Meian Medical Advances GERD Diagnostics in China with Non-Invasive Peptest Following Multidisciplinary Consensus Launch

On September 7, 2019, the Multidisciplinary Consensus on the Diagnosis and Treatment of Gastroesophageal Reflux Disease in China (hereinafter referred to as the “Consensus”), organized and compiled by the Gastroesophageal Reflux Multidisciplinary Branch of the China International Exchange and Promotive Association for Medical and Health Care, was officially released. The Consensus took nearly four months to complete, comprising 11 sections and over 30,000 words, and represents the collective expertise and dedication of 43 experts from more than ten disciplinary fields across China.

Professor Wu Jimin, Vice Chairman and Secretary-General of the Multidisciplinary Branch on Gastroesophageal Reflux Disease under the China International Exchange and Promotive Association for Medical and Health Care, stated, “As the first multidisciplinary consensus on gastroesophageal reflux disease (GERD) in China, the release of this consensus is of milestone significance. We believe that with its vigorous promotion, the diagnosis and treatment of GERD in China will truly become evidence-based and standardized.”

“The Consensus” indicates that the prevalence of gastroesophageal reflux disease (GERD) in China is lower than that in European and American countries, but it shows an upward trend and is close to the levels in South Korea and Japan. Current data show that the prevalence of GERD with typical symptoms in China is 2.5%-7.8%, which is lower than the 18.1%-27.8% in North America and 8.8%-25.9% in Europe.

From 2005 to 2008, the annual growth rate of GERD prevalence in South Korea was 15.3%, reaching 7.3% by 2008. In Japan, GERD prevalence began to rise in the late 1990s and reached 13.1% between 2000 and 2010.

The prevalence of GERD in China has shown a year-on-year upward trend. The aging population, the increasing prevalence of overweight and obesity, and the improved diagnostic rate of GERD may all contribute to the rise in reported GERD prevalence statistics in China.

Professor Wu Jimin stated:“Currently, the medical”Public awareness and education remain severely inadequate and imbalanced; healthcare professionals have insufficient understanding of the disease, resulting in low rates of screening and curative treatment, with overall diagnostic and therapeutic standards still lagging behind international benchmarks.”

RecentOver the past 20 years, the prevalence and hazards of GERD have been increasingly recognized, drawing growing attention and emphasis from physicians.. In particular, the addition of respiratory medicine, otolaryngology, minimally invasive surgery, and gastroesophageal reflux disease (GERD) specialties, along with the improvement and widespread adoption of specialized diagnostic and therapeutic methods, has effectively promotedClinical Advances in the Field of GERD.

“The Consensus” states that “the clinical manifestations of GERD vary significantly among patients, making it a highly heterogeneous disease. There is considerable diversity in how individuals describe the same symptom, the combination of different symptoms, the severity and frequency of multiple symptoms, the patterns of exacerbation and relief, responses to pharmacological treatment, as well as patients’ understanding of their condition and self-management capabilities. Symptoms and signs of GERD that are emphasized and recognized differ across medical specialties; therefore, interdisciplinary communication and mutual understanding should be strengthened.”

The Multidisciplinary Branch of Gastroesophageal Reflux of the China International Exchange and Promotive Association for Medical and Health Care stated: “The release of this consensus is one of the association’s key initiatives. In the future, we will promote it through multiple online and offline channels, targeting 50 member units of the Gastroesophageal Reflux Disease (GERD) Specialist Alliance and 500 target hospitals covered by the National GERD Awareness Week. It is expected that within the next year, 8,000–10,000 physicians will be trained, covering 20 provinces, 4 autonomous regions, 135 cities, and 470 hospitals, thereby truly achieving multidisciplinary, multi-level, and multidimensional diagnosis and treatment, and providing comprehensive care for patients with gastroesophageal reflux disease.”

It is evident that gastroesophageal reflux disease (GERD) will gradually come into public focus, and the market for its prevention, diagnosis, and treatment will increasingly heat up.

The distressing symptoms and high prevalence of GERD adversely affect patients’ work and daily life, imposing a significant societal burden. Regarding the diagnosis of GERD, the Consensus indicates that pepsin monitoring in secretions such as saliva, nasal discharge, and sputum, as a simple and non-invasive test, may hold promising application prospects for diagnosing laryngopharyngeal reflux disease. As the first pepsin-based reflux detection kit introduced to China, Peptest is the world’s first non-invasive in vitro diagnostic reagent for esophageal reflux diseases, enabling rapid and safe diagnosis of reflux and reflux-related respiratory and otolaryngological conditions. It has completed clinical trials involving more than 1,000 cases and obtained registration approval from the National Medical Products Administration (NMPA).

It is reported that Peptest was launched in the Chinese market through a collaboration between Maxhealth Medical Group Co., LTD and RD Biomed Ltd. (UK). Mr. Miao Fengdong, President of Maxhealth Medical, stated, “Peptest is user-friendly, easy to operate, and delivers accurate results, enabling physicians to promptly diagnose gastroesophageal reflux and related conditions. The exclusive introduction of Peptest by Maxhealth Medical holds significant importance for the rapid diagnosis of gastroesophageal reflux disease (GERD) in China. Furthermore, Peptest offers greater convenience to patients suffering from these related conditions.”

“Previously, the diagnosis of reflux typically required invasive, time-consuming, and expensive tests to help physicians establish a definitive diagnosis, such as gastroscopy and 24-hour pH-impedance monitoring. Compared with conventional diagnostic methods, Peptest is not only more cost-effective but also simpler and completely non-invasive.”

Peptest works by measuring pepsin in saliva samples to indicate the severity of reflux based on pepsin concentration. Since pepsin is produced exclusively in the stomach, its presence in the esophagus, throat, oral cavity, or lungs confirms that it has arrived there due to reflux. Various clinical trials have demonstrated that Peptest is a highly sensitive test with simple operation, which can assist physicians across multiple specialties in making accurate differential diagnoses for diverse clinical presentations.

“Peptest obtained the registration certificate for imported medical devices on September 2, with CRO+CDMO service provider Mediscreation also providing assistance in the product’s registration.”

“A representative from Medisino stated, ‘Peptest is the first domestically developed Class II in vitro diagnostic reagent of its kind in China, requiring comparison with the clinical gold standard during the registration application process. However, monitoring the gold standard for gastroesophageal reflux is challenging, as it necessitates 24-hour cooperation from subjects, including meal intake and sample collection. Medisino provided Maxhealth Medical Group Co., LTD. with comprehensive clinical trial services, including protocol development, monitoring, quality control, statistical analysis, and report writing. By helping Maxhealth select scientifically sound and reasonable evaluation endpoints, Medisino ensured the authenticity and regulatory compliance of the trial, facilitating its successful and timely completion.’”

Maxhealth Medical is an integrated platform for the R&D, manufacturing, and commercialization of innovative medical technologies. Founded in 2009 and headquartered in Wuxi, Maxhealth Medical maintains offices or R&D centers in Shanghai, Beijing, Hong Kong, the United Kingdom, Japan, and Australia. Currently, Maxhealth Medical focuses on the fields of gastroenterology, women’s health, neurology, and neurological rehabilitation.

Mr. Miao stated, “We focus on global innovative medical technologies and advance their R&D, manufacturing, and commercialization in China and worldwide through cross-border collaborations. Guided by unmet real-world clinical needs, the company integrates cutting-edge advances in global clinical science to continuously drive technological progress, improve diagnosis and treatment, and benefit patients.”

“The company has partnered with numerous global medical innovation institutions and Fortune 500 pharmaceutical enterprises to carry out collaborative R&D, manufacturing, market access, academic initiatives, and product marketing in the Chinese market, successfully establishing a platform for Sino-foreign medical technology research and development.”

In addition to Peptest, which has recently obtained medical registration certification, Maxhealth Medical Group Co.,LTD also maintains a product portfolio that includes the REX lower-limb exoskeleton robot, anti-reflux medications, equipment and consumables for anti-reflux surgical procedures, FOB early-screening diagnostic reagents for colorectal cancer, Legacy botanical drugs for dermatology and oncology, and the Zedscan electrical impedance cervical cancer detection system.

Among them,REX is the world’s only fully self-stabilizing, self-supporting exoskeleton robotic device, playing a significant role in early rehabilitation and long-term continuous physical training for stroke and paraplegia patients. Meanwhile, EZ Detect enables a 2-minute self-administered fecal occult blood (FOB) test, providing early warning for colorectal cancer and related diseases, and is suitable for individuals under high work pressure or with irregular schedules and dietary habits.

Regarding Maxhealth Medical, Mr. Miao emphasized: “Maxhealth Medical possesses efficient R&D, manufacturing, and commercialization capabilities.”

For Efficient R&D and Production:
1. In the academic realm, establish a global framework for specialized technological development research and an expert network to better grasp clinical needs and research advancements, thereby facilitating continuous innovation and R&D in technology.

2. In terms of R&D, we continuously expand our product portfolio within the specialized therapeutic area system, and accelerate the efficiency of clinical research and production through successful commercial channels and expert networks.

3. In terms of production, leveraging accumulated resources within the industry and sector to establish a mature product manufacturing model, continuously reduce costs, and optimize the supply chain and production processes.

Commercialization:

1. Maxhealth MedicalDrive hospital formulary inclusion, sales, and academic engagement in traditional public hospitals through an in-house team and distributors.: Achieve rapid sales and expert consensus.

2. Leveraging success in the public hospital market, establish a multi-tiered sales system through channel penetration into lower-tier markets.

3. Continuously launch leading medical technologies and products within the specialty, iterate and update them, strengthen the product portfolio, cultivate expert loyalty, and improve sales efficiency.

4. Leverage user acquisition, follow-up medical education, and marketing campaigns to drive direct-to-consumer (2C) sales or channel consumer traffic to partnered B-end providers, while establishing patient communities to foster consumer stickiness and generate data assets.

Miao Fengdong concluded by stating:“We will continue to focus on the fields of gastroenterology, women’s health, neurology, and neurological rehabilitation, with the aim of bringing greater benefits to more patients.”

References:

Multidisciplinary Branch of Gastroesophageal Reflux, China International Exchange and Promotive Association for Medical and Health Care. Multidisciplinary Diagnosis and Treatment Consensus on Gastroesophageal Reflux Disease in China [J]. Chinese Journal of the Frontiers of Medicine (Electronic Edition), 2019, 11(9): 30-56.