Core Viewpoint - Huadong Medicine Co., Ltd. announced the approval of a clinical trial for 0.3% roflumilast foam for seborrheic dermatitis, marking a significant step in its product development [2][3] Group 1: Product Development - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for a Phase III clinical trial of 0.3% roflumilast foam [2] - Roflumilast foam is an innovative topical formulation introduced through a collaboration with Arcutis Biotherapeutics, Inc., with exclusive rights in Greater China and Southeast Asia [2] - The product has already been approved in the U.S. and Canada for local treatment of seborrheic dermatitis in patients aged 9 and older, representing the first new mechanism topical treatment approved in over 20 years [2] Group 2: Clinical Research Progress - The Phase III clinical studies for 0.15% and 0.3% roflumilast creams in China have commenced, with the first subject enrolled and treated in November 2024 [3] - The recent approval signifies a critical advancement in the development of this product line, potentially enhancing Huadong Medicine's core competitiveness in the fields of autoimmune and topical formulations [3]

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].