Great news! AstraZenecon constipation drug Linzess (Linalopeptide) has been approved in China and will fill domestic treatments:
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Last Update: 2021-02-17
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Source: Internet
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Author: User
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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 the adult patient population in China.
Linzess' approval, based on a global multi-center Phase III study conducted by AstraZeneta China in five countries, assessed the efficacy and safety of Linzess in treating adult IBS-C patients. 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 to co-direct the development and commercialization of 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 cyclic enzyme-C (GC-C) exciter that binds to and localizes GC-C subjects that act locally on the surface of the small intestine's upper cortive tube cavity. Activation of GC-C resulted in elevated concentrations of bird glycosides (cGMP) in the cell and outside the cell. 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)
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