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[Pharmaceutical Network Enterprise News] On June 15, Hengrui Pharmaceutical issued an announcement that the company's SHR4640 tablets obtained the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administrati.
Uricemia clinical tria.
According to the announcement, SHR4640 tablet is a class 1 anti-gout drug independently innovated by the company, and its positive control drug is Lesinurad developed by Ardea Biosciences Inc, a subsidiary of AstraZene.
Lesinurad was approved by the.
FDA on December 22, 2015 under the trade name Zurampic for the treatment of gout associated with unachieved target serum uric acid levels following xanthine oxidase inhibitor monotherapy in combination with a xanthine oxidase inhibitor of hyperuricemia, the dosage form is tablet, the specification is 200.
On February 18, 2016, Lesinurad received EU approval with the same indications, dosage forms and strengths as those approved by the F.
On August 18, 2017, AstraZeneca's fixed-dose combination of Lesinurad and allopurinol was approved by the US FDA under the trade name Duzal.
At present, no Lesinurad and Duzallo preparations have been approved in China, and the company has not yet inquired about the global sales data of Lesinurad and Duzallo in 202Up to now, Hengrui Medicine has invested about 1808 million yuan in research and development in this research and development proje.
In addition to the clinical trial approval of SHR4640 tablets, Hengrui Medicine has received many good news since Ju.
For example, the company recently announced that Haitrombopag ethanolamine tablets have been granted orphan drug qualification by the US F.
On June 14, Hengrui announced that the company's product Haitrombopag ethanolamine tablets for the indication of thrombocytopenia caused by chemotherapy for malignant tumors has been granted orphan drug designation by the US FDA, which means that the company will have the opportunity to develop products, Enjoy the policy support of the United States in terms of registration and commercializati.
Hetrombopag ethanolamine is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating TPO-R-mediated STAT and MAPK signaling pathwa.
The product has been approved for marketing for two indications, including for the treatment of adult patients with chronic primary immune thrombocytopenia who have not responded well to glucocorticoids, immunoglobulins, e.
, and for the efficacy of immunosuppressive therapy Poor treatment of adults with severe aplastic anem.
At present, Eltrombopag, Avatrombopag and Lusutrombopag, which are similar products of Haitrombopag ethanolamine tablets, have been approved for marketing abro.
In China, Eltrombopag was approved for marketing in 2017, and the product name is Eltrombopag ethanolamine tablets, which is used for adult patients with chronic immune (idiopathic) thrombocytopenia, and will be extended to children aged 6-11 in May 202Avatrombopag was approved for marketing in 2020 under the product name Avatrombopag maleate tablets for adult patients with chronic liver disease-related thrombocytopenia who are scheduled for diagnostic procedures or surge.
After querying the EvaluatePharma database, the global sales of the above three similar products in 2021 will be approximately US$143 billi.
Up to now, Hengrui has invested about 2368 million yuan in research and development expenses related to Hengrui's Haitropopa ethanolamine tablet-related projec.
It is understood that after years of "from imitation to innovation", Hengrui Medicine's innovative drugs are accelerating into the harvest peri.
By the end of 2021, Hengrui Medicine has listed 10 innovative drugs, and more than 60 innovative drugs are under clinical development, and more than 250 clinical trials are being carried out at home and abro.
Internationalization is a major strategy of Hengrui Medicine at prese.
The 2021 annual report shows that the company's annual overseas R&D investment totaled 236 billion yuan, accounting for 193% of the total R&D investme.
At present, Hengrui has a total of more than 170 overseas R&D teams, including 104 in the American team and 50 in the European te.
The team members are all middle and high-level talents with rich experience in global R&.
Click to enter the exhibition page
Uricemia clinical tria.
According to the announcement, SHR4640 tablet is a class 1 anti-gout drug independently innovated by the company, and its positive control drug is Lesinurad developed by Ardea Biosciences Inc, a subsidiary of AstraZene.
Lesinurad was approved by the.
FDA on December 22, 2015 under the trade name Zurampic for the treatment of gout associated with unachieved target serum uric acid levels following xanthine oxidase inhibitor monotherapy in combination with a xanthine oxidase inhibitor of hyperuricemia, the dosage form is tablet, the specification is 200.
On February 18, 2016, Lesinurad received EU approval with the same indications, dosage forms and strengths as those approved by the F.
On August 18, 2017, AstraZeneca's fixed-dose combination of Lesinurad and allopurinol was approved by the US FDA under the trade name Duzal.
At present, no Lesinurad and Duzallo preparations have been approved in China, and the company has not yet inquired about the global sales data of Lesinurad and Duzallo in 202Up to now, Hengrui Medicine has invested about 1808 million yuan in research and development in this research and development proje.
In addition to the clinical trial approval of SHR4640 tablets, Hengrui Medicine has received many good news since Ju.
For example, the company recently announced that Haitrombopag ethanolamine tablets have been granted orphan drug qualification by the US F.
On June 14, Hengrui announced that the company's product Haitrombopag ethanolamine tablets for the indication of thrombocytopenia caused by chemotherapy for malignant tumors has been granted orphan drug designation by the US FDA, which means that the company will have the opportunity to develop products, Enjoy the policy support of the United States in terms of registration and commercializati.
Hetrombopag ethanolamine is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating TPO-R-mediated STAT and MAPK signaling pathwa.
The product has been approved for marketing for two indications, including for the treatment of adult patients with chronic primary immune thrombocytopenia who have not responded well to glucocorticoids, immunoglobulins, e.
, and for the efficacy of immunosuppressive therapy Poor treatment of adults with severe aplastic anem.
At present, Eltrombopag, Avatrombopag and Lusutrombopag, which are similar products of Haitrombopag ethanolamine tablets, have been approved for marketing abro.
In China, Eltrombopag was approved for marketing in 2017, and the product name is Eltrombopag ethanolamine tablets, which is used for adult patients with chronic immune (idiopathic) thrombocytopenia, and will be extended to children aged 6-11 in May 202Avatrombopag was approved for marketing in 2020 under the product name Avatrombopag maleate tablets for adult patients with chronic liver disease-related thrombocytopenia who are scheduled for diagnostic procedures or surge.
After querying the EvaluatePharma database, the global sales of the above three similar products in 2021 will be approximately US$143 billi.
Up to now, Hengrui has invested about 2368 million yuan in research and development expenses related to Hengrui's Haitropopa ethanolamine tablet-related projec.
It is understood that after years of "from imitation to innovation", Hengrui Medicine's innovative drugs are accelerating into the harvest peri.
By the end of 2021, Hengrui Medicine has listed 10 innovative drugs, and more than 60 innovative drugs are under clinical development, and more than 250 clinical trials are being carried out at home and abro.
Internationalization is a major strategy of Hengrui Medicine at prese.
The 2021 annual report shows that the company's annual overseas R&D investment totaled 236 billion yuan, accounting for 193% of the total R&D investme.
At present, Hengrui has a total of more than 170 overseas R&D teams, including 104 in the American team and 50 in the European te.
The team members are all middle and high-level talents with rich experience in global R&.
Click to enter the exhibition page
