NANJING, China, April 30, 2024 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as 'Leads Biolabs') announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights has received approval to conduct the single-arm pivotal study for registration and market authorization from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

南京，中国，2024年4月30日/PRNewswire/--南京Leads Biolabs有限公司（以下简称“Leads Biolabs”）宣布，由具有全球知识产权的Leads Biolabs独立开发的抗PD-L1/4-1BB双特异性抗体LBL-024已获得国家医疗产品管理局（NMPA）药物评估中心（CDE）的批准，可以进行单臂关键性注册和市场授权研究。

Currently, there are no similar products approved for marketing domestically or internationally..

目前，国内外均未批准销售类似产品。。

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Mechanism of LBL-024

LBL-024的机理

LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies. It binds to PD-L1 with high affinity, blocking the PD-L1/PD-1 immunosuppressive pathway while conditionally activating the 4-1BB costimulatory pathway in the tumor microenvironment.

LBL-024是由抗程序性死亡配体-1（PD-L1）和抗4-1BB（CD137）抗体组成的双特异性抗体。它以高亲和力与PD-L1结合，阻断PD-L1/PD-1免疫抑制途径，同时有条件地激活肿瘤微环境中的4-1BB共刺激途径。

This activation of T cells exerts a powerful immune response, resulting in a stronger antitumor effect than anti-PD-1/PD-L1 monoclonal antibodies alone..

T细胞的这种激活发挥了强大的免疫反应，比单独的抗PD-1/PD-L1单克隆抗体具有更强的抗肿瘤作用。。

LBL-024 received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase Ⅰ/Ⅱ clinical research, and has achieved outstanding results. The clinical study results of LBL-024 monotherapy in patients with advanced malignant tumors demonstrated good safety profile and encouraging efficacy signals in the advanced solid tumors..

LBL-024分别于2021年7月30日和2021年9月9日获得FDA和NMPA的IND批准，进行Ⅰ/Ⅱ期临床研究，取得了突出的成果。LBL-024单药治疗晚期恶性肿瘤的临床研究结果显示，在晚期实体瘤中具有良好的安全性和令人鼓舞的疗效信号。。

The approved Phase IIb pivotal clinical study is led by Professor Shen Lin from Peking University Cancer Hospital, and detailed clinical data will be disclosed during the ASCO Annual Meeting on May 31st to June 4th, 2024. LBL-024 has First-in-Class potential and is expected to offer an effective treatment option to patients with advanced solid tumors.Dr.

批准的IIb期关键临床研究由北京大学肿瘤医院的沈林教授领导，详细的临床数据将在2024年5月31日至6月4日的ASCO年会上披露。LBL-024具有一流的潜力，有望为晚期实体瘤患者提供有效的治疗选择。博士。

Charles Cai, Chief Medical Officer of Leads Biolabs, said ' The approval of this pivotal clinical study is an encouraging news. Based on the current treatment status and the available safety and efficacy data, LBL-024 meets the requirements of the drug registration management measures for 'innovative drugs used to prevent and treat diseases that seriously endanger life or severely affect the quality of life, and for which there are no effective prevention or treatment methods, or there is sufficient evidence to demonstrate significant clinical advantages compared to existing treatment methods.' The approval of the single-arm pivotal clinical study by CDE will help accelerate the marketing process of LBL-024 and bring more effective treatment options to patients as early as possible.'Dr.

Leads Biolabs首席医学官查尔斯·蔡（CharlesCai）表示，“这项关键临床研究的批准是一个令人鼓舞的消息。根据目前的治疗现状和可用的安全性和有效性数据，LBL-024符合《药物注册管理办法》的要求，即“用于预防和治疗严重危及生命或严重影响生活质量的疾病的创新药物，并且没有有效的预防或治疗方法，或者有足够的证据表明与现有治疗方法相比具有显着的临床优势。”CDE批准单臂关键临床研究将有助于加速LBL-024的营销过程，并尽早为患者带来更有效的治疗选择。”博士。

Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said ' We are delighted to see the positive progress of LBL-024, which has the potential to become an effective immunotherapy and prove 4-1-BB to be druggable immune checkpoint target approved for marketing following PD-1/PD-L1, CTLA-4, and LAG-3.

Leads Biolabs创始人、董事长兼首席执行官康晓强表示，“我们很高兴看到LBL-024取得了积极进展，它有可能成为一种有效的免疫疗法，并证明4-1-BB是PD-1/PD-L1，CTLA-4和LAG-3之后批准上市的可药物免疫检查点目标。

This milestone achievement also reflects our corporate philosophy of focus on innovation and our determination to discover and advance First-in-Class products. We have always been guided by clinical needs in our differentiated approach to innovation, deploying novel targets while combining some targets based on a deep understanding of .

这一里程碑式的成就也反映了我们专注于创新的企业理念，以及我们发现和改进一流产品的决心。在我们的差异化创新方法中，我们始终以临床需求为指导，部署新的目标，同时在深入了解的基础上结合一些目标。