Takeda's Novel Potassium-Competitive Acid Blocker Vonoprazan Fumarate (Takecab®) Approved in China for Reflux Esophagitis

Takeda China Announces aNovel Mechanism Acid-Suppressing Drug: Vonoprazan Fumarate (Brand Name: Vocinti®), it has now received approval from the National Medical Products Administration (NMPA) to officially enter the Chinese market, with the approved indication for the treatment of reflux esophagitis (RE).

Vonoprazan Fumarate Tablets are the first potassium-competitive acid blocker (P-CAB) approved for the Chinese market. Clinical data demonstrate their characteristics of full efficacy with the first dose [1], sustained acid suppression [2], and convenient administration [3]. The approval of Vonoprazan Fumarate Tablets in China provides a new therapeutic option for reflux esophagitis, significantly improving the quality of life for patients with this condition.

Professor Chen Minhu, Chairman of the Chinese Society of Gastroenterology under the Chinese Medical Association, stated, “Currently, proton pump inhibitors (PPIs) are the primary pharmacological treatment for reflux esophagitis; however, some patients exhibit suboptimal therapeutic responses, necessitating novel treatment approaches. Vonoprazan fumarate tablets represent a novel class of acid-suppressive agents—potassium-competitive acid blockers (P-CABs)—with a mechanism of action distinct from that of PPIs. Stable in acidic environments, its acid-suppressive efficacy is unaffected by food intake, and it demonstrates robust acid suppression from the first day of administration, indicating significant clinical advantages for vonoprazan.” Professor Chen further remarked, “We look forward to the clinical application of vonoprazan fumarate in China, hoping that its availability will benefit more adult patients with reflux esophagitis and enhance their quality of life.”

Reflux esophagitis is a common digestive system disease, characterized by symptoms such as heartburn and acid regurgitation caused by the reflux of gastric contents. It may be accompanied by extra-esophageal symptoms and involves erosion of the esophageal mucosa, significantly affecting patients' quality of life and sleep. Epidemiological data shows that the incidence rate of reflux esophagitis in the general population in China is as high as 6.4% [5].

Currently, the primary goals in the treatment of reflux esophagitis are to alleviate symptoms, promote mucosal healing, maintain remission of reflux esophagitis, prevent related complications, and improve health-related quality of life. As a novel acid-suppressive medication with a new mechanism of action, vonoprazan fumarate tablets block the K+ channel of H+,K+-ATPase and competitively inhibit the binding of K+ to this enzyme. This allows the drug to remain in gastric parietal cells for an extended period, thereby rapidly suppressing gastric acid secretion and providing a new therapeutic option for patients with reflux esophagitis.

Vonoprazan Fumarate Tablets were launched in Japan in February 2015 for the treatment of acid-related disorders, including reflux esophagitis, gastric ulcers, duodenal ulcers, prevention of recurrence of gastric or duodenal ulcers during treatment with low-dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), and eradication of Helicobacter pylori. The Center for Drug Evaluation of the National Medical Products Administration officially accepted the marketing application for Vonoprazan Fumarate Tablets in March 2018 and formally approved them for marketing on December 18, 2019.

Mr. Shan Guohong, President of Takeda China, stated, “We extend our sincere gratitude to the National Medical Products Administration for approving VOQUEZNA® (vonoprazan fumarate tablets) for entry into the Chinese market. The approval of VOQUEZNA® fully demonstrates the Chinese government’s determination to deepen healthcare reform, accelerate the introduction of innovative medicines, and continuously improve people’s health and well-being. Upholding the principle of putting patients first, Takeda will continue to dedicate itself to the research and development of highly innovative drugs and breakthrough therapies, bringing more innovative gastrointestinal treatments to China at a faster pace, thereby safeguarding the healthy lives and bright future of the Chinese people.”

As a values-based, R&D-driven global leading biopharmaceutical company, Takeda focuses on drug development in four key therapeutic areas: oncology, gastroenterology, neuroscience, and rare diseases, while also making targeted investments in plasma-derived therapies and vaccines. Leveraging its R&D strength and leadership in gastroenterology, Takeda has been actively promoting and participating in the continuous advancement of scientific research and clinical practice in this field in China since its entry into the Chinese market in 1994, consistently demonstrating its commitment to scientific innovation and improving patient outcomes.

[1] SakuraiY, et al. Aliment pHarmacol Ther. 2015 Sep; 42(6):719-730.

[2] HuntRH, et al. Curr Treat Options Gastroenterol.2018 Dec;16(4):570-590

[3] MartinucciI, et al. Expert Opin pHarmacother. 2017;18(11):1145-1152.

[4] XiaoY, Zhang S, Dai N, et al. Phase III, randomized, double-blind, multicenterstudy to evaluate the efficacy and safety of vonoprazan compared withlansoprazole in Asian patients with erosive oesophagitis. Gut. 2019 Aug 13.pii: gutjnl-2019-318365. doi: 10.1136/gutjnl-2019-318365. [Epub ahead of print]

[5] ZouD, et al. Scand J Gastroenterol. 2011;46(2):133-41