May 13 Quick Takes: China proposes exclusivity for orphan, pediatric drugs

China’s National Medical Products Administration is proposing to provide sponsors of treatments for rare diseases with up to seven years of market exclusivity, provided that the sponsor ensures supply of the drug. In a draft rule circulated by the Chinese government, the regulator is also proposing up to 12 months of market exclusivity for pediatric formulations and indications of approved drugs.

Type II diabetics may now be prescribed Mounjaro tirzepatide from  Eli Lilly and Co. (NYSE:LLY), following its approval by FDA to improve blood sugar control in adults, in addition to diet and exercise. Mounjaro, a dual GIP and GLP-1 agonist, lowered HbA1c levels 1.6% vs. placebo as a 15 mg standalone therapy and 1.5% vs placebo when used with a long-acting insulin. The drug is also being developed for obesity, and Lilly said last month that it led to about 20% weight reduction at week 72 in a Phase III study, position it as potentially best in class.  ...