On February 3, 2026, Huadong Medicine (stock code: 000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd., had its marketing authorization application for the innovative topical skin preparation roflumilast cream (ZORYVE®) 0.05% accepted by the National Medical Products Administration (NMPA). The product is indicated for the topical treatment of mild to moderate atopic dermatitis in patients aged 2 to 5 years. This marks an important milestone in the research and development of this series of products and will further consolidate and enhance the company's core competitiveness in the field of autoimmune skin treatment.

The product has significant advantages, building dual barriers in both clinical and commercial applications.

The announcement indicates that the active ingredient in ZORYVE® is Roflumilast, a highly active and selective nonsteroidal phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and reduces the production of anti-inflammatory mediators. Inhibiting PDE4 can alleviate the inflammatory response.

Roflumilast cream is an innovative topical skin preparation product introduced by the company's wholly-owned subsidiary, Sino-American East China, in August 2023 through a cooperation agreement signed with Arcutis Biotherapeutics, Inc., a Nasdaq-listed company. Sino-American East China holds the exclusive license for this product in Greater China and Southeast Asia, including the rights to develop, register, manufacture, and commercialize it.

Atopic dermatitis (AD) is a common, chronic or relapsing, itchy, inflammatory skin disease that affects children and adults. Most cases are mild to moderate in severity, and clinical manifestations include itching, erythema, dryness, exudation, crusting, and secondary lesions (such as lichenification and epidermal shedding), which seriously affect patients' quality of life.

China has a large population suffering from atopic dermatitis (AD), and clinical needs urgently need to be met. According to research by Guojin Securities, there are approximately 67 million AD patients in China, indicating a significant unmet market demand. Furthermore, epidemiological data in China shows that the prevalence rate among children aged 1-7 years is 12.94%, highlighting a substantial gap in safe and effective treatment options for younger patients.

The core value of Roflumilast cream's application lies in its precise targeting of a niche market with clearly unmet needs. Currently, treatment options for children aged 2 to 5 years with atopic dermatitis in China are extremely limited, mainly relying on traditional topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI). Compared to systemic therapy, safe and effective topical treatments are more suitable and urgently needed for patients in this age group. The acceptance of the 0.05% marketing authorization application for Roflumilast cream not only provides an important new option for children with atopic dermatitis, but also signifies that Huadong Medicine has built a differentiated market barrier and first-mover advantage in the highly competitive autoimmune market by precisely targeting a specific population.

For children aged 2 to 5 years, the clinical compliance advantage of roflumilast cream is particularly prominent. Roflumilast 0.05% cream not only offers the convenience of being used on various parts of the body, but its simplified once-daily (QD) dosing regimen eliminates the need for frequent re-administration, significantly improving treatment adherence. This characteristic significantly increases the likelihood of children continuing standardized treatment while ensuring efficacy and long-term safety.

Deepen the strategic layout of self-exemption and strengthen innovation-driven research and development.

It is worth mentioning that Huadong Medicine's roflumilast (ZORYVE®) has established a differentiated R&D layout covering multiple age groups and indications. In addition to the acceptance of its application for the 0.05% cream for children aged 2 to 5 years, its marketing authorization applications for a higher concentration 0.15% cream (for topical treatment of mild to moderate atopic dermatitis in patients aged 6 years and older) and a 0.3% cream (for topical treatment of plaque psoriasis in patients aged 6 years and older, including intertriginous areas) have also been accepted by regulators. Meanwhile, the Phase III clinical trial of roflumilast foam (ZORYVE®) 0.3% for seborrheic dermatitis patients aged 9 years and older is progressing smoothly in China.

This series of developments indicates that Huadong Medicine is systematically and methodically introducing this product line into the Chinese market, aiming to form a comprehensive layout spanning three major autoimmune skin disease areas—atopic dermatitis, psoriasis, and seborrheic dermatitis—from children to adults, thereby strengthening its overall competitiveness and market coverage in the autoimmune field.

Autoimmune diseases are one of the three core therapeutic areas that Huadong Medicine focuses on. The company continuously drives its development through a dual approach of "introduction and cooperation" and "independent innovation" to build a globally competitive product pipeline. Huadong Medicine's existing and pipeline products cover a variety of diseases, including transplant immunology, psoriasis, atopic dermatitis, and rheumatoid arthritis, making it one of the most comprehensive pharmaceutical companies in China in the field of autoimmune diseases. Particularly in the treatment of psoriasis, the company has formed a "golden product portfolio" of oral, biological, and topical formulations, committed to providing full-cycle treatment solutions for patients of different ages.

The company continues to steadily develop its core pipeline in the autoimmune field. Regarding its collaboration with Quanxin Biotech, the ustekinumab biosimilar HDM3001 (QX001S), jointly developed by the two companies, received approval for a new indication in pediatric plaque psoriasis in March 2025. Simultaneously, the marketing authorization application and related supplemental applications for this product for Crohn's disease were accepted by the National Medical Products Administration in February 2025. Furthermore, another collaborative innovative drug, HDM3016 (QX005N), is currently undergoing Phase III clinical trials in China for two indications: nodular prurigo and atopic dermatitis. The Phase III study for atopic dermatitis has completed enrollment.

The company's independently developed improved new drug, ruxolitinib gel (HDM3010), has obtained topline results in its Phase I/II clinical trial for the treatment of nodular prurigo, and a Pre-III communication application was submitted in September 2025. In addition, this product is currently undergoing a Phase III clinical trial for the treatment of vitiligo. The company's independently developed first-in-class bispecific antibody candidates, HDM3018 injection and HDM4002 injection, are currently undergoing IND development, with IND applications expected in China and the United States in 2026.

It is worth mentioning that in early 2026, Huadong Medicine deepened its strategic cooperation with MC2 Therapeutics of Denmark, introducing the Biomee® series to enter the topical skin formulation market. Huadong Medicine obtained exclusive commercialization rights for MC2's dermatological-grade skin care cream Biomee® series in Greater China (Mainland China, Hong Kong, Macau, and Taiwan), further deepening the strategic partnership between the two parties. Previously, the Phase III clinical study of the efficacy and safety of MC2-01 cream in treating plaque psoriasis in China had completed the enrollment and dosing of the first subject.

The acceptance of Huadong Medicine's application for a new indication for roflumilast cream not only demonstrates its innovative R&D and strategic product acquisition capabilities but also signifies that the company's strategic layout in the autoimmune dermatology field is entering a harvest period. With the synergistic advancement of multiple differentiated product pipelines, Huadong Medicine is expected to continue expanding its influence in China's multi-billion-dollar autoimmune market, further solidifying its leading position in the dermatology sector. In the future, driven by both "bringing in" and "going out" strategies, the company is expected to continuously enhance its participation and influence in the global innovative pharmaceutical industry chain, injecting certain growth momentum into its long-term development.

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