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SAN DIEGO, Oct. 14, 2026 /PRNewswire/ -- Equity Insider News Commentary - Global spending on cancer medicines reached $252 billion in 2024 and is forecast to exceed $400 billion by 2028, according to the IQVIA Institute, with the United States accounting for roughly 46% of the total. The pace of new treatments has picked up with it: about 150 new active substances entered the U.S. oncology market between 2015 and 2024, and launch activity in 2020 to 2024 ran nearly 40% ahead of the prior five years. Active Companies from around the markets with current developments this week include: Oncolytics Biotech, Inc. (NASDAQ: ONCY), Revolution Medicines, Inc. (NASDAQ: RVMD), Eli Lilly and Company (NYSE: LLY), Genmab A/S (NASDAQ: GMAB), Exelixis, Inc. (NASDAQ: EXEL). The past several weeks have shown how quickly that pipeline is turning into new standards of care. On August 26, the U.S. Food and Drug Administration approved the first broad RAS-targeted medicine for metastatic pancreatic cancer, one of the hardest-to-treat solid tumors. In the first two weeks of October, regulators approved a new first-line use for a blood cancer therapy, a first-line maintenance treatment for HER2-positive metastatic breast cancer and a checkpoint inhibitor combination for stage III mismatch repair-deficient colon cancer, while two large Phase 3 trials in lymphoma and multiple myeloma reported positive topline results. Gastrointestinal cancers are drawing a growing share of that attention. RAS mutations drive many pancreatic and colorectal tumors, and for years they were considered nearly impossible to drug. Colorectal cancer adds a second challenge: most metastatic cases are microsatellite stable, a form that has generally responded poorly to the checkpoint inhibitors that transformed treatment in other cancers. Companies are attacking the problem from several directions, with targeted RAS inhibitors, new drug combinations and therapies designed to make tumors more visible to the immune system. Investors will get a fresh look at much of this work soon. The European Society for Medical Oncology holds its 2026 Congress in Madrid from October 23 to 27, one of the largest annual meetings for new cancer data, and two of the companies below have pointed to colorectal cancer updates before year-end. Oncolytics Biotech, Inc. (NASDAQ: ONCY) Oncolytics is developing pelareorep, an intravenously delivered immunotherapy designed to turn immunologically "cold" tumors "hot," and colorectal cancer is now at the center of its clinical plans. On September 28 the company reported accelerating enrollment in REO 033, a randomized study in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer that compares pelareorep plus FOLFIRI and bevacizumab with FOLFIRI and bevacizumab alone. Part A is expected to randomize about 60 patients, with objective response rate as the primary endpoint and progression-free survival, overall survival, safety and biomarkers as additional endpoints. The study builds on REO 022, a smaller non-randomized trial in which the same pelareorep combination produced a 33% objective response rate, median progression-free survival of 16.6 months and median overall survival of 27.0 months. Oncolytics has said it aligned with the FDA on the concept of a potential pivotal Part B expansion, with a proposed accelerated approval path based on response rate and progression-free survival as the basis for potential full approval. Pelareorep holds FDA Fast Track designation in colorectal, anal and pancreatic cancer and has been administered to more than 1,200 patients. "Given the current pace of enrollment, we expect to have the ability to report interim data from Part A by year-end," said John McAdory, Chief Operating Officer. The company has also been adding scientific support around the program. In September it reported preclinical results combining pelareorep with a pan-RAS inhibitor in a RAS-driven colorectal cancer model, in which the combination showed no evidence of antagonism, and it announced a peer-reviewed publication in the Proceedings of the National Academy of Sciences showing that pelareorep changed the liver tumor microenvironment from immunologically inactive to active in preclinical models. CONTINUED... Read more oncology sector coverage at: Equity Insider In other industry developments and happenings in the market this week include: Revolution Medicines, Inc. (NASDAQ: RVMD) Revolution Medicines announced on August 26 that the FDA approved RASONQUE (daraxonrasib), a once-daily oral tablet, for adults with metastatic pancreatic cancer who have received at least one prior systemic therapy or cannot receive multiagent therapy. In the Phase 3 RASolute 302 trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy. The company has said it expects to share updated colorectal cancer data and strategy in the fourth quarter of 2026. "The FDA approval of RASONQUE is a monumental step forward for patients with pancreatic cancer and for the oncology field," said Mark A. Goldsmith, M.D., Ph.D., Chief Executive Officer and Chairman. Eli Lilly and Company (NYSE: LLY) Lilly announced on October 2 that the FDA approved Jaypirca (pirtobrutinib) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a known 17p deletion. In the BRUIN CLL-313 trial, Jaypirca reduced the risk of progression or death by 80% compared with bendamustine plus rituximab, with an overall response rate of 94% versus 81%. Genmab A/S (NASDAQ: GMAB) Genmab and AbbVie announced on October 5 that the Phase 3 EPCORE DLBCL-2 trial of epcoritamab plus R-CHOP met its primary endpoint in newly diagnosed diffuse large B-cell lymphoma, reducing the risk of progression or death by 51% compared with R-CHOP alone. The companies plan to present the data at a future medical meeting and to engage with global regulators. Exelixis, Inc. (NASDAQ: EXEL) Exelixis disclosed that the FDA extended its review of zanzalintinib in combination with atezolizumab for metastatic colorectal cancer by three months after the company submitted updated safety and efficacy information, which the agency classed as a major amendment. The new target action date is March 3, 2027. Know Which Biotech Names Are Moving First Clinical readouts and FDA decisions can reprice a stock in minutes. 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 as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a market commentary and is not a paid advertisement. It is neither an offer nor a recommendation to buy or sell any security. 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 an independent market commentary published on a non-paid basis. MEL has not been paid any fee by any company mentioned in this article for its production or distribution. MEL was previously paid a fee by Oncolytics Biotech, Inc. for advertising and digital media services under an arrangement that has since expired. MEL and/or its owners, operators, directors, and affiliates own shares of Oncolytics Biotech, Inc. purchased in the open market, and reserve the right to buy and sell shares of Oncolytics Biotech, Inc. at any time without any further notice. The prior compensation and this share ownership constitute a conflict of interest as to our ability to remain objective in our communication regarding Oncolytics Biotech, Inc. Because of this conflict, individuals are strongly encouraged not to use this publication as the basis for any investment decision. 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礼来吡托布鲁替尼首次挺进一线 美国 FDA 批准礼来的 Jaypirca（pirtobrutinib，吡托布鲁替尼）用于无已知 17p 缺失、既往未经治疗的慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）成人患者，使这一非共价（可逆）BTK 抑制剂从后线挽救治疗正式挺进一线用药。支持批准的 BRUIN CLL-313 随机研究显示，与苯达莫司汀联合利妥昔单抗的免疫化疗方案相比，pirtobrutinib 显著延长无进展生存期（PFS）；该药与 BTK 以非共价、可逆方式结合，设计上可绕开共价 BTK 抑制剂常见的 C481S 耐药突变。一线获批意味着 CLL/SLL 治疗进一步'去化疗化'，也为共价 BTK 抑制剂耐药后的序贯策略留出空间，将直接改写 NCCN 等指南的一线推荐格局，并加剧 BTK 赛道的市场竞争。 来源：Pharmacy Times FDA Updates FDA批准辉瑞/SeagenTucatinib 美国 FDA 批准辉瑞/Seagen 的 Tukysa（tucatinib，图卡替尼）联合曲妥珠单抗与帕妥珠单抗，用于诱导治疗后不可切除局部晚期或转移性 HER2 阳性乳腺癌成人患者的维持治疗，为'诱导—维持'全程抗 HER2 策略补齐口服 TKI 一环。支持批准的 654 例患者 Ⅲ 期 HER2CLIMB-05 研究显示，tucatinib 维持方案中位无进展生存期（PFS）达 24.9 个月，对照组为 16.3 个月，延长逾 8 个月；tucatinib 为高选择性 HER2 酪氨酸激酶抑制剂，血脑屏障穿透能力较好，对脑转移高风险人群尤具价值。该批准确立了'化疗诱导 + 全靶向维持'的新范式，巩固 tucatinib 在 HER2 阳性乳腺癌后线与维持双线地位，也将与 DS-8201 等 ADC 形成序贯与竞争并存的格局。 来源：Targeted Oncology（10 月 FDA 简报） 罗氏III期结肠癌辅助治疗覆盖2岁及以上人群获批 美国 FDA 批准罗氏/基因泰克的 Tecentriq（阿替利珠单抗）联合氟嘧啶类与奥沙利铂，用于 III 期错配修复缺陷（dMMR）结肠癌成人及 2 岁及以上儿童患者的辅助治疗；同日其皮下制剂 Tecentriq Hybreza 亦获批用于 12 岁及以上且体重≥40 kg 人群。批准基于 ATOMIC 试验数据：dMMR 肿瘤因 DNA 错配修复功能缺失、突变负荷高、免疫原性强，对 PD-L1 免疫检查点抑制高度敏感，将免疫治疗从晚期一线前移至根治术后辅助阶段，有望显著降低这一分子亚型患者的复发风险。这是免疫检查点抑制剂在结直肠癌辅助场景的重要突破，标志'基于分子分型的辅助免疫'路径获得监管确认，将进一步推动术后 MMR/MSI 常规检测的普及。 来源：美国 FDA 官网 罗氏最高12.7亿美元与Alector达成许可协议 罗氏旗下基因泰克与美国生物技术公司 Alector 达成许可协议，以 1 亿美元首付款、最高 11.7 亿美元开发/监管/销售里程碑（合计最高 12.7 亿美元）外加销售提成，获得帕金森病候选药物 AL050 的全球独家权益；消息公布后 Alector 盘前股价一度飙升约 72%。AL050 为靶向 GCase（葡萄糖脑苷脂酶）缺陷的脑渗透酶替代疗法：GCase 活性降低导致葡糖鞘氨醇等脂质在神经元内蓄积，是帕金森病（尤其 GBA1 突变携带者）神经退行的重要驱动因素；AL050 将工程化 GCase 与 Alector 专有的血脑屏障递送平台 Alector Brain Carrier（ABC）偶联，突破大分子入脑瓶颈。该资产尚处临床前阶段。罗氏目前尚无获批的帕金森病疾病修饰疗法，核心管线为抗 α-突触核蛋白抗体 prasinezumab；本次交易是其十年来帕金森领域最受瞩目的 BD 动作之一，押注'酶替代 + 脑递送平台'这一区别于抗体与小分子的机制路线。 来源：Reuters / Global Banking & Finance Review 盐野义拟20亿美元收购美国罕见病药企IntraBio 日本盐野义制药宣布将以 20 亿美元现金收购美国奥斯汀罕见病生物技术公司 IntraBio 全部流通股，这是盐野义继今年 4 月以 25 亿美元搭建以 ALS 药物 Radicava 为核心的罕见病商业化平台后，半年内第二笔罕见病大额并购。IntraBio 成立于 2015 年，核心资产为 Aqneursa（levacetylleucine，左旋乙酰亮氨酸），已在美国获批两个罕见神经疾病适应症（C 型尼曼匹克病神经症状、共济失调毛细血管扩张症 A-T），2025 年销售额约 6786 万美元；交易同时为盐野义带来在美欧进一步扩张罕见病管线的平台。该交易显示中型药企正通过'收购已获批罕见病资产 + 自建商业化平台'的路径快速切入高壁垒、高定价的罕见病市场，行业罕见病资产估值热度持续攀升。 来源：时事通信社 / BioWorld CSL首付3.55亿美元联手 Alentis加码肾病管线 10 月 6 日，澳大利亚 CSL 公司宣布与瑞士 Alentis Therapeutics 达成合作，支付 3.55 亿美元首付款及最高 12 亿美元里程碑付款，共同开发 first-in-class 抗 Claudin-1 单克隆抗体 lixudebart，用于罕见肾脏与肝脏疾病。Claudin-1 是细胞紧密连接蛋白家族成员，在器官纤维化进程中异常表达，抗 Claudin-1 抗体旨在阻断纤维化信号、延缓肾功能恶化；该交易建立在 CSL 收购 Vifor Pharma 后持续扩张的肾科版图之上，体现其'在患者进展至透析前干预'的肾病战略。器官纤维化长期缺乏有效抗纤维化药物，本次合作是 2026 年肾科领域最大单笔 BD 之一，也标志 Claudin 家族靶点从肿瘤向纤维化疾病的跨界延伸。 来源：BioWorld 阿斯利康两款重磅 ADC 在华获批 阿斯利康宣布其与第一三共联合开发的达卓优（注射用德达博妥单抗，Dato-DXd）于 9 月 29 日正式获国家药监局批准，用于治疗不适合接受 PD-1/PD-L1 抑制剂治疗的不可切除或转移性三阴性乳腺癌成人患者；同日优赫得（注射用德曲妥珠单抗，T-DXd）亦在华获批新适应证。达卓优为靶向 TROP2 的 ADC，采用 DXd 拓扑异构酶Ⅰ抑制剂载荷与可裂解连接子设计，此次获批为三阴性乳腺癌——这一长期缺乏有效靶向手段、以化疗为主的难治亚型——提供了化疗之外的新选择；优赫得作为 HER2 ADC 标杆，持续拓展适应症版图。两款明星 ADC 同日落地，进一步巩固阿斯利康在乳腺癌领域的优势地位，也加剧国内 ADC 市场与科伦博泰 SKB264 等国产 TROP2 ADC 的正面对垒。 来源：每日经济新闻（医药早参） 恒瑞医药第二款自研创新药向欧盟递交上市申请 恒瑞医药公告称欧洲药品管理局（EMA）已正式确认并受理公司递交的氟唑帕利胶囊上市许可申请，拟定适应症为联合醋酸阿比特龙和泼尼松（龙）治疗转移性去势抵抗性前列腺癌（mCRPC）成年患者，这是公司第二款自主研发创新药向欧盟递交上市申请。氟唑帕利为 PARP 抑制剂，通过'合成致死'机制杀伤同源重组修复缺陷的肿瘤细胞；该项目累计研发投入约 12.04 亿元（未经审计）。据 EvaluatePharma 数据，2025 年全球同类 PARP 抑制剂（奥拉帕利、卢卡帕利、尼拉帕利、他拉唑帕利）合计销售额约 45.6 亿美元，国内百济神州帕米帕利、英派药业塞纳帕利已获批。继首款自研新药欧盟递表后，恒瑞'自主出海'再落一子；但在 PARP 赛道全球竞争充分的背景下，后续商业化表现取决于差异化数据与合作渠道建设。 来源：财信证券晨会纪要 / 恒瑞医药公告 众生药业RAY1225减重Ⅲ期临床达主要终点 众生药业公告其控股子公司众生睿创自主研发的一类创新多肽药物 RAY1225 注射液在超重或肥胖受试者中的 Ⅲ 期临床试验获得顶线分析数据，达到主要终点。RAY1225 为国产自主创新的多肽类减重候选药物，Ⅲ 期顶线达标意味着其距申报上市迈出关键一步；完整结果以最终临床总结报告为准，后续注册审评与产能准备仍是主要不确定性。在诺和诺德、礼来双寡头主导、国内数十条管线竞逐的减重赛道，继恒瑞 HRS-1596 授权诺和诺德、乐普 ActRIIA/B 单抗获 FDA 临床批准后，国产减重管线密集读出数据，行业进入'数据兑现期'。 来源：每日经济新闻（医药早参） 东阳光药德谷门冬双胰岛素获批上市 10 月 8 日，东阳光药公告其自主研发的德谷门冬双胰岛素注射液获国家药监局批准上市，用于治疗 2 型糖尿病；该制剂由长效基础胰岛素德谷胰岛素与速效门冬胰岛素组成，兼具平稳控糖与餐时快速降糖特点，目前尚未纳入国家集采，补齐了公司第四代胰岛素布局的关键一环。同日，翰宇药业公告其 HY3003 注射液获美国 FDA 临床试验申请受理，拟用于减重、2 型糖尿病、代谢相关脂肪性肝炎（MASH）等适应症，标志公司代谢领域原创新药管线国际化迈出实质一步；节后亦有多家药企披露获批：亨迪药业精氨酸布洛芬颗粒、新华制药沙库巴曲缬沙坦钠片（2025 年国内公立机构销售额约 78 亿元）获药品注册证书，ST 人福盐酸地尔硫䓬片获 FDA 批准文号，甘李药业门冬胰岛素获埃塞俄比亚注册批件。国产企业在糖尿病、心血管等慢病大品种上的'仿创结合 + 出海注册'节奏明显加快，胰岛素国产替代与国际化双线推进。 来源：每日经济新闻（医药早参）/ 证券时报  26年诺贝尔生理学或医学奖授予光遗传学奠基人 10 月 5 日，瑞典卡罗琳医学院宣布将 2026 年诺贝尔生理学或医学奖授予美国科学家卡尔·戴塞罗思（Karl Deisseroth）、德国科学家彼得·黑格曼（Peter Hegemann）与格奥尔格·内格尔（Georg Nagel），表彰他们在光门控离子通道与光遗传学（optogenetics）方面的奠基性发现，三人将均分 1200 万瑞典克朗（约合 802 万元人民币）奖金。黑格曼与内格尔在单细胞藻类中发现光敏蛋白'通道视紫红质'，其受蓝光照射时离子通道如闸门般开放、使细胞产生电信号，并证明将其导入其他细胞同样可赋予光响应性；戴塞罗思 2005 年将该基因导入大鼠神经细胞并以蓝光成功触发神经信号，2007 年进一步实现在活体小鼠脑内用光控制神经活动，由此开创光遗传学——使科学家得以在活体大脑中精确开关单个神经细胞，解析记忆、感觉与行为的神经回路。该技术已展现临床转化潜力：研究人员正尝试用其帮助部分视网膜疾病患者恢复视觉功能，并用于探索抑郁症、阿尔茨海默病与疼痛的神经机制，对神经科学与脑疾病药物研发的工具价值获最高科学荣誉确认。 来源：新华社 / 中国网 北京拟出集采药品质量监管新规 由北京市药监局起草的《关于进一步加强集采中选药品质量监管的通知（征求意见稿）》在首都之窗网站公开征求意见，明确集采药品须'降价不降质'，不符合要求、不达预期效果、存在不良趋势的药品将不得放行上市。征求意见稿针对企业赶量压成本可能牺牲质量的风险划出多条红线：严禁以销售目标、交货期限、降低成本等商业理由向生产、质量部门施加不当压力，迫使降低质量标准或放行存在质量隐患的产品；关键人员须全职在岗，严禁'挂名''空降'，原关键人员对在职期间质量活动终身负责；原料、工艺、操作步骤坚持'非必要不变更'原则，批准参数范围内的'微调'亦须谨慎。国家组织药品集采已运行 8 年，今年启动的第 12 批集采强调'挤掉流通环节虚高水分，绝不能牺牲产品质量'、不唯低价论；北京率先以地方细则落实全链条质量监管，呼应国家层面对集采提质扩面与质量底线并重的政策导向，中选企业的合规成本与质量体系要求将系统性抬升。 来源：北京日报 END