301207SZSE
🚨 Material Event

Announcement on the Approval of Clinical Trial for Novel Adjuvanted Influenza Virus Split Vaccine

Hualan Biological Vaccine Inc.··3 pages

✨ AI Summary

Hualan Biological Vaccines Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its novel adjuvanted influenza virus split vaccine. This vaccine aims to enhance immune responses, particularly in vulnerable populations such as the elderly. The approval marks a significant step in the vaccine's development, paving the way for further safety and efficacy validation.

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Full Translation

AI Translation· azure_openai

The company and all members of the board guarantee that the content of this information disclosure is true, accurate, and complete, with no false records, misleading statements, or significant omissions.
Securities Code: 301207
Securities Abbreviation: Hualan Vaccine
Announcement Number: 2026-024

Hualan Biological Vaccines Co., Ltd. (hereinafter referred to as "the Company") has recently received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for the novel adjuvanted influenza virus split vaccine. The specific details are as follows:

1. Basic Information of the Notice

  • Product Name: Novel Adjuvanted Influenza Virus Split Vaccine
  • Registration Classification: Class 3.2 preventive biological products
  • Application Type: New drug
  • Indication: This vaccine stimulates the body to produce immunity against influenza viruses, used for the prevention of influenza caused by vaccine-related strains, particularly enhancing the immune response in vulnerable populations such as the elderly.
  • Applicant: Hualan Biological Vaccines Co., Ltd.
  • Notice Number: 2026LP01706
  • Conclusion of the Notice: According to the "Drug Administration Law of the People's Republic of China," the "Vaccine Administration Law of the People's Republic of China," and relevant regulations, the novel adjuvanted influenza virus split vaccine, accepted on March 10, 2026, meets the relevant requirements for drug registration and is approved to conduct clinical trials for the prevention of influenza caused by vaccine-related strains.

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