BeiGene acquires exclusive option for global license to investigational antibody drug conjugate; DualityBio to continue preclinical research activities and support Investigational New Drug filing

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. & SUZHOU, China & SHANGHAI--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and DualityBio, a next-generation ADC company, today announced an agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors.

“With one of the industry’s leading global oncology research teams, we are investing in highly impactful therapeutic modalities such as ADCs that complement our dynamic and growing pipeline in solid tumors,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our end-to-end ADC manufacturing capabilities.”

“Duality is dedicated to becoming a leading next-generation ADC company, and the assets built upon our DITAC platform show encouraging efficacy and safety in preclinical as well as global clinical studies,” said John Zhu, Ph.D., CEO at DualityBio. “We are excited to partner with BeiGene to accelerate the development of this asset. In combining the strengths of BeiGene and Duality, we believe more breakthrough ADC medicines will be brought to patients worldwide.”

Under the terms of the agreement, DualityBio will receive an upfront payment, and will be eligible for a payment contingent upon BeiGene exercising its option and additional payments based upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.3 billion, in addition to tiered royalties. Upon exercising its option, BeiGene will hold global clinical, manufacturing, and commercial rights while DualityBio will perform all research activities through IND-enabling studies and support future IND filings by BeiGene.

About DualityBio

DualityBio is a clinical-stage company focusing on the discovery and development of the next generation ADC therapeutics for patients with cancer and autoimmune diseases. DualityBio has successfully established a number of next-generation ADC technology platforms with global intellectual property rights. Building upon deep understanding of disease biology and translational capability, DualityBio has advanced four assets into global clinical studies, and developed more than 10 innovative product candidates that are currently in preclinical stage. Additionally, DualityBio is continuing to evolve its novel protein engineering and ADC technology platforms for the next wave of “super ADC” molecules including diverse payload classes, bispecific ADCs and dual-payload ADCs. To learn more about DualityBio, please visit www.dualitybiologics.com.

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 9,400 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. 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 future payments under the terms of this agreement, future IND filings for the asset, future clinical, manufacturing or commercial activities within the scope of the agreement, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230710061783/en/

Investor Contact
Liza Heapes
+1 857 302-5663
Ir@beigene.com

Gabrielle Zhou
+1 908 306-9922
Ir@beigene.com

Media Contact
Kyle Blankenship
+1 667 351-5176
media@beigene.commedia

DualityBio Contact
Business Development
bd@dualitybiologics.com

Source: BeiGene