Tislelizumab

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, April 14, 2025 /PRNewswire/ -- Equity Insider News Commentary – Routine medical appointments or cancer screenings—critical for catching the disease in earlier, more treatable stages—has dropped to just over 50% of the population. At the same time, doctors are raising alarm bells over a noticeable increase in cancer diagnoses among younger adults, especially women. With proposed funding cuts to the NIH now on the table and new estimates suggesting that drug tariffs could add $10,000 or more to treatment costs, the path forward may rely less on government programs and more on private-sector breakthroughs. So far in 2025, several oncology innovators have stepped forward with meaningful updates, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), CEL-SCI Corporation (NYSE-American: CVM), OS Therapies Incorporated (NYSE-American: OSTX), BeiGene, Ltd. (NASDAQ: ONC), and Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM). Continue Reading Pelareorep Facts Forecasts show cancer's global footprint expanding sharply, with annual case counts expected to rise 20% by 2030 and swell by 75% by mid-century, according to Statista. Meanwhile, Precedence Research projects the global immunotherapy drugs market will reach nearly US$1.2 trillion by 2033, driven by an 18% compound annual growth rate. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently turned heads after securing a new share purchase agreement with Alumni Capital that could provide up to US$20 million in flexible financing, and potentially increase available capital by nearly 45% of the company's valuation at the time of the announcement. The deal gives Oncolytics the right—but not the obligation—to raise capital over a 15-month period through equity sales under its own control. For a clinical-stage company heading toward multiple inflection points, the agreement offers an important advantage: access to cash if and when it's strategically needed. The announcement was met with heightened market interest, driving a notable spike in share price and trading volume on Friday, as investors reacted to the added financial runway and the timing of upcoming trial updates. The capital agreement reinforces a broader narrative taking shape in 2025. Oncolytics continues to advance pelareorep, its intravenously delivered immunotherapy, which triggers a systemic immune response against tumors. Pelareorep is being tested across multiple solid tumor types where outcomes remain poor, including HR-positive HER2-negative metastatic breast cancer, pancreatic ductal adenocarcinoma (PDAC), and advanced anal cancer. All three indications are now being studied in multi-drug combination trials that reflect real-world treatment settings and physician preferences. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO in a recent update. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." In breast cancer, the company recently completed a randomized Phase 2 trial called BRACELET-1. In this study, patients treated with pelareorep and paclitaxel outperformed those receiving paclitaxel alone, showing a near doubling in progression-free survival. The company has stated that the data support moving ahead with a larger registrational study, expected to begin later this year. If new results mirror those seen in BRACELET-1, Oncolytics may have the foundation to submit for accelerated approval in this indication. Meanwhile, the company continues to expand its gastrointestinal cancer program. A pancreatic cancer cohort within the GOBLET study is moving toward full enrollment, after clearing safety hurdles with regulators in Germany. Patients will receive pelareorep alongside a modified FOLFIRINOX chemotherapy regimen—with or without the checkpoint inhibitor atezolizumab. Interim efficacy results from this arm are expected later in 2025 and may inform the structure of a future registration-enabling trial. Notably, Oncolytics is working with the Pancreatic Cancer Action Network (PanCAN) on this cohort, as they provided a US$5 million grant to fund it. In advanced anal cancer, pelareorep is being tested with atezolizumab in another GOBLET cohort. Among the first 12 patients, four showed partial responses and one had a complete response lasting over 15 months. Based on these early outcomes—stronger than what's typically seen from checkpoint inhibitors alone—the company has expanded the cohort to include an additional 18 patients. Pelareorep's unique mechanism of action has garnered attention from key opinion leaders in immunotherapy. During a recent event hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized pelareorep's ability to turn so-called "cold" tumors "hot," potentially enhancing the effectiveness of checkpoint inhibitors and other cancer therapies in difficult-to-treat cancers like PDAC and HR+/HER2- metastatic breast cancer. As of the end of Q4 2024, Oncolytics reported $15.9 million in cash on hand, with operations funded into the third quarter of 2025. With late-stage trials being planned, multiple data readouts on the horizon, and a flexible US$20 million equity facility now in place, the company enters Q2 not just with momentum—but with the financial agility to match it. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: CEL-SCI Corporation (NYSE-American: CVM) is gaining traction after a study published in Cancer Cell validated its approach to seeking early approval for Multikine, its lead immunotherapy candidate for head and neck cancer. "The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival," said Geert Kersten, CEO of CEL-SCI. "This is quite logical—when a person's tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better." Patients who responded to Multikine before surgery had significantly higher survival rates than those who didn't respond. The FDA has approved a 212-patient confirmatory trial to support the company's regulatory path forward. "We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts," added Kersten. OS Therapies Incorporated (NYSE-American: OSTX), has completed its acquisition of Advaxis Immunotherapies' listeria-based cancer programs, securing full IP ownership and strengthening its leadership in this emerging therapeutic category. "We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead," said Paul Romness, CEO of OS Therapies. "We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform." The company's pipeline now includes three clinical-stage immunotherapies and eight additional preclinical assets aimed at more than 30 cancer types. Its lead candidate, OST-HER2, is expected to be submitted for FDA accelerated approval by year-end for recurrent, lung-metastatic osteosarcoma. If approved, the company would become eligible for a Priority Review Voucher, currently valued at $150 million. BeiGene, Ltd. (NASDAQ: ONC) recently received a positive opinion from the European Medicines Agency's CHMP for TEVIMBRA (tislelizumab) in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer, based on a Phase 3 study showing a significant overall survival benefit. Weeks earlier, the FDA approved TEVIMBRA with chemo for first-line treatment of PD-L1-positive esophageal squamous cell carcinoma after another Phase 3 trial showed a 34% reduction in the risk of death. "Today's positive CHMP opinion marks another important step for TEVIMBRA to potentially expand its indications in a fourth disease area in Europe to reach more patients affected by cancer," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "TEVIMBRA is the cornerstone of our solid tumor portfolio with 58 regulatory approvals in 18 months and is being studied in combination with multiple novel molecules with the potential to herald the next wave of cancer therapeutics." TEVIMBRA is now approved in over 45 countries and remains the backbone of BeiGene's expanding solid tumor portfolio. Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM) recently unveiled ATNM-400, a first-in-class, non-PSMA targeting prostate cancer radiotherapy powered by the potent alpha-emitter Actinium-225, showing 99.8% tumor inhibition in preclinical models. The company plans to present these data at AACR 2025, targeting a major unmet need in patients who progress after Pluvicto. "The current era of radiotherapy is built on the clinical and commercial success of Pluvicto in prostate cancer," said Sandesh Seth, Chairman and CEO of Actinium. "The field is now looking to address patients that do not respond or progress after Pluvicto therapy. We believe ATNM-400 can address this high unmet need and we are incredibly excited by our data to date." Alongside ATNM-400, Actinium is advancing clinical programs across AML, solid tumors, and cell therapy conditioning—backed by a robust patent portfolio and expanding in-house manufacturing infrastructure. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 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 paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. 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The owner/operator of MIQ 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. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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药企高额的研发投入，是在创新药领域不断前行的驱动力，也是全球医药市场中保持竞争力的关键所在。同花顺财经数据显示，2024年A股上市药企研发投入TOP10总计投入达387.73亿元，相比2023年的356.64亿元，同比增长9%。从榜单来看，TOP3企业的研发投入均超过50亿元，第一名高达143亿元。值得一提的是，2024年A股上市药企研发投入TOP10中，有5家企业实现研发投入同比正增长（4家增长超10%），其中百利天恒增长率最高（93%），从2023年约7亿元增长至2024年14亿元。表1 2024年A股上市药企研发投入TOP10数据来源：同花顺财经1百济神州遥遥领先百济神州以19.53亿美元（约合人民币143亿元）的研发投入，成为2024年A股上市药企研发投入第一名，再次彰显了其在创新药研发领域的雄心与实力。财报显示，凭借“快速概念验证”的优势，百济神州2024年共完成了将13个新分子实体推进临床开发阶段。预计在2025年，将于2025年上半年对BGB-43395（CDK4抑制剂）、BG-68501（CDK2抑制剂）和BG-C9074（B7H4 ADC）进行数据读出；预计将于2025年下半年取得多个项目的内部概念验证数据，包括：BG-60366（EGFR CDAC）、BGB-53038（泛KRAS抑制剂）等。图1 百济神州全球自主研发和合作管线图片来源：百济神州官网在重点瘤种的深度布局上，百济神州展现了其在血液瘤和实体瘤领域的强大竞争力。泽布替尼（BTK抑制剂）和替雷利珠单抗（PD-1单抗）作为其明星产品，继续在全球市场上取得突破性进展。泽布替尼2024年销售额达到26亿美元，同比大增105%，并获得多个新适应症批准；替雷利珠单抗2024全年销售额为6.21亿美元，同比增长16%。这些成果不仅证明了百济神州在创新药研发上的实力，也为其全球化战略奠定了坚实基础。百济神州的国际化优势是其研发管线得以快速推进的重要保障。2024年，其海外收入占比超过60%，显示出其在全球范围内的强大竞争力。通过与诺华等国际药企的合作，百济神州不仅共享了资源和技术，还进一步拓展了市场渠道。这种全球化布局不仅提升了其研发效率，也为其产品进入欧美等高价值市场提供了保障。值得一提的是，2024年百济神州实现营收38亿美元，同比增长55%，净亏损持续收窄。尽管短期内仍面临盈利压力，但随着研发管线的逐步推进和明星产品的持续放量，百济神州有望在2025年实现经营利润为正。2恒瑞医药再创新高2024年，恒瑞医药以82.28亿元的研发投入，创下其历史新高。图2 恒瑞医药2015年—2024年研发投入（点击查看大图）图片来源：同花顺财经这一年，恒瑞医药的研发管线布局呈现出多点开花、全面发力的态势，从肿瘤到代谢疾病，从免疫到呼吸系统疾病，恒瑞医药在多个领域都取得了显著的进展。2024年至今，恒瑞医药共获得了9项创新药的上市批准，其中包括4款1类创新药，如富马酸泰吉利定、夫那奇珠单抗等。在持续加大自主创新力度的同时，恒瑞医药也积极开展国际合作，通过BD授权交易等方式，将自主研发的创新药推向国际市场。2024年，恒瑞医药实现了多笔创新药海外授权合作，其中包括将GLP-1类创新药许可给美国Kailera公司，首付款加里程碑付款累计可高达60亿美元。在研管线方面，恒瑞医药涵盖了肿瘤、代谢及心血管疾病、免疫和呼吸系统疾病等多个治疗领域。截至2024年底，恒瑞医药共有18项上市申请获NMPA受理，90多个自主创新产品正在临床开发，约400项临床试验在国内外开展。值得关注的是，未来三年恒瑞医药预计有47项创新成果获批上市，其中包括HER2 ADC、GLP-1药物等重磅产品。临床试验方面也取得了显著的进展。2024年，恒瑞共取得创新药临床批件112个，24项临床推进至Ⅲ期，27项进入Ⅱ期，26项启动Ⅰ期临床试验。此外，恒瑞医药的多项临床试验获得了国家药监局的突破性治疗品种认定，以及美国FDA快速通道资格和EMA孤儿药认证。3复星医药重金押注2024年，复星医药以55.54亿元的研发投入，成为2024年A股上市药企研发投入第三名。在这55.54亿元研发投入中，其中研发费用为36.44亿元；制药业务研发投入49.1亿元，占制药业务收入的16.98%。如此高强度的研发投入，使得复星医药在创新药领域不断取得突破。图3 2024年复星医药研发投入情况图片来源：复星医药官微2024年，复星医药自主研发及许可引进的7个创新药/生物类似药共16项适应症获批上市，8个创新药/生物类似药进入上市前审批/关键临床阶段，共有18项创新药/生物类似药项目（按适应症计算）获批开展临床试验。在乳腺癌、胃癌等高发癌症领域，复星医药自主研发的单抗生物类似药汉曲优（注射用曲妥珠单抗）已成功在中国、欧盟、美国等50个国家和地区获批上市，并进入中国、英国等多个国家的医保目录。在非肿瘤领域，复星医药自主研发的冻干人用狂犬病疫苗（Vero细胞）、汉达远（阿达木单抗注射液）4项新增适应症以及许可引进普瑞尼（普托马尼片）、苏可欣（马来酸阿伐曲泊帕片）第二项适应症于中国境内获批。在持续加大自主创新力度的同时，复星医药积极开展国际合作，通过BD授权交易等方式，将自主研发的创新药推向国际市场。2024年，复星医药实现了多笔创新药海外授权合作，其中包括将DAXXIFY（达希斐）引入中国市场，填补了管线空白。4结语2024年A股上市药企研发投入TOP10榜单上的这些行业领军者通过持续的研发投入，不断推动技术创新，为患者提供了更多高质量的治疗选择。唯有坚持创新驱动，药企才能在全球医药市场中持续前行，为人类健康事业贡献更大的力量。参考来源：1.同花顺财经2.各公司官网和财报3.https://mp.weixin.qq.com/s/_IpSY_8nXlhaTLzZ_YEo5Q4.https://mp.weixin.qq.com/s/TB3pPpem4l9a3lEEcWZJmw声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号   粉丝群/投稿/授权/广告等请联系公众号助手 觉得本文好看，请点这里↓