Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Takecab (vonoprazan) to eradicate Helicobacter pylori (HP) when combined with appropriate antibiotics. The vonoprazan-based quadruple regimen, which includes bismuth, is the first of its kind to be approved in China.
Helicobacter pylori, the only confirmed bacterial pathogen closely linked to the occurrence of gastric cancer, is classified as a Class I carcinogen. China bears a significant disease burden of gastric cancer, with the incidence rate of gastric cancer ranking fourth among all malignant tumors and third in mortality. Gastric cancer deaths account for 12.4% of all cancer deaths in the country. Data from 2018 indicate that there were approximately 780,000 cancer cases in China caused by infections, of which 340,000 were attributed to HP infection, representing about 43.6%.
The approval is supported by a multi-center Phase III clinical study conducted in the Chinese population. Takecab is already approved for this indication in Japan and the United States, among other countries.- Flcube.com
