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1. Helicobacter pylori is a common culprit in the digestive system, more than half of the world's people are infected, and the Hp infection rate in China's family is more than 70%.

2. Since 2025, affected by changes in global gastric cancer prevention and control policies and breakthroughs in new drugs by pharmaceutical companies, the A-share Helicobacter pylori sector has been active, and related companies have increased by more than 10% during the year.

3. However, it is still a long time before new drugs and new therapies are rolled out and prove that they are indeed better than traditional quadruple therapy, and the competition between traditional drugs and testing products is fierce at this stage.

4. In terms of traditional medicines, companies related to quadruple therapy, such as Oriental Ocean and Asia-Pacific Pharmaceutical, have increased by more than 10% during the year.

5. In terms of testing products, the average detection rate in China is less than 10%, and there is still a lot of room for penetration, and the competition is fierce.

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Author/Braised under the stars

Edit/Spinach's Starry Sky

Typesetting/Mung bean soup under the stars

Helicobacter pylori is a fairly common cause of disease in the digestive system, and according to epidemiological studies, more than half of all people worldwide are infected. This is one of the main causes of stomach cancer and has long been a threat to human health. The situation in China is also grim, with the household Hp infection rate exceeding 70%, and the necessity of Helicobacter pylori eradication treatment is becoming more and more prominent.

Since 2025, due to changes in global gastric cancer prevention and control policies and breakthroughs in new drugs and new treatments by several pharmaceutical companies, the A-share Helicobacter pylori (Hp) sector has been active. Companies such as Oriental Ocean (002086) and Asia-Pacific Pharmaceutical (002370) have risen by more than 10% during the year, and Osaikang (002755), which produces esomeprazole magnesium enteric-coated dry suspension, has soared by 46.97% during the year.

Aosaikang's stock price trend chart during the year Source: iFinD, compiled by the author

This reflects the high level of attention of the capital market to the Helicobacter pylori sector. However, it will take a long time for new drugs and new treatments to be rolled out and prove that they are indeed better than traditional quadruple therapy, while there is no obvious change in the industry pattern and demand side of traditional drugs and testing products.

1. Policy environment care, on the eve of the outbreak of new drugs?

The American College of Gastroenterology (ACG) released its latest recommendations for Helicobacter pylori prevention and control in 2024. In this version of the guidelines, traditional antibiotic combination therapy is still the mainstream treatment regimen, and quadruple therapy with low drug resistance is gradually replacing triple therapy that is gradually declining due to the increasing resistance rate of drugs such as clarithromycin and metronidazole.

Common treatment regimens for Helicobacter pylori infection Source: Leopard Research Institute

However, the field of Hp treatment, which has been silent for many years, has finally ushered in a glimmer of light, and new drugs and new therapies are constantly emerging. Some new combination therapies such as antibiotics + probiotics are being experimented, which are theoretically expected to further reduce drug resistance while improving treatment efficacy.

At the end of last year, we can focus on the successful completion of phase III clinical trials of TNP-2198, a new drug for Helicobacter pylori infection, which showed that it was superior to the traditional bismuth quadruple, with an eradication rate of more than 90%. In January this year, Grand Life Science announced that it was exclusively responsible for the commercialization and promotion of TNP-2198 in China, which proves that the market is optimistic about this drug, after all, it is expected to rewrite the embarrassing history of no approved new drugs in the field of Helicobacter pylori for more than 30 years.

Luoxin Pharmaceutical (002793) officially announced in October last year that its new generation antacid product tegola sheng tablets was approved for the indication of Hp, and the results of clinical trials showed that the combined effect was better than that of pantoprazole, a proton pump inhibitor as a control group; Ketuo Biosciences (300858) has claimed that its plant lactobacter products can inhibit Helicobacter pylori by regulating intestinal flora, and the anti-Hp effect has entered the stage of clinical verification; JuneYao Health (605388) cooperated with universities to develop a product that claims to have a certain effect on the prevention and treatment of Hp, but of course, the author will not comment much on the actual effect.

The White Paper on the Prevention and Control of Helicobacter pylori Infection in China and the Implementation Plan for the Healthy China Initiative for Cancer Prevention and Control (2023-2030) issued in 2023 clearly state that it is necessary to promote nationwide screening to prevent bacteria associated with the occurrence of cancer, such as Hp. Driven by this, the Shanghai Data Exchange took the lead in establishing the Helicobacter pylori data space in September last year to provide data support for the research and development of related drugs and diagnostic reagents. Large-scale screening organized by provincial organizations is also being implemented one after another, such as Jiangsu Province last year, which included Helicobacter pylori in the screening focus of several layers of the medical system, and many places in the Yangtze River Delta are promoting similar policies.

Second, the traditional medicine track is crowded

In any case, it will take time for these new drugs and new therapies to move from clinical trials to commercialization. At this stage, what can really contribute to the performance of relevant listed companies is the traditional "2 antibiotics + 1 bismuth + 1 proton pump inhibitor" quadruple therapy-related drugs.

Asia-Pacific Pharmaceutical (002370), as one of the major manufacturers of digestive system drugs, has a product matrix that includes a variety of proton pump inhibitors (PPIs), including omeprazole and pantoprazole, which have been around for many years, as well as new proton pump inhibitors such as tatoprazole. In 2024, the company will lose 28 million yuan to 40 million yuan after excluding the impact of non-recurring profit and loss items, a decrease of 41.98%-59.39% compared with the same period. Since H. pylori-related drugs are only a part of the digestive system drugs, the performance is not separately disclosed.

In addition, PPI products such as omeprazole and rabeprazole are also owned by Huana Pharmaceutical (688799), Teyi Pharmaceutical (002728), Hanshang Group (600774), Anglikang (002940), and Xinhua Pharmaceutical (000756). Moreover, there are companies that are laying out PPI business, such as Yuekang Pharmaceutical (688658) announced in 2024 that its subsidiary's esomeprazole sodium for injection has obtained a registration certificate.

In terms of bismuth agents, Warner Pharmaceutical is a first-line leader, accounting for more than 30% of the domestic market. Colloidal pectin bismuth capsules are its flagship products, which have maintained rapid growth for many years. However, since it has been included in the scope of centralized procurement, the production and sales analysis table of Warner Pharmaceutical no longer includes this bismuth agent. The author believes that this is of course due to the spread of new products such as montmorillonite powder, but the more important factor is probably the greater impact on sales.

Warner Pharmaceuticals 2024H1 report, source: company announcement

Not only bismuth, but also proton pump inhibitors and antibiotics are also under pressure from centralized procurement. Since the third batch of centralized drug procurement in 2020 covered a variety of PPI drugs, the PPI market capacity showed negative growth for the first time that year. Not to mention antibiotics, clarithromycin, amoxicillin and other broad-spectrum antibiotics have a variety of uses, so they have been the focus of centralized procurement "care", and the core varieties included in the negotiation have been reduced by as much as five or six percent on average.

2016-2022 domestic proton pump inhibitor market sales Source: public information, Zhongkang Industry Research Institute

In addition to the pressure of centralized procurement, in fact, the problem of Hp drug resistance has indeed affected the effectiveness of traditional treatment regimens, so the necessity of vaccines has become more and more prominent. A-share vaccine leaders Zhifei Biotech (300122) and CanSino (688185) have applied for Helicobacter pylori vaccine-related patents, but the research and development progress is not reliable, and there is no possibility that similar products will be successfully marketed in the short term.

Third, the penetration rate of testing is not high, and the performance of home self-inspection product manufacturers is questioned

In addition to drug treatment, what about testing products? After all, compared with more than half of the prevalence rate, the average detection rate in China is less than 10%, and there is still a lot of room for penetration. There are many methods for the examination and diagnosis of Hp, ranging from invasive gastroscopic biopsy to non-invasive urea breath test, etc., Runda Medical (603108) disclosed that its subsidiary is developing a Helicobacter pylori breath detector.

The detection kit is also a large category of non-invasive detection, and the threshold of such products is limited and there are many manufacturers, and the competitive situation can be imagined. Manufacturers such as Kaipu Biotech (300639), Zhijiang Biotech (688317), and Jimin Health (603222) all have related products or carry out Hp testing services through third-party testing business. And this track is becoming more and more crowded, Kangwei Century (688426) obtained the registration license of Hp gene mutation detection kit at the end of last year, which is the first Helicobacter pylori drug resistance gene detection product based on fecal samples in China; Oriental Ocean (002086) also announced in March this year that the Helicobacter pylori (Hp) detection kit (urease method) independently developed by its subsidiary Avico Biotechnology was officially approved for marketing.

Because Hp has a high correlation with digestive tract cancer, early cancer screening products are naturally aimed at this segment. At the beginning of 2022, Hong Kong stock Nuohui Health (06606) launched a home self-inspection product "Youyou Tube" and claimed to have good sales, and the 2023 interim report disclosed that it achieved sales of 207 million yuan in the first half of that year, a year-on-year increase of 147.4%! However, readers should be reminded that Nuohui Health has been deeply questioned about financial fraud since 2023, and in 2024, it has failed to disclose the annual report and has been suspended since 2024 due to the accounting firm's questioning of the annual report data.

Nuohui Health's announcement on delaying the publication of the 2023 annual results Source: company announcement

In short, the diagnosis and treatment of Helicobacter pylori, which has not been new for many years, seems to have ushered in the dawn of new therapies and new drugs, which is expected to change the dilemma that this field has been affected by drug resistance for a long time. However, it will take time to move from clinical to commercial promotion, and it will take time to verify whether it can replace the traditional quadruple scheme. From this stage, both traditional drugs and testing products have limited application maturity thresholds, and no manufacturer has the possibility of running out under fierce competition.

Note: This article does not constitute any investment advice. The stock market is risky, and you need to be cautious when entering the market. There is no harm in buying and selling.

Personal opinion, for reference only