Sanofi SA / Hanmi Pharmaceutical Co., Ltd. (Quantum Project)

Type 2 Diabetes Mellitus

$53.0B Global GLP-1 drugs market 2025 (~58% T2D segment)

Disease Overview

Type 2 diabetes mellitus is a chronic metabolic disorder characterized by insulin resistance and progressive beta-cell dysfunction, leading to hyperglycemia and elevated cardiovascular and renal risk. It affects an estimated 38 million Americans, with treatment typically escalating from metformin to incretin-based therapies (GLP-1 receptor agonists, DPP-4 inhibitors), SGLT2 inhibitors, and ultimately basal and prandial insulin. Long-acting weekly options have become the standard of care.

Competitive Landscape

When Sanofi licensed Hanmi's Quantum Project in November 2015, the GLP-1 receptor agonist class was being defined by Novo Nordisk's Victoza (daily liraglutide) and the long-acting Bydureon (exenatide weekly, AstraZeneca/BMS) and Trulicity (dulaglutide weekly, Eli Lilly, launched 2014). Sanofi was a distant fourth in GLP-1s with Lyxumia/Adlyxin (lixisenatide) and was simultaneously launching Toujeo (insulin glargine U-300) to defend its franchise against biosimilar Lantus. The Quantum Project — efpeglenatide (weekly GLP-1), a weekly basal insulin, and a fixed-ratio weekly GLP-1/insulin combination, all built on Hanmi's LAPSCOVERY half-life-extension platform — was framed by FierceBiotech as 'Sanofi playing pipeline catch-up with Novo and Lilly'. The deal unraveled in stages: Sanofi returned the weekly insulin and combination rights in December 2016, then under new CEO Paul Hudson exited diabetes/CV R&D entirely, returning efpeglenatide rights to Hanmi in May 2020 — even after AMPLITUDE-O (n=4,076) showed a 27% MACE reduction and 33% kidney-event reduction. Novo's Ozempic (semaglutide) approval in 2017 and oral Rybelsus in 2019, plus Lilly's Mounjaro (tirzepatide) in 2022, ultimately defined the modern incretin standard, leaving the Hanmi platform commercially stranded.