Helsinn Group and Ono Pharmaceutical Co., Ltd. announced that ONO received the manufacturing and marketing approval of Adlumiz® (generic name: anamorelin hydrochloride) Tablet 50mg (“Adlumiz”), a ghrelin receptor agonist, for the treatment of cancer cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer or colorectal cancer in Japan. This approval is mainly based on the results from the following two clinical studies conducted in Japan in patients with cancer cachexia: Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study in cancer cachexia patients with non-small cell lung cancer (ONO-7643-04). Phase III multi-center, open-label, uncontrolled study in cancer cachexia patients with gastric, pancreatic or colorectal cancer (ONO-7643-05). Cancer cachexia is a complex metabolic disorder syndrome, characterized by decreased body weight (especially decreased muscle mass) and anorexia associated with cancer. It has been well documented that cancer cachexia causes a significant impact on patients’ quality of life and prognosis. To date, an effective treatment method for cancer cachexia has not yet been established. Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Anamorelin has shown effects in increasing body weight and muscle mass, as well as appetite in patients with cancer cachexia.