The first!

According to CDE's official website, Qilu Pharmaceutical 's "roprostim for injection" submitted a marketing application in China and was accepted
.
It is worth mentioning that the drug is declared under Category 3.

(Source: CDE official website)

The full name of roprostim (R&D code: QL0911) of Qilu Pharmaceuticals is recombinant human thrombopoietin peptidomimetic-Fc fusion protein for injection.

Roprostim was originally a thrombopoietin (TPO) receptor agonist developed by Amgen, and Kyowa Kirin has the right to develop this product in Greater China, South Korea, Singapore, Malaysia and other regions

In January 2022, roprostim for injection (previously used name: romiprostim for injection, trade name: Whirlpool) declared by Kyowa Kirin was approved by NMPA for the treatment of immune thrombocytopenia (ITP).
)
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Roprostim is the first second-generation long-acting TPO receptor agonist in China

(Source: NMPA official website)

Two months after the original research was approved, Qilu submitted a listing application, which is very fast

       There are 5 TPO-R agonist drugs listed in China

       Primary immune thrombocytopenia (ITP) is a rare, severe autoimmune disorder characterized by low platelet counts in the blood that can lead to serious bleeding events
.
In people with ITP, the immune system attacks and destroys the body's own platelets, which play an active role in blood clotting and wound healing

       The first-line treatment of ITP is mainly glucocorticoids and immunoglobulin, and if first-line treatment fails or relapses, second-line treatment is required

       The first generation TPO-R agonists are PEGylated human megakaryocyte growth and development factor (PEG-rhMGDF) and recombinant human thrombopoietin (rhTPO)

       At present, there are 6 TPO-R agonist drugs in the world, and 5 TPO-R agonist drugs are listed in China
.

       At present, Novartis' Eltrombopag, Fosun's Avatrombopag, and Hengrui's Hytrombopag ethanolamine have been included in the medical insurance
.
Then, at that time, it is still unknown what advantages Qilu 's Ropstin will rely on to occupy the market
.