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RSS FeedPosted by Michael Wonder on 01 Nov 2023
CStone announces NMPA approval of sugemalimab for patients with relapsed or refractory extranodal NK/T-cell lymphoma, the first anti-PD-1/PD-L1 mAb approved for this indication
31 October 2023 - Sugemalimab is the world’s first anti-PD-1/PD-L1 monoclonal antibody approved for relapsed or refractory extranodal NK/T-cell lymphoma indication. ...
Posted by Michael Wonder on 26 Oct 2023
ViiV Healthcare receives approval from China’s National Medical Products Administration for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment
26 October 2023 - The marketing authorisation for rilpivirine long-acting injection was received on the 18 October 2023. ...
Posted by Michael Wonder on 18 Oct 2023
Soliris approved in China for the treatment of adults with neuromyelitis optica spectrum disorder
18 October 2023 - Approval exemplifies commitment to broadening access for patients living with rare diseases globally. ...
Posted by Michael Wonder on 25 Sep 2023
Golidocitinib granted priority review by China NMPA for the treatment of relapsed/refractory peripheral T-cell lymphoma
21 September 2023 - Dizal announced today that the China National Medical Products Administration has granted priority review status to golidocitinib, ...
Posted by Michael Wonder on 15 Sep 2023
Dizal announces China CDE acceptance of new drug application for golidocitinib for relapsed or refractory PTCL
14 September 2023 - Dizal today announced that the Center for Drug Evaluation of the China NMPA has accepted the new ...
Posted by Michael Wonder on 04 Sep 2023
Calquence approved in China for chronic lymphocytic leukaemia
4 September 2023 - Approval based on results from ASCEND global Phase III trial and a Phase I/II local trial, ...
Posted by Michael Wonder on 30 Aug 2023
Zai Lab announces breakthrough therapy designation granted for repotrectinib for treatment of patients with NTRK positive TKI-pretreated advanced solid tumours in China
30 August 2023 - Candidate precision medicine has shown encouraging clinical activity for both ROS1 positive NSCLC and NTRK fusion-positive advanced ...
Posted by Michael Wonder on 21 Aug 2023
Innovent announces the NMPA approval of Sintbilo (tafolecimab injection) for the treatment of adult patients with primary hypercholesterolaemia and mixed dyslipidaemia
17 August 2023 - Innovent Biologics announces that China's National Medical Products Administration has approved Sintbilo (tafolecimab injection, anti-PCSK9 monoclonal ...
Posted by Michael Wonder on 18 Aug 2023
Forxiga approved in China to reduce the risk of cardiovascular death and hospitalisation in adult patients with symptomatic chronic heart failure
18 August 2023 - The first and only heart failure therapy with a proven mortality benefit now approved for patients ...
Posted 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 ...