Securities code: 600436 securities abbreviation: Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) Announcement No.: 2022-011 Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436)
Announcement on receiving the notice of approval of 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.
Important content tips:
Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) (hereinafter referred to as "the company" or "the company") becoming the holder of the listing license of desloratadine oral solution will have no significant impact on the financial status and operating performance of the company this year.
As the production and sales of drugs are affected by uncertain factors such as changes in national policies and bidding procurement, please make careful decisions and pay attention to preventing investment risks.
Recently, the company received the notice of approval of drug supplementary application approved and issued by the State Drug Administration and agreed to change the holder of the listing license of desloratadine oral solution to the company. The relevant information is disclosed as follows:
1、 Main contents of the notice of approval of supplementary drug application
Drug name: desloratadine oral solution
Dosage form: Oral Solution
Classification of registered chemicals
Specification: 30ml: 15mg
Package specification: 30ml / bottle
Application content: the holder of the drug marketing license is changed from Shandong Bainuo Pharmaceutical Co., Ltd. to Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) .
Acceptance No.: cyhb2200030
Notice No.: 2022b00397
Drug approval No.: gyzz h20213056
Listing Permit Holder: Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) (address: No. 1, Amber Road, Xiangcheng District, Zhangzhou City, Fujian Province)
Manufacturer: Shandong LANNUO Pharmaceutical Co., Ltd. (address: No. 127, Qizhong Avenue, Yanbei sub district office, Qihe County, De Zhou City, Shandong Province)
Approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the application of this product meets the relevant requirements of drug registration, and it is agreed to comply with the relevant provisions of the measures for the administration of changes after drug listing (Trial), The holder of the approval for the listing of this product is changed from "Shandong Bainuo Pharmaceutical Co., Ltd. (address: 201, block C, century wealth center, east of Chonghua Road, Jinan area, China (Shandong) pilot Free Trade Zone)" to " Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) " (address: No. 1 Amber Road, Xiangcheng District, Zhangzhou City, Fujian Province) ", and the drug approval number remains unchanged. The production site, prescription, production process and quality standard of the transferred drug are consistent with the original drug without change. After the transferred drugs have passed the compliance inspection of drug production quality management standards and meet the requirements for product release, they can be sold on the market.
2、 Relevant information of drugs
In December 2019, the company signed the technical entrustment development contract for desloratadine oral solution with Shandong Bainuo Pharmaceutical Co., Ltd. (hereinafter referred to as "Bainuo pharmaceutical"), which agreed that after desloratadine oral solution obtained the drug registration certificate, it would change its listing license holder to the company.
Desloratadine is a non sedative long-acting histamine antagonist, which is used to alleviate the systemic and local symptoms of chronic idiopathic urticaria and allergic rhinitis. According to PDB drug comprehensive database, the global market sales of desloratadine reached about 582 million US dollars in 2020, and the sales of sample hospital drugs in China market reached about 325 million yuan in 2020.
The original research company of the dosage form of desloratadine oral solution is MSD, which was first approved to be listed in Europe in 2007, but not in China. At present, Shandong Dayin marine biopharmaceutical Co., Ltd., Hefei enruite Pharmaceutical Co., Ltd. and Guangdong Jiuming Pharmaceutical Co., Ltd. have been approved to produce this product in China.
Up to now, the company has invested about 16.385 million yuan (Unaudited) in desloratadine oral solution project.
3、 Relevant impact and risk tips
1. Desloratadine oral solution is the second chemical product of the company as the holder of marketing license, which helps to enrich the company's chemical product line.
2. The company's becoming the listing permit holder of desloratadine oral solution will have no significant impact on the company's financial status and operating performance this year.
3. As the production and sales of drugs are affected by uncertain factors such as changes in national policies and bidding procurement, please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) board of directors
February 10, 2022
