Topical Ointments Market Surges Toward RMB 7 Billion: Top 20 Rankings Reshuffled, Six Products Achieve Exclusive Generic Approval, Fuyuan and Qilu Race for First-to-File, Seven Class 1 New Drugs Enter Clinical Trials

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Recently, there is another piece of good news from the chemical pharmaceutical ointment market. Front Pharmaceutical PLC's Lidocaine and Prilocaine Cream, Zhejiang Fonow Medicine Co., Ltd.

Zhejiang Cdmo Pharmaceutical's Mupirocin Ointment production report has been accepted by the CDE. To date, a total of 17 varieties (73 acceptance numbers) have been submitted for production review under the new classification. Companies such as Qilu Pharmaceutical and Front Pharmaceutical PLC are striving for the first generic approval. Data from Menet shows that in the first half of 2023, the sales of chemical ointments at China’s public medical institutions increased by nearly 15% year-on-year, with the potential to exceed 7 billion yuan for the entire year. The top 20 products have seen changes, with Mometasone Furoate Cream reclaiming the "top-seller" position; seven products have increased by over 20%, and Chongqing Huapont, Hong Kong Aomei, and Heng'an Fulin have made the list. Since the beginning of this year, five varieties (11 acceptance numbers) have been approved for marketing, and seven Class 1 new drugs have been approved for clinical trials. Currently, eight varieties have passed the evaluation, six of which are exclusive evaluations.

Ointment Market Surges Towards 7 Billion! Six Exclusive Products Pass Evaluation

Sales of Chemical Ointments in Chinese Public Medical Institutions in Recent Years (Unit: Billion Yuan)

Source: MiNeiNet China Public Medical Institution Pharmaceutical Terminal Competition Pattern

Data from MiNei Network shows that the terminal market size of chemical ointments in China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) has steadily increased in recent years. Sales exceeded 6 billion yuan in 2021, reached a new high in 2022, and grew by nearly 15% year-on-year in the first half of 2023. The full-year sales are expected to exceed 7 billion yuan.

Chemical drug ointments approved this year

Source: MiNeiNet China Application Progress (MED) Database

Since the beginning of this year, 11受理号 (acceptance numbers) for chemical ointments have been approved under the new classification for production and are considered to have passed the evaluation. These include tacrolimus ointment from Hangzhou Zhongmei Huadong Pharmaceutical and lidocaine-prilocaine cream from Sichuan Haisi Pharmaceutical, covering therapeutic subcategories such as anesthetics, corticosteroid preparations for dermatological use, and systemic antifungal drugs.

Ointment Passing Evaluation

Source: MiNeiNet China Listed Drugs (MID) Database

As of now, there are eight varieties of ointments that have passed the evaluation. Among them, Tacrolimus Ointment has the highest number of enterprises passing the evaluation, with five companies. Lidocaine and Prilocaine Cream has two companies. Desonide Cream from Hubei Renfu Chengtian Pharmaceutical, Diflorasone Diacetate Ointment from Tianjin Jinyao Pharmaceutical, Niconazole Hydrochloride Cream from Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical, Pimecrolimus Cream from Jiangsu Zhiyuan Pharmaceutical, Mupirocin Ointment from Front Pharmaceutical PLC, and Tacalcitol Ointment from Nanjing Hairong Pharmaceutical are all exclusively approved. It is worth mentioning that all ointment varieties that have passed the evaluation were approved under the new classification for production and are considered to have passed the evaluation. Additionally, there are currently no supplementary applications for consistency evaluation under review.

TOP20 Shuffle! 7 Products Increase Over 20%, Huapont,澳美, and Hengan Fulin Make the List

Top 20 Chemical Drug Ointment Products in Chinese Public Medical Institutions, H1 2023 (Unit: Billion Yuan)

Source: MiNei Network's Competitive Landscape of Drug Terminals in China's Public Medical Institutions

Note: Sales below 100 million yuan are indicated with *.

Among the top 20 products, 12 have sales exceeding 100 million yuan, with Mometasone Furoate Cream reclaiming the top sales position. In terms of growth rate, there are more increases than decreases; seven products—Mometasone Furoate Cream, Fluticasone Propionate Cream, Triamcinolone Acetonide and Econazole Nitrate Cream, Halometasone/Triclosan Cream, Crisaborole Ointment, Naftifine Hydrochloride and Ketoconazole Cream, and Calcipotriol Betamethasone Dipropionate Ointment—have growth rates exceeding 20%. From the perspective of therapeutic categories, dermatological drugs continue to dominate.

Seven exclusive products, namely, Compound Polymyxin B Ointment (Zhejiang Fonow Medicine Co., Ltd.), Nifuratel Nystatin Vaginal Ointment (Nanjing Nanda Pharmaceutical Co., Ltd.), Mucopolysulfate Cream (Bridging), Halometasone/Triclosan Cream (Recordati AG), Crisaborole Ointment (Anacor), Naftifine Ketoconazole Cream (Chongqing Huapont Pharmaceutical Co., Ltd.), and Calcipotriol Betamethasone Ointment (Jacobson Pharmaceutical Research and Manufacturing Co., Ltd.). Among them, Crisaborole Ointment (Anacor) and Calcipotriol Betamethasone Ointment (Jacobson Pharmaceutical Research and Manufacturing Co., Ltd.) are newly listed products.

Top 20 Chemical Ointment Brands in Chinese Public Medical Institutions (H1 2023) (Unit: Billion Yuan)

Source: MiNei Network's Competitive Landscape of Drug Terminals in China's Public Medical Institutions

Note: Sales below 100 million yuan are indicated with *.

Among the top 20 brands, 10 have sales exceeding 100 million yuan. Desonide Cream by Chongqing Huapont Pharmaceutical Co., Ltd., Compound Lidocaine Cream by Tongfang Pharmaceutical Group Co., Ltd., and Compound Polymyxin B Ointment by Zhejiang Fonow Medicine Co., Ltd. ranked in the top three.

In terms of growth rate, Anacor's Crisaborole Ointment showed the fastest growth at 116.05%. Four brands, including Hubei Hengan Fulin Pharmaceutical's Mometasone Furoate Cream, Zhejiang Xianju Pharmaceutical's Fluticasone Propionate Cream, and Chongqing Huapont Pharmaceutical's Naftifine Ketoconazole Cream, all achieved growth rates exceeding 30%. In terms of quantity, Chongqing Huapont Pharmaceutical, Aomei Pharmaceutical, Hubei Hengan Fulin Pharmaceutical, and Xi'an Janssen each had two products on the list.

Sales of Mometasone Furoate Cream in Chinese Public Medical Institutions in Recent Years (Unit: Billion Yuan)

Source: MiNei Network's Competitive Landscape of Drug Terminals in China's Public Medical Institutions

Mometasone Furoate Cream is suitable for eczema, neurodermatitis, atopic dermatitis, etc. Data from Menet shows that the sales of Mometasone Furoate Cream in Chinese public medical institutions have steadily increased in recent years, with a year-on-year increase of over 20% in the first half of 2023. Nine enterprises hold the production approval for Mometasone Furoate Cream, among which Hubei Hengan Fulin Pharmaceutical has the largest market share. Currently, only Front Pharmaceutical PLC has submitted a Class 3 generic drug application for this product under review.

Front, Qilu... Aggressively Pursue First Generic Drugs, 7 Class 1 New Drugs Are Heating Up

No generic drugs have been approved and no chemical ointments are under review for production in China.

Source: MiNeiNet China Application Progress (MED) Database

As of now, there are over 70 application numbers for chemical drug ointments under review in the new classification, involving 17 products. Nearly 80% of the application numbers were submitted this year. Lidocaine Prilocaine Cream is the most popular, involving up to 23 companies including Hainan Hailing Chemical Pharmaceutical, Suzhou Erye Pharmaceutical, and Hunan Jiudian Pharmaceutical. Next is Mupirocin Ointment, with 10 companies.

From the perspective of enterprises, Front Pharmaceutical PLC has the most products under review, with 5 in total: Fluticasone Propionate Cream, Calcipotriol Ointment, Desonide Cream, Fusidic Acid Cream, and Mometasone Furoate Cream; Hangzhou Lingye Pharmaceutical Technology, Jiangsu Knoworigin Pharmaceutical, and Zhejiang Gaochi Pharmaceutical each have 3.

Crisaborole Ointment, Fusidic Acid Cream, Minocycline Hydrochloride Ointment, and Viflufolide Cream have no generic drug enterprises approved in China. Qilu Pharmaceutical, Front Pharmaceutical, Baolong Pharmaceutical, Zhejiang Fonow Medicine and others are expected to obtain the first generic approval.

Clinical Approval Status of New Category 1 Chemical Ointments Since This Year

Source: MiNeiNet China Application Progress (MED) Database

In addition, since the beginning of this year, 13 new chemical ointment agents have been approved for clinical trials in China, seven of which are Class 1 new drugs, involving multiple therapeutic subcategories such as immunosuppressants and psoriasis treatments.

Source: Menet database, company announcements

Note: The terminal competitive landscape of public medical institutions in China by Menet, the statistical scope includes: urban public hospitals, county-level public hospitals, urban community centers, and township health centers, excluding private hospitals, private clinics, and village health stations; the above sales are calculated based on the average retail price of products at the terminal. Any corrections or omissions are welcome!