Sunshine Lake Pharma Secures $938M Global Licensing Deal for GLP-1/FGF21 Dual Agonist APL-18881 (HEC88473)

On November 12, Apollo Therapeutics announced that it had entered into an exclusive license agreement with Sunshine Lake Pharma (Guangdong Dongyangguang Pharmaceutical Co., Ltd.) for the development of APL-18881 (HEC88473). APL-18881 is a bispecific fusion protein targeting the FGF21 receptor and the GLP-1 receptor, developed by Sunshine Lake Pharma.

Under the terms of the agreement, Guangdong Dongyangguang Pharmaceutical Co., Ltd. will retain the rights to develop, manufacture, and commercialize APL-18881 in China, while granting Apollo Therapeutics the rights to develop, manufacture, and commercialize the drug for all current and future indications in the rest of the world. In return, Guangdong Dongyangguang Pharmaceutical will receive an upfront payment of $12 million and up to $926 million in development, regulatory, and commercial milestone payments. The commercial milestone payments are contingent upon achieving specified annual sales thresholds in key markets. Additionally, Guangdong Dongyangguang Pharmaceutical will receive tiered royalties ranging from high single digits to low double digits on net sales. (The total potential value amounts to $938 million, equivalent to approximately RMB 6.78 billion.)

APL-18881 (HEC88473) is a bispecific fusion protein developed by Dongyangguang Pharmaceutical that activates the clinically validated FGF21 and GLP-1 receptors. Multiple single-target agonists for these two receptors are already in late-stage development or have been approved for the treatment of various indications.

Fibroblast Growth Factor 21 (FGF21) is an endogenous metabolic hormone that regulates energy expenditure as well as glucose and lipid metabolism. FGF21 is primarily expressed in the liver and plays a critical role in the regulation of glucose and lipid metabolism. Dual FGF21/GLP-1R agonists are expected to produce synergistic effects in lowering blood glucose and reducing body weight.

This collaboration between Dongyangguang Pharmaceutical and Apollo Therapeutics on the APL-18881 (HEC88473) project also marks Dongyangguang Pharmaceutical’s first international partnership in the field of novel biologics. The successful overseas launch of another domestically developed innovative GLP-1 drug undoubtedly serves as a significant boost to the highly competitive domestic GLP-1 sector.

Apollo Therapeutics is a UK-based biotechnology company founded in 2016. It has raised over $400 million in cumulative financing, with its lead pipeline candidate being an IL-18 antibody currently undergoing Phase II clinical trials for atopic dermatitis.

Apollo Therapeutics is building a large and diverse pipeline of novel drug candidates, with APL-18881 being the fifth project to advance into clinical development. An Investigational New Drug (IND) application for APL-18881 has been submitted in the United States. Apollo Therapeutics will explore the therapeutic potential of this drug across a range of potential indications in cardiometabolic, hepatic, and related disease areas in clinical trials; specific indications have not yet been disclosed.

Currently, APL-18881 (HEC88473) is undergoing a double-blind, placebo- and active-controlled Phase II clinical trial in patients with type 2 diabetes in China (NCT06148649). The preliminary results of this study are expected to be released in the first half of 2025. Furthermore, APL-18881 has received an Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). This candidate drug has also successfully completed two Phase I clinical trials in Australia and China, involving healthy and obese subjects as well as patients with type 2 diabetes. Trial data indicate that APL-18881 (HEC88473) demonstrates favorable safety and tolerability at therapeutic doses for both FGF21 and GLP-1 receptors, while showing encouraging potential in pharmacodynamic responses. Both Guangdong Dongyangguang Pharmaceutical Co., Ltd. and Apollo Therapeutics plan to continue or initiate clinical proof-of-concept studies in 2025.

In 2019, Boehringer Ingelheim licensed Yuhan’s GLP-1/FGF21 dual agonist with a $40 million upfront payment and up to $830 million in milestone payments. In recent years, FGF21 fusion proteins from Akero Therapeutics and 89bio have achieved significant breakthroughs in the treatment of non-alcoholic steatohepatitis (NASH).

In China, Guangdong Dongyangguang Pharmaceutical and Apollo Therapeutics/Chia Tai Tianqing have developed GLP-1/FGF21 dual agonists, while Daoer Biopharma has developed a GLP-1/GCG/FGF21 triple agonist; all have entered clinical trials.