百奥泰宣布BAT8006（一种靶向叶酸受体α的抗体药物偶联物，用于治疗铂类耐药卵巢癌）的III期临床试验完成首例患者给药-动脉网

Bio-Thera Solutions Announces First Patient Dosed in Phase 3 Clinical Trial for BAT8006, an Antibody Drug Conjugate Targeting Folate Receptor α for the Treatment of Platinum-Resistant Ovarian Cancer

CISION 等信源发布 2025-06-25 19:00

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可切换为仅中文

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GUANGZHOU, China

中国广州

，

June 25, 2025

2025年6月25日

/PRNewswire/ -

Bio-Thera Solutions

百奥泰生物制药

Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has begun in a phase 3 clinical study for BAT8006, an antibody drug conjugate targeting folate receptor α for the treatment of platinum-resistant ovarian cancer.

商业阶段的生物制药公司 Inc.（688177:SH），专注于开发创新疗法和生物类似药的管线，今日宣布，针对铂类耐药卵巢癌治疗的抗体药物偶联物 BAT8006（靶向叶酸受体α）的3期临床研究已经开始给药。

The phase 3, randomized, open-label, parallel-group clinical trial (Clinical Trial Registration Number: CTR20251345) of BAT8006 is designed to assess the efficacy of BAT8006 versus investigator's choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer..

BAT8006的三期、随机、开放标签、平行组临床试验（临床试验注册号：CTR20251345）旨在评估BAT8006与研究者选择的单药化疗在铂类耐药的高级别浆液性上皮卵巢癌、原发性腹膜癌或输卵管癌患者中的疗效。

At the Rapid Oral Abstract Session of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, early clinical data of BAT8006 demonstrated promising results in platinum-resistant ovarian cancer. Among 133 enrolled patients (regardless of FRα expression levels or prior lines of therapy) in the dose-escalation and expansion study, the therapy achieved a median progression-free survival (PFS) of 7.63 months, with an objective response rate (ORR) of 40.7% and disease control rate (DCR) of 80.5%.

在2025年美国临床肿瘤学会（ASCO）年会的快速口头摘要会议上，BAT8006的早期临床数据显示在铂耐药卵巢癌中取得了令人鼓舞的结果。在剂量递增和扩展研究中，入组的133名患者（无论FRα表达水平或先前治疗线数如何），该疗法实现了7.63个月的中位无进展生存期（PFS），客观缓解率（ORR）为40.7%，疾病控制率（DCR）为80.5%。

Importantly, no cases of interstitial lung disease or ocular toxicity were observed. These findings indicate that BAT8006 exhibits significant clinical efficacy and a favorable safety profile, highlighting its strong clinical potential for platinum-resistant ovarian cancer..

重要的是，未观察到间质性肺病或眼部毒性病例。这些发现表明BAT8006具有显著的临床疗效和良好的安全性，突显其在铂耐药卵巢癌中的强大临床潜力。

Platinum-resistant ovarian cancer remains a significant clinical challenge with poor patient prognosis and limited treatment options. Currently, only one FRα-targeting antibody-drug conjugate (ADC) is approved globally, and its indication is restricted to patients with FRα expression ≥75% (only 25%-30% of the platinum-resistant population).

铂耐药卵巢癌仍然是一个重大的临床挑战，患者预后较差且治疗选择有限。目前，全球仅有一种靶向FRα的抗体药物偶联物（ADC）获批，且其适应症仅限于FRα表达≥75%的患者（仅占铂耐药人群的25%-30%）。

This approved therapy demonstrates limited median progression-free survival (mPFS) and is associated with ocular toxicity. .

这种获批的治疗方法显示出有限的中位无进展生存期 (mPFS)，并且与眼部毒性相关。

As one of the first FRα ADCs in

作为首批 FRα ADC 之一

China

中国

entering a pivotal phase 3 clinical trial, BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients (regardless of FRα expression levels). These promising data suggest BAT8006 may offer a novel therapeutic option for this difficult-to-treat population..

进入关键的3期临床试验，BAT8006有望在全谱铂耐药卵巢癌患者（无论FRα表达水平如何）中展现出具有临床意义的疗效。这些令人鼓舞的数据表明，BAT8006可能为这一难以治疗的群体提供一种新的治疗选择。

About Bio-Thera Solutions

关于百奥泰生物制药

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou,

百奥泰生物制药股份有限公司，一家位于广州的领先的创新型全球生物制药公司，

China

中国

, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI.

，致力于研究和开发用于治疗癌症、自身免疫疾病、心血管疾病、眼科疾病以及其他严重未满足医疗需求的新型疗法，同时也在开发生物类似药以替代现有的品牌生物制品，用于治疗多种癌症和自身免疫疾病。作为下一代抗体发现与工程领域的领导者，该公司已将多个候选药物推进到后期开发阶段，其中包括五款已获批产品：QLETLI。

(adalimumab) and BETAGRIN

（阿达木单抗）和 BETAGRIN

(bevifibatide citrate) Injection in China, STARJEMZA

（贝维伐肽柠檬酸盐）注射液在中国，STARJEMZA

in the US, and BAT1806/TOFIDENCE

在美国，以及BAT1806/TOFIDENCE

商标

(tocilizumab) and AVZIVI

（托珠单抗）和 AVZIVI

(bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY

在美国和欧盟，（贝伐单抗-tnjn），又称为 POBEVCY

在

China

中国

. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit

此外，该公司还有20多个有希望的候选药物正在进行临床试验，专注于后PD-1时代的免疫肿瘤学和抗体药物偶联物（ADCs）等靶向疗法。欲了解更多信息，请访问

www.bio-thera.com/en/

www.bio-thera.com/zh/

or follow us on X (

或在X上关注我们 (

@bio_thera_sol

) and WeChat (Bio-Thera).

）和微信（百奥泰）。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的谨慎声明

This news release contains certain forward-looking statements relating to BAT8006 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing 'could,' 'may,' 'should,' 'will,' 'would,' 'anticipate,' 'believe,' 'plan,' 'promising,' 'potentially,' or similar expressions.

本新闻稿包含某些与BAT8006或百奥泰产品管线相关的前瞻性陈述。读者被强烈警告，依赖任何前瞻性陈述涉及已知和未知的风险和不确定性。这些前瞻性陈述包括但不限于含有“可能”、“或许”、“应该”、“将会”、“预期”、“相信”、“计划”、“有前景”、“潜在”或类似表达的陈述。

They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies.

它们反映了公司对未来事件的当前看法，这些看法基于公司认为合理的假设，鉴于百奥泰目前可获得的信息，并不代表对未来业绩或发展的保证。实际结果和事件可能与前瞻性陈述中包含的信息存在重大差异，这是由于多种因素造成的，包括但不限于药物研发过程中固有的风险和不确定性，例如临床前和临床研究的不确定性，例如开发过程可能会很漫长，高体外亲和力可能无法转化为理想的体内结果或成功的临床研究。

Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc.

其他风险和不确定性包括：获得监管批准、生产、营销、竞争、知识产权、产品功效或安全性、全球医疗保健形势变化、公司财务状况变化以及适用法律法规变化等方面的挑战等。

Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertake no obligation to publicly update any forward-looking statement, whether as a result of new in.

本文件中包含的前瞻性陈述仅于其首次发布之日作出。除非法律或法规要求，百奥泰生物制药公司不承担公开更新任何前瞻性陈述的义务，无论是否由于新的信息。

QLETLI

is a registered trademark of Bio-Thera Solutions, Ltd.

是百奥泰生物制药有限公司的注册商标。

BETAGRIN

贝塔格林

is a registered trademark of Bio-Thera Solutions, Ltd.

是百奥泰生物制药有限公司的注册商标。

STARJEMZA

星际迷航

is a registered trademark of Hikma Pharmaceuticals.

是Hikma Pharmaceuticals的注册商标。