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Recently, according to the official website of NMPA, Selinexor was approved for listing
.
According to previously disclosed information, the approved indication for Celinisole this time is the combination with dexamethasone to treat at least one proteasome inhibitor, one immunomodulator and one anti-CD38 drug.
Anti-refractory relapsed or refractory multiple myeloma
.
Celiniso is an oral XPO1 inhibitor that can promote the nuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and down-regulate the levels of multiple oncogenic proteins in the cytoplasm to induce tumor cell apoptosis
.
Celiniso was developed by Karyopharm Therapeutics, and Deqi Pharmaceuticals obtained its commercialization rights in China through introduction
.
In July 2019, the U.
S.
Food and Drug Administration (FDA) approved selinexor (XPOVIO®) combined with low-dose dexamethasone for the treatment of patients with refractory relapsed multiple myeloma (rrMM)
.
In June 2020, the US FDA again approved selinexor (XPOVIO®) as a single-agent treatment for patients with refractory and relapsed diffuse large B-cell lymphoma (rrDLBCL)
.
In December 2020, the US FDA approved selinexor (XPOVIO®) combined with bortezomib and dexamethasone for the treatment of multiple myeloma patients who have previously received at least one treatment regimen
.
A marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA), requiring conditional approval of selinexor for rrMM indications
.
Selinexor (XPOVIO®) is currently the first and only oral SINE compound approved by the US FDA and the first drug that can be used to treat multiple myeloma and diffuse large B-cell lymphoma
.
In addition, selinexor (XPOVIO®) has conducted multiple mid- and late-stage clinical trials for multiple solid tumor indications, including liposarcoma and endometrial cancer
.
In November 2020, Karyopharm, a partner of Deqi Pharmaceuticals, reported positive data from the Phase 3 SEAL trial at the Connective Tissue Oncology Annual Meeting (CTOS 2020) in 2020
.
SEAL is a randomized, double-blind, placebo-controlled crossover trial designed to compare the efficacy of oral single-agent selinexor (XPOVIO®) and placebo in patients with liposarcoma
.
In addition, Karyopharm announced that the ongoing phase 3 SIENDO trial of selinexor (XPOVIO®) for the treatment of endometrial cancer patients has completed the planned interim invalidity analysis.
The Data Security Monitoring Board (DSMB) recommends that the trial does not need to be modified.
Continue as planned
.
According to public news, Deqi Pharmaceutical has made preparations in advance for the commercialization of the drug
.
In August of this year, Deqi Pharmaceuticals and Shanghai Pharmaceutical Holdings reached cooperation on Celiniso's import authorization, distribution business, supply chain services and innovative value-added in China
.
Among them, Shanghai Pharmaceutical Holdings will serve as the general distributor of Celiniso's imports from China
.
End reference materials: [1]http:// past issues Featured onlookers: Tojoo Pharmaceuticals Bevacizumab Injection, Park Xinting® was approved for marketing, is Tojoo Pharmaceutical's first antibody drug approved to be marketed.
The hot article "The Lancet" sub-issue: HPV vaccine is no longer exclusive to women ! Male vaccination can also prevent cancer! How will the world's top ten breakthrough technologies in 2021, "flow code" mRNA evolve? Rewen, the first domestic RNAi therapy company, Senno Pharmaceuticals passed the hearing and has completed 7 rounds of nearly US$270 million in financing.
Rewen TIL therapy: anti-solid tumor "dark horse", "accelerated" medical immunotherapy to overcome a variety of cancers | Biosimilars | Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast cancer| Pancreatic cancer| Heart Vascular diseases | Neurodegenerative diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | 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 | Filing System | Registrant System | Healthy China | New Edition of Essential Medicine Catalog | AI Medical Devices | Telemedicine | Same Equity Different Rights Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext Board | R&D Investment | Acquisitions | Market & Consumption
.
According to previously disclosed information, the approved indication for Celinisole this time is the combination with dexamethasone to treat at least one proteasome inhibitor, one immunomodulator and one anti-CD38 drug.
Anti-refractory relapsed or refractory multiple myeloma
.
Celiniso is an oral XPO1 inhibitor that can promote the nuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and down-regulate the levels of multiple oncogenic proteins in the cytoplasm to induce tumor cell apoptosis
.
Celiniso was developed by Karyopharm Therapeutics, and Deqi Pharmaceuticals obtained its commercialization rights in China through introduction
.
In July 2019, the U.
S.
Food and Drug Administration (FDA) approved selinexor (XPOVIO®) combined with low-dose dexamethasone for the treatment of patients with refractory relapsed multiple myeloma (rrMM)
.
In June 2020, the US FDA again approved selinexor (XPOVIO®) as a single-agent treatment for patients with refractory and relapsed diffuse large B-cell lymphoma (rrDLBCL)
.
In December 2020, the US FDA approved selinexor (XPOVIO®) combined with bortezomib and dexamethasone for the treatment of multiple myeloma patients who have previously received at least one treatment regimen
.
A marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA), requiring conditional approval of selinexor for rrMM indications
.
Selinexor (XPOVIO®) is currently the first and only oral SINE compound approved by the US FDA and the first drug that can be used to treat multiple myeloma and diffuse large B-cell lymphoma
.
In addition, selinexor (XPOVIO®) has conducted multiple mid- and late-stage clinical trials for multiple solid tumor indications, including liposarcoma and endometrial cancer
.
In November 2020, Karyopharm, a partner of Deqi Pharmaceuticals, reported positive data from the Phase 3 SEAL trial at the Connective Tissue Oncology Annual Meeting (CTOS 2020) in 2020
.
SEAL is a randomized, double-blind, placebo-controlled crossover trial designed to compare the efficacy of oral single-agent selinexor (XPOVIO®) and placebo in patients with liposarcoma
.
In addition, Karyopharm announced that the ongoing phase 3 SIENDO trial of selinexor (XPOVIO®) for the treatment of endometrial cancer patients has completed the planned interim invalidity analysis.
The Data Security Monitoring Board (DSMB) recommends that the trial does not need to be modified.
Continue as planned
.
According to public news, Deqi Pharmaceutical has made preparations in advance for the commercialization of the drug
.
In August of this year, Deqi Pharmaceuticals and Shanghai Pharmaceutical Holdings reached cooperation on Celiniso's import authorization, distribution business, supply chain services and innovative value-added in China
.
Among them, Shanghai Pharmaceutical Holdings will serve as the general distributor of Celiniso's imports from China
.
End reference materials: [1]http:// past issues Featured onlookers: Tojoo Pharmaceuticals Bevacizumab Injection, Park Xinting® was approved for marketing, is Tojoo Pharmaceutical's first antibody drug approved to be marketed.
The hot article "The Lancet" sub-issue: HPV vaccine is no longer exclusive to women ! Male vaccination can also prevent cancer! How will the world's top ten breakthrough technologies in 2021, "flow code" mRNA evolve? Rewen, the first domestic RNAi therapy company, Senno Pharmaceuticals passed the hearing and has completed 7 rounds of nearly US$270 million in financing.
Rewen TIL therapy: anti-solid tumor "dark horse", "accelerated" medical immunotherapy to overcome a variety of cancers | Biosimilars | Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast cancer| Pancreatic cancer| Heart Vascular diseases | Neurodegenerative diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | 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 | Filing System | Registrant System | Healthy China | New Edition of Essential Medicine Catalog | AI Medical Devices | Telemedicine | Same Equity Different Rights Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext Board | R&D Investment | Acquisitions | Market & Consumption
