News Release

Asieris and BeiGene Enter into Clinical Collaboration to Evaluate Combinations of APL-1202 and Tislelizumab

Shanghai, China, May 6, 2021 – Asieris Pharmaceuticals (“Asieris”) and BeiGene, Ltd. (“BeiGene”) today announced that they have entered into a clinical collaboration agreement to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC). Asieris plans to submit INDs in China and United States for an open-label, multi-center Phase I/II clinical study with primary objectives including: to evaluate the safety in MIBC patients; determine the RP2D (recommended phase 2 dose), and efficacy as neoadjuvant therapy for MIBC.

APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It has been approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with high expression of PD-L1 who have failed to receive platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that has progressed within 12 months.

“We are excited to collaborate with BeiGene to further explore the potential of APL-1202,” said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. “We found that synergistic effects of APL-1202 and immunotherapies have been shown in orthotopic prostate cancer and MIBC efficacy animal models. Based on these preclinical data, we hope that this clinical trial will prove the concept of APL-1202’s activity in modulating tumor microenvironment, and believe that APL-1202 in combination with tislelizumab could be an effective neoadjuvant therapy for patients with MIBC.”

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 5,400+ employees around the world are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market additional oncology products in China licensed from Amgen Inc.; Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company; and EUSA Pharma; and have entered a collaboration with Novartis Pharma AG for Novartis to develop and commercialize tislelizumab in North America, Europe, and Japan. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.

About Asieris

Asieris Pharmaceuticals, founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.