BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as "BIO-THERA" or the "Company", today announced that it has entered into a license and commercialization agreement with Macter International Limited ("Macter") for BAT1706, an Anviva reference product. The Company announced today that it has entered into a license and commercialization agreement with Macter International Limited ("Macter") for BAT1706, a biosimilar developed with reference to Avastin® bevacizumab. Under the terms of the agreement, Macter will have exclusive distribution and marketing rights for BAT1706 in Pakistan and Afghanistan.

BAT1706 has completed global Phase III clinical studies, demonstrating a high degree of safety, efficacy, and immunogenicity similarity to the originator, and BAT1706 (PuperChi®) has been approved for marketing by the National Drug Administration (NMPA) of China in November 2021, and BAT1706 (Avzivi®) has been approved for marketing by the U.S. Food and Drug Administration (FDA) in December 2023; and BAT1706 (Avzivi®) has been approved for marketing by the FDA of the United States. Administration (FDA) in November 2021; BAT1706 (Avzivi®) was approved by the U.S. Food and Drug Administration (FDA) in December 2023; and BIO-THERA has also filed a marketing application with the European Medicines Agency (EMA). Under the terms of the agreement, Macter will be responsible for filing the marketing application for BAT1706 in Pakistan and Afghanistan.

Macter will be responsible for the commercialization of BAT1706 in Pakistan and Afghanistan, where it has a well-established commercial network and marketing capabilities, and BIO-THERA will be responsible for the commercial supply of BAT1706. By partnering with Macter, BIO-THERA will be able to bring bevacizumab to Pakistan and Afghanistan, providing a new treatment option for patients in need.

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