Fourth Indication! VC005 Topical Gel of Vcare PharmaTech Obtains IND Approval in China for Seborrheic Dermatitis

　　Recently, VC005 topical gel,balanced, highly selective new-generation JAK1 inhibitor, independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Vcare PharmaTech), has officially received the IND clearance from the NMPA. It is intended for the topical treatment of seborrheic dermatitis. This IND approval marks another key milestone for VC005 topical gel in the topical formulation space, following its clearances for mild-to-moderate atopic dermatitis, non-segmental vitiligo and plaque psoriasis. It further enriches and expands the company’s pipeline in autoimmune and inflammatory diseases, and is expected to deliver a new targeted small-molecule topical therapeutic option for patients with seborrheic dermatitis in China.

　　Seborrheic dermatitis is a very common chronic inflammatory skin disorder that predominantly affects sebum-rich areas including the scalp, face, chest and back. It follows a chronic, relapsing clinical course. Topical glucocorticoids are widely used for anti-inflammatory management at present; nevertheless, long-term use of glucocorticoids (steroids) may cause skin thinning (atrophy), erythema and secondary infection. There is an urgent unmet clinical need for non-steroidal therapies suitable for long-term topical administration with favorable safety and tolerability to help patients sustain disease control.

　　As a balanced, highly selective new-generation JAK1 inhibitor,, VC005 topical gel exerts therapeutic effects against seborrheic dermatitis via inhibition of the JAK/STAT signaling pathway. Following IND approval for seborrheic dermatitis, Vcare PharmaTech will rapidly advance clinical development for this indication, thoroughly evaluating the efficacy and safety of VC005 gel in patients with seborrheic dermatitis, and strive to bring benefits to patients at an early date.

　　About VC005 Topical Gel

　　VC005 is a balanced, highly selective next-generation JAK1 inhibitor. It exerts potent inhibition of JAK1 combined with moderate inhibition of TYK2 to target the Th2/Th1/Th17 inflammatory axes for improved overall therapeutic efficacy. Currently, both oral and topical formulations in multiple strengths have been developed, forming a product portfolio covering a wide range of indications. The VC005 topical gel adopts a unique pharmaceutical base, it supports high drug loading while maintaining robust stability, favorable safety profile without irritation, and a light, refreshing gel texture to improve patient adherence.In the completed Phase II clinical trial for mild-to-moderate atopic dermatitis, VC005 topical gel demonstrated notable pruritus relief and lesion improvement at the early stage of treatment. Pruritus relief was observed on Day 1, with an approximate 14% reduction in the mean NRSfor pruritus within 12 hours. Around 30% of subjects achieved ≥50% improvement in eczema area and severity index (EASI-50 response) after one week of dosing, translating to meaningful improvements in patients’ quality of life. In terms of safety, the incidence of TRAEswas lower than that of the vehicle group, with no SARsreported and favorable patient tolerability. Pharmacokinetic data showed extremely low plasma exposure, even lower in adolescent populations, with no drug accumulation. VC005 is expected to address the black box warning concerns associated with marketed topical agents of the same target.

　　About Seborrheic Dermatitis

　　Seborrheic dermatitis is a prevalent chronic inflammatory skin disease, affecting 1%–3% of the general population and 34%–83% of immunocompromised patients or those with neurological disorders, with a higher prevalence in males than females. It preferentially involves sebum-rich sites such as the scalp, face, chest and back; 70.3% of patients present with scalp involvement, termed scalp seborrheic dermatitis. The disease arises during periods of active sebaceous gland function, exhibiting a bimodal age distribution with peaks in infancy and adulthood (30–60 years). It runs a chronic, recurrent course.

　　Seborrheic dermatitis results from the interplay of endogenous and exogenous triggers. Its pathogenesis is linked to colonization and overgrowth of Malassezia, seborrhea, epidermal barrier disruption, immune dysregulation, neurogenic factors, as well as dietary and environmental contributors. The pathogenic cascade proceeds as follows: genetic or environmental stimuli drive abnormal sebum secretion, enabling excessive proliferation of Malassezia. Its metabolites act as DAMPsto activate TLR signaling and the NLRP3 inflammasome in keratinocytes, triggering the release of proinflammatory cytokines. Subsequently, Langerhans cells mediate Th17 and Th1 differentiation; ILC3, γδT cells and other immune cells collaboratively secrete a spectrum of inflammatory mediators, recruiting inflammatory infiltrates and resulting in inflammation, epidermal hyperplasia and skin barrier impairment, which fuels disease progression of seborrheic dermatitis.

　　Disclaimer

　　1.This press release shares cutting‑edge R&D progress of the Company for informational purposes only and is not intended for advertising. Information herein is not directed at patients and is for reference by healthcare professionals only.

　　2.Nothing in this press release constitutes a recommendation for any medicinal product and/or indication.

　　3.All information contained herein is for reference only. Company press releases and announcements shall in no way substitute for professional medical advice and shall not be construed as medical guidance. Please consult physicians or other qualified healthcare professionals for disease‑specific diagnosis and treatment advice.

　　4.As of the release date of this document, VC005 Topical Gel have not obtained marketing approval from the NMPA.

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