Securities code: 600812 stock abbreviation: North China Pharmaceutical Company.Ltd(600812) No.: pro 2022-003 North China Pharmaceutical Company.Ltd(600812)
Suggestive announcement on the approval of omutezumab injection for marketing
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.
North China Pharmaceutical Company.Ltd(600812) (hereinafter referred to as the “company”) learned from the subsidiary North China Pharmaceutical Company.Ltd(600812) group new drug research and Development Co., Ltd. (hereinafter referred to as the “new drug company”) that according to the website of the State Drug Administration, the State Drug Administration approved the listing of omtivimab injection declared by the new drug company through the priority review and approval procedure. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Drug name: omativumab injection
English name / Latin name ormutivimab injection
Acceptance No.: cxss2000039
Main component: omativumab
Dosage form injection
Application item drug registration (domestic production)
Registration classification: Class 1 biological products for treatment
Specification: 200iu (1ml) / bottle
Package specification: 1 bottle / box
Name of listing Permit Holder: North China Pharmaceutical Company.Ltd(600812) group new drug research and Development Co., Ltd
Address: room 901, innovation building, Jinshi Park, No. 368, Xinshi North Road, Shijiazhuang
Manufacturer name: North China Pharmaceutical Company.Ltd(600812) Jintan Biotechnology Co., Ltd
Address: No. 106, Tianshan South Street, high tech Zone, Shijiazhuang
Note: the above information shall be subject to the official documents issued by the State Drug Administration.
2、 Other relevant information of drug research
This product is a recombinant human anti rabies virus monoclonal antibody injection. The international non patent common name is ormutivimab, and the Chinese common name is olmutivimab. This variety is an independent research and development project of the new drug company. Its action mechanism and indication are to combine this product with human rabies vaccine to supplement the antibody blank in the process of active immunization of human rabies vaccine. It can directly neutralize the rabies virus in the body and play a passive immune role. It is used for passive immunity of patients bitten and scratched by rabies or other rabies virus susceptible animals.
The phase I clinical trial of the project was completed in October 2013, the phase II clinical trial was completed in April 2018, and the phase III clinical trial was completed in April 2020. The application for registration of this product was accepted by the drug evaluation center of the State Drug Administration in June 2020 and included in the priority evaluation and approval procedure in August 2020. (for details, see the company’s announcement Lin 2020-015 and Lin 2020-057)
Up to now, the cumulative R & D investment of the drug is 198722400 yuan.
3、 Market situation of similar drugs
At present, there is no recombinant anti rabies virus monoclonal antibody on the market in China. The passive immune agents that can be used to prevent rabies virus exposure in China are anti rabies serum and rabies patient immunoglobulin. According to the data query results on the website of the State Drug Administration, up to now, 18 enterprises in China have the approval number of rabies immunoglobulin and have not approved the sales of imported products. According to the batch issuance data of dingxiangyuan biological products, the batch issuance quantity of rabies patient immunoglobulin (specification: 200iu / bottle) in 2020 is about 11.82 million bottles; According to the query of yaodu.com, the bidding price of rabies patients’ immunoglobulin in 2020 (200iu / bottle) is 140 ~ 180 yuan / bottle. The company failed to inquire the market sales data of the above products from public channels.
4、 R & D and registration of similar drugs
In China, in addition to companies, there are three companies carrying out similar research. The recombinant humanized monoclonal antibody syn023 developed by Shenzhen Longrui Pharmaceutical Co., Ltd. and Xingmeng Biotechnology (Beijing) Co., Ltd. is in the stage of phase III clinical trial. The phase II clinical trial of gr1801 injection developed by Zhixiang (Shanghai) Pharmaceutical Technology Co., Ltd. / Chongqing Zhixiang Jintai biopharmaceutical Co., Ltd. has been started. Zhuhai Tainuo Mabo Biotechnology Co., Ltd. transferred the developed “all human anti rabies virus monoclonal antibody” to Changchun Changchun Bcht Biotechnology Co(688276) Technology Co., Ltd. for further development. According to the official website data of Changchun Baike company, the variety is in the stage of preclinical research.
Abroad, the recombinant anti rabies virus monoclonal antibody injection siirmab (rabishield) developed by the Indian Institute of serum has been approved for listing in India in December 2016; Rabimabs (twinrab), a mixed preparation of murine monoclonal antibodies developed by zydus Cadila in India, was approved in India in September 2019. The company failed to inquire the above-mentioned company’s market sales data about the product from public channels.
5、 Impact on the company and risk tips
As a class 1 new drug for therapeutic biological products, the injection of omativivir monoclonal antibody has no similar product on the market in China, and its competitive products are anti rabies serum and rabies patient immunoglobulin. The sales business of preparation products is vulnerable to China Meheco Group Co.Ltd(600056) industry policy changes, market environment changes and other factors, and there is uncertainty. At present, the new drug company has not obtained the official approval. After obtaining the relevant official documents issued by the State Drug Administration, the company will disclose the relevant information of the drug approval in time. Please invest rationally and pay attention to investment risks.
It is hereby announced.
North China Pharmaceutical Company.Ltd(600812)
January 25, 2022
