Pembrolizumab

摘要:据 Nature 预测，2024-2026 年全球畅销药格局剧变。肿瘤领域，Keytruda以294.8 亿美元蝉联 2024 年销冠，皮下剂型与联合疗法应对专利危机；Darzalex增速超 20%。代谢领域，礼来替尔泊肽系列2026年合计超450亿美元反超诺和诺德，司美格鲁肽因专利到期份额下滑。自免领域，Skyrizi2026年以210亿美元登顶。双靶点、新剂型成竞争核心，专利周期主导市场洗牌。 肿瘤领域：剂型创新破局，头部药攻守博弈 默沙东 Keytruda（帕博利珠单抗）仍是肿瘤领域核心，2024 年以 294.8 亿美元蝉联全球畅销药榜首，增长近 18%，获批适应症超 40 种。但危机显现：核心专利 2028 年到期，生物类似药布局者涌现，FDA 提议缩小部分适应症适用范围，叠加美国 IRA 价格谈判压力，2027 年后销售额或下滑。默沙东以剂型革新应对，其 Keytruda 皮下注射剂型 III 期试验疗效不劣于静脉注射，给药时间缩至 2-3 分钟，已提交上市申请；同时构建“专利丛林”，拟将保护期延长至 2036 年，并通过 mRNA 疫苗联用、ADC 药物合作等联合疗法抵御风险。强生 Darzalex（达雷妥尤单抗）稳健增长，2024 年销售额破 100 亿美元，2025 年前三季度达 104.48 亿美元（+21.7%），预计全年超 140 亿美元。皮下注射剂型将给药时间压缩至 3-5 分钟，成增长核心，2025 年预计占多发性骨髓瘤市场 56% 份额。但 TCE 双抗、CAR-T 疗法崛起分流患者，未来份额或受挤压。 代谢领域：GLP-1 双雄争霸，礼来反超改写格局代谢领域爆发式增长源于 GLP-1 类药物突破。2024 年诺和诺德司美格鲁肽系列合计销售额超 296 亿美元领跑，Ozempic 单药 166.31 亿美元居全球第二，凭单靶点（GLP-1）与多剂型成“初代王者”。2025 年礼来替尔泊肽系列以双靶点（GLP-1/GIP）反超，Mounjaro 销售额近 200 亿美元，Zepbound 破 110 亿美元，合计超 310 亿美元（增速均超 50%），第二季度单季销售额 85.80 亿美元首次超越司美格鲁肽，美国处方占比达 57.9%。这一优势源于头对头试验：替尔泊肽 72 周平均减重 22.8 公斤，较司美格鲁肽多减 7.8 公斤。2026 年预测显示，替尔泊肽系列合计超 450 亿美元，Mounjaro 居全球第二；诺和诺德司美格鲁肽预测销售额降至 197 亿美元（排名第六），核心专利 2026 年到期，国内 20 余家企业布局生物类似药，叠加美国 CMS 价格谈判影响，股价曾单月暴跌超 30%。目前 GLP-1 市场向多极发展，安进 MariTide、信达生物玛仕度肽等进入临床后期，玛仕度肽与替尔泊肽的头对头试验将影响 2026 年格局。 2026 top 10 畅销药预测 2025 top 10 畅销药预测 2024 top 10 畅销药预测 自免领域：Skyrizi 异军突起，Dupixent 稳中有进赛诺菲与再生元的 Dupixent（度普利尤单抗）长期领跑，2024 年销售额 130.72 亿美元，2025 年预计近 170 亿美元，新增 COPD 适应症打开增长空间，成自免领域“压舱石”。艾伯维 Skyrizi（利生奇珠单抗）成“黑马”，2024 年销售额 117.18 亿美元（+50.9%），2025 年达 137 亿美元升至全球第五，2026 年预测 210 亿美元，将超越 Dupixent 成新龙头。其成功源于差异化疗效与适应症拓展，验证了 IL-23p19 靶点潜力，该靶点药物 2025 年合计销售额超 220 亿美元，未来将达 300-400 亿美元规模。Dupixent 虽有 10 项获批适应症，但增速放缓至 15% 左右，2026 年份额或遭压缩。 全球医药市场三大核心趋 一是治疗领域重心转移，代谢领域跃升为核心，2026 年 GLP-1 类药物将占全球畅销药 TOP10 中 4 席，合计销售额超 870 亿美元。二是技术路线迭代加速，双靶点、多剂型成竞争关键，替尔泊肽双靶点设计、Keytruda 剂型革新构建壁垒。三是专利周期主导风险，头部药物面临市场分流，剂型创新、联合疗法、专利布局成药企核心应对策略。未来新兴疗法将推动格局进一步发展。 参考来源: https://www.nature.com/articles/d41573-025-00203-x 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

Poster PS5-08-16 Reports Early Observations from the INVINCIBLE-4 Study, an Ongoing Randomized, Presurgical Phase 2 Clinical Trial for Triple Negative Breast Cancer continue to show favorable safety 50% fewer grade 3 or higher Adverse Events were observed in the INT230-6 cohort compared to the Standard of Care ("SOC") neoadjuvant chemotherapy alone cohort. Poster PS4-10-15 Describes An Overview of a Potential Phase 3 Clinical Study Design with INT230-6 plus standard of care with and without the toxic anthracycline, doxorubicin SHELTON, Conn., Dec. 11, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, announces it will present two posters at the San Antonio Breast Cancer Symposium ("SABCS"), in San Antonio, TX being held at the Henry B. Gonzalez Convention Center. On Friday, December 12, 2025 at 12:30 PM CST, Andreas Müller, M.D., from the Department of Medicine at the Kantonsspital Winterthur, Switzerland and Head of the Breast Center will present on behalf of the Swiss Cancer Institute abstract #1589 PS5-08-16, titled, Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer (TNBC): Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Clinical Trial. Today, December 11, 2025 at 5 PM CST, Lewis H. Bender, M.S., M.A., M.B.A., Intensity Therapeutics Founder, President and CEO, will present abstract #801 Poster PS4-10-15, titled , Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations. INVINCIBLE-4 Study Observations The INVINCIBLE-4 study was activated in 2024. Fourteen patients have been treated to date with 7 in each cohort. Observations to date include the following: The safety data for the patients who received INT230-6 plus SOC ("Cohort A"), continues to be favorable compared to the standard of care ("SOC") alone ("Cohort B") Seven patients have been treated per cohort (14 patients total); there were nine grade 3 or higher adverse events in the INT230-6 plus SOC and 20 events in the SOC alone through November 10th (see Figure below) A patient with a 2.2 cm tumor who received one dose of INT230-6 showed skin irritation at the time of surgery. However, skin and adipose tissue necrosis on MRI scans were observed in some patients who received two doses, thereby requiring more surgery. As a result, the protocol is being modified to administer a single dose at lower volumes for each tumor size. If tumor necrosis is observed on MRI after the first dose of INT230-6 prior to the start of SOC, then a second dose will not be made. Potential Phase 3 Clinical Study Design If safety and efficacy trends continue in the INVINCIBLE-4 Study, a Phase 3 clinical study design may include a treatment arm using INT230-6 and SOC without anthracycline compounds such as doxorubicin, a highly cardiotoxic agent. Doxorubicin is often referred to by patients and physicians as "the red devil" because of its red color and harsh effects. In today's presentation, Mr. Bender discusses a potential Phase 3 clinical study concept using INT230-6 with SOC with and without doxorubicin compared to SOC alone . Currently, the SOC treatment includes immunotherapy (pembrolizumab), an anthracycline (usually doxorubicin), carboplatin, cyclophosphamide, and taxane. Depending on the strength of the pCR data from the INVINCIBLE-4 Study and a lead-in cohort of patients in a potential Phase 3 trial, a three-arm randomized, controlled Phase 3 trial could be 1) INT230-6 with SOC, 2) current SOC, and 3) INT230-6 with SOC without the anthracycline. Christine Handy, a patient advocate and co-author on the poster number PS4-10-15 noted, "I have experienced permanent cardiotoxicity using the red devil, doxorubicin, when treated for my breast cancer and know full well how that agent can disrupt the lives and health of those fighting cancer. Patients can be harmed by the treatment for this potentially deadly disease and often have to make a difficult choice as some fear the harmful effects of therapy as much as the cancer itself. I am encouraged by companies such as Intensity Therapeutics with new concepts for improving safety and efficacy for patients and am excited by the early observations of this new and novel drug treatment." Mr. Bender concluded, "Triple Negative Breast Cancer is one of the most aggressive and difficult to treat breast cancer subtypes. While our INVINCIBLE-4 Study is still early, we are encouraged by the observed safety as reported in the PS5-8-16 poster and pCR results received to date when our drug is combined with SOC immunochemotherapy. These new safety results are consistent with the data from pre-clinical and clinical data when our drug is combined with immunotherapies. We look to restart patient enrollment in INVINCIBLE-4 study using the modified dosing regimen to improve our results as soon as possible. Should the safety and pCR results remain favorable, we plan to approach regulatory authorities with a Phase 3 study design that could yield a safer, more effective presurgical dosing regimen with good cosmetic outcomes for patients. Subject to regulatory agreement, using pCR as the surrogate endpoint could allow for an accelerated approval of a TNBC regimen without the red devil in a timeframe sooner than current trials that are evaluating event free survival." About Triple Negative Breast Cancer in the Presurgical Setting Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of recurrence. Approximately 11-17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, the majority of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients. About a Potential INT230-6 Approval Pathway in the Presurgical Setting The U.S Food and Drug Administration ("FDA") instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. Pathological complete response ("pCR") is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as TNBC subtype. Pathological complete response is defined as the absence of residual invasive and in situ cancer after evaluation of the complete resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy. If a product is approved using pCR, companies must still seek full approval using event free survival as an endpoint. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit or review our SEC filings. About Christine Handy Christine Handy is an American model, author, motivational speaker, Executive producer and breast cancer survivor. She has been a print model for over 40 years. Handy was diagnosed with an aggressive form of breast cancer on October 1, 2012. She experienced 28 rounds of chemotherapy and a double mastectomy. Handy's 2016 novel Walk Beside Me is a fictionalized story of the ordeal of a successful model who receives a breast cancer diagnosis and several rounds of chemotherapy using doxorubicin. It was a national bestseller. In May of 2025, the independent film, Hello Beautiful, based on Christine's life, won the Golden Palm Best Picture Award at the prestigious and influential 25th Annual Beverly Hills Film Festival. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik CORE IR [email protected] (516) 222-2560 Media Contact: Matt Cossel CORE IR [email protected] SOURCE Intensity Therapeutics Inc. 21% more press release views with Request a Demo