Qilu Pharmaceutical's Romiplostim Biosimilar Receives NMPA Approval for Chronic Immune Thrombocytopenia

Apr 11, 2024 15:37 CST Updated 15:38

Qilu Pharmaceutical

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Today (April 11), the official website of China's National Medical Products Administration (NMPA) showed that Qilu Pharmaceutical Co., Ltd. submittedRomiplostim BiosimilarMarketing application has been approvedPublic information shows that Romiplostim is a thrombopoietin (TPO) receptor agonist, mainly used for the treatment ofPrimary Chronic Immune Thrombocytopenia。

Screenshot source:NMPA Official Website

Immune thrombocytopeniaPlatelet ReductionSyndrome (ITP) is aA rare and severe autoimmune disease characterized by a low platelet count in the blood, which can lead to serious bleeding events.In ITP patients, the immune system attacks and destroys the body's own platelets, which play an active role in blood clotting and wound healing.Common symptoms of ITP include excessive bruising, bleeding, and fatigue.People with chronic ITP face an increased risk of serious bleeding events, which can lead to severe complications or even death.

Romiplostim is a recombinant protein and a TPO receptor agonist that stimulates intracellular transcription pathways by binding to the TPO receptor, leading to increased platelet production.. This drug is produced in E. coli through recombinant DNA technology and can mimic the effects of natural human thrombopoietin, thereby increasing platelet count. When it binds to the TPO receptor, it promotes the growth of bone marrow megakaryocyte colony-forming units (CFU-Meg) and leads to increased platelet production through the JAK2 and STAT5 kinase pathways.Romiplostim has been approved in China for the treatment of primary chronic immune thrombocytopenia.。

According toQilu Pharmaceutical's previously released press release`, developed by the company`A comprehensive structural, physicochemical property, and quality comparison study as well as stability comparison study, and similarity analysis were conducted between the Romiplostim for injection and the original research drug. The test data shows that its development...Romiplostim BiosimilarConsistent with the original research drug in terms of quality, safety, and efficacy.

In December 2023, Qilu Pharmaceutical announced that the phase 3 study results of its Romiplostim for Injection (QL0911) were published in the academic journal *Translational Internal Medicine*. This was a study evaluating QL0911 inAdult patients with chronic primary immune thrombocytopeniaThe phase 3 trial on efficacy and safety was led by Professor Hou Ming from Qilu Hospital of Shandong University, with Professor Hou Ming and Professor Shi Yan as the corresponding authors.

The research results showed that, at 24 weeks of treatment,61.8% of patients in the Romiplostim group achieved a sustained platelet response.No patients in the placebo group showed a sustained platelet response. A total of 20 patients (9.3%) had previously undergone splenectomy, among whom61.5% of patients in the Romiplostim group achieved a sustained platelet response.No patients in the placebo group showed a sustained platelet response.
Patients in the Romiplostim groupThe average platelet response time was 15.9 weeks (placebo group: 1.9 weeks).。In patients who had previously undergone splenectomy, the mean platelet response time was 15.9 weeks (placebo group:0 weeks).The median time for platelet counts to reach ≥50×10^9/L after treatment in the romiplostim group was 6 weeks, while no significant change from baseline was observed in platelet counts during treatment in the placebo group.The median time to the first platelet response (platelet count ≥50×10^9/L) in the romiplostim group was 3.29 weeks (placebo group was18.86 weeks).
The incidence of adverse events was similar between the romiplostim group and the placebo group (91.7% vs 88.9%).

Researchers believe that intravenous romiplostim has shown significantly superior efficacy compared to the placebo group in clinical trials involving adult patients with chronic primary immune thrombocytopenia (ITP), rapidly increasing and maintaining platelet counts with good tolerance. It can provide an effective and accessible treatment option for Chinese patients with primary immune thrombocytopenia.

References:

[1] Drug Approval Certificate Delivery Information on April 11, 2024. Retrieved Apr 11, 2024 from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240411151118145.html

[2] A New Heavyweight Drug in the ITP Field: TPO Receptor Agonist Romiplostim Approved for Marketing! Retrieved Jan 27, 2022. From https://www.kyowa-kirin.com.cn/romiplate/

[3] Qilu Pharmaceutical's TPO Receptor Agonist Romiplostim Injection Marketing Application Accepted. Retrieved Mar 24，2022. From https://mp.weixin.qq.com/s/ghK4H5lqLNgn5Xg2GqIpEQ

[4] Qilu Pharmaceutical's Romiplostim Injection Phase III Study Results Published. Retrieved Dec 22，2023. From https://mp.weixin.qq.com/s/ucLtqlnrT65AONCer1Cqag

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