2025年2月6日，复宏汉霖（2696.HK）宣布与Dr. Reddy’s Laboratories的全资子公司Dr. Reddy’s Laboratories SA就公司自主开发的在研达雷妥尤单抗生物类似药HLX15（重组抗CD38全人单克隆抗体注射液）签署授权许可协议。Dr. Reddy’s Laboratories（及其子公司以下统称为 “Dr. Reddy’s” ）于孟买证券交易所（股份代号：500124）、 印度国家证券交易所（股份代号：DRREDDY）、纽约证券交易所（股份代号：RDY）、印度国家证券交易所国际金融服务中心（股份代号：DRREDDY）上市。Dr. Reddy’s将拥有HLX15皮下注射和静脉注射两种剂型在美国及42个欧洲国家和地区的独家商业化权益，共计覆盖43个国家和地区。
根据协议条款，复宏汉霖将负责HLX15的研发、生产以及商业化供应，并从交易中获得1.316亿美元，其中3300万美元为交易首付款。此外，复宏汉霖还将获得基于产品年度净销售额的分级特许权使用费。Dr. Reddy’s是一家全球性制药公司，其业务遍布全球逾75个国家和地区。此次复宏汉霖携手Dr. Reddy’s，将加速推进公司产品进入并渗透欧美市场，为当地患者带来更多治愈可能。
此次与Dr. Reddy’s就HLX15达成合作，是我们响应全球健康需求、提升先进生物药可及性的重要实践。Dr. Reddy’s长期深耕肿瘤学，秉持‘健康不能等待’理念，致力于让患者更快地获得可负担得起的优质药物，这与复宏汉霖以患者为中心、聚焦临床需求的研发初心不谋而合。我们深信，这一合作的达成将进一步加强双方在肿瘤治疗领域的全球市场竞争力，助力我们造福全球更多患者。
很高兴携手Dr. Reddy’s，这是复宏汉霖拓展全球合作伙伴网络的关键一步。凭借复宏汉霖在生物类似药方面强大的产品研发、前沿的生产与质量体系的专业能力，以及Dr. Reddy’s在生物类似药的全球商业化网络方面积淀了深厚经验和资源，我们相信此次合作能够充分发挥双方所长，为欧美市场带来更多高质量可负担的治疗方案。
Dr. Reddy’s首席执行官Erez Israeli
我们很高兴与复宏汉霖达成合作，将这款达雷妥尤单抗生物类似药推向美国和欧洲市场。多年来，我们已打造了一系列生物类似药产品，并在多个新兴市场实现销售。此次与复宏汉霖的最新合作，将进一步拓展我们在生物类似药领域监管市场布局。此外，肿瘤一直是我们重点聚焦的治疗领域。我们期待凭借在这些市场强大的商业化实力，确保患者能够获得一流的治疗方案和可负担的治疗选择。
HLX15是复宏汉霖自主开发的一款全人源抗CD38 IgG1κ单克隆抗体，是达雷妥尤单抗Darzalex®和Darzalex Faspro®*的生物类似药候选药物。Darzalex®和Darzalex Faspro®已被获批用于治疗多发性骨髓瘤（Multiple myeloma，MM）。参照中国、欧盟和美国的生物类似药技术指导原则的要求，复宏汉霖采用逐步递进、比对及相似性评价原则对HLX15进行开发。基于分析相似性研究和临床前研究，HLX15与原研达雷妥尤单抗被认为具有可比性。2024年6月，HLX15（重组抗CD38全人单克隆抗体注射液）的I期临床研究（NCT05679258）已成功完成，达到了所有预设的研究终点，研究结果表明，HLX15与美国、欧盟和中国市售的原研达雷妥尤单抗的药代动力学特征相似，安全性和免疫原性均可比。目前，HLX15的疗效比对研究正在推进中。
*Darzalex®和Darzalex Faspro®为强生公司（Johnson & Johnson）的注册商标
Dr. Reddy’s Laboratories Ltd.是一家总部设在印度海得拉巴的全球性制药公司，并于纽约证券交易所（股份代号：RDY）、印度国家证券交易所（股份代号：DRREDDY）、印度国家证券交易所国际金融服务中心（股份代号：DRREDDY）及孟买证券交易所（股份代号：500124）上市。Dr. Reddy’s Laboratories Ltd.成立于1984年，致力于提供可负担的创新药物。在“健康不能等待”的宗旨下，Dr. Reddy’s Laboratories Ltd.提供一系列的原料药、仿制药、品牌仿制药、生物类似药及非处方药品，主要市场包括美国、印度、俄罗斯及独联体区域国家、中国、巴西、南非及欧洲。作为一家拥有深厚科学底蕴并在行业内屡创先河的公司，我们始终着眼于未来，持续投资于具有前瞻性的业务。作为可持续发展和ESG行动的早期践行者，我们于2004年发布了首份可持续发展报告。现阶段我们的ESG目标致力于在环境保护、患者药品可及性与可负担性、多元化以及公司治理等方面树立行业标杆。如需了解更多相关信息，请访问：www.drreddys.com。
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，已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别获中国药监局、美国FDA和欧盟EMA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，公司商业化生产基地已相继获得中国、欧盟和美国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50多个分子，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。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧盟商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就16个产品在全球范围内开展30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。
Henlius and Dr. Reddy’s Ink Licensing Deal for HLX15 (investigational daratumumab biosimilar) Expansion in Europe and the U.S.
Shanghai, China, February 6, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license agreement with Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy’s”) for the company's independently developed investigational daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection. Dr. Reddy’s will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States (U.S.).
Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including a $33 million upfront payment and additional milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s is a global pharmaceutical company, operating in over 75 countries across the globe. Through a partnership with Dr. Reddy’s, Henlius aims to boost the growth and reach of its products in the European and U.S. markets, providing local patients with enhanced treatment options.
“This collaboration with Dr. Reddy’s on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “Dr. Reddy’s has a long-standing dedication to oncology, driven by the purpose that ‘Good Health Can’t Wait’, and is committed to timely access to affordable and high-quality medicines, which complement Henlius’ focus on addressing unmet medical needs in research and development. We are confident that this partnership will enhance the global market competitiveness of both organizations in oncology treatment, ultimately allowing us to reach and support more patients around the world.”
“We are pleased to join hands with Dr. Reddy’s, signifying a pivotal moment in Henlius’ journey to expand our global partner network,” said Ping Cao, Chief Business Development Officer and SVP of Henlius, “Henlius' robust product development capabilities in biosimilars, along with its advanced manufacturing and quality systems that meet global standards, paired with Dr. Reddy’s vast experience and resources in the global commercialization of biosimilars, positions this collaboration to effectively harness the strengths of both organizations. Together, we aim to deliver more high-quality and affordable treatment options to the U.S. and European markets.”
Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said: “We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the U.S., and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options.”
HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to Darzalex® & Darzalex Faspro®* which are indicated for the treatment of multiple myeloma. In accordance with the biosimilar guidelines of NMPA, EMA, and USFDA, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered comparable based on analytical similarity assessment and pre-clinical studies. In June 2024, the Phase 1 clinical study (NCT05679258) of HLX15 was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab. Comparative efficacy studies are currently underway.
*Darzalex® & Darzalex Faspro® are registered trademarks of Johnson & Johnson.
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. 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. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in the EU), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.
媒体：PR@Henlius.com
投资者：IR@Henlius.com
