Merck’s Keytruda (pembrolizumab) approved in China in combination with chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic oesophageal or gastro-oesophageal junction carcinoma

7 September 2021 - Keytruda is now approved for eight indications across five different types of cancer in China. ...

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JW Therapeutics announces NMPA approval of relmacabtagene autoleucel injection in China

6 September 2021 - The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and ...

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CStone announces China's NMPA has accepted its new drug application for sugemalimab in the treatment of stage III NSCLC

2 September 2021 - Sugemalimab becomes the world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage ...

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Ligand’s Partner Gloria Biosciences receives approval in China for zimberelimab for the treatment of recurrent or refractory classical Hodgkin’s lymphoma

31 August 2021 - First regulatory approval of an OmniAb derived antibody. ...

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BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in nasopharyngeal cancer

22 August 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...

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BeiGene and EUSA Pharma announce China NMPA approval of Qarziba (dinutuximab beta) for patients with high risk neuroblastoma

17 August 2021 - BeiGene and EUSA Pharma today announced that the China National Medical Products Administration has granted Qarziba (dinutuximab ...

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Novartis secures new approval in China for Cosentyx (secukinumab) in paediatric psoriasis

17 August 2021 - China NMPA approval reinforces that Cosentyx (secukinumab) is safe and effective for children and adults with psoriasis. ...

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GC Pharma announces GreenGene F approval in China for the treatment of haemophilia A

12 August 2021 - GreenGene F now approved in China, provides more haemophilia A patients access to proven therapy. ...

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New drug application for penpulimab monoclonal antibody (PD-1) for third-line treatment of metastatic nasopharyngeal carcinoma accepted by NMPA

5 August 2021 - Akeso announced that the new drug application of penpulimab (AK105) for third-line treatment of metastatic nasopharyngeal ...

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RareStone announces submission of new drug application of Wakix (pitolisant) for narcolepsy with and without cataplexy in China

21 July 2021 - Application is supported by data used in the Wakix EMA and the U.S. FDA approvals. ...

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Sorrento announces its partner Mabpharm has received marketing approval in China for infliximab biobetter

20 July 2021 - Sorrento to exclusively market the product outside of China including US, Japan and Europe. ...

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Imfinzi approved in China for the treatment of extensive-stage small cell lung cancer

19 July 2021 - Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination ...

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BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in oesophageal squamous cell carcinoma

7 July 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...

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Y-mAbs announces NMPA submission of BLA for Danyelza (naxitamab-gqgk) in China

6 July 2021 - Y-mAbs Therapeutics today announced that SciClone Pharmaceuticals has submitted the biologics license application for Danyelza (naxitamab-gqgk) for ...

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Innovent announces the China NMPA approval of Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar injection) as first-line therapy for people with hepatocellular carcinoma

28 June 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has approved the supplemental ...

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