Shanghai Securities News, China Securities Network – Zhifei Biological announced on the evening of December 17 that its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., recently received the "Drug Clinical Trial Application Acceptance Notice" (Acceptance No.: CXSL2501083) from the National Medical Products Administration (NMPA) for its "Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine." If no negative feedback or queries are received from the Center for Drug Evaluation within 60 days from the acceptance date, clinical trials may proceed according to the submitted plan.

Background information indicates that monkeypox is a zoonotic disease caused by the monkeypox virus. Its clinical course typically consists of two phases: the invasive phase and the rash phase. The invasive phase lasts 0–5 days and is characterized by fever, intense headache, lymphadenopathy, back pain, myalgia, and profound asthenia. Lymphadenopathy is a distinctive feature of monkeypox. The virus primarily spreads through close skin contact (particularly sexual contact), contact with virus-contaminated items (such as clothing or bedding), and prolonged face-to-face respiratory droplet transmission. Monkeypox transmission exhibits clear gender and age differences, with notably higher incidence among young males. Among cases with available data, over 90% of reported cases are male. Although monkeypox is generally a self-limiting disease, children, pregnant women, and immunocompromised individuals are more susceptible to severe complications. Therefore, vaccination with a monkeypox attenuated live vaccine is of significant importance for reducing disease incidence and burden.

The Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine developed by Zhifei Longcom is intended for the prevention of monkeypox disease caused by the monkeypox virus and is proposed for use in individuals aged 6 years and above. As of now, based on queries of the NMPA official website, no monkeypox vaccine has been approved for marketing in China.

According to Zhifei Biological, the company’s Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine adopts an attenuated live vaccine technology platform, utilizing the Modified Vaccinia Ankara (Ankara) strain for vaccine production. The Ankara strain is unable to replicate efficiently in human cells and does not spread within the body or cause secondary transmission, resulting in a favorable safety profile. The acceptance of this vaccine’s clinical trial application marks a critical breakthrough in the company’s matrix for emerging and re-emerging infectious disease vaccines and reflects its focus on innovative technologies and enhanced core R&D capabilities. This breakthrough advancement will not only support the company’s long-term steady development but also contribute to strengthening China's independent innovation capacity in the prevention and control of major infectious diseases. If the project progresses smoothly, it will further enrich the company’s vaccine portfolio, optimize its product布局, and reinforce its market position.

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