Golidocitinib approved in China as first in class JAK1 only inhibitor for the treatment of relapsed or refractory peripheral T-cell lymphoma

19 June 2024 - Golidocitinib is a first-in-class Janus kinase 1 only inhibitor approved for the treatment of relapsed/refractory PTCL based ...

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Ivonescimab in combination with chemotherapy approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A clinical trial: positive trend observed in overall survival towards ivonescimab plus chemotherapy

31 May 2024 - Separate and distinct from HARMONi-2 announcement, HARMONi-A showed clinically meaningful and statistically significant benefit: progression-free survival hazard ...

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Zai Lab announces approval of Augtyro (repotrectinib) for patients with ROS1 positive NSCLC by China’s NMPA

12 May 2024 - The approval is based on the pivotal TRIDENT-1 trial, in which Augtyro achieved a high response ...

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China's National Medical Products Administration accepts Astellas and Pfizer's supplemental biologics license application for enfortumab vedotin with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer

28 March 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing ...

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NMPA approves the NDA for CARsgen's BCMA CAR-T therapy zevorcabtagene autoleucel for relapsed or refractory multiple myeloma

1 March 2024 - CARsgen Therapeutics announces that today the National Medical Products Administration of China has approved the new drug ...

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Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype

10 January 2024 - Approval based on a separate Phase 3 trial among Chinese patients reinforcing mepolizumab’s efficacy and safety ...

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Leqembi approved for the treatment of Alzheimer's disease in China

9 January 2024 - BioArctic's partner Eisai announced today that Leqembi (lecanemab-irmb) has been approved in China as a treatment for ...

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Beyfortus approved in China for the prevention of RSV disease in infants

2 January 2024 - First and only RSV preventive option authorised for use in China ...

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Takeda announces China NMPA approval of Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus refractory to prior therapies

21 December 2023 - Approval based on Phase 3 TAK-620-303 SOLSTICE study demonstrating maribavir was superior to conventional therapies at week ...

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RemeGen announces continued inclusion of telitacicept and disitamab vedotin in China National Reimbursement Drug List, ensuring continuous accessibility of innovative drugs for more patients

18 December 2023 - RemeGen has recently confirmed that under the 2023 simple renewal mechanism of China National Healthcare Security ...

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AnHeart Therapeutics and Innovent Announce China’s NMPA has granted taletrectinib (ROS1 inhibitor) priority review designation

18 December 2023 -AnHeart Therapeutics and Innovent Biologics today announced the Center for Drug Evaluation of China’s National Medical Products ...

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Zai Lab announces the first listing of Vyvgart (efgartigimod alfa) and other updates in China’s National Reimbursement Drug List

12 December 2023 - Zai Lab today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare ...

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Antengene announces inclusion of Xpovio (selinexor) in 2023 China's National Reimbursement Drug List

13 December 2023 - Antengene today announced that Xpovio (selinexor) has been added to the National Reimbursement Drug List (2023 Version) ...

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Hutchmed announces continued inclusion of Elunate (fruquintinib) and Sulanda (surufatinib) in the National Reimbursement Drug List in China at current terms

12 December 2023 - Hutchmed today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration, ...

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CStone announces NMPA approval of sugemalimab as first-line treatment for oesophageal squamous cell carcinoma

8 December 2023 - This marks the 13th new drug application approval obtained by CStone and sugemalimab's fourth indication approved in ...

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