Stock code: 603676 Securities abbreviation: Wilson Kang Announcement number: 2020-012
The Board of Directors and all Directors of the Company warrant that the contents of this announcement are free from any misrepresentation, misleading statement or material omission and accept sole and several liability for the truthfulness, accuracy and completeness of the contents.
Recently, Inner Mongolia Baiyi Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Tibet Weixinkang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the Drug Registration Approval Document for a variety of trace element injections approved and issued by the State Drug Administration. The relevant matters are hereby announced as follows:
First, the basic situation of drugs
Drug name: a variety of trace element injection
Dosage form: injection
Spec.: 40ml
Application matters: Domestic drug registration
Declaration stage: production
Applicant: Inner Mongolia Baiyi Pharmaceutical Co., Ltd
Acceptance number: CYHS1301831 Mongolia
Batch number: 2020S00141
Drug approval number: National Medicines Approval Word H20203105
The drug approval number is valid until March 16, 2025
Main approval opinions: According to the "Drug Administration Law of the People's Republic of China" and relevant provisions, after review, this product meets the relevant requirements of drug registration, approves registration, and issues a drug approval number.
Second, other relevant situations of drugs
In November 2013, Inner Mongolia Baiyi Pharmaceutical Co., Ltd. submitted a drug registration application to the Food and Drug Administration of Inner Mongolia Autonomous Region with the drug name mixed trace element injection (10) and was accepted, and at the same time, the relevant raw materials were declared: gluconolactone, manganese gluconate, copper gluconate, cobalt gluconate, chromium chloride, ammonium heptamolybdenumate, sodium iodide, sodium fluoride, and the above related raw materials and excipients have passed the technical review, and the filing status is: A.
A variety of trace element injections are trace element supplements containing 10 trace elements and are suitable for adult patients who require parenteral nutrition. A variety of trace element injection original research products for the French LABELATOIRE AGUETTANT company DECAN?, has been in France, Britain, Greece, Italy, Poland, Austria, Denmark, Spain, Finland, Luxembourg, the Netherlands, Portugal, Sweden, the Republic of Ireland and other countries listed for sale, has been approved in December 2011 to import to China, the commodity name is "Laiwei", import drug registration certificate number H20110522.
After inquiry, the only domestic approved manufacturer of a variety of trace element injections is the French LABELATOIRE AGUETTANT company. After searching, as of the disclosure date of this announcement, no other manufacturers in China have made declarations for a variety of trace element injections. The domestic manufacturers of similar preparations for adults to supplement trace elements (II.) are: Baizheng Pharmaceutical Co., Ltd., Fresenius Kabi Huarui Pharmaceutical Co., Ltd., Jilin Sichang Pharmaceutical Co., Ltd., Sichuan Meida Kangjiale Pharmaceutical Co., Ltd.
A variety of trace element injections and a variety of trace elements injections (II.) have been included in the 2019 National Medical Insurance Catalogue (Class B).
According to the statistics of the intranet, in 2018, the sales amount of a variety of trace element injections in china's three major terminal public medical institutions in cities, counties, communities and townships was about 232 million yuan, and in 2018, the sales amount of multiple trace element injections (II.) in China's cities, counties, communities and townships was about 567 million yuan.
Up to now, a variety of trace element injection projects have invested about 25.7103 million yuan in research and development costs.
3. Risk warning
At present, the company has begun to prepare for production, due to the characteristics of high-tech, high risk, high value-added pharmaceutical products, the future market sales after the drug is put into production may be affected by changes in the market environment, bidding and bidding and other factors, there is uncertainty, please be cautious in the majority of investors to make decisions, pay attention to prevent investment risks.
This is hereby announced.
Tibet Weixinkang Pharmaceutical Co., Ltd
board of directors
March 20, 2020