BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. & WALTHAM, Mass. / Nov 21, 2023 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and Ensem Therapeutics, Inc. (ENSEM), a biotechnology company focusing on high-value and difficult-to-drug oncology targets, today announced an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor.

“We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership fits well with our strategic focus on breast cancer as an area with tremendous unmet need for innovative treatment options,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “This CDK2 inhibitor from ENSEM complements our internally discovered Phase 1 CDK4 inhibitor, which has the potential to improve upon current CDK4/6 inhibitors in some breast cancer patients, and strengthens our early development pipeline in breast cancer and other solid tumors. We are excited to work with ENSEM to bring this molecule into the clinic in the near future.”

Under the terms of the agreement, ENSEM will receive an upfront payment, and will be eligible for additional payments upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.33 billion, in addition to tiered royalties.

“We are pleased to partner with BeiGene on the development of this differentiated CDK2 inhibitor,” said Shengfang Jin, Ph.D., President and Chief Executive Officer at ENSEM. “We believe BeiGene is the right partner to advance our first IND-ready asset due to their wealth of expertise in bringing innovative cancer therapies to patients globally. This partnership validates the capabilities of ENSEM’s drug discovery and development team and the ability to rapidly advance potential best-in-class or first-in-class molecules utilizing our Kinetic Ensemble^® platform. We look forward to progressing our additional pipeline programs to help patients in need and supporting BeiGene’s important work to take this therapy into clinical trials.”

About Ensem Therapeutics

ENSEM is a pioneering drug discovery and development company that leverages its unique Kinetic Ensemble® platform to develop innovative small molecule precision medicines for oncology. ENSEM integrates computational and AI deep learning methodologies with advanced experimental techniques to identify non-obvious binding pockets and accelerate structure-based drug design, with a focus on high-value and difficult-to-drug targets.

For more information, please visit www.ensemtx.com, or engage with us on LinkedIn.

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 develop novel molecules with the potential to transform the therapeutic landscape for cancer patients; the ability of ENSEM’s CDK2 inhibitor to complement BeiGene’s CDK4 inhibitor and strengthen BeiGene’s pipeline; whether BeiGene is the right partner to advance ENSEM’s first IND-ready asset; ENSEM’s ability to rapidly advance potential best-in-class or first-in-class molecules; 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 and commercialization 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 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.