2024-06-27 12:42:07
Public Info Statement Station Vital Info Announcement
(6547) Excessive-end Vaccine – Our firm has utilized to the Meals and Drug Administration of the Ministry of Well being and Welfare for a high-end trivalent influenza vaccine drug approval (NDA)
1. Date of prevalence: 2013/06/27
2. Identify or code of the brand new drug below growth: Excessive-end trivalent influenza vaccine
3. Use: To forestall influenza-related illnesses brought on by two sorts of influenza A viruses and one kind of influenza B virus.
4. All deliberate R&D levels: Apply to the Meals and Drug Administration of the Ministry of Well being and Welfare for drug inspection, registration and overview.
5. Present R&D stage (please point out whether or not the present R&D stage is software submitted/authorised/not authorised. If not authorised, please clarify the dangers confronted by the corporate and the corresponding measures; please additionally clarify the longer term enterprise course and the amassed R&D bills invested):
(1) Utility submitted/authorised/disapproved/outcomes of every section of human trials (together with interim evaluation)/different main occasions that have an effect on new drug growth: Apply to the Meals and Drug Administration of the Ministry of Well being and Welfare for drug registration and overview (NDA).
(2) Dangers confronted by the corporate and its response measures if the corporate fails to acquire approval from the competent authority of the goal trade, the outcomes of every section of human medical trials (together with interim evaluation) fail to succeed in statistical significance, or different main occasions that have an effect on the event of recent medicine happen: Not relevant.
(3) For firms which have obtained approval from the competent authority of the goal trade, have achieved statistically important ends in numerous phases of human medical trials (together with interim evaluation), or have skilled different main occasions that have an effect on the event of recent medicine, future enterprise course: Not relevant.
(4) Cumulative R&D bills: Based mostly on enterprise technique issues, they won’t be disclosed publicly in the meanwhile.
6. The subsequent stage of analysis and growth will probably be carried out (please point out the estimated completion time and the estimated obligations to be borne):
(1) Estimated completion time: Relies on the overview progress of the pharmaceutical administration authorities.
(2) Estimated obligations: All related bills for making use of for drug inspection and registration.
7. Market standing: The United Nations World Well being Group (WHO) really helpful on February 23, 2024 that the B/Yamagata virus pressure antigen be faraway from the quadrivalent influenza vaccine. America, Europe and different international locations have additionally step by step modified the general public influenza vaccine to the trivalent influenza vaccine. With the intention to enhance the corporate’s influenza vaccine product line and regulatory traits, the applying for inspection and registration of the trivalent influenza vaccine was submitted to fulfill future market demand.
8. Different issues that must be described (if the principle system of the occasion or decision is a public providing or above firm, this materials data additionally meets the provisions of Article 7, Paragraph 8 of the Guidelines for the Implementation of the Securities and Change Act which have a big impression on shareholders’ fairness or securities costs): None.
9. The event of recent medicine takes a very long time, requires excessive funding prices, and there’s no assure of success. This will likely expose funding to dangers. Traders ought to make cautious judgments and make investments cautiously.
Additional studying:
Main shareholders offered greater than 130,000 shares in Might
Prime 20 shares in after-hours odd-lot buying and selling within the OTC market on 6/20
source-MoneyDJ Monetary Community
1719518246
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