On October 26, 2022 BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported significant progress in efforts to unlock global opportunities for BRUKINSA (zanubrutinib) with recent regulatory approvals in six Latin American countries (Press release, BeiGene, OCT 26, 2022, View Source [SID1234622412]):

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Argentina Relapsed/refractory (r/r) mantle cell lymphoma (MCL)
Chile r/r marginal zone lymphoma (MZL) and Waldenström’s macroglobulinemia (WM)
Ecuador r/r MZL and WM
El Salvador r/r MCL, r/r MZL, and WM
Mexico r/r MCL
Paraguay r/r MCL
"It has only been one year since the first approval for BRUKINSA in Latin America and these approvals, including the most recent in Argentina, demonstrate our drive to accomplish our mission and broaden access to innovative medicines," said Eduardo Molinari, Senior Director of New Market Development in Latin America at BeiGene. "I look forward to collaborating with our partner, Adium, on commercialization activities to provide this important treatment option to people living with MCL, MZL, and WM in Latin America."

Dr. Maria Silvana Cugliari, Head of Hematology, Angel Roffo Institute of Oncology University of Buenos Aires, Argentina commented, "BTK inhibition has proven to be a highly effective treatment strategy for a number of indolent B-cell malignancies and BeiGene’s expansive clinical development program for BRUKINSA in multiple indications has provided evidence of strong efficacy and durable response rates, along with a consistent safety profile."

The announcement of regulatory approvals for BRUKINSA in Latin America follows a recent positive CHMP Opinion for BRUKINSA as a treatment for chronic lymphocytic leukemia (CLL) in the European Union.

About BRUKINSA

BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,500 subjects in 35 trials across 28 markets. To date, BRUKINSA has received approvals covering more than 55 countries and regions, including the United States, China, the EU, Switzerland, Great Britain, Canada, Australia, and additional international markets.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology, and solid tumor targeted therapies, and immuno-oncology are key focus areas for the Company, with both monotherapies and combination therapies prioritized in our research and development. BeiGene currently has three licensed medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Switzerland, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis oncology products across designated regions of China.