6919 Kangpei* Submits Clinical Trial Application for CBL-514 Injection in China

Release Date: August 4, 2026 Statement Date: August 3, 2026 Statement Time: 17:43:06 Company Code: 6919 Company Name: Kangpei* Subject: The company has submitted a clinical trial application for its new drug CBL-514 injection to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).

Applicable Clause: Clause 10 Factual Date: August 3, 2026

Details:

1. Factual Date: 08/03/2026

2. Name or Code of the New Drug in Development: CBL-514

3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Dugen Syndrome D. Reduction of subcutaneous fat in overweight or obese adults

4. All Planned Development Stages: A. Phase 1 Clinical Trial: Application submitted for Phase 1 clinical trial CBL-0102 in China to NMPA CDE. B. Phase 2 Clinical Trial: Multiple Phase 2 trials including CBL-0205 have been completed. CBL-0206 has been approved for execution by Australia's HREC and Taiwan's TFDA IND. C. Phase 3 Clinical Trial: Pivotal Phase 3 trials CBL-0301 and CBL-0302 have been approved for execution. CBL-0301 has submitted a protocol amendment application to the U.S. FDA and Canada HC based on FDA recommendations. The Phase 3b long-term follow-up trial CBL-0303 has been approved for execution in the U.S. D. New Drug Application (NDA) Review: Not yet initiated.

5. Current Development Stage (Please specify whether the current stage is application submitted/approved/not approved. If not approved, describe risks and mitigation measures. Also state future business direction and cumulative R&D expenses incurred):

(1) Application submitted/approved/not approved / Results of human trials at each phase (including interim analysis) / Other major events affecting new drug development:

The company has completed a Pre-IND written consultation meeting with China's NMPA CDE. To evaluate potential ethnic differences in drug efficacy and safety between Chinese and non-Chinese populations, the company will first conduct a Phase 1 clinical trial (CBL-0102) in China using CBL-514 injection to reduce abdominal subcutaneous fat, followed by a Phase 3 clinical trial application in China upon completion. The company completed the IND application for CBL-0102 to China's NMPA CDE on August 3, 2026. The trial aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of CBL-514 injection in healthy Chinese subjects, with approximately 30 subjects to be enrolled in China.

A. Clinical Trial Design Overview (including trial name, objective, phase, drug name, indication, evaluation endpoints, and number of enrolled subjects): a. Trial Name: A randomized, open-label, single-dose, parallel-group, Phase 1 clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of CBL-514 injection in healthy Chinese subjects. b. Trial Objective: To evaluate the pharmacokinetic characteristics, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat. c. Trial Phase: Phase 1 Clinical Trial d. Drug Name: CBL-514 e. Indication: Reduction of abdominal subcutaneous fat f. Evaluation Endpoints: Evaluation of pharmacokinetic characteristics, safety, and tolerability of CBL-514 injection in healthy Chinese subjects. g. Number of Enrolled Subjects: Approximately 30

B. Statistical Results of Primary and Secondary Endpoints (including P-values) and Statistical Significance (including whether statistical significance was achieved). If statistical data cannot be disclosed due to other significant reasons, please state the reason: Not applicable

C. If statistical data from Phase 3 human clinical trials (including interim analysis) are known, please describe the future market entry plan (however, avoid content that triggers the requirement for financial forecasting under the 'Criteria for Full Financial Projections by Listed Companies'): Not applicable.

D. A single clinical trial result (including statistical P-values and significance for primary and secondary endpoints) alone is insufficient to fully reflect the success or failure of future drug development and commercialization. Investors should carefully assess and make prudent investment decisions.

(2) Risks and mitigation measures if not approved by the competent authority, if human clinical trial results (including interim analysis) at any phase fail to achieve statistical significance, or if other major events affecting drug development occur: Not applicable.

(3) Future business direction if approved by the competent authority, if human clinical trial results (including interim analysis) at any phase achieve statistical significance, or if other major events affecting drug development occur: Under company evaluation.

(4) Cumulative R&D expenses incurred: For strategic marketing considerations and to protect company and investor interests, disclosure is currently withheld.

6. Next Development Stage (Please specify expected completion time and expected obligations):

(1) Expected completion time: Adjusted according to actual clinical trial progress. (2) Expected obligations: None.

7. Market Status: The primary purpose of localized fat reduction is to reduce subcutaneous fat in the treated area. Current treatment methods include invasive surgical procedures and non-invasive product-based therapies. While surgical methods offer more noticeable reduction of localized subcutaneous fat, they involve significant tissue and nerve damage at the treatment site, carry high risks, have obvious side effects, and require longer recovery periods. Therefore, non-surgical fat reduction products have rapidly emerged in recent years. However, currently marketed non-surgical fat reduction products have limited efficacy, cannot significantly reduce subcutaneous fat in the treated area, require multiple treatment sessions, and may be associated with severe side effects or irreversible risks. The current fat reduction market is large and still has substantial unmet demand.

8. Other Matters to be Disclosed (If the entity involved in the event or resolution is a publicly traded company or above, and this material information simultaneously meets the criteria under Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act regarding matters significantly affecting shareholder rights or securities prices): Not applicable.

9. New drug development is a long-term process requiring substantial investment and does not guarantee success, which may expose investors to risks. Investors should carefully assess and make prudent investment decisions.