Hyaluronidase Recombinant Human

SAN DIEGO and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 17, 2025 /PRNewswire/ -- Merus N.V. (Nasdaq: MRUS) ("Merus"), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), and Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme"), a leader in subcutaneous drug delivery solutions, today announced they have entered into a global non-exclusive collaboration and license agreement. Under the collaboration, Merus has licensed Halozyme's ENHANZE® drug delivery technology, for the development and potential commercialization of subcutaneous administration of petosemtamab, an EGFR x LGR5 bispecific antibody. "Petosemtamab continues to show encouraging results in the clinical studies across numerous solid tumor cancers and has the potential to become a first and best in class treatment in head and neck cancer and beyond. We are proud to collaborate with Halozyme and look forward to working closely with their team on a subcutaneous administration," said Peter Silverman, Chief Operating Officer, General Counsel of Merus. "We are excited to collaborate with Merus to advance treatment options for patients with r/m HNSCC and other potential indications," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "This collaboration represents a new opportunity for our ENHANZE® technology to improve treatment efficiency and enhance the patient treatment experience. Together, we aim to accelerate innovation for patients and healthcare providers." Under the terms of the agreement, Merus will make an upfront payment to Halozyme, and potential future milestone payments related to commercial and sales attainment, if approved. Halozyme will also be entitled to up to low-mid single digit royalties on net sales of petosemtamab formulated with the ENHANZE® technology during the royalty term. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter. Ab out Merus N.V. Merus is an oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus' website and LinkedIn. Merus Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding our belief that petosemtamab' results in the clinical studies of numerous solid tumor cancers; petosemtamab's potential to become a first and best in class treatment in head and neck cancer and beyond; the future performance under the global non-exclusive collaboration and license agreement with Halozyme and development of subcutaneous administration of petosemtamab; the timing of such development; the opportunity of the ENHANZE® technology to improve treatment efficiency and enhance the patient treatment experience; the potential future milestone payments or royalties related to commercial and sales attainment, if approved; the clinical development of our clinical candidates, including petosemtamab, future clinical trial results or interim data, clinical activity and safety profile, and development plans in the on-going trials. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended September 30, 2025, filed with the Securities and Exchange Commission, or SEC, on October 31, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Multiclonics®, Biclonics®, Triclonics®, and ADClonics® are registered trademarks of Merus N.V. Halozyme Forward-Looking Statements In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden and improving the treatment experience for patients. These forward-looking statements also include statements regarding the product development and commercialization efforts of Halozyme's ENHANZE® partner (including the potential regulatory approval and launch of ENHANZE® products as a result of such efforts and the potential future market opportunity for such products) and Halozyme's potential receipt of an upfront payment and payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue" and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including risks and uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized and the potential future market for such products, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Investor and Media Inquiries Sherri Spear Merus N.V. SVP Investor Relations and Strategic Communications 617-821-3246 s.spear@merus.nl Kathleen Farren Merus N.V. Director Investor Relations and Corporate Communications 617-230-4165 k.farren@merus.nl Tram Bui Halozyme VP, Investor Relations and Corporate Communications 609-359-3016 tbui@halozyme.com View original content to download multimedia:https://www.prnewswire.com/news-releases/merus-and-halozyme-enter-global-collaboration-and-license-agreement-to-develop-subcutaneous-formulation-of-petosemtamab-302616859.html SOURCE Halozyme Therapeutics, Inc.

展位/招商合作：黄女士13245277589（微信同号） 扫码加入资源共享群 商务合作 罗氏 PD-L1 单抗阿替利珠单抗皮下注射剂获 NMPA 批准上市。作为国内首款进口 PD-(L) 1 皮下注射剂，这款 “明星药” 的落地不仅为癌症患者带来用药革命，更预示着免疫治疗领域 “剂型革新竞赛” 已进入白热化阶段。 打破输液桎梏：7 分钟完成治疗，患者体验实现质的飞跃 阿替利珠单抗并非新药，但其皮下注射剂型的获批堪称 “老树开新花”，核心突破在于给药方式的颠覆性升级。 注射效率飙升，传统静脉注射需 30-60 分钟，皮下注射仅需 7 分钟，大幅缩短患者就医时间，缓解医院输液资源紧张压力。 疗效安全性双保障，III 期临床数据显示，皮下注射与静脉注射的中位总生存期（10.7 个月 vs10.1 个月）、中位无进展生存期（2.8 个月 vs2.9 个月）基本一致，不良事件发生率相近且无新安全信号。 患者偏好度显著提升，超 70% 患者更倾向选择皮下注射剂型，85.8% 的使用者对其表示满意，大幅改善长期治疗的依从性。 作为全球销售额 2023 年就达 41.98 亿美元的重磅产品，阿替利珠单抗皮下剂型的上市，将进一步巩固其在免疫治疗领域的市场地位。 技术破局：Enhanze 平台加持，罗氏的 “剂型革新密码” 这款皮下注射剂的成功，离不开罗氏与 Halozyme Therapeutics 的技术合作，其核心是重组人透明质酸酶 PH20（rHuPH20）的应用。 酶解技术突破吸收瓶颈，rHuPH20 可降解皮下组织中的透明质酸，拓宽药物扩散通道，实现大分子单抗的高效皮下吸收，解决了传统皮下注射生物利用度低的难题。 平台化布局构建壁垒，罗氏依托该技术在肿瘤领域布局 9 个皮下注射抗体药项目，其中 7 款已获批上市，此前 HER2 药物帕妥珠曲妥珠单抗注射剂（Phesgo）2024 年销售额达 19.72 亿美元，同比大增 58%，验证了技术平台的商业价值。 全球同步推进抢占先机，该剂型 2024 年 9 月先于英国全球首批，随后快速登陆欧盟、加拿大、美国，国内从 2024 年 7 月受理到 2025 年 11 月获批，审批效率凸显，彰显中国市场在全球新药布局中的重要性。 行业震动：PD-(L) 1 剂型竞赛升级，专利悬崖下的破局之道 阿替利珠单抗皮下剂型的获批，正搅动全球 PD-(L) 1 市场的竞争格局，剂型革新已成为药企应对专利悬崖、延长产品生命周期的核心策略。 跨国药企集体入局，默沙东 K 药、BMS O 药的皮下剂型已陆续在海外获批，辉瑞 PD-1 皮下注射剂 Sasanlimab 的 III 期临床数据积极，海外巨头纷纷加码布局。 国内企业紧追不舍，百济神州、君实生物、恒瑞医药等头部药企均已推进自家 PD-1 单抗的皮下剂型开发，恒瑞医药更同步布局 PD-L1 阿得贝利单抗皮下注射剂，本土企业正从跟跑向并跑加速。 赛道拥挤催生差异化竞争，目前全球在研 PD-(L) 1 皮下制剂项目超十余款，企业需在给药频率、适用人群、联合疗法等方面挖掘差异，避免同质化竞争。 对于面临专利到期压力的成熟 PD-(L) 1 产品而言，皮下剂型不仅能延长独占期，更能通过给药便捷性抢占基层市场，打开增长新空间。 未来展望：皮下注射成免疫治疗新主流？三大趋势值得关注 阿替利珠单抗皮下剂型的上市，为免疫治疗领域带来多重行业启示，未来三大趋势或将重塑市场格局。 剂型革新常态化，从静脉注射到皮下注射、口服制剂，免疫治疗药物正朝着 “更便捷、更友好” 的方向发展，给药方式将成为产品核心竞争力之一。 基层市场渗透加速，皮下注射无需专业输液设备，更适合基层医疗机构推广，有望推动免疫治疗从大三甲向县域医院下沉，进一步扩大患者覆盖范围。 支付体系面临新挑战，虽然皮下剂型能降低医院输液成本，但新药定价与医保准入仍将是市场推广的关键，企业需平衡创新价值与可及性。 随着技术迭代与竞争加剧，PD-(L) 1 领域的 “下半场” 竞争已从靶点争夺转向剂型、疗效、可及性的综合比拼。罗氏此次率先布局国内市场，无疑为行业树立了新标杆。 免责声明：网上信息整理，若有涉及侵权请予以告知，我们会尽快在24小时内删除相关内容 资源对接、沟通交流 找项目、找供应商、找资源 1V1供需对接专员服务 群聊: 资源共享群 仅为公众号粉丝供需交流群 添加公众号专员加入 活动推荐 找批文、找项目、找CRO/CMO、找场地 欢迎会议现场深度对接交流~ 点击了解详情 ▼ 展位/招商合作：黄女士13245277589（微信同号） 【关于药融圈】 【药融圈PRHub】流量渠道覆盖150万+垂直用户，已完成了百余场线下千人规模的生物医药研发类会议，涵盖创新药，改良型新药，仿制药，MAH，合成生物学等领域，以及生物医药上下游研发到产业端全覆盖的【中国制药工业博览会 CMC-CHINA】，服务了百余家上市/独角兽/生物技术/制药企业。 【生态圈合作伙伴· CXO企业】 青木制药、FLAMMA、汉康医药、国标医药、慧聚药业、华威医药、华仁医学、美迪西、成都海通、杭州澳亚、天津信诺、瀚合瑞、四川科伦、汇宇制药、广东星昊、中肽生化、健元医药、优尼特尔、兄弟药业、赛业生物、康日百奥、珠海亿胜、倍特药业、艾奇西医药、常熟神隆、上海玉函、华阳制药、常州阳光、湖北澳格森、杭州肽佳、世纪迈劲、南京哈柏、宏昇药业、普利制药、大连美创、皓元/药源、昂博生物、深圳药欣、亚邦生缘、星诺医药 【生态圈合作伙伴· 制药装备&仪器】 深圳华溶、ATS安拓思、齐蓁科技、赛默飞、安捷伦、黄海药检、晓东宜健、德衡纳米、河北华胜、莱顿科学、思勃分离、泰灵佳、相流科技 【生态圈合作伙伴·综合服务企业】 桐晖医药、仅三生物、壹生科、恩泰医药、STD标准药物、斯坦德、欣诺科催化、双峰格雷斯海姆、嘉树医疗、齐鲁MAH创新创业基地、青岛明月海藻、盛德伟业、诚利恩、泰矶林、青松医药 点分享 点收藏 点在看 点点赞