Luye Pharma Group has announced that the company’s new compound candidate, extended release tablet ‘LY03012’, a China Class 1 new chemical drug, has been approved by the National Medical Products Administration (NMPA) (previous known as the China Food and Drug Administration) to begin clinical trials. LY03012 is an investigational drug for analgesia.
The good news comes off the back of a number of other recent progresses related to Luye Pharma’s product pipeline development. Recent clinical progress with new investigational biological antibody drugs, the development of next generation drugs for use in immuno-oncology, as well as partnerships with a number of global leading biotechnology companies have together showcased the kind of strategic positioning and comprehensive planning employed by Luye Pharma to secure its global product pipeline.
LY03012 is an orally-administered small molecule compound. Non-clinical studies have shown that LY03012 can act as an inhibitor to 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. By enhancing the descending inhibitory pain pathway, LY03012 can exert an analgesic effect. Different from other marketed drugs with the same indications, LY03012 can also 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 revenues for 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. Meanwhile, 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 patents of the chemical compounds and the crystal forms have been granted in China, the United States, Europe, Japan and Korea, among other countries. The declared indications include the treatment of chronic pain, such as Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia (FM) and Musculoskeletal Pain. In addition to the Chinese market, Luye Pharma is also committed to the registration and launch of LY03012 in the United States, Europe and Japan, as well as in other countries and regions.
Luye Pharma has several drugs in the analgesic therapeutic field including fentanyl patches and buprenorphine patches. The local manufacturing and NDA preparation work for buprenorphine patches are also both progressing well.
"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 commented. "Recently, drugs which have been under development for years are now gradually coming into fruition. We plan 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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