Kangpei Completes FDA IND Submission for Phase 2 Trial of CBL-514 Injection in Combination with tirzepatide (Eli Lilly) for Abdominal Subcutaneous Fat Reduction in Overweight or Obese Adults

1. Date of Event: July 27, 2026 2. Name or Code of Investigational Drug: CBL-514 3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Donohue syndrome 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: Application submitted. C. Phase 3 Clinical Trial: Not yet initiated. 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 investment): (1) Application submitted/approved/not approved / results of human trials (including interim analysis) / 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, completed U.S. FDA IND clinical trial application on July 27, 2026. The trial will use MRI to measure changes in abdominal subcutaneous fat volume as the efficacy endpoint and plans to enroll 120 participants in the United States. A. Clinical Trial Design Overview (including trial name, objective, phase, drug name, claimed indication, evaluation metrics, and number of enrolled participants): a. Trial 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: Phase 2 Clinical Trial d. Drug Name: CBL-514 e. Claimed Indication: Reduction of abdominal subcutaneous fat in overweight or obese adults f. Evaluation Metric: Efficacy endpoint is change in abdominal subcutaneous fat volume measured by MRI g. Number of Enrolled Participants: 120 planned B. Statistical Results of Primary and Secondary Endpoints (including P-values) and Statistical Significance. If statistical data cannot be disclosed due to compelling reasons, please explain: Not applicable C. If aware of Phase 3 human clinical trial (including interim analysis) statistical data, please describe future market entry plans (content should avoid triggering full financial forecasting obligations under disclosure standards for listed companies): Not applicable. D. A single clinical trial result (including P-values and statistical significance of 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 exercise caution. (2) Risks and mitigation measures if not approved by regulatory authority, trial results fail to achieve statistical significance, or other significant events affecting drug development occur: Not applicable. (3) Future business direction if approved by regulatory authority, trial results achieve statistical significance, or other significant events occur: Under company evaluation. (4) Cumulative R&D investment to date: Not disclosed at this time to protect company and investor interests, considering future marketing strategy. 6. Next Development Stage (Please specify expected completion time and anticipated obligations): (1) Expected Completion Time: Actual timeline subject to adjustment based on clinical trial progress. (2) Anticipated Obligations: None. 7. Market Overview: The claimed indication for CBL-0201WR IND submission—reduction of abdominal subcutaneous fat in overweight and obese adults—spans two rapidly growing, high-unmet-need markets: 'localized fat reduction' and 'weight management'. Current localized fat reduction methods include invasive surgical procedures and non-invasive product-based treatments. While surgical methods offer more visible results, they involve significant tissue and nerve damage, high risks, and long recovery periods. Approved non-surgical fat reduction products often have limited efficacy, require repeated treatments, and may carry severe side effects or irreversible risks. Due to these limitations, consumers and patients face a dilemma between 'effective but risky' and 'safe but ineffective' options, creating urgent demand for a next-generation localized fat reduction therapy that is both safe and fundamentally effective. Meanwhile, the global weight management market is rapidly expanding due to the rise of GLP-1 class drugs, with focus shifting from 'significant weight loss' to 'greater fat reduction, weight maintenance after discontinuation, and metabolic health'. GLP-1 drugs achieve weight loss by suppressing appetite, which only temporarily shrinks fat cell volume without reducing their number, offering limited improvement for stubborn fat deposits such as abdominal subcutaneous fat. After prolonged use, the body's energy metabolism adapts, causing weight loss to plateau—the so-called 'weight loss plateau'—with diminishing marginal efficacy. Upon discontinuation and appetite recovery, the shrunken fat cells preferentially reabsorb energy, leading to significant expansion and proliferation, along with visceral fat accumulation and increased insulin resistance, resulting in 'weight rebound' and 'deterioration of body composition'—a dual crisis that remains an unsolved challenge in current weight management. As weight management needs become increasingly diverse, obesity treatment has evolved beyond a single weight metric to include fat distribution adjustment, body composition improvement, and healthy weight loss. Market consensus is increasingly clear: the next-generation therapy 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 approach—directly reducing the number of abdominal subcutaneous fat cells to fundamentally resolve localized fat, while synergistically combining with GLP-1 class drugs to further eliminate 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 point in the localized fat reduction market for a safe and effective therapy, and the urgent need 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 continuum. 8. Other Matters to be Disclosed (If the entity involved is a publicly listed company and this material information qualifies under Article 7, Paragraph 8 of the Enforcement Rules of the Securities Trading Act as having significant impact on shareholder权益 or securities price): None. 9. Drug development is a long-term process involving high investment and no guarantee of success, which may expose investors to risks. Investors should carefully assess and exercise caution.