FREEZE-DRIED HUMAN RABIES VACCINE CANDIDATE (SERUM-FREE VERO CELL) OBTAINED THE CLINICAL TRIAL APPROVAL ISSUED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
This announcement is made by AIM Vaccine Co., Ltd. (the “Company”, together with its subsidiaries, the “Group”) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business updates of the Group.
The board of directors of the Company (the “Board”) is pleased to announce that Ningbo Rong’an Biological Pharmaceutical Co., Ltd. (寧波榮安生物藥業有限公司), a wholly-owned subsidiary of the Company, has recently obtained the clinical trial approval for the freeze-dried human rabies vaccine candidate (serum-free Vero cell) issued by the Center for Drug Evaluation of National Medical Products Administration. The Group plans to commence a Phase III clinical trial for such vaccine candidate in the first half of 2023.
Rabies is an acute encephalitis caused by the rabies virus, which usually enters the human body through bites by infected animals. Typical symptoms include pain or extreme discomfort caused by the wound, fever, paralysis, obnubilation, convulsion, and fear of water. The incubation period of the rabies virus typically lasts from one to three months. After seizure, it usually causes death within seven to ten days. Rabies is a high-risk disease with no effective treatment, while it is vaccine-preventable post exposure to the virus.
Vero cell is the mainstream manufacturing technology route for human rabies vaccines worldwide. It is sensitive to virus, which means it can be used to culture virus strain with high titer. Also, the strain can be produced massively through the highly stable serial passage with low unit cost and high level of quality control.
As compared to the current human rabies vaccine (Vero cell), the freeze-dried human rabies vaccine candidate (serum-free Vero cell) of the Group can avoid the biosafety risks relating to the use of serum in production with potentially improved safety and immunogenicity profile and less adverse side effects. In addition, the solution used to grow Vero cell is artificially synthesized, thereby providing superior stability and composition consistency compared to serum, which in turn results in higher batch-to-batch consistency.
In 2021, the Group was the second largest supplier of human rabies vaccines globally and in the PRC in terms of approved lot release volume and sales revenue. The human rabies vaccine (Vero cell) of the Group is one of the major products of the Group and occupies a market-leading position. The Group plans to launch three new human rabies vaccines in or after 2025 (including the human rabies vaccine candidate (serum-free Vero cell), mRNA human rabies vaccine candidate and human rabies vaccine candidate (HDC)), so as to continue to help the Group to solidify the market-leading position and increase the Group’s market share in China’s human rabies vaccine market.
Meanwhile, investors are advised to exercise caution when dealing in the securities of the Company.
By order of the Board AIM Vaccine Co., Ltd.
Mr. Yan ZHOU
Chairman of the Board, Executive Director and Chief Executive Officer
Hong Kong, October 24, 2022