Four poster presentations at SABCS provide a first look at BeiGene’s breast cancer portfolio

Phase 1a data show promising safety and tolerability for CDK4 inhibitor BGB-43395 in HR+/HER2− breast cancer

Company to host an investor call on Monday, December 16^th at 8:30 a.m. EST to discuss ASH and SABCS presentations

SAN MATEO, Calif. – December 12, 2024 -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today shared new data on its emerging breast cancer portfolio following its first-ever presentations at the San Antonio Breast Cancer Symposium (SABCS). Poster presentations included first-in-human data for BeiGene’s investigational cyclin-dependent kinase (CDK) 4 inhibitor BGB-43395 in hormone receptor- positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Two posters highlighting the designs of in-progress trials for BGB-43395 and CDK2 inhibitor BG-68501/EXT-197 and a poster detailing the preclinical characterization of BGB-43395 were also presented.

“Despite treatment advances, breast cancer remains the fourth leading cause of cancer mortality worldwide and the number one cause of cancer death in women,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “We are advancing a robust portfolio of investigational medicines for breast cancer and are pleased to share our first clinical data for our investigational CDK4 inhibitor BGB-43395 at SABCS. We’ve made tremendous progress with this program, having enrolled over 100 patients in the first year of clinical development, and the early results are encouraging. We look forward to continuing its development alongside other molecules in our breast cancer pipeline, including additional cell cycle dependent kinase inhibitors and ADCs.”

BeiGene’s breast cancer pipeline features cell cycle dependent kinase inhibitors designed to potentially deliver better efficacy and reduced toxicity than currently available options, initially for HR+/HER2- disease. CDK inhibitors target checkpoint proteins that control cell division to stop the growth of cancer cells. Widely used CDK4/6 inhibitors have been shown to provide substantial clinical benefit for patients with certain breast cancers. However, dose-limiting toxicities, thought to be the result of CDK6 inhibition, and the development of resistance mutations, curb the utility of these medicines. BeiGene’s CDK4 inhibitor, BGB-43395, is highly potent and selective for CDK4 relative to CDK6, and it has the potential to reduce dose-limiting toxicities, improving tolerability while achieving comparable or better efficacy.

BGB-43395 is being investigated in an ongoing phase 1 study (NCT06120283). Early safety and tolerability data for 65 patients with metastatic HR+/HER2- breast cancer or other advanced solid tumors who received BGB-43395 either as monotherapy or in combination with fulvestrant or letrozole in escalating dose cohorts were presented in a poster at SABCS. To date, the results indicate that BGB-43395 has been generally well tolerated across different dose levels, with encouraging early signs of clinical activity emerging. The data support continued development; more than 100 patients have been enrolled to date across the program, and further results of ongoing studies will be presented at future scientific conferences.

Complementing BGB-43395, BeiGene’s CDK2 inhibitor, BG-68501/EXT-197, targets elevated CDK2 activity, which is a key resistance mechanism to CDK4/6 inhibition in HR+/HER2- breast cancer. BG-68501 is currently being evaluated in a first-in-human Phase 1 study (NCT06257264). In addition to small molecule cell cycle dependent kinase inhibitors, BeiGene’s pipeline in breast and gynecologic cancers includes novel antibody-drug conjugates (ADCs) and other molecularly targeted agents and modalities. BG-C9074, an ADC targeting the B7H4 protein, which is broadly expressed in breast and gynecologic cancers, is currently in Phase 1 development (NCT06233942). BeiGene also plans to evaluate the potential of BCL2 inhibition in breast cancer, with next-generation BCL2 inhibitor BGB-21447 expected to begin clinical testing in solid tumor indications soon. Multispecific antibodies and targeted protein degraders with potential applications in breast cancer are among the preclinical assets being developed.

BeiGene recently launched the Cancer Has No Borders podcast, featuring engaging discussions on the world of oncology and BeiGene. The first episode features Claire Saxton, Executive Vice President, Insights & Impact at Cancer Support Community (CSC), and BeiGene’s Dr. Lanasa discussing the unmet need in breast cancer, the realities of the current treatment landscape, and the need for innovation. CSC is a global nonprofit that uplifts and strengthens people impacted by cancer by providing support, fostering compassionate communities, and breaking down barriers to care. Listen on podcast platforms: Apple Podcasts, Spotify, iHeartRadio, Amazon, and YouTube.

BeiGene will host an investor conference call and webcast on Monday, December 16th, 2024, at 8:30 a.m. EST to discuss recent data presented at the American Society of Hematology 2024 Annual Meeting and at SABCS. A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at http://ir.beigene.com, http://hkexir.beigene.com, or https://sseir.beigene.com. An archived replay will be available for 90 days following the event.

The Company recently announced its intent to change its name to BeOne, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.

About Breast Cancer

Breast cancer accounts for close to one in four cancer cases and one in six cancer deaths in women worldwide.¹ Globally, breast cancer is the second most common cancer and the fourth highest cause of cancer mortality as well as the leading cause of cancer death in women.¹ More than 2.3 million patients were diagnosed with breast cancer in 2022, and over 666,000 deaths were reported globally.¹ Approximately two-thirds of breast cancer cases are the HR+/HER2- subtype.²

About BeiGene

BeiGene, which plans to change its name to BeOne Medicines, is a global oncology company that is discovering and developing innovative 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 nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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 advancement of BeiGene’s pipeline in breast and gynecologic cancers; the future development and results of BeiGene’s CDK4 inhibitor; BeiGene’s clinical testing of BGB-21447; 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; BeiGene’s 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.