MediLink Therapeutics Co., Ltd. a clinical-stage biotech company, today announced a global clinical trial collaboration and supply agreement with Amgen Inc. Amgen will lead a global clinical study to evaluate the therapeutic potential of the combination of MediLink's B7-H3-targeting antibody-drug conjugate (ADC) YL201 and Amgen's DLL3- and CD3-targeting bispecific T-cell engager (BiTE®) IMDELLTRA™ in extensive-stage small cell lung cancer (ES-SCLC) under the clinical trial collaboration and supply agreement.

MediLink Therapeutics Co。，有限公司是一家临床阶段生物技术公司，今天宣布与安进公司达成全球临床试验合作和供应协议。安进公司将领导一项全球临床研究，以评估MediLink的B7-H3靶向抗体-药物偶联物（ADC）YL201和安进的DLL3和CD3靶向双特异性T细胞接合器（BiTE®）IMDELLTRA™在广泛期小细胞肺癌（ES-SCLC）中的治疗潜力。

MediLink will provide the investigational drug YL201 for the combination study.This open-label, global, multi-center Phase Ib clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of this combination regimen in ES-SCLC patients.Both YL201 and IMDELLTRA™ have shown potential in ES-SCLC.

MediLink将为联合研究提供研究药物YL201。这项开放标签的全球多中心Ib期临床研究旨在评估这种联合方案在ES-SCLC患者中的安全性，耐受性，药代动力学和疗效。YL201和IMDELLTRA™都在ES-SCLC中显示出潜力。

In May of this year, IMDELLTRA™ received accelerated approval from the FDA and is currently marketed in the US for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response.

今年5月，IMDELLTRA™获得了FDA的加速批准，目前在美国上市，用于治疗铂类化疗期间或之后疾病进展的成年ES-SCLC患者。根据总体响应率和响应持续时间，该适应症在加速批准下获得批准。

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The efficacy of YL201 monotherapy is encouraging in ES-SCLC. MediLink has announced the data of a Phase I/II clinical trial of YL201 in patients with advanced solid tumors including SCLC as a selected oral presentation at the ESMO Congress 2024.

继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。YL201单药治疗ES-SCLC的疗效令人鼓舞。MediLink宣布了YL201在包括SCLC在内的晚期实体瘤患者中进行的I/II期临床试验的数据，作为2024年ESMO大会上的选择性口头报告。

This clinical trial collaboration aims to explore the potential of the two innovative drugs in the treatment of ES-SCLC and offer a novel and synergetic mechanism of action for clinical benefit.About ES-SCLCSCLC is an aggressive high-.

这项临床试验合作旨在探索这两种创新药物在治疗ES-SCLC中的潜力，并为临床获益提供一种新的协同作用机制。关于ES-SCLCSCLC是一个积极的高-。