复宏汉霖与Palleon达成战略合作，共同开发双功能唾液酸酶融合蛋白疗法
Palleon 和复宏汉霖将共同开发一款双功能抗HER2 抗体-唾液酸酶融合蛋白和一款待共同设计的双功能抗体-唾液酸酶融合蛋白；
复宏汉霖获得两款产品在中国（包括港澳台地区）的独家许可；Palleon 则保留其他全球区域的权利；
Palleon 将获得首付款及可达1.965 亿美元的里程碑付款。
上海和马萨诸塞州沃尔瑟姆，2022年6月28日，复宏汉霖（2696.HK）与Palleon Pharmaceuticals Inc.（“Palleon”）宣布达成战略合作，共同开发和商业化两款双功能抗体-唾液酸酶融合蛋白。Palleon是一家领先的应用糖免疫疗法治疗癌症和炎症性疾病的公司，这两款合作产品通过其酶-抗体聚糖配体编辑（Enzyme-Antibody Glyco-Ligand Editing, EAGLE）平台设计，包括一款Palleon的现在在临床前开发阶段的双功能抗HER2抗体-唾液酸酶融合蛋白，以及一款将基于复宏汉霖针对肿瘤相关抗原（tumor-associated-antigen, TAA）靶点开发的抗体设计的双功能唾液酸酶融合蛋白。
Palleon 自主开发的EAGLE 平台通过酶促反应去除肿瘤和免疫细胞表面的唾液酸，解除其诱导的免疫抑制作用，从而增强抗肿瘤免疫能力。EAGLE 平台可将蛋白工程改造过的人类唾液酸酶与抗体结构域进行基因融合重组为融合蛋白，已设计研发出多种唾液酸酶融合蛋白，包括一款已进入临床阶段的双唾液酸酶以及各种双功能抗体-唾液酸酶融合蛋白。此次合作的双功能抗HER2 抗体-唾液酸酶融合蛋白是Palleon 研发管线中进度最快的产品之一，即将进入临床试验支持性研究，该产品在肿瘤细胞表面中至高表达唾液酸聚糖的HER2 低表达和HER2 高表达肿瘤中均显示出治疗潜力。
复宏汉霖在生物药领域积累了先进技术和丰富资源，已建成一体化生物制药平台，创新能力贯穿研发、生产及商业运营全产业链，前瞻性布局了一个多元化、高质量的产品管线，覆盖众多市场广阔的肿瘤相关抗原（tumor-associated-antigen, TAA）靶点。公司协同中国和美国的创新中心和全球临床开发团队，以抗体技术为核心，结合新型偶联技术，探索多种形式的抗体偶联物，持续构建更加丰富的创新管线。复宏汉霖覆盖从细胞株构建至商业化生产的生物药工艺开发和生产全流程能力，有效支持公司产品在全球的商业化。
Palleon首席执行官兼创始人Jim Broderick医学博士表示：“我们很高兴与复宏汉霖合作开发和扩展Palleon 的产品线，以实现双功能唾液酸酶成为多种癌症的治疗选项的潜力。复宏汉霖在为中国患者提供开拓性和可负担的药物方面拥有良好的实践，此次合作的两款候选药物的开发将受益于复宏汉霖的专业知识和能力。”
根据协议条款，Palleon 将主导两款产品的早期研究，双方将共同负责临床前和全球临床开发并分担相应费用。复宏汉霖将拥有两款产品在中国（包括香港、澳门及台湾地区）的独家许可，Palleon将保留其它的全球区域的权利。针对合作开发的第二款产品，复宏汉霖将根据其提供的抗体技术在Palleon 区域授予Palleon 独家许可，并有权根据该许可享有Palleon 区域的销售分成。Palleon 将获得首付款，以及不超过1.965 亿美元的研发及商业化里程碑付款，此外还将享有在复宏汉霖区域的销售分成。
复宏汉霖董事长、执行董事兼首席执行官张文杰先生表示：“复宏汉霖一直以来致力于为患者提供可负担的创新生物药。公司以抗体技术为核心，结合新型偶联技术，着力探索多种形式的抗体偶联分子，此次与 Palleon 的合作运用了Palleon 创新的EAGLE 平台，将成为复宏汉霖临床前创新管线的有益补充，并进一步加速我们为临床需求尚未被满足的患者提供突破性治疗方案的进程。”
关于Palleon Pharmaceuticals
Palleon Pharmaceuticals 是一家领先的生物技术公司，致力于开发利用糖介导的免疫调节以治疗癌症和炎症性疾病。该公司的专有平台支持新靶点发现，患者选择和以免疫系统功能障碍为特征的破坏性疾病的新型疗法的开发。Palleon 在肿瘤疾病领域的主要项目 E-602 是肿瘤和免疫细胞上的免疫抑制性唾液聚糖的同类第一酶降解剂，目前处于临床 I/II期研究阶段(NCT05259696)。
公司官网：www.palleonpharma.com
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在欧洲上市1款产品，13项适应症获批，2个上市注册申请获得中国药监局受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，上海徐汇基地已获得中国和欧盟药品GMP认证，松江基地（一）也已获得中国GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、10个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
Palleon Pharmaceuticals and Henlius Enter into Strategic Collaboration to Develop Bifunctional Sialidase Therapies
Palleon and Henlius to co-develop Bifunctional HER2-Sialidase and a second bifunctional sialidase to be jointly designed -
Henlius received exclusive license for two products in China (including Hong Kong, Macau, and Taiwan); Palleon retains all other global rights -
Palleon receives upfront payment and is eligible for up to $196.5 million in milestone payments -
WALTHAM, Mass. & SHANGHAI, June 28, 2022 — Palleon Pharmaceuticals Inc., a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, today announced a strategic collaboration with Shanghai Henlius Biotech, Inc. (2696.HK) to develop and commercialize two bifunctional sialidase programs from Palleon’s EAGLE (Enzyme-Antibody Glyco-Ligand Editing) immuno-oncology platform, including Palleon’s Bifunctional HER2-Sialidase now in preclinical development and a second bifunctional sialidase to be developed with a proprietary target provided by Henlius.
Palleon’s EAGLE platform potentiates antitumor immunity by enzymatically removing immunosuppressive sialic acids from tumor and immune cell surfaces. The EAGLE platform is created by genetic fusion of an engineered human sialidase with antibody domains, and includes clinical stage Bi-Sialidase, as well as various bifunctional sialidases comprising a sialidase together with a targeting arm. As one of Palleon’s most advanced bifunctional sialidases, the Bifunctional HER2-Sialidase has shown the potential to treat both HER2-low and HER2-high expressing tumors with modest to high levels of tumor surface sialoglycans, and the candidate is on the verge of entering IND-enabling studies.
Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the entire product life cycle of R&D, manufacturing, and commercialization, expediting a diversified and robust pipeline covering tumor-associated-antigen (TAA) targets with high market potential. Fully leveraging its experience in biologics development and harnessing the power of innovation, Henlius implements its proprietary antibody and novel conjugating technologies to explore various forms of antibody conjugates to continue building a more diverse innovative pipeline by synergizing its innovation centers in China and the US, as well as its global clinical development teams. Henlius has process development capabilities that span the product lifecycle, starting with cell line development and continuing through commercial manufacturing, effectively supporting the commercialization of its products around the world.
“We’re very pleased to partner with Henlius to develop and expand Palleon’s pipeline to realize the potential of bifunctional sialidases as a treatment option for a wide range of cancer types,” said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. “Henlius has a strong track record of providing groundbreaking and cost-effective medicines for patients in China, and the development of these two therapeutic candidates will benefit from their expertise and capabilities.”
Under the terms of the agreement, Palleon will perform research and the parties will then share preclinical and global clinical development responsibilities and costs for the Bifunctional HER2-Sialidase and a second bifunctional sialidase. Henlius has an exclusive license to the two investigational therapies in China (including Hong Kong, Macau, and Taiwan), while Palleon retains all other global rights and, for the second product, receives a royalty-bearing exclusive license to Henlius’ antibody technology outside China. Palleon received an upfront payment and is further eligible to receive up to $196.5 million in certain predetermined R&D and commercial milestones, in addition to royalties upon Henlius commercialization in China.
“We strive to offer innovative and affordable biologics to all patients,” said Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius. “Henlius is currently exploring various forms of antibody conjugates utilizing our proprietary antibody expertise and novel conjugating technologies. Together with Palleon’s cutting-edge EAGLE immuno-oncology platform, we believe that this collaboration will complement Henlius’ innovative early-stage pipeline and accelerate our progress of providing breakthrough treatments for patients with unmet medical needs.”
About Palleon Pharmaceuticals
Palleon Pharmaceuticals is the leading biotechnology company developing drugs that harness glyco-immunology to treat cancer and inflammatory diseases. The company’s proprietary platforms enable new target discovery, patient selection, and the development of novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, E-602, is a first-in-class enzymatic degrader of immunosuppressive sialoglycans on tumors and immune cells which is now being evaluated in a Phase 1/2 study (NCT05259696).
www.palleonpharma.com
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with a vision to provide high-quality, affordable, and innovative biologic medicines to patients worldwide, with a specific focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, Henlius has launched five products in China and one in Europe, and has had thirteen indications approved worldwide. In addition, Henlius has had two New Drug Applications (NDA) accepted for review in China.
Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the whole product life cycle, including R&D, manufacturing and commercialization. Henlius has established global innovation centers and Shanghai-based manufacturing facilities aligned with global Good Manufacturing Practice (GMP) standards. These facilities include the Xuhui Plant, which has received Chinese GMP and EU GMP certification, and the Songjiang First Plant, which has received Chinese GMP certification.
Henlius has actively built a diversified and high-quality product pipeline covering over twenty innovative monoclonal antibodies (mAbs). In addition, Henlius has continued to explore immunooncology combination therapies with its proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone of this pipeline. Henlius has also launched HANLIKANG (rituximab), the first-ever China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved in both China and Europe, HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab). In addition, Henlius’ innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, and its NDAs for the treatment of squamous non-small cell lung cancer and extensive small cell lung cancer (ES-SCLC) are under review. Henlius has conducted over twenty clinical studies for twelve products and ten combination therapies.