PD-1 inhibitor tislelizumab under review by Brazil’s National Health Surveillance Agency to treat non-small cell lung cancer and esophageal cancer

Future regional expansion planned in Argentina, Mexico, Chile, Colombia, Uruguay, and other countries

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the first major step in the company’s expansion in Latin America (LATAM) with the formal opening of its office in São Paulo, Brazil.

The São Paulo office will house BeiGene administrative, commercial, and clinical operations colleagues in Brazil, which is the largest oncology market in LATAM with approximately 53% of all patients in the region.

“Expanding our global footprint into LATAM advances BeiGene’s global growth and commitment to providing affordable and accessible medicines to more patients around the world,” said John V. Oyler, Chairman, Co-Founder and CEO at BeiGene. “Our office in São Paulo is the first step in a planned broader expansion in LATAM, and we are excited about the opportunity to serve patients in this critical region of the world.”

“As the largest market in LATAM with significant unmet need, Brazil represents a crucial foothold in the global fight against cancer,” said Alex Carvalho, General Manager of Brazil at BeiGene. “We are excited to build our presence here in Brazil as we continue to develop and deliver highly innovative medicines for patients.”

Earlier this year, BeiGene submitted tislelizumab, a potentially differentiated anti-PD-1 immunotherapy, for review by Brazil’s National Health Surveillance Agency (Anvisa) to treat non-small cell lung cancer and esophageal cancer.

BeiGene is building a robust clinical trial footprint in Brazil as part of the company’s global clinical development program that has enrolled more than 20,000 patients to date in more than 45 markets. BeiGene is currently seeking local approval for patient enrollment in Brazil for 12 ongoing global clinical trials, including pivotal and registrational studies, for tislelizumab and BTK inhibitor BRUKINSA^® as well as multiple investigational therapies including TIGIT inhibitor ociperlimab, BCL-2 inhibitor BGB-11417 and first-in-class OX40 agonist BGB-A445.

The Company is developing plans for future LATAM regional expansion in Argentina, Mexico, Chile, Colombia, Uruguay, and other countries.

About BeiGene

BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more 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 9,000 colleagues spans five continents, with administrative offices in Basel, Beijing and Cambridge, Mass. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

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 the potential for BeiGene’s expansion in Latin America to provide affordable and accessible therapies for patients, the approval of tisleizumab by Anvisa, BeiGene’s future clinical trial footprint in Brazil, BeiGene’s expansion plans in Latin America 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 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 the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230413005329/en/