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[1] Haycock J W, Rowe S J, Cartledge S, et al. Alpha-melanocyte-stimulating hormone reduces impact of proinflammatory cytokine and peroxide-generated oxidative stress on keratinocyte and melanoma cell lines[J]. J Biol Chem, 2000, 275(21):15629-36.

[2] Mehta P, Kaye W, Raymond J, et al. Prevalence of Amyotrophic Lateral Sclerosis - United States, 2015[J]. MMWR Morb Mortal Wkly Rep, 2018, 67(46):1285-1289.

[3] Wang W, Guo D Y, Lin Y J, et al. Melanocortin Regulation of Inflammation[J]. Front Endocrinol (Lausanne), 2019, 10:683.

[4] Auriemma M, Brzoska T, Klenner L, et al. alpha-MSH-stimulated tolerogenic dendritic cells induce functional regulatory T cells and ameliorate ongoing skin inflammation[J]. J Invest Dermatol, 2012, 132(7):1814-24.

[5] Bystryn J C, Rudolph J L. Pemphigus[J]. Lancet, 2005, 366(9479):61-73.

[6] Murrell D F, Dick S, Ahmed A R, et al. Consensus statement on definitions of disease, end points, and therapeutic response for pemphigus[J]. J Am Acad Dermatol, 2008, 58(6):1043-6.

[7] Herbst A, Bystryn J C. Patterns of remission in pemphigus vulgaris[J]. J Am Acad Dermatol, 2000, 42(3):422-7.

[8] Bohm M, Luger T. Are melanocortin peptides future therapeutics for cutaneous wound healing?[J]. Exp Dermatol, 2019, 28(3):219-224.

[9] Minder E I, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders[J]. Clin Pharmacokinet, 2017, 56(8):815-823.

[10] Understanding the Unmet Needs of the Pemphigus & Pemphigoid Community. IPPF Externally-Led Patient-Focused Drug Development Meeting, January 25, 2023

[11] https://www.gelonghui.com/p/2071680

[12] https://pre.gelonghui.com/p/2502356

[13] https://www.wiseguyreports.com/cn/reports/mucous-membrane-pemphigoid-treatments-market

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