Breakthrough in China: Four Pharma Giants Secure First Generic Approval for $2B 'Blood-Boosting Blockbuster' Eltrombopag Olamine Tablets

On January 16, the National Medical Products Administration released the delivery information of drug approval certificates. Eltrombopag Ethanolamine Tablets from four companies were approved for marketing on the same day, determining the first generic. The four companies are Jiangsu Aosaikang Pharmaceutical Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical Co., Ltd., and Sichuan Kelun Pharmaceutical Co., Ltd.

Image Source: NMPA Official Website

Multiple pharmaceutical companies compete
"The First Generic 'Blood-Making Miracle Drug' Finally Decided"

Immune Thrombocytopenia (ITP) is a common acquired bleeding disorder, characterized by platelet-specific autoantibodies sensitizing platelets for excessive destruction by the mononuclear phagocyte system. Other mechanisms include autoantibodies inhibiting megakaryocyte production of platelets, cytotoxicity, direct lysis of platelets by T cells, and antigen-specific T cell immune tolerance loss, resulting in thrombocytopenia (<100×10^9/L). Clinically, glucocorticoids are commonly used as first-line treatment for ITP. However, since ITP is a chronic condition requiring long-term medication, prolonged use of glucocorticoids may lead to various adverse effects.

Eltrombopag is the world's first approved small-molecule non-peptide TPO receptor agonist. This drug can interact with the transmembrane domain of the human TPO receptor, initiating a signaling cascade that stimulates the proliferation and differentiation of bone marrow megakaryocytes, thereby promoting platelet production and release. According to relevant studies, eltrombopag can significantly reduce patients' need for concomitant medications and salvage therapy, and patients show good tolerance.

Source of the image: YAOZHI Data Enterprise Edition——Global Drug Analysis System Database

In 2008, Eltrombopag Olamine Tablets were approved by the U.S. FDA for marketing, becoming the world's first "hematopoietic miracle drug." In December 2017, Novartis' original Eltrombopag Olamine Tablets were approved for marketing in China (brand name: Revolade), for the treatment of ITP, becoming China's first non-peptide oral TPO receptor agonist, and were included in the National Medical Insurance Catalog. Over the years, the sales of Revolade have continued to grow, with annual sales exceeding 2 billion US dollars.

Source of the image: Pharma Intelligence Enterprise Edition —— Global Best-Selling Drug Sales Data

It is reported that more than 10 companies in China have submitted applications for the consistency evaluation of Eltrombopag Ethanolamine Tablets, and now the first generic has finally been determined.

Conclusion

It is reported that after Novartis' Eltrombopag Ethanolamine Tablets were approved in China in 2017 for adult ITP patients who had previously responded poorly to treatments such as glucocorticoids and immunoglobulins, the indication was further expanded to include patients over 6 years old. As a "miracle drug for hematopoiesis," the simultaneous approval and market launch of generic versions of Eltrombopag Ethanolamine Tablets by multiple companies is expected to reshape the market landscape for ITP treatment drugs.

References:

1. "The First in China! 3SBio/Zespro Pharmaceutical's 'Eltrombopag Ethanolamine for Oral Suspension' Granted Priority Review," Pharma Intelligence Data, 2023-12-22

Editor: Muyan

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