Casdozokitug

- Oppenheimer Initiates a Robust Process with Global Reach for the Benefit of Shareholders - REDWOOD CITY, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced that it has initiated the process to market and sell the remaining assets associated with the Company’s former biosimilars business (the “Legacy BioSim Assets”). The Company has retained Oppenheimer & Co. Inc. (“Oppenheimer”) to serve as its financial advisor in connection with the sale. Parties interested in the opportunity should direct inquiries to the Oppenheimer contacts listed below. “We are pleased to be working with a bank of Oppenheimer’s caliber to market our legacy biosimilars assets,” said Denny Lanfear, President and Chief Executive Officer of Coherus. “We are confident that this will result in a robust process with global reach to solicit interest and bids for this attractive asset package, for the benefit of our shareholders.” As previously announced on August 17, 2026, the Company declared a special dividend of contingent value rights (each, a “CVR” and collectively, the “CVRs”), which will be distributed pro rata to stockholders of record of the Company’s common stock as of September 30, 2026 (the “Record Date”), with distribution occurring on October 7, 2026. CVR holders are entitled to receive their pro rata share of any net cash proceeds, and the net cash value of any other consideration, actually received by the Company from third parties in connection with the sale of the Legacy BioSim Assets or as licensing fees under any licensing agreement covering the Legacy BioSim Assets. The Legacy BioSim Assets include: • Patents and other intellectual property • Royalties under an existing license agreement • Cell lines • Related materials, including laboratory notebooks, regulatory filings, and product samples To be eligible to receive the CVRs, an investor must be a stockholder of record of the Company’s common stock as of the Record Date. Investors should contact their brokers with any questions regarding their holder status as of the Record Date. Further Information The terms of the CVRs are set forth in, and the CVRs are governed by, the Contingent Value Rights Agreement by and between the Company and Equiniti Trust Company, LLC, as rights agent (the “CVR Agreement”). The Company’s stockholders are also encouraged to review the FAQ concerning the CVRs. The CVR Agreement and the FAQ were included as exhibits to the Form 8-K that the Company filed with the SEC on August 17, 2026, and are available on the Investors & Media – Shareholder Services section of the Company’s website. Stockholders who hold their shares through a broker should note that the crediting of CVRs may be subject to the practices and procedures of such intermediary. In certain circumstances, including where shares are rehypothecated or loaned out, different mechanics may apply, and it is possible that an investor will not receive the CVRs if its shares are rehypothecated or loaned out as of the Record Date. Stockholders are encouraged to contact their broker directly for confirmation and for additional information regarding the timing and manner in which the CVRs will be reflected in their accounts. About Coherus Oncology Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 (“PD-1”) inhibitor, LOQTORZI ® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, prostate, head & neck, colorectal and other cancers. The Company’s strategy is to grow sales of LOQTORZI in R/M Nasopharyngeal Carcinoma while advancing the development of its two pipeline candidates in combination with LOQTORZI, and additionally through strategic partnerships. The Company has global rights to both clinical stage-candidates and plans to execute ex-U.S. licensing deals as the clinical data supports such transactions. Coherus’ innovative oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Tagmokitug is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b/2a studies in patients with advanced solid tumors; including head and neck squamous cell carcinoma, colorectal cancer, gastric, gastro-esophageal-junction, esophageal adenocarcinoma and esophageal squamous cell carcinoma. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first-line hepatocellular carcinoma. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the anticipated distribution of the CVRs, the expected record date and distribution date, the proposed process to market and sell the Legacy BioSim Assets, the timing and outcome of that process, and the value, timing, and amount, if any, of proceeds that may become distributable to CVR holders. These statements are based on Coherus’ current expectations and involve substantial risks and uncertainties that could cause actual results to differ materially, including the risk that no sale or licensing transaction involving the Legacy BioSim Assets is consummated, that any transaction that is consummated is on terms less favorable than anticipated, and that CVR holders may receive little or no payment under the CVRs. These and other risks are described in Coherus’ filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Coherus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Oppenheimer Contact Information: Stefan Loren, Ph.D. Managing Director — Oppenheimer & Co. Inc. Stefan.Loren@opco.com Arif Sheikh Managing Director — Oppenheimer & Co. Inc. Arif.Sheikh@opco.com Coherus Contact Information: For Investors & Media: Carrie Graham Vice President, Investor Relations and Advocacy IR@coherus.com

前言 原发性肝癌包含多种亚型，其中肝细胞癌（HCC）约占80%，肝内胆管癌（iCCA）约占15%，其余5%为罕见的组织学类型1。在过去十年中，肝胆肿瘤的系统治疗取得了突破性进展，在晚期HCC的一线治疗中，PD-1/PD-L1和CTLA-4抑制剂已成为一线标准治疗策略，延长了患者的总生存（OS）获益。尽管如此，肝胆肿瘤的总体预后依然严峻，五年生存率普遍低于20%2,3，改善患者长期预后的需求依然迫切。为了突破现有的治疗瓶颈，临床研究正朝着两个核心方向演进，其一是研发新型免疫疗法，如探索新型靶点或开发双特异性抗体；其二则是针对β-catenin、KRAS等既往被认为“不可成药”的靶点开发新型靶向药物。近期，Journal of Hepatology发表的综述基于最新的临床研究进展，深度解析了肝胆肿瘤治疗范式的变革4。医脉通将文章整理如下，以期为临床医生提供前瞻性的科研与诊疗参考。 新型免疫疗法 1. 靶向TIGIT和TIM-3等其他免疫检查点 除CTLA-4和PD-1外，免疫细胞上还表达多种免疫检查点，其同样参与T细胞耗竭等免疫耐受效应，这为针对这些靶点的抑制剂的进一步应用提供了理论依据。这其中，TIGIT和TIM-3已经取得了多项进展。 Ib/II期MORPHEUS-Liver研究显示，抗TIGIT单抗Tiragolumab联合PD-L1单抗和贝伐珠单抗表现出43%的客观缓解率（ORR），对照组则为11%。然而，近期公布的III期IMbrave152研究结果显示，该三联疗法未能改善无进展生存期（PFS）和OS。另一款抗TIGIT药物Ociperlimab在II期研究中报告的ORR为35.5%。 在针对晚期HCC的一线治疗研究中，抗TIM-3药物Cobolimab联合Dostarlimab显示出46%的ORR，包括1例完全缓解（CR）。 2. 细胞因子靶向治疗 作为免疫应答的调节中介，细胞因子可通过调节肿瘤微环境影响抗肿瘤疗效。在HCC领域，白细胞介素-27（IL-27）和生长分化因子15（GDF-15）是值得关注的研究方向。 Casdozokitug（CHS-388）是一种靶向IL-27的单抗，II期研究显示，其联合PD-L1单抗及贝伐珠单抗的ORR达37.9%，中位OS达19.9个月。 GDF-15与HCC的血管生成、转移及恶病质相关，高血清水平预示预后不良。I/IIa期试验初步数据显示，对于20例经治晚期HCC患者，GDF-15单抗Visugromab联合PD-1单抗可实现3例部分缓解（PR）和1例CR。 3. 细胞疗法 包括NK细胞、T细胞受体（TCR）修饰的T细胞和CAR-T细胞在内的细胞疗法已经在血液系统恶性肿瘤的治疗中取得了成功，近期的研究表明，细胞疗法在肝胆恶性肿瘤的治疗中同样展现出良好前景。 GPC3是HCC极富前景的治疗靶点，在超过70%的HCC中均有表达。多项GPC3 CAR-T研究正在进行中，其中表达IL-15的GPC3 CAR-T在12例患者中实现了33%的ORR和66%的疾病控制率（DCR）。此外，装甲型CAR-T C-CAR031的早期研究显示ORR可达50%，肿瘤缩小中位数为44%。 AFP是另一备受关注的细胞疗法靶点，针对AFP/HLA-A2复合物的TCR-T疗法在20例HCC患者的研究中显示出良好的耐受性，且有2例获得客观缓解。 此外，对于胆道系统肿瘤（BTC），CLDN18.2的相关进展同样令人振奋。CLDN18.2表达于90%的肝外胆管癌（hCCA）和43%的iCCA中，一项研究显示，CLDN18.2 CAR-T治疗消化系统肿瘤的ORR达48.6%，其中包括2例胆道癌患者和1例胆囊癌患者。 新型靶向治疗 1. 抗体偶联药物（ADCs） ADCs可以将细胞毒性药物精准递送至肿瘤细胞，在提高疗效的同时减少了对健康组织的损伤。在实体瘤患者中，靶向HER2的ADC研究最为广泛。 约10%的BTC患者存在HER2扩增或突变，尤其是在胆囊癌和hCCA癌患者中。由于BTC是除尿路上皮癌外Nectin-4扩增率最高的肿瘤，因此该靶点的临床应用前景同样可观。维恩妥尤单抗等相关ADC药物在BTC中的应用正在积极推进中。 2. “不可成药”靶点的新策略 除已投入临床应用的靶点以外，肝胆肿瘤领域还存在部分始终难以推动进入临床的治疗靶点，即“不可成药”靶点，主要包括β-catenin、PPARα和KRAS等。 Wnt-β-catenin通路的异常激活存在于约30%的HCC中，FOG-001一种竞争性抑制剂，可破坏β-catenin与Wnt通路下游分子T细胞因子之间的相互作用，从而有效抑制信号传导，且已在异种移植模型中得到证实。目前针对该药物的I/II期临床试验正在进行中。 随机II期研究显示，PPARα拮抗剂Amezalpat（TPST-1120）联合PD-L1单抗及贝伐珠单抗治疗一线HCC，中位OS可达21个月，对照组则为13个月。 KRAS是肿瘤发生发展的重要参与者，在多种肿瘤中存在表达。数据显示，约20-30%的BTC患者存在KRAS突变。随着KRAS抑制剂在非小细胞肺癌和结直肠癌等癌种中的成功，BTC领域也开始了探索。研究显示，KRAS G12C抑制剂Adagrasib在12例BTC患者中实现了41.7%的ORR。 3. 已知靶点的深度开发 HDAC8在维持T细胞排除型肿瘤中起关键作用，选择性I级HDAC抑制剂Zabadinostat（CXD101）联合PD-1单抗治疗经治HCC，DCR达到55%，中位OS为8.16个月。 此外，约30%的HCC过表达FGF-19。Irpagratinib在FGF-19扩增的患者中表现出24.1%的ORR，联合免疫单抗抗是其未来重要的应用方向。 罕见原发性肝癌的治疗 尽管仅占原发性肝癌总数的5%，但近年来，除HCC和CCA以外的罕见原发性肝癌的诊疗被日益看重，其中包括混合型HCC-CCA（cHCC-CCA）、肉瘤样HCC（s-HCC）及纤维板层癌等。由于缺乏标准推荐，目前的治疗方案多基于小规模队列或借鉴常见肝癌的经验。 对于cHCC-CCA，此类肿瘤具有HCC和CCA的共同遗传特征。研究表明，免疫高水平亚群可能从免疫治疗中获益。s-HCC仅占HCC的不到1%，极具侵袭性。其组织学特征是PD-L1高表达和免疫细胞大量浸润，提示免疫治疗具有潜在效力。纤维板层癌的特征为DNAJB1-PRKCA融合。虽然发病机制明确，但目前尚无指导特异性靶向治疗的临床靶点。 小结 总而言之，肝胆肿瘤的治疗正在经历一场范式革命，预计在不久的将来，肝胆肿瘤的治疗选择将日益增多。其作用机制可能涵盖免疫介导的肿瘤杀伤以及既往认为无法成药的靶点。从精准打击分子靶点到重塑免疫杀伤机制，一系列创新疗法有望在未来十年内彻底改变临床实践，为患者提供更多生存希望。 参考文献 1. Rumgay H, Ferlay J, de Martel C, Georges D, Ibrahim AS, Zheng R, et al. Global, regional and national burden of primary liver cancer by subtype. Eur J Cancer 2022;161:108- 118. 2. Tran S, Zou B, Kam L, Lee K, Huang DQ, Henry L, et al. Updates in Characteristics and Survival Rates of Hepatocellular Carcinoma in a Nationwide Cohort of Real-World US Patients, 2003-2021. J Hepatocell Carcinoma 2023;10:2147-2158. 3. Izquierdo-Sanchez L, Lamarca A, La Casta A, Buettner S, Utpatel K, Klumpen HJ, et al. Cholangiocarcinoma landscape in Europe: Diagnostic, prognostic and therapeutic insights from the ENSCCA Registry. J Hepatol 2022;76:1109-1121. 4. Chan S L, Lamarca A, Hsu C, et al. New targets and new drugs for hepatobiliary cancers[J]. Journal of Hepatology, 2025. 审批编号：CN-190732 有效期至：2027-08-18 本材料由阿斯利康提供，仅供医疗卫生专业人士参考，不用于推广目的。若涉及具体药物使用，请参考相关药物说明书，阿斯利康不建议您将产品超说明书使用。 撰写：Babel 审核：Babel 排版：Aurora 执行：Atai 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。