Multiple Chinese Pharma Firms Including Wanrong Jiancheng, Qilu, and Thermo Compete for First Generic of Crisaborole Ointment in Pediatric Atopic Dermatitis

　　【Pharmaceutical Network Industry DynamicsAtopic Dermatitis (AD) is a chronic, recurrent, inflammatory skin disease that usually begins in infancy and can persist through childhood, adolescence, and even adulthood. The disease has a chronic course with various clinical manifestations. The basic characteristics are dry skin, chronic eczematous lesions, and significant pruritus. Some patients may also have other allergic diseases such as allergic asthma and allergic rhinoconjunctivitis. Currently, in the field of pediatric atopic dermatitis, a large number of pharmaceutical companies in China are competing for the first generic version of the promising drug Crisaborole ointment.
 

Data shows that Crisaborole is a new type of small molecule, non-hormonal, non-steroidal anti-inflammatory phosphodiesterase 4 (PDE-4) inhibitor originally developed by Anacor. In 2016, Pfizer acquired Anacor for $5.2 billion, gaining Crisaborole and others. In China, in July 2020, Pfizer's Crisaborole received NMPA approval for marketing with an indication for treating mild to moderate AD in patients aged 2 years and above, becoming the first non-hormonal PDE-4 inhibitor approved in China. In August 2023, Crisaborole ointment was approved for a new indication, expanding the applicable age range from over 2 years to over 3 months.
 

It is reported that currently, in China, only Pfizer's original drug Crisaborole Ointment has been approved for marketing, and no company has been approved to produce a generic version of Crisaborole Ointment. However, in this drug field, a battle surrounding the race to imitate the original drug companies has already begun.
 

Recently, the website of the National Medical Products Administration showed that the marketing application for crisaborole ointment submitted by Zhejiang Cdmo Pharmaceutical Co., Ltd. as a Category 4 generic drug has been accepted by the CDE. Zhejiang Cdmo Pharmaceutical seems determined to obtain approval for Pfizer's crisaborole ointment this time.
 

In addition, currently in China, several pharmaceutical companies have submitted applications for the market launch of generic crisaborole ointment, including Nanjing Wanrong Jiancheng Pharmaceutical, Qilu Pharmaceutical, Hangzhou Lingye Pharmaceutical, Zhejiang Gaozhi Pharmaceutical, Jiangxi Kerui Pharmaceutical, and Jiangsu Wango Pharmaceutical. Among them, Nanjing Wanrong Jiancheng is one of the earlier companies in China to submit an application for marketing generic crisaborole ointment (having submitted the application as early as March 2023). Two months after their submission, Qilu Pharmaceutical's application was also accepted.
 

It is reported that currently, topical corticosteroids (TCS) are recommended as the first-line treatment for childhood AD in China. However, long-term and large-scale use may lead to skin and systemic adverse reactions. The main adverse reactions of topical TCI include local burning and irritation. Treatment options for pediatric AD patients (especially children under 2 years old) still fall short of medical needs, but the emergence of Crisaborole Ointment has helped alleviate this situation.
 

In recent years, sales data shows that Pfizer's Crisaborole Ointment has also performed well in the market. With its good safety profile, Crisaborole Ointment has achieved annual sales of approximately 300 million US dollars. In the Chinese market, in 2021, Crisaborole Ointment was included in the Class B directory of the National Medical Insurance through national negotiations. After entering the medical insurance, Crisaborole Ointment is in a stage of rapid growth in the domestic market. Data shows that in 2022, the sales of Crisaborole Ointment soared to 26.01 million yuan.
 

Statistics show that globally, approximately 10% of adults and 20% of children are affected by atopic dermatitis. In infants, skin lesions mostly begin before the age of 2. Affected children will experience skin damage and intense itching, severely impacting their sleep and growth development. As the condition progresses, it is also prone to complications such as asthma, allergic rhinitis, and allergic conjunctivitis. In the Chinese market, the prevalence of atopic dermatitis (AD) has rapidly increased over the past decade, showing a trend where the incidence rate is higher in younger age groups. With the growing demand from patients, the market for crisaborole ointment is also expected to expand into a broader space.
 

It is reported that in the current market in China, apart from the above-mentioned pharmaceutical companies that have already entered the review and approval process, nearly 30 generic drug companies have registered for the BE trials of Crisaborole Ointment, indicating that the future competition may be extremely fierce.
 

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