SHANGHAI, June 19, 2018 /PRNewswire/ — June 19, 2018, Luye Pharma Group announced that clinical applications of the company’s new compound candidate, extended release tablets (”LY03012”), a China Class 1.1 new chemical drug, have been formally accepted by the China Food and Drug Administration. LY03012, an investigational drug for analgesia, will now soon commence Phase I clinical trials.
There has been lots of good news lately related to Luye Pharma’s pipeline development. Recent clinical progress with the investigational biological antibody drug LY01008, the development of the next generation of drugs for use in immuno-oncology and partnerships with a number of global leading biotechnology companies have showcased the strategic positioning and comprehensive planning employed by Luye Pharma in securing its global product pipeline.
LY03012 is an orally-administered small molecule compound. Non-clinical studies have shown that LY03012 can inhibit presynaptic membrane 5-hydroxytryptamine transporter (SERT), noradrenaline transporter (NET) and dopamine transporter (DAT), thereby increasing the concentration of norepinephrine, 5-hydroxytryptamine, and dopamine in the synaptic cleft. LY03012, by enhancing the descending inhibitory pain pathway, can exert an analgesic effect. Different from other marketed drugs with the same indications, LY03012 can regulate the body’s sleep-wake cycle, and while producing an analgesic effect will not cause adverse events associated with CNS inhibition, such as sedation and somnolence.
Luye Pharma believes that analgesic drugs have optimistic market prospects and growth potential, both in China and in other major pharmaceutical markets. According to IQVIA (previously known as IMS) data, sales revenue of analgesic drugs in the U.S. and European markets combined to total US$17.946 billion in 2017, with sales in China totaling RMB 11.473 billion. Sales of analgesics have maintained double-digit growth over the past two years in these markets.
At present, Luye Pharma owns LY03012 patents covering the chemical compounds, the crystal forms and the formulation of the extended release tablets. The declared indications include the treatment of chronic pain, such as diabetic peripheral neuralgia, musculoskeletal pain and fibromyalgia. In addition to the Chinese market, Luye Pharma is also dedicated to the registration and launching of LY03012 in the United States, Europe and Japan, as well as other countries and regions.
In addition to LY03012, Luye Pharma has also been developing several other analgesic candidates. The acquisition of Europe-based Acino’s transdermal and implant business at the end of 2016 improved Luye Pharma’s R&D capabilities, as well as facilitating with R&D and reducing time-to-market for fentanyl three-day and buprenorphine seven-day patches, among others.
“LY03012 will enrich and expand our current analgesic pipeline, promoting the company’s development in the field of pain relief”, a senior management spokesperson for Luye Pharma said. “Recently, drugs which have been under our development are now gradually coming into their harvest season. We hope to continue to increase investment in R&D for innovative drugs, planning comprehensively for subsequent products in the pipeline to lay a solid foundation for the company’s future growth in the global market.”
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