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The latest announcement is out from Shanghai Fudan Zhangjiang Bio Pharmaceutical Co ( (HK:1349) ).
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan-Zhangjiang Pharmaceutical Co., Ltd., received a notification of non-approval from the National Medical Products Administration of the PRC for its Abbreviated New Drug Application for Obeticholic Acid Tablets. The drug, intended for the treatment of primary biliary cholangitis, was not approved due to concerns over its benefits versus risks and the lack of routine overseas approval for the original reference preparations. Despite the non-approval, the company stated that the financial impact would not be material as the R&D investments have already been accounted for in previous periods.
More about Shanghai Fudan Zhangjiang Bio Pharmaceutical Co
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. operates in the pharmaceutical industry, focusing on the development and marketing of generic chemical drugs. The company targets the Chinese market, which has a high incidence of hepatobiliary diseases, and has made significant progress in overcoming patent restrictions for its products.
Average Trading Volume: 18,449,479
Current Market Cap: HK$1.12B
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