West China Hospital Licenses Helicobacter pylori Drug Susceptibility Testing Patent for RMB 850,000 Plus Royalties
Recently, West China Hospital of Sichuan University hasRMB 850,000 + 0.5% Commission on Sales Revenuethe proposed transaction price, ""A Method for Drug Susceptibility Testing of Helicobacter pylori"Invention Patent (Patent No. ZL202111596521.4), assigned toChengdu Shunkangyuan Medical Device Co., Ltd.. The transaction completed its public notice period on the 26th.
This patented invention originates from the team led by Professor Tang Hong, Director of the Center for Infectious Diseases at West China Hospital, Sichuan University. Professor Tang is a recipient of the State Council Special Government Allowance and an Academic and Technical Leader in Sichuan Province. He has long been engaged in clinical and research work on viral hepatitis and liver diseases, and has undertaken more than 20 major projects, including the National Science Fund for Distinguished Young Scholars, national “863” and “973” programs, major national science and technology projects on infectious diseases during the 11th and 12th Five-Year Plan periods, and grants from the National Natural Science Foundation.
In June 2023, the National Institute for Communicable Disease Control and Prevention of the Chinese Center for Disease Control and Prevention, among other institutions, released the White Paper on “Prevention and Control of Helicobacter pylori Infection in China,” which pointed out that the prevalence of H. pylori infection in China is nearly 50%, meaning thatApproximately 700 million people harbor Helicobacter pylori in their stomachs, and 70% of gastric cancer cases are associated with Helicobacter pylori infection.As early as 1994, Helicobacter pylori was classified by the International Agency for Research on Cancer (IARC), an agency under the World Health Organization (WHO), as a Group 1 carcinogen for gastric cancer.
Helicobacter pylori (Hp) is currently the only known bacterium capable of surviving in the human stomach. It is a microaerophilic, Gram-negative bacillus that parasitizes the human digestive tract, exhibiting a spiral or S-shaped morphology with flagella at one end. Hp can survive in the highly acidic environment of the stomach, penetrate the mucus layer, reach the epithelial surface, and adhere firmly, thereby avoiding gastric emptying. It derives its name from its predilection for the pylorus and gastric antrum.
The relatively high prevalence of Helicobacter pylori infection in China is closely linked to local dietary habits. The primary modes of transmission are fecal-oral and oral-oral routes. Additionally, cultural practices such as communal dining, limited sanitary conditions in certain regions, and a preference for raw foods have further facilitated the spread and infection of Helicobacter pylori.
In the early stages of infection, patients may exhibit no obvious symptoms, yet gastric mucosal inflammation is present. Some patients may experience a chronic, progressive course, gradually developing gastric mucosal atrophy and intestinal metaplasia, which can even progress to carcinogenesis. Eradication of Helicobacter pylori hinges on two critical steps: detection and treatment. This article focuses primarily on the screening and detection aspect.
Currently, screening for Helicobacter pylori mainly includes the urease breath test, urease tissue biopsy, fecal antigen immunoassay, serum antibody immunoassay, fecal nucleic acid testing, urease tissue biopsy, and endoscopy. Among these,The urea breath test is the most commonly used method, while molecular detection of fecal nucleic acids serves as an adjunctive tool for confirming Helicobacter pylori eradication.。
The non-invasive urea breath test (UBT) using C-13/C-14 isotopes is currently recognized as the gold standard for detecting Helicobacter pylori. Among these, C-14 exhibits a certain level of radioactivity and is therefore unsuitable for special populations such as pregnant or lactating women and children, whereas C-13 has negligible radioactivity and is suitable for the majority of individuals. However, this testing method is constrained by factors such as limited production capacity and a shortage of testing institutions. In the Chinese market, C-13 breath test products can only meet the testing needs of 6 million people annually on average, accounting for merely 1% of H. pylori carriers.
Stool nucleic acid testing enables both qualitative detection of Helicobacter pylori and molecular identification using the same sample type and detection platform, thereby guiding precise medication for subsequent eradication therapy, improving H. pylori eradication rates, and reducing antibiotic resistance caused by blind empirical treatment. This is not achievable with the urea breath test (UBT).
A search on the official website of the National Medical Products Administration (NMPA) using “Helicobacter pylori” as a keyword revealed a total of 119 registered products for Helicobacter pylori testing. These products employ various detection methods, including chemical reaction assays, antigen tests, antibody tests, quantum dot immunofluorescence assays, microbiological tests, and testing instruments.
From the perspective of application scenarios, while Helicobacter pylori-induced carcinogenesis is a serious medical issue, many H. pylori-related products are targeted at the consumer market. The key factor lies in the high prevalence of H. pylori infection.
Widespread prevalence implies a vast market, yet it also presents significant challenges for the implementation of large-scale screening. Helicobacter pylori continues to spread through daily interpersonal interactions, making long-term prevention and control particularly difficult. Requiring everyone to undergo hospital-based testing is impractical, given the limitations in the supply of breath test kits and the capacity constraints of healthcare facilities. Therefore,Consumer-oriented home testing products have emerged, addressing hospital capacity constraints, reducing physicians’ time costs, and significantly lowering the time burden of testing for target populations.
In the Helicobacter pylori testing market, typical companies such asNew Horizon Health, Kangwei Century, Aowei Technology, Olymvax Biopharmaceuticals, Shenji Pharmaceutical, New Asia Biotechnology, Anxu Biology, etc.
In January 2022, New Horizon Health’s Helicobacter pylori detection product, YouYou Tube, received approval from the National Medical Products Administration (NMPA) for its Class III medical device registration application. The product adopts a stool sample-based latex agglutination assay, a method validated through extensive long-term practice. In a clinical trial conducted at three tertiary hospitals—Sir Run Run Shaw Hospital affiliated with Zhejiang University School of Medicine, Zhejiang Provincial People’s Hospital, and Peking University Shougang Hospital—with urea breath test as the gold standard, 1,644 eligible subjects suspected of H. pylori infection were enrolled. The test demonstrated a sensitivity of 96.5% and a specificity of 99.1%. YouYou Tube is the first H. pylori detection product approved for both professional antigen testing by healthcare personnel in medical institutions and self-testing by consumers.
In late 2022, Kangjianyou, a subsidiary of Kangwei Century, obtained a Class III medical device registration certificate from the National Medical Products Administration (NMPA). This marked the first Class III registration in China for Helicobacter pylori nucleic acid testing based on stool samples, filling a gap in the industry. Kangjianyou employs PCR fluorescent probe technology to detect H. pylori nucleic acids in human stool samples by targeting specific gene sequences of the bacterium. The assay offers high sensitivity and strong specificity, and its results are not affected by antibiotics, proton pump inhibitors, bismuth agents, or other antimicrobial drugs. Testing can be conducted in standard PCR laboratories, and the extracted nucleic acids can also be used for detecting multiple antibiotic resistance genes.
Subsequently, a wave of Helicobacter pylori self-test products entered the market. As recently as September 13, two H. pylori detection and testing products under Shenji Pharmaceutical successively received Class II and Class III medical device registration approvals from the National Medical Products Administration (NMPA).
As public health awareness continues to strengthen and early screening for gastric cancer becomes more widely promoted and accessible, coupled with increased recognition of Helicobacter pylori, the penetration rate of related diagnostic tests will rise rapidly.Driven by the robust development of the internet, this consumer-oriented medical product has also reached a broader market through e-commerce channels.
According to JD Health’s data, during the first 28 hours of the 2024 JD.com 618 Shopping Festival kickoff,The number of paying users for at-home health testing services increased by 3.6 times year-on-year. Among these, gastrointestinal health has attracted greater user attention, with search volume for keywords related to “Helicobacter pylori” testing rising by 14 times year-on-year, and the gross merchandise value (GMV) of “Helicobacter pylori”-related tests surging by 40 times year-on-year. C-13 urea breath tests and molecular diagnostic tests are particularly favored by users.
According to data from the research firm GMI, the market size for Helicobacter pylori testing was USD 483 million in 2023. Driven by rising care demands resulting from the increasing prevalence of various gastrointestinal diseases, the compound annual growth rate (CAGR) is projected to be 6.8% from 2024 to 2032. Furthermore, under the significant new consumer trend of at-home self-testing for health, the Helicobacter pylori testing market still has room for growth.