FOSUN PHARMA announced that its subsidiary, Henlius USA Inc., has received orphan drug designation from the USA FDA for HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) for the treatment of gastric cancer. HLX22 has been licensed from AbClon, Inc. and independently developed by the group, intended for the treatment of solid tumors such as gastric cancer and breast cancer. As of February 2025, the group's cumulative R&D investment in HLX22 is about 0.304 billion yuan. In 2024, the global sales of HER2-targeted monoclonal antibody products are expected to be about 9.029 billion USD. This designation will help HLX22 to enjoy policy support for subsequent research and development, registration, and commercialization in the USA.
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复星医药:控股子公司药品获美国FDA孤儿药资格认定
FOSUN PHARMA: A subsidiary's pharmaceutical has received orphan drug designation from the USA FDA.
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