Chongqing Zhifei Biological Products Co., Ltd. (300122.SZ) announced that its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. ("Zhifei Longcom"), has received the acceptance notice (No. CXSL2501083) from the National Medical Products Administration (NMPA) for the clinical trial application of its Modified Ankara Vaccinia Virus (MVA) Monkeypox Attenuated Live Vaccine.
If no negative or questioning opinions are received from the Center for Drug Evaluation (CDE) within 60 days from the acceptance date, Zhifei Longcom may proceed with clinical trials according to the submitted protocol.
The vaccine adopts an attenuated live vaccine technology route, utilizing the Modified Vaccinia Ankara (MVA) strain for production. The MVA strain cannot effectively replicate in human cells, preventing systemic spread or secondary transmission, thereby ensuring high safety.
The acceptance of this clinical trial application marks a critical breakthrough in the company's emerging infectious disease vaccine portfolio, demonstrating its commitment to innovation and core technological advancement. This milestone not only strengthens the company's long-term growth prospects but also enhances China's independent innovation capabilities in major infectious disease prevention and control.
Successful development of this project will further diversify the company's vaccine pipeline, optimize its product portfolio, and reinforce its market competitiveness.
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