April 3, 2025
Source: drugdu
68
Recently, the topical drug calcipotriol-betamethasone ointment for the treatment of psoriasis developed by Chongqing Huabang Pharmaceutical was approved for marketing by the State Food and Drug Administration, becoming the first generic drug of calcipotriol-betamethasone ointment in China .
Behind this is the story of how Huabang Pharmaceutical's "China Solution" took ten years of research and development to finally break the 16-year market monopoly of original drugs in China.
Ten Years of Breakthrough of the “China Solution”
Calcipotriol-betamethasone ointment was originally developed by LEO Pharma and first launched in Denmark in March 2001. It was subsequently launched in many European countries and the United States (2006) and in China in September 2008 (trade name: Defubao).
This product is a compound preparation of calcipotriol and betamethasone dipropionate. It inhibits the proliferation of keratinocytes through the vitamin D analog calcipotriol, combined with the anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive effects of betamethasone dipropionate, making it a classic treatment for psoriasis.
The localization of this product faces many technical bottlenecks . For example, how to effectively control impurities in raw materials and how to ensure the uniformity of particle size and dispersion of the low-content main drug calcipotriol in ointment preparations have become difficult problems that need to be overcome urgently.
As early as 2014, Huabang Pharmaceutical began the marketing research of calcipotriol-betamethasone ointment. After ten years of dedicated research, it finally broke through the technical barriers. In March 2025, the ointment with the same ingredients (specifications 15g/30g) developed by Huabang Pharmaceutical was approved for marketing. Compared with the original research, Huabang Pharmaceutical's calcipotriol-betamethasone ointment shows significant comprehensive advantages.
High quality standards : Huabang Pharmaceutical's Calcipotriol Betamethasone Ointment strictly adheres to higher quality standards, with higher purity of active ingredients and higher safety.
Stable product quality : Relying on Winbond's digital intelligent factory production system, product quality is more stable.
High cost-effectiveness : While the quality standards are comprehensively improved, the pricing of Huabang Calcipotriol Betamethasone Ointment is expected to be lower than the original research product, providing patients with a more economical and efficient treatment option.
The launch of Winbond Calcipotriol Betamethasone Ointment provides more prescription and medication options for clinicians and psoriasis patients.
Seize the market opportunity
Since the original product Defubao entered the Chinese market in 2008, it has formed a long-term market advantage. Faced with this mature competitor with 16 years of deep cultivation, how can the newly launched domestic first-generation generic drugs differentiate themselves and open up new space in the market structure dominated by original research?
Psoriasis is an immune-mediated, chronic, recurrent, inflammatory, systemic disease induced by the combined effects of genetics and the environment, and it is incurable. According to Sullivan's report, the global prevalence of psoriasis is about 0.14% to 1.99%, and the prevalence of psoriasis in China is about 0.50%, which will increase from 6.6 million in 2018 to 6.7 million in 2022, and is expected to reach 6.8 million in 2030.
According to the Sullivan report, China's psoriasis drug market has grown rapidly from US$604.2 million in 2018 to US$1,435.8 million in 2022. It is estimated to reach US$3,254.6 million in 2025 and will further increase to US$9,943.6 million in 2030, with a compound annual growth rate of 25.0% from 2025 to 2030.
In the treatment of psoriasis, topical medications are suitable for the vast majority of patients and are the preferred treatment method.
At a time when biologics are gradually being used to treat psoriasis, calcipotriol betamethasone ointment is still one of the key drugs for the treatment of psoriasis. The "Guidelines for the Diagnosis and Treatment of Psoriasis in China (2023 Edition)" points out that for patients who have a poor response to monotherapy with biologics or who have a decline in efficacy, the use of a treatment model that combines biologics with topical medications can improve the overall treatment effect. For people with refractory psoriasis, compared with increasing the dose of biologics or changing treatment plans, the treatment strategy of combining biologics with calcipotriol betamethasone ointment can achieve better clinical outcomes. The "Guidelines for the Treatment of Psoriasis with Biologics and Small Molecule Drugs in China (2024)" lists the combination of vitamin D3 derivatives and biologics for the treatment of psoriasis as a Class A recommendation.
The average annual treatment cost of original drugs in China is about 12,000 yuan. Huabang Ointment has the same efficacy as the original drug and has certain advantages. Referring to the pricing strategy of the similar generic drug calcipotriol, it is predicted that Huabang's product pricing will be lower than the original drug. Huabang Calcipotriol Betamethasone Ointment has been approved for marketing, which can enable patients to obtain high-quality treatment options at a more affordable price. And with the further normalization of national centralized procurement of drugs, the market share of domestic drugs is expected to continue to increase.
Yaozhi data shows that currently only Chongqing Huabang Pharmaceutical has obtained the production approval for calcipotriol-betamethasone ointment, and no other company has submitted an application for listing, which means that Huabang is at least three years ahead of other companies in this first generic drug.
The psoriasis market in China has huge potential, and topical drugs such as calcipotriol betamethasone ointment have a lasting influence in the field of psoriasis treatment. In terms of topical drugs for the treatment of psoriasis, there is only one original drug for calcipotriol betamethasone ointment, and the choices are very limited. Huabang's first generic drug will seize the market opportunity with its price advantage and localized channel strategy.
Huabang Pharmaceutical’s new paradigm in the skin field
After more than 30 years of continuous research and development, Huabang Pharmaceutical has now formed a product family of 67 products in 3 major fields, 21 categories, and 67 products. Among them, skin drugs are the most abundant, basically covering common dermatological diseases such as allergies, dermatitis and eczema, fungal diseases, acne, psoriasis, vitiligo, etc., forming a complete skin treatment product line. At the same time, it has laid out a multi-variety portfolio in the field of tuberculosis to continue to consolidate its market leadership.
The company has mastered core technologies in the fields of retinoid/vitamin D drug development, high-end steroid hormone drug synthesis, in vitro drug release and transdermal analysis. It also has many awards including 4 national major new drug creations, 5 national torch plans, 7 national key new products, and more than 200 authorized patents. These technologies not only support drug research and development, but also form unique technical barriers by enabling the development of functional skin care products.
The company’s 21 products have been included in the “Catalogue of Marketed Drugs in China”, including several first-copy products, forming a high-quality product cluster.
In the field of psoriasis, the company has formed a combination of 7 core products, covering all scenarios of oral and topical use. Among them, Acitretin Capsules, as the only oral preparation approved in China, have great market potential. Tazarotene Cream, as a third-generation retinoic acid drug, has higher receptor selectivity and ranks high in sales in sample hospitals. Calcipotriol Ointment achieves long-term control through the mechanism of vitamin D3 derivatives.
In the field of dermatitis and eczema treatment, the company has built a "weak-strength" hormone drug echelon: Desonide Cream, as the earliest weak-strength preparation approved in China, can meet the needs of infants and sensitive skin. According to Yaozhi data, Desonide Cream is Huabang Pharmaceutical's product with the largest hospital sales volume in 2024 (first three quarters), and the domestic market for this product is mainly occupied by Huabang Pharmaceutical. Betamethasone propionate cream, halometasone cream, and clobetasone butyrate cream have become important treatment options for moderate to severe skin lesions due to their potent anti-inflammatory properties.
In the anti-allergic field, Huabang Pharmaceutical's first generic version of levocetirizine hydrochloride oral solution can be used for allergic rhinitis, urticaria and other allergic symptoms in infants and young children over 6 months old. This product provides a safe and effective treatment option for more children with allergies. It is suitable for a wider range of people than other antihistamines and is expected to bring significant growth to the market.
Based on its accumulation of drug research and development, Huabang Pharmaceutical is deeply expanding from disease treatment to the field of skin health management. It is understood that Huabang Pharmaceutical established a wholly-owned subsidiary, Chongqing Huapangli Biotechnology Co., Ltd., in 2021 to continue to deepen its roots in the skin field and embark on a new journey of business expansion. Backed by Huabang Pharmaceutical, Huapangli has successively launched the "Sanrui" functional skin care brand and the "Zhiminjia" baby skin care brand, covering multiple categories such as cleansing, oil control and acne removal, soothing and repairing, and baby skin care, further enriching Huabang Pharmaceutical's product matrix in the pan-skin field.
The value of first copycat is not only to break the monopoly, but also to reshape the accessibility of patients and the industry standards. Huabang's breakthrough allows more patients to afford efficient and safe psoriasis drugs. In the sub-segment of dermatology, a competition about technology, ecology and industry discourse power is quietly changing the global coordinates of China's pharmaceutical industry.
https://news.yaozh.com/archive/45235.html
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