[Kangpu*] Announcement: Company's Second Multinational, Multicenter Pivotal Phase 3 Clinical Trial (CBL-0302) of New Drug CBL-514 Injection for Reducing Abdominal Subcutaneous Fat, Health Canada CTA Submission Completed Today

1. Date of Fact Occurrence: 115/04/30
2. Research and Development New Drug Name or Code: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate/severe cellulite
C. Treatment of rare disease Dercum's disease
4. All R&D Stages to be Conducted:
A. Phase 1 Clinical Trial: Completed.
B. Phase 2 Clinical Trial: Multiple Phase 2 trials, including CBL-0205, have been completed. CBL-0206 has been approved for execution by the Australian HREC and an application has been submitted in Taiwan.
C. Phase 3 Clinical Trial: The first pivotal Phase 3 trial, CBL-0301, has been approved for execution in the US and Canada. The second pivotal Phase 3 trial, CBL-0302, has had an application submitted in the US and Canada.
D. New Drug Application Review (NDA): Not yet initiated.
5. Current R&D Stage (Please state if application submitted/approved/not approved, risks and countermeasures if not approved; also state future business direction and accumulated R&D expenses incurred):
(1) Application Submitted/Approval Obtained/Not Approved/Results of Human Trials (including interim analysis)/Other Major Events Affecting New Drug R&D:
Kangpu's new drug CBL-514 injection for reducing abdominal subcutaneous fat has completed the submission of a Clinical Trial Application (CTA) to Health Canada (HC) on April 30, 2026, for the second multinational, multicenter pivotal Phase 3 clinical trial (SUPREME-02). This trial will use MRI to measure changes in abdominal subcutaneous fat volume and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) to assess improvement in abdominal fat grading as primary efficacy endpoints. It is expected to enroll 320 subjects in the US, Canada, and Australia.
A. Clinical Trial Design Introduction (including trial plan name, objective, phase classification, drug name, claimed indication, assessment indicators, number of enrolled subjects, etc.):
a. Trial Plan Name:
A Phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection in reducing abdominal subcutaneous fat (SUPREME-02).
b. Trial Objective: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
c. Trial Phase Classification: Phase 3 Clinical Trial
d. Drug Name: CBL-514
e. Claimed Indication: Reduction of abdominal subcutaneous fat
f. Assessment Indicators: Primary efficacy indicators include measurement of abdominal subcutaneous fat volume change using MRI and assessment of abdominal fat grading improvement using PR-AFRS (Patient Report-Abdominal Fat Rating Scale).
g. Trial Plan Subject Enrollment Number: Approximately 320 subjects.
B. Statistical results of primary and secondary assessment indicators (including but not limited to P-value) and statistical significance (including but not limited to statistical significance achieved), and if company is unable to disclose statistical data due to other important reasons, state the reason: Not applicable.
C. If statistical data for the new drug's Phase 3 human clinical trial (including interim analysis) is known, please explain the future market launch plan (however, the content described should be careful to avoid situations that require financial forecasts according to the company's "Standards for Determining Comprehensive Financial Forecasts Publicly Disclosed by Listed Companies"): Not applicable.
D. The results of a single clinical trial (including statistical P-values for primary and secondary assessment indicators and whether statistical significance was reached) are not sufficient to fully reflect the success or failure of future new drug development and market launch. Investors should judge prudently and invest cautiously.
(2) Risks and countermeasures faced by the company if permission is not obtained from the competent authority, if the results of human trials in each phase (including interim analysis) do not reach statistical significance, or if other major events affecting new drug R&D occur: Not applicable.
(3) Future business direction if permission is obtained from the competent authority, if the results of human trials in each phase (including interim analysis) reach statistical significance, or if other major events affecting new drug R&D occur: Under company evaluation.
(4) Accumulated R&D expenses incurred: Considering future market marketing strategies and to protect the rights and interests of the company and investors, disclosure is temporarily withheld.
6. Next Phase of R&D to be Conducted (Please state estimated completion time and estimated obligations to be borne):
(1) Estimated Completion Time: Actual schedule will be adjusted based on the progress of clinical trial execution.
(2) Estimated Obligations to be Borne: None.
7. Current Market Situation:
Currently, over 80% of fat reduction treatments still involve invasive surgical procedures, including liposuction and abdominoplasty. Although surgical procedures are significantly more effective in fat reduction than current non-surgical fat reduction products, they are accompanied by many obvious side effects and sequelae, as well as serious side effects that can threaten life. Therefore, non-surgical fat reduction products have rapidly emerged in recent years, including cryolipolysis, ultrasonic fat reduction, and fat-dissolving injections (containing deoxycholic acid or its salts). However, most current non-surgical fat reduction products have poor efficacy, cannot significantly reduce subcutaneous fat in the treated area, and require more than 12 weeks to show results, along with risks of moderate to severe side effects such as skin necrosis, nerve damage and paralysis, scar tissue, lumps, and paradoxical adipose hyperplasia (paradoxica