Regulatory marketing applications for U.S. and EU under review, with plans to expand TEVIMBRA commercial presence worldwide

TEVIMBRA is the cornerstone of BeiGene’s solid tumor portfolio, potentially pairing with more than 20 internal investigational assets as part of a broad, flexible combination strategy

Regaining global rights furthers Company’s mission of bringing innovative, affordable medicines to more patients and addressing areas of high unmet need

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--$BGNE #BeiGene--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA (tislelizumab).

“We are excited to regain the global rights to TEVIMBRA, which enables us to build out our in-house solid tumor commercial capabilities and complements our deep pipeline presented at our recent R&D Day. With more than 12,000 patients enrolled in our TEVIMBRA global clinical trial program, we plan to rapidly accelerate our regulatory and development plans across a wider range of tumor types,” said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. “BeiGene will continue to work with Novartis on development, regulatory and manufacturing priorities. Novartis will manufacture TEVIMBRA for many markets worldwide and explore its potential in combination with their oncology assets.”

BeiGene has launched more than 20 potentially registration-enabling trials with TEVIMBRA, of which 10 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts. Through these trials, TEVIMBRA has demonstrated its ability to safely deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types – in many cases, regardless of PD-L1 status – both as a monotherapy and in combination with other regimens. More than 750,000 patients have been prescribed TEVIMBRA to-date.

“TEVIMBRA is the backbone of our diverse solid tumor development pipeline focused on developing novel combination regimens with precision medicine targets – such as OX40, HPK1, and LAG3 – in our next wave immuno-oncology portfolio. It also nicely complements our diversified research portfolio, which includes additional modalities such as antibody drug conjugates and bispecific antibodies, many of which have blockbuster potential,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “We are eager to continue to explore TEVIMBRA’s full potential to address unmet clinical needs around the world, including in combination with our deep and diverse solid tumor pipeline, which has over 20 immuno-oncology and targeted molecules that could be paired with TEVIMBRA to help more patients.”

Terms of the Agreement

The parties mutually agreed to terminate the previous collaboration and license agreement entered into on January 11, 2021, and, pursuant to the new agreement, BeiGene regained full global rights to TEVIMBRA with no royalty payments due to Novartis. In addition, Novartis will provide transition services and support to BeiGene to enable key aspects of the TEVIMBRA development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support. BeiGene has agreed to provide Novartis with ongoing clinical supply of TEVIMBRA to support its clinical trials.

Under the previous agreement, BeiGene and Novartis were jointly developing TEVIMBRA in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Under the agreement, Novartis was responsible for regulatory submissions and had the right to commercialize in these licensed countries following regulatory approval.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

TEVIMBRA is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is reviewing a marketing authorization application for TEVIMBRA as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated locally advanced or metastatic NSCLC. Regulatory submissions for TEVIMBRA are also under review by authorities in the U.K., Australia, China, New Zealand, Brazil, Korea, Switzerland, Israel and Indonesia. Tislelizumab is approved as a treatment in 11 indications in China and is the leading PD-1 inhibitor in the country.

The tislelizumab development program encompasses 21 registration-enabling clinical trials in more than 30 countries and regions. To date, BeiGene has announced positive readouts from 10 Phase 3 pivotal studies across multiple tumor types and disease settings such as NSCLC, small cell lung cancer, gastric cancer, ESCC, hepatocellular cancer, and nasopharyngeal cancer. More information on the clinical trial program for tislelizumab can be found at: https://www.beigene.com/en-us/science-and-product-portfolio/pipeline.

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, and Cambridge, 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 ability to build out in-house solid tumor commercial capabilities; BeiGene’s plan to rapidly accelerate regulatory and development plans across a wider range of tumor types; the future development, regulatory filing, approval and commercialization of TEVIMBRA; 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.

Contacts

Investor:
Liza Heapes

+1 857-302-5663

[email protected]

Media:
Kyle Blankenship

+1 667-351-5176

[email protected]