China-based Luye Pharma Group (HKG: 2186) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug candidate, LY 03014. The multi-center, randomized, double-blind, placebo-controlled, and positive drug parallel control study aims to assess the preliminary efficacy and safety of the drug in treating moderate and severe pain following abdominal surgery.
Drug Profile and Development
LY 03014 is a small molecule Gi protein biased MOR agonist being developed to address moderate to severe pain and explosive cancerous pain after surgery. Previous study results indicated that the drug significantly inhibited postoperative and cancer pain while reducing respiratory depression, constipation, and opioid tolerance. Additionally, toxicological studies and long-term telemetry tests of the cardiovascular system showed that LY 03014 did not cause liver toxicity or changes in cardiac QT intervals.
Market Context
The anesthesia and analgesia market in China reached RMB 38.8 billion (USD 7.37 billion) in 2021, with a compound annual growth rate of 13.6% over the period from 2017 to 2021. In 2021, sales of opioids amounted to RMB 18.1 billion (USD 2.53 billion), following a compound annual growth rate of 16.6% from 2017 to 2021. Luye Pharma has previously launched buprenorphine and fentanyl patches, along with other analgesic drugs globally, and is developing additional products, including the Category 1 drug LY 03012.-Fineline Info & Tech
