The announcement that the subsidiary oxycodone hydrochloride API has passed the CDE approval and oxycodone hydrochloride injection has obtained the drug registration certificate is 3 pages in total
Securities code: 000931 securities abbreviation: Beijing Centergate Technologies (Holding) Co.Ltd(000931) Announcement No.: 2022-002
Beijing Beijing Centergate Technologies (Holding) Co.Ltd(000931) technology development (holding) Co., Ltd
Announcement on the subsidiary company oxycodone hydrochloride API passing the CDE approval and oxycodone hydrochloride injection obtaining the drug registration certificate
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.
Beijing HuaSu Pharmaceutical Co., Ltd. (hereinafter referred to as Beijing HuaSu) "oxycodone hydrochloride API and injection", a subsidiary of Beijing Beijing Centergate Technologies (Holding) Co.Ltd(000931) science and technology development (holding) Co., Ltd. (hereinafter referred to as the company), recently passed the technical review of the drug review center of the State Drug Administration (hereinafter referred to as CDE), Oxycodone hydrochloride injection has obtained the drug registration certificate approved and issued by the State Drug Administration (hereinafter referred to as the State Drug Administration). The relevant information is hereby announced as follows:
1、 Basic drug information
(I) oxycodone hydrochloride API
Product Name: oxycodone hydrochloride
Registration No.: y2019000561
Product source: Domestic
Approval result jointly with the preparation: a (raw materials approved for use in the marketed preparation)
Manufacturer: Beijing HuaSu Pharmaceutical Co., Ltd
(II) oxycodone hydrochloride injection
Drug name: oxycodone hydrochloride injection
Dosage form: injection
Specification: (1) 1ml: 10mg (2) 2ml: 20mg
Clinical indications: This product is a powerful analgesic. It is used to treat moderate to severe acute pain, including moderate to severe pain caused by surgery and severe pain requiring treatment with strong opioids.
Drug validity: 24 months
Application item: listing
The announcement that the subsidiary oxycodone hydrochloride API has passed the CDE approval and oxycodone hydrochloride injection has obtained the drug registration certificate is 3 pages in total
Registration classification: Class 4 chemicals
Drug approval No.: gyzz h20213987, gyzz h20213988
Holder of drug marketing license: Beijing HuaSu Pharmaceutical Co., Ltd
Manufacturer: Beijing HuaSu Pharmaceutical Co., Ltd
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. The registration is approved and a drug registration certificate is issued. The production process, quality standards, instructions and labels shall be implemented in accordance with the attached. A pharmaceutical production enterprise shall meet the requirements of the standards for the quality control of pharmaceutical production before it can produce and sell. This product is managed according to narcotic drugs.
2、 Other relevant information of drugs
Oxycodone hydrochloride injection is a powerful analgesic for the treatment of moderate to severe acute pain, including moderate to severe pain caused by surgery and severe pain requiring the use of strong opioids. The product has been listed in class B drugs of the national medical insurance catalogue (2020 Edition).
Oxycodone hydrochloride injection was marketed in China in 2013. According to statistics, the sales volume of oxycodone hydrochloride injection in China in 2019 was about 298 million yuan, and the sales volume of oxycodone hydrochloride injection in China in 2020 was about 200 million yuan (the data came from intranet).
Up to now, there are also Northeast Pharmaceutical Group Co.Ltd(000597) Group Shenyang first pharmaceutical Co., Ltd. and Jiangsu Nhwa Pharmaceutical Co.Ltd(002262) Chinese manufacturers who have obtained the drug registration certificate of the product.
3、 Impact on the company
(I) oxycodone hydrochloride API has passed the CDE review and approval, indicating that the API meets the relevant technical standards for drug review in China and has been approved for use in the preparations listed in China, which improves the competitiveness of the company's products in the market.
(II) oxycodone hydrochloride injection has obtained the drug registration certificate issued by the State Food and drug administration, which further enriches the company's product line, strengthens the company's leading position in China of narcotic analgesics, and helps to enhance the market competitiveness of the company's products. According to relevant national policies, oxycodone hydrochloride injection is approved to be produced according to category 4 chemicals, which can be regarded as passing the consistency evaluation, and the product has been listed in category B drugs in the national medical insurance catalogue (2020 Edition), which is conducive to expanding the market sales of the company's products and has a positive impact on the company's business performance.
The announcement that the subsidiary oxycodone hydrochloride API has passed the CDE approval and oxycodone hydrochloride injection has obtained the drug registration certificate is 3 pages in total
4、 Risk tips
(I) as the product is affected by GMP compliance inspection progress, national policies, changes in market environment and other factors, the production and sales time and specific sales of the above API products are uncertain. Please make careful decisions and pay attention to preventing investment risks.
(II) the company attaches great importance to drug R & D and strictly controls the quality and safety of drug R & D, manufacturing and sales. Due to the characteristics of high technology, high risk and high added value of pharmaceutical products, drug production and sales are easily affected by factors such as GMP compliance inspection progress, national policies and market environment, with great uncertainty. Please make careful decisions and pay attention to preventing investment risks.
5、 Documents and websites for future reference
1. Website of original and auxiliary package registration information platform: https://www.cde.org.cn./ mai n/xxgk/listpage/ba7aed094c29ae31467c0a35463a716e ； 2. Drug registration certificate.
It is hereby announced
Board of directors of Beijing Beijing Centergate Technologies (Holding) Co.Ltd(000931) science and technology development (holding) Co., Ltd
January 7, 2002
