MG-K10 made a grand debut at the American Academy of Dermatology (AAD) conference: 94.3% achieved EASI-75 at 52 weeks, marking a new chapter in convenient and efficient treatment for moderate to severe atopic dermatitis with long-acting anti-IL-4Rα.

As a common pruritic, chronic inflammatory skin disease, AD has seen a rapid increase in prevalence in China over the past 20 years² It is estimated that in 2024 there were more than 54 million AD patients in China. Based on SCORAD scores, moderate-to-severe AD accounted for 27%, representing more than 14.5 million patients³ and can cause extensive, widespread skin damage, seriously interfering with patients’ work and daily life¹ Among existing systemic treatments for moderate-to-severe AD, marketed anti-IL-4Rα monoclonal antibodies require dosing once every two weeks, which can reduce patient adherence, while high treatment costs also limit drug accessibility¹ Therefore, therapies that combine durable efficacy with a low treatment burden remain an important unmet clinical need.

This pivotal Phase III study was a multicenter, randomized, double-blind, placebo-controlled trial consisting of four stages: a screening period (5 weeks), a double-blind treatment period (16 weeks), an open-label maintenance treatment period (36 weeks), and a follow-up period (8 weeks). During the double-blind treatment period, patients received either MG‑K10 or placebo 300 mg Q4W (600 mg as the first dose). After entering the maintenance treatment period, both groups received MG‑K10 300 mg Q4W (Figure 1). Baseline demographic and disease characteristics were generally consistent between the two groups⁴ (Table 1).

Figure 1 Study design

Table 1 Baseline patient characteristics

➤ Long-term MG‑K10 treatment can continuously improve disease severity and the extent of skin lesion involvement

Analysis of the primary endpoints showed that the study met the prespecified primary clinical trial endpoints. For the EASI-75 response rate, during the double-blind treatment period, Week 4already showed a statistically significant difference between the two groups; during the maintenance treatment period, the response rate in the MG-K10 group continued to increase to 94.3% by Week 52 Meanwhile, after the placebo group switched to MG-K10 treatment, efficacy also showed a trend of continued improvement⁴ For the response rate of IGA 0/1 with a ≥2-point decrease from baseline, during the double-blind treatment period, Week 8showed a significant difference compared with the placebo group. During the open-label treatment period, the response rate in the MG-K10 group increased to 76.6% by Week 52 while after the placebo group switched to MG-K10 treatment, efficacy also showed a trend of continued improvement⁴ (Figure 2).

Figure 2 Time-course line charts of EASI-75 response rate (left) and IGA 0/1 with a ≥2-point decrease from baseline (right) during treatment (****: P<0.0001)

For the EASI‑90 response rate, the MG-K10 group at Week 16was significantly superior to the placebo group (P<0.0001). By Week 52, the EASI‑90 response rate in the MG-K10 group further increased to 79.1% In addition, for the EASI‑50 response rate, the MG-K10 group at Week 16was also significantly superior to the placebo group (P<0.0001).By Week 52, the EASI‑50 response rate in the MG-K10 group further increased to 99.3% (Figure 3). These results indicate that long-term MG-K10 treatment can rapidly and continuously improve disease severity and the extent of skin lesion involvement in patients with AD⁴.

Figure 3 Time-course line charts of EASI-90 response rate (left) and EASI-50 response rate (right) during treatment (****: P<0.0001)

➤ MG‑K10 treatment can rapidly and continuously improve pruritus symptoms

In terms of improvement in pruritus symptoms, at Week 16, the proportion of patients in the MG‑K10 group with a ≥3-point improvement from baseline in PP-NRSwas significantly superior to the placebo group (P<0.0001);by Week 52, this proportion in the MG‑K10 group increased to 84.6% In addition, at Week 16, the proportion of patients in the MG‑K10 group with a ≥4-point improvement from baseline in PP-NRSwas significantly superior to the placebo group (P<0.0001);by Week 52, this proportion in the MG‑K10 group increased to 71.7% (Figure 4). These results indicate that MG‑K10 treatment can rapidly and continuously improve pruritus symptoms in patients with AD⁴.

Figure 4 Time-course line charts of the proportion of subjects achieving a ≥3-point (left) and ≥4-point (right) improvement from baseline in PP-NRS during treatment (****: P<0.0001)

➤ MG‑K10 treatment can continuously improve quality of life in patients with AD

In terms of quality-of-life improvement, at Week 16, the response rate for a ≥4-point improvement from baseline in DLQI in the MG‑K10 groupwas significantly higher than that in the placebo group (P<0.0001).By Week 52, the response rate in the MG‑K10 group increased to 81.9% In addition, at Week 16, the response rate for a ≥4-point improvement from baseline in POEM in the MG‑K10 groupwas significantly higher than that in the placebo group (P<0.0001).By Week 52, the response rate in the MG‑K10 group increased to 91.1% (Figure 5). Therefore, improvement in clinical symptoms after MG‑K10 treatment can translate into clinically meaningful improvements in quality of life⁴.

Figure 5 Time-course line charts of response rates for a ≥4-point improvement from baseline in DLQI (left) and POEM (right) during treatment (****: P<0.0001)

➤ Long-term MG‑K10 treatment has favorable safety and tolerability

During the 52-week treatment period, MG‑K10 300 mg Q4W demonstrated favorable safety and tolerability. Treatment-emergent adverse events (TEAEs) were mostly mild to moderate, with no adverse events of special interest (AESIs) and no adverse events leading to death.The incidence rates of conjunctivitis during the double-blind treatment period and maintenance treatment period were only 3.0% and 2.4%, respectively, and the incidence rates of injection-site reactions were only 1.8% and 0.9%, respectively (all CTCAE Grade 1)⁴ The safety profile during the maintenance treatment period was similar to that during the double-blind treatment period, and no new safety signals were identified.

MG‑K10 300 mg Q4W demonstrated highly effective and durable efficacy in patients with moderate-to-severe AD. EASI‑75 and IGA 0/1 responses improved significantly as early as Weeks 4 and 8, and high response rates were stably maintained through Week 52. In addition, MG‑K10 not only achieved deep skin-lesion clearance and significant pruritus relief, but also substantially improved patients’ quality of life. It also showed favorable safety and tolerability, with low incidence rates of conjunctivitis and injection-site reactions. These results support MG‑K10 as an IL‑4Rα-targeted therapy for the long-term management of moderate-to-severe AD⁴.The extended dosing interval of MG-K10 (Q4W) will provide patients with AD with an innovative, effective treatment option that offers significant efficacy, favorable safety, and greater convenience.

The presentation of these important MG-K10 research findings as an oral presentation on the top international academic stage of AAD 2026 fully demonstrates that its innovative mechanism and outstanding clinical value have been highly recognized by the international academic community. It also marks a key step forward for the product in the treatment of moderate-to-severe AD and highlights its potential to influence the AD treatment landscape. Looking ahead, once MG-K10 is approved and introduced into clinical use, it will benefit more patients with moderate-to-severe AD, especially those who find it difficult to adhere to long-term standardized treatment because of frequent injections, by providing a more convenient regular treatment option and helping achieve long-term stable disease control. In addition, MG-K10’s clinical application potential in asthma, prurigo nodularisand other type 2 inflammatory diseases is also worth anticipating. It is expected to continue expanding therapeutic boundaries and benefit a broader patient population.