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RSS FeedPosted by Michael Wonder on 12 Aug 2023
Jacobio Pharma announces breakthrough therapy designation from China CDE for KRAS G12C inhibitor glecirasib for the treatment of pancreatic cancer
7 August 2023 - Jacobio Pharma today announced that Jacobio's in house KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation ...
Posted by Michael Wonder on 03 Aug 2023
China’s NMPA accepts and grants priority review designation to the new drug application for Luye Pharma’s rotigotine extended release microspheres
1 August 2023 - The drug is the world’s first innovative microsphere formulation for treating Parkinson’s disease. ...
Posted by Michael Wonder on 01 Aug 2023
China’s National Medical Products Administration accepts Astellas’ biologics license application for zolbetuximab
31 July 2023 - Astellas Pharma today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...
Posted by Michael Wonder on 24 Jul 2023
Overland ADCT BioPharma announces NMPA accepts biologics license application and grants priority review for Zylonta for treatment of relapsed or refractory diffuse large B-cell lymphoma
24 July 2023 - Overland ADCT BioPharma today announced that the China NMPA has accepted the Biologics License Application for ...
Posted by Michael Wonder on 21 Jul 2023
HUTCHMED receives breakthrough therapy designation in China for fruquintinib combination with sintilimab for treatment of advanced endometrial cancer
19 July 2023 - HUTCHMED today announces that the Center for Drug Evaluation of China’s NMPA has granted breakthrough therapy ...
Posted by Michael Wonder on 20 Jul 2023
Yikaida CAR-T cell therapy approved as a second-line therapy for new indication
18 July 2023 - The product of Fosun Kite, jointly established by Shanghai Fosun Pharmaceutical and Kite Pharma (Yikaida) for ...
Posted 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 ...