/PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) today announced that the

/PRNewswire/ -- Caliway Biopharmaceuticals（台股代码：6919）今天宣布

U.S. Food and Drug Administration (FDA) has granted clearance to proceed with SUPREME-01

美国食品药品监督管理局 (FDA) 已批准继续进行 SUPREME-01。

(CBL-0301), a global, multicenter, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localized fat reduction. This milestone marks a critical step forward in Caliway's global regulatory strategy for CBL-514.

(CBL-0301)，一项关于CBL-514的全球、多中心、关键的三期临床研究，CBL-514是首个用于大面积局部减脂的研究性药物。这一里程碑标志着Caliway在全球范围内对CBL-514的监管策略上迈出了关键一步。

Subject recruitment is expected to begin in Q3 2025 at 29 clinical sites across

预计将于2025年第三季度在29个临床站点开始受试者招募工作。

the United States

美国

and

和

Canada

加拿大

, with a total of 300 participants randomized 1:1 to receive either CBL-514 or placebo.

，共有300名参与者随机1:1分配接受CBL-514或安慰剂。

SUPREME-01 is a randomized, double-blind, placebo-controlled Phase 3 study. The primary estimand is a multicomponent responder endpoint,

SUPREME-01 是一项随机、双盲、安慰剂对照的 3 期研究。主要估计量是一个多组分应答者终点，

comprising: (1) abdominal fat volume change measured by MRI, and (2) abdominal fat level change assessed by Patient Reported-Abdominal Fat Rating Scale (PR-AFRS).

包括：(1) 通过MRI测量的腹部脂肪体积变化，以及 (2) 通过患者报告的腹部脂肪评级量表（PR-AFRS）评估的腹部脂肪水平变化。

These endpoints were previously evaluated and met in Caliway's completed Phase

这些端点之前已在 Caliway 完成的阶段中进行了评估并达成。

2b

2b

studies, CBL-0204 and CBL-0205.

研究，CBL-0204 和 CBL-0205。

CBL-514 is the first 505(b)(1) investigational drug with FDA clearance to enter Phase 3 for the proposed indication of 'Reduction of Abdominal Subcutaneous Fat.' If approved, it may offer a novel therapeutic option beyond traditional aesthetic treatments, which have long been approved solely for 'improvement in appearance,' potentially offering greater medical value and expanded market opportunities..

CBL-514 是首个获得 FDA 批准进入第 3 阶段的 505(b)(1) 研究性药物，用于“减少腹部皮下脂肪”的拟定适应症。如果获批，它可能会提供一种超越传统美学治疗的全新治疗选择，这些传统疗法长期以来仅被批准用于“改善外观”，而 CBL-514 则可能提供更大的医学价值和更广阔的市场机会。

Caliway has also completed the Clinical Trial Application (CTA) submission for SUPREME-01 to Health Canada and is preparing to submit the second global pivotal Phase 3 study SUPREME-02 (CBL-0302) in the U.S.,

Caliway 还完成了向加拿大卫生部提交的 SUPREME-01 临床试验申请 (CTA)，并准备在美国提交第二项全球关键性 3 期研究 SUPREME-02 (CBL-0302)。

Canada

加拿大

, and

，以及

Australia

澳大利亚

later this year. The topline results from SUPREME-01 are expected between Q4 2026 and Q1 2027.

今年晚些时候。SUPREME-01 的顶线结果预计在 2026 年第四季度和 2027 年第一季度之间发布。

In addition, Caliway also plans to submit a Phase 2 IND application to the U.S. FDA in Q4 2025 for the combination of CBL-514 with Tirzepatide, a

此外，Caliway还计划在2025年第四季度向美国FDA提交CBL-514与Tirzepatide联合使用的二期IND申请，

GLP-1

GLP-1

receptor agonist used to treat obesity, for the maintenance of weight loss, thereby expanding the therapeutic landscape of CBL-514 and entering the high-demand global weight management market.

用于治疗肥胖症的受体激动剂，用于维持体重减轻，从而扩展CBL-514的治疗领域，并进入需求旺盛的全球体重管理市场。

With SUPREME-01 now officially cleared to begin by the U.S. FDA, Caliway continues to advance its global development plan, aiming to provide a safe, effective, and innovative fat reduction solution beyond current aesthetic treatment standards.

随着SUPREME-01正式获得美国FDA批准开始，Caliway继续推进其全球发展计划，旨在提供一种安全、有效且创新的减脂解决方案，超越当前的美学治疗标准。

About CBL-514

关于CBL-514

CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas

CBL-514是由Caliway公司开发的一种505(b)(1)类和首创的小分子药物，是全球首款通过诱导脂肪细胞凋亡来减少目标部位皮下脂肪的注射型溶脂药。

without causing any systemic side effects on the central nervous system, cardiovascular system, and respiratory system.

不会对中枢神经系统、心血管系统和呼吸系统造成任何系统性副作用。

As of

截至

May 2025

2025年5月

, 10 clinical trials with a total of 520 subjects have been completed with all

，已经完成了10项临床试验，共有520名受试者全部完成。

efficacy and safety endpoints met

疗效和安全性终点达到

.

。

Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and

Caliway目前正在研究CBL-514的多种适应症，包括非手术脂肪减少、中至重度 cellulite，以及

Weight management (to reduce post-weight-loss fat rebound)

体重管理（减少减重后的脂肪反弹）

. CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum's disease and more.

CBL-514D，相同的活性药物成分（APIs），但在不同的制剂下，正在研究用于其他适应症，如德康病等。

About AFRS (Abdominal Fat Rating Scale)

关于AFRS（腹部脂肪评级量表）

AFRS is a five-grade rating scale developed by Caliway and validated in accordance with U.S. FDA guidance and relevant regulations, including the FDA's guideline on Patient-Focused Drug Development. The Clinician Reported-AFRS (CR-AFRS) and the Patient Reported-AFRS (PR-AFRS) are used to assess treatment response based on the physician's evaluation and the participant's self-assessment, respectively..

AFRS是一个由Caliway开发的五级评分量表，并依据美国FDA指南和相关法规进行验证，包括FDA关于以患者为中心的药物开发指南。临床医生报告的AFRS（CR-AFRS）和患者报告的AFRS（PR-AFRS）分别用于根据医生评估和参与者自我评估来评价治疗反应。

About Caliway Biopharmaceuticals

关于嘉立维生物制药

Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases.

Caliway生物制药公司（Caliway）是一家临床阶段的生物制药公司，致力于突破性地发现新型小分子治疗药物。公司在台湾证券交易所上市（TWSE-6919），目标是成为医学美容及其他疾病领域的创新型制药领导者。