BeiGene and Shoreline Biosciences Announce Global Strategic Collaboration to Develop and Commercialize Gene-Modified Natural Killer (NK) Cell Therapies

SAN DIEGO, Calif., CAMBRIDGE, Mass., and BEIJING, June 9, 2021 /PRNewswire/ --Shoreline Biosciences, Inc. is a biotechnology company dedicated to leveraging intelligent technologies to design and develop allogeneic, off-the-shelf, standardized targeted natural killer (NK) cell and macrophage therapies using induced pluripotent stem cells (iPSCs) for the treatment of cancer and other serious diseases.BeOne Medicines(NASDAQ: BGNE; HKEX: 06160) is a global biotechnology company. The two parties today announced a global exclusive strategic collaboration, integrating Shoreline’s iPSC-derived NK cell technology with BeOne Medicines’ preclinical research and clinical development capabilities to develop and commercialize a portfolio of NK cell therapy-based products for the treatment of various malignant tumors.

Dr. Kleanthis G. Xanthopoulos, Chairman and CEO of Shoreline Biosciences, stated: “BeOne Medicines is a globally recognized leader in biotechnology, and we are thrilled about the collaboration announced today. We look forward to combining our iPSC NK cell technology with BeOne Medicines’ research and clinical development capabilities to accelerate the development of next-generation cell therapies and benefit patients worldwide.”

Under the terms of the agreement, Shoreline will receive a $45 million upfront cash payment from BeOne Medicines and will be eligible to receive R&D funding, milestone payments, and royalties upon the achievement of specified R&D, regulatory, and commercialization milestones. The parties have reached an agreement on this multi-target collaboration to jointly develop cell therapies targeting four therapeutic targets, with an option to expand the collaboration in the future. Under the collaboration framework, BeOne Medicines will lead global clinical development, while Shoreline will be responsible for clinical manufacturing. BeOne Medicines will hold global commercialization rights, while Shoreline retains commercialization rights for two of the targets in the United States and Canada. In conjunction with this agreement, subject to certain conditions, BeOne Medicines has the right to acquire a partial equity stake in Shoreline during its next equity financing round.

Mr. John V. Oyler, Co-founder, Chairman, and Chief Executive Officer of BeOne Medicines, stated: "We are excited about our collaboration with Shoreline. In addition to small molecule and antibody therapies, BeOne Medicines' transformative drug pipeline continues to expand, and we are now entering the field of off-the-shelf cell therapies. This therapeutic area remains not widely accessible in many parts of the world and warrants in-depth research and development. By partnering with Shoreline, a leader in iPSC-based allogeneic cell therapies, we aim to combine our protein engineering and modification technologies with their standardized NK cell therapy technology. We believe that this combination, together with our clinical development capabilities in solid and hematologic tumors, will enable us to bring cell therapies to more patients in need."

AboutShoreline iPSC NK`Cell Technology`

Through precise and scientifically rigorous genetic engineering, Shoreline has developed a proprietary patented technology for the development of iPSC-derived NK cell and macrophage therapies. Shoreline’s NK cell and macrophage therapies are designed as a highly effective solution to target and eliminate tumor tissue while restoring tissue homeostasis. Leveraging the advantages of Shoreline’s iPSC cell modification and expansion technologies, this approach establishes a highly efficient, affordable, and scalable manufacturing process, thereby enabling the delivery of cell therapies to patients in a more cost-effective and time-efficient manner. Leading the field of regenerative medicine, Shoreline’s technology is currently being utilized to develop therapeutic candidates for a broad spectrum of indications, including cancer, inflammatory diseases, and genetic disorders.

AboutShoreline Biosciences

Shoreline is a biotechnology company dedicated to leveraging intelligent technology to design and develop allogeneic, off-the-shelf, standardized targeted cell therapies derived from induced pluripotent stem cells (iPSCs) for the treatment of cancer and other serious diseases. Shoreline is currently focused on building a pipeline of natural killer (NK) cell and macrophage therapy candidates, drawing on its extensive expertise in iPSC differentiation methodologies and gene reprogramming of disease-related pathways. Shoreline maintains a strategic manufacturing partnership with Advanced Cell Therapy Laboratory and is backed by leading institutional investors including Boxer Capital, BVF, Commodore, Cormorant, Janus Henderson Investors, Logos, Kite (a Gilead company), Wedbush Healthcare Partners, and Stork Capital. Shoreline Biosciences is headquartered in San Diego, California.

For more information, please visithttps://shorelinebio.com/Or follow the Shoreline LinkedIn page.

About BeOne Medicines

BeOne Medicines is a science-driven global biotechnology company dedicated to developing innovative and affordable medicines to improve treatment outcomes and enhance medicine accessibility for patients worldwide. The company’s extensive portfolio currently comprises more than 40 clinical-stage candidates. By strengthening our proprietary capabilities and collaborating with external partners, we are committed to accelerating the development of our diverse and innovative drug pipeline, with the goal of comprehensively improving medicine accessibility for over 2 billion people globally by 2030. BeOne Medicines has built a team of nearly 6,000 professionals across five continents. For more information, please visitwww.beigene.com。

BeOne Medicines 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 BeOne Medicines' future development and potential commercialization plans for candidate products utilizing in-licensed technology; potential payments to Shoreline Biosciences; the potential of the in-licensed technology; and the potential benefits of the commitments and collaboration made by both parties to the agreement. Actual results may differ materially from those in the forward-looking statements due to a variety of important factors. These factors include risks relating to: BeOne Medicines' ability to demonstrate the efficacy and safety of its product candidates; the possibility that clinical results for the product candidates 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 of drugs; BeOne Medicines' ability to achieve commercial success for its marketed drugs and product candidates (if approved); BeOne Medicines' ability to obtain and maintain intellectual property protection for its drugs and technology; BeOne Medicines' reliance on third parties for drug development, manufacturing and other services; BeOne Medicines' limited experience in obtaining regulatory approval and commercializing pharmaceutical products, and its ability to secure additional working capital to complete the development of product candidates and achieve and maintain profitability; the impact of the global COVID-19 pandemic on BeOne Medicines' clinical development, regulatory, commercial operations and other business; various risks more fully discussed in the "Risk Factors" section of BeOne Medicines' most recent Quarterly Report on Form 10-Q; and discussions in BeOne Medicines' subsequent filings with the U.S. Securities and Exchange Commission regarding potential risks, uncertainties and other important factors. All information in this press release is as of the date of this press release, and BeOne Medicines undertakes no obligation to update such information unless required by law.