The first product of CDK4/6 inhibitors will be sold this year or over $2.3 billion
October 25, 2016 Source: Yaodu Consulting Pabusini Research Report
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Breast cancer is the highest incidence of cancer in women worldwide. Traditionally, breast cancer is divided into three subtypes: sex hormone HR-positive breast cancer (overexpression of estrogen ERs and/or progesterone PRs), HER2-positive breast cancer, and triple-negative breast cancer (ER, PR, and HER2) None of them have been expressed). Approximately 83% of breast cancer patients are HR positive, of which 15% are HER2 positive, 5% are HER2 positive and ER negative. Only 12% were triple negative breast cancer patients.
Breast cancer drug market panorama
According to IMS statistics, the global breast cancer market in 2014 was as high as $11.27 billion. Roche, Novartis and AstraZeneca are the top three in the breast cancer drug market, with breast cancer drug sales accounting for 75% of the global market.
Trastuzumab, developed by Roche, is the leader in the world with annual sales of $4.5 billion in 2014, accounting for 40% of the global breast cancer market. Sales of trastuzumab, Everolimus, Pertuzumab, Fulvestrant, and Bevacizumab accounted for 62% of global market sales. .
In 2019, the global breast cancer market is expected to exceed $16 billion. The market growth is mainly driven by HER2-positive treatments such as Pertuzumab (trade name Perjeta) and Ado-trastuzumab emtansine (trade name Kadcyla).
However, there are still no effective drugs available for HER2-negative breast cancer and triple-negative breast cancer. Some PARP inhibitors under development may be effective for triple-negative breast cancer, and if they are listed in the future, they will further expand the size of the breast cancer market.
Progress in the development of CDK4/6 inhibitors
For ER-positive breast cancer, CDK4/6 inhibitors are currently the most concerned. By selectively inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), cell cycle control is restored and tumor cell proliferation is blocked.
Among them, Palbociclib, which was developed by Pfizer, was approved by the FDA at the end of 2015. It is the world's first CDK4/6 inhibitor and was awarded the breakthrough therapy by the FDA. The PALOMA-1 clinical trial showed that the progression-free survival PFS of the Palbociclib plus letrozole group was significantly higher than that of the letrozole control group (20.2 months vs. 10.2 months), and the overall response rate was 16% higher than the control group (55.4%). Vs39.4%), known as another heavyweight drug in the breast cancer market.
At present, there are 7 CDK4/6 inhibitors in the world, among which three varieties of Eli Lilly, Pfizer and Novartis have entered Phase III clinical practice, and the indications are not limited to breast cancer.
The first listed drug, Palbociclib
Since its FDA approval on February 3, 2015, Palbociclib has been known for its first CDK4/6 small molecule inhibitors, and its sales performance has not been disappointing.
Palbociclib's global sales in the first year of its launch were as high as $723 million. Sales in the first two quarters of 2016 were close to $1 billion ($943 million). According to current conservative growth forecasts, Palbociclib's full-year sales will exceed $2.3 billion in 2016. Previously Evaluate pharma predicted that global sales in 2020 would be as high as $3.83 billion, underestimating its market potential. Palbociclib is now only taking the US market. After China, the European Union, and Japan are approved for listing, they can expect new performance.
Domestic competition pattern
In the domestic market, anti-breast cancer drugs are concentrated in several old varieties, such as trastuzumab, fulvestrant, everolimus and bevacizumab, as well as chemotherapeutic drugs such as cyclophosphamide and paclitaxel.
For the CDK4/6 target, only 1.1 drugs have been reported to the CDE for domestically developed 1.1 drugs. SHR6390, developed by Jiangsu Hengrui Medicine, was approved in October 2015 and is currently in clinical phase I. Once listed, it will seize the domestic breast cancer market.
Palbociclib's current major domestic competitor is the old anti-breast cancer drug that has been marketed.
However, as of August 2016, CDE declared Palbociclib's manufacturers, in addition to its original research company, there are 14 Chinese pharmaceutical companies. Pfizer's declaration was approved in July 2014. No domestic manufacturers have been approved for clinical use. Two of them were not approved, eight were clinically under review, three were in the process of approval, and one was approved for certification.
In addition, the domestic target giant Hengrui independently developed the same target small molecule SHR6390 has entered the clinical phase I, once approved in the domestic market before Palbociclib, will seize the breast cancer market, and squeeze the market of Palbociclib.
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