Alar announced that a Phase I clinical trial of ALA 3000 Injection in treatment resistant depression patients has been approved by the US FDA.

 Alar announced that a Phase I clinical trial of
ALA-3000 Injection in treatment-resistant depression
patients has been approved by the US FDA.

1.Date of occurrence of the event:2024/12/14
2.New drug name or code:ALA-3000 Injection
3.Indication:Treatment-resistant depression (TRD)
4.Planned development stages:Phase 1 clinical trial, Phase 2 clinical trial,
 Phase 3 clinical trials, and New Drug Application submission
5.Current development stage:
  (1) Application submission/approval/disapproval/each of clinical trials
      (include interim analysis)：The company received a notification from
      the US FDA today to approve the application for Phase I clinical trial
      in TRDpatients. This is the first-in-human trial of ALA-3000 Injection
      to evaluate the safety, tolerability, pharmacokinetics, and preliminary
      efficacy exploration in 44 US patients approximately.
  (2) Once disapproved by competent authority or each of clinical trials
      (include interim analysis) results less than statistically significant
      sense, the risks & the associated measures the Company may occur：N/A
  (3) After obtaining official approval or the results of statistically
      significant sense, the future strategy：N/A
  (4) Accumulated investment expenditure incurred：Undisclosed
6.Upcoming development plan:
  (1) Estimated date of completion：The clinical trial is expected to be
      completed by the end of 2025. The time of completion will be determined
      by the actual recruitment progress.
  (2) Estimated responsibilities：N/A
7.Market situation:
  TRD is a subset of Major Depressive Disorder (MDD), defined as a medical
  condition when at least two different first-line antidepressants are
  inadequate to manage the depressive condition during an episode. According
  to the article published in Psychiatric Quarterly, there are one-third of
  depression patients belong to TRD. Based on the statistics data of the 2021
  National Survey on Drug Use and Health (NSDUH), approximately 21 million US
  adults had experienced at least one MDD; approximately 14.5 million adults
  had at least one MDD with severe impairment within the past year. According
  to the market survey data from Allied Market Research, the global
  antidepressant drug market size was US$15.651 billion in 2020 and is
  expected to reach US$21 billion by 2030, with a compound annual growth
  rate of 3%.
8.Any other matters that need to be specified(the information
 disclosure also meets the requirements of Article 7, subparagraph 8
 of the Securities and Exchange Act Enforcement Rules, which brings
 forth a significant impact on shareholders rights or the price of
 the securities on public companies.):None
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:"，