Jiangsu Hansoh Pharmaceutical received the Approval Document on the Drug Supplementary Application for imatinib mesylate issued by SDA (State Drug Administration of China, formerly CFDA) on July 5, to become the first pharmaceutical enterprise in passing the consistency evaluation of this pharmaceutical product in China. Currently, the imatinib mesylate capsules under Chia Tai Tianqing is also in the process of application for generic drug consistency evaluation, besides the relevant tablets of Hansoh Pharmaceutical.
The story behind the miracle drug
Imatinib mesylate is a first-line drug for chronic myeloid leukemia (CML). The ten-year survival in CML patients has increased from previously less than 50% to about 90% thanks to this anti-cancer miracle drug. The trade name of original drug of this life-saving drug is Gleevec which was developed by Novartis, with the capsules marketed in the U.S. in May 2001 and entering the Chinese market in April 2002, and the tablets approved in China in December 2004.
|
Drug name |
Trade name |
FDA approval time |
CFDA approval time |
|
Imatinib Mesylate Capsules |
Gleevec |
2001 |
2002 |
|
Imatinib Mesylate Tablets |
2001 |
2004 |
The compound patent of this original drug of Novartis expired in China in 2013, and currently there are 3 Chinese pharmaceutical enterprises with generic drugs of Gleevec approved for marketing in China, separately Hansoh Pharmaceutical, Chia Tai Tianqing, and CSPC Ouyi.
Gleevec, the first small molecule targeted anti-cancer drug successfully developed in human history, took 42 years and cost billions of USD, from the discovery of the therapeutic target "Philadelphia chromosome" to the successful marketing for the cancer treatment. During the breeding of Gleevec, the humanity discovered the chromosome variation and chromosomal translocation in tumor cells for the first time, and it led to 5 members of the National Academy of Sciences and 1 winner of the U.S. National Natural Science Award. This anti-cancer miracle drug can be said to be crystallization of common wisdom of mankind.
Chinese-produced imatinib mesylate’s passing of the consistency evaluation from the perspective of the bid-winning price
The realistic film Dying to Survive starring Xu Zheng directed by Wen Muye has been hotly released recently; the topic involved in this film has rapidly ignited the WeChat Moments, and the realistic story has moved many Chinese people.
The miracle drug in the film, i.e., the original drug "Glinic" with a sky-high price, in fact alludes to Gleevec. The price of Gleevec when it entered China in 2001 was RMB 23,500/box, and a patient needed to pay more than RMB 280,000 a year for the drug and take it for life: the drug expenses could be called sky-high.
There are currently 4 manufacturers selling imatinib mesylate on the Chinese market. According to the data of the Insight database, the sales of imatinib mesylate reached RMB 1.918 billion in China in 2016, wherein, Novartis’ Gleevec accounted for 80.29% of the entire market, followed by Hansoh Pharmaceutical’s Xinwei, Chia Tai Tianqing’s Genike, and CSPC Ouyi’s Nuolining.
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