FAST NEWS: Luye Pharma’s Schizophrenia Drug Wins FDA Approval

The latest: Drug maker Luye Pharma Group Ltd. announced Sunday that its drug Rykindo has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for schizophrenia and bipolar disorder in adults.

Looking up: Rykindo is the first FDA-approved complex dosage form product developed by a pharmaceutical company in China. The company is also developing the drug in Europe and plans to expand it to other global markets.

Take Note: Bringing the product to new markets will require a wide range of costs, from conducting clinical trials to actual commercialization once the drug is approved.

Digging Deeper: Luye Pharma develops and sells innovative medicines focusing on central nervous, oncology and cardiovascular diseases, and was listed in Hong Kong in 2014. The company’s revenue in the first half of last year reached 2.85 billion yuan ($425 million), mainly from nine commercialized products. At the end of June last year its drug pipeline consisted of 32 products under development in China and 13 products under development in the U.S., Europe and Japan. Rykindo, the drug just approved by the FDA, was previously approved by China in January 2021 and entered the country’s subsidized drug list in its national medical insurance program in December the same year.

Market Reaction: Luye Pharma shares surged 13.7% in early trading on Monday, but later gave back some of those gains and closed up 6.1% at HK$4.34 by the midday break, a new 52-week high.

Translation by Jony Ho

To subscribe to Bamboo Works free weekly newsletter, click here