Securities code: Cansino Biologics Inc(688185) securities abbreviation: Cansino Biologics Inc(688185) Announcement No.: 2022026 Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) company
Voluntary disclosure of New Coronavirus mRNA vaccine
Announcement of obtaining approval of drug clinical trial
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 legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
Important content tips:
Recently, the Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) company (hereinafter referred to as “the company”) received the approval of the National Drug Administration (hereinafter referred to as the “State Drug Administration”) issued by the “drug clinical trial approval”. The company’s application for clinical trial of New Coronavirus mRNA vaccine was approved by the company and its subsidiary Cansino Biologics Inc(688185) (Shanghai) Biotechnology Co., Ltd.
As there are many unpredictable factors in the process of drug clinical trial, the results and time of clinical trial, review and approval are uncertain. Please make careful decisions and pay attention to risk prevention. The relevant information is hereby announced as follows:
1、 Basic information of drug clinical trial approval documents
Product Name: New Coronavirus mRNA vaccine
Dosage form: injection
Application item: clinical trial
Registration classification: biological products for prevention
Applicant for registration: Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) company, Cansino Biologics Inc(688185) (Shanghai) Biotechnology Co., Ltd
Conclusion: in response to the epidemic situation of New Coronavirus infection, according to the drug administration law of the People’s Republic of China, the People’s Republic of China vaccine management law, the measures for the administration of drug registration and the special examination and approval procedures of the State Food and drug administration, the clinical trial of this product is carried out in an emergency way to prevent New Coronavirus infection caused by COVID-19.
2、 Other relevant information of the product
Covid-19 vaccine developed on the basis of prototype strain decreased the neutralizing antibody titer and protection rate to varying degrees. Therefore, the company and its subsidiary company Cansino Biologics Inc(688185) (Shanghai) Biotechnology Co., Ltd. jointly developed the New Coronavirus mRNA vaccine, which is a new generation of vaccine that has protective effect on the existing mutation, and is clinically used to prevent COVID-19 pneumonia. Preclinical research results show that this vaccine can induce high titer neutralizing antibodies against a variety of important variants identified by who (including current epidemic strains). Compared with the covid-19 vaccine developed based on the prototype strain, it has a wider spectrum and can more effectively protect the body from the infection of existing variants.
The mRNA technology platform currently established by the company has independently designed and developed sequence optimization software, which can obtain the key sites affecting stability and effectively improve the optimal sequence in antigen expression. The process is simple and conducive to industrialization.
3、 Risk tips
1. According to the requirements of laws and regulations related to national drug registration, after obtaining the approval of clinical trial, drugs need to carry out clinical trial, obtain safety and effectiveness data and be approved by the State Food and drug administration before production and marketing. Taking into account the potential impact of the COVID-19 epidemic, the clinical entry and research plan implementation of New Coronavirus mRNA vaccine is affected by many uncertain factors. The specific clinical research plan and research cycle may be adjusted according to the actual situation. In addition, there is uncertainty about whether the New Coronavirus mRNA vaccine will be approved and approved by the State Food and drug administration.
2. Up to now, 19 types of vaccines have been approved for clinical trials in China, and more than 19 types of vid-5 products have been approved for emergency use. Even if New Coronavirus mRNA vaccine is approved successfully, it will face more intense market competition in the future. Meanwhile, it will be affected by many factors such as the development of China’s external epidemic situation and COVID-19 vaccination rate.
3. New Coronavirus mRNA vaccine is used for the prevention of biological products. According to the vaccination situation, the epidemic prevention effect, individual protection level and adverse reactions may be affected by individual differences.
4. In order to ensure the smooth development of clinical research, the company needs to continue to pay relevant clinical trial expenses. In addition, it is expected that it will not have a significant impact on the company’s operating performance in the short term. The company will actively promote the above R & D projects and carry out follow-up related work in accordance with relevant national regulations.
The company’s information shall be subject to the announcements published in the China Securities Journal, securities times, Securities Daily, Shanghai Securities News and the website of Shanghai Stock Exchange. Please make careful decisions and pay attention to investment risks.
It is hereby announced.
Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) board of directors April 6, 2022
