Securities code: Ningbo Menovo Pharmaceutical Co.Ltd(603538) securities abbreviation: Ningbo Menovo Pharmaceutical Co.Ltd(603538) Announcement No.: 2022021
Convertible bond Code: 113618 convertible bond abbreviation: Meinuo convertible bond
Ningbo Menovo Pharmaceutical Co.Ltd(603538)
Announcement on the holding subsidiary mirtazapine API passing the CDE technical review
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.
Recently, Zhejiang Liaoyuan Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhejiang Liaoyuan”), a holding subsidiary of Ningbo Menovo Pharmaceutical Co.Ltd(603538) (hereinafter referred to as “the company”), mirtazapine API passed the technical review of the drug evaluation center of the State Drug Administration (hereinafter referred to as “CDE”) The registration number displayed on the registration information publicity platform of pharmaceutical excipients and drug packaging materials has changed to “a”, and the relevant information is announced as follows:
1、 Main contents of registration information
Registration No.: y202 Shenzhen Zhenye(Group)Co.Ltd(000006) 69
Variety name: mirtazapine
Company name: Zhejiang Liaoyuan Pharmaceutical Co., Ltd
Enterprise address: Linhai Park, chemical API base, Zhejiang Province
Product source: domestic production
Package specification: 25kg / barrel
Review and approval results: a (raw materials approved for use in marketed preparations)
2、 Indications and pharmacological effects
Drug indications: applicable to the treatment of depression. It can improve depressive symptoms and sleep structure of patients, and improve sleep quality; Cause less sexual dysfunction and improve patient compliance; Easy to use, less drug interaction and good tolerance.
Pharmacological action: mirtazapine has a four ring structure and belongs to piperazine azoles. It is a powerful antagonist of H1 receptor. This property can produce sedative effect.
3、 Description of drug registration and its impact on the company
On July 15, 2019, the State Food and Drug Administration issued the “on further improving the review and approval of drug associations”
Announcement on matters related to supervision (No. 56 of 2019), which requires: imitation or import into China
The API used in the listed pharmaceutical preparations can be reviewed and approved separately after being registered by the API registrant
The registration status that has been reviewed and approved is marked as “a”.
Zhejiang Liaoyuan submitted the application for review of mirtazapine to CDE on June 19, 2020, March 2022
On June 14, mirtazapine passed the review and approval, and the registration status was marked as “a” (approved for use in marketed preparations)
Raw materials).
Because mirtazapine was a product successfully developed by Liaoyuan in Zhejiang in its early years, the above drug list was not approved due to historical reasons
The R & D investment is calculated independently, and the R & D investment amount of a single product cannot be provided. The application fee is about RMB
183600 yuan.
The mirtazapine API from Liaoyuan, Zhejiang Province has passed the CDE technical review, which proves that the API has met the relevant national standards
The technical standards for drug evaluation can be sold to the Chinese market, which will further enrich the company’s product line and help expand the market
The expansion of the company’s business areas is conducive to further expand the company’s integrated production scope of API preparations and enhance the company’s competitiveness
Advantages of integrated production.
4、 Drug market situation
Product name and market conditions of other major manufacturers
Main manufacturers in China: Shanxi Kangbao biological products. As of December 31, 2020, the sales volume of mirtazapine API quanmirtazapine (API) Co., Ltd., Huayu (Wuxi) Pharmaceutical Co., Ltd. and ball was 68.27 tons, including 41.87 tons of sales volume in European market, including Lanxi Harbin Medisan Pharmaceutical Co.Ltd(002900) Pharmaceutical Co., Ltd, The sales volume in North America is 11.03 tons, and the sales volume of major foreign manufacturers of mirtazapine in Latin America is 4.00 tons.
Sunpharm, Teva, medichem, etc
Note: product market data comes from IMS data.
5、 Risk tips
Due to the industry characteristics of pharmaceutical products, the production and future sales of the drug may be difficult
Due to the changes of market environment and other factors, it has great uncertainty. Please pay attention to the investment wind
It is hereby announced.
Ningbo Menovo Pharmaceutical Co.Ltd(603538)
Board of directors
March 16, 2022
