biosimilar – Finance Colombia https://www.financecolombia.com Connecting Colombia to the global capital markets, analysts, economists, investors, and executives that matter Tue, 04 Nov 2025 11:22:42 +0000 en-US hourly 1 https://www.financecolombia.com/wp-content/uploads/2016/01/cropped-Favicon-32x32.png biosimilar – Finance Colombia https://www.financecolombia.com 32 32 BioDlink and Kexing BioPharm Initiate Shipment of Bevacizumab Biosimilar to Colombia https://www.financecolombia.com/biodlink-and-kexing-biopharm-initiate-shipment-of-bevacizumab-biosimilar-to-colombia/ Tue, 04 Nov 2025 11:24:53 +0000 https://www.financecolombia.com/?p=36668 Suzhou, China based BioDlink (1875.HK) announced the inaugural international shipment of its bevacizumab injection biosimilar to Colombia. The shipment was conducted in partnership with Jinan, China based Kexing BioPharm (SHA:688136), the company’s licensee for emerging markets. This initial distribution follows the marketing approval granted to the product by the Colombian National Institute for Surveillance of Medicines and Foods (INVIMA) in July 2025. The drug is targeted for use in cancers such as lung and colorectal, which are classified by the International Agency for Research on Cancer (IARC) GLOBOCAN 2022 as being among the top three cancer-related causes of death in Colombia.

The therapy is used to treat various cancers, including colorectal and lung cancer.

The shipment to Colombia was dispatched approximately two months after receiving the regulatory authorization. Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF), a factor involved in blood vessel formation. The therapy is used in the treatment of various cancers, including metastatic colorectal cancer (mCRC) and metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). Industry estimates indicate that global sales for bevacizumab injection reached $8.5 billion USD in 2023.

The arrival of the initial shipment in Colombia marks the execution of the companies’ commercial strategy for the region. The Colombian cancer burden is characterized by patterns aligning with bevacizumab’s indications, with 11,163 colorectal cases and 7,196 lung cases reported out of 117,620 new cancer cases in 2022, according to IARC GLOBOCAN 2022.

Manufacturing and Global Strategy

BioDlink’s manufacturing facilities, spanning 50,000 square meters, have undergone five audits by an EU Qualified Person (QP) for antibody drugs and antibody-drug conjugates (ADCs) over the past four years without any critical defects being reported. The company states that its quality system has supported over 100 clinical projects, providing development, clinical filings, and manufacturing services in global markets including Europe and the US.

The partnership operates under an international commercialization agreement signed in early 2022, establishing a framework where BioDlink focuses on manufacturing and supply chain management while Kexing BioPharm leverages its distribution network for market access in emerging regions. Kexing BioPharm, which holds the global license for the bevacizumab injection in emerging markets, has achieved Good Manufacturing Practice (GMP) certification for the product in China, Colombia, Brazil, Argentina, Egypt, Indonesia, Pakistan, and Thailand. In collaboration with BioDlink, Kexing BioPharm has initiated regulatory filings in 35 countries. GMP certification in Brazil, Colombia, and Argentina covers South America’s three most populous countries.

BioDlink reports that its international focus remains on emerging markets, including South America, South Asia, Southeast Asia, and Africa.

Above photo courtesy Kexing Biopharm

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