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[Pharmaceutical Network Industry News] On August 16, the website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of the People's Republic of China showed that Merck's Class 1 new drug MK-4830 injection has obtained an implied license for clinical trials and is intended to be developed for use in Treatment of advanced solid tumor.
According to public information, MK-4830 is a fully humanized immunoglobulin G4 (IgG4) monoclonal antibody developed by Merck, and Phase 2 clinical trials are being carried out oversea.
Preclinical data show that MK-4830 can bind to monocytes and granulocytes in the peripheral blood of healthy volunteers and cancer patient.
In a humanized mouse tumor model, treatment with MK-4830 significantly inhibited tumor growt.
At present, Merck is still exploring the effect of MK-4830 alone or in combination with other drugs in the treatment of various solid tumor.
Among them, research on melanoma, colorectal cancer, small cell lung cancer, non-small cell lung cancer, renal cell cancer, ovarian cancer, et.
has entered the second stag.
The acquisition of the implied license for clinical trials means that the drug will soon enter clinical research in Chin.
In fact, in recent years, in order to maintain growth and benefit more patients, Merck has been investing in the Chinese market and providing innovative product.
In recent years, the number of new products introduced into China ranks among the forefront of multinational companies, including vaccines, small molecule drugs, and macromolecular drug.
In April of this year, Merck announced that the NMPA had approved the new indications of its antifungal drug Norcofi (posaconazole enteric-coated tablets 100mg, posaconazole injection 17ml: 300mg.
Among them, posaconazole enteric-coated tablets are approved for the treatment of invasive aspergillosis, and posaconazole injection is approved for the treatment of invasive aspergillosi.
In January, Merck announced that its novel non-nucleoside cytomegalovirus (CMV) inhibitor, Premin® (Litemovir tablets), has been approved by the State Drug Administration for patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT.
Prevention of cytomegalovirus infection and cytomegalovirus disease in adult recipients with cytomegalovirus (CMV) seropositive [R+.
On September 2, 2021, the Center for Drug Evaluation (CDE) of the State Drug Administration of China announced that belzutifan tablets, a class 1 new drug declared by Merck & C.
(MSD), have obtained an implied license for clinical trials and are intended to be developed for renal cell carcinoma (RCC).
.
In addition to Merck, a large number of multinational pharmaceutical companies, including Bayer, Novo Nordisk, Pfizer, Novartis, Merck, and GlaxoSmithKline, are also constantly "overweighting" the Chinese marke.
Among them, many pharmaceutical companies also expressed that they will accelerate the entry of new drugs into the Chinese market in the futur.
For example, AstraZeneca Global R&D China Center stated that it will introduce the CoSolve innovation plan project of AstraZeneca Global Open Innovation (Open Innovation Platform) into China, and will recruit more Chinese innovative forces to participate in global new drug research and development to accelerate Chinese wisdom Benefit the worl.
At the same time, it also stated that after upgrading to a global R&D center, 10 to 15 new R&D pipeline projects in China will be added every year; by 2023, the center's R&D investment in China will reach 5 times that of 2020, and the number of teams will also increase to 5 times that of 202 More than 800 people; in the next five years, the number of new drugs or new indications approved in China is expected to reach 60 to 65, including 15 new molecular entities (NMEs.
In recent years, under the continuous innovation and improvement of China's drug review and approval system, more and more innovative drugs are achieving "synchronization between China and the world.
It is worth mentioning that by 2025, Pfizer also plans to introduce 25 new products or new indications or new dosage forms to China, with a strong and complete product line to meet the health needs of Chinese patients at all stages of lif.
In general, with the rapid growth of Chinese biopharmaceuticals into an emerging cluster of global innovation, more and more global pharmaceutical companies have seen China's innovative R&D ecological environment and prospect.
The investment is expected to continue to increas.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyon.
According to public information, MK-4830 is a fully humanized immunoglobulin G4 (IgG4) monoclonal antibody developed by Merck, and Phase 2 clinical trials are being carried out oversea.
Preclinical data show that MK-4830 can bind to monocytes and granulocytes in the peripheral blood of healthy volunteers and cancer patient.
In a humanized mouse tumor model, treatment with MK-4830 significantly inhibited tumor growt.
At present, Merck is still exploring the effect of MK-4830 alone or in combination with other drugs in the treatment of various solid tumor.
Among them, research on melanoma, colorectal cancer, small cell lung cancer, non-small cell lung cancer, renal cell cancer, ovarian cancer, et.
has entered the second stag.
The acquisition of the implied license for clinical trials means that the drug will soon enter clinical research in Chin.
In fact, in recent years, in order to maintain growth and benefit more patients, Merck has been investing in the Chinese market and providing innovative product.
In recent years, the number of new products introduced into China ranks among the forefront of multinational companies, including vaccines, small molecule drugs, and macromolecular drug.
In April of this year, Merck announced that the NMPA had approved the new indications of its antifungal drug Norcofi (posaconazole enteric-coated tablets 100mg, posaconazole injection 17ml: 300mg.
Among them, posaconazole enteric-coated tablets are approved for the treatment of invasive aspergillosis, and posaconazole injection is approved for the treatment of invasive aspergillosi.
In January, Merck announced that its novel non-nucleoside cytomegalovirus (CMV) inhibitor, Premin® (Litemovir tablets), has been approved by the State Drug Administration for patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT.
Prevention of cytomegalovirus infection and cytomegalovirus disease in adult recipients with cytomegalovirus (CMV) seropositive [R+.
On September 2, 2021, the Center for Drug Evaluation (CDE) of the State Drug Administration of China announced that belzutifan tablets, a class 1 new drug declared by Merck & C.
(MSD), have obtained an implied license for clinical trials and are intended to be developed for renal cell carcinoma (RCC).
.
In addition to Merck, a large number of multinational pharmaceutical companies, including Bayer, Novo Nordisk, Pfizer, Novartis, Merck, and GlaxoSmithKline, are also constantly "overweighting" the Chinese marke.
Among them, many pharmaceutical companies also expressed that they will accelerate the entry of new drugs into the Chinese market in the futur.
For example, AstraZeneca Global R&D China Center stated that it will introduce the CoSolve innovation plan project of AstraZeneca Global Open Innovation (Open Innovation Platform) into China, and will recruit more Chinese innovative forces to participate in global new drug research and development to accelerate Chinese wisdom Benefit the worl.
At the same time, it also stated that after upgrading to a global R&D center, 10 to 15 new R&D pipeline projects in China will be added every year; by 2023, the center's R&D investment in China will reach 5 times that of 2020, and the number of teams will also increase to 5 times that of 202 More than 800 people; in the next five years, the number of new drugs or new indications approved in China is expected to reach 60 to 65, including 15 new molecular entities (NMEs.
In recent years, under the continuous innovation and improvement of China's drug review and approval system, more and more innovative drugs are achieving "synchronization between China and the world.
It is worth mentioning that by 2025, Pfizer also plans to introduce 25 new products or new indications or new dosage forms to China, with a strong and complete product line to meet the health needs of Chinese patients at all stages of lif.
In general, with the rapid growth of Chinese biopharmaceuticals into an emerging cluster of global innovation, more and more global pharmaceutical companies have seen China's innovative R&D ecological environment and prospect.
The investment is expected to continue to increas.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyon.
