Fudan-Zhangjiang's drug application rejected, boosts capital with deposit product

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. announced that its subsidiary received a non-approval notification from the NMPA for its Abbreviated New Drug Application (ANDA) for Obeticholic Acid Tablets (5 mg, 10 mg) for primary biliary cholangitis. The drug, a Category 3 Generic Chemical Drug, was not approved because existing data could not fully support approval per technical requirements, given that benefits did not outweigh risks identified post-marketing of original preparations overseas. Cumulative R&D investment in the drug amounted to approximately RMB125 million, but the non-approval is not expected to materially impact the company's financial performance.

In a separate development, the company entered a Discloseable Transaction by subscribing to a Ping An Bank Structured Deposit Product with an amount of RMB220 million, utilizing idle self-owned funds. This principal-guaranteed product, linked to Shanghai Gold, has a term of 79 days and an expected annualized return rate ranging from 0.45% to 1.90%.

The board of directors views the structured deposit as beneficial for enhancing the group's overall capital gain and ensuring liquidity, offering a higher return compared to fixed-term deposits. The company continues to increase R&D investments while expediting the commercialization of new products.