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[Pharmaceutical Industry News] According to statistics released on the website of the Drug Administration, in April, FDA, EMA, NMPA, and PMDA approved 10, 4, 13, and 1 new drugs, respectively, with indications covering tumors, autoimmune diseases, neurological systemic diseases,e.
Among them, the number of domestic new drugs on the market is significantly larg.
It is generally believed in the industry that this is due to the accelerated review and deliberation of domestic drugs and medical devices for listing under favorable polici.
At present, the speed of new drugs and medical devices at home and abroad is obviously accelerating in the domestic mark.
Recently, a number of new products and indications have been approved for marketi.
Merck's new antiviral drug approved for marketing in China On the 13th, the NMPA website showed that Merck's new antiviral drug, letermovir injection, has been approved for marketi.
It is understood that cytomegalovirus (CMV), as a widespread herpes virus, poses a serious threat to the life and health of patients with hematopoietic stem cell transplantation (HSC.
Letemovir is a novel non-nucleoside CMV inhibitor (3,4-dihydroquinazolin.
Public information shows that the product has a new anti-CMV effect, by inhibiting the activity of the cytomegalovirus terminal enzyme complex, preventing the processing and packaging of viral DNA, thereby exerting an anti-viral effe.
In November 2020, Letermovir submitted and accepted four new drug marketing applications in China, including injection and tablet formulatio.
In January this year, the tablet dosage form of the drug was approved in China for the preventive treatment of cytomegalovir.
Transcatheter implantable leadless pacing system approved for listing by NMPA On the 12th, the website of the State Food and Drug Administration showed that after review, the application for registration of the innovative product "transcatheter implantable leadless pacing system" produced by Medtronic was approv.
The system consists of an implantable pulse generator (including fixed wings) and a delivery cathet.
The patient's cardiac activity is sensed in the right ventricle, the bradycardia rhythm is monitored, and pacing therapy is provided for the bradycard.
The system is a medical device with safe magnetic resonance environment conditio.
Under the premise of the specified conditions and special protection measures for patients and implanted devices, patients can accept clinical magnetic resonance imaging examinations with 5T and 0T field strengt.
Junshi Bio's Toripalimab was approved for the fifth indication in China on the 13th, the NMPA website announced that the new indication of the PD-1 inhibitor Toripalimab (Tuoyi) developed by Junshi Bio was listed on the market Application has been approv.
According to public information, Toripalimab is a recombinant humanized anti-PD-1 monoclonal antibody injection independently developed by Junshi Bio, and has previously been approved for 4 indications in Chi.
The approved indication is the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma in combination with platinum-containing chemotherapy, which is also the fifth indication for toripalimab approved in Chi.
Conclusion In addition to the above pharmaceutical equipment, there are a number of domestic generic drug listing applications that have recently been included in the priority review varieties, from Chengdu Yuandong Biological, Chengdu Better Pharmaceutical, Yichang Renfu, Sichuan Huiyu Pharmaceutical, Shijiazhuang Four Medicines and Shenzhen Kangzhe Biotechnology,e.
The industry predicts that as domestic pharmaceutical companies accelerate their transformation from generic companies to innovative R&D companies, a group of rapidly developing pharmaceutical companies will gradually become a new force in China's pharmaceutical innovation, contributing more to the development of China's pharmaceutical indust.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
Among them, the number of domestic new drugs on the market is significantly larg.
It is generally believed in the industry that this is due to the accelerated review and deliberation of domestic drugs and medical devices for listing under favorable polici.
At present, the speed of new drugs and medical devices at home and abroad is obviously accelerating in the domestic mark.
Recently, a number of new products and indications have been approved for marketi.
Merck's new antiviral drug approved for marketing in China On the 13th, the NMPA website showed that Merck's new antiviral drug, letermovir injection, has been approved for marketi.
It is understood that cytomegalovirus (CMV), as a widespread herpes virus, poses a serious threat to the life and health of patients with hematopoietic stem cell transplantation (HSC.
Letemovir is a novel non-nucleoside CMV inhibitor (3,4-dihydroquinazolin.
Public information shows that the product has a new anti-CMV effect, by inhibiting the activity of the cytomegalovirus terminal enzyme complex, preventing the processing and packaging of viral DNA, thereby exerting an anti-viral effe.
In November 2020, Letermovir submitted and accepted four new drug marketing applications in China, including injection and tablet formulatio.
In January this year, the tablet dosage form of the drug was approved in China for the preventive treatment of cytomegalovir.
Transcatheter implantable leadless pacing system approved for listing by NMPA On the 12th, the website of the State Food and Drug Administration showed that after review, the application for registration of the innovative product "transcatheter implantable leadless pacing system" produced by Medtronic was approv.
The system consists of an implantable pulse generator (including fixed wings) and a delivery cathet.
The patient's cardiac activity is sensed in the right ventricle, the bradycardia rhythm is monitored, and pacing therapy is provided for the bradycard.
The system is a medical device with safe magnetic resonance environment conditio.
Under the premise of the specified conditions and special protection measures for patients and implanted devices, patients can accept clinical magnetic resonance imaging examinations with 5T and 0T field strengt.
Junshi Bio's Toripalimab was approved for the fifth indication in China on the 13th, the NMPA website announced that the new indication of the PD-1 inhibitor Toripalimab (Tuoyi) developed by Junshi Bio was listed on the market Application has been approv.
According to public information, Toripalimab is a recombinant humanized anti-PD-1 monoclonal antibody injection independently developed by Junshi Bio, and has previously been approved for 4 indications in Chi.
The approved indication is the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma in combination with platinum-containing chemotherapy, which is also the fifth indication for toripalimab approved in Chi.
Conclusion In addition to the above pharmaceutical equipment, there are a number of domestic generic drug listing applications that have recently been included in the priority review varieties, from Chengdu Yuandong Biological, Chengdu Better Pharmaceutical, Yichang Renfu, Sichuan Huiyu Pharmaceutical, Shijiazhuang Four Medicines and Shenzhen Kangzhe Biotechnology,e.
The industry predicts that as domestic pharmaceutical companies accelerate their transformation from generic companies to innovative R&D companies, a group of rapidly developing pharmaceutical companies will gradually become a new force in China's pharmaceutical innovation, contributing more to the development of China's pharmaceutical indust.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
