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The first domestic first-line hepatocellular carcinoma targeted drug is about to be approved for listing.
The official website of the State Food and Drug Administration shows that the new drug application for the new drug listing of Zejing Pharmaceutical's Class 1 new drug, Donafinil tosylate tablets, is in the "under review" stage and will be obtained in the near future.
NMPA is approved for marketing for the treatment of advanced (inoperable or metastatic) hepatocellular carcinoma.
Donafenib tosylate tablets is an oral multi-target, multi-kinase inhibitor class of small molecule anti-tumor drugs.
Preclinical pharmacological studies have confirmed that Donafenib can not only inhibit the activity of VEGFR, PDGFR and other receptor tyrosine kinases, but also directly inhibit various Raf kinases, and inhibit the downstream Raf/MEK/ERK signal transduction pathway , Inhibit the proliferation of tumor cells and the formation of tumor blood vessels, and exert the anti-tumor effect of multiple inhibition and multi-target blocking.
In addition, the mechanism of action of Donafenib allows it to improve the tumor immune microenvironment through multiple pathways, thereby reducing the resistance to anti-PD-1 or anti-PD-L1 antibodies, resulting in a synergistic effect on tumor treatment and enhancing the efficacy .
Cinda Bio's PD-1 inhibitor is expected to usher in the third indication in China.
The results of the National Medical Products Administration (NMPA) drug registration progress query show that Cinda Bio and Eli Lilly and Company jointly developed PD The third indication of the -1 inhibitor Sintilizumab has been "under approval" for the first-line treatment of squamous non-small cell lung cancer (NSCLC).
Sintilimab is an innovative PD-1 inhibitor drug jointly developed by Innovent and Eli Lilly.
It can specifically bind to PD-1 molecules on the surface of T cells, thereby blocking PD that causes tumor immune tolerance.
-1/PD-L1 pathway reactivates the anti-tumor activity of lymphocytes, so as to achieve the purpose of treating tumors.
In August 2020, Eli Lilly and Cinda Biosciences expanded their cooperation and obtained the exclusive license of Sintilimab outside of China.
In China, Sintilimab has been approved for two indications: for the treatment of relapsed or refractory classic Hodgkin’s lymphoma that has undergone at least second-line systemic chemotherapy, and combined with pemetrexed and platinum-based chemotherapy First-line treatment of advanced non-squamous NSCLC with EGFR or ALK negative.
Yangzijiang Pharmaceutical's anti-infective Class 1 new drug was approved.
On May 31, China's National Food and Drug Administration (NMPA) announced that Yangzijiang Pharmaceutical's new drug application for Levoornidazole Disodium Phosphate has been officially approved.
It is reported that this is the company’s first innovative drug, and its indications are: it is used to treat a variety of infectious diseases caused by a variety of sensitive anaerobic bacteria, prevent infections before surgery, and anaerobic infections after surgery.
Treatment and amebiasis.
Levoornidazole Disodium Phosphate The sodium salt of the levorotatory enantiomer phosphate derivative of ornidazole.
Pharmacokinetic studies have shown that disodium levornidazole phosphate can be rapidly decomposed into levornidazole in the body.
According to reports in the literature, the pharmacodynamic effects of the left and right optical enantiomers of ornidazole are similar, but the adverse drug reactions of the dextrorotor are significantly stronger than that of the levorotatory, especially in the central nervous system.
The central inhibitory effect of the dextrorotor is stronger than that of the levorotatory.
.
Levoornidazole is made into Levoornidazole Phosphate Disodium Salt, which improves the water solubility of the drug and is expected to further reduce adverse reactions such as vascular irritation.
Toyo Pharmaceuticals Temozolomide Capsules (TOZ309) Approved for Marketing On May 31, 2021, Toyo Pharmaceuticals Temozolomide Capsules (TOZ309) independently developed by Toyo Pharmaceuticals was approved for marketing by the National Medical Products Administration (NMPA) for treatment: (1 ) Newly diagnosed glioblastoma multiforme, initially combined with radiotherapy, and then as maintenance therapy; (2) Glioblastoma multiforme or anaplastic astrocytoma that recurred or progressed after conventional treatment .
The clinical research results show that the two specifications of Temozolomide Capsules 20mg/capsule and 100mg/capsule of Toyo Pharmaceuticals are bioequivalent to Taidao® 20mg/capsule and 100mg/capsule respectively, similar to Taidao®, and there was no research drug during the study period.
Related unexpected serious adverse events. End reference materials: [1] The company's official website and related media reports selected onlookers Cell Breakthrough in the past: The foodies are moved and cry! Scientists have found a new fat-burning pathway with the potential for long-lasting effect.
Finally! Sinopharm officially announced the Phase 3 clinical data of two new crown inactivated vaccines, both of which are more than 70% effective in preventing COVID-19.
Scientists from Peking University publish the top issue of Cell: Using spliceosome inhibitors to produce all-round stem cells in mice.
The world's "popular fried chicken"! New research reveals: Nicotinamide can also regulate retinal function, effectively improve glaucoma craze and write a new legend in gene therapy.
Optogenetic therapy has revived blind people who have been blind for 40 years for the first time.
Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug Targets| Healthy 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 Diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | Medical devices | Bio-nano | 3D printing | Genetic testing | Single cell sequencing | Gene editing | Assisted reproduction | Artificial intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing System | Registrant System | Healthy China | New Edition of Essential Medicines Directory | AI Medical Devices | Telemedicine | Same Equity Different Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext | R&D Investment | Acquisitions | Market & Consumption
The official website of the State Food and Drug Administration shows that the new drug application for the new drug listing of Zejing Pharmaceutical's Class 1 new drug, Donafinil tosylate tablets, is in the "under review" stage and will be obtained in the near future.
NMPA is approved for marketing for the treatment of advanced (inoperable or metastatic) hepatocellular carcinoma.
Donafenib tosylate tablets is an oral multi-target, multi-kinase inhibitor class of small molecule anti-tumor drugs.
Preclinical pharmacological studies have confirmed that Donafenib can not only inhibit the activity of VEGFR, PDGFR and other receptor tyrosine kinases, but also directly inhibit various Raf kinases, and inhibit the downstream Raf/MEK/ERK signal transduction pathway , Inhibit the proliferation of tumor cells and the formation of tumor blood vessels, and exert the anti-tumor effect of multiple inhibition and multi-target blocking.
In addition, the mechanism of action of Donafenib allows it to improve the tumor immune microenvironment through multiple pathways, thereby reducing the resistance to anti-PD-1 or anti-PD-L1 antibodies, resulting in a synergistic effect on tumor treatment and enhancing the efficacy .
Cinda Bio's PD-1 inhibitor is expected to usher in the third indication in China.
The results of the National Medical Products Administration (NMPA) drug registration progress query show that Cinda Bio and Eli Lilly and Company jointly developed PD The third indication of the -1 inhibitor Sintilizumab has been "under approval" for the first-line treatment of squamous non-small cell lung cancer (NSCLC).
Sintilimab is an innovative PD-1 inhibitor drug jointly developed by Innovent and Eli Lilly.
It can specifically bind to PD-1 molecules on the surface of T cells, thereby blocking PD that causes tumor immune tolerance.
-1/PD-L1 pathway reactivates the anti-tumor activity of lymphocytes, so as to achieve the purpose of treating tumors.
In August 2020, Eli Lilly and Cinda Biosciences expanded their cooperation and obtained the exclusive license of Sintilimab outside of China.
In China, Sintilimab has been approved for two indications: for the treatment of relapsed or refractory classic Hodgkin’s lymphoma that has undergone at least second-line systemic chemotherapy, and combined with pemetrexed and platinum-based chemotherapy First-line treatment of advanced non-squamous NSCLC with EGFR or ALK negative.
Yangzijiang Pharmaceutical's anti-infective Class 1 new drug was approved.
On May 31, China's National Food and Drug Administration (NMPA) announced that Yangzijiang Pharmaceutical's new drug application for Levoornidazole Disodium Phosphate has been officially approved.
It is reported that this is the company’s first innovative drug, and its indications are: it is used to treat a variety of infectious diseases caused by a variety of sensitive anaerobic bacteria, prevent infections before surgery, and anaerobic infections after surgery.
Treatment and amebiasis.
Levoornidazole Disodium Phosphate The sodium salt of the levorotatory enantiomer phosphate derivative of ornidazole.
Pharmacokinetic studies have shown that disodium levornidazole phosphate can be rapidly decomposed into levornidazole in the body.
According to reports in the literature, the pharmacodynamic effects of the left and right optical enantiomers of ornidazole are similar, but the adverse drug reactions of the dextrorotor are significantly stronger than that of the levorotatory, especially in the central nervous system.
The central inhibitory effect of the dextrorotor is stronger than that of the levorotatory.
.
Levoornidazole is made into Levoornidazole Phosphate Disodium Salt, which improves the water solubility of the drug and is expected to further reduce adverse reactions such as vascular irritation.
Toyo Pharmaceuticals Temozolomide Capsules (TOZ309) Approved for Marketing On May 31, 2021, Toyo Pharmaceuticals Temozolomide Capsules (TOZ309) independently developed by Toyo Pharmaceuticals was approved for marketing by the National Medical Products Administration (NMPA) for treatment: (1 ) Newly diagnosed glioblastoma multiforme, initially combined with radiotherapy, and then as maintenance therapy; (2) Glioblastoma multiforme or anaplastic astrocytoma that recurred or progressed after conventional treatment .
The clinical research results show that the two specifications of Temozolomide Capsules 20mg/capsule and 100mg/capsule of Toyo Pharmaceuticals are bioequivalent to Taidao® 20mg/capsule and 100mg/capsule respectively, similar to Taidao®, and there was no research drug during the study period.
Related unexpected serious adverse events. End reference materials: [1] The company's official website and related media reports selected onlookers Cell Breakthrough in the past: The foodies are moved and cry! Scientists have found a new fat-burning pathway with the potential for long-lasting effect.
Finally! Sinopharm officially announced the Phase 3 clinical data of two new crown inactivated vaccines, both of which are more than 70% effective in preventing COVID-19.
Scientists from Peking University publish the top issue of Cell: Using spliceosome inhibitors to produce all-round stem cells in mice.
The world's "popular fried chicken"! New research reveals: Nicotinamide can also regulate retinal function, effectively improve glaucoma craze and write a new legend in gene therapy.
Optogenetic therapy has revived blind people who have been blind for 40 years for the first time.
Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug Targets| Healthy 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 Diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | Medical devices | Bio-nano | 3D printing | Genetic testing | Single cell sequencing | Gene editing | Assisted reproduction | Artificial intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing System | Registrant System | Healthy China | New Edition of Essential Medicines Directory | AI Medical Devices | Telemedicine | Same Equity Different Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext | R&D Investment | Acquisitions | Market & Consumption
