Securities code: 603858 securities abbreviation: Shandong Buchang Pharmaceuticals Co.Ltd(603858) Announcement No.: 2022-006 Shandong Buchang Pharmaceuticals Co.Ltd(603858)
Announcement on the company's obtaining the notice of approval for supplementary drug application
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Shandong Buchang Pharmaceuticals Co.Ltd(603858) (hereinafter referred to as "the company") recently received the notice of approval of supplementary drug application for Xuanfei Baidu granule approved and issued by the State Drug Administration. The relevant information is disclosed as follows:
1、 Basic information of drugs
Drug name: Xuanfei Baidu granule
Dosage form: granules
Specification: 10g in each bag (equivalent to 119g of decoction pieces)
Drug approval No.: gyzz c20210003
Acceptance No.: cyzb2102084
Notice No.: 2022b00233
Registration category: Traditional Chinese Medicine
Drug registration Standard No.: ybz00032022
Application content: others
Approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, the product meets the relevant requirements of drug registration. Approve this product to complete the supplementary application for part of the study according to the approval conclusion of the drug registration certificate.
Listing Permit Holder: Shandong Buchang Pharmaceuticals Co.Ltd(603858) No. 369, Zhonghua West Road, Heze City
Manufacturer: Shandong Buchang Pharmaceuticals Co.Ltd(603858) No. 369, Zhonghua West Road, Heze City
2、 Other information about drugs
Xuanfei Baidu granule is mainly used for dispersing lung dampness, clearing heat and evil, purging lung and detoxifying. It is used for epidemic diseases caused by dampness toxin stagnation of the lung. Symptoms include fever, cough, pharyngeal discomfort, shortness of breath, fatigue, stupidity and poor stool; The tongue is dark red, the coating is yellow and greasy or yellow and dry, and the pulse is slippery or string is slippery.
Xuanfei Baidu granule obtained the drug registration certificate approved and issued by the State Drug Administration in March 2021. It is the exclusive variety of the company. As of the date of this announcement, the R & D cost invested by the company in Xuanfei Baidu granules was about 125.3711 million yuan.
3、 Impact on listed companies and risk tips
The company attaches great importance to drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales. The approval notice of drug supplementary application of Xuanfei Baidu granule is conducive to the large-scale production and sales of the product and has a positive impact on the company's future operation.
As pharmaceutical products have the characteristics of high technology, high risk and high added value, the production and sales of drugs are vulnerable to some uncertain factors. Subsequent companies will actively carry out relevant work according to requirements. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Shandong Buchang Pharmaceuticals Co.Ltd(603858) board of directors January 22, 2022
