According to International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), China reported about 4.57 million new cancer cases in 2020, around 3 million of which were dead. Cancer treatments include surgery, radiation therapy and chemotherapy. Radiation therapy is one of the treatments that involve the use of high-energy waves (such as X-rays) to kill cancer cells.
Radiotherapy can be used alone or in combination with other treatments (systemic therapy, surgery, etc.) to cure or stabilize cancer. Chemotherapy, on the other hand, uses anti-cancer drugs, and it is one of the most important methods of treating tumors at the current stage. The clinic uses of both radiotherapy and chemotherapy will cause different degrees of toxic side effects, which will also kill normal cells.
In response to those side effects of chemotherapy, the dose of chemotherapy drugs is usually reduced. But as the dose is positively correlated with the efficacy, once it is reduced, the anti-tumor effect will also decrease. Then if long-acting G-CSF is used to prevent neutropenia with fever (FN) at the end of chemotherapy, the risk of FN will be reduced, greatly improving the safety of chemotherapy.
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 includes filgrastim, pegfilgrastim, and mecapegfilgrastim.
According to CRI’s market research, 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 CRI’s market research, 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. CRI 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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