Shanghai, August 1, 2023 – ZB-001, a new antimicrobial drug developed by BioDuro-Sundia partners Zhiben Pharma, has received the implied license from the China CDE to initiate clinical trials. ZB-001 is a new bacterial topoisomerase inhibitor with new structure and new mechanism and global compound patent rights. It is intended to treat a variety of bacterial infectious diseases such as simple gonorrhea.
Bacterial drug resistance is considered by WHO to be one of the top ten health threats globally, and it is expected to cause 10 million deaths per year by 2050. However, new antibacterial drugs have not received sufficient awareness and support.
Preclinical studies have shown that ZB-001 has no cross-resistance with existing antibacterial drugs with significant efficacy and good dose-effect relationship in various classic infection in vivo models. Meanwhile, ZB-001 has shown rapid absorption and distribution, high oral bioavailability, and good dose-exposure relationship with no effect on animal respiratory system or cardiovascular system or nervous system in preclinical animal experiments. And the results of genotoxicity combination tests are all shown negative, presenting a good safety margin.
Dr. Mingyan Qin, Founder and General Manager of Zhiben Pharma, emphasized that ZB-001 will enrich the available clinical antibacterial drug options and provide new solutions for dealing with more severe bacterial resistance (gonococcus, Staphylococcus aureus, etc.).
"As an excellent partner of Zhiben Pharma in 2022, we sincerely congratulate ZB-001 for receiving the implicit approval of CDE," said Dr. Jim Li, President, and Global CMC Solutions (China). BioDuro-Sundia has always been committed to providing one-stop new drug R&D solutions for global biotech partners, and constantly improving service quality and platform capabilities to help partners accelerate the development milestones of new and good drugs, and ultimately add more therapy options for patients. We look forward to the early clinical trial of ZB-001, which will enrich the choice of antibacterial drugs".
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 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