December 13, 2023 Source: drugdu 95
Important Notice:
Changchun BCHT Biotechnology Co. (hereinafter referred to as the "Company") has recently received the Notice of Approval of Drug Clinical Trial from the State Drug Administration.
2, the freeze-dried human rabies vaccine (human diploid cells) subsequent clinical trials are uncertain, and there is a certain degree of uncertainty whether the commercial purpose can ultimately be achieved. Investors are kindly advised to make decisions with caution and pay attention to the prevention of investment risks.
The relevant information is announced as follows:
I. Main information of the Notice of Approval of Drug Clinical Trial
Acceptance No.: CXSL2300615
Notification No.: 2023LP02456
Drug Name: Lyophilized Human Rabies Vaccine (Human Diploid Cells)
Conclusion: Agree to carry out clinical trials for the prevention of rabies.
Approval date: December 6, 2023
The freeze-dried human rabies vaccine (human diploid cell) approved by the Company this time is freeze-dried human rabies vaccine (MRC-5 cell).
II. Introduction of Lyophilized Human Rabies Vaccine (Human Diploid Cells)
Rabies is the disease with the highest morbidity and mortality rate in the world, once the disease develops, the morbidity and mortality rate is close to 100%, and it is widely distributed in the world, and about 60,000 people die of this disease every year. There is no effective treatment for rabies, and post-exposure prophylaxis is still the mainstay. China's listed rabies vaccine products can be divided into: human diploid cells, Vero cells (African green monkey kidney cells), gopher kidney cells and chicken embryo cell rabies vaccine according to the different cell substrates used. The human diploid cell rabies vaccine has a natural safety advantage and is known as the gold standard vaccine for rabies prevention by the World Health Organization.
The freeze-dried human rabies vaccine (human diploid cells) approved by the Company is made from human diploid cells, which are widely used in the production of vaccines in the world. The cells are derived from healthy human embryonic lung tissue, with no foreign cell residues and no potential risks such as foreign protein and DNA introduction. It has the advantages of good immunogenicity, fast onset of action, good safety and long duration of immunization. It is especially suitable for people with low immunity such as allergy, the elderly and children. Freeze-dried human rabies vaccine (human diploid cells), with its differentiated advantages, will enrich the company's research and development product lineup and meet the market demand to a greater extent.
III. Impact on the company
If the vaccine successfully completes clinical trials and is approved for marketing, it will help the Company optimize its product structure, industrial layout and overall development of its main business, and enhance its long-term profitability.
IV. Risk Reminder
1. There is a certain degree of uncertainty as to whether the subsequent clinical trials of the Company's lyophilized human rabies vaccine (human diploid cell) will be carried out and whether it can ultimately achieve its commercial purpose.
2. The Company will actively promote the aforesaid research and development project in accordance with relevant national regulations and fulfill its information disclosure obligations on the subsequent progress of the project in a timely manner.
3、This Freeze-dried Human Rabies Vaccine (Human Diploid Cells) obtaining the Notice of Approval for Clinical Trial of Drugs will not have a significant impact on the Company's recent performance, and we respectfully request investors to make decisions cautiously and pay attention to the prevention of investment risks.
We hereby make this announcement.
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