Shanghai, June 30, 2023 – Salubris Pharmaceuticals, a partner of BioDuro-Sundia, announced that an investigational new drug (IND) application for SAL0119 has been accepted by the FDA.
SAL0119 is an oral small molecule immunosuppressant independently developed by Salubris Pharmaceuticals. Currently, it is developed for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA). SAL0119’s IND application was approved by the National Medical Products Administration (NMPA) in January 2023, and phase I clinical trials are being conducted in China.
AS and RA share many characteristics, including a long course of the disease, a tendency to relapse, and a need for lifelong treatment, which seriously impact patients' physical and mental health and quality of life.
BioDuro-Sundia works closely with Salubris Pharmaceuticals and maintains a good partnership in drug discovery. Salubris Pharmaceuticals has an excellent innovative drug development team adopting scientific and efficient screening methods, combining with BioDuro-Sundia's mature and stable animal models, successfully completed the SAL0119 IND application research. Salubris Pharmaceuticals stated that SAL0119 has a unique mechanism of action different from JAK and broad-spectrum cytokine inhibition, and it showed good efficacy and safety in preclinical studies.
John Liu, Head of BioDuro-Sundia Non-Tumor Pharmacology Department, described BioDuro-Sundia's adherence to a science-driven approach to support new drug discovery. "At present, the Oncology Department and Pharmacology Department have built mature disease models in many therapeutic areas including tumors, immune inflammation, cardiovascular metabolic diseases, neurological diseases, and rare diseases, which can be used for pharmacological efficacy research of different mechanisms. We will continue to expand our models, and help our partners discover new drugs with advanced and 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 10 global sites across 7 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