生物城市生物制药有限公司宣布临床合作，评估BC3195联合KEYTRUDA®（帕博利珠单抗）治疗局部晚期或转移性实体瘤患者的效果-动脉网

BioCity Biopharmaceutics Co., Ltd. Announces Clinical Collaboration to Evaluate BC3195 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Locally Advanced or Metastatic Solid Tumors

CISION 等信源发布 2025-03-13 13:17

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SHANGHAI

上海

，

March 13, 2025

2025年3月13日

/PRNewswire/ -- BioCity Biopharmaceutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc.,

/PRNewswire/ -- 临床阶段生物制药公司BioCity生物医药有限公司今日宣布，已与MSD（默克公司）达成一项临床试验合作协议，

Rahway, NJ

新泽西州拉威市

, USA), to evaluate the combination of BioCity's BC3195 and MSD's anti-PD-1 therapy, KEYTRUDA

，美国），以评估BioCity的BC3195与MSD的抗PD-1疗法KEYTRUDA的组合

(pembrolizumab), in a global phase 1/2 trial in patients with locally advanced or metastatic solid tumors.

(pembrolizumab)，在全球性1/2期试验中，针对局部晚期或转移性实体瘤患者。

Under the terms of the agreement, BioCity will conduct a phase 1/2 clinical trial to evaluate the safety and efficacy of BC3195 in combination with KEYTRUDA. BioCity and MSD each retain all commercial rights to their respective compounds. The recruitment in the clinical study is expected in Q4 2025..

根据协议条款，BioCity 将开展一项 1/2 期临床试验，以评估 BC3195 联合 KEYTRUDA 的安全性和有效性。BioCity 和 MSD 各自保留对其各自化合物的所有商业权利。该临床研究的招募预计在 2025 年第四季度进行。

'We are encouraged by the clinical data we have seen thus far for BC3195 as monotherapy, which have demonstrated improved anti-tumour activity in patients with certain non-small cell lung and breast cancers. We now look forward to exploring the potential of BC3195 in combination with KEYTRUDA through this collaboration, as we continue to advance our clinical program and seek to further validate our differentiated drug discovery and development approach.' Said by .

“我们对迄今为止看到的BC3195作为单一疗法的临床数据感到鼓舞，这些数据已证明在某些非小细胞肺癌和乳腺癌患者中具有增强的抗肿瘤活性。我们现在期待通过此次合作探索BC3195与KEYTRUDA联合使用的潜力，同时我们将继续推进临床项目，并寻求进一步验证我们独特的药物发现和开发方法。”

Ivy Wang

王常青

, Co-founder and Executive President of BioCity.

BioCity的联合创始人兼执行总裁。

KEYTRUDA

is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,

是默克 Sharp & Dohme LLC（默克公司子公司）的注册商标，

Rahway, NJ

新泽西州拉威

, USA.

，美国。

About BC3195

关于BC3195

BC3195 is currently the only ADC targeting CDH3 (P-Cadherin) in clinical development globally. In preclinical studies, BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells, as well as surrounding cells, which is known as the bystander effect.

BC3195 是目前全球唯一一个处于临床开发阶段的靶向 CDH3（P-钙粘蛋白）的抗体药物偶联物 (ADC)。在临床前研究中，BC3195 以强亲和力结合到膜 CDH3 上，并能高效内化。BC3195 设计采用了临床上已验证的可裂解连接子和有效载荷（vc-MMAE），能够摧毁靶向癌细胞及周围细胞，这被称为旁观者效应。

In animal models, BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers..

在动物模型中，BC3195 表现出良好的安全性，并在某些携带已建立癌症的动物中显示出强劲的抗肿瘤活性，肿瘤生长抑制率 ≥100%。

BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in

BC3195目前正在进行I期剂量优化和剂量扩展的同步研究。

China

中国

and in US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics, significant antitumor activity with confirmed PRs observed across multiple tumor types.

在美国，BC3195 展现出可控的安全性特征和良好的药代动力学特性，并在多种肿瘤类型中观察到具有确认的部分缓解（PR），显示出显著的抗肿瘤活性。

About BioCity

关于生物城

Founded in

成立于

December 2017

2017年12月

, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC)..

BioCity是一家临床阶段的生物制药公司，致力于为癌症和包括慢性肾病在内的自身免疫性疾病开发新颖且高度差异化的、不受治疗模式限制的疗法。BioCity已经建立了一个包含10多种创新药物候选品的管线，包括小分子、单克隆抗体和双特异性抗体以及抗体-药物偶联物（ADC）。

Currently, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca.

目前，BioCity有五个核心肿瘤资产处于1/2期临床开发阶段，包括首创的靶向CDH3的抗体偶联药物（ADC）和靶向GPC3的抗体偶联药物、靶向DNA损伤应答（DDR）通路的WEE1和ATR抑制剂，以及与阿斯利康合作开发的靶向TIM-3的单克隆抗体。

In addition, BioCity's SC0062, a highly selective ETA antagonist, is in phase 3 clinical development for IgA nephropathy and a global phase 3 registration trial is being planned..

此外，BioCity的SC0062是一种高选择性的ETA拮抗剂，正在针对IgA肾病进行3期临床开发，并计划开展全球3期注册试验。

For more information, please visit

更多信息，请访问

www.biocitypharma.com

Or LinkedIn BioCity Biopharma

或者 LinkedIn BioCity 生物制药

Contact:

联系人：

BD@biocitypharma.com

IR@biocitypharma.com

SOURCE BioCity Biopharma

源生物城生物医药