(BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin.

Biocon Ltd（BSE代码：532523，NSE：BIOCON）的子公司BBL今天宣布，美国食品药品监督管理局（美国FDA）已批准Jobevne™（贝伐单抗-nwgd），一种用于静脉注射的生物类似药贝伐单抗。JOBEVNE是一种重组人源化单克隆抗体，用于治疗多种不同类型的癌症，是参考产品Avastin的生物类似药。

(bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor.

（贝伐单抗）。JOBEVNE 是一种血管内皮生长因子 (VEGF) 抑制剂，它与 VEGF 结合并阻止其与受体的相互作用，从而抑制血管生成——通过限制肿瘤的血液供应来对抗癌症。

The approval of JOBEVNE expands Biocon Biologics' biosimilar oncology portfolio in

JOBEVNE的批准扩大了Biocon Biologics的生物类似药肿瘤学产品组合。

, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in

，其中还包括OGIVRI（曲妥珠单抗-dkst）和FULPHILA（培非格司亭-jmdb）。该公司还销售贝伐单抗在

The U.S. FDA has approved Jobevne™ (bevacizumab-nwgd) from Biocon Biologics to treat several different types of cancer.

美国食品药品监督管理局（FDA）已批准 Biocon Biologics 公司的 Jobevne™（贝伐珠单抗-nwgd）用于治疗多种不同类型的癌症。

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd.

Shreehas Tambe，首席执行官兼董事总经理，Biocon Biologics Ltd.

, said:

，说道：

'The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics.

“JOBEVNE™（贝伐珠单抗-nwgd）获得美国FDA批准是一个重要的里程碑——这是我们在美国获批的第七个生物类似药，也是我们强大的肿瘤学产品组合的有力补充。这凸显了我们深厚的科学专业知识和致力于扩大获得高质量、可负担的生物制剂的承诺。”

We look forward to working with all stakeholders to bring more treatment options to patients.'.

我们期待与所有利益相关者合作，为患者带来更多的治疗选择。'

In the U.S., sales of bevacizumab were approximately

在美国，贝伐单抗的销售额大约为

$2.0 billion

20亿美元

in 2023.**

在2023年。**

Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many 'firsts' in the industry including the first to receive approval of a trastuzumab in

Biocon Biologics 是生物仿制药和胰岛素生产的全球领先企业，并在业内取得了多项“第一”，包括首个获得曲妥珠单抗批准的公司。

, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in .

，OGIVRI（曲妥珠单抗-dkst）、FULPHILA（培非格司亭-jmdb）以及SEMGLEE（甘精胰岛素）的首个美国可互换生物类似药批准。Biocon Biologics 每年为超过 500 万患者提供服务，拥有涵盖多种治疗领域的在市和在研生物类似药的全面产品组合，包括七种已获批的生物类似药。

, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.

，拥有20种生物类似药的强劲开发管线，包括跨越多个治疗领域的胰岛素和单克隆抗体。

About JOBEVNE:

关于JOBEVNE：

The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab).

JOBEVNE（贝伐珠单抗-nwgd）的批准基于一套全面的比较药代动力学、安全性、有效性、非临床、结构、分析和功能数据，这些数据证实 JOBEVNE 与 Avastin®（贝伐珠单抗）高度相似。

The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity.

数据显示，JOBEVNE与Avastin®在药代动力学、安全性、有效性和免疫原性方面均无临床意义上的差异。

About Biocon Biologics Limited:

关于百康生物制品有限公司：

Biocon Biologics Ltd. (BBL)

百康生物制药有限公司 (BBL)

, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars.

，是一家隶属于百康有限公司的子公司，是一家独特的、完全集成的全球生物仿制药公司，致力于改变医疗保健和改变生活。它正在利用其“从实验室到市场”的能力，通过使患者能够负担得起高质量的生物仿制药，为120多个国家的数百万患者提供服务。

The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes..

公司正在利用前沿科学、创新技术平台、全球规模的制造能力和世界级的质量体系，在降低生物治疗药物成本的同时改善医疗保健效果。