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RSS FeedPosted by Michael Wonder on 12 Jul 2023
Enhertu approved in China as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 July 2023 - Approval based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of ...
Posted by Michael Wonder on 12 Jul 2023
Junshi Biosciences announces acceptance of the supplemental new drug application for toripalimab
11 July 2023 - Shanghai Junshi Biosciences announced that the supplemental new drug application for toripalimab, the company’s anti-PD-1 monoclonal antibody, ...
Posted by Michael Wonder on 11 Jul 2023
Zai Lab announces acceptance by China’s NMPA of the BLA for efgartigimod alfa injection (subcutaneous injection) for patients with generalised myasthenia gravis
10 July 2023 - Zai Lab today announced that China’s NMPA has accepted the biologics license application for efgartigimod alfa for ...
Posted by Michael Wonder on 05 Jul 2023
China NMPA approves RareStone's pitolisant (Wakix) for the treatment of narcolepsy
4 July 2023 - Pitolisant is the first and only treatment drug approved in mainland China for narcolepsy. ...
Posted by Michael Wonder on 03 Jul 2023
Eddingpharm announces approval of Mulpleta (lusutrombopag) in China
30 June 2023 - Shionogi today announced that Eddingpharm has received approval for Mulpleta (lusutrombopag), a once daily, orally administered, small ...
Posted by Michael Wonder on 03 Jul 2023
Zai Lab and argenx announce approval of Vyvgart (efgartigimod alfa injection) for generalised myasthenia gravis in China
30 June 2023 - Zai Lab and argenx today announced that China’s National Medical Products Administration has approved the biologics license ...
Posted by Michael Wonder on 03 Jul 2023
Innovent and IASO Bio announce the NMPA approval of Fucaso, the first fully human BCMA CAR-T therapy, for the treatment of relapsed or refractory multiple myeloma
3 July 2023 - Innovent Biologics and IASO Biotechnology announce that China's National Medical Products Administration has approved the ...
Posted by Michael Wonder on 29 Jun 2023
Zai Lab announces NDA acceptance of repotrectinib for patients with ROS1 positive NSCLC by China’s NMPA
28 June 2023 - Zai Lab today announced that the National Medical Products Administration (NMPA) in China has accepted the New ...
Posted by Michael Wonder on 27 Jun 2023
CStone announces Gavreto (pralsetinib) sNDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion positive non-small cell lung cancer
27 June 2023 - The approval for the first-line treatment of RET fusion positive non-small cell lung cancer marks the third ...
Posted 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 ...