Takeda Announces NMPA Approval of Vonoprazan Fumarate Tablets for Helicobacter pylori Eradication in China

Shanghai, November 24, 2023 /PRNewswire/ -- Takeda China announced today that the new indication for its innovative digestive product, Vonoprazan Fumarate Tablets, has been officially approved by the National Medical Products Administration (NMPA) of China. It will be used in combination with appropriate antibiotics to eradicate Helicobacter pylori. The quadruple regimen based on Vonoprazan Fumarate Tablets is the first bismuth-containing quadruple regimen approved in China, providing a "new weapon" for the large population infected with Helicobacter pylori in China, opening a new chapter in "eliminating H. pylori," strengthening the primary prevention line against gastric cancer, and further positively impacting the situation of gastric cancer prevention and control in China.

Helicobacter pylori is a pathogenic bacterium associated with various major chronic diseases. It is contagious and can cause multiple gastrointestinal and extragastrointestinal diseases, including chronic gastritis, peptic ulcers, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Helicobacter pylori infection is difficult to self-heal, imposing a heavy disease burden on patients. Without eradication treatment, the infection often persists for life and may lead to gastric cancer in severe cases. Data shows that the Helicobacter pylori infection rate among residents in China is approximately 46.7%.^[1], with characteristics of high infection rate in the population, heavy disease burden, and high drug resistance rate. The infection rate of Helicobacter pylori in households is as high as 71.2%.^[2], with obvious family clustering.

Helicobacter pylori is the only bacterium currently identified as closely associated with the development of gastric cancer and is classified as a Class I carcinogen.^[3]China bears a high disease burden of gastric cancer, with its incidence ranking 4th among all malignant tumors and its mortality ranking 3rd.^[4]Deaths caused by stomach cancer account for 12.4% of all cancer-related deaths.^[5]Data show that in 2018, there were approximately 780,000 infection-related cancer cases in China, of which 340,000 were attributed to Helicobacter pylori infection, accounting for about 43.6%.^[6]In June 2023, the first White Paper on the Prevention and Control of Helicobacter pylori Infection in China was officially released. The white paper particularly emphasized: "The prevention and control of Helicobacter pylori infection should focus on appropriate diagnosis, treatment, and eradication. Once Helicobacter pylori infection is detected, eradication treatment should be encouraged unless there are counterbalancing factors." Additionally, it is recommended that family members infected with Helicobacter pylori undergo joint treatment, which will help reduce reinfection after eradication.

Professor Liya Zhou, Chief Physician of the Department of Gastroenterology at Peking University Third Hospital, stated:Improving the First-time Eradication Rate of Helicobacter Pylori is Crucial

The degree of gastric acid suppression (i.e., pH) and the percentage of time duration (i.e., HTR) are important factors influencing the eradication rate of Helicobacter pylori. Currently, a gastric pH > 6 and HTR > 75% have become the clinical acid suppression standards for eradicating Hp.^[7], Vonoprazan Fumarate, as a new generation of innovative drug - Potassium-Competitive Acid Blocker (P-CAB), is not affected by food intake^[8], and is not affected by CYP2C19 gene polymorphism. Studies have shown that taking it twice a day results in 85% of gastric pH >6 HTR.^[9], plays an important role in the clinical treatment of eradicating Helicobacter pylori and can effectively improve the eradication rate of Helicobacter pylori. The approval of the new indication for Vonoprazan Fumarate Tablets for eradicating Helicobacter pylori is mainly based on a multi-center Phase III study conducted in the Chinese population.^[10]To date, the new indication for the combination of vonoprazan fumarate tablets with antibiotics to eradicate Helicobacter pylori has been approved in 15 countries and regions worldwide, including Japan and the United States.

Takeda has always adhered to the original intention of "putting patients first." Since the comprehensive implementation of its "Expand China" strategy, the speed at which it brings cutting-edge international innovative treatment solutions to Chinese patients has accelerated, and its reach has broadened. As one of Takeda's four core therapeutic areas in its strategic focus on the Chinese market, gastroenterology has now entered a new stage of development. In the future, Takeda will continue to prioritize public health needs in China, deepen its commitment to the field of gastroenterology, and provide more and better medical solutions for patients in China and around the world.Case.

[1] Li M, Sun Y, et al , Helicobacter. 2020 Jul 19:e12729

[2] Zhou XZ, et al. Gut. 2023 Jan 23:gutjnl-2022-328965.

[3] Li, W.Q., et al., Effects of Helicobacter pylori treatment and vitamin and garlic supplementation on gastric cancer incidence and mortality: follow-up of a randomized intervention trial. BMJ, 2019. 366: p.l5016

[4] He Jie, Chen Wanqing, Li Zhaoshen, et al. Chinese Guidelines for Gastric Cancer Screening and Early Detection and Treatment (2022, Beijing) [J]. Chinese Journal of Oncology, 2022, 44(7):634-666.

[5] Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660 IF：508.703

[6] The relative and attributable risks of cardia and non-cardia gastric cancer associated with Helicobacter pylori infection in China:a case-cohort study.thelancet.2021.11.25

[7] Yuan Yaozong. Chinese Journal of Digestion, 2023, 43(9): 579-582.

[8] Report on the Deliberation Results, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau. https://www.pmda.go.jp/english/index.html. November 26, 2014.

[9] Kagami T, et al. Aliment Pharmacol Ther, 2016, 44(3):305.

[10] LY zhou et al, United European Gastroenterology Journal 2022, Vol 10, 42