Huadong Medicine Gets NMPA Green Light for Clinical Trials of Roflumilast Cream

Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its Zoryve cream (roflumilast) in concentrations of 0.15% and 0.3%. These formulations are indicated for the treatment of mild to moderate atopic dermatitis (AD) and plaque psoriasis in patients aged 6 years and above, respectively.

In August 2023, Huadong Med entered into a licensing agreement valued at USD 94.25 million with Arcutis Biotherapeutics, Inc., a U.S. firm. Through this agreement, Huadong Med obtained exclusive rights to Daxas (roflumilast, including cream Zoryve and foam agent ARQ-154) external preparations in Greater China and Southeast Asia.

Roflumilast is a phosphodiesterase4 (PDE4) inhibitor, which works by reducing the production of pro-inflammatory mediators and increasing the production of anti-inflammatory substances. It has been approved in the U.S. for the treatment of atopic dermatitis, seborrheic dermatitis, and plaque psoriasis.- Flcube.com

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