On June 30, the official website of the National Medical Products Administration showed that Jiangsu Hengrui Medicine Co., Ltd.'s new Class 1 drug, the highly selective JAK1 inhibitor emaprizitnib sulfate tablets (brand name: Aisuda)^®) new indication approved,Indicated for adult patients with severe alopecia areata. This is the fourth indication following ankylosing spondylitis, rheumatoid arthritis, and atopic dermatitis.ImsidolimabThe fourth major indication obtained consecutively this year.

This approval not only provides a new treatment option for patients with alopecia areata, but also further demonstrates the research and development capabilities of Chinese innovative pharmaceutical companies in the field of autoimmune diseases.

Figure 1. Approval of new indication for Imsidolimab tablets, source: NMPA official website

Alopecia areata is a chronic immune-mediated inflammatory non-scarring hair loss that can occur at any age and significantly negatively impacts patients' mental health and quality of life. Epidemiological data show that the global lifetime prevalence of alopecia areata is as high as2%, Asian countries andThe prevalence is higher in the region.2021About the number of alopecia areata patients in China in the year349ten thousand, and the disease burden cannot be ignored.

Currently, patients with alopecia areata still have multiple unmet needs.Most patients with mild alopecia areata can spontaneously recover or be cured after treatment, but severe alopecia areata is difficult to cure. Long-term use of glucocorticoids and immunosuppressants not only causes significant side effects, but also faces challenges such as diminishing efficacy, treatment resistance, and high relapse rates after discontinuation. Moreover, alopecia areata severely impacts patients' work, daily life, and mental health, with patients suffering from severe forms showing higher prevalence of depression and anxiety. Therefore, there is an urgent need for innovative treatment options for alopecia areata patients that can effectively promote and sustain hair regrowth, offer good long-term safety, and allow convenient administration.

Emapticib is a highly selectiveJAK1Inhibitor, its mechanism of action based on theJAK/STATBlockade of signaling pathways.JAK/STATSignaling pathways play a key role in various immune-mediated diseases, including alopecia areata.

by inhibitingJAK1, emapticapibart can effectively inhibitTcell-induced immune responses and cytokines that play an important role in the development and progression of alopecia areata, includingIFN-γ、IL-2、IL-7、IL-15、IL-21), thereby exerting therapeutic effects. This precise targeting mechanism demonstrates significant efficacy and favorable safety in treating alopecia areata.

ImsidolimenibAdopting an optimized structure of "two double rings plus one single ring," it enables a precise "lock-and-key match" for JAK1. According to a press release from Jiangsu Hengrui Medicine Co., Ltd.,Ivarmacitinib is the first self-developed, highly selective JAK1 inhibitor in China.

The approval of emapticapib is based on a randomized, double-blind, placebo-controlledIIIpositive data from the phase clinical trial. The study was conducted in China31conducted simultaneously at hospitals, with enrollment of330Example of an adult patient with severe alopecia areata (scalp hair loss area)≥50%, including complete baldness/Pu-tu), were treated with imetelstat respectively4mg QD、8mg QDTreatment or placebo. The primary endpoint of the study was at week24Zhou ShidaSALTScore≤20(i.e., the scalp hair loss area≤20%) of patients, with secondary efficacy endpoints including at different time pointsSALTScores, overall subject assessments (satisfaction with hair regrowth and acceptability of hair regrowth), and safety data.

The results show,Treatment Day8Zhou,4mgGroup and8mgGroupSALTScore≤20response rates were all higher than those in the placebo group; the 24Zhou,4mgGroup and8mgGroupSALTScore≤20The response rates were respectively34.9%and40.6%。52During weekly treatmentSALTScores continue to decline; the52Zhou,4mgGroup and8mgGroupSALTScore≤20The response rates were respectively46.8%and63.1%。As symptoms improved, patients' satisfaction and acceptance of hair regrowth were significantly better than those in the placebo group.

In terms of safety, the overall safety profile is good.，24Weekly core treatment period adverse events (TEAEs) the incidence rate is similar to that of the placebo group, and one tablet per day (4mg), convenient for oral administration, helping to improve patient treatment compliance.

Emma昔tini is the first self-developed highly selective drug in ChinaJAK1Inhibitor, whose approval has completely broken the long-standing situation in ChinaJAK1an end to the import monopoly of inhibitors, bringing new opportunities for the clinical management of alopecia areata“China Innovation Solution”。

The approval of emapticib will bringPatient clinical benefit，It is completely bald/First oral targeted therapy for patients with alopecia areata, Japanese server1Piece (4mg) administration method improves patient compliance and can significantly reduce the risk of depression (clinical studies showPHQ-9Score improvement37%）。

Business perspectiveRegarding Emma, Xitinib has been approved for four indications within the year (spondylitis)/Rheumatoid/Dermatitis/Alopecia areata), covering ultra3000ten thousand Chinese patients; it also reflects Jiangsu Hengrui Medicine Co., Ltd.'s deep strategic layout in the autoimmune pipeline. In addition to the already launched imsidolimab and funazicimab, there are6One product under development.

• Related review:Jiangsu Hengrui Medicine's JAK1 inhibitor "Ivarmacitinib" approved for marketing in China

This approval also marks the achievement ofTechnological independence breakthrough, breaking the importJAKInhibitors (such as Pfizer's tofacitinib) have long held a monopoly, but prices are expected to decrease significantly.. The future,"Precise inhibitionJAK1"Platform technology can be extended to psoriasis, lupus erythematosus, etc.20+Indications.

This approval not only provides a new treatment option for patients with alopecia areata, but also sets a benchmark for domestic pharmaceutical companies in research and development for autoimmune diseases. As an innovative international pharmaceutical enterprise, Jiangsu Hengrui Medicine Co., Ltd. has continuously focused on innovative R&D addressing urgent clinical needs and has received approval for multiple drugs to be marketed in China.23Kuan1innovative drugs,4Type2Classified as new drugs, additionally90Multiple self-developed innovative products are in clinical development, approximately400Clinical trials are being conducted both domestically and abroad. In the field of autoimmunity, Jiangsu Hengrui Medicine Co., Ltd., after years of development and strategic planning, is continuously achieving research breakthroughs.