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On May 10, according to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Hengrui Medicine’s CDK4/6 inhibitor dalpiciclib (SHR6390 tablets) 150mg and 125mg specification listing applications were included in the publicity of the proposed priority review varieties In the list, the indication is combined with fulvestrant for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, recurrent or metastatic breast cancer that has progressed after endocrine therapy.
Image from CDE According to data released by the World Health Organization's International Agency for Research on Cancer (IARC) in 2020, breast cancer has become the world's largest malignant tumor.
In my country, the incidence of breast cancer in 2020 accounts for 9.
1% (416,400) of the incidence of various malignant tumors in the whole body, which is the first in the incidence spectrum of female tumors, and nearly 50% of patients will experience recurrence and metastasis after treatment.
Luminal type (hormone receptor positive type) constitutes the main type of breast cancer disease burden, accounting for about 70% of all breast cancers.
Endocrine therapy is a common treatment for this type of breast cancer disease, but the resulting primary and secondary Sexual resistance often leads to treatment failure.
Because cell cycle-dependent protein kinase 4/6 (CDK4 and CDK6) play an important role in the regulation of the cell cycle, in recent years, CDK4 and CDK6 have become important molecular targets for hormone receptor (HR)-positive metastatic breast cancer.
SHR6390 is a new class 1 chemical drug independently developed by Hengrui Medicine.
It is an oral, highly effective and selective small molecule CDK4/6 inhibitor that can selectively inhibit the activity of CDK4/6 kinase, thereby blocking CDK4/6- The Rb signal pathway induces cell G1 blockade, and selectively inhibits the proliferation of tumor cells with high Rb expression to achieve anti-tumor effects.In December 2020, Hengrui announced that the combination of SHR6390 tablets and fulvestrant in the treatment of HR-positive and HER2-negative multi-center, randomized, controlled, double-blind phase III clinical study (SHR6390-III-301) achieved the pre-specified advantages of the plan.
Efficiency standard.
In 361 subjects, SHR6390 tablets combined with fulvestrant compared with standard treatment of placebo combined with fulvestrant can significantly prolong the progression-free survival (PFS) of patients.
Currently, Hengrui Medicine is carrying out a number of clinical studies on SHR6390 in HR-positive breast cancer, involving the treatment of breast cancer at different stages of disease development, including a combination of SHR6390 combined with aromatase inhibitors versus aromatase inhibitors in the treatment of HR Phase 3 study of positive and HER2-negative advanced breast cancer.
Globally, a total of four CDK4/6 inhibitors have been approved for marketing, namely Pfizer's Palbociclib (Ibrance, piperacillin), Novartis's Ribociclib (Kisqali, Ribocili), and Eli Lilly's Abemaciclib (Verzenio, Abeciclib ) And G1 Therapeutics' Trilaciclib (Cosela), the global market size in 2020 will be US$6.
992 billion.
Domestically, only two CDK4/6 inhibitors, Pfizer's piperacillide and Eli Lilly's Abbecile, have been approved, and Hengrui's SHR6390 tablets are expected to become the third domestically marketed CDK4/6 inhibitor.
End reference materials: [1] Hengrui Pharmaceutical WeChat public account [2] Related media reports selected in the past to be scary! This substance, which is found in 1,000 kinds of food, may seriously damage the human immune system! Revan Bill Gates announced his divorce and counted the contributions of the Gates Foundation, the “booster” of global health services.
Reven finally found the culprit that corrodes the body.
Are you happy if you drink "Happy Fatty Water"? Hot text Nature is heavy! Nobel Prize Winner Reveals "Alternative" Potential Anticancer Methods: "Squeeze" Cancer Cells Out of Hot Text India Mutant Strain First Serological Evidence Released Medical Immunotherapy | Biosimilars | Vaccines | Drug Resistance | Drug Targets | Health Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Basic Research on Drug Side Effects/Translational Medicine Leukemia| Lung Cancer| Gastric Cancer| Colorectal Cancer| Liver Cancer| Breast Cancer| Pancreatic Cancer| Cardiovascular Disease| Neurodegenerative Disease| Intestinal Microbial Medicine Devices/Biotechnology In Vitro Diagnosis| Medical Devices| Bio-Nano| 3D Printing| Gene Testing| Single Cell Sequencing| Gene Editing| Assisted Reproduction| Artificial Intelligence| Precision Medicine Policy Anticancer Drugs| 4+7 Volume Procurement| Consumables| Record-keeping System | Registrant System | Healthy China | New Essential Drug Catalog | AI Medical Devices | Telemedicine | Same Equity Different Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext Board | R & D Investment | Acquisition | Market & Consumption
Image from CDE According to data released by the World Health Organization's International Agency for Research on Cancer (IARC) in 2020, breast cancer has become the world's largest malignant tumor.
In my country, the incidence of breast cancer in 2020 accounts for 9.
1% (416,400) of the incidence of various malignant tumors in the whole body, which is the first in the incidence spectrum of female tumors, and nearly 50% of patients will experience recurrence and metastasis after treatment.
Luminal type (hormone receptor positive type) constitutes the main type of breast cancer disease burden, accounting for about 70% of all breast cancers.
Endocrine therapy is a common treatment for this type of breast cancer disease, but the resulting primary and secondary Sexual resistance often leads to treatment failure.
Because cell cycle-dependent protein kinase 4/6 (CDK4 and CDK6) play an important role in the regulation of the cell cycle, in recent years, CDK4 and CDK6 have become important molecular targets for hormone receptor (HR)-positive metastatic breast cancer.
SHR6390 is a new class 1 chemical drug independently developed by Hengrui Medicine.
It is an oral, highly effective and selective small molecule CDK4/6 inhibitor that can selectively inhibit the activity of CDK4/6 kinase, thereby blocking CDK4/6- The Rb signal pathway induces cell G1 blockade, and selectively inhibits the proliferation of tumor cells with high Rb expression to achieve anti-tumor effects.In December 2020, Hengrui announced that the combination of SHR6390 tablets and fulvestrant in the treatment of HR-positive and HER2-negative multi-center, randomized, controlled, double-blind phase III clinical study (SHR6390-III-301) achieved the pre-specified advantages of the plan.
Efficiency standard.
In 361 subjects, SHR6390 tablets combined with fulvestrant compared with standard treatment of placebo combined with fulvestrant can significantly prolong the progression-free survival (PFS) of patients.
Currently, Hengrui Medicine is carrying out a number of clinical studies on SHR6390 in HR-positive breast cancer, involving the treatment of breast cancer at different stages of disease development, including a combination of SHR6390 combined with aromatase inhibitors versus aromatase inhibitors in the treatment of HR Phase 3 study of positive and HER2-negative advanced breast cancer.
Globally, a total of four CDK4/6 inhibitors have been approved for marketing, namely Pfizer's Palbociclib (Ibrance, piperacillin), Novartis's Ribociclib (Kisqali, Ribocili), and Eli Lilly's Abemaciclib (Verzenio, Abeciclib ) And G1 Therapeutics' Trilaciclib (Cosela), the global market size in 2020 will be US$6.
992 billion.
Domestically, only two CDK4/6 inhibitors, Pfizer's piperacillide and Eli Lilly's Abbecile, have been approved, and Hengrui's SHR6390 tablets are expected to become the third domestically marketed CDK4/6 inhibitor.
End reference materials: [1] Hengrui Pharmaceutical WeChat public account [2] Related media reports selected in the past to be scary! This substance, which is found in 1,000 kinds of food, may seriously damage the human immune system! Revan Bill Gates announced his divorce and counted the contributions of the Gates Foundation, the “booster” of global health services.
Reven finally found the culprit that corrodes the body.
Are you happy if you drink "Happy Fatty Water"? Hot text Nature is heavy! Nobel Prize Winner Reveals "Alternative" Potential Anticancer Methods: "Squeeze" Cancer Cells Out of Hot Text India Mutant Strain First Serological Evidence Released Medical Immunotherapy | Biosimilars | Vaccines | Drug Resistance | Drug Targets | Health Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Basic Research on Drug Side Effects/Translational Medicine Leukemia| Lung Cancer| Gastric Cancer| Colorectal Cancer| Liver Cancer| Breast Cancer| Pancreatic Cancer| Cardiovascular Disease| Neurodegenerative Disease| Intestinal Microbial Medicine Devices/Biotechnology In Vitro Diagnosis| Medical Devices| Bio-Nano| 3D Printing| Gene Testing| Single Cell Sequencing| Gene Editing| Assisted Reproduction| Artificial Intelligence| Precision Medicine Policy Anticancer Drugs| 4+7 Volume Procurement| Consumables| Record-keeping System | Registrant System | Healthy China | New Essential Drug Catalog | AI Medical Devices | Telemedicine | Same Equity Different Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext Board | R & D Investment | Acquisition | Market & Consumption