BeiGene and Ensem Therapeutics Announce Collaboration to Advance a Differentiated Oral CDK2 Inhibitor for Cancer Treatment

Beijing, China; Cambridge, MA, USA; and Basel, SwitzerlandNovember 21, 2023PR Newswire -- BeOne Medicines Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and Ensem Therapeutics, Inc. ("Ensem"), a biotechnology company focused on high-value, difficult-to-drug targets in the field of oncology, jointly announced today a licensing agreement. Under this agreement, BeOne Medicines has obtained the global exclusive rights to an oral investigational cyclin-dependent kinase 2 (CDK2) inhibitor that is expected to file an Investigational New Drug (IND) application soon.

Dr. Jane Wang, Senior Vice President and Global Head of Research & Development at BeOne Medicines, stated: "BeOne Medicines is committed to developing novel molecules to improve the treatment landscape for cancer patients. There is a significant and unmet clinical need in the field of breast cancer, and this collaboration aligns perfectly with our strategic focus in that area. Ensem Therapeutics' CDK2 inhibitor complements our internally developed CDK4 inhibitor, which is currently in Phase 1 clinical trials, with the potential to enhance the therapeutic effects of existing CDK4/6 inhibitors in specific breast cancer patient populations. This also strengthens our early-stage R&D pipeline in breast cancer and other solid tumors. We look forward to working with Ensem Therapeutics to advance this molecule into clinical trials in the near future."

According to the terms of the agreement, Ensem Therapeutics will receive an upfront payment and is entitled to receive up to a total of $1.33 billion based on achieving specific R&D, registration, and commercialization milestones, as well as tiered sales royalties.

Dr. Kim Sung-bang, President and CEO of Ensem Therapeutics, stated: "We are delighted to collaborate with BeOne Medicines on the development of this differentiated CDK2 inhibitor. BeOne Medicines has extensive experience in delivering innovative anti-cancer drugs to patients worldwide, and we believe they are the ideal partner to advance Ensem’s first project nearing IND submission. This collaboration also highlights the capabilities of Ensem's drug discovery and clinical development teams, as well as our utilization of the Kinetic Ensemble platform."^®Platform, with the ability to rapidly advance potential 'best-in-class' or 'first-in-class' molecules. We look forward to progressing more pipeline projects to benefit patients in need and fully support BeOne Medicines in moving this therapy into clinical trials."

AboutOncoMed Pharmaceuticals

Ensem Therapeutics is a pioneering drug discovery company leveraging its unique Kinetic Ensemble^® Ensem Therapeutics Develops Innovative Small-Molecule Precision Oncology Therapies. Ensem focuses on high-value and difficult-to-drug targets, combining algorithms and AI deep learning methods with leading experimental techniques to discover hidden binding pockets and accelerate structure-based drug design.

For more information, please visitwww.ensemtx.com。

About BeOne Medicines

BeOne Medicines is a global biotechnology company focused on developing innovative anti-cancer drugs for cancer patients worldwide. Through strong in-house R&D capabilities and external strategic collaborations, we continuously accelerate the development of a diverse and innovative pipeline of drugs and product portfolios, committed to enhancing drug accessibility and affordability for more patients globally. Across five continents, we have a team of over 10,000 people, with major offices located in Beijing, China; Cambridge, Massachusetts, USA; and Basel, Switzerland. For more information, please visitwww.beigene.com.cnOr follow the WeChat Official Account "BeOne Medicines".

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as defined under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These include statements regarding BeOne Medicines' ability to develop novel molecules and improve the treatment landscape for cancer patients; Ensem Therapeutics’ CDK2 inhibitors complementing and strengthening BeOne Medicines' pipeline with its CDK4 inhibitor; BeOne Medicines being an ideal partner to advance Ensem’s first IND submission candidate; Ensem’s ability to rapidly advance potential best-in-class or first-in-class molecules; and the plans, commitments, aspirations, and goals of BeOne Medicines as referenced under the "About BeOne Medicines" subheading. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including: BeOne Medicines’ ability to demonstrate the efficacy and safety of its drug candidates; clinical results that may not support further development or marketing approval; actions by regulatory authorities that may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne Medicines’ ability to achieve commercial success for its marketed products and drug candidates, if approved; BeOne Medicines’ ability to obtain and maintain protection of intellectual property for its drugs and technology; BeOne Medicines’ reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne Medicines’ limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to secure additional operating capital to complete the development of its drug candidates and achieve and sustain profitability; the various risks discussed more fully under the caption “Risk Factors” in BeOne Medicines’ most recent quarterly report on Form 10-Q; and discussions of potential risks, uncertainties, and other important factors in BeOne Medicines’ 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 BeOne Medicines undertakes no duty to update such information unless required by law.