China FDA accepts zanubrutinib NDA filing for MCL

28 August 2018

China and USA-based biotech firm BeiGene (Nasdaq: BGNE) today announced the acceptance by the China Drug Administration (CDA) of a new drug application (NDA) for its zanubrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

Zanubrutinib was discovered in BeiGene's research facilities in Beijing, China, and is being developed globally by BeiGene as a monotherapy and in combination with other therapies to treat various hematologic malignancies.

News of the acceptance sent BeiGene’s share up 2.66% to HK$104.30. Earlier this month, BeiGene announced the closing of its $903 million Hong Kong initial public offering, with the proceeds earmarked for the development of its lead drug candidates zanubrutinib, tislelizumab and pamiparib, as well as to fund continued expansion of its product portfolio in cancer and potentially other therapeutic areas, and for working capital, expanding internal capabilities, and general corporate purposes.

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