CDK4/6 inhibitor first imitation! Zilupasili capsules have been approved for sale

On December 18, Qilu Pharmaceuticals' Cymru Pharmaceuticals capsule (acceptance number: CYHS1800441) was approved by NMPA as the first generic drug for Pfizer's heavyweight breast cancer drug Iberance.
incidence of breast cancer has been increasing year by year, its treatment has been paid more and more attention by doctors, the annual number of new breast cancer cases in the national cancer registration area 545.29 per 100,000, urban areas are higher than rural areas, in new breast cancer patients, 6% to 6% Seven percent of patients are first diagnosed with stage stage breast cancer, and 30 percent of those initially diagnosed with advanced breast cancer will eventually experience relapsed metastasis after receiving complementary treatment, which means that in the next few years, the proportion of progressive breast cancer in China will increase and a larger group will emerge.
breast cancer can be divided into 5 subtypes according to molecular parts, respectively, tube cavity epithet A type, tube cavity epithet B type, human epithetular growth factor subject (HER2) positive, 3 negative, normal breast type.
tube cavity endocrine type A is also known as hormone-dependent breast cancer, accounting for about 60% of all breast cancer, more commonly over 50 years of age, characterized by sensitivity to endocrine treatment, good prognostication, less sensitive to chemotherapy than other subtypes, is the most common type of breast cancer.
pathological immunogroupization (IHC) expression of type A breast cancer in the tube cavity was estrogen-positive (ER)-positive/progesterone-like (PR) positive, and PR high expression (≥20%), HER2 negative, Ki-67 low expression.
cycle protein-dependent kinase (CDK) is a member of the serine/suline protein kinase family and plays a vital role in cell cycle mediation.
In many CDKs, CDK4/6 releases the transcription factor E2F by forming a complex with the cell cycle protein D (cyclinD), which in turn releases the transcription factor E2F, triggering the cell cycle from the pre-DNA synthesis stage (G1 phase) to the DNA replication phase (S phase).
CDK4/6 overexploitation in many cancers, causing the cell division cycle to spiral out of control.
pyridbergelli blocks cell proliferation in cancer cells by blocking tumor cells from stage S.
, developed by Pfizer, is the world's first CDK4/6 inhibitor to go on sale.
was first approved in the United States in February 2015 as an initial endocrine treatment for ER-positive/HER2-negative post-menoptocratic advanced breast cancer, followed by the development of three new adaptations.
treatment of ER-positive/HER2-negative relapsed breast cancer in the first-line treatment of pyrethroid persili was tested in a Phase III clinical trial.
Phase III clinical trial PALOMA-2 included a total of 666 post-menoptoral ER-positive/HER2-negative Asian breast cancer patients, and the results showed that the medium non-progressive survival time of patients in the pyridoxic acid group was longer than in the placebo combined terpene group (25.7 vs. 13.9 months).
studies have shown that the Pirsili combined fluoravis group can be a new option for second-line treatment in patients with HR-positive HER2-negative post-menopaus progressive breast cancer.
Phase III clinical trial PALOMA-3 included patients with advanced breast cancer who were HR-positive, HER2-negative and progressed in past endocrine therapy, and the results showed that the medium non-progressive survival time was 9.5 months and 4.6 months, respectively, in patients with the combined fluovis group of pyridoxili and the placebo combined fluorovis group.
Another study showed that the mean survival time was 34.9 months and 28.0 months, respectively, for patients treated with the combined fluorovis group therapy and the fluovis group monotherapy, with the former benefiting from survival of 6.9 months, but the differences were not statistically significant.
, as a CDK4/6 inhibitor for first in class, the company has a large market share with a market-first advantage, with global sales of $4,961 million in 2019.
Pharmaceutical Rubik's Cube Next Pharma Pfizer's original Pybersili capsule was approved for import by NMPA in July 2018 for initial endocrine therapy in patients with localized late stage or metastatic HR-, HER2-post menopaian female breast cancer.
's compound patent in China will expire on January 10, 2023, in addition to Qilu Pharmaceutical's approval this time, Synth Pharmaceuticals also submitted a listing application, in addition to Hengrui, Fosun, Haizheng and other 15 enterprises for the variety of generic layout.
source: Pharmaceutical Rubik's Cube Pharma GoZiru Pharmaceuticals has received provisional approval for the U.S. Pharma Sili capsule ANDA, which will be officially launched in the U.S. when the drug's patent term expires.
CDK 4/6 as a star target, there are many enterprises in the domestic layout to develop me too innovations, in addition to Lilly's Abesili, Novarco's Riposili, Hengrui's SHR6390 progress is the fastest, is currently in phase III.
source: PharmaGo