Qilu Pharmaceutical's Romiplostim Biosimilar QL0911 Enters Phase III Clinical Trial, Leading Domestic Development for Chemotherapy-Induced Thrombocytopenia

On November 10, the Insight database showed that Qilu Pharmaceutical’s QL0911 has initiated Phase III clinical trials. QL0911 is a romiplostim biosimilar indicated for chemotherapy-induced thrombocytopenia. Currently, in China, apart from the originator product, which filed for marketing approval in April, there are four other companies developing similar products; all except Qilu are in early-stage clinical trials.

Source: Insight Database (http://db.dxy.cn/v5/home/)

Romiplostim is a second-generation oral TPO receptor agonist that was first launched in Australia in July 2008 and subsequently approved by the FDA and EMA for the second-line treatment of immune thrombocytopenic purpura, featuring rapid onset of action, low dosing frequency, and an improved safety profile.

Currently in China, except for Kyowa Kirin’s biologic which has been submitted for marketing approval this year, all domestically produced biosimilars are in the clinical trial stage. Among them, Qilu Pharmaceutical has initiated Phase III trials; Beijing Tide Pharmaceutical and Shandong Quangang Pharmaceutical are in Phase I clinical trials; and Kelun-Biotech has received clinical trial approval.

Source: Insight Database (http://db.dxy.cn/v5/home/)

Insight database shows that there are currently five TPO-R drugs approved globally: lusutrombopag from Shionogi/Eterna Medical, eltrombopag from GSK/Novartis, romiplostim, and avatrombopag from AkaRx/Fosun Pharma.

Among them, Novartis’s eltrombopag olamine tablets were approved for import in China in 2017 (brand name: Revolade). According to Novartis’s financial report, the global sales of eltrombopag reached USD 1.416 billion in 2019, representing a year-on-year increase of 21%. Avatrombopag, introduced by Fosun Pharma, was approved for marketing in China on April 15, 2020, becoming the second TPO-RA drug approved in the country.

In addition, 3SBio’s recombinant human thrombopoietin (brand name: TPIAO) was approved for marketing in China as early as 2005. Public data show that TPIAO generated RMB 974 million in revenue in 2017, with a market share of 51%. This product is currently included in Category B of the National Reimbursement Drug List.

Source: Insight Database (http://db.dxy.cn/v5/home/)

In addition, on June 18, 2020, Hengrui’s Class 1 new drug, hetrombopag olamine tablets, was submitted for marketing approval; this drug also belongs to the class of TPO-R agonists.