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RSS FeedPosted by Michael Wonder on 19 Jun 2021
HutchMed announces NMPA approval of surufatinib (Sulanda in China) for advanced pancreatic neuroendocrine tumours
18 June 2021 - Second new drug application approved for Sulanda in China. ...
Posted by Michael Wonder on 09 Jun 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in microsatellite instability-high or mismatch repair-deficient solid tumours
7 June 2021 -BeiGene today announced that the Center for Drug Evaluation of the China NMPA has accepted a supplemental ...
Posted by Michael Wonder on 10 May 2021
China NMPA approves PARP inhibitor pamiparib for patients with previously treated advanced ovarian cancer
7 May 2021 - This marks the first approval of pamiparib and the third BeiGene discovered medicine to receive regulatory approval. ...
Posted by Michael Wonder on 19 Apr 2021
Citrine Medicine and Sinopharm Group announce strategic partnership to broaden and accelerate access to rare disease drugs in China
19 April 2021 - Citrine Medicine and Sinopharm Group today announced a strategic partnership to accelerate the commercialisation of rare ...
Posted by Michael Wonder on 14 Apr 2021
Tagrisso approved in China in early lung cancer
14 April 2021 - Approval based on unprecedented results from the ADAURA Phase III trial where Tagrisso reduced the risk ...
Posted by Michael Wonder on 13 Apr 2021
Qilian International announces inclusion of 16 products into China's National Reimbursement Drugs List
13 April 2021 - Qilian International today announced that 16 of its products have been included in the latest version of ...
Posted by Michael Wonder on 13 Apr 2021
NMPA approves toripalimab in patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neo-adjuvant or adjuvant platinum-containing chemotherapy
12 April 2021 - Third indication approved for toripalimab in China. ...
Posted by Michael Wonder on 05 Apr 2021
BeyondSpring announces submission of new drug application to U.S. FDA and China NMPA for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
31 March 2021 - Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers ...
Posted by Michael Wonder on 01 Apr 2021
CStone announces China NMPA new drug approval of precision therapy Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutant gastro-intestinal stromal tumour
31 March 2021 - Ayvakit is China’s first approved precision therapy for patients with PDGFRA exon 18 mutant gastro-intestinal stromal tumour. ...
Posted by Michael Wonder on 25 Mar 2021
CStone announces new drug approval of Gavreto (pralsetinib) as first selective RET inhibitor in China, providing a new therapy for a subset of non-small cell lung cancer patients
24 March 2021 - Gavreto is the first approved selective RET inhibitor in China and first approved precision therapy for CStone. ...
Posted by Michael Wonder on 23 Mar 2021
Everest Medicines announces acceptance of new drug application by China NMPA for Xerava for the treatment of complicated intra-abdominal infections
21 March 2021 - Everest Medicines announced today that the China National Medical Products Administration has accepted its new drug ...
Posted by Michael Wonder on 24 Feb 2021
Antengene announces new drug application for ATG-010 (selinexor) granted priority review by China's NMPA
23 February 2021 - Antengene today announced that China's National Medical Products Administration has granted priority review to the new drug ...
Posted by Michael Wonder on 23 Feb 2021
The BCMA CAR-T co-developed by Innovent and IASO was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma
22 February 2021 - Innovent Biologics today jointly announce that the Center for Drug Evaluation of China's National Medical Products Administration ...
Posted by Michael Wonder on 20 Feb 2021
Junshi Biosciences announces acceptance by the NMPA of supplemental new drug application for toripalimab combined with chemotherapy for the first-line treatment of nasopharyngeal carcinoma
19 February 2021 - Third sNDA for toripalimab in China. ...
Posted by Michael Wonder on 04 Feb 2021
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab) by China NMPA in combination with pemetrexed and platinum chemotherapy as first-line therapy for non-squamous non-small cell lung cancer
3 February 2021 - Innovent Biologics and Eli Lilly today jointly announced that the National Medical Products Administration of China has ...