CR-003 (Crescent)

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ('Kelun-Biotech', 6990.HK), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, and Crescent Biopharma, Inc. (“Crescent”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that the companies have entered into a strategic partnership to develop and commercialize oncology therapeutics, including novel combinations.. 四川科伦博泰生物医药股份有限公司（“科伦博泰”，6990.HK），专注于创新生物药物和小分子药物的研发、生产、商业化及全球合作，与新月生物制药公司（“新月生物”）（纳斯达克：CBIO），一家致力于快速推进癌症患者下一代疗法的生物技术公司，今日宣布双方已达成一项战略合作伙伴关系，以开发和商业化包括新型组合在内的肿瘤治疗药物。The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026.. 该合作涉及Crescent公司的CR-001，一种PD-1 x VEGF双特异性抗体，以及科伦生物技术公司的SKB105，一种靶向整合素β-6（ITGB6）的抗体药物偶联物（ADC），带有拓扑异构酶载荷。这两种候选药物均正在开发用于治疗实体瘤，并预计于2026年第一季度进入1/2期单药临床试验。Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China. 根据合作协议的条款，Crescent 已授予科伦生物技术在大中华区（包括中国大陆、香港、澳门和台湾）独家研究、开发、制造和商业化 CR-001 的权利。此外，科伦生物技术还授予 Crescent 在美国、欧洲以及大中华区以外所有市场独家研究、开发、制造和商业化 SKB105 的权利。The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105. Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.. 该合作包括这些候选药物作为单药疗法的开发，以及CR-001与SKB105联合使用的评估。Crescent和科伦生物都有权独立开发CR-001与其他药物的组合，包括CR-001与其专有的ADC管线资产的组合。Dr. Michael Ge, chief executive officer of Kelun-Biotech, said, “We are pleased to have entered into a partnership with Crescent for two innovative assets, CR-001 and SKB105. This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 in the global market, bolstering its potential commercial value and our global collaboration network. 科伦博泰首席执行官葛明博士表示：“我们很高兴与新月公司就两项创新资产CR-001和SKB105达成合作。此次合作通过引入CR-001进一步完善并增强了我们差异化的肿瘤学管线，同时也使我们能够推动SKB105在全球市场的开发，提升其潜在商业价值并巩固我们的全球合作网络。”Our creative global partnership combines the capabilities of both companies to explore novel monotherapies and combination strategies for tumor treatments with SKB105 and CR-001. By leveraging China’s abundant clinical resources and execution efficiency, we aim to expedite clinical development while rigorously maintaining the highest global standards. 我们的创新全球合作伙伴关系结合了两家公司的能力，探索 SKB105 和 CR-001 在肿瘤治疗中的新型单药疗法和联合策略。通过利用中国丰富的临床资源和执行效率，我们旨在加速临床开发，同时严格保持全球最高标准。We believe this partnership creates a powerful synergy to maximize the potential of these two drug candidates for the treatment of patients in both China and the rest of the world.”. 我们相信，这一合作将创造强大的协同效应，最大程度地挖掘这两种候选药物在治疗中国乃至全球患者方面的潜力。"“We are thrilled to be partnering with Kelun-Biotech, an established leader in the development and commercialization of ADCs who shares our commitment to bringing next generation therapeutics that can improve outcomes for people living with cancer,” said Joshua Brumm, chief executive officer of Crescent. “我们非常高兴能与科伦博泰合作，他们是ADC开发和商业化的知名领导者，与我们一样致力于带来能够改善癌症患者预后的下一代疗法，”新月公司首席执行官Joshua Brumm表示。“This collaboration expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001, which has the potential to be a foundational backbone therapy. We look forward to working with Kelun-Biotech to drive innovative therapeutics with the potential to address multiple tumor types and transform cancer care.”. “此次合作通过新增SKB105扩展了我们的产品线，进一步推动了我们在投资组合中推进多种模式的战略，并加速了我们与CR-001协同组合的研发工作，CR-001有潜力成为基础骨干疗法。我们期待与科伦博泰合作，推动具有解决多种肿瘤类型潜力的创新治疗方案，并改变癌症治疗方法。”Under the collaboration, Kelun-Biotech will receive an upfront payment of US$80 million from Crescent and is also eligible to receive additional milestones of up to US$1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105. Kelun-Biotech is also eligible to receive additional payment from Crescent if Crescent undergoes a near-term change of control or enters into a sublicense agreement with a third party. 根据合作协议，科伦博泰将获得新月公司8000万美元的首付款，并有资格获得高达12.5亿美元的额外里程碑付款，以及SKB105净销售额的分级中个位数到低两位数的特许权使用费。如果新月公司在近期发生控制权变更或与第三方达成分许可协议，科伦博泰还有资格获得额外付款。Crescent will receive an upfront payment of US$20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$30 million, plus tiered low to middle single digit royalties on net sales of CR-001.. 新月公司将从科伦生物技术公司获得2000万美元的预付款，并且还有资格获得高达3000万美元的额外里程碑付款，以及CR-001净销售额的分级低至中个位数的特许权使用费。About CR-001 (also known as SKB118) 关于CR-001（也称为SKB118）CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. CR-001 是一种四价双特异性抗体，正在开发用于治疗实体瘤，它通过阻断 PD-1 和 VEGF，结合了肿瘤学中两种互补且经过验证的机制。PD-1 检查点抑制旨在恢复 T 细胞识别和摧毁肿瘤细胞的能力，而阻断 VEGF 则旨在减少对肿瘤细胞的血液供应并抑制肿瘤生长。In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with antibody-drug conjugates (ADCs). 在临床前研究中，CR-001 在 VEGF 存在的情况下表现出与 PD-1 结合增加和信号阻断的协同药理作用，并显示出强大的抗肿瘤活性。CR-001 的抗 VEGF 活性还可能使肿瘤部位的血管正常化，这有望提高联合疗法的定位和效果，例如将 CR-001 与抗体药物偶联物 (ADC) 联合使用。A global Phase 1/2 trial of CR-001 in patients with solid tumors is anticipated to commence in the first quarter of 2026.. 预计CR-001在实体瘤患者中的全球1/2期试验将于2026年第一季度开始。About SKB105 (also known as CR-003) 关于SKB105（也称为CR-003）SKB105 is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. SKB105 是一种差异化的抗体药物偶联物 (ADC)，靶向整合素 beta-6 (ITGB6)，搭载拓扑异构酶 1 抑制剂有效载荷。ITGB6 在许多实体瘤中过度表达，但在大多数正常组织中几乎没有表达，从而可能降低系统毒性和脱靶效应的风险。SKB105 由抗 ITGB6 的全人源 IgG1 单克隆抗体组成，通过稳定且经过临床验证的可裂解连接子进行偶联。The molecule incorporates proprietary Kthiol® irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models. A Phase 1/2 clinical trial of SKB105 in patients with solid tumors is anticipated to commence in the first quarter of 2026.. 该分子采用了专有的Kthiol®不可逆偶联技术，旨在提高稳定性并增强肿瘤特异性载荷递送，同时减少不良反应。SKB105在临床前模型中展现出良好的疗效、安全性和药代动力学（PK）特性。预计SKB105针对实体瘤患者的I/II期临床试验将于2026年第一季度启动。About Kelun-Biotech 关于科伦生物技术Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. 科伦博泰（6990.HK）是科伦药业（002422.SZ）的控股子公司，专注于创新生物药物和小分子药物的研发、生产、商业化及全球合作。科伦博泰重点关注实体瘤、自身免疫、炎症及代谢疾病等重大疾病领域，并致力于构建全球化的药物开发与产业化平台，以满足中国及全球未被满足的医疗需求。Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. 科伦博泰致力于成为创新药物领域的全球领先企业。目前，科伦博泰拥有30余项重点创新药物项目在研，其中4项已获批上市，1项处于NDA阶段，10余项处于临床阶段。Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.. 科伦博泰已建成全球领先水平的自主ADC和新型DC平台OptiDC™，已有2项ADC项目获批上市，多项ADC和新型DC资产处于临床或临床前研究阶段。欲了解更多信息，请访问https://en.kelun-biotech.com/。About Crescent Biopharma 关于新月生物制药Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. Crescent ’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. 新月生物制药公司的愿景是打造一家世界领先的肿瘤学公司，为癌症患者带来下一波疗法。新月的管线包括其主导项目——PD-1 x VEGF双特异性抗体，以及新型抗体药物偶联物（ADC）。通过利用多种模式和已确立的靶点，新月旨在快速推进可能具有变革性的疗法，无论是作为单一药物还是联合治疗方案的一部分，以治疗多种实体瘤。For more information, visit www.crescentbiopharma.com and follow Crescent on LinkedIn and X.. 欲了解更多信息，请访问 www.crescentbiopharma.com 并在 LinkedIn 和 X 上关注 Crescent。Forward-Looking Statements of Crescent 新月的前瞻性声明Certain statements in this press release, other than purely historical information, may constitute 'forward-looking statements' within the meaning of the federal securities laws, including for purposes of the 'safe harbor' provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Crescent’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the expected benefits or opportunities with respect to the strategic partnership between Crescent and Kelun-Biotech, the ability for each of CR-001 and SKB105 (CR-003) to perform as monotherapies and in combination, the potential for CR-001 to be developed in additional combinations, including with proprietary ADC pipeline assets, the initiation, timing, progress, and results of clinical trials for CR-001 and SKB105 (CR-003), including the initiation of Phase 1/2 monotherapy clinical trials in the first quarter of 2026, Crescent’s expectations regarding the potential benefits of the strategic partnership with Kelun-Biotech, the potential benefits of treatment with and the market for CR-001, and our expectations regarding milestone, royalty, or other payments that could be due under the license agreements. 本新闻稿中的某些声明，除纯历史信息外，可能构成联邦证券法意义上的“前瞻性声明”，包括1995年《私人证券诉讼改革法案》中“安全港”条款的目的。这些前瞻性声明包括但不限于与Crescent的预期、希望、信念、意图或策略有关的明确或隐含声明，涉及其管线和业务的未来，包括不限于Crescent与科伦生物技术之间的战略合作伙伴关系的预期利益或机会，CR-001和SKB105（CR-003）作为单药治疗及联合使用的潜力，CR-001在其他组合中开发的潜力，包括与专有ADC管线资产的组合，CR-001和SKB105（CR-003）临床试验的启动、时间、进展和结果，包括2026年第一季度启动的1/2期单药治疗临床试验，Crescent对与科伦生物技术的战略合作潜在益处的预期，CR-001治疗的潜在益处及其市场，以及我们关于根据许可协议可能到期的里程碑付款、特许权使用费或其他款项的预期。The words 'opportunity,' 'potential,' 'milestones,' 'pipeline,' 'can,' 'goal,' 'strategy,' 'target,' 'anticipate,' 'achieve,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'plan,' 'possible,' 'project,' 'should,' 'will,' 'would' and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does . “机会”、“潜力”、“里程碑”、“渠道”、“能够”、“目标”、“策略”、“靶向”、“预期”、“实现”、“相信”、“考虑”、“继续”、“可能”、“估计”、“期望”、“意图”、“可以”、“计划”、“可能”、“项目”、“应该”、“将”、“会”等词语及类似表达（包括这些词的否定形式或其变体）可能用于识别前瞻性陈述，但没有这些词则不一定如此。Crescent Contact: 新月接触：Amy Reilly 艾米·瑞利Chief Communications Officer 首席通信官amy.reilly@crescentbiopharma.com 艾米·雷利@crescentbiopharma.com617-465-0586 617-465-0586Kelun-Biotech Contact: 科伦生物技术联系方式：klbio_pr@kelun.com klbio_pr@kelun.comSource: crescentbiopharma.com 来源：crescentbiopharma.com

Crescent Biopharma与科伦博泰（Kelun-Biotech）近日宣布达成一项肿瘤领域的双向独家授权及合作开发协议，围绕Crescent的PD‑1×VEGF双特异性抗体CR‑001以及科伦博泰的整合素β6（ITGB6）靶向抗体偶联药物（ADC）SKB105，在大中华区与全球其他市场分别划分开发和商业化权利。 根据披露安排，Kelun将获得CR‑001在大中华区的独家权益，使这款PD‑1×VEGF双特异新药正式“驶向中国”，而Crescent则获得SKB105在大中华区以外地区的独家开发和商业化权利，双方计划在2026年一季度分别启动两款产品的全球及中国Ⅰ\u002FⅡ期单药临床试验。\n\t\n根据双方公告，本次合作聚焦两大候选品种：Crescent开发的CR‑001（PD‑1×VEGF双特异性抗体）以及科伦博泰开发的SKB105（ITGB6靶向ADC，后在Crescent体系内命名为CR‑003）。 协议明确，Crescent授予科伦博泰在大中华区（包括中国内地、香港、澳门及台湾）对CR‑001的独家研发、生产和商业化权利，涵盖临床开发、注册及上市后推广等完整链条。\n\t\n与之对应，科伦博泰则授予Crescent在美国、欧洲以及除大中华区以外其他所有市场对SKB105的独家研发、生产和商业化权利，使这款ITGB6靶向ADC在海外由Crescent主导推动。 协议还包括双方分别在各自主导区域内对CR‑001和SKB105开展单药开发的权利，并在联合开发部分由双方协同推进组合方案。\n\t\n在财务安排方面，Crescent将向科伦博泰支付8000万美元的首付款，作为获得SKB105在大中华区以外市场独家权益的对价。 此外，围绕开发进展、监管批准及销售表现，科伦博泰有资格获得累计最高达12.5亿美元的分期里程碑付款，并在产品上市后按销售额获得分级特许使用费（royalty）。\n\t\n反向来看，科伦博泰将向Crescent支付2000万美元首付款，以获得CR‑001在大中华区范围的独家权益，同时还可在达到特定研发和监管节点时获得最多3000万美元的额外里程碑支付安排，以及基于区域销售表现的分级专利使用费。\n\t\n（字数限制，详细内容请查看图片）\n\t\n#科伦博泰 #生物医药 #生物科技 #ADC药物 #抗体 #免疫治疗 #PD1 #PDL1 #临床试验 #创新药