Topical MC2-01 Cream Achieves Primary Endpoint in Phase III Trial for Plaque Psoriasis in China

On September 29, 2026, Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Zhongmei Huadong”), recently obtained the top-line data from the Phase III clinical trial of MC2-01 Cream (Calcipotriol and Betamethasone Dipropionate Cream), an innovative topical dermatological formulation, for the treatment of plaque psoriasis in adults in China. Preliminary results demonstrated that MC2-01 Cream exhibited significant efficacy and a favorable safety profile, meeting the prespecified primary endpoints of the study. It is expected to provide a new therapeutic option for adult patients with plaque psoriasis in China, further enriching the company’s product portfolio in the field of topical dermatological treatments.

Innovative Topical Dermatological Preparations Demonstrate Significant Efficacy, Bringing New Options for the Topical Treatment of Psoriasis

It is understood that MC2-01 Cream is an innovative topical dermatological product introduced through a collaboration agreement signed in August 2023 between Huadong Medicine’s subsidiary Zhongmei Huadong and MC2 Therapeutics Ltd. (“hereinafter referred to as MC2”), a wholly-owned subsidiary of MC2 Therapeutics A/S. Zhongmei Huadong holds the exclusive license for the product in the Greater China region, including rights for clinical development, regulatory registration, and commercialization. MC2-01 Cream is a fixed-dose combination topical formulation of calcipotriol and betamethasone, utilizing MC2’s proprietary PAD™ drug delivery system to form a user-friendly aqueous cream indicated for the topical treatment of plaque psoriasis (including scalp psoriasis) in adults. The product has been approved sequentially in the United States (2020), Europe (2021), Australia (2024), and Canada (2025) under the brand name WYNZORA.^®。

The Phase III study of MC2-01 cream in China was a multicenter, randomized, investigator-blinded, active-controlled (calcipotriol/betamethasone gel) and vehicle-controlled clinical trial conducted at 55 clinical centers across China. A total of 539 participants were actually enrolled, receiving once-daily treatment for 8 weeks, with the top-line analysis recently completed.

The primary endpoint of this study was the proportion of participants achieving Physician’s Global Assessment (PGA) treatment success in affected body areas (trunk and/or limbs) after 8 weeks of treatment. Treatment success was defined as a PGA score of 0 or 1, with an improvement of ≥2 points from baseline. The results showed that after 8 weeks of treatment, the PGA treatment success rates were 55.7% in the MC2-01 cream group, 38.1% in the active control group, and 1.3% in the vehicle control group. The difference between the MC2-01 cream group and the vehicle control group was statistically significant (P<0.0001). The between-group difference in efficacy compared to the active control group was 17.6% (95% CI: 9.0–26.2), meeting the prespecified criteria for non-inferiority.

For secondary endpoints, including improvements in the modified Psoriasis Area and Severity Index (mPASI) score and treatment success rates based on the Physician’s Global Assessment (PGA) for scalp psoriasis, the MC2-01 cream group demonstrated superior efficacy compared to both the active control group and the vehicle control group. In terms of safety, MC2-01 cream exhibited an overall favorable safety and tolerability profile. No treatment-related serious adverse events occurred during the study, and no new safety signals were observed.

Psoriasis is a chronic, recurrent, inflammatory, and systemic immune-mediated disease triggered by the interplay of genetic and environmental factors. Clinically, it presents as scaly erythema or plaques, which may be localized or widely distributed. Psoriasis can be associated with systemic comorbidities, significantly impairing patients' quality of life. In recent years, the psoriasis treatment market in China has been growing rapidly. According to data from Global Market Insights, the global psoriasis treatment market size was USD 26.5 billion in 2022 and is projected to reach USD 60.5 billion by 2032, representing a compound annual growth rate (CAGR) of 8.6%. The Chinese market is expanding even more rapidly, with its market size increasing from USD 604 million in 2018 to USD 1.436 billion in 2022, and is expected to further reach USD 9.944 billion by 2030, indicating substantial potential in the psoriasis medication market.

Notably, among the various subtypes of psoriasis, plaque psoriasis is the most common. According to the Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition), approximately 80%–90% of psoriasis patients worldwide have the plaque subtype. Plaque psoriasis is a chronic immune-mediated disease characterized by excessive proliferation of skin cells, leading to the formation of inflamed, scaly plaques that may be accompanied by itching or pain. There is an urgent need among patients with plaque psoriasis in China for safer and more effective innovative treatment options.

The Phase III clinical trial for the treatment of plaque psoriasis in China has met its primary endpoint, marking a significant milestone in the product’s development process. This achievement will further enhance Huadong Medicine’s core competitiveness in the fields of autoimmune diseases and topical dermatological preparations, accelerating the availability of this therapy to benefit patients with plaque psoriasis in China.

Building Differentiated Advantages Through a Multi-Pipeline Strategy in the Autoimmune Field, Gradually Entering the Phase of Value Realization

As a leading enterprise in China's pharmaceutical industry, Huadong Medicine’s existing and pipeline products in the autoimmune field cover indications such as transplant immunology, psoriasis, atopic dermatitis, rheumatoid arthritis, seborrheic dermatitis, prurigo nodularis, vitiligo, recurrent pericarditis, and cryopyrin-associated periodic syndromes. These products span therapeutic areas including dermatology, rheumatology, cardiology, respiratory medicine, and transplantation, making Huadong Medicine one of the pharmaceutical companies in China with the most comprehensive coverage in the autoimmune disease sector. The company collaborates with Quanxin Biologics to develop the autoimmune disease product ustekinumab (Sailexin).^®As the first ustekinumab biosimilar approved in China, and the first commercialized biosimilar product in the company’s autoimmune pipeline, it is poised to become a new core product in the company’s autoimmune portfolio. Sailexin^®/Saijiening^®Domestic sales (including VAT) in the first half of 2026 exceeded RMB 300 million, surpassing the full-year total of 2025, with a year-on-year increase of over 100%.

Meanwhile, the Company’s innovative drug R&D center has independently developed multiple early-stage immunology projects featuring novel targets and biological mechanisms, all of which are progressing smoothly. Leveraging its strengths in the autoimmune field, the Company has extended its capabilities to topical formulations by establishing a dedicated R&D platform, steadily advancing innovation in topical and complex formulations. Currently, Huadong Medicine (Xi’an) Bohua Pharmaceutical Co., Ltd., a wholly-owned subsidiary, and Shaanxi Jiuzhou Pharmaceutical Co., Ltd., a holding subsidiary, have jointly established four production lines for topical formulations. The Company has more than 10 topical formulation products either under development or already commercialized.

In the field of autoimmune diseases, Huadong Medicine has established a "golden product portfolio" for psoriasis treatment, comprising monoclonal antibodies, oral formulations, and topical agents. This portfolio will provide more medication options for adult and pediatric psoriasis patients in China, achieving comprehensive coverage across all patient populations and throughout the entire disease course. The company has significantly accelerated its clinical progress in the autoimmune sector.The supplemental application for the subcutaneous injection of the ustekinumab biosimilar (developed in collaboration with Quanxin Biotech) for Crohn's disease, as well as the marketing authorization for its intravenous infusion, were approved in April and May 2026, respectively. The supplemental application for the new 90mg specification is expected to be approved by the end of 2026. The Phase III clinical trial for HDM3010, a self-developed improved new drug for vitiligo, is progressing steadily.The New Drug Applications (NDAs) for roflumilast cream for three indications—plaque psoriasis and atopic dermatitis—have either been accepted or passed inspection, with approval expected in 2027. Notably, the Phase III clinical study in China for VC005 tablets, a second-generation highly selective JAK1 inhibitor from Jiangsu Weikai'er (exclusively commercialized by the company), has achieved positive top-line data and met its primary endpoint in the treatment of moderate-to-severe atopic dermatitis. Meanwhile, Phase III clinical trials for ankylosing spondylitis, as well as Phase II trials for vitiligo and alopecia areata, are being advanced concurrently.

Huadong Medicine’s Innovation-Driven Transformation Accelerates FruitionInterim report data indicates that, leveraging its leading R&D system and core technology platforms, the company has established a diversified portfolio of innovative products. Huadong Medicine’s Innovative Drug R&D Center is currently advancing 96 innovative drug pipelines, achieving multiple positive outcomes in the first half of 2026. Meanwhile, previously approved innovative products have entered a phase of scaled-up commercialization. In the first half of 2026, revenue from Huadong Medicine’s innovative product business totaled RMB 1.684 billion, representing a year-on-year increase of 52%, thereby becoming the core engine driving growth in its pharmaceutical industrial segment. Looking ahead, Huadong Medicine will continue to prioritize innovation as its primary driver, steadily progressing toward becoming an innovative pharmaceutical enterprise with global influence. The company remains committed to delivering more breakthrough therapeutic solutions for patients and injecting strong momentum into the high-quality development of China’s pharmaceutical innovation landscape.