On July 28, 2021, the Class 1 innovative drug LDS tablets developed by Shanghai Leado Pharma Technology Co., Ltd. (Leado Pharma) received the National Medical Products Administration (NMPA) Clinical Trial Approval Notice.
Shanghai Medicilon Inc. (Medicilon) provided a full set of preclinical research services including pharmacokinetics and safety evaluation in the development of LDS tablets. Medicilon successfully assisted China’s first targeted transient receptor LDS, a small molecule inhibitor of potential channels, to enter the clinical trial stage.
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.
LDS tablets are a class 1 innovative drug with global intellectual property rights incubated from the ion channel drug research and development platform of Leado Pharma. It is used for the treatment of fibromyalgia by selectively targeting transient receptor potential channels. LDS tablets have the advantages of good analgesic effect, no addiction and no respiratory depression. At present, there are limited treatment options for FMS patients, and LDS tablets are expected to bring new treatments to patients with fibromyalgia. In addition, preclinical studies have shown that LDS tablets have the potential to treat a variety of neuralgias.
As an innovation-driven preclinical R&D CRO, Medicilon is fortunate to participate in the research that benefits patients with fibromyalgia, providing pharmacokinetic and safety evaluation tests for the development of LDS tablets, breaking through the limitations of traditional R&D technologies, overcoming the numerous difficulties and speeding up the clinical approval with the professionalism.
Medicilon congratulates Leado Pharma’s LDS tablets for obtaining clinical approval. Medicilon is always on the way of insight into unmet medical needs, forward-looking innovations in new drug R&D technologies, and continuing to provide new drug developers with faster and better pre-clinical R&D services.
Leado Pharma is a high-tech enterprise and one of the 50 best enterprises in Shanghai with the most investment potential. Leado Pharma was founded in 2016. The company has successfully conducted 3 rounds of financing and has been recognized and supported by well-known investment institutions in the industry. Leado Pharma insists on innovation, is oriented by clinical unmet needs and creates value for patients around the world through differentiated drug mechanisms. The company’s research and development aims at a variety of intractable pains. Leado Pharma has leading ion channel drug research and development technology and platforms, which can detect and evaluate all ligand-gated and voltage-gated ion channels, and carry out drug screening and early safety pharmacology research for ion channel targets.
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.
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