Fudan-Zhangjiang's Obeticholic Acid Tablets fail to gain China approval

Taizhou Fudan-Zhangjiang Pharmaceutical Co., Ltd., a subsidiary of Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd., announced its Abbreviated New Drug Application (ANDA) for Obeticholic Acid Tablets was not approved by the National Medical Products Administration of the PRC. The drug, intended for the treatment of primary biliary cholangitis (PBC), is a Category 3 Generic Chemical Drug.

The non-approval stems from concerns that the drug, while conditionally approved abroad, lacks routine overseas approvals for its original reference preparations. Additionally, the NMPA noted that existing data does not fully support that the benefits of Obeticholic Acid outweigh its risks, failing to meet technical requirements for routine approval of Class 3 generic drugs.

As of October 13, 2025, the cumulative R&D investment for this drug totaled approximately RMB125m (unaudited). All such R&D expenses have been fully recognized in the company's profit and loss during their respective accounting periods. The company does not anticipate a material adverse impact on its financial performance from this decision.