Chronic gastritis

Recently, ZBD Pharmaceutical made a breakthrough in the field of traditional Chinese medicine innovation, and its self-developed 1.1 new drug - Qingdown and Wei Granules successfully approved to enter the clinical trial stage. In China, chronic diseases of the digestive tract, especially gastric ulcer, gastroesophageal reflux and other chronic diseases, have long posed a major challenge to public health, and the value of the gastric medicine market, especially the Zhongcheng gastric medicine market, is gradually widely recognized and valued by the industry. The vigorous development of China's stomach medicine market cannot be separated from the huge patient base as support. According to the 2019 China Gastropathy Survey Report, among the 1.3 billion population at that time, the number of patients with gastropathy has reached 120 million, of which the elderly account for more than 70%. The incidence of gastrointestinal ulcer has reached 10%, and the incidence of chronic gastritis has climbed to 30%, which all indicate the severity of stomach problems. Further investigation found that based on 22,152 valid sample statistics, mainly young and middle-aged people, up to 65.55% of the respondents clearly said that they suffer from stomach problems, another 22.18% of the patients have a vague attitude toward their illness, and only 12.27% of the people confidently said that they are not affected by stomach problems. The results of this survey undoubtedly provide a strong demand support for the continued growth of the stomach medicine market. In recent years, the scale of China's stomach medicine market continues to expand, especially the market performance of Chinese patent medicine stomach medicine (for gastritis, ulcer and other diseases) is particularly eye-catching. According to statistics, between 2021 and 2022, the total market size of Chinese patent medicine stomach medicine in China's three major terminal markets has exceeded 10.4 billion yuan. Among them, the sales of Chinese patent medicine stomach medicine in urban physical pharmacies exceeded 2.7 billion yuan, an increase of 2.46%; The online pharmacy terminal sales of proprietary Chinese medicine stomach medicine soared to 440 million yuan, a year-on-year growth rate of 70.04%, showing a strong growth momentum. In the fierce market competition, some brands stand out with their excellent product quality and marketing strategies. For example, in China's public medical institutions terminal Chinese patent medicine stomach medicine market in 2023, there are three brands with sales of more than 500 million yuan. They are Good Doctor Group's rehabilitation new liquid (sales of more than 700 million yuan), Yangzijiang's Weisu Granule (sales of more than 600 million yuan) and Kelun Pharmaceutical's rehabilitation new liquid (sales of more than 600 million yuan). The success of these brands not only reflects their deep strength in product development, marketing and other aspects, but also sets a benchmark for the entire stomach medicine market. From the perspective of sales channels, the sales of proprietary Chinese medicine stomach medicine are mainly divided into online and offline two major sectors. In the online field, with the rise of e-commerce platforms and the change of consumer shopping habits, the online market of stomach medicine has formed a considerable scale and is in a stage of steady expansion. In terms of physical stores, some brands have achieved rapid growth through continuous innovation and optimization of product mix, improving service quality and other means. For example, among the Top 20 brands in physical stores, the fast stomach tablet of Qingdao Guofeng Pharmaceutical Industry, owned by Shanghai Pharmaceutical, performed particularly well, with a year-on-year growth rate of 179.34% in the first half of 2023. In addition, Li Wanshan Pharmaceutical Co., Ltd. also achieved more than 100% growth in Hewei Chengchang pills, with total sales among the top three. It is worth mentioning that in recent years, the rapid development of online pharmacies has injected new vitality into the Chinese patent medicine stomach medicine market. According to statistics, the compound annual growth rate (CAGR) of drug sales in online pharmacies between 2014 and 2021 has reached a staggering 50.54%. In 2021, the sales of drugs in online pharmacies have reached 36.8 billion yuan, an increase of 51.5% year-on-year, of which the growth of OTC drugs is mainly driven by proprietary Chinese medicines. In particular, among the three newly listed top20 online sales drugs in online pharmacies, Yunnan Plant Pharmaceutical's Hawthorn and Poria granules, Ark Pharm's Yangweishu tablets and Yunnan Baoyuantang Pharmaceutical The year-on-year growth rate of Weikang capsules and other products of Industry has exceeded thousands, showing strong growth potential. Looking forward to the future with the continuous improvement of people's health awareness and the continuous progress of medical science and technology, the market of proprietary Chinese medicine stomach medicine will usher in a broader space for development. On the one hand, existing brands will continue to increase research and development investment to promote product upgrading to meet the increasingly diverse needs of patients; On the other hand, emerging brands will continue to emerge to seize market share through differentiated competitive strategies. At the same time, with the further popularization of the Internet and the continuous innovation of online sales model, the online sales share of the Chinese patent medicine stomach medicine market is also expected to continue to grow, bringing more opportunities and challenges to the entire industry. In this process, ZBD Pharmaceutical's Qingxin and Wei granules are undoubtedly a bright new star. The innovative drug Qingjiang and Weiwei Granules, developed by ZBD Pharmaceutical in collaboration with Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, has demonstrated good safety and efficacy in the preclinical research phase. The drug is mainly used in the treatment of non-erosive gastroesophageal reflux disease (NERD) cold and heat syndrome, filling the gap in the field of proprietary Chinese medicine. According to relevant data, it is estimated that the number of NERD patients in China has exceeded 40 million, which means that Qingjiang and Wei granules have huge market potential. In the future, with the smooth promotion of clinical trials and the gradual development of market promotion of the drug, Qingjianghewei Granule is expected to become a dark horse in the market of patent Chinese medicine stomach medicine, injecting new impetus into the development of ZBD Pharmaceutical and the entire industry.

Scientists have decoded critical genetic factors in intestinal metaplasia patients, shedding light on early signs and prevention strategies for stomach cancer -- often a 'ticking time bomb' as patients experience no or only mild symptoms in the early stages. In a breakthrough study published in the journal Cancer Cell, researchers have decoded critical genetic factors in intestinal metaplasia patients, shedding light on early signs and prevention strategies for stomach cancer -- often a "ticking time bomb" as patients experience no or only mild symptoms in the early stages. Intestinal metaplasia, which is a change in the cells of the mucous membrane lining the stomach that often stems from chronic gastritis and manifests with symptoms akin to acid reflux, is also a sinister link to stomach cancer. Individuals afflicted with intestinal metaplasia cells face a sixfold increased risk of succumbing to this lethal cancer. In Singapore alone, stomach cancer ranks as the fourth leading cause of cancer deaths in men and the fifth among women, claiming 300 to 500 lives annually, largely due to late detection. Two thirds of stomach cancer patients are only diagnosed at an advanced stage. Unveiling early indicators through collaborative breakthrough research The longitudinal study, which represents the world's largest genomic survey of patients with intestinal metaplasia, examines more than 1,100 tissue samples using powerful technologies such as single-cell RNA sequencing and spatial transcriptomics*. Based on this extensive survey, researchers identified 26 'driver genes' that play a pivotal role in the transition to stomach cancer. This landmark finding provides a glimpse into the mechanisms governing the transformation and offers a critical window for early detection and targeted prevention. "Advances in DNA sequencing have made it possible for us to uncover diverse cell populations within these stomach changes, hinting at their potential transformation into cancerous cells influenced by various factors. It's akin to understanding the ticking mechanism of a time bomb," explained Dr Huang Kie Kyon, co-first author and Senior Research Fellow with the Cancer & Stem Cell Biology Programme at Duke-NUS Medical School (Duke-NUS). Professor Patrick Tan, Senior Vice-Dean for Research at Duke-NUS and a professor with the School's Cancer & Stem Cell Biology Programme said: "The comprehensive dataset we've assembled provides unprecedented insights into the progression of cell changes in the stomach to cancer. By using both clinical information and genetic data from advanced molecular technologies, we can better predict which stomach conditions might turn into stomach cancer compared to using only clinical information. This can help in the development of new and more precise ways to prevent and stop stomach cancer." Prof Tan is also a member of the Genome Institute of Singapore, Cancer Science Institute of Singapore, and Precision Health Research Singapore (PRECISE). The multi-institutional effort by researchers from Duke-NUS, National University Hospital (NUH), National University of Singapore's Yong Loo Lin School of Medicine (NUS Medicine) and Seoul National University Hospital reflects the strengths of Singapore's multi-institutional cancer research ecosystem and its strong links with global partners. This study was supported by the Singapore Gastric Cancer Consortium (SGCC), a national translational research group comprising clinicians and scientists working in stomach cancer research from academic medical centres, universities, hospitals and research institutes across Singapore. The published work is derived from the prospective Gastric Cancer Epidemiology Programme cohort. The study offers clues into whether intestinal metaplasia cells directly transform into stomach cancer. It was revealed that a subpopulation of intestinal stem-like cells in patients with intestinal metaplasia closely resembles early stomach cancer cells, pointing to a possible early origin and potential of its malignant future. This discovery highlights the importance of screening for intestinal metaplasia in managing stomach cancer risk. Co-senior author Professor Jimmy So, Head & Senior Consultant, Division of General Surgery (Upper Gastrointestinal Surgery), NUH commented on the clinical implications: "This molecular roadmap of disease progression from intestinal metaplasia offers many translational opportunities. We can now explore more targeted surveillance for patients at highest risk, as well as anti-inflammatorial or antibiotic agents to intercept premalignant clones before they evolve into cancer, potentially leading to improved patient outcomes through early detection." He is also a professor at the Department of Surgery, NUS Medicine. More efficient and targeted preventive measures for populations At the population level, the findings hold promise for refining screening strategies and allocating resources more effectively to intercept the development of gastric cancer in high-risk individuals, ultimately contributing to more efficient and targeted preventive measures. This is especially relevant in countries such as Singapore, where the incidence of stomach cancer is moderate compared to Japan and South Korea where stomach cancer incidence is high enough to warrant mass screening. "Encouragingly, our results revealed that combining genomic data with clinical check-ups can make predictions about stomach cancer more accurate. This means we might use genetic tests, including simple and inexpensive blood tests, to identify people who are at a very high risk of getting stomach cancer. With this approach, we can divide people into groups based on their risk using either regular check-ups or these affordable blood tests. This helps to save resources by making sure those at the highest risk get the right tests and care they need," added Professor Khay Guan Yeoh, Lead Principal Investigator of the Singapore Gastric Cancer Consortium and Senior Consultant in the Division of Gastroenterology & Hepatology, National University Hospital. Prof Yeoh is also the Kishore Mahbubani Professor in Medicine and Health Policy, Department of Medicine, NUS Medicine. Senior author Associate Professor Chung Hyunsoo from Seoul National University Hospital stressed the clinical ramifications: "This breakthrough may refine screening protocols, enabling early interventions for high-risk patients, while sparing others unnecessary procedures." The research was funded by the Open Fund-Large Collaborative Grant that is supported by the National Research Foundation, Singapore and administered by the Singapore Ministry of Health's National Medical Research Council. The team also received support from Singapore's Ministry of Education, Cancer Science Institute of Singapore under the National University of Singapore and the Francis Crick Institute. In addition, the project could not have been made possible without the contributions of researchers from Tan Tock Seng Hospital, Singapore General Hospital, Changi General Hospital, Nihon University School of Medicine, Yonsei University Wonju College of Medicine and The Chinese University of Hong Kong. * Single-cell RNA sequencing (scRNA-seq) is a powerful technology that allows scientists to study individual cells' genetic material (RNA) one cell at a time. Spatial transcriptomics is another technique used to study gene expression in tissues but with an added dimension of spatial information. It allows scientists to see where specific genes are being expressed within tissues or organs, providing insight into the organisation and communication between cells in their actual location within the tissue.

SINGAPORE, 10 August 2023 – Mirxes Corporation USA, the wholly owned subsidiary of Mirxes Pte Ltd, a Singapore-headquartered RNA technology company that is making diagnostic solutions for the early detection of diseases accessible on a global scale, announced today that its flagship product GASTROClearTM, a PCR-based in vitro diagnostic test for early detection of gastric (stomach) cancer, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). Globally, this marks the first time that 1) a blood miRNA test, 2) an in vitro diagnostic (IVD) test for early detection of gastric cancer, and 3) a molecular in vitro diagnostic test developed in Southeast Asia, has received a Breakthrough Device Designation from the U.S. FDA. This designation is only granted to certain medical devices that address unmet needs and provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer. Launched in 2019, GASTROClearTM is the world’s first molecular blood test for the early detection of gastric cancer, enabling physicians and patients to act early before symptoms occur. The disease is the fourth most common cause of cancer death worldwide and a major cancer burden in Asia. WHO projects gastric cancer incidence to increase from 1.09 million new cases in 2020 to 1.81 million in 2040, with 75 per cent of new cases diagnosed in Asia. Gastric cancer detected early at asymptomatic stage can be cured with affordable treatment costs. Currently, most gastric cancers are diagnosed at late stage due to the lack of accurate and accessible mass screening tools. GASTROClearTM was developed and manufactured in Singapore through a seven-year public-private partnership by physicians and scientists at the Agency for Science, Technology, and Research (A*STAR)’s Bioprocessing Technology Institute (BTI), Diagnostics Development Hub (DxD Hub), the Singapore Gastric Cancer Consortium (SGCC), the National University of Singapore (NUS), the National University Hospital (NUH), Tan Tock Seng Hospital (TTSH) and Mirxes. GASTROClearTM was first approved by the Singapore Health Science Authority (HSA) in 2019, after a prospective clinical validation in more than 5,200 patients in Singapore. More recently, Mirxes, in collaboration with seven academic clinical institutions in China, conducted a large prospective clinical trial involving more than 9,000 patients, for registration of GASTROClearTM with China’s National Medical Product Administration (NMPA). Post-pandemic, Mirxes is making GASTROClearTM accessible in key Asia Pacific markets and is evaluating partnership to enable its launch in the United States. Dr. ZHOU Lihan, Co-founder and CEO, Mirxes, said, “It’s a privilege for GASTROClearTM to be granted Breakthrough Device Designation by FDA. Today, GASTROClearTM is available in six Asia Pacific markets and can be made accessible to millions of potential customers through PCR capabilities leapfrogged by the pandemic. The Breakthrough Device Designation further validated the novelty and clinical impact that GASTROClearTM can deliver in the field of gastric cancer early detection. As part of the Breakthrough Program, we are looking forward to interacting with FDA’s experts to obtain their continuous guidance during our pre-market review.” The goal of the FDA Breakthrough Device Program is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment and review, while preserving the statutory standards for pre-market approval.[i] Under the Program, GASTROClear™ could become available as an early detection test option sooner for people at high-risk for gastric cancer. Professor YEOH Khay Guan, Lead Principal Investigator of the Singapore Gastric Cancer Consortium and Senior Consultant in the Division of Gastroenterology & Hepatology, Department of Medicine, NUH, said, “The FDA Breakthrough Device Designation for GASTROClearTM marks a notable advance in the fight against gastric cancer. This non-invasive blood test has the potential to transform our management of this devastating disease, allowing us to identify individuals at high risk even before symptoms appear. Early detection enables curative treatment and will significantly improve survival for this otherwise fatal disease.” He is also the Kishore Mahbubani Professor in Medicine and Health Policy, Department of Medicine, NUS Yong Loo Lin School of Medicine. Prof. YEO Yee Chia, Assistant Chief Executive of A*STAR’s Innovation & Enterprise Group said, “We are proud that Mirxes, an A*STAR spinoff strongly supported by NUS, has received the U.S. FDA’s validation of their flagship product GASTROClearTM. We are glad to see that this Singapore technology, developed by Mirxes’s founders as scientists at A*STAR’s Bioprocessing Technology Institute, DxD Hub, and our ecosystem partners, has reached a new product milestone. A*STAR will continue to support our spinoffs and foster strong ecosystem partnerships to accelerate the commercialization and delivery of innovative healthcare solutions that benefit society.” “This designation granted to GASTROClearTM is a remarkable recognition that early diagnosis of gastric cancers is possible using non-invasive blood tests. The liquid biopsy approach will enable early interventions which can lead to better management of gastric cancer, and improve the quality of life and survival. The journey, though long, has been worthy, and is the fruit of the labor of a number of clinicians and scientists working closely together, sharing a common vision of translating research into societal impact,” said Associate Professor TOO Heng-Phon, Department of Biochemistry and NUS Centre for Cancer Research (N2CR) at the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine). He is also the Co-founder, Chief Scientific Advisor and Non-Executive Chairman, Mirxes. Dr. GOH Liuh Ling, Senior Principal Scientific Officer, Personalized Medicine Service, Tan Tock Seng Hospital said, “Screenings can help detect cancers early. This major development will be pivotal in ensuring that patients have timely access to early testing, detection, and increase their chances of recovery. Our joint collaboration in providing screenings for gastric cancer across all parties has allowed us to expand our knowledge, and exchange expertise and technical skills with other experts in the field to explore and deploy testing at scale in healthcare settings.” Built in Singapore for the world: scaling the adoption of GASTROClearTM GASTROClearTM has been successfully commercialized in Singapore after obtaining Class C IVD certification from the HSA in September 2019. It had also obtained the CE Mark in November 2017. Furthermore, GASTROClearTM has been used as a valuable reference for the drafting and publication of miRNA molecular detection industry standards, including the SS 650: 2020 Singapore standard and ISO21474 international standard, demonstrating its outstanding clinical performance. The FDA Breakthrough Device Designation will enable Mirxes to advance and scale the adoption of GASTROClearTM globally. Gastric cancer is associated with high mortality due to its late presentation.[ii] However, in most countries, early detection is neither feasible nor cost-effective due to high costs and the invasive nature of available screening methods that lead to poor compliance.[iii] Hence, an early detection and minimally invasive test becomes essential in improving patient outcomes.[iv] [v] Dr. Zhou added, “The FDA Breakthrough Device Designation is designed to accelerate patient access to promising innovative technologies, and receiving the FDA Breakthrough Device Designation provides credibility to GASTROClearTM as a high impact product and opens access to international markets, increasing Mirxes’s global reach. This is an important milestone for Mirxes in charting the way forward in preventive healthcare, by shifting the way we are diagnosing cancer to substantially reduce the economic burden and improve quality of life.” GASTROClearTM is currently available in Southeast Asia, including Singapore, Indonesia, Malaysia and Philippines. [i] https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program [ii] Van Cutsem E, Sagaert X, Topal B, et al. 2016. Gastric Cancer . Lancet, 388:2654–64. [iii] Van Cutsem E, Sagaert X, Topal B, et al. 2016. Gastric Cancer . Lancet, 388:2654–64. [iv] Leung WK, Wu M-shiang, Kakugawa Y, et al. 2008. Screening for gastric cancer in Asia: current evidence and practice. Lancet Oncol, 9:279–87. [v] Choi KS, Jun JK, Suh M, et al. 2015. Effect of endoscopy screening on stage at gastric cancer diagnosis: results of the National cancer screening programme in Korea. Br J Cancer, 112:608–12. About the Breakthrough Device Designation for GASTROClear™ by U.S. FDA GASTROClear™ was granted Breakthrough Device Designation based on the following indication for use proposed for the U.S. market. “Mirxes GASTROClear™ Assay, is an in vitro diagnostic multiplex reverse transcription quantitative polymerase chain reaction (RT-qPCR) test intended for semi-quantitative detection of twelve (12) gastric cancer miRNA biomarkers associated with gastric cancer from human serum. The test is intended for early detection of gastric cancer in high-risk patients. The test is intended to be used prior to gastroscopy. Mirxes GASTROClear™ Assay is indicated for adults who are 40 years of age or older and who are at high risk for gastric cancer defined as having one or more of the following risk factors: diagnosed first degree relatives with gastric cancer, chronic history of Helicobacter pylori (H. pylori) infection, chronic gastritis, and intestinal metaplasia as an aid in the detection of gastric cancer. The Mirxes GASTROClear™ Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures in a laboratory setting and under the supervision of a trained laboratory professional. The Mirxes GASTROClear™ Assay is not intended for self-testing.”