This early phase I trial tests the safety and how well N-803 works in treating patients with synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) that is growing, spreading, or getting worse (progressive) after being treated with adoptive cellular therapy (ACT) using T-cell receptor therapy (T-CRT). Synovial sarcoma is a rare, slow-growing cancer that affects the soft tissues, like muscles or ligaments near the joints. Myxoid/round cell liposarcoma is a rare type of soft tissue sarcoma cancer that originates from fat cells usually in the arms and legs. N-803 is a type of immunotherapy-a treatment that helps patients' own immune system fight cancer, and it is made up of a natural protein called interleukin-15 (IL-15) that is important for growing and activating immune cells. Studies have shown that patients can progress after initially responding to TCR-T, so this trial will use N-803 to stimulate rare persisting cells (cells that survive treatment and cause treatment failure and disease relapse) to make them work better at attacking the cancer. Adoptive cell therapy is a type of therapy that uses a patient's own immune cells to fight cancer. T-cell receptor therapy is a type of ACT that can recognize better recognize and bind to protein in cancer cells. Giving N-803 may be safe and tolerable in patients with SS or MRCL.

开始日期2026-09-02

申办/合作机构

Northwestern University

[+1]

NCT07492875

/ Not yet recruiting临床3期

Phase 3 Randomized, Blinded, Placebo-Controlled Study Evaluating Nogapendekin Alfa Inbakicept and iNKT Cells In Critically Ill Adults With Severe Community-Acquired Pneumonia With or Without Sepsis/Acute Respiratory Distress Syndrome

This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis or acute respiratory distress syndrome.
The study aims to determine if adding the experimental agents, Nogapendekin Alfa Inbakicept and iNKT cells, to standard medical care can reduce the 28-day all-cause mortality rate compared to standard care alone with a placebo.

开始日期2026-04-15

申办/合作机构

ImmunityBio, Inc.

NCT07492888

/ Not yet recruiting临床2期

Phase 2 Study Evaluating Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia With or Without Sepsis/Acute Respiratory Distress Syndrome.

This Phase 2 study tests whether adding two immune therapies - nogapendekin alfa-inbakicept (NAI) and off-the-shelf iNKT cell infusions - to standard care can safely help critically ill adults with severe community-acquired pneumonia (CAP) (with or without sepsis/ARDS) recover. The study will give NAI by subcutaneous injection (Days 1 and 10) and one IV dose of iNKT cells (Day 3), then follow participants for 90 days.

开始日期2026-04-15

申办/合作机构

ImmunityBio, Inc.

100 项与诺格白介素α-因奇西普相关的临床结果

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100 项与诺格白介素α-因奇西普相关的转化医学

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100 项与诺格白介素α-因奇西普相关的专利（医药）

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343

项与诺格白介素α-因奇西普相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

作者: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Lotan, Yair ; Zhao, Angela

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

2026-05-01·Biomaterials advances

A novel ROS switcher potentiates the type-I photodynamic effect of sodium zinc chlorophyllin against Pseudomonas aeruginosa in diabetic wounds

Article

作者: Yuan, Cai ; Wang, Guodong ; Chen, Hongjie ; Huang, Mingdong ; Wu, Lusheng

Skin wound infections present a serious threat to human health, with bacterial infections in diabetic wounds being particularly challenging due to impaired healing. Gram-negative bacteria are common pathogens in diabetic wound infections and often exhibit high resistance to conventional treatments, necessitating prolonged and costly therapies. Photodynamic antibacterial therapy (PACT) is regarded as a non-invasive and effective approach, with minimal risk of inducing resistance. Sodium zinc chlorophyllin (ZnChl), a water-soluble metalloporphyrin photosensitizer, offers multiple advantages such as low cost, high safety, and the ability to promote wound healing. However, its bactericidal efficacy against Gram-negative bacteria is limited under the hypoxic conditions typically found in diabetic wounds. Herein, we report a strategy to develop an efficient chlorophyll-based photosensitizer operating via an oxygen-independent Type I mechanism by combining ZnChl with inorganic salts (NaI, KBr, or KI). This approach significantly improved antibacterial performance, particularly with NaI or KI. Upon 630 nm light irradiation, low concentrations of KI (5 mM) markedly enhanced the bactericidal effect of ZnChl (50 μM), reducing the survival of three Gram-negative bacterial strains by 3 logs (99.9%). Interestingly, we further discovered that KI acts as a "reactive oxygen species (ROS) converter," shifting the photodynamic mechanism of ZnChl from a mixed Type I/Type II mode to a dominant Type I mechanism, generating highly reactive hydroxyl radicals (OH). Moreover, the ZnChl-KI combination demonstrated significant therapeutic efficacy in treating Pseudomonas aeruginosa-infected diabetic wounds without inducing apparent toxicity in rats. This work provides a foundation for developing efficient and economical Type I photosensitizers for the treatment of bacterial infections in diabetic wounds.

2026-03-02·Zhonghua er ke za zhi = Chinese journal of pediatrics

[Analysis of viral nucleic acid negativity and neuraminidase inhibitor use in children with severe influenza].

Article

作者: Li, Z ; Liu, Y C ; Fang, B L ; Li, K C ; Qian, S Y ; Liu, G

Objectives: To determine the time to influenza virus nucleic acid clearance and the treatment duration of neuraminidase inhibitors (NA) in children with severe influenza admitted to the pediatric intensive care unit (PICU) following NA initiation. This study further aimed to identify factors associated with delayed viral clearance and to evaluate the appropriateness of different NA discontinuation strategies. Methods: In this retrospective cohort study, we analyzed the clinical data of 79 children with severe influenza admitted to the PICU of Beijing Children's Hospital between November 2019 and July 2024. Inclusion criteria were continuous NA administration for ≥72 h after admission, and serial nasopharyngeal swab tests for influenza virus nucleic acid performed at 3 to 5 d intervals following NA initiation until clearance or discharge. Collected data included demographic characteristics, serial nucleic acid test results, body temperature, NA treatment duration, and in-hospital mortality were collected. Children were stratified into three groups based on time from NA initiation to viral nucleic acid clearance:≤5 d, 6-10 d, and >10 d, the latter 2 of which belong to the delayed clearance group. They were also categorized according to clinical status at NA discontinuation: the fever group (fever present, nucleic acid negative), the necleic acid-positive group (afebrile, nucleic acid positive) and the double-negative group (afebrile, nucleic acid negative). Select the appropriate statistical test from among the Chi-square test, Kruskal-Wallis H test, or Mann-Whitney U test to compare between-group differences in the following variables: duration of NA use, co-infection rate, proportion of patients with fever after 5 days of NA use, pediatric risk of mortality Ⅲ score (PRISM Ⅲ) at 48 h after NA discontinuation, pediatric sequential organ failure assessment score (pSOFA) , and in-hospital mortality rate. Results: Of the 79 children with severe influenza, 43 (54%) were male and 36 (46%) female. The age was 4.6 (2.3,7.7) years. Patients were categorized into the ≤5 d (30 cases), 6-10 d (34 cases), and >10 d (15 cases) groups. The overall proportion of delayed clearance was 62% (49/79). The >10 d group demonstrated a significantly longer duration of NA therapy, higher co-infection rate, and a greater proportion of patients with persistent fever after 5 d of treatment compared to the other groups (all P<0.05). The ≤5 d group had the lowest incidence of lymphopenia detected on days 4 and 5 after PICU admission (χ²=6.08, P<0.05). No significant differences were observed among the fever (11 cases), nucleic acid-positive (26 cases), and double-negative (42 cases) groups regarding in-hospital mortality, PRISM Ⅲ, or pSOFA at 48 h after NA discontinuation (P>0.05). Conclusions: A considerable proportion of children with severe influenza in the PICU experienced delayed viral clearance after NA initiation, which was associated with a longer treatment course, particularly in those requiring >10 d for clearance. Discontinuation of NA upon achieving virological clearance or defervescence may be considered, but this strategy requires careful clinical judgment tailored to the individual patient.

351

项与诺格白介素α-因奇西普相关的新闻（医药）

2026-04-07

·PRNewswire

IBRX SHAREHOLDER UPDATE: ImmunityBio (IBRX) Sued After FDA Flags Misleading Cancer Claims, Shares Plunge 21%, $2B Market Cap Lost -- Hagens Berman

SAN FRANCISCO, April 7, 2026 /PRNewswire/ -- ImmunityBio, Inc. (NASDAQ: IBRX) faces a securities class action lawsuit which seeks to represent investors who purchased or otherwise acquired ImmunityBio securities between January 19, 2026 and March 24, 2026. The lawsuit follows news that the FDA sent a warning letter to the company concerning claims made by its executive chairman and Chief Scientific and Medical Officer (Dr. Patrick Soon-Shiong) regarding ImmunityBio's lead biologic product (Anktiva), which the FDA said were misleading efficacy claims. This news drove the price of ImmunityBio shares down over 21% on March 24, 2026. The developments have prompted national shareholders rights firm Hagens Berman to investigate claims that ImmunityBio violated the federal securities laws. The firm urges investors in ImmunityBio who suffered significant losses to submit your losses now. The firm also encourages witnesses who may be able to assist in the investigation to contact its attorneys. Class Period: Jan. 19, 2026 – Mar. 24, 2026 Lead Plaintiff Deadline: May 26, 2026 Visit: Contact the Firm Now: [email protected] 844-916-0895 ImmunityBio, Inc. (IBRX) Securities Class Action: ImmunityBio is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. The company's Anktiva is an FDA-approved immunotherapy used with Bacillus Calmette-Guérin ("BCG") to treat non-muscle invasive bladder cancer ("NMIBC"). The lawsuit is focused on the propriety of ImmunityBio's claims about Anktiva's efficacy for treating other forms of cancer. On January 19, 2026, a direct-to-consumer podcast ("Is the FDA BLOCKING Life Saving Cancer Treatments?") aired, featuring Soon-Shiong. During the podcast, he said in part that, while Anktiva is approved for bladder cancer, "it actually can treat all cancers." Soon-Shiong made other questionable claims about Anktiva, which together were flagged by the FDA as misleading. On March 24, 2026, the financial press reported that the FDA sent a warning letter to ImmunityBio over claims made in the podcast and a TV ad. The warning letter states the "FDA has determined that the TV ad and podcast are false or misleading." The FDA explained, "the promotional materials create the misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer." In addition, the FDA warned that "the representations in the TV ad and podcast misleadingly suggest that Anktiva will allow all NIMBC patients treated with Anktiva to be cancer-free for the long term, when this has not been demonstrated" and "we are not aware of data that support the efficacy claims and representations that Anktiva can 'cure' cancer." The FDA also said ImmunityBio's promotional materials were misleading because "they fail to provide material information regarding Anktiva's full FDA-approved indication." Lastly, the FDA warned that ImmunityBio's "consistent and pervasive misleading efficacy claims and representations presented across promotional materials on different platforms are especially concerning from a public health perspective, given they grossly misrepresent the benefits of Anktiva." This news drove the price of ImmunityBio shares down over 21% on March 24, 2026, erasing nearly $2 billion of the company's market capitalization. "We're investigating claims that ImmunityBio intentionally misled investors about Anktiva efficacy and indications," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation. If you invested in ImmunityBio and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the ImmunityBio case and the firm's investigation, read more » Whistleblowers: Persons with non-public information regarding ImmunityBio should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. About Hagens Berman Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. SOURCE Hagens Berman Sobol Shapiro LLP 21% more press release views with Request a Demo

免疫疗法

2026-04-06

·BioSpace

ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance

Company initiated a comprehensive review of promotional materials and is implementing enhanced advertising compliance measures, including expanded promotional review protocols, executive training, and external regulatory oversight Company has removed the identified podcast from its corporate website and formally requested its removal from all third-party hosting platforms Company confirmed that the television advertisement cited in the FDA correspondence was never broadcast, aired, or disseminated to the public CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced it has submitted a comprehensive response to the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) regarding issues raised on March 13, 2026 related to a television advertisement and a podcast. The company addressed the concerns related to the podcast and informed OPDP that the television advertisement was never aired. The response outlines the company's immediate and planned corrective actions and its ongoing commitment to ensuring all promotional communications for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) are accurate, balanced, and compliant with FDA regulations. Commitment to Advertising Compliance and Resolution ImmunityBio has taken proactive steps to address the OPDP’s concerns, including the removal of the identified podcast from its corporate website and requesting its removal from third-party platforms. Additionally, the company confirmed that a television advertisement mentioned in the OPDP letter was never broadcast or disseminated to the public. “ImmunityBio takes promotional compliance with the utmost seriousness,” said Richard Adcock, President and CEO of ImmunityBio. “We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies. We believe our substantive remedial actions and enhanced internal protocols address the Agency’s concerns.” Upon receipt of the letter from OPDP, ImmunityBio initiated a comprehensive review of all promotional materials and external communications claims with its legal and regulatory teams. The company is implementing a robust suite of corrective actions and compliance enhancements, including mandatory executive training, expanded Promotional Review Committee (PRC) protocols, and the engagement of external regulatory counsel to audit future high-visibility communications. Clarifying the Context of Scientific Innovation In its response, ImmunityBio also provided background regarding the statements cited by the Office of Prescription Drug Promotion, which occurred during a podcast appearance by Founder and Executive Chairman Dr. Patrick Soon-Shiong. The company noted that these remarks were intended to convey Dr. Soon-Shiong’s aspirational and forward-looking opinions regarding his vision for the company’s drug development pipeline and the underlying science supporting the strategy of treating patients with cancer. Other key points of clarification include: The characterization of the IL-15 molecule, the foundation of ANKTIVA, as a highly promising agent was based on an independent assessment by the National Cancer Institute (NCI) during its Immunotherapy Agent Workshop dated July 12, 2007. 1 The discussion focused on the investigational applications of the IL-15 platform across multiple oncology indications, where it is currently being studied under FDA-authorized investigational programs. References to "cancer vaccines" were intended to describe the mechanistic potential of immunotherapies that induce memory T cells, a fundamental goal of the company’s long-term research strategy, as stated in multiple scientific publications. 2 About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA ® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA ® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA ® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA ® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA ® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA ® at Anktiva.com . About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding our planned corrective actions and compliance enhancements. These statements are based on the Company’s current expectations, beliefs, assumptions, and plans and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the Company’s ability to successfully execute on these corrective action and compliance enhancement plans and the reliance on the cooperation of third-parties for certain corrective actions. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. References: Cheever, Martin A. Twelve immunotherapy drugs that could cure cancers. Immunological Reviews. 2008;222(1):357–368. doi:10.1111/j.1600-065X.2008.00604.x. Kartikasari AER, Prakash MD, Cox M, Wilson K, Boer JC, Cauchi JA, Plebanski M. Therapeutic Cancer Vaccines—T Cell Responses and Epigenetic Modulation . Front Immunol. 2019 Jan 25;9:3109. Contacts Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com

免疫疗法疫苗放射疗法

2026-04-03

·中国食品药品网

2月份中美欧批准上市新药盘点我国自主研发的三款新药在全球范围内首次获批上市

2月份，中美欧批准上市的新药中，中国批准的新药数量最多，为5款；美国批准4款；欧盟批准3款新药上市。中国批准5款新药上市2月份，我国共批准5款新药上市（详见表1）。根据Pharmadigger数据库，安沐奇塔单抗注射液、罗伐昔替尼片和硫酸索西美雷塞片为我国企业自主研发的全球范围内首次获批上市的新药。精氨酸艾曲莫德片（商品名：维适平）是一款高选择性鞘氨醇-1-磷酸受体（S1PR）调节剂，可选择性作用于S1PR1、S1PR4和S1PR5靶点。该药最初由美国Arena Pharmaceuticals开发，2017年12月，云顶新耀以总交易额2.24亿美元获得其在大中华区和韩国的独家开发、生产及商业化权益。2021年12月，辉瑞完成对Arena的收购，进而取得该产品的全球剩余权益。该药本次获批的适应证为：对传统治疗或生物制剂应答不充分、失应答或不耐受的成人中度至重度活动性溃疡性结肠炎。其亚洲多中心Ⅲ期临床研究数据显示，经40周维持治疗后，艾曲莫德组在主要终点及全部关键次要终点上，均较安慰剂组实现具有临床意义与统计学意义的改善。该药最早于2023年10月在美国获批上市。米吉珠单抗注射液[商品名：安妥来（皮下注射）；安妥来利（静脉输注）]由礼来研发，是一款选择性靶向白细胞介素-23（IL-23）p19亚基的单克隆抗体。该药通过阻断IL-23与受体结合，抑制促炎细胞因子和趋化因子释放，从而发挥抗炎作用。该药本次获批用于治疗成人中重度活动性克罗恩病及溃疡性结肠炎。其中，克罗恩病适应证的获批主要依据其VIVI D-1全球Ⅲ期临床研究。研究结果显示，米吉珠单抗组较安慰剂组在联合主要终点及全部关键次要终点上均实现具有临床意义的改善。溃疡性结肠炎适应证的获批则基于LUCENT系列全球Ⅲ期临床研究结果：米吉珠单抗组64%的患者获得临床应答，24%的患者达到临床缓解，数据均显著优于安慰剂组。该药此前已于2023年3月在日本获批上市。安沐奇塔单抗注射液（商品名：益赛拓）由三生国健自主研发，为抗白细胞介素17A（IL-17A）单克隆抗体，用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病成人患者。该药也是目前国内已获批上市产品中，少数可在维持期实现每8周1次给药的IL-17A抑制剂之一。在作用机制方面，安沐奇塔单抗拥有独特的抗原结合表位，对IL-17A表现出较高亲和力、较强抑制活性和较好稳定性，同时免疫原性较低。该药本次获批主要基于其Ⅲ期临床研究结果：约三分之二的患者在第52周时可实现皮损完全清除。罗伐昔替尼片（商品名：安煦）是正大天晴自主研发的新型口服JAK/ROCK双靶点抑制剂，适用于中危-2或高危的原发性骨髓纤维化、真性红细胞增多症后骨髓纤维化或原发性血小板增多症后骨髓纤维化成人患者的一线治疗，主要改善疾病相关脾肿大或疾病相关症状。作用机制方面，罗伐昔替尼既可抑制JAK家族激酶活性、阻断JAK/STAT通路异常持续激活，又可抑制ROCK2、降低STAT3磷酸化水平，进而在一定程度上重建免疫平衡。该药本次获批主要基于其一项关键注册研究结果：经独立评审委员会评估，治疗第24周时，罗伐昔替尼组脾脏体积缩小≥35%的患者比例为58.33%，显著高于对照组的22.86%。今年3月4日，正大天晴宣布将罗伐昔替尼在全球范围内开发、生产和商业化的独家许可授权给赛诺菲。根据公开信息，正大天晴母公司中国生物制药可获得最高15.3亿美元交易总金额，其中包括1.35亿美元的首付款，以及后续开发、注册与销售相关里程碑付款，并可基于罗伐昔替尼年度净销售额获得最高双位数阶梯式特许权使用费。硫酸索西美雷塞片（商品名：济乐美）是杭煜制药自主研发的KRAS G12C抑制剂，适用于至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因G12C突变型晚期非小细胞肺癌成人患者。其临床前研究显示，与同靶点药物相比，该药物具有更强的脑通透性，且无明显心脏毒性及药物相互作用风险。该药本次获批基于其Ⅱ期临床试验数据，结果显示，约半数患者达到客观缓解，中位缓解时间为1.4个月。美国批准4款新药上市2月份，美国批准4款新药上市（详见表2）。根据Pharmadigger数据库，Milsaperidone为全球范围内首次获批。Difamilast（商品名：Adquey）由大塚制药研发，是一款非甾体、高选择性外用磷酸二酯酶4（PDE4）抑制剂，用于2岁及以上儿童与成人轻中度特应性皮炎的局部治疗。其作用机制为精准抑制与炎症密切相关的PDE4B亚型，阻断IL-4、IL-13、TNF-α等促炎细胞因子释放，从源头控制炎症与瘙痒。该药本次获批基于其关键全球Ⅲ期临床研究。研究结果显示，患者接受1% Difamilast治疗后，从研究者整体评估（IGA）看，其治疗成功率显著优于安慰剂组，且差异具有统计学意义。该药最早于2021年9月在日本获批上市。Milsaperidone（商品名：Bysanti）由Vanda公司研发，为伊洛哌酮的前体药物，口服后可迅速转化为伊洛哌酮并发挥药理作用。该药本次获批用于治疗成人精神分裂症，以及成人双相I型障碍伴发躁狂或混合发作急性期治疗。其核心机制为拮抗中枢多巴胺D2受体与5-羟色胺2A（5-HT2A）受体。其中，对D2受体的拮抗有助于调节中脑边缘通路的多巴胺能神经传递，是控制精神分裂症阳性症状及躁狂期精神运动性兴奋的重要基础；对5-HT2A受体的拮抗，则有助于改善阴性症状和部分认知功能，同时降低单纯D2拮抗所致锥体外系不良反应风险。该药本次获批主要基于一项为期4周的多中心、随机、双盲、安慰剂对照试验。试验结果显示，Milsaperidone 12mg每日两次给药组在精神症状和体征量表改善方面显著优于安慰剂组。Pegzilarginase-nbln（商品名：Loargys）由Immedica公司研发，是经PEG修饰的重组人精氨酸酶1，通过金属离子优化提升酶活性与体内半衰期，用于治疗精氨酸酶1缺乏症（ARG1-D）相关高精氨酸血症。ARG1-D是一种极为罕见的常染色体隐性遗传代谢病，是尿素循环障碍中最少见的亚型之一。该药本次获批基于一项Ⅲ期临床试验。试验结果显示，在2至29岁ARG1-D患者中，经Pegzilarginase-nbln治疗24周后，约90.5%的患者血精氨酸水平降至正常范围或指南目标值以下，显著优于安慰剂组。该药此前已于2023年12月在欧盟获批上市。Navepegritide（商品名：Yuviwel）由Ascendis公司基于TransCon技术平台研发，是一款C型利钠肽（CNP）前药，采用每周一次皮下注射给药。该药通过持续释放活性CNP，拮抗软骨发育不全患者体内过度激活的FGFR3信号通路，从而促进线性生长。其关键研究结果表明，Navepegritide可显著提高2岁及以上、骨骺未闭合的软骨发育不全儿童的年化生长速度，达到预设主要疗效终点。欧盟批准3款新药上市2月份，欧盟批准3款新药上市（详见表3）。根据Pharmadigger数据库，均非全球首次批准上市的新药。Nogapendekin alfa inbakicept（商品名：Anktiva）是ImmunityBio公司研发的IL-15受体激动剂。该药可联合卡介苗（BCG），用于治疗对BCG无应答的成人非肌层浸润性膀胱癌，伴原位癌，伴或不伴乳头状肿瘤。该药此前已于2024年4月在美国获批上市。Depemokimab（商品名：Exdensur）是葛兰素史克研发的新一代抗IL-5单克隆抗体，用于治疗重度哮喘。该药具有半衰期长、结合亲和力高、药效强的特点，仅需每半年注射一次。该药此前已于2025年12月在美国获批上市。Aficamten（商品名：Myqorzo）是Cytokinetics公司研发的选择性小分子心肌肌球蛋白抑制剂，用于治疗NYHA（纽约心脏协会）心功能分级Ⅱ-Ⅲ级的梗阻性肥厚型心肌病成人患者，以改善运动能力与临床症状。该药通过化学结构优化提升治疗指数与药代动力学特征，减少每个心动周期中活性肌球蛋白产力横桥的数量，从而抑制肥厚型心肌病相关的心肌过度收缩。该药此前已于2025年12月在美国获批上市。（注：本文中的新药分别按中国、美国、欧盟三地新分子实体或生物药首次NDA/BLA来统计，一些药物首先在美国上市后首次在中国或欧盟上市时也会纳入统计）《中国医药报》社版权所有，未经许可不得转载使用。 (责任编辑：刘思慧)

100 项与诺格白介素α-因奇西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12888	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
原位癌	欧盟	ImmunityBio, Inc.	2026-02-16
原位癌	冰岛	ImmunityBio, Inc.	2026-02-16
原位癌	列支敦士登	ImmunityBio, Inc.	2026-02-16
原位癌	挪威	ImmunityBio, Inc.	2026-02-16
非肌层浸润性膀胱尿路上皮癌	沙特阿拉伯	ImmunityBio, Inc.	2026-01-14
淋巴细胞减少	美国	ImmunityBio, Inc.	2025-06-02
非肌层浸润性膀胱肿瘤	美国	Altor BioScience Corp.	2024-04-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
社区获得性肺炎	临床3期	-	ImmunityBio, Inc.	2026-04-15
急性呼吸窘迫综合征	临床3期	-	ImmunityBio, Inc.	2026-04-15
脓毒症	临床3期	-	ImmunityBio, Inc.	2026-04-15
脓毒性休克	临床3期	-	ImmunityBio, Inc.	2026-04-15
肺癌	临床3期	美国	ImmunityBio, Inc.	2022-07-27
晚期非小细胞肺癌	临床3期	美国	ImmunityBio, Inc.	2018-05-18
转移性非小细胞肺癌	临床3期	美国	ImmunityBio, Inc.	2018-05-18
膀胱癌	临床3期	美国	ImmunityBio, Inc.	2017-06-02
复发性非小细胞肺癌	临床2期	美国	ImmunityBio, Inc.	2026-03-31
新冠肺炎后遗症	临床2期	美国	ImmunityBio, Inc.	2025-09-04

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02523469 (CTgov)	临床1/2期	转移性非小细胞肺癌	67	ALT-803+Nivolumab (Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg)	糧廠獵醖蓋簾鏇憲廠糧 = 蓋網廠製積遞蓋繭廠夢觸願膚蓋積壓製餘鏇齋 (網鹽衊憲壓糧範鏇齋構, 繭衊遞觸鹹壓艱遞顧壓 ~ 顧壓構衊窪膚夢鹽繭積) 更多	-	2026-02-17
				ALT-803+Nivolumab (Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg)	糧廠獵醖蓋簾鏇憲廠糧 = 鹽願觸顧夢鹽壓網淵鹽觸願膚蓋積壓製餘鏇齋 (網鹽衊憲壓糧範鏇齋構, 鬱醖觸衊鹽構鹹遞獵艱 ~ 鹹遞觸淵鹽餘壓製製範) 更多
NCT04491955 (Pubmed \| Oncologist)	临床1/2期	转移性结直肠癌 pMMR	32	CV-301 + N-803 + bintrafusp alfa + PDS01ADC	蓋壓鹹襯醖廠夢顧遞憲(鬱壓獵醖繭窪鹹網範蓋) = 繭醖艱簾範積鹽獵觸壓選遞襯淵鏇糧廠構壓糧 (憲窪鏇膚襯鬱蓋淵夢遞 ) 更多	不佳	2026-02-05
NCT03520686 (QUILT-2.023, Company_Website) 人工标引	临床3期	转移性非小细胞肺癌 \| 晚期非小细胞肺癌一线	-	ANKTIVA + CPI	糧壓糧鹽壓鑰壓遞夢繭(鑰築鏇遞觸鹹醖淵選觸): P-Value = 0.0065	积极	2026-01-13
				CPI
NCT03228667 (QUILT-3.055, Company_Website) 人工标引	临床2期	非小细胞肺癌二线	-	ANKTIVA + CPI (NSCLC)	醖築餘膚餘構選觸遞網(襯夢鹽窪壓夢醖鹹襯簾) = 衊製獵衊選夢鹹簾糧壓壓窪鑰糧鏇壓鹽壓範鏇 (網願壓鏇獵膚鑰壓膚齋 )	积极	2026-01-13
				ANKTIVA + CPI (NSCLC + Responders)	網夢構膚範衊觸鬱觸願(鏇繭鏇願遞顧構顧膚齋) = 鏇鬱膚願廠鏇簾憲網顧膚廠淵鹹鬱築鏇襯網糧 (鑰網願範淵夢餘積簾製 )
NCT03022825 (QUILT-3.032, Pubmed \| J Urol)	临床2期	-	54	NAI plus BCG (BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer)	網窪壓齋淵願襯淵襯繭(製醖淵選壓壓範繭獵醖) = 顧繭遞鹹顧鑰繭鹹糧積鏇積艱壓選鏇簾鏇糧選 (窪艱膚範鹹築顧膚積鹹, 46.6 ~ 68.2) 更多	积极	2026-01-01
NCT03493945 (QuEST1, SITC2025)	临床1/2期	去势抵抗性前列腺癌	37	BNVax+BA+NAI	衊衊淵衊夢鬱繭淵構顧(築齋夢鏇積醖鬱憲餘衊) = 鹽醖範獵艱窪糧鑰鏇築艱廠獵積憲壓網襯鏇齋 (積窪窪構窪製鬱鹹窪製 )	积极	2025-11-05
NCT03022825 (QUILT-3.032, Pubmed \| J Urol)	临床2期	-	54	NAI plus BCG (BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer)	齋艱鬱蓋繭繭鬱範蓋選(膚遞願鏇膚襯廠範糧積) = 鏇鏇淵構顧蓋鏇網鬱築鹹憲淵膚齋艱鬱繭獵構 (糧鑰繭繭壓鬱膚蓋糧簾, 46.6 ~ 68.2) 更多	积极	2025-11-03
NEWS 人工标引	N/A	复发性胶质母细胞瘤	5	Anktiva	膚範鹹構膚築築醖壓願(繭網顧齋網艱鹽願餘鬱) = 鹽蓋糧築蓋淵窪簾醖築製艱憲壓襯鑰窪獵簾網 (範襯獵範膚製積齋簾糧 )	积极	2025-08-29
NCT03493945 (QuEST1, CTgov)	临床1/2期	局部晚期恶性实体瘤 \| 晚期恶性实体瘤	59	castration+M7824+BN-Brachyury (Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A)	鬱構膚壓願鏇齋膚艱膚 = 廠顧窪襯遞蓋艱鏇艱獵構膚夢觸餘簾鬱鑰蓋壓 (膚繭憲積艱範築醖窪齋, 鏇網餘壓顧鑰糧顧觸網 ~ 鏇鬱範夢鬱衊網鬱糧憲) 更多	-	2025-06-08
				N-803+M7824+BN-Brachyury (All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion)	鬱構膚壓願鏇齋膚艱膚 = 廠製蓋衊廠製網願顧顧構膚夢觸餘簾鬱鑰蓋壓 (膚繭憲積艱範築醖窪齋, 鏇淵鑰製製鑰齋繭糧願 ~ 糧壓艱糧願顧獵糧觸簾) 更多
NCT04390399 (QUILT-88, ASCO2025)	临床2期	转移性胰腺癌 ALC \| CA19-9	84	N-803 and PD-L1 t-haNK chemo-immunotherapy	蓋構築遞網壓選築餘糧(範鏇簾簾醖簾鹽觸鬱衊) = Grade 3 or higher TEAEs occurred in 95% of patients and were largely chemotherapy-associated 簾蓋衊醖齋網繭齋範鹹 (鏇窪鬱鑰膚廠壓鏇鏇顧 )	积极	2025-05-30
				Low-dose SBRT and low-dose chemotherapy