On January 16th, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration (NMPA), approving the registration and marketing of Eltrombopag olamine tablets (trade name: Tepsin) for the following indications: for use in patients with chronic immune thrombocytopenia (ITP) who have had a poor response to previous treatments of glucocorticosteroids and immunoglobulins, as well as in children aged 6 years and above. ) patients to raise platelet counts and reduce or prevent bleeding. This product is intended for use only in patients with ITP who are at increased risk of bleeding due to thrombocytopenia and clinical conditions.

Eltrombopag olamine tablets are an oral, small-molecule, nonpeptide thrombopoietin receptor agonist (TPO-RA) that works by increasing platelet counts. In the Chinese Guidelines for the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults (2020 Edition), Eltrombopag is the only drug with the highest level (1a) of evidence and A recommendation, and it is also the only thrombopoietic drug approved for ITP indication for children aged 6 years and above in China.

Compared with other ITP drugs, Eltrombopag has the following advantages:

1. High efficiency: no matter short-term or long-term treatment of ITP, it can significantly increase platelet count and reduce bleeding symptoms. After the failure of first-line ITP treatment or refractory ITP patients can be treated with Eltrombopag, most of which can effectively increase platelet counts and reduce the risk of bleeding;

2. Convenient dosing and high compliance: oral administration is simple and convenient. There is no need to take it on an empty stomach, lifting the restriction of food for taking medication, and compliance is greatly improved.

ITP is an acquired, immune, bleeding disorder, an autoimmune disease caused by immune-mediated injury to megakaryocytes leading to functional thrombocytopenia and defective platelet production, often characterized by thrombocytopenia and systemic bleeding of the skin, mucous membranes and internal organs. The incidence of the disease in adults is about 5~10/100,000, with women of childbearing age and the elderly being the most common groups. The incidence of children is about 4~5/100,000, but the incidence of severe bleeding is significantly higher than that of adult patients, requiring long-term standardized management, poor quality of life, and in urgent need of effective treatment. Eltrombopag olamine tablets are the world's first oral drug for this indication, with global revenues of over $2 billion in 2022.

Tepsion is consistent with the original dosage form, and bioequivalence between Tepsion and the reference formulation has been fully confirmed by fasting and postprandial human bioequivalence testing. The approval of Tepsin will further enrich the therapeutic choices for ITP patients, reduce the cost of treatment, alleviate the economic pressure on patients' medication, and at the same time, contribute to the development of children's medication in China. In the future, the company will continue to introduce clinically needed, high-quality and economical drugs to bring benefits to the majority of patients.

https://mp.weixin.qq.com/s/k6qQdrw7xYK9xaYVJvSPKw