BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Follicular Lymphoma

CHMP recommends approval for BRUKINSA plus obinutuzumab as a treatment for adult patients who have received at least two prior lines of therapy

If approved, BRUKINSA will be the first and only BTK inhibitor approved for follicular lymphoma

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE #BeiGene–BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of BRUKINSA^® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.

“Follicular lymphoma remains an incurable disease and an ongoing challenge for healthcare providers. Despite advances in the treatment landscape, patients often relapse and experience shorter response times to subsequent treatments,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “Today’s positive CHMP opinion is a testament to our continued commitment to bringing innovative medicines to patients and demonstrates the value of BRUKINSA, which – if approved in FL – will become the BTK inhibitor with the broadest label in the EU.”

The CHMP recommendation is based on positive results from the ROSEWOOD study and supported by the BGB-3111-GA101-001 study. The pivotal ROSEWOOD study (BGB-3111-212; NCT03332017) is an ongoing global Phase 2 study of BRUKINSA plus obinutuzumab compared with obinutuzumab alone in 217 patients with R/R FL who received at least two prior lines of systemic therapy. In the randomized, open-label study, the overall response rate was 69.0% in the BRUKINSA plus obinutuzumab arm versus 45.8% in the obinutuzumab arm (p = 0.0012), with a median follow-up of approximately 20 months. BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines. BGB-3111-GA101-001 (NCT02569476) is a Phase 1b study designed to assess the safety, tolerability and antitumor activity of BRUKINSA with obinutuzumab in participants with B-cell lymphoid malignancies.

Following the CHMP positive opinion, the European Commission will consider BeiGene’s Marketing Application, with a final decision expected within 67 days. The decision will be applicable to all 27 member states of the European Union (EU), plus Iceland and Norway.

BRUKINSA is currently approved in the EU as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia and as monotherapy for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy. It is also approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities in the United States and China. Additionally, BeiGene’s submission for BRUKINSA in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom as part of the Access Consortium New Active Substance Work-sharing Initiative.

BRUKINSA is approved in more than 65 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland in selected indications and under development for additional approvals globally. Product information may differ from country to country. Prescribers should consult the product information approved in their respective countries. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

About Follicular Lymphoma

FL is the second most common type of non-Hodgkin lymphoma (NHL), accounting for 22 percent of all NHL cases.ⁱ Across Europe, over 122,000 people each year are diagnosed with NHL.ⁱⁱ FL is a slow-growing cancer but can become more aggressive over time. While FL remains incurable, people with the condition can live a long time. The five-year survival rate is about 90 percent, and approximately half of people diagnosed with FL can live with the disease for nearly 20 years.^iii,iiii

About BRUKINSA^® (zanubrutinib)

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. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete 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.

About BeiGene

BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, Cambridge, and U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s commitment to bring innovative medicines to patients; BeiGene’s advancement, anticipated clinical development, regulatory submissions and commercialization of zanubrutinib, particularly as a treatment for R/R FL; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

References

ⁱLeukemia & Lymphoma Society. Treatment for Indolent NHL Subtypes. Available at: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes/treatment-indolent-nhl-subtypes.

ⁱⁱWorld Health Organization. Non-Hodgkin lymphoma. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/34-Non-hodgkin-lymphoma-fact-sheet.pdf.

ⁱⁱⁱAmerican Cancer Society. Survival Rates and Factors That Affect Prognosis (Outlook) for Non-Hodgkin Lymphoma. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/detection-diagnosis-staging/factors-prognosis.

^ivCarton, G, et al., Time for an Individualized Approach to First-Line Management of Follicular Lymphoma. Haematologica. 2022. Vol 107 No. 1.

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