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An announcement from Luye Pharma Group ( (HK:2186) ) is now available.
Luye Pharma Group has announced that China’s drug regulator has accepted a New Drug Application for a new indication of its Class 1 innovative drug Ruoxinlin (toludesvenlafaxine sustained-release tablets) to treat generalized anxiety disorder (GAD), building on its prior approval for major depressive disorder. Supported by positive Phase III data showing rapid and broad symptom relief, high response and remission rates, and a favorable safety profile compared with standard SSRIs and SNRIs, Ruoxinlin could become the first serotonin, norepinephrine and dopamine reuptake inhibitor approved for GAD in China, addressing a large, under-treated patient population and a market that has seen no Class 1 innovative anxiety drug approvals in two decades; if approved, the new use and existing reimbursement status are expected to deepen Ruoxinlin’s clinical penetration and strengthen Luye Pharma’s positioning in China’s CNS and mental health therapeutics market.
The most recent analyst rating on (HK:2186) stock is a Hold with a HK$3.50 price target. To see the full list of analyst forecasts on Luye Pharma Group stock, see the HK:2186 Stock Forecast page.
More about Luye Pharma Group
Luye Pharma Group is a China-focused biopharmaceutical company specializing in central nervous system (CNS) therapies, including antidepressants and other innovative psychiatric treatments. Its flagship product Ruoxinlin (toludesvenlafaxine) is a locally developed Class 1 chemical antidepressant that has rapidly gained market share, serving nearly 190,000 patients since launch and recently entering China’s National Reimbursement Drug List, bolstering its accessibility and commercial prospects in the domestic mental health drug market.
Average Trading Volume: 23,230,865
Technical Sentiment Signal: Strong Sell
Current Market Cap: HK$11.2B
For a thorough assessment of 2186 stock, go to TipRanks’ Stock Analysis page.