Apollo Therapeutics and Sunshine Lake Pharma Enters into Exclusive License Agreement for APL-18881

Wednesday, November 13, 2024

Apollo Therapeutics has signed an exclusive license agreement with Sunshine Lake Pharma.

APL-18881 (HEC88473) is designed to simultaneously activate FGF21 and GLP-1 receptors, with both pathways showing potential for treating a variety of metabolic diseases. The collaboration between Apollo and Sunshine Lake underscores their shared goal of addressing unmet medical needs in global markets.

This partnership is for the development of APL-18881 (HEC88473), a promising bi-specific fusion protein targeting FGF21 and GLP-1 receptors. These receptors are well-established in clinical research, with several monoclonal agonists in late-stage development or already approved for various conditions.

Under the terms of the agreement, Sunshine Lake will retain the rights for the development, manufacturing, and commercialization of APL-18881 in China. Apollo, meanwhile, will manage these rights in all other global markets. 

Sunshine Lake will receive an upfront payment of $12 million, with the potential to earn up to $926 million in development, regulatory, and commercial milestone payments. These milestones are tied to specific sales targets in major markets, in addition to tiered royalties based on net sales, ranging from high single to low double digits.

This collaboration marks an important step for both companies. For Apollo, APL-18881 will be its fifth program in clinical development, complementing its expanding portfolio of novel drug candidates. 

Apollo’s strategy includes not only discovering new treatments in partnership with academic institutions but also acquiring and licensing promising clinical-stage assets that align with its expertise in genetics, discovery science, and preclinical research.

APL-18881 is currently undergoing Phase 2 clinical trials for type 2 diabetes in China, with results expected in the first half of 2025. 

The compound has already completed Phase 1 trials in Australia and China, with encouraging results showing a safe profile and strong pharmacodynamic responses at therapeutic doses. The drug has an open Investigational New Drug (IND) application with the US FDA, and both parties plan to initiate additional clinical studies in 2025.

Sunshine Lake Pharma has built a strong pipeline of innovative drugs in areas like anti-infection, oncology, and chronic metabolic diseases. While its primary focus has been on the Chinese market, the company is increasingly exploring international expansion opportunities.

This agreement with Apollo represents Sunshine Lake’s first international collaboration for novel biologics, highlighting its commitment to growing its global footprint.

 

Source: apollotx.com