Qilu Pharmaceuticals Class 4 generic drug "Pybersili Capsules" has been approved for market

On December 18, NMPA issued a batch, Qilu Pharmaceuticals Class 4 generic drug "Pybersili Capsules" was approved for the first time in the country.
its adaptive disorders are: first-line combined aromatase inhibitors to treat post-menopenerial women, hormone-positive (HR-plus), human skin growth factor inhibitors 2 negative (HER2-) local late stage or metastasis breast cancer.
first developed by Pfizer and is the world's first CDK4/6 inhibitor to go on sale.
February 2015, Phoepersili was approved by the U.S. FDA for the accelerated review process (trade name: Ibrance) for the treatment of advanced breast cancer in HR-/HER2-as an initial endocrine therapy.
, Ibrance has been listed in the European Union, Japan and other countries and regions.
is a well-deserved heavyweight, and its global sales have grown year after year since its launch, reaching $4,961 million in annual sales by 2019.
July 2018, the original Pyrethroid was first approved in China as a product called Aiboxin, which is used in combination with aromatase inhibitors as an initial endocrine therapy to treat HR-/HER2-local late stage or metastatic breast cancer.
Currently, in addition to the original research Pfizer, 19 companies have laid out their generic drugs, of which the first sound drug has been reported in March this year, Osaikang, Howson, Colum, Zhengda Tianqing and other 6 enterprises are in the BE trial phase, and 11 enterprises have been approved clinically.
from insight database (), three CDK4/6 inhibitors have been approved worldwide: Pfizer's palbociclib, Novarma's Ribociclib and Lilly's Abemaciclib.
, however, no CDK4/6 inhibitors have been approved domestically, with only Lilly Abemaciclib tablets reported in November 2019.
the approval of Qilu's Pybersili generic drug, which means that the country ushered in the first domestic CDK4/6 inhibitors, breast cancer patients will usher in new treatment options.
, CDK4/6 targets are also popular targets in China.
With the target new drug has 11 domestic enterprises in the clinical stage, involving Fosun Pharma, Howson, Zhengda Tianqing, etc. , of which Hengrui's SHR6390 progress is the fastest, November 17, SHR6390 combined endocrine therapy in HR-positive, HER2-negative female breast cancer complementary treatment of the international multi-center, randomized, double-blind phase III clinical trial is expected to be approved.
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