Press Release．2025.10.16
Announcement: The Company Has Received the Type C Meeting Minutes from the U.S. FDA
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- Date of Occurrence: October 16, 2025.
- Name or Code of the New Drug in Development: NORA520.
- Indication: NORA520 is an oral prodrug that is indicated for the treatment of CNS disease, such as postpartum depression (PPD) and major depressive disorder (MDD).
- All Planned Development Phases: Phase II study.
- Current Development Status
(1) Status (Application Submitted/Approved/Not Approved/Results of Each Phase of Clinical Trials (Including Interim Analysis)/ or Other Significant Events Affecting New Drug Development): The Company’s investigational new drug, NORA520, indicated for the treatment of postpartum depression (PPD), was discussed in the Type C meeting with the U.S. Food and Drug Administration (FDA) on September 24, 2025, and the Company received the official meeting minutes on October 16, 2025.
(a) Prior to submitting a 505(b)(2) New Drug Application (NDA) for NORA520, the Company is required to conduct a bridging study and a safety study. The study designs and methodologies of these studies must be further reviewed and approved by the FDA.
(b) The ongoing Phase II clinical trial may serve as a pivotal study for NDA submission if the results meet expectations.
(2) Risks and mitigation measurements in Case of Non-Approval by the Competent Authority, Statistically Non-Significant Results from Clinical Trials (Including Interim Analysis), or Other Significant Events Affecting New Drug Development: Not applicable.
(3) Future Business Direction in Case of Approval by the Competent Authority, Statistically Significant Results from Clinical Trials (Including Interim Analysis), or Other Significant Events Affecting New Drug Development: Not applicable.
(4) Cumulative R&D Expenses Incurred: To align with future marketing strategies and protect investors’ rights, this information is not disclosed. - The next phase of development (please indicate the expected completion time and obligations):
(1) Estimated completion time: The Phase II trial is expected to be unblinded in the fourth quarter of 2025. However, the actual timeline will be adjusted based on the implementation progress.
(2) Estimated obligations: Not applicable. - Market Overview: The prevalence of postpartum depression (PPD) among puerperae is approximately 10–20%. Currently, there is only one approved drug for the treatment of postpartum depression (PPD) on the market, indicating a significant unmet medical need. According to Fortune Business Insights, the global postpartum depression market is projected to grow from USD 79.9 million in 2024 to USD 970 million by 2032, with a remarkable compound annual growth rate (CAGR) of 36.7% during the period. Based on data on the prevalence of major depressive disorder (MDD) in the United States in 2021, it is estimated that 21 million adults in the United States have experienced at least one major depressive episode, representing 8.3% of the U.S. adult population with a prevalence rate of 10.3% among women and 6.2% among men. According to an industry research by GlobalData, the global market for MDD is projected to grow from USD 8.8 billion in 2019 to USD 14.4 billion by 2029.
- Other Matters to be Noted: None. (The material matters that comply with Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act, with a significant impact on shareholders’ equity or securities prices if the entity involved in the event or decision is a publicly listed company.)
- Disclaimer: The development of new drugs involves long timelines and high investment costs, with no guaranteed success, which may pose risks to investors. Investors are advised to exercise caution and make prudent judgments when investing.