EASTONBIOPHARMACEUTICALS(SH:688513) Ge Long Hui A P P·2025-12-24 09:09Core Viewpoint - The approval of the ANDA for Methylene Blue Injection by the FDA marks a significant milestone for the company, enhancing its international product pipeline and supporting its globalization strategy [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., received notification from the FDA regarding the approval of the ANDA for Methylene Blue Injection [1] - The active ingredient of Methylene Blue Injection is Methylene Blue, indicated for the treatment of acquired methemoglobinemia in children and adults [1] Group 2: Product Commercialization - Methylene Blue Injection is the company's third formulation to enter the international market, with the raw material also registered with the FDA [1] - The company has signed an exclusive supply and distribution agreement with an international pharmaceutical company for the commercialization of Methylene Blue Injection in the U.S. [1] - Under the agreement, the international company will be responsible for the comprehensive commercialization operations in the U.S., while the company will focus on production and supply, receiving milestone payments, sales revenue, and a share of the sales profits [1]