Tislelizumab

国内财报季接近尾声，Insight 数据库根据已披露的药企财报，整理了 24 年国产创新药销售额榜单。其中，泽布替尼在国产创新药销售额榜单上一骑绝尘。BCMA CAR-T 西达基奥仑赛市场表现强劲，全年销售近 70 亿元。和黄医药有三款化药强势上榜，其中与礼来、武田达成合作的呋喹替尼增速狂飙 235.83%，年销售额超 29 亿元。而国产 PD-1/PD-L1 赛道上演着「冰与火之歌」，既有增速 195% 的黑马杀出，也有玩家首次实现负增长。2024 年国产创新药销售额榜单（亿元）截图来源：Insight 数据库（根据已公布药企财报人工整理，如有错漏还请评论区指正）   百济神州领衔，和黄医药 3 款上榜百济神州手握泽布替尼和替雷利珠单抗两款重磅药物，合计销售额超 234 亿元，占总榜单销售额的 43.38%。泽布替尼以 190.22 亿元销售额稳居榜首，同比增速 106.46%，其中美国市场销售额占比高达 75.6%。作为一款「同类最佳」BTK 抑制剂，其自 2019 年首次获批以后持续放量，成为国产创新药「出海」的标杆产品。PD-1 抗体替雷利珠单抗销售稳健增长，2024 全年销售额为 44.68 亿元，同比增长 17.48%，主要得益于医保目录报销范围扩大以及药品进院数量增加。在中国，该药已经获批 14 项适应症，其中 13 项适应症已纳入国家医保目录。西达基奥仑赛是传奇和强生合作开发的一款 BCMA CAR-T，目前已经在中国、美国、欧盟、日本等多个国家和地区上市，获批用于治疗多发性骨髓瘤。2024 年全球销售额达 69.28 亿元（9.63 亿美元），同比增长 95.51%。其中美国市场销售 62.52 亿元，占比超 90%。4 月 15 日，强生发布一季度财报，西达基奥仑赛 Q1 销售额为 3.69 亿美元（约合 26.5 亿元），同比增长 135%。其中美国市场收入 3.18 亿美元，同比增长 127%。按照这个趋势，2025 年西达基奥仑赛有望突破 10 亿美元年销售额门槛，正式跻身重磅炸弹药物行列。和黄医药呋喹替尼、索凡替尼、赛沃替尼三款化药同时上榜，合计销售额达 35.98 亿元，占总榜单销售额的 6.6%。呋喹替尼以 235.83% 的同比增速成为「增速黑马」。这是第一个批准用于治疗转移性结直肠癌（mCRC）的针对所有三种血管内皮生长因子受体（VEGFR）亚型的选择性抑制剂，无论患者的生物标志物状态如何。如此强劲的增速，一方面是该药在保持其 mCRC 竞争力的同时获批了新的子宫内膜癌适应症。另一方面，也得益于其在美国市场迅速获得患者接纳，并在全球十多个国家上市。索凡替尼是一种新型的口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性，目前已获批用于胰腺神经内分泌肿瘤和非胰腺神经内分泌肿瘤。主要得益于医生对该产品的认知度提升及神经内分泌瘤诊断改善，推动了处方增长，24 年市场份额从 21% 提高至 27%，全年销售额达 3.53 亿元。赛沃替尼受到几种用于二线治疗 MET 外显子 14 跳变非小细胞肺癌的同类 MET TKI 上市以及纳入国家医保药品目录的竞争影响，24 年市场份额与过去几乎持平。但该药于 2025 年 1 月获得 NMPA 一线治疗批准，其市场占有率将有机会进一步扩大。   肿瘤疗法狂揽八成市场，非肿瘤赛道暗藏黑马在 2024 年国产创新药销售榜单中，抗肿瘤药物以压倒性优势占据主导地位，20 款上榜新药中，16 款为抗肿瘤药物，占比达到了 80%，合计创造 464.7 亿元销售额，贡献总榜单 85.8% 的销售业绩。从肿瘤药物类型来看，有 2 款 CAR-T、6 款单抗、8 款化药。传奇生物西达基奥仑赛与药明巨诺瑞基奥仑赛 2 款 CAR-T 产品总共贡献了 70.86 亿元。而单抗产品和小分子化药的销售额分别达到了 118.12 亿元和 275.74 亿元。不同药物类型的抗肿瘤药数量截图来源：Insight 数据库在肿瘤药物高歌猛进之时，非肿瘤领域同样有着亮眼表现。三生制药特比澳获批上市近 20 年，时至今日仍然是全球唯一商业化的重组人血小板生成素产品，24 年实现超 50 亿元销售额，占据中国内地血小板减少症治疗 66.6% 的市场份额。康诺亚司普奇拜单抗是国产首个获批的 IL-4R 抗体药物，也是全球第二款，仅次于自免「药王」度普利尤单抗。该药于 2024 年 9 月首次获 NMPA 批准用于特应性皮炎，上市销售仅 3 个半月即斩获 4300 万元销售额，并快速拓展慢性鼻窦炎伴鼻息肉病和季节性过敏性鼻炎新适应症。除了度普利尤单抗以外，司普奇拜单抗在国内 IL-4R 赛道虽是独树一帜。然而就首先上市的特应性皮炎适应症来说，国内已获批多款其他类型的药物，包括 JAK1 抑制剂（阿布昔替尼、乌帕替尼等）、PDE4 抑制剂（克立硼罗乳膏）等。司普奇拜单抗面临激烈竞争。好在康诺亚对其进行了差异化布局，后来获批的 2 项适应症面临的竞争压力相对较小，且还在不断布局新的适应症。据 24 年财报显示，司普奇拜单抗还有望治疗多种 II 型免疫性疾病，包括但不限于结节性痒疹、中重度哮喘及慢阻肺等，未来有望打开超百亿市场规模。   PD-1/PD-L1：红海竞争下的分化与突围作为肿瘤免疫治疗的核心靶点，PD-1/PD-L1 领域向来竞争激烈。24 年榜单中共有 7 款国产单抗产品上榜，除了司普奇拜单抗为一款 IL4R 单抗，其余 6 款单抗药物均涉及 PD-1/PD-L1 靶点。从药品销售额来看，有 4 款 PD-1/PD-L1 单抗突破了 10 亿元，除了百济的 PD-1 抗体替雷利珠单抗以外，还有信达的信迪利单抗、君实的特瑞普利单抗、复宏汉霖的斯鲁利单抗，24 年分别斩获了 37.84 亿元（同比增长 35.73%）、15.01 亿元（同比增长 63.33%）、13.13 亿元（同比增长 17.25%）。其中信迪利单抗已在中国获批 8 项适应症，涉及肝细胞癌、胃癌、非小细胞肺癌等。此外，信达还在积极探索信迪利单抗的联合用药以及辅助疗法等来延长产品的生命周期，包括和呋喹替尼联用治疗子宫内膜癌（已获批）、联合伊匹木单抗（CTLA-4 单抗）用于结肠癌新辅助治疗（报上市）、与托莱西单抗（PCSK9 单抗）联用治疗非小细胞肺癌、与维迪西妥单抗（HER2 ADC）联用治疗胃癌等。君实的特瑞普利单抗以 63.33% 增速逆势突围，目前已获批 11 项适应症，布局肾细胞癌、三阴性乳腺癌等差异化适应症，其鼻咽癌适应症获 FDA 批准并纳入《NCCN 指南》，成为复发/转移性鼻咽癌全线治疗唯一首选药物。值得一提的是，乐普生物普特利单抗在一众 PD-1/PD-L1 单抗中强势出击，全年销售额达 3 亿元，是 2023 年 1.01 亿元的 3 倍。这主要得益于乐普生物为其建立了一支高效的销售和营销团队，提高医生和患者群体对产品的认知度。同时，该药被纳入用于治疗黑色素瘤和 MSI-H/dMMR 实体瘤的 23 年 CSCO 及 CSGO 指南。乐普生物还在积极探索其联用方案，分别联用 MRG003（EGFR ADC）和 MRG002（HER2 ADC）探索用于治疗 EGFR 阳性实体瘤和 HER2 阳性实体瘤，未来的潜力不可估量。思路迪和康宁杰瑞联合开发的恩沃利单抗是榜上唯一一款负增长的药物，销售额同比下滑 29.75%，主要是红海市场竞争激烈。但从销售数据来看，2024 年下半年的销售较上半年增长 15.9%，反映出销售趋势出现了积极的转变。未来，企业考虑实施改进销售策略和扩大重要适应症，该药的销售将会进入一个正增长周期。封面来源：站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：ccaiPR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn

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. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation 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 to not use this publication as the basis for any investment decision. 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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