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Global new Drug R&D express: AstraZeneca selumetinib,BeiGene zanubrutinib,Edralbrutinib

1. Astra Zeneca's Selumetini Approved for the Neurofibromatosis Type 1 and Plexiform Neurofibromas in China

AstraZeneca announced Koselugo (selumetinib) has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. Koselugo has become the first and only approved treatment in China for rare and progressive genetic condition, which can result in growth of benign tumours along nerves throughout the body. The approval by the NMPA in China was based on positive results from the SPRINT Stratum 1 trial. The results showed Koselugo demonstrated an ORR of 66% in paediatric patients with PNs in NF1.

2 BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China

BeiGene announced the NMPA approved 4 applications for zanubrutinib, including two sNDA for treatment-naïve adults with CLL or SLL and Waldenström's macroglobulinemia (WM), and two Supplemental Applications for conversions from conditional approval to regular approval. The new approvals of BRUKINSA for CLL/SLL are supported by data from SEQUOIA (NCT03336333), in patients with previously untreated CLL/SLL. The new approvals of BRUKINSA for WM are based on data from ASPEN (NCT03053440), the first and only global Phase 3 head-to-head clinical trial of BTK inhibitors in WM.

3 Hengrui Medicine Received FDA Orphan Drug Designation for Edralbrutinib for the Treatment of Neuromyelitis Optica

Hengrui Medicine announced the US FDA granted Orphan Drug Designation for Edralbrutinib for the Treatment of Neuromyelitis Optica (NMOSD). Edralbrutinib is a highly potent, novel, irreversible second-generation oral BTK inhibitor. Edralbrutinib could selectively inhibit the activation, proliferation and survival of B cells, which are key pathologies in neuromyelitis optica spectrum disease (NMOSD).



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