BeiGene and Medison Announce Approval and National Reimbursement in Israel for BRUKINSA® (zanubrutinib) for the Treatment of Waldenström’s Macroglobulinemia

Second Regulatory Approval for BRUKINSA in Israel

PETACH TIKVA, Israel & CAMBRIDGE, Mass. & BEIJING & BASEL, Switzerland--(BUSINESS WIRE)--BeiGene (NASDAQ: BGNE; HKEX: 06160, SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Medison Pharma Ltd. a global pharma company focused on providing access to highly innovative therapies to patients in international markets ("Medison"), today announced that the State of Israel Ministry of Health has approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM). BRUKINSA is reimbursed nationally for patients with second- or third-line WM. This is the second approval for BRUKINSA in Israel, following its initial marketing and reimbursement approval in 2021 for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

“We are delighted that patients with WM in Israel will now have access to BRUKINSA, a potentially best-in-class BTK inhibitor. We are committed to expanding access to high-impact medicines on behalf of the patients who need them, all over the world. With two approvals and reimbursement coverage in Israel, we are working with Medison Pharma to bring BRUKINSA to the patients in Israel who need it,” commented Itzik Mizrahi, General Manager of Israel, at BeiGene.

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

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