Zhitong Finance App News, Fussen Pharmaceutical (01652) announced that “etripopa ethanolamine tablets” (trade name: Ai Fusheng) developed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of the group, have obtained marketing approval from the China National Drug Administration and approved for use in adults and chronic immune (idiopathic) thrombocytopenia (ITP) patients aged 6 and above who have previously had poor response to treatment with glucocorticoids, immunoglobulins, etc. This product is only used in ITP patients with increased risk of bleeding due to thrombocytopenia and clinical conditions.
Etripopa ethanolamine tablets are an oral, small-molecule, non-peptide thrombocytopoietin receptor agonist (TPO-RA) that works to increase the number of platelets. In the “Chinese Guidelines for the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults (2020 Edition)”, etrapopa is the only drug with the highest level (1a) evidence and a grade A recommendation. It is also the only thrombocytopenic drug approved for ITP for children aged 6 and above in China. Compared to other ITP drugs, etrapopa ethanolamine tablets have the following advantages:
1. Fast effect: This drug works within 1-2 weeks, and can effectively help severe ITP patients quickly increase platelet count and reduce the occurrence of bleeding events;
2. Strong response and high efficiency: Whether ITP is treated in the short or long term, it can significantly increase platelet count and reduce bleeding symptoms;
3. Long-term relief can be obtained through personalized continuous medication, thereby improving the quality of life;
4. Easy medication use and high compliance: oral administration, simple and convenient. There is no need to take it on an empty stomach. Food restrictions on medication intake have been lifted, and compliance has been greatly improved;
5. Highly safe for long-term use;
6. The instructions clearly indicate drugs that can be used to treat chronic ITP in children: Among the 7 drugs currently approved by the China National Drug Administration to treat chronic ITP, etrapopa ethanolamine tablets are drugs clearly approved in the instructions for use in children.
In addition, TPO drugs can also be combined with rituximab to treat patients with impaired glucocorticoid effects or recurrent ITP, and the overall efficiency is higher. Precisely based on the above advantages, TPO drugs have become the first choice for ITP second-line treatment.
The bioequivalence between Ai Fusheng and the reference formulation was fully confirmed through human bioequivalence tests on an empty stomach and after meals. The approval of Ai Fusheng will further enrich treatment options for ITP patients, reduce treatment costs, reduce the financial pressure on patients to take medication, and contribute to the development of pediatric medication in China. In the future, the company will continue to introduce clinically needed, high-quality and economical drugs to bring good news to patients.