Shanghai, December 15, 2023 - The pre-formulation team of BioDuro-Sundia Formulation Department has been awarded the "2023 Outstanding Contribution Award" for its outstanding performance in Asieris' new drug R&D programs. Thanks to BioDuro-Sundia’s technical expertise and quality service during 2023, we are honored to receive recognition from our valued client this year.
Asieris Pharmaceuticals is a global biopharma company specializing in discovery, development, and commercialization of innovative drugs for the treatment of genitourinary tumors and other related diseases. This year, the company's core products under development, APL-1706, APL-1702 and APL-1202, have each achieved several positive clinical results. Recently, the New Drug Application (NDA) for APL-1706 (Hexvix®), a drug for the diagnosis and management of bladder cancer, has been formally accepted by the National Medicinal Products Administration (NMPA). APL-1702 (Cevira®) successfully met its primary endpoint during its multinational Phase III clinical trial and is expected to be the world's first non-surgical product with proven efficacy against cervical HSIL. APL-1202 (Vesique®) is the first oral targeted therapy for non-muscle invasive bladder cancer (NMIBC) to enter multinational pivotal/phase III clinical trials.
Ms. Lanping Zhou, CMC Manager of Asieris, said, "The pre-formulation team of BioDuro-Sundia is very rigorous in the handling of candidate compounds and professional in communicating about the project. The results delivered have strengthened my confidence in our future collaboration." Dr. Shenyi Shi, Associate Director of BioDuro-Sundia Formulation Department, said, "We are very glad to establish the long-term and mutual trust with Asieris, and BioDuro-Sundia will continue to complete each project with high standards and high quality. We look forward to utilizing our one-stop integrated solutions to accelerate and empower innovation at Asieris Pharmaceuticals."
BioDuro-Sundia is committed is to provide global biopharmaceutical companies with an integrated one-stop service platform for new drug R&D services and professional technical support. The Formulation Department consists of Pre-Formulation, Formulation R&D and Clinical materials and Commercial manufacturing, including several unique proprietary technology platforms such as the Solution Engine 2.0 (Bioavailability Enhancement) and the Modified Release Platforms. The Formulation team with experienced technical professionals, has established quality management system, and standardized project workflows to provide a full range of services from preclinical development to commercial manufacturing. Looking forward, BioDuro-Sundia will continue to invest in our Formulation capabilities and help our partners to develop new drugs with high quality technical services.
BioDuro-Sundia, an Advent International portfolio company, is a trusted, leading contract research development, and manufacturing organization (CRDMO) for over 27 years. We provide our biotech and pharmaceutical partners with fully integrated services to support their efforts from target identification through to commercial drug product manufacturing. The company is based in the US and China with more than 3,000 employees and 9 global sites across 6 cities.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The one-stop-shop operation helps biotech and pharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes. We adhere to one global highest standard of compliance and business operation code. Our science-driven, customer-oriented, people-focused culture enables us to provide top-tier integrated, fast, and flexible tailored services to our customers, to meet their unique needs and accelerate development timelines. For more information, please visit www.bioduro-sundia.com.