Shanghai Fosun Pharmaceutical (02196): The drug registration application for cisplatin injection has been accepted by the National Medical Products Administration.
Shanghai Fosun Pharmaceutical (02196) announced in a statement that the drug registration application for the self-developed cisplatin injection, by its holding subsidiary Jisimei (Wuhan) Pharmaceutical Co., Ltd., has recently been accepted by the National Medical Products Administration.
This new drug is a chemical medicine independently developed by the group (including the company and its holding subsidiaries/units). It is intended to be used in combination with other approved chemotherapy drugs in patients with metastatic testicular tumors who have undergone appropriate surgery and/or radiation therapy. It is also intended to be used as adjunctive therapy in patients with metastatic ovarian tumors who have not previously received cisplatin injection and are difficult to treat with standard chemotherapy, or in patients with metastatic ovarian tumors who have undergone appropriate surgery and/or radiation therapy and are being treated in combination with other approved chemotherapy drugs (the established combination includes this new drug and cyclophosphamide). Additionally, it is intended to be used in patients with transitional cell carcinoma of the bladder who are no longer suitable for local treatment (such as surgery and/or radiation therapy).
As of the date of this announcement, the cisplatin preparations of the same category that have been approved for marketing in China (excluding Hong Kong, Macau, and Taiwan) mainly include oxaliplatin by Jiangsu Hengrui Medicine Co., Ltd., cisplatin injection by Qilu Pharmaceutical Co., Ltd., and Libin by Yunnan Plant Pharmaceutical Co., Ltd. According to the latest data from IQVIA CHPA, in 2022, the sales of similar cisplatin preparations in China amounted to approximately RMB 124 million.
As of July 2023, the cumulative research and development investment in this new drug by the group is approximately RMB 2.27 million (unaudited).
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