Allergopharma's 50-Year Journey: China's Sole Dual-Dermatophagoides Allergen Immunotherapy Provider Files IPO Prospectus

Allergies are by no means unfamiliar to the general public.

According to the World Allergy Organization, 30%–40% of the global population suffers from allergic diseases, making them the sixth most prevalent chronic disease worldwide. The World Health Organization has long listed allergic diseases as one of the key conditions for priority research and prevention in the 21st century.

Looking at the domestic landscape, the number of individuals with allergic diseases in China is increasing year by year due to factors such as environmental conditions and lifestyle habits. According to survey estimates by the Branch of Allergy of the Chinese Medical Association, the number of adult patients with allergic rhinitis in China alone has reached as high as 150 million.

In stark contrast to the vast patient population is the scarcity of medical resources. According to data from the Allergy Branch of the Chinese Medical Association, there are fewer than 350 allergists nationwide, and no more than 3,000 physicians are qualified to diagnose and treat allergic diseases. Less than 1% of medical institutions in China have dedicated allergy departments. As an emerging specialty, allergy is not a standard department in most hospitals. This imbalance between supply and demand has resulted not only in a shortage of diagnostic and treatment services but also in widespread irregularities and non-standardized practices.

Allergopharma (hereinafter referred to as: Allergopharma Pharmaceuticals) is a German company with over 50 years of history, holding a leading position in the global field of diagnostic testing and desensitization therapy for allergic diseases.

Since entering the Chinese market in 1999, asThe Only Domestic Pharmaceutical Company Producing “Dual Mite Desensitization Preparations”, Allergopharma has been committed to accelerating the introduction and development of a broader range of allergen diagnostic products and specific immunotherapy products, while actively promoting physician training and industry exchanges in China, thereby contributing to the continuous improvement of research and treatment standards for allergic diseases in the country.

“Over the course of half a century, Allergopharma has remained steadfast in its original commitment to bringing relief to patients with allergic diseases, aiming for a complete cure and dedicating itself to discovering better and optimal treatments for allergic conditions.”Qiu Ning, President of Arogue Pharmaceuticals ChinaSpeak.

Alergopharma is a privately held company founded in 1969 by two scientists. Since its inception, the company has been dedicated to the diagnosis and treatment of allergic diseases. Within just three years of its establishment, it developed its first product and immediately introduced this natural allergen preparation for clinical use, benefiting a vast number of patients suffering from allergies.

In the 1980s, Allergopharma began to rapidly expand its business while diversifying the research and development of a series of diagnostic and therapeutic products. In the field of allergen diagnosis, its offerings expanded from initial skin prick test products to in vitro diagnostic products; in desensitization therapy, its portfolio includes subcutaneous formulations and sublingual drops, and even extends to allergen avoidance measures, emergency rescue products, and anti-mite bedding detergents. Its ultimate goal is to identify the most effective comprehensive treatment strategies for allergic diseases.

“Exploring the diagnosis and treatment of allergic diseases can be a viable direction, but cleaning products should not be the focus of a pharmaceutical company,” said Qiu Ning. Therefore, in the 1990s, Allergopharma adjusted its business strategy and optimized its R&D efforts by eliminating non-core products and concentrating all resources on the development of its core product portfolio.

It is understood that allergen immunotherapy generally consists of two phases: the initial treatment phase and the maintenance treatment phase. During the initial treatment phase, the dosage is gradually increased from the lowest concentration and smallest dose to the highest concentration, reaching the maximum tolerated dose, provided that the patient can tolerate it. Once the maintenance phase begins, the injection interval is extended to once every 1 to 1.5 months, with the entire course of treatment lasting no less than three years.

During its business expansion phase, Allergan Pharmaceuticals completed the upgrade of its first-generation products.Second-generation products achieve reduced allergenicity while retaining immunogenicity through chemical modification of natural allergens, significantly reducing the number of injections required during the dose-escalation phase., shortening the injection course of the initial treatment phase from an average of 4–5 months to 1.5 months, significantly improving patient tolerance and adherence while ensuring the efficacy of immunotherapy, thereby optimizing the entire immunotherapy process.

According to Qiu Ning,Regardless of whether they are first-generation or second-generation products, their manufacturing is constrained by natural raw materials.Therefore, Allergopharma pioneered the global exploration of subcutaneous recombinant humanized desensitization agents. Although the Phase II clinical study of the recombinant formulation was successful, it failed to meet the primary endpoints in Phase III clinical trials. Nevertheless, its nearly two decades of R&D experience have made outstanding contributions to the global development of recombinant products. During this period, it was confirmed that the previously recognized major allergen components are indeed the primary causes of allergic diseases; however, focusing solely on these major sensitizing components is far from sufficient, a fact that has also been demonstrated in recent clinical trials. Allergopharma has continuously pursued innovation in understanding disease mechanisms and developing product formulations, steadily unraveling the mysteries of allergic diseases in the process.

In February 2020, Merck Group transferred its equity stake in Allergopharma to Germany’s Dermapharm Holding. Allergopharma continues to operate independently, maintaining its focus on research and development of products in the allergy field.

Looking back on over 50 years of trials and tribulations, Allergopharma has remained committed to providing optimal solutions for patients with allergic diseases. By harnessing the expertise of the world’s leading scientists, we jointly explore the diagnosis and treatment of allergic conditions, striving to develop the most effective desensitization products.

To date, Allergopharma has firmly established a leading position in the global field of allergic disease diagnosis and desensitization therapy,The company's allergen diagnostics and subcutaneous immunotherapy products (first-generation natural allergens and second-generation chemically modified allergens) cover more than 100 types of allergens., supplementing and enriching Debiotech’s product portfolio in the allergy field, and creating more opportunities for its expansion into international markets.

The Chinese market is a key growth engine for Aroge Pharmaceuticals and one of the most strategically significant markets for Debai Group globally.

As early as 1999, Allergopharma’s product Alutard (Dermatophagoides farinae + Dermatophagoides pteronyssinus) was approved for marketing in China. Since 2000, the Allergy Business Unit of Merck Group has been operating in China for over two decades, providing healthcare professionals and patients with etiology-specific immunotherapy (desensitization therapy) for allergic diseases. It has also helped establish nearly 400 “Desensitization Therapy Centers” in large and medium-sized hospitals, cumulatively treating approximately 100,000 patients with allergic conditions.

Following its spin-off from Merck KGaA, Allergopharma (Beijing) Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Allergopharma China”), the wholly-owned Chinese subsidiary of Germany’s Allergopharma, was established in Beijing in May 2020. The company is committed to providing healthcare professionals and patients in China with premium services and high-quality products, enabling more patients to benefit from Allergopharma’s allergen immunotherapy products and find relief from allergic diseases.

Relevant statistics indicate that the prevalence of allergic diseases (allergic rhinitis, allergic asthma, and atopic dermatitis) in China has surged over the past two decades. Specifically, the prevalence of allergic rhinitis among adults rose from 11.1% in 2005 to 17.6% in 2011, while the prevalence of allergic asthma among children increased from 1.09% in 1990 to 3.02% in 2010.

Among them,The primary allergen responsible for causing disease is dust mites., significantly higher than that of other allergens such as pollen. During the ten-year period from 2008 to 2018, the sensitization rate to Dermatophagoides farinae increased from 45.4% to 52.1%, and the sensitization rate to Dermatophagoides pteronyssinus rose from 44.5% to 51.7%. Furthermore, nearly 80% of patients allergic to dust mites were simultaneously sensitized to both subspecies, Dermatophagoides farinae and Dermatophagoides pteronyssinus.

Allergovit (Dermatophagoides farinae + Dermatophagoides pteronyssinus) is the first-generation product developed by ALK-Abelló in 1972. As of 2020, more than 560,000 patients worldwide have received Allergovit treatment, and its clinical efficacy and safety have been fully validated.

Alutard SQ (Dermatophagoides farinae + Dermatophagoides pteronyssinus): The indication approved in China is for IgE-mediated allergic diseases induced by inhalant allergens.: such as allergic rhinitis, allergic conjunctivitis, and bronchial asthma. This productIt is the only standardized subcutaneous desensitization preparation approved in China that contains both Dermatophagoides farinae and Dermatophagoides pteronyssinus.Following its initial clinical registration in 1999, two large-scale post-marketing Phase IV clinical trials were conducted in China in 2012 (adults and children) and 2016 (children), respectively. The results fully validated that Alorag demonstrates favorable efficacy and safety in both adult and pediatric patients with allergic rhinitis and/or allergic asthma in China.

Given the epidemiological characteristics of allergic diseases in China—where the vast majority of patients are sensitized to either *Dermatophagoides farinae* or *Dermatophagoides pteronyssinus*, and most are concurrently allergic to both—Aluogel (*Dermatophagoides farinae* + *Dermatophagoides pteronyssinus*) better meets the therapeutic needs of Chinese patients with allergic diseases, providing more reliable efficacy assurance.

A 2021 international study (Augustin S, 2021) employed mass spectrometry, an internationally recognized method for analyzing the composition of desensitization diagnostic and therapeutic products, to examine multiple subcutaneous immunotherapy (SCIT) formulations commonly used in clinical practice across Europe (including those currently in clinical use in China), with the aim of determining whether they contained the 36 known allergen components derived from house dust mites.

The results indicate that Allergo (Dermatophagoides farinae + Dermatophagoides pteronyssinus) covers 94.4% of dust mite allergen components (34/36, encompassing all major and intermediate allergen components), whereas other products cover only some intermediate allergen components and a small number of minor allergen components. This finding further solidifies the unique product advantages of Allergo (Dermatophagoides farinae + Dermatophagoides pteronyssinus), making it the standardized desensitization agent approved on the Chinese market that best meets the treatment needs for allergic diseases in China.

According to the guidelines of international professional societies on allergen immunotherapy, the treatment course for AluGel (Dermatophagoides farinae + Dermatophagoides pteronyssinus) is divided into an initial phase (dose escalation) and a maintenance phase, with the entire course lasting at least three years. Compared with other desensitization products available in China,Aroluo is not only a dual-mite formulation that covers nearly all dust mite allergen components, but also better aligns with the characteristics of allergic diseases in China and the treatment needs of Chinese patients sensitized to dust mites.

Over the past decade, allergy has emerged as one of the most prominent therapeutic areas in China. Chinese research findings are being continuously published in high-impact international academic journals, underscoring that this multidisciplinary field is garnering increasing attention from clinicians and has become a hotspot for generating high-quality basic and clinical research.

As mentioned at the beginning, within China’s specialist physician training system, allergy has not yet been established as a hospital “specialty.” The diagnosis and treatment of allergic diseases are largely dispersed across departments such as Otolaryngology, Respiratory Medicine (for adults or pediatrics), and Dermatology, where direct allergen testing is typically unavailable.

In order toAddressing the Challenge of Non-Standardized Clinical Practices in Allergic Diseases, since 2016, Arrogance China has been conducting training for healthcare professionals, on the one hand,In collaboration with the Allergy Branch of the Chinese Medical Association, launch the “Model Clinic” initiative, aiming to invite experienced experts in the field of desensitization therapy to conduct training for doctors and nurses across China, explaining specific procedures, including how to diagnose allergens, how to perform desensitization therapy, and how to provide comprehensive management for allergy patients throughout the entire process.

“This is a learning process that combines theory, hands-on practice, and observation, lasting two to two and a half days. From 2016 to the end of 2019, we conducted a total of 10 complete training sessions,” Qiu Ning introduced.

Another task is to hold ““European Master Class” TrainingIn collaboration with Germany’s leading allergy department, we annually sponsor 10–12 young physicians aged 30–40 for a one-week program comprising lectures and on-site observations. The curriculum covers fundamentals of diagnosis and treatment of allergic diseases, manifestations across different organ systems, and real-case-based teaching. During the pandemic, Allergopharma China also launched a domestic “Elite Class,” leveraging experienced Chinese allergy research centers as training bases and inviting senior experts to instruct young physicians in the diagnosis and management of allergic diseases.

Furthermore, in standardizing the desensitization therapy protocols for physicians, Allergopharma China and Kaning Technology jointly developed a set ofIntelligent Guidance System for Desensitization Therapy—Minshi Yiyun, providing standardized guidance services for healthcare professionals, including patient assessment, patient scoring, test items, post-injection observation, and precautions. Currently, more than 80 centers across China are using this system. “Minshi Yilu” is a platform designed for all healthcare professionals involved in desensitization therapy, offering knowledge updates and exchange services for specialists.

At the kick-off meeting, Qiu Ning, President of Alog Pharmaceuticals China, delivered a speech.

December 17, 2022Official Launch of the Committee on Environmental and Allergy Medicine under the China Biodiversity Conservation and Green Development Foundation. As a sponsor and strategic partner of the Special Committee, Allergopharma China will promote academic exchanges and collaboration in the fields of environment and allergy, contributing to the advancement of research and treatment standards for allergic diseases in China.

Plaque Awarding Ceremony for Special Committee Members at the Launch Event

Qiu Ning stated that the environment is closely linked to allergic diseases, and effective management of both indoor and outdoor environments is particularly crucial for their prevention. The establishment of the Professional Committee on Environmental and Allergy Medicine aims to facilitate the exchange of academic expertise and advanced technologies in the field of allergy medicine, enhance clinical and academic standards, provide a platform for mutual communication and learning among clinicians specializing in allergy diagnosis and treatment, and offer a standardized framework for advancing the prevention, diagnosis, and treatment of allergic conditions.

In the future, AllergoChina will continue to focus on the “diagnosis and treatment of allergic diseases.” Targeting allergens prevalent in China, the company will explore various innovative approaches to accelerate the introduction and development of additional allergen diagnostic products and specific immunotherapy products in the Chinese market, thereby helping healthcare professionals and healthcare systems better address the growing societal burden posed by the rising prevalence of allergic diseases.

Meanwhile, the company plans to relaunch the “European Masterclass” and conduct more in-person training sessions after the full relaxation of pandemic-related policies, enabling more young doctors in China to gain exposure to the highest global standards and most advanced concepts in allergy treatment, thereby enhancing the diagnosis and treatment of allergic diseases in China.

Furthermore, by leveraging innovative business models such as “cross-border e-commerce,” we will introduce Derbai’s high-quality products—including vitamins, trace elements, hormonal agents, dermatological products, and women’s health solutions, which rank first in their respective European niche markets—into China. This initiative aims to better serve China’s healthcare sector and the vast patient population, thereby contributing to the healthy lifestyles of the Chinese people.