HONG KONG SAR - Media OutReach Newswire - 20 December 2024 - AIM Vaccine (06660.HK) has added good news to the research and development of its heavyweight single product. According to the announcement on December 19, the clinical trial approval for the Group's suspension culture quadrivalent influenza vaccine (MDCK cells) with new technological route and second generation of highly-effective absorbed tetanus vaccine have been recently obtained from the National Medical Products Administration. AIM Vaccine was intensively applied for and won two more clinical trial approvals in this year, creating new growth driver for the company's future performance.

According to the announcement, currently, all influenza vaccines available on the domestic market are produced using chicken embryo technology. There have not been cell-based influenza vaccines approved for marketing. Compared with the traditional chicken embryo influenza split vaccine, the influenza vaccine (MDCK cells) developed by the Group has been significantly improved in terms of production quality and safety.

The MDCK cells developed by AIM Vaccine has the characteristics of easy cultivation, fast proliferation and susceptibility to influenza virus, etc. By large-scale cultivation of influenza virus in MDCK cells, it can achieve higher production volume, more stable production quality and lower production cost. Furthermore, this product has robust capability to withstand virus mutations, and does not contain ovalbumin, significantly reducing the risk of allergic reactions.

Compared with the influenza vaccines (MDCK cells) developed by other domestic manufacturers, AIM Vaccine adopts the suspension culture method for cell culture, which can be cultivated in bioreactors at scale with low contamination risks and is conducive to large-scale industrial production.

According to the announcement, based on the research and development of the second generation of highly-effective absorbed tetanus vaccine, AIM Vaccine is actively promoting the research and development of diphtheria, tetanus and acellular pertussis – HIB combined vaccine (the "Tetravaccine"), pentavalent vaccine and other multidisease vaccine. Among them, the Tetravaccine is used to prevent invasive infections caused by pertussis, diphtheria, tetanus and Haemophilus Influenzae type b, and has the advantages of reducing the number of vaccinations for infants and young children, and enhancing the vaccination compliance of parents, infants and young children.

The two heavyweight vaccine products announced by AIM Vaccine successfully obtained clinical trial approval documents, and its research and development has entered a new stage. According to the data of China Insights Industry Consultancy Limited, China's influenza vaccine market will reach approximately RMB20 billion and , the Chinese market size of the multidisease vaccine is expected to reach RMB10 billion in 2030. Therefore, the suspension culture quadrivalent influenza vaccine (MDCK cells) with new technological route and the Tetravaccine will further improve the company's product pipeline after the market, help enrich the product pipeline, consolidate the industry position, and promote the continued rapid growth of performance.

AIM Vaccine has always focused on unmet clinical needs in key disease areas to advance vaccine development. This year is an intensive year for AIM Vaccine. Up to now, the company has obtained 17 clinical approvals and carried out 21 clinical trials, among which international cutting-edge technology products such as mRNA respiratory syncytial virus (RSV) vaccine (large age group) have also obtained clinical approvals. In addition, the 13-valent pneumonia conjugate vaccine has been accepted, and the serum-free iterative rabies vaccine has also submitted a pre-registration application for listing, and the upcoming blockbuster new product is expected to bring stable revenue growth.

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