Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the Acceptance Notification from the National Medical Products Administration (NMPA) for the market approval application of Roflumilast Cream (ZORYVE) 0.3% [1] Group 1 - The active ingredient of ZORYVE is Roflumilast, which is a highly active and selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor [1] - PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases the production of anti-inflammatory mediators [1] - Inhibition of PDE4 can alleviate inflammatory responses [1]

Core Viewpoint - Huadong Medicine Co., Ltd. has received approval for a Phase III clinical trial of 0.3% roflumilast foam (ZORYVE®) for the treatment of seborrheic dermatitis in patients aged 9 and above, which is expected to provide new treatment options for patients in China [1][2]. Group 1: Company Developments - Huadong Medicine's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has been granted a clinical trial approval by the National Medical Products Administration (NMPA) for a multi-center, randomized, double-blind Phase III clinical trial [1]. - The roflumilast foam product was introduced from Arcutis Biotherapeutics, Inc. and Huadong Medicine holds exclusive rights for its development, registration, production, and commercialization in Greater China and Southeast Asia [1]. - The approval of the clinical trial is a significant milestone, leveraging Huadong Medicine's strong innovation and research capabilities [1]. Group 2: Industry Context - Seborrheic dermatitis is a common chronic inflammatory skin disease with limited effective treatments and significant unmet clinical needs [2]. - Roflumilast foam has already received regulatory approvals in the U.S. and Canada for the same indication, marking it as the first new mechanism topical treatment for seborrheic dermatitis approved by the FDA in over 20 years [2]. - The product is also expected to be approved for treating scalp and body psoriasis in patients aged 12 and above by May 2025 [2]. Group 3: Ongoing Research and Development - In addition to the foam formulation, the development of roflumilast cream is progressing, with various approvals for different indications already achieved in the U.S. [3]. - Clinical studies for roflumilast cream in treating mild to moderate atopic dermatitis and plaque psoriasis in patients aged 6 and above are underway in China, addressing significant unmet clinical needs in these areas [3].