Chongqing Pharma Firm Wins First Domestic Approval for Autoimmune Drug Calcipotriol/Betamethasone Ointment

On March 27, HUAPONT LIFE SCIENCES announced that its wholly-owned subsidiary, Chongqing Huapont Pharmaceutical Co., Ltd., had recently received the Drug Registration Certificate for Calcipotriol and Betamethasone Dipropionate Ointment, approved and issued by the National Medical Products Administration. The approved product, Calcipotriol and Betamethasone Dipropionate Ointment, is primarily indicated for the topical treatment of stable plaque psoriasis in adults. This product is the first domestic generic version and the first to pass the consistency evaluation in China for this category, marking a significant breakthrough in the research and development of generic drugs for psoriasis treatment in China and breaking the market monopoly previously held by Leo Pharma’s Calcipotriol and Betamethasone Dipropionate Ointment.

Psoriasis, also known as "niupixuan," is a common chronic autoimmune inflammatory skin disease.Its pathogenic factors include genetic background, environmental triggers, and abnormal immune responses. Based on different clinical features, psoriasis is primarily classified into plaque psoriasis (including guttate and plaque subtypes), pustular psoriasis (including generalized and localized forms), erythrodermic psoriasis, and psoriatic arthritis. The main symptoms of this condition include skin erythema, scaling, pruritus, and joint pain.

According to data from Health Times, there are over 125 million psoriasis patients worldwide. The prevalence of psoriasis in China is 0.47%, which translates to an estimated 6.5 million patients in the country. Human efforts in the treatment and research of psoriasis have spanned a long period, with more than 160 psoriasis medications currently developed and marketed. Treatment modalities primarily include topical therapy, physical therapy, and systemic therapy.

Relevant research data indicate that calcipotriol and betamethasone dipropionate ointment demonstrates significant clinical advantages in the treatment of psoriasis, offering numerous benefits to patients. This medication can rapidly alleviate the clinical symptoms of psoriasis, such as erythema and scaling, helping patients achieve prompt relief from disease-related distress and restore the normal appearance and function of their skin. Furthermore, it quickly relieves pruritus associated with psoriasis, thereby improving patients’ quality of life and sleep quality, enabling them to better engage in work and daily activities.

The product approved for Huapont Pharmaceutical is a combination formulation consisting of calcipotriol and betamethasone dipropionate. As a vitamin D analog, calcipotriol inhibits the proliferation of keratinocytes and promotes their differentiation, which forms the key basis for treating psoriasis. Betamethasone dipropionate possesses anti-inflammatory, antipruritic, vasoconstrictive, and immunosuppressive properties, effectively alleviating the inflammatory and pruritic symptoms of psoriasis. Calcipotriol and Betamethasone Dipropionate Ointment exerts therapeutic effects from multiple angles, providing synergistic treatment for psoriasis.

According to data from PharmCube, sales of calcipotriol-related formulations in the Chinese pharmaceutical market reached RMB 356 million in 2023, demonstrating their sustained influence in specific therapeutic areas. Specifically, the hospital channel contributed 42.70% of total sales, amounting to approximately RMB 152 million, while pharmacy outlets accounted for the remaining 57.30% market share, reflecting a balanced distribution of the drug across different sales channels. Furthermore, data from Menet indicates that calcipotriol and betamethasone dipropionate ointment has been included in Category B of the National Reimbursement Drug List. In recent years, its sales across China’s three major terminals and six major markets have shown a year-on-year upward trend, approaching RMB 200 million in 2023 and exceeding RMB 100 million in the first half of 2024.

Chongqing Huapont Pharmaceutical Co., Ltd.’s Calcipotriol and Betamethasone Dipropionate Ointment, as the first domestically manufactured generic product and the first to pass the quality and efficacy consistency evaluation in China for this category, marks a significant breakthrough in the research and development of generic drugs for psoriasis treatment in China, breaking the market monopoly previously held by LEO Pharma’s Calcipotriol and Betamethasone Dipropionate Ointment from Denmark.

Chongqing Huapont Pharmaceutical Co., Ltd., established in 1994 and currently headquartered in the Liangjiang New Area of Chongqing, is a National High-Tech Enterprise, a National Innovative Enterprise, a National-Level “Green Factory,” and a Municipal Industrial Design Center. The company possesses a National Enterprise Technology Center, multiple municipal-level R&D platforms, two formulation manufacturing facilities, and two API manufacturing facilities.

According to Trend Cloud data, Huapont Pharmaceutical has maintained a leading position in the domestic clinical dermatology market for many years. With a comprehensive range of pharmaceutical categories, it boasts China’s most complete portfolio of dermatological products, which are sold in both domestic and overseas markets. Notably, its retinoic acid active pharmaceutical ingredients (APIs) account for one-third of the global market share, and it is the only enterprise in China that produces Acitretin Capsules for the treatment of psoriasis. After more than 30 years of dedicated development, Huapont Pharmaceutical has grown into a niche market leader in the field of clinical dermatology in China, establishing an integrated full-industry-chain model encompassing APIs, formulations, medical aesthetics, and healthcare services.

Huapont Pharmaceutical boasts a robust pipeline of dermatological products, including two Class 1 new drugs approved at the national level. Huapont^®Biliang^®Naftifine Ketoconazole Cream, Huapont^®Tazarotene and Betamethasone Cream; 17 domestically first-to-market generic products, such as those from Huapont^®Liyanzhuo^®Desonide Cream, Huapont^®Dim^®Levocetirizine Hydrochloride Tablets/Oral Solution, Huapont^®Jin Diyin^®Calcipotriol ointment and other products cover a wide range of indications, including psoriasis, acne, fungal infections, and dermatitis/eczema, serving hundreds of millions of patient visits annually.

In addition to its comprehensive layout across the dermatology industry chain, Chongqing Huapont Pharmaceutical Co., Ltd. also boasts a robust product portfolio in the anti-tuberculosis field. Furthermore, the company has extensive operations in respiratory, cardiovascular and cerebrovascular, hematology, oncology, and systemic hormonal therapies, accumulating a significant pipeline of blockbuster drugs. In 2021, it officially launched the skincare brand “Sanrui,” expanding its business presence into the broader skin health sector. The company has been granted over 200 invention patents and registered more than 560 trademarks. It has been recognized as a National Intellectual Property Demonstration Enterprise, and its registered trademarks “Bangli,” “Bifu,” and “Liyanzhuo” have successively been awarded the title of “Chongqing Famous Trademark.”

Including Chongqing Huapont Pharmaceutical Co., Ltd., the pharmaceutical industry in Chongqing has witnessed robust overall development in recent years. Taking psoriasis as an example, in addition to the chemical drug ointment approved for Chongqing Huapont Pharmaceutical, there is also Secukinumab Injection (brand name: Jinlixi), a Class 1 new drug independently developed by Zhixiang Jintai.^®, product code GR1501, a recombinant fully human anti-IL-17 monoclonal antibody) was approved for market launch last August for the treatment of moderate-to-severe plaque psoriasis. The secukinumab injection is the first domestically produced anti-IL-17A monoclonal antibody to be approved for market launch, breaking the monopoly held by foreign pharmaceutical companies in the anti-IL-17A monoclonal antibody sector and filling the gap in the field of domestic biological agents for psoriasis.

Nowadays, pharmaceutical enterprises in Chongqing Municipality cover multiple fields, including chemical drugs, traditional Chinese medicine (TCM), biological products, and active pharmaceutical ingredients (APIs), forming a diversified and comprehensive development pattern. According to data from the Chongqing Drug Administration, as of 2024, Chongqing had a cumulative total of 909 biopharmaceutical enterprises. These included 133 chemical drug manufacturers, 124 TCM enterprises, 26 biological product enterprises, 52 API enterprises, 623 medical device enterprises, 40 pharmaceutical packaging material enterprises, 20 pharmaceutical excipient enterprises, and 35 health supplement enterprises (statistics are based on corporate product pipelines, with the scope primarily covering production and R&D-oriented enterprises). Within the biopharmaceutical industry sector, Chongqing had a cumulative total of 233 high-tech enterprises, 208 specialized, refined, distinctive, and innovative (“SRDI”) enterprises, 17 “Gazelle Enterprises,” and 20 SRDI “Little Giant” enterprises.

According to Chongqing drug regulatory data, from 2016 to 2024, Chongqing conducted a total of 451 drug clinical trials (by product variety), ranking 11th among all cities in China. In 2024, the number of drug clinical trials conducted in Chongqing was 79. The total number of drug marketing applications (by product variety) was 380, also ranking 11th among all cities in China, with 127 drug marketing applications submitted in Chongqing in 2024. The total number of drugs approved for marketing (by product variety) was 217, ranking 13th among all cities in China, with 102 drugs approved for marketing in Chongqing in 2024.

Chongqing Pharmaceutical is showcasing its robust strength to the outside world.

References:

1. “Chongqing’s Biopharmaceutical Industry Booms”
2. “First in China! Huapont Pharmaceutical’s Calcipotriol and Betamethasone Ointment Approved!”