Panitumumab

2025年12月21日，一辆满载药品的运输车从齐鲁制药生物医药产业园驶出。12天前，这款药刚拿到国家药监局的上市批文。4小时后，华东一家三甲医院开出了全国第一张处方——一位RAS野生型晚期结直肠癌患者完成了首次输注。 安可泽首批发运冷藏车从产业园驶出 在中国，每年新增的结直肠癌患者超过51万例。确诊时超过一半人已经进入晚期，手术窗口关闭。其中50%到60%属于“RAS野生型”——简单说，癌细胞的表面恰好暴露了一个可供攻击的靶点，EGFR。 问题在于，攻击这个靶点需要一把能精准识别目标的武器。过去近20年，国内医生手里只有一种选择：人鼠嵌合型抗EGFR单抗。 这种药的蛋白序列里混有鼠源成分，人体免疫系统一看“这东西不是纯自己的”，就容易拉响警报——部分患者输注前必须提前用抗组胺药和激素做预处理，输注过程中也需要密切监护。高龄和过敏体质的患者尤其犯难。 而国际上早在2006年就有一款全人源抗EGFR单抗获批，并逐步成为国际指南推荐的标准治疗之一。全人源意味着蛋白序列全部来自人类基因，不掺杂鼠源片段，免疫系统不会把它当“外来者”攻击。但这款药始终没进中国市场。 齐鲁制药的帕妥尤单抗N01（商品名安可泽），就是来堵这个缺口的。它的分子是全国第一个获批的全人源IgG2型抗EGFR单抗，本质上是一款帕尼单抗的生物类似药。用大白话说：把一根用本地材料做的钥匙，插进了那个暴露了20年的锁孔。 全人源到底解决了什么，用打游戏来打比方 如果把免疫系统想象成一个只认本地口音的保安： 人鼠嵌合抗体一进门，保安立刻听出外地口音，拦住盘问，甚至吹哨叫支援——这就是输液反应、皮疹、严重过敏。 全人源抗体说的是纯本地口音，保安抬个头就放行了。它不用提前打“招呼针”（抗组胺药和激素），输注时出状况的概率也大幅降低。齐鲁制药公布的三期临床数据证实了这一点：药物相关的输液反应发生率仅1.2%，且全部为1到2级，即最轻度的脸发红、发热这类反应。 半衰期也更长，支持2到3周给药一次。原来的方案要求患者每周或每两周跑一次医院，现在大幅压缩了往返次数。对于家不在大城市、需要子女请假陪同的老人来说，这不是小账。 肿瘤控制时间多了近3个月，七成人肿瘤明显缩小 三期临床试验纳入了641例中国RAS野生型晚期转移性结直肠癌患者，结果写得很清楚： 中位无进展生存期从对照组的8.3个月提升至 11.2个月 ，疾病进展风险降低39% 客观缓解率从47.9%提升到 68.3% ，近七成患者的肿瘤显著缩小 中位总生存期也从24.5个月延长到27.3个月。 客观缓解率从不到一半跳到接近七成，还附带一个关键意义：对于“潜在可切除”的患者，肿瘤缩小意味着有机会从“不能手术”变成“可以手术”。2026年CSCO年会上，专家已明确这款药后续还将被纳入CSCO指南的转化治疗推荐，正是冲着这个高缓解率来的。 从获批到进指南，间隔不到半年。2026年3月，新版CSCO结直肠癌诊疗指南发布，原本推荐目录里只列了单一西妥昔单抗的位置，现在统一改成了“抗EGFR单抗”大类，帕妥尤单抗N01作为新增选项被纳入。 近20年的缺口，为什么现在才补上 这个问题有两个层面的答案。 市场层面：帕尼单抗原研药一直没进中国 ，等于留给国内患者的只有人鼠嵌合抗体这一种选择。中国RAS野生型晚期转移性结直肠癌患者，这个适应症人群等了近20年。 技术层面：不是没人想仿 ，是难度太高。IgG2亚型单抗的空间结构比常见的IgG1型复杂得多，按生物类似药路径做研发就是硬啃。更要命的是，这个分子在生产过程中容易形成不溶性颗粒，临床必须用0.2微米在线过滤器来过滤，这个难题挡住了绝大多数企业。 齐鲁制药2012年立项，2025年获批，整13年。研发团队在不溶性颗粒这个公认的硬骨头上提前布局，做了一整套多维度研究，最终靠完整数据链说服了国家药监局的专家审评会。 科研人员在制药实验室开展研发检测工作 还有一个“观念的软钉子”：长久以来，临床认为抗EGFR治疗一旦耐药就等于路走到头。但近年研究发现，停药一段时间后，RAS野生型克隆会重新占据主导——这意味着耐药可能并不是不可逆的，药物“休假”后或许还能再次获益。 帕妥尤单抗N01的上市，让这种策略落地有了实际可用的药。 但现在说“普及”为时尚早 目前落地的事只有这几样：药获批了、指南写了、首批货发了、首张处方开了。 安可泽首批发运相关工作人员合影留念 一家年营收371亿元的民营企业投了13年搞出这款药，从获批到发货只用了12天，说明商业化端的动员能力和效率都在线。但最后一公里的可及性，还是要靠价格和医保这两只手来接。 对符合条件的晚期肠癌患者来说，这不是“又多了一种理论上可选的药”。这是一个真实落地的、不用先打抗过敏针再做输注的、能多争取近3个月控制时间的方案。近半数晚期肠癌患者，终于和国际标准站在了同一条起跑线上。

SAN DIEGO, Sept. 28, 2026 /PRNewswire/ -- Equity Insider News Commentary - For most of the last four decades, RAS was the target oncology could not hit. That has changed quickly, and the commercial numbers are starting to follow. According to DelveInsight, the KRAS inhibitors market across the seven major markets was valued at approximately $526 million in 2025 and is projected to reach approximately $7.85 billion by 2034, a compound annual growth rate of roughly 35% over its 2024 to 2034 forecast period, with the United States expected to account for nearly 70% of the total. As the first generation of RAS-targeted drugs gives way to broader multi-selective inhibitors, the field's central question is shifting from whether RAS can be drugged to how long those responses can be made to last. Active Companies from around the markets with current developments this week include: Oncolytics Biotech® Inc. (Nasdaq: ONCY) , Revolution Medicines, Inc. (Nasdaq: RVMD) , Amgen Inc. (Nasdaq: AMGN) , Eli Lilly and Company (NYSE: LLY) , and Verastem Oncology (Nasdaq: VSTM) . Other forecasters size the category differently but point in the same direction. Roots Analysis projects the global KRAS market will grow from approximately $557 million in 2025 to approximately $3.98 billion by 2035, a CAGR of about 21%, and expects intravenously administered therapies to grow at a faster rate than the oral drugs that dominate the category today. The scale of the opportunity comes down to how common these mutations are. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, according to Eli Lilly and Company. In colorectal cancer, KRAS mutations appear in approximately 40% of all cases, according to Amgen, yet the G12C subtype that the first approved inhibitors were built to target is present in only about 3% to 5% of colorectal cancers. That gap is why the pipeline has moved toward multi-selective and mutation-specific agents aimed at G12D, G12V and other variants that drive pancreatic and colorectal disease. The clinical bar moved sharply in April 2026, when a Phase 3 trial of an oral RAS(ON) multi-selective inhibitor in previously treated metastatic pancreatic cancer reported a median overall survival of 13.2 months versus 6.7 months for chemotherapy, according to the sponsor's SEC filing. Results like that have changed the conversation. With RAS inhibition now showing it can extend survival in one of the hardest cancers to treat, attention is turning to what limits it: tumors that adapt, and responses that fade as resistance emerges. That is where combination strategies come in. Developers are pairing RAS blockade with EGFR antibodies, chemotherapy, immunotherapy and other agents in an effort to deepen responses and push resistance further out. Among the approaches being tested is whether an agent that engages the immune system through a different mechanism can work alongside RAS inhibition rather than against it. Oncolytics Biotech® Inc. (Nasdaq: ONCY) Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer Pelareorep activity was maintained in the presence of RAS inhibition, with no evidence of antagonism between the two therapies in a RAS-driven colorectal cancer model Findings support further evaluation of optimized pelareorep dosing with RAS inhibitors and the hypothesis that it could deepen or prolong responses to RAS-targeted therapy FDA written feedback in August 2026 aligned on a potential pivotal Part B expansion of the ongoing REO 033 colorectal cancer study Pelareorep holds FDA Fast Track designation in colorectal, anal and pancreatic cancer Oncolytics Biotech (Nasdaq: ONCY), a clinical-stage immunotherapy company developing pelareorep, announced positive preclinical results on September 10, 2026, from a study evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. During the initial treatment period, when pelareorep was administered every other day, pelareorep, the pan-RAS inhibitor and the combination each reduced tumor growth compared to the control. The greatest tumor reductions were observed in the RAS inhibitor and combination groups, showing that pelareorep activity was maintained alongside RAS inhibition without evidence of antagonism. The Company was direct about the limits of the result. Following the transition to less frequent weekly pelareorep dosing, the incremental activity associated with pelareorep became less evident. Oncolytics said that, taken together, the findings support further evaluation of optimized pelareorep dosing with RAS inhibitors, and the hypothesis that sustained pelareorep activity could potentially deepen or prolong responses to RAS-targeted therapy and thereby delay the emergence of resistance. The Company also noted the findings are consistent with previously published independent research showing that RAS inhibitors do not interfere with the mechanism through which pelareorep selectively infects tumor cells. "These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies," said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. "We observed pelareorep activity during the initial intensive dosing period as well as biologic compatibility between pelareorep and RAS inhibition, supporting the continued evaluation of pelareorep/RAS inhibitor combination therapy. Because acquired resistance remains a major limitation of RAS-targeted therapies, we believe these findings provide a compelling rationale to investigate whether sustained pelareorep activity can deepen and prolong responses to RAS inhibition and potentially delay the emergence of resistance. Similarly, pelareorep, because of its unique mechanism of action, may offer a treatment option for patients who become resistant to RAS inhibitors." Oncolytics plans to expand its preclinical evaluation of pelareorep with RAS inhibitors across additional dosing schedules and RAS-driven tumor models, designed to further characterize pelareorep's contribution to the combination, including its potential impact on the depth and durability of tumor response and the development of resistance. Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action: it selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses. It has been administered to over 1,200 patients, and the Company is advancing it in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers. The preclinical work sits alongside a colorectal program already moving toward a registrational decision. On August 18, 2026, Oncolytics announced it had received written feedback from the FDA on the design of a potential pivotal Part B expansion of REO 033, its ongoing randomized study of pelareorep with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone in second-line RAS-mutant, microsatellite stable metastatic colorectal cancer. The Company said the feedback represents important alignment on a pathway in which objective response rate could support potential accelerated approval and progression-free survival could support full approval. The FDA also suggested an End-of-Phase meeting to reach final agreement on key elements of the registration program. "We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B," said Jared Kelly, Chief Executive Officer of Oncolytics. "Importantly, the feedback provides alignment around the potential use of response rate to support an accelerated approval pathway and progression-free survival to support full approval." The ongoing Part A enrolls 60 patients, and the Company intends to decide whether to launch the pivotal expansion once initial clinical data from Part A are available. Elsewhere in the portfolio, pelareorep received Fast Track designation in July 2026 in combination with a checkpoint inhibitor for second-line and later squamous cell anal cancer, following April 2026 FDA alignment on a pivotal study design in that indication. Oncolytics has also secured a new U.S. patent covering key aspects of pelareorep's commercial manufacturing process, which the Company expects to provide protection into 2044. There are several risks associated with the Company's plans. The RAS combination findings are preclinical results from a single colorectal cancer model, and preclinical results may not be predictive of results in clinical studies; the Company itself reported that pelareorep's incremental contribution became less evident under weekly dosing. No clinical data combining pelareorep with a RAS inhibitor have been reported. Pelareorep is investigational and has not been approved by the FDA or any other regulator for any indication. FDA written feedback and Fast Track designation do not guarantee approval, the End-of-Phase meeting has not yet been held, and the decision to launch REO 033 Part B depends on Part A data that are not yet available. As a clinical-stage company, Oncolytics will require additional capital to advance its programs and is pursuing strategic partnerships that may not materialize. Readers should review the Company's filings on EDGAR and SEDAR+ and the forward-looking statements in its releases. Read this and more news for Biotech Sector at: In other industry developments and happenings in the market this week include: Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company focused on RAS-addicted cancers, announced that the FDA accepted for review its New Drug Application for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma. The application is supported by the Phase 3 RASolute 302 trial, in which daraxonrasib delivered a median overall survival of 13.2 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.40, and the drug was selected for the FDA Commissioner's National Priority Voucher pilot program. In its second quarter 2026 update, Revolution Medicines reported that the FDA also granted daraxonrasib Breakthrough Therapy Designation for certain patients with previously treated metastatic RAS-mutant non-small cell lung cancer, and that it opened an FDA-cleared Expanded Access Program in May. The company continues to advance daraxonrasib into earlier lines of pancreatic cancer through the global Phase 3 RASolute 303 and RASolute 304 studies in the first-line metastatic and adjuvant settings. Amgen Inc. (Nasdaq: AMGN) markets LUMAKRAS® (sotorasib), one of the first approved KRAS G12C inhibitors, which is approved in combination with its anti-EGFR antibody Vectibix® (panitumumab) for previously treated KRAS G12C-mutated metastatic colorectal cancer. In its second quarter 2026 results, Amgen reported LUMAKRAS/LUMYKRAS sales up 23% year-over-year to $111 million, primarily on volume growth, while total revenues rose 10% to $10.1 billion. Amgen is pushing the colorectal program into the first-line setting through CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI in patients with first-line KRAS G12C-mutated metastatic colorectal cancer, alongside CodeBreaK 202 in first-line KRAS G12C-mutated, PD-L1 negative non-small cell lung cancer. Eli Lilly and Company (NYSE: LLY) announced that the FDA granted Breakthrough Therapy designation to olomorasib, an investigational next-generation KRAS G12C inhibitor, as a monotherapy for adults with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation. It is the second Breakthrough Therapy designation for olomorasib, following a September 2025 designation in combination with pembrolizumab for first-line KRAS G12C-mutant non-small cell lung cancer with high PD-L1 expression. "Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. Lilly noted there are currently no approved therapies that specifically target KRAS G12C-mutant pancreatic cancer, and olomorasib is also being studied in the pivotal SUNRAY-01 and SUNRAY-02 lung cancer studies. Verastem Oncology (Nasdaq: VSTM), which focuses on RAS/MAPK pathway-driven cancers, announced it will host an investor event on October 14, 2026 to present initial efficacy and updated safety and tolerability data for VS-7375, its investigational oral KRAS G12D (ON/OFF) inhibitor, in pancreatic, lung and colorectal cancers from the TARGET-D clinical program. VS-7375 has FDA Fast Track Designation in KRAS G12D-mutated metastatic pancreatic cancer in both the first-line and previously treated settings, and in previously treated KRAS G12D-mutated non-small cell lung cancer. Verastem already has a commercial RAS pathway product in AVMAPKI® FAKZYNJA® CO-PACK, approved for KRAS-mutated recurrent low-grade serous ovarian cancer. In its second quarter 2026 results, the company reported net product revenue of $25.1 million for the co-pack and said first patients had been dosed in all three registration-directed TARGET-D Phase 2 trials, including TARGET-D 203 in metastatic colorectal cancer. Track the Signals Before the Crowd The best positioning happens before the crowd catches on. Eagle Eye is a real-time investor signal-intelligence platform that surfaces sentiment shifts, news flow, and trending tickers as they form, so you see attention building instead of chasing it. Watch it live at eagle-eye.dev. Contact Information: Equity Insider Media Contact: [email protected] DISCLAIMER: Nothing in this publication should be considered personalized financial advice. We are not licensed under securities laws to address your particular financial situation, and no communication from us should be deemed personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This publication is neither an offer nor a recommendation to buy or sell any security. We hold no investment licenses and are neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by Equity Insider, which is wholly owned and operated by Market Equities Limited ("MEL"), a company incorporated under the laws of Ireland. This is not a paid advertisement. MEL has not been paid any fee for this article. MEL and/or its owners, operators, directors, and affiliates have previously been paid fees directly by Oncolytics Biotech Inc. for Oncolytics Biotech Inc. advertising and digital media services under prior arrangements, which have since expired. As of the date of publication, MEL does not have any current agreement with Oncolytics Biotech Inc. and does not expect to receive further compensation from Oncolytics Biotech Inc. in connection with this article. The prior compensation described above, together with the share ownership described below, constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged not to use this publication as the basis for any investment decision. MEL and/or its owners, operators, directors, and affiliates own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell, shares of Oncolytics Biotech Inc. at any time without any further notice, commencing immediately and ongoing, in the open market, through private placements, and/or through other investment vehicles. There may also be third parties who hold shares of Oncolytics Biotech Inc. and may liquidate their shares, which could have a negative effect on the price of the stock. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in this publication is not trustworthy unless verified by their own independent research. Because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may lose some or all of your investment. Cautionary Note Regarding Clinical and Preclinical Results: Oncolytics Biotech Inc. is a clinical-stage company. Pelareorep is an investigational product candidate that has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication and has not been demonstrated to be safe or effective. The pelareorep and pan-RAS inhibitor findings referenced in this article are preclinical results from a single colorectal cancer model; preclinical results may not be predictive of results in clinical studies, and no clinical data combining pelareorep with a RAS inhibitor have been reported. Fast Track designation does not guarantee approval or a shortened review. FDA written feedback on the design of a potential pivotal study does not constitute agreement on a registration program, which the FDA has suggested be finalized at an End-of-Phase meeting that has not yet been held. Any decision to initiate REO 033 Part B depends on Part A data that are not yet available. Other companies' product candidates referenced in this article are likewise investigational unless stated to be approved. Referenced Companies and Market Data: References to Revolution Medicines, Inc., Amgen Inc., Eli Lilly and Company and Verastem Oncology are provided solely as market and sector context. Those companies are not peers, competitors, or financial comparables of Oncolytics Biotech Inc., were not involved in the preparation of this article, and their results are not indicative of Oncolytics Biotech Inc.'s prospects. The pan-RAS inhibitor used in the Oncolytics preclinical study was not identified by the Company, and nothing in this article implies it is a product of any company named herein. No partnership, affiliation, or endorsement is implied. Market-size figures are third-party projections by DelveInsight and Roots Analysis, are not addressable revenue for any company named in this article, and may not be realized. Eagle Eye Disclosure: Eagle Eye is an investor signal-intelligence platform affiliated with the publisher of this article, and any reference to it constitutes promotion of an affiliated product. Eagle Eye is not a broker-dealer, and nothing in the platform or in this article is financial, investment, tax, or legal advice. Data provided in the platform is for informational purposes only and may be delayed. Always do your own research before making any investment decision. Forward-Looking Statements: This publication contains forward-looking information which is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ from those projected in the forward-looking statements. Forward-looking statements in this publication include statements regarding the potential of pelareorep in combination with RAS inhibitors, the design, timing and outcome of current and future clinical and preclinical studies, potential regulatory pathways and approvals, anticipated patent protection, and the size and growth of the KRAS inhibitor market. These forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties including regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of publication. Please refer to Oncolytics Biotech Inc.'s public filings with securities regulators in the United States () and Canada () for more information. We undertake no obligation to update forward-looking statements, except as required by law. This document is governed by the laws of Ireland. SOURCE Equity Insider 21% more press release views with Request a Demo