Granulocyte Colony Stimulating Factor (G-CSF) is a glycoprotein that stimulates the survival, proliferation, differentiation and activation of neutrophil progenitor cells and mature neutrophils, and plays an important role in non-specific cellular immunity against infection. G-CSF is mainly used for the prevention and treatment of leukopenia caused by radiotherapy or chemotherapy, the treatment of myelopoietic dysfunction and myelodysplastic syndrome, and the prevention of potential infectious complications of leukopenia. G-CSF currently available on the market include filgrastim, pegfilgrastim, and mecapegfilgrastim.
According to researcher, Amgen launched Neupogen (filgrastim), the world's first recombinant human granulocyte colony-stimulating factor, on February 20, 1991, which was quickly and widely accepted clinically, and its sales value have remained stable at more than USD1 billion for the last two decades. On January 31, 2002, Amgen again, launched Neulasta (polyethylene glycol filgrastim), the world's first long-acting G-CSF drug, which has seen its market share climb all the way to a peak of USD4.72 billion in 2015 and has almost monopolized the sales of long-acting G-CSFs worldwide.
On May 18, 2018, the NMPA announced the approval of Jiangsu Hengrui Medicine's mecapegfilgrastim injection (polyethylene glycol recombinant human granulocyte-stimulating factor injection, HHPG-19K), marketed under the brand name Aido®, for the indication of adult patients with non-myeloid malignancies who are prone to febrile neutropenia because the treatment of myelosuppressive anticancer drugs, reducing the incidence of infections manifested as febrile neutropenia.
The road to market for Jiangsu Hengrui Medicine's mecapegfilgrastim in China has been very tortuous. It took the company about ten years from clinical filing in 2008 to production in 2013. The company went through clinical self-examination and withdrawal, resubmission under a new generic name, public announcement of inclusion in priority review, and cancellation before its drug was finally approved for marketing.
According to researcher, the sales value of mecapegfilgrastim has grown significantly since its launch in China in 2018, reaching approximately CNY432 million (USD66.5 million) in 2020, with a CAGR of 1154% from 2018 to 2020. researcher expects that from 2021 to 2025, with the rising number of cancer cases in China, its mecapegfilgrastim market is still able to grow significantly. Similar drugs from other Chinese pharmaceutical companies are also expected to be marketed in the coming years.
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