GLP-1/FGF21 dual agonist

CAMBRIDGE, UK & DONGGUAN, China I November 12, 2024 I Apollo Therapeutics Group Limited (“Apollo”), the portfolio biopharmaceutical company, and Sunshine Lake Pharma Co., Ltd. (“Sunshine Lake”), an innovative pharmaceutical company and a member of HEC Group, one of the top 500 private business entities in China, have entered into an exclusive license agreement for the development of APL-18881 (HEC88473). Under the terms of the agreement, Sunshine Lake will retain development, manufacturing and commercialization rights in China and has granted Apollo development, manufacturing and commercialization rights in the rest of the world for all current and future therapeutic indications. Sunshine Lake is to receive $12m upfront and up to $926m in development, regulatory and commercial milestone payments. The commercial milestone payments are contingent upon reaching defined annual sales thresholds across major markets. In addition, Sunshine Lake stands to receive tiered royalties ranging from high single to low double digits on net sales. Apollo is building a large and diversified pipeline of novel drug candidates and APL-18881 (HEC88473) will be its fifth program in clinical development. As well as discovering and developing new drugs based on breakthroughs in basic science made at its partner universities, Apollo also in-licenses or acquires clinical-stage assets based on strict selection criteria including the exploitation of unique insights and synergies arising from its discovery, human genetics, and other preclinical activities. APL-18881 (HEC88473) has an open US Investigational New Drug Application (IND) and Apollo will be clinically developing the molecule in a range of potential indications in the cardiometabolic, liver, and related disease areas that are not currently disclosed. Sunshine Lake has long been dedicated to innovative drug development in anti-infection, oncology, and chronic metabolic disease areas, establishing a robust pipeline with multiple programs in mid-to-late clinical stages. While mainly focusing on domestic development and commercialization within China for novel drugs, Sunshine Lake is also actively exploring opportunities to expand into international markets. The collaboration with Apollo on the APL-18881 (HEC88473) program marks Sunshine Lake’s first international partnership for novel biologics, further emphasizing Sunshine’s commitment to global expansion efforts. More about APL-18881 (HEC88473) APL-18881 (HEC88473) is a bi-specific fusion protein developed by Sunshine Lake that agonizes FGF21 and GLP-1 receptors, both clinically validated targets, with several mono agonists in late-stage development or approved for a variety of indications. APL-18881 (HEC88473) is currently in a double blind, placebo- and active agent-controlled Phase 2 trial in patients with type 2 diabetes in China (NCT06148649), where headline results are expected in H1 2025. There is also an open IND with the US Food and Drug Administration (FDA). The drug candidate has successfully completed Phase 1 trials (NCT05943886 and NCT04829123) in Australia and China in healthy and obese subjects, as well as type 2 diabetics. Data from these trials suggests APL-18881 (HEC88473) has an acceptable safety and tolerability profile and impressive pharmacodynamic responses at both the FGF21 and GLP-1 receptors at therapeutic doses. The clinical data was published last year at AASLD 1 . Both parties are planning to continue or initiate clinical proof-of-concept studies during 2025. “This transaction further delivers on our strategy to generate a large and diversified clinical portfolio of programs in major commercial indications with real unmet medical need,” said Dr. Richard Mason, Chief Executive Officer of Apollo Therapeutics . “The development of APL-18881 (HEC88473) completed by Sunshine Lake to date strongly suggests that this novel FGF21 and GLP-1 dual receptor agonist has clinical potential in multiple disease areas where these individual mechanisms have already been demonstrated to show robust clinical efficacy and where we anticipate synergies could occur between the two distinct mechanisms of action. We are excited to partner with the world-class team and exceptional R&D capabilities at Sunshine Lake who will develop APL-18881 (HEC88473) across a range of indications in China whilst we focus on development ex-China.” “We are thrilled about this collaboration and are looking forward to working closely with Apollo on this exciting program,” said Dr. Zhang Yingjun, Chairman of the Board of Sunshine Lake Pharma . “HEC88473 is one of Sunshine Lake’s very first novel biologics programs, showcasing strong therapeutic potential with its differentiated mechanism of action. Apollo’s vision and clinical expertise will undoubtedly help accelerate the delivery of this novel treatment to patients.” About Apollo Therapeutics Group Limited Apollo Therapeutics is a portfolio biopharmaceutical company based in the UK and USA. Apollo translates breakthroughs in biology and basic medical research into innovative new medicines. With over 20 active therapeutic programs, five of which are in clinical development, the company is building a large, diversified portfolio of novel therapeutics with uncorrelated risk. Apollo has a scalable R&D platform enabled by an unprecedented level of access to breakthroughs in biology and basic medical research made at six of the world’s leading universities and research institutes. The company also in-licenses or acquires clinical-stage programs where it has unique insights and synergies. Backed by leading specialist health care investors, Apollo has raised a total of over $450m since its inception. Visit www.apollotx.com About Sunshine Lake Pharma Limited Sunshine Lake Pharma is a vertically integrated pharmaceutical company focused on the R&D, production, and commercialization of innovative drugs, and has a presence in the field modified new drugs, generic, and biosimilars. Since its founding in 2003, Sunshine Lake has built industry-leading R&D platforms, manufacturing facilities, and a global sales network. The company strategically targets infectious diseases, oncology, and chronic metabolic diseases, with products launched in China, the US, and Europe. Sunshine Lake Pharma’s mission is to provide innovative, high-quality, and affordable medications globally. 1 Lin Xianga, Jiangyu Yanb, Lin Luob, Hong Zhanga, Can Xieb,c, Yuyu Pengb, Hong Chena, Qianqian Lia, Xiaoping Lib,c, Yulei Zhuangb, Linfeng Guob,c, Yanhua Dinga, 2023. Safety, Pharmacokinetics and Pharmacodynamics of a Novel GLP-1/FGF21 Dual Agonist HEC88473 in Type 2 Diabetes Patients with Nonalcoholic Fatty Liver Disease: a randomized, double-blind, placebo-controlled, Phase 1b/2a multiple-ascending-dose study. SOURCE: Apollo Therapeutics