AstraZeneta's new constipation drug Linzess (Linalotide) has been approved in China and will fill the gap in domestic treatment

AstraZeneca and partner Ironwood recently announced that Linzess, a new constipation drug, has been approved by China's State Drug Administration (NMPA) for the treatment of adult patients with constipation-type irritable bowel syndrome (IBS-C). AstraZeneta said the drug would be available in China in the second half of 2019.In China, irritable bowel syndrome (IBS) is a common chronic debilitating disease, IBS-C is one of its subtypes, the main symptoms of most patients are repeated constipation, accompanied by bowel pain and bloating symptoms, the quality of life of patients affected by frequent recurrence.estimates that there are about 13 million IBS-C patients in China. Linzess is a pioneering bird nucleotide cyclase-C (CG-C) perturbation agent, which is available in China and will fill the gap in the field of IBS-C treatment and will provide an important treatment option for adult patients in China.Linzess' approval is based on a global multi-center Phase III study conducted by AstraZeneta China in five countries to assess the efficacy and safety of Linzess in treating adult patients with IBS-C. In this study, Linzess had significant efficacy, reached all major and secondary endpoints, including abdominal pain and constipation symptoms, and was safe.AstraZene Cumbertrain in 2012 with Ironwood to develop and commercialize Linzess in China. Under the terms of the agreement, AstraZeneta made an advance payment of $25 million, which will share the net profit and losses. In addition, Ironwood will be eligible for an additional $125 million in commercial milestones. Both sides hope to take this opportunity to bring Linzes into the huge and fast-growing Chinese market.Linzess' active pharmaceutical ingredient is linaclotide, a bird nucleotide cyclase-C (GC-C) exciter that binds and localizes GC-C subjects that act locally on the surface of the small intestine's cortective tube cavity. Activation of GC-C resulted in elevated concentrations of bird glycosides (cGMP) in cells and outside cells. Intracular cGMP elevation stimulates the secretion of chlorine and bicarbonate root ions into the intestinal cavity, leading to increased and accelerated passage of small intestine secretions. In animal models, linaclotide also showed a role in reducing pain in the small intestine, which is thought to be mediated by an increase in extracellular cGMP, which reduces the activity of the intestinal pain-sensing nerve, thereby inducing a reduction in visceral pain. (Bio Valley)