China's National Medical Products Administration has approved Pfizer Inc.'s
Pfizer's Competition
Bloomberg noted that Pfizer is entering a market currently dominated by Novo Nordisk A/S
The company has not disclosed pricing or a launch timeline. The approval also comes as Novo Nordisk's Wegovy nears patent expiry later this month, potentially paving the way for lower-cost copycat versions.
Hangzhou Sciwind Biosciences Co., Ltd. announced the regulatory clearance on Friday, positioning the therapy as a new option for long-acting weight management in China.
In February, Hangzhou Sciwind Biosciences collaborated with Pfizer China for Ecnoglutide injection, obtaining exclusive commercialization rights in Mainland China.
Sciwind Biosciences is eligible to receive up to $495 million in upfront, regulatory, and sales milestone payments.
Phase 3 Trial Shows Significant Weight Loss
The approval is supported by results from the Phase 3 SLIMMER trial conducted among Chinese adults with overweight or obesity.
Clinical data from the SLIMMER Phase 3 study demonstrated meaningful weight reduction after 48 weeks of treatment.
At the highest dose of 2.4 mg, patients receiving Ecnoglutide achieved an average weight reduction of 15.4% from baseline, representing a 15.1% placebo-adjusted decrease.
Nearly 92.8% of participants achieved clinically meaningful weight loss of at least 5%, a response rate roughly seven times higher than placebo.
In addition, 79.6% of participants achieved weight loss of at least 10%, while 63.5% reached reductions of 15% or more.
Patients continued to lose weight through the 48 weeks without reaching a plateau, suggesting the potential for further reductions with longer treatment durations.
Pfizer's Drug Shows Broader Cardiometabolic Improvements
Beyond weight loss, the treatment also showed improvements across several cardiometabolic markers.
Participants experienced reductions in waist circumference, blood pressure, lipid levels, HbA1c, fasting glucose, insulin levels, and HOMA-IR.
The therapy also lowered uric acid levels by up to 54.3 µmol/L and reduced the incidence of hyperuricemia.
Ecnoglutide additionally demonstrated a significant reduction in liver fat content. Among patients with baseline liver fat levels of at least 8%, liver fat declined by an average of 53.1% by week 40 in the 2.4 mg treatment group.
Across all tested doses, patients receiving Ecnoglutide also showed greater reductions in liver enzyme concentrations compared with placebo.
PFE Price Action: Pfizer shares were down 0.38% at $26.51 during premarket trading on Friday, according to Benzinga Pro data.
