September 6, 2019, Shanghai, China -- HaiHe Biopharma announced today the completion of the phase I clinical trial of RMX2001, a new antibiotic HaiHe Biopharma in-licensed from LegoChem Biosciences, Inc. (hereinafter referred to as “LCB”) in 2016 for the China territory. The objective of this study was to evaluate the safety, tolerance and pharmacokinetic characteristics of RMX2001 in the healthy Chinese adult subjects. The principal investigators were Professor Zhang Jing, Deputy Director of the Institute of Antibiotics of Huashan Hospital affiliated to Fudan University and Director of Phase I Clinical Research Office and Professor Zhang Wenhong, Director of the Infectious Diseases Department.
RMX2001 (LCB compound code: LCB01-0371, generic name: Delpazolid) is a second-generation oxazolidinone small molecule antibiotic in-licensed from LCB in 2016 for the China territory. The project has filed IND in US in January 2018 and obtained US FDA's ODD (Orphan Drug Designation), QIDP (Qualified Infectious Disease Product Designation) and Fast Track Designation. It is in phase II clinical studies for MDR-TB in South Korea, and the phase I clinical trial has been completed in China in August 2019. RMX2001 project aims to provide new treatment options for MDR-TB patients and develop additional indications for Gram-positive bacterial infections in parallel.
Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, “Inclusive and open to diversity, innovation oriented to win together and benefit the mankind”, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and validation, medical strategy and clinical study, etc. The company has established a globally competitive innovative drug R&D system and robust product pipeline. There are 7 compounds in clinical and 3 compounds in preclinical studies, among which 7 compounds are discovered in-house.
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LegoChem Biosciences (KOSDAQ: 141080) is a biopharmaceutical company focusing on the development of next generation novel therapeutics utilizing its proprietary medicinal drug discovery technology ‘LegoChemistry’ & ADC platform technology ‘ConjuAll’. Since its foundation in 2006 LCB has focused on the research and development of ADC (Antibody-Drug Conjugate), Anti-biotics, Anti-coagulants & Anti-cancer therapeutics based on proprietary platform technologies. Its lead antibiotic candidate Delpazolid (LCB01-0371) had shown efficacy & safety over various gram-positive super-bacteria including MDR-TB, MRSA & VRE through preclinical & clinical trial phase I studies and currently in clinical trial phase II for TB in oral formulation in South Korea. Delpazolid has been granted qualified infectious disease product (QIDP), fast track designation and orphan drug designation by the US FDA.
Please visit the company website for more information:?http://www.dhpharm.co.kr