CAMBRIDGE, England & DONGGUAN, China--(BUSINESS WIRE)--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).

英国剑桥和中国东莞——（商业新闻短讯）——阿波罗治疗集团有限公司（以下简称“阿波罗”）是一家投资组合生物制药公司，阳光湖制药有限公司（以下简称“阳光湖”）是一家创新制药公司，也是中国500强私营企业之一HEC集团的成员，已就APL-18881（HEC88473）的开发签订了独家许可协议。

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.

根据协议条款，阳光湖将保留在中国的开发、制造和商业化权利，并授予阿波罗在世界其他地区的所有当前和未来治疗适应症的开发、制造和商业化权利。阳光湖将获得1200万美元的预付款，以及高达9.26亿美元的开发、监管和商业里程碑付款。

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..

商业里程碑付款取决于各主要市场达到规定的年度销售阈值。此外，阳光湖将获得从净销售额的高单位数到低两位数不等的分层版税。。

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.

阿波罗正在建立一个庞大而多样化的候选新药管道，APL-18881（HEC88473）将是其临床开发的第五个项目。除了根据其合作大学在基础科学方面取得的突破发现和开发新药外，阿波罗还根据严格的选择标准（包括利用其发现，人类遗传学和其他临床前活动产生的独特见解和协同作用）许可或收购临床阶段资产。

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..

APL-18881（HEC88473）具有开放的美国研究性新药申请（IND），阿波罗将在临床上开发该分子，用于心脏代谢，肝脏和相关疾病领域的一系列潜在适应症，目前尚未公开。。

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.

阳光湖长期以来一直致力于抗感染，肿瘤学和慢性代谢疾病领域的创新药物开发，建立了一个强大的管道，在中晚期临床阶段有多个项目。在主要关注国内新药开发和国内新药商业化的同时，阳光湖也在积极探索拓展国际市场的机会。

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..

与阿波罗在APL-18881（HEC88473）项目上的合作标志着阳光湖首次建立新型生物制剂国际合作伙伴关系，进一步强调了阳光对全球扩张努力的承诺。。

More about APL-18881 (HEC88473)

有关APL-18881（HEC88473）的更多信息

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）是由Sunshine Lake开发的双特异性融合蛋白，可激动FGF21和GLP-1受体，这两种受体都是临床验证的靶标，在后期开发中有几种单激动剂或被批准用于多种适应症。

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.

APL-18881（HEC88473）目前正在中国进行一项针对2型糖尿病患者的双盲，安慰剂和活性药物对照的2期临床试验（NCT06148649），预计2025年上半年将获得主要结果。美国食品和药物管理局（FDA）也有一个开放的IND。该候选药物已在澳大利亚和中国的健康和肥胖受试者以及2型糖尿病患者中成功完成了1期临床试验（NCT05943886和NCT04829123）。

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 AASLD1. Both parties are planning to continue or initiate clinical proof-of-concept studies during 2025..

这些试验的数据表明，APL-18881（HEC88473）在治疗剂量下对FGF21和GLP-1受体均具有可接受的安全性和耐受性，并具有令人印象深刻的药效学反应。临床数据于去年在AASLD1上发表。双方计划在2025年继续或启动临床概念验证研究。。

“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.

阿波罗治疗公司（Apollo Therapeutics）首席执行官理查德·梅森（Richard Mason）博士表示：“这项交易进一步实现了我们的战略，即在主要商业适应症中产生大量多样化的临床项目组合，真正满足了医疗需求。”。“迄今为止，Sunshine Lake完成的APL-18881（HEC88473）的开发强烈表明，这种新型FGF21和GLP-1双受体激动剂在多种疾病领域具有临床潜力，这些个体机制已被证明具有强大的临床疗效，我们预计这两种不同的作用机制之间可能会产生协同作用。

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.”.

我们很高兴能与阳光湖的世界级团队和卓越的研发能力合作，他们将在中国开发一系列适应症的APL-18881（HEC88473），同时我们专注于中国以外的开发。”。

“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.

阳光湖制药董事会主席张英军博士表示：“我们对此次合作感到兴奋，并期待着与阿波罗在这一激动人心的项目上密切合作。”。“HEC88473是阳光湖最早的新型生物制剂项目之一，以其不同的作用机制显示出强大的治疗潜力。

Apollo’s vision and clinical expertise will undoubtedly help accelerate the delivery of this novel treatment to patients.”.

阿波罗的远见和临床专业知识无疑将有助于加速向患者提供这种新型治疗。”。

About Apollo Therapeutics Group Limited

关于阿波罗治疗集团有限公司

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 Therapeutics是一家总部位于英国和美国的投资组合生物制药公司。Apollo将生物学和基础医学研究的突破转化为创新的新药。该公司拥有20多个积极的治疗计划，其中五个正在临床开发中，该公司正在建立一个大型，多样化的新型治疗组合，具有不相关的风险。

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.

阿波罗拥有一个可扩展的研发平台，这是由于六所世界顶尖大学和研究机构在生物学和基础医学研究方面取得了前所未有的突破。该公司还在许可证或收购临床阶段项目中具有独特的见解和协同作用。

Backed by leading specialist health care investors, Apollo has raised a total of over $450m since its inception. Visit www.apollotx.com.

在领先的专业医疗保健投资者的支持下，阿波罗自成立以来共筹集了4.5亿美元。访问www.apollotx.com。

About Sunshine Lake Pharma Limited

关于阳光湖制药有限公司

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.

阳光湖制药是一家垂直整合的制药公司，专注于创新药物的研发，生产和商业化，并在改性新药，仿制药和生物仿制药领域拥有一席之地。自2003年成立以来，阳光湖已经建立了业界领先的研发平台、制造设施和全球销售网络。

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..

该公司的战略目标是传染病、肿瘤学和慢性代谢疾病，产品在中国、美国和欧洲推出。阳光湖制药的使命是在全球范围内提供创新、高质量和负担得起的药物。。

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..

1林湘佳，姜瑜，林洛，洪章，坎谢伯，c，余玉鹏，洪陈娜，李倩倩，小平，c，余磊，庄斌，林峰，c，燕华丁加，2023年。新型GLP-1/FGF21双重激动剂HEC88473在非酒精性脂肪肝病2型糖尿病患者中的安全性，药代动力学和药效学：一项随机，双盲，安慰剂对照，1b/2a期多剂量递增研究。。