1.Date of occurrence of the event:2026/04/04
2.New drug name or code:ALA-3000 (a long-acting injectable of ketamine)
3.Indication:Treatment-resistant depression
(https://clinicaltrials.gov/study/NCT06965569)
4.Planned development stages:Phase 2 clinical trial(s), phase 3 clinical
trial(s), and new drug application submission
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials
    (include interim analysis):
  A.Clinical study design
  a.Protocol title: A randomized, double-blind, placebo-controlled,
    multiple-dose study of ALA-3000, evaluating the safety, tolerability,
    pharmacokinetics and preliminary efficacy in subjects with
    treatment-resistant depression (TRD)
  b.Study objective: To evaluate the safety, tolerability, pharmacokinetics,
    and exploratory efficacy of ALA-3000 in TRD patients, with subcutaneous
    dosing on Day 1 and Day 8 during a 50-day study period (including follow
    up phase), in combination with a daily oral antidepressant
  c.Phase of clinical study: Phase 1 clinical trial
  d.Investigational product: ALA-3000(a long-acting injectable of ketamine)
  e.Indication: Treatment-resistant depression
  f.Endpoints：
  (i)Primary endpoints:The safety and tolerability of ALA-3000 were assessed
     through adverse events (AEs), vital signs, 12-lead electrocardiogram
     (ECG), clinical laboratory tests, dissociative symptoms, alertness/
     sedation symptoms, psychosis-like side effects, suicidal ideation/
     behavior, withdrawal symptoms after cessation of ALA-3000, and injection
     site tolerability
  (ii)Secondary endpoints: The pharmacokinetic parameters of ALA-3000
      included maximum observed plasma concentration (Cmax), time to reach
      the maximum observed plasma concentration (Tmax), area under the plasma
      concentration-time curves (AUCs),and terminal elimination half-life
      (t1/2).
  (iii)Exploratory endpoints: The efficacy of ALA-3000 was explored using
       the Montgomery Asberg Depression Rating Scale (MADRS), Clinical
       Global Impression – Severity (CGI-S), Clinical Global Impression –
       Improvement (CGI-I), and Generalized Anxiety Disorder 7-item Scale
       (GAD-7).
Note:
This study was a first-in-human (FIH) clinical trial and an early-stage,
small-scale clinical investigation. The primary objectives were to evaluate
the safety, tolerability, and pharmacokinetics of the investigational drug.
Efficacy endpoints were exploratory in nature. Due to the limited sample
size and insufficient statistical power to support hypothesis testing, no
statistical analyses for efficacy endpoints were planned in the study
protocol,and no p-values were calculated, in order to avoid potentially
misleading statistical inferences.
  g.Number of subjects randomized: A total of 37 subjects with TRD were
    randomized in a multicenter US study to receive 150 mg ALA-3000, 250 mg
    ALA-3000, or placebo in a ratio of 1:1:1. No subject discontinued study
    participation due to any adverse event or for any other reason.
B.Study endpoint results
  a.Primary endpoints：
    This first-in-human study of ALA-3000 met its primary endpoint,
    demonstrating a favorable safety profile and tolerability in patients
    with treatment-resistant depression (TRD).
  (i)Adverse events (AEs)
     Treatment-related AEs were all mild to moderate in severity. The most
     commonly related AEs across all groups, including placebo group, were
     injection site reactions, headache, and diarrhea. These events were
     transient, resolvable, and did not lead to early termination or
     treatment discontinuation. No adverse events of special interest were
     observed during the study, including no drug abuse-related or urinary
     AEs reported in this study.
  (ii)Vital signs
      There were no overall changes in blood pressure, pulse rate, oxygen
      saturation, respiratory rate, or body temperature values or changes
      from baseline attributable to ALA-3000 reported during the study.
  (iii)12-lead ECG
       No clinically significant ALA-3000 related changes were observed,
       and no QTc interval prolongation attributable to ALA-3000 was
       identified.
  (iv)Clinical laboratory tests
      No clinically meaningful ALA-3000 related changes were observed in
      hematology, chemistry, coagulation, or urinalysis during the study.
      Urine cytology results were all negative, with no abnormal findings
      identified.
  (v)Assessment of dissociative symptoms,
     From postdose through the end-of-study visit (Day 36),
     Clinician-Administered Dissociative States Scale (CADSS; total score
     range: 0-92) mean total scores were ≦ 0.7 across all groups and were
     comparable between treatment and placebo groups. In addition, no
     adverse events related to dissociative symptoms were reported.
  (vi)Assessment of alertness/sedation
      There was no overall sedative effect of study treatment on the MOAA/S
      assessment as all subjects responded readily to name spoken in a
      normal tone post injection.
  (vii)Assessment of psychosis-like side effects
       There was no overall effect of study treatment on potential
       treatment-emergent psychotic symptoms, based on the BPRS+ subscale
       consists of suspiciousness, hallucinations, unusual thought content,
       and conceptual disorganization. No treatment-emergent psychotic
       symptoms were observed during the study period.
  (viii)Assessment of suicidal ideation/behavior
        There were no reports of worsening suicidal ideation at any visit
        in any subject during the study and no reports of suicidal behavior
        at any visit in any subject during the study.
  (ix)Assessment of withdrawal symptoms after cessation
      There was no clinically meaningful indication of PWC-20 withdrawal
      symptoms after cessation of ALA-3000 in this study.
   (x)Tolerability
      Injection site tolerability was assessed using a visual analog scale
      (VAS) for injection site pain and an injection site grading scale
      for pain, tenderness, erythema, induration, and swelling. Generally,
      mean injection site pain VAS scores remained in the mild range and
      resolved within a few days. Injection site grading scale ranged from
      0 to 2 (no reaction to moderate). All observed injection site reactions
      were clinically manageable, and no subjects discontinued treatment due
      to these events, indicating that repeated injections under the study
      dosing regimen were well tolerated.
  b.Secondary endpoints
    Following the subcutaneous administrations of ALA-3000 in this study,
    ketamine and norketamine exhibited extended-release pharmacokinetic
    characteristics, indicating a well-controlled release profile,
    characterized by delayed Tmax, minimal initial burst, sustained and
    steady exposure, absence of dose dumping, and low peak-to-trough
    fluctuation.
  c.Exploratory endpoints
    Clinically meaningful improvements in MADRS total scores, response rates
    and remission rates were observed following ALA 3000 150 mg and 250 mg
    administered on Day 1 and Day 8 with newly initiated daily oral AD
    medication.
   (i)MADRS total score and change from baseline
      Starting from 24-hour postdose, the MADRS total score decreased
      (improved) in all three groups. From Day 9 through the end-of-study
      visit (Day 36), the mean change from baseline in MADRS total score
      showed a difference of approximately 3 to 6 points for the 150 mg
      group relative to placebo, and approximately 2 to 4 points for the
      250 mg group relative to placebo.
   (ii)Response, defined as a ≧ 50% reduction from baseline in MADRS
      total score
      From Day 11 through the end-of-study visit(Day 36), the MADRS response
      rate was 60% or above in the 150 mg group, 54% to 69% in the 250 mg
      group, and 36% to 45% in the placebo group.
   (iii)Remission, defined as a MADRS total score ≦ 10
        From Day 22 through the end-of-study visit (Day 36), the MADRS
        remission rate was 50% in the 150 mg group, 23% to 31% in the
        250 mg group, and 18% in the placebo group.
   (iv)There was separation of the mean CGI S scores and mean CGI-S change
       from baseline scores over time between ALA-3000 150 and 250 mg groups
       compared to placebo group on Day 22. Median CGI-I scores for all
       treatment groups at most visits and time points were between 2.0
       to 3.0, indicating a trend toward clinical improvement.
   (v)The GAD-7 scores indicated a decreasing trend in anxiety symptoms
      following treatment.
C.Results from a single clinical trial are not sufficient to fully reflect
   the success or failure of new drug development and commercialization in
   the future. The investors shall make a prudent judgment.
(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:
    Not Applicable.
(3)After obtaining official approval or the results of statistically
    significant sense, the future strategy: Initiate a subsequent licensing
    strategy and advance the planning of follow-up clinical trials.
(4)Accumulated investment expenditure incurred: As this involves future
    international licensing negotiations, disclosure is withheld.
6.Upcoming development plan:
(1)Estimated date of completion: The finalized clinical study report has
    been obtained, and applications for subsequent clinical trials will be
    submitted.
(2)Estimated responsibilities: Not Applicable.
7.Market situation:
(1)Treatment-Resistant Depression (TRD) is a type of Major Depressive
    Disorder (MDD) in which patients have an inadequate response to at least
    two different antidepressant treatments. According to the market analysis
    from Fortune Business Insights,the global market size of TRD is USD 2.40
    billion in 2025 and anticipated to expand to USD 6.15 billion by 2034,
    with a CAGR of 11.00%. Selective Serotonin Reuptake Inhibitors (SSRIs)
    and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) are commonly
    used as first-line treatments and hold the largest market share;
    however, the application of N-methyl-D-aspartate (NMDA) receptor
    antagonists, such as ketamine therapy, is increasingly being adopted
    and is expected to exhibit the fastest growth rate.
(2)The long-acting formulations of ketamine not only alleviate the burden
    on TRD patients caused by frequent clinic visits for dosing, but also
    potentially exempt both patients and physicians from at least 2-hour
    on-site mandatory observation (which is used to monitor AEs such as
    sedation, dissociation, and dizziness that may result from high surge
    peak of ketamine). In addition, long-acting formulations may reduce
    the need for psychedelic-assisted psychotherapy. In summary, beyond
    the advantage of improved treatment convenience, long-acting
    formulations demonstrate the potential to maintain antidepressant
    efficacy, highlighting the significant value in clinical development
    and application.
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.):Not Applicable.
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.:，