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Medicilon Assists Neupharma's RX108 to Enter Phase I Clinical Trials

2019-12-27
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Recently, Suzhou Neupharma, an important partner of Shanghai Medicilon, announced that RX208 China phase I clinical research has completed the administration of the first patient in Shanghai Dongfang Hispital.

It is reported that RX208 is the third Class 1 new drug independently developed by Neupharma to enter clinical trials after RX108 and RX518. Among them, RX108 is undergoing clinical trials in China and Australia. Medicilon is honored to undertake the whole set of studies on preclinical pharmacokinetics and safety evaluation of RX108. Medicilon's colleagues overcame difficulties, fought continuously, actively took effective measures to solve various problems encountered in each stage, and made every effort to promote the high-quality and efficient completion of the project.

Medicilon’s preclinical research is one of the three core business segments of Medicilon. Our company has comprehensive preclinical new drug research and development capabilities, providing customers with one-stop pharmaceutical preclinical research and development services from lead compound screening and optimization to new drug clinical approval application, becoming a major domestic comprehensive CRO company covering all processes of new drug preclinical research and development. In preclinical research, the company introduced international high-end precision instruments and equipment to carry out pharmacokinetics and bioanalysis (DMPK) services earlier in China, and established unique analysis methods for a large number of chemical drugs and biological drugs, providing efficient and efficient research and development of new drugs throughout the cycle. High-quality pharmacokinetic outsourcing services, complete the DMPK screening of thousands of compounds every year, and support the FDA/NMPA/TGA clinical trial application (IND) for more than one hundred new drugs; in terms of drug safety evaluation, the company's preclinical drug safety evaluation service has established a drug safety evaluation quality management system that complies with international and domestic GLP specifications. It has systematic evaluation techniques covering multiple toxicity endpoints, including evaluation models and key technologies for general acute toxicity, long-term toxicity, reproductive toxicity, genotoxicity, immunogenicity, local toxicity, safety pharmacology, and carcinogenicity. According to the characteristics of different types of innovative drugs, formulate personalized integrated evaluation research strategies, Medicilon also has an integrated evaluation technology platform for specialty drugs such as inhaled drugs, ophthalmic drugs, and ADC biomacromolecular drugs.

Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

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