Kangpei Announces FDA IND Clearance for Phase 2 Trial of CBL-514 Injection in Combination with tirzepatide (Eli Lilly) to Reduce Abdominal Subcutaneous Fat in Overweight or Obese Adults

1. Date of Event: August 24, 2026 2. Name or Code of the Investigational Drug: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Darier's disease D. Reduction of subcutaneous fat in overweight or obese adults 4. All Planned Development Stages: A. Phase 1 Clinical Trial: Completed. B. Phase 2 Clinical Trial: Approved. C. Phase 3 Clinical Trial: Not yet conducted. D. New Drug Application (NDA) Review: Not yet conducted. 5. Current Development Stage (Please describe whether the current stage is under application/approved/not approved. If not approved, please explain the risks faced by the company and mitigation measures; also describe future business direction and cumulative R&D expenses incurred): (1) Application status/approval status/non-approval status, results of human trials at each phase (including interim analysis), or other significant events affecting drug development: The multicenter Phase 2 clinical trial CBL-0201WR, evaluating CBL-514 injection in combination with tirzepatide (Eli Lilly) for reducing abdominal subcutaneous fat in overweight or obese adults, has received U.S. FDA IND clinical trial application approval on August 24, 2026. This trial will use MRI to measure changes in abdominal subcutaneous fat volume as the efficacy endpoint and plans to enroll 120 subjects in the United States. A. Introduction of Clinical Trial Design (including trial protocol name, objective, phase classification, drug name, claimed indication, assessment endpoints, and number of enrolled subjects): a. Trial Protocol Name: A randomized, placebo-controlled Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection in combination with tirzepatide for reducing abdominal subcutaneous fat in overweight or obese adults. b. Trial Objective: To evaluate the efficacy, safety, and tolerability of CBL-514 injection in combination with tirzepatide for reducing abdominal subcutaneous fat in overweight or obese adults. c. Trial Phase Classification: Phase 2 Clinical Trial d. Drug Name: CBL-514 e. Claimed Indication: Reduction of abdominal subcutaneous fat in overweight or obese adults f. Assessment Endpoint: Efficacy endpoint is change in abdominal subcutaneous fat volume measured by MRI g. Number of Subjects to be Enrolled in Trial Protocol: Planned for 120 B. Statistical results of primary and secondary endpoints (including P-values) and their statistical significance (including whether statistical significance was achieved). If the company cannot disclose statistical data due to other important reasons, please explain: Not applicable C. If aware of statistical data from Phase 3 human clinical trials (including interim analysis), please describe future market entry plans for the new drug (however, content should avoid triggering requirements under the 'Standards for Full Financial Forecast Disclosure for Listed Companies' that would necessitate financial forecasting): 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 market launch. Investors should carefully assess and exercise caution. (2) Risks faced by the company and mitigation measures if not approved by the competent authority, if human trial results (including interim analysis) do not achieve statistical significance, or if other significant events affecting drug development occur: Not applicable. (3) Future business direction if approved by the competent authority, if human trial results (including interim analysis) achieve statistical significance, or if other significant events affecting drug development occur: Under company evaluation. (4) Cumulative R&D expenses incurred: For consideration of future marketing strategy and to protect company and investor interests, not disclosed at this time. 6. Next Development Stage to be Conducted (Please describe expected completion time and expected obligations): (1) Expected completion time: Actual timeline subject to adjustment based on clinical trial progress. (2) Expected obligations: None. 7. Market Situation: The claimed indication for CBL-0201WR IND is the reduction of abdominal subcutaneous fat in overweight and obese adults, spanning two rapidly growing and highly underserved markets: 'localized fat reduction' and 'weight management'. Current methods for localized fat reduction include invasive surgical procedures and non-invasive product treatments. While surgical procedures offer more noticeable results, they involve significant tissue and nerve damage, high risk, and long recovery periods. Marketed non-surgical fat reduction products have limited efficacy, often require repeated treatments, and may be associated with severe side effects or irreversible risks. Due to the limitations of current treatments, consumers and patients face a dilemma between 'effective but risky' or 'safe but ineffective', creating an urgent demand for a new generation of localized fat reduction therapies that are both safe and fundamentally effective. Meanwhile, the global weight management market is rapidly expanding due to the rise of GLP-1 class drugs, with the focus shifting from 'significant weight loss' to 'reducing more fat, maintaining weight after discontinuation, and metabolic health'. Weight loss achieved by GLP-1 drugs through appetite suppression only 'temporarily shrinks' fat cell volume without reducing their 'number', offering limited improvement for stubborn fat deposits such as abdominal subcutaneous fat. After a period of use, as the body's energy metabolism adapts, weight loss typically plateaus into a 'weight loss plateau phase', with diminishing marginal efficacy. Once discontinued and appetite returns, the shrunken fat cells preferentially reabsorb energy, greatly expanding and proliferating, accompanied by visceral fat accumulation and increased insulin resistance, leading to a 'double crisis' of 'weight regain' and 'deterioration of body composition'—an unresolved challenge in current weight management. As weight management needs become increasingly diverse, obesity treatment has evolved from a single weight metric to include fat distribution adjustment, body composition improvement, and healthy weight loss. Market consensus is becoming clear: the next generation of therapies must reduce fat cell numbers at the root, rather than merely suppressing appetite or shrinking fat volume. CBL-514 strategically enters both markets with this positioning—on one hand, directly reducing the number of abdominal subcutaneous fat cells to fundamentally address localized fat; on the other hand, synergistically combining with GLP-1 class drugs to further clear stubborn fat on top of weight loss, effectively maintain weight after discontinuation, improve body composition, and prevent rebound and metabolic deterioration. This dual action simultaneously addresses the pain points in the localized fat reduction market for safe and effective therapies, and the urgent needs in the weight management market for post-discontinuation weight maintenance and body composition quality, positioning CBL-514 as a potentially complementary first-choice therapy in both fields and filling a critical gap in the current treatment pathway. 8. Other Matters to be Disclosed (If the subject of the event or resolution is a publicly issued company or above, this material information also符合Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act regarding matters having a significant impact on shareholder rights or securities prices): None. 9. Drug development takes a long time, requires high investment, and does not guarantee success, which may pose risks to investors. Investors should carefully assess and exercise caution.