Fos un Pharma announced on May 5 that the European Commission has approved a marketing author isation application (MA A) for car plat in and et ho pos ide using Sul ly mono anti body inje ction (anti - PD - 1 mono anti body) developed by Fos un Pharma ' s holding subsidi ary , Shanghai F uh ong Han lin Bi ote ch nology Co ., Ltd . (here ina fter referred to as " F uh ong Han lin ") and its holding subsidi ary .
With this approval , the drug will now be author ized for centra lized marketing in all EU member states , as well as in European Economic Area countries such as Iceland , Liechtenstein , and Norway . This histor ic event marks the first EU approval of an anti - PD - 1 single anti body for the treatment of exten sive - sta ge small cell lung cancer (ES - SC LC).
Ext ended - sta ge small cell lung cancer (ES - SC LC) is one of the most rapid ly progr essing and difficult to treat types of lung cancer . With the aim of providing a new option to con venti onal chem other apy in its treatment , Fu Hong Han lin has been working on developing this innovative drug . This approval is an appreci ation of the company ' s acc um ulated research and development achie v ements over the years , and marks a major step towards future market launch .
Yu Lei , CEO of Fos un Pharma ceu tic als , said , " This important approval is a testament to our commitment to improv ing the quality of patient care . In particular , exten sive small cell lung cancer is a very serious disease , and we want to bring hope to patients fac ing this disease through the provision of new treat ments . "
S ulu li mono anti body inje ction tar gets an immune check point called PD - 1, which works to prevent cancer cells from escap ing the immune system . It is believed that the combination of car plat in and eto pos ide can provide a more effective treatment plan for patients . It is hop ed that the effe cti veness and safety of this treatment will be further demonstrat ed through future clini cal tri als .
With the approval in the EU , Fos un Pharma ceu tic als is rapid ly prepar ing for market launch , while also developing a strategy to expand access to patients . In addition , Fu Hong Han lin has indi cated his intention to purs ue further research and aim to develop ther ape u tic drugs for other types of cancer .
This approval will also represent a significant growth opportunity for Fos un Pharma ceu tic als . With the focus on future develop ments , Fos un Pharma ceu tic als and F uh ong Han lin will continue to purs ue innov ations for patients .
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Release date: 2025-09-13 14:27:51
