On December 17, the Class 3 generic drug Eltrombopag ethanolamine dry suspension submitted by Zezheng Pharmaceutical was approved for marketing and deemed to have passed the review, becoming the first generic drug
in China . Immune thrombocytopenia (ITP) is a common acquired bleeding disease. Platelets sensitized by platelet-specific autoantibodies are excessively destroyed by the mononuclear macrophage system, autoantibodies inhibit megakaryocytes from producing platelets and cytotoxicity, T cells directly lyse platelets, and antigen-specific T cell immune intolerance cause thrombocytopenia (<100×10^9/L).

In clinical practice, glucocorticoids are the first-line drugs commonly used to treat ITP. However, since ITP is a chronic disease that requires long-term medication, the long-term use of glucocorticoids may produce a variety of adverse reactions. Eltrombopag is the world's first small molecule non-peptide TPO receptor agonist approved for marketing. The drug can interact with the transmembrane domain of the human TPO receptor, initiate a signal cascade reaction, stimulate the proliferation and differentiation of bone marrow megakaryocytes, and thus promote the production and release of platelets. According to relevant studies, Eltrombopag can significantly reduce the need for concomitant medication and rescue treatment, and is well tolerated by patients.

In 2008, Eltrombopag Ethanolamine Tablets were approved for marketing by the US FDA, becoming the world's first "hematopoietic magic drug". In December 2017, Novartis's original Eltrombopag Ethanolamine Tablets were approved for marketing in China (trade name: Refulan) for the treatment of ITP, becoming China's first non-peptide oral TPO receptor agonist and included in the national medical insurance catalog. Over the years, Refulan's sales have continued to grow, with annual sales exceeding US$2 billion.
In December 2023, 3SBio and Zezheng Pharmaceutical reached a cooperation agreement to carry out a series of cooperation on the technical development and commercialization of the eltrombopag dry suspension product. It is reported that compared with other eltrombopag drugs, the dry suspension has better palatability, can effectively improve patient compliance, and is convenient for adjusting the dosage to achieve precise drug delivery. Previously, many pharmaceutical companies have applied for this product.
As the first imitation of this dosage form, the eltrombopag dry suspension of 3SBio and Zezheng Pharmaceutical is expected to bring new options to relevant patients.

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