Recently, Hengrui Medicine announced that its application for marketing authorization of emasitinib sulfate tablets (SHR0302 tablets) was accepted by the National Medical Products Administration for the treatment of severe alopecia areata in adults. It is the first domestic JAK inhibitor to be accepted for marketing approval for alopecia areata indications in China.

This also means that after Eli Lilly and Pfizer products have been approved in China, Hengrui is likely to become the first domestic company to enter the domestic alopecia areata market.

Severe alopecia areata in adults is the fourth indication reported by emasitinib. Last year, it also reported moderate to severe atopic dermatitis, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis in adults and adolescents aged 12 and above.

Referring to the progress of Pfizer's application for listing of Litixitinib Capsules accepted by the National Medical Products Administration in September 2022, included in the priority review and approval process in November, and officially approved for listing in October of the following year, if Hengrui's imatinib for alopecia areata can also be included in the priority review and approval process, it may be approved for listing in the second half of next year.

Previously, the Phase II data of imatinib showed that 2mg, 4mg, 8mg imatinib and placebo were used to treat alopecia areata, and the 24-week SALT decreased by 30.51%, 56.11%, 51.01% and 19.8% compared with the baseline.

It can be found that imatinib is dose-dependent in the 2mg and 4mg groups, but there is no dose dependence in the 4mg and 8mg groups, that is, imatinib can achieve a therapeutic effect at 4mg.

In June this year, imatinib tablets reached the preset superior efficacy standard in the main research endpoint of the Phase III clinical trial.

The study was jointly participated by 31 centers across the country, and a total of 330 adult patients with severe alopecia areata were enrolled. The results showed that both the 8mg and 4mg dose groups of emasitinib tablets were significantly better than the placebo group in the primary endpoint, and the safety and efficacy of medium- and long-term treatment in adult patients with severe alopecia areata were good, and no new safety signals were found compared with other JAK1 inhibitors.

In addition to Hengrui, the JAK and ACVR1 dual inhibitor gecaxitinib hydrochloride (formerly known as jacotinib hydrochloride) independently developed by Zejing Pharmaceutical also completed the Phase III clinical study of severe alopecia areata in June this year.

In addition, the alopecia areata indications of Kelun Pharmaceutical's JAK1/2 inhibitor KL130008 capsules and Qiyuan Bio's JAK1/TYK2 inhibitor QY201 have also entered the Phase II clinical stage.

According to data from the National Health Commission, there are currently more than 250 million people in China suffering from hair loss problems. According to a report by Frost & Sullivan, this group will reach 343 million by 2026.

In addition to alopecia areata, androgenic alopecia and scarring alopecia are also common types of hair loss, among which patients with androgenic alopecia account for more than 90% of all types of hair loss. The "Guidelines for the Diagnosis and Treatment of Androgenic Alopecia in Chinese" show that in China, the prevalence of androgenic alopecia in men is about 21.3%, and the prevalence in women is about 6%.

It is reported that androgenic alopecia is a progressive aggravation process, starting from the miniaturization of hair follicles, shortening of the growth period, thinning and less hair, and then hair loss. From the perspective of treatment, long-term medication is required.

The large patient population and the long-term medication attributes make the market size of androgenic alopecia treatment also considerable. According to Frost & Sullivan data, the size of China's hair medical service market has reached 18.4 billion yuan in 2020, and is expected to reach 138.1 billion yuan by 2030, with an annual compound growth rate of up to 22.3%.

In terms of specific drugs, the "Guidelines for the Diagnosis and Treatment of Androgenic Alopecia in Chinese" highly recommends both finasteride and minoxidil. Among them, finasteride is an oral drug, mainly suitable for men, and minoxidil is an external drug with no obvious restrictions on gender.

According to the data of Minnet, in recent years, the combined sales scale of minoxidil in the three major terminals has increased year by year, exceeding 2.5 billion yuan in 2023. In terms of brands, Sansheng Pharmaceutical's minoxidil tincture (Mandi), Zhendong Pharmaceutical's minoxidil lotion (Dafeixin) and Meishang Pharmaceutical's minoxidil tincture (Meishang) ranked the top three, with sales exceeding 100 million yuan.

Compared with alopecia areata, which has the attributes of immune diseases, the market for male hair loss treatment drugs has a broader space outside the hospital, especially in online channels.

Taking minoxidil as an example, its sales in public medical institutions exceeded 200 million yuan in 2023; in urban physical pharmacy terminals, it maintained a double-digit growth rate for three consecutive years, with sales exceeding 300 million yuan; in online pharmacy terminals, minoxidil sales exceeded 1.9 billion yuan, setting a record high.

TOP6 Minoxidil Brands in China's Three Major Terminals and Six Major Markets in 2023 (Unit: 100 million yuan)

Note: Sales of less than 100 million yuan are indicated by *

While the sales scale of traditional drugs maintains rapid growth, the hair loss treatment market is still in constant iteration.

On the one hand, there is innovation in old drugs. Many companies have improved the drug penetration rate by optimizing the dosage forms of traditional products such as minoxidil.

On the other hand, new drug research and development, in May this year, the clinical trial of KX-826 tincture 1.0% independently developed by Kaituo Pharmaceuticals for the treatment of male pattern baldness was approved by NMPA; in February, the first Phase II clinical trial of TDM-105795, a topical preparation for the treatment of male pattern baldness, was successfully completed by Tekoro Biotechnology; in January, the Phase Ib clinical study of HMI-115 for the treatment of male pattern baldness by Heqirui Pharmaceuticals was completed and achieved positive results.