Chi-Med cuts surufatinib PhIII short; FDA greenlights Herceptin copycat from Amgen, Allergan
→ One of Chi-Med’s late-stage favorites is graduating early from its Phase III study, having met its primary endpoints at interim analysis. The Hong Kong-headquartered biotech left out the numbers in its brief statement, which noted that surufatinib hit a PFS goal among patients with extra-pancreatic neuroendocrine tumors. CEO Christian Hogg has tapped the drug, alongside savolitinib, for approvals over the next two years to follow up on the landmark OK for fruquintinib in China.
→ Amgen $AMGN and Allergan $AGN have nabbed an OK to market their Herceptin copycat — christened Kanjinti — in the US for all approved indications of the Roche blockbusters including HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma. “Kanjinti is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA,” David Nicholson, Allergan’s chief research and development officer, noted.
→ Last year, Sun Pharmaceuticals entered the crowded market for plaque psoriasis with its IL-23 inhibitor Ilumya. On Friday, the Indian drugmaker said the monoclonal antibody — in-licensed from Merck $MRK back in 2014 for $80 million — cleared a mid-stage study in patients with psoriatic arthritis. The interim analysis revealed that over 71% of patients treated with the drug experienced a 20% improvement in joint and skin symptoms, meeting the primary endpoint of the study.