Blog
RSS FeedPosted by Michael Wonder on 27 Jun 2023
Xigduo XR approved in China for adults with type 2 diabetes
27 June 2023 - Approval makes Xigduo XR the only once daily fixed-dose combination of an SGLT2 inhibitor and metformin ...
Posted by Michael Wonder on 19 Jun 2023
How health technology reassessment can support disinvestment in China’s national drug reimbursement list
15 June 2023 - A requirement to assess actual use of reimbursed medicines would enable transparent, documented, evidence based decisions ...
Posted by Michael Wonder on 17 Jun 2023
Using health technology assessment to inform insurance reimbursement of high technology medicines in China: an example of cancer immunotherapy
15 June 2023 - Yingyao Chen and colleagues examine what can be learnt from China’s approach to funding expensive high ...
Posted by Michael Wonder on 16 Jun 2023
Chugai files new drug application in Japan for crovalimab for paroxysmal nocturnal hemoglobinuria
16 June 2023 - The application was submitted based on several studies, including the global Phase 3 clinical studies COMMODORE 2 ...
Posted by Michael Wonder on 13 Jun 2023
Soliris approved in China for the treatment of adults with refractory generalised myasthenia gravis
13 June 2023 - Regulatory milestone marks third approval for Soliris in China, further expanding access to rare disease medicines ...
Posted by Michael Wonder on 07 Jun 2023
PharmaMar and Luye Pharma announce the acceptance of new drug application for lurbinectedin in China
6 June 2023 - PharmaMar and Luye Pharma have announced today that the new drug application submission of lurbinectedin has been ...
Posted by Michael Wonder on 05 Jun 2023
Amarin Partner EddingPharm receives regulatory approval for Vascepa (icosapent ethyl) in Mainland China
1 June 2023 - Vascepa approved by the NMPA as an adjunct to diet to reduce triglyceride levels in adult patients ...
Posted by Michael Wonder on 05 Jun 2023
NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications
1 June 2023 - Akeso announced today that China's NMPA has accepted its new drug application for its fully human anti-PCSK9 ...
Posted by Michael Wonder on 02 Jun 2023
AD treatment Dupixent approved for use in China for young children
31 May 2023 - Sanofi announced on Tuesday that Dupixent, the world's first targeted biological agent for atopic dermatitis treatment, ...
Posted by Michael Wonder on 08 May 2023
BeiGene receives new approvals for Brukinsa (zanubrutinib) in China
6 May 2023 - Brukinsa is approved for first-line treatment for CLL/SLL and Waldenström's macroglobulinaemia in China and has multiple approved indications ...
Posted by Michael Wonder on 08 May 2023
Koselugo approved in China for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
8 May 2023 - First and only approved treatment in China for rare and progressive genetic condition, which can result ...
Posted by Michael Wonder on 18 Apr 2023
HUTCHMED announces NDA acceptance in China for fruquintinib in second-line gastric cancer
18 April 2023 - HUTCHMED today announces that its new drug application for fruquintinib in combination with paclitaxel for the treatment ...
Posted by Michael Wonder on 23 Mar 2023
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
23 March 2023 - Across two clinical trials 82% overall response and 35% complete response rate were observed in Chinese ...
Posted by Michael Wonder on 15 Mar 2023
China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma
14 March 2023 - GSK today announced that the China National Medical Products Administration has accepted for review a new drug ...
Posted by Michael Wonder on 13 Mar 2023
Haihe Biopharma announces gumarontinib receives approval from the NMPA of China for the treatment of locally advanced or metastatic NSCLC with MET exon 14 skipping mutation
8 March 2023 - Haihe Biopharma today announced that the NMPA of China has given conditional approval to gumarontinib, an oral ...