs for chemical drug injection (No. 62 in 2020), the product has passed the evaluation of the quality and efficacy consistency of generic drugs.
2、 Other relevant information of drugs
Phloroglucinol injection is mainly applicable to acute spastic pain caused by digestive system and biliary tract dysfunction, acute spastic urethral, bladder and renal colic, and gynecological spastic pain. It belongs to category B of the national medical insurance catalogue (version 2021).
Phloroglucinol can directly act on the smooth muscle of gastrointestinal tract and genitourinary tract. It is an antispasmodic drug for smooth muscle. Compared with other smooth muscle antispasmodics, it is characterized by no anticholinergic effect. While relieving smooth muscle spasm, it will not produce a series of anticholinergic side effects, cause hypotension, accelerated heart rate, arrhythmia and other symptoms, and has no effect on cardiovascular function.
3、 Impact on the company and risk tips
The company's phloroglucinol injection is the first in China to pass the conformity evaluation of generic drugs, which is conducive to improving the company's market competitiveness. Phloroglucinol API is one of the company's existing API products. The company will speed up the market promotion of phloroglucinol injection by relying on its production advantages of API + preparation.
Phloroglucinol injection is the first injection product of the company to pass the consistency evaluation, which accumulates valuable experience for the follow-up injection products to carry out the conformity evaluation of generic drugs.
As drug sales are affected by national policies, market environment and other uncertain factors, the company is still unable to predict its specific impact on the company's future performance. Please pay attention to investment risks.
It is hereby announced.
Wanbangde Pharmaceutical Holding Group Co.Ltd(002082)
Board of directors
March 2, 2002
