A Phase I/II Study of Natalizumab as a Single Agent in Children, Adolescents and Young Adults With Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

The purpose of this study is to evaluate the safety and tolerability of Natalizumab in children, adolescent and young adult patients with pulmonary metastatic osteosarcoma (pOS) and to assess clinical response associated with this treatment as well as overall survival.

开始日期2024-12-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT05658497

/ RecruitingN/A

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

开始日期2023-10-27

申办/合作机构

Biogen, Inc.

NCT05618301

/ Active, not recruiting临床1期IIT

A Pilot Safety and Feasibility Study to Evaluate Motixafortide (CXCR4/SDF-1 Inhibition) and Natalizumab (VLA-4/VCAM-1 Inhibition) as a Novel Regimen to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate the therapeutic product, and currently available mobilization regimens carry unacceptable risk for patients with SCD or do not reliably yield optimal numbers of HSCs for gene therapy.
The investigators hypothesize that HSC mobilization with motixafortide (CXCR4i) alone and the combination of motixafortide plus natalizumab (VLA-4i) will be safe and tolerable in SCD patients. In addition, the investigators hypothesize that combined CXCR4 and VLA-4 blockade with motixafortide plus natalizumab will result in a rapid, robust, and synergistic increase in HSC mobilization to peripheral blood (PB) in patients with SCD, when compared to motixafortide alone.

开始日期2023-07-07

申办/合作机构

Washington University School of Medicine

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100 项与那他珠单抗相关的专利（医药）

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项与那他珠单抗相关的文献（医药）

2025-08-01·Current Neuropharmacology

Comparing STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV Tests in RRMS to Assess PML Risk

Article

作者: Marinelli, Fabiana ; Zanghì, Aurora ; Avolio, Carlo ; Filippo, Paola Sofia Di ; D’Amico, Emanuele

Background::

The risk of developing progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal opportunistic infection of the Central Nervous System caused by the J.C. virus (JCV), remains a primary concern associated with natalizumab therapy in the clinical management of patients diagnosed with multiple sclerosis (MS).

Materials and Methods::

This study compared two tests, STRATIFY JCV™ DxSelect™, and IMMUNOWELL ™ JCV IgG, for assessing the risk of PML in patients diagnosed with relapsingremitting multiple sclerosis (RRMS) who had received disease-modifying therapy (DMT) with branded natalizumab (Tysabri®). The main objective was to determine the comparability of these tests in classifying PML risk. Eligible patients were selected from a database, and all specimens for the STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV IgG tests were collected on the same day. Patients were classified into three risk categories (low, intermediate, or high) based on threshold values for each test.

Results::

The analysis showed 85.5% agreement between the two tests for risk classification. Ten discordant cases were identified, mainly between intermediate- and high-risk categories. Compared to STRATIFY JCV™ DxSelect™, IMMUNOWELL™ tended to categorize more patients as higher risk. No significant association was found between discordance and prior use of immunosuppressant drugs and >24 doses of natalizumab. The agreement between tests, assessed with the weighted Kappa coefficient, was moderate (κ=0.6222).

Conclusions::

Compared to the STRATIFY JCV™ DxSelect™, the IMMUNOWELL™ JCV test tends to place more patients in higher risk categories. Further, longitudinal studies are needed to evaluate the clinical impact of these differences in PML risk assessment.

2025-07-01·Multiple Sclerosis and Related Disorders

Comparison of CSF biomarkers in multiple sclerosis patients treated with natalizumab and rituximab

Article

作者: Hansson, Oskar ; Hellgren, Johan ; Jonsson, Magnus Förnvik ; Ahlström, Isabella ; Svenningsson, Anders ; Källén, Kristina ; Janelidze, Shorena ; Strandberg, Maria Compagno

BACKGROUND:

Patients with relapsing remitting multiple sclerosis (RRMS) treated with the high-efficacy drugs natalizumab (NTZ) or rituximab (RTX) generally show no evidence of disease activity. Currently, there is no head-to-head comparison between NTZ and RTX of neurodegenerative and neuroinflammatory biomarkers in cerebrospinal fluid (CSF).

OBJECTIVES:

To compare CSF biomarkers in a stable RRMS cohort treated with NTZ or RTX. A secondary objective was to explore potential associations between CSF biomarkers, fatigue, and cognition.

METHODS:

This Swedish multicentre cross-sectional study assessed kappa-free light chain (k-FLC) index, oligoclonal bands (OCBs), glial fibrillary acidic protein (GFAP) and neurofilament light (NfL) in CSF of 30 RRMS patients on NTZ or RTX for at least 24 months. A longitudinal comparison of biomarkers was performed for IgG Indices. Fatigue and cognition outcomes were explored in relation to CSF biomarkers.

RESULTS:

GFAP level was significantly higher in the NTZ group compared to RTX (mean difference (CI): 2 716 (155; 5278) ng/L, p=0.047). NfL concentration did not differ between the groups. OCBs and k-FLC index were present and elevated in 97 % and 87 % of participants, respectively. IgG-index was significantly reduced only for NTZ. No significant associations were found between fatigue, cognition and the biomarkers.

CONCLUSION:

Our results support that intrathecal inflammatory activity is still ongoing in patients with NTZ and RTX. Cross-sectional GFAP might indicate a lower risk for long-term disability in the RTX group. Our data should be interpreted with caution because of small sample size, making it difficult to control for multiple confounders.

2025-07-01·PEDIATRIC NEUROLOGY

Pediatric Multiple Sclerosis: A Systematic Exploration of Effectiveness in Current and Emerging Therapeutics

Review

作者: Ghojazadeh, Morteza ; Habibi, Parinaz ; Mirzohreh, Seyedeh Tarlan ; Zafardoust, Hooman ; Shoaran, Maryam ; Panahi, Padideh

BACKGROUND:

Pediatric-onset multiple sclerosis (POMS) is a rare but severe neurological condition that poses unique challenges in terms of diagnosis and treatment. With the increasing number of therapeutic options emerging in recent years, it is essential to systematically evaluate the efficacy of current and emerging treatments in the pediatric population. This systematic review and meta-analysis aims to evaluate the efficacy of current and emerging therapeutics for pediatric multiple sclerosis, providing a comprehensive overview of their effectiveness and safety profiles.

METHODS:

This systematic review was prepared using Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. The databases searched were PubMed, Scopus, Web of Science, and Cochrane. Risk of bias was assessed using ROBINS-I and ROBINS-II. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was employed to evaluate the level of certainty in the evidence for each outcome. A meta-analysis was conducted using the Comprehensive Meta-Analysis software. To identify the underlying cause of high heterogeneity, a subgroup analysis was conducted. Sensitivity analysis was checked.

RESULTS:

Sixty-five studies were included in this review. Fifty-two of them enrolled in meta-analysis and the rest in qualitative synthesis. The majority of outcomes showed a moderate certainty of evidence according to the GRADE framework. Results of meta-analysis demonstrated that studies using high-efficacy therapies (HETs), notably natalizumab and ocrelizumab, showed a greater decrease in annualized relapse rate (ARR) with an effect size of -2.821, compared with the studies using moderate-efficacy therapies (METs) with an effect size of -2.028. A significant reduction in Expanded Disability Status Scale following administration of HETs (notably natalizumab and rituximab) was revealed. The results of univariate meta-regression demonstrated that ARR reduction following METs was significantly correlated with treatment duration.

CONCLUSIONS:

In this comprehensive review and meta-analysis assessing the effectiveness of current and new treatments for POMS, we highlight the considerable impact of HETs like natalizumab and ocrelizumab in managing this intricate condition. Our study found that HETs were significantly more effective in lowering relapse rates than METs, demonstrating a distinct benefit in treating POMS.

222

项与那他珠单抗相关的新闻（医药）

2025-05-27

·PRNewswire

BioLineRx Reports First Quarter 2025 Financial Results and Provides Corporate Update

- Reports continued progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare disease - - New data from pilot phase of ongoing CheMo4METPANC Phase 2b combination trial of motixafortide in PDAC, sponsored by Columbia University, to be presented at upcoming 2025 ASCO Annual Meeting – - APHEXDA performing well under Ayrmid stewardship - - Management to host conference call today, May 27th, at 8:30 am EDT - TEL AVIV, Israel, May 27, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update. "Following our announcement last November that we out-licensed APHEXDA®, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year." "At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded. Financial Updates Completed financing in January 2025 raising gross proceeds of $10 million. Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company's U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions. Reaffirms cash runway through the second half of 2026. APHEXDA Performance Update APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million . Clinical Updates Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed. An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO Annual Meeting on Saturday, May 31st. Key highlights include: Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. Sickle Cell Disease (SCD) & Gene Therapy Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's Research Hospital. Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis. Financial Results for the Quarter Ended March 31, 2025 Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company's operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S. Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales. Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses. Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price. Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits. Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024. As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million Conference Call and Webcast Information To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's first approved product is APHEXDA® (motixafortide), with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, which is being developed and commercialized by Ayrmid Ltd. (globally, excluding Asia) and Gloria Biosciences (in Asia). BioLineRx is utilizing its end-to-end expertise in development, regulatory affairs and manufacturing to advance its innovative pipeline and ensure life-changing discoveries move beyond the bench to the bedside. Learn more about who we are, what we do, and how we do it at , or on Twitter and LinkedIn.  Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential success of the license agreement with Ayrmid and the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2025. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Logo: Contacts: United States Irina Koffler LifeSci Advisors, LLC [email protected] Israel Moran Meir LifeSci Advisors, LLC [email protected] SOURCE BioLineRx Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期引进/卖出财报临床2期上市批准

2025-05-01

·Pharmaceutical Technology

Biogen’s Q1 revenue soars past estimates as rare disease pivot pays off

Spinal muscular atrophy treatment Spinraza (nusinersen) became Biogen’s best-selling drug in Q1 2025. Image credit: Shutterstock/ Tada Images. Biogen has unveiled Q1 2025 revenues above estimates, spurred by strong sales of rare disease assets amid a sales dropoff from its multiple sclerosis business. Quarterly revenues for the neurological disease drugmaker were $2.43bn, above analyst group William Blair’s estimates of $2.3bn. The Q1 sales performance represents a 6% increase compared to the same period in 2024, with Biogen ramping up commercial duties for existing drugs and buying assets during that time. One of those assets is Skyclarys, a drug picked up in a $7.3bn acquisition of Reata Pharmaceuticals in September 2023. The treatment for the neurodegenerative disorder Friedreich’s ataxia generated revenue of $124m in Q1, a value that had already taken into account the impact seen in US sales due to Medicare discount dynamics. Approved in the US, Europe, and UK, amongst others, Skyclarys has a high growth ceiling. GlobalData’s Pharma Intelligence Centre forecasts sales of $1.3bn by 2031. GlobalData is the parent company of Pharmaceutical Technology . Skyclarys is one of the drugs spurring a change of the guard in Biogen’s pipeline. The company is well known for its host of multiple sclerosis treatments, such as Vumerity (diroximel fumarate), Tysabri (natalizumab), and Avonex (interferon beta-1a). But, sales for these treatments have declined over the years as biosimilars entered the market. The company’s multiple sclerosis business shrank 11% in Q1 2025 compared to the same period last year. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Biogen is really, a tale of two companies in my view. There’s one company which has been a multiple sclerosis company, and that portfolio, as you all know, has been gradually declining,” said Biogen’s CEO Chris Vibacher in a Q1 earnings call. “But there’s a new Biogen emerging. And when I look at the rare disease business […] we actually have a commercial portfolio that we’re actively promoting that’s now gotten to be about 45% of our product revenue. And those products mostly have a very long runway to continue to grow,” Vibacher added. Alongside Skyclarys, Biogen’s rare disease business is headed by spinal muscular atrophy treatment Spinraza (nusinersen). Spinraza generated global Q1 2025 sales of $423.9m, up from $341.3m in Q1 2024. This increase, coupled with the decline of Tysabri, meant Spinraza was Biogen’s best-selling drug in Q1 2025. Leqembi’s “modest growth” Another key part of Biogen’s business model is its Alzheimer’s segment, now solely headed by Leqembi (lecanemab) after the company discontinued Aduhelm (aducanumab) at the start of 2024. Biogen splits revenue from Leqembi with co-developer Eisai equally, the latter reporting Q1 sales of $96m for the drug. The US, where Leqembi got a full approval in July 2023, accounted for $52m of those sales. Biogen has already secured key milestones for Leqembi this year. In January, the US Food and Drug Administration (FDA) approved maintenance dosing of Leqembi, a move expected to expand its market share. Then in April, the Leqembi was authorised for use in the European Union (EU). Biogen said the Q1 sales for Leqembi represented “continued sequential growth.” William Blair analyst Myles R. Minter said in a research note that: “Skyclarys had a strong quarter, but the commercial focus remains on Leqembi, which has seen only modest growth, in our view.” In the mergers and acquisitions space, Biogen failed a $469m takeover bid of Sage Therapeutics in January.

上市批准并购生物类似药

2025-04-30

·GlobeNewswire-Health Care

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the latest Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

生物类似药上市批准临床3期临床1期并购

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外链

KEGG	Wiki	ATC	Drug Bank
D06886	那他珠单抗	L04AA23	DB00108

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
克罗恩病	美国	Biogen, Inc.	2008-01-14
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2006-06-27
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2006-06-27
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2006-06-27
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2006-06-27
多发性硬化症	美国	Biogen, Inc.	2004-11-23

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适应症	最高研发状态	国家/地区	公司	日期
继发进展型多发性硬化	临床3期	美国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	比利时	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	加拿大	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	捷克	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	丹麦	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	芬兰	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	法国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	德国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	爱尔兰	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	以色列	Biogen, Inc.	2011-09-13

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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


NCT00027300 (AFFIRM, Pubmed \| Mult Scler) 人工标引	临床3期	复发-缓解型多发性硬化	-	Natalizumab	築選觸網夢鏇鬱壓範襯(遞願鑰選夢艱醖齋製淵) = 獵齋製鏇顧簾顧鹹獵鹽壓憲構範選艱齋構淵願 (觸壓壓壓顧簾鑰憲衊襯 ) 更多	积极	2024-03-12
				placebo	-
ACTRIMS2024	N/A	复发性多发性硬化	69	Natalizumab	獵憲壓餘鑰鹽夢觸製觸(獵製獵獵鑰顧糧構壓鏇) = 製鹹遞顧鏇醖築壓簾鑰鹽艱壓鑰蓋顧廠夢壓醖 (醖餘蓋簾憲遞積鑰選網 ) 更多	积极	2024-03-01
				Ocrelizumab	獵憲壓餘鑰鹽夢觸製觸(獵製獵獵鑰顧糧構壓鏇) = 糧製網顧蓋遞觸顧選鏇鹽艱壓鑰蓋顧廠夢壓醖 (醖餘蓋簾憲遞積鑰選網 ) 更多
ACTRIMS2024	N/A	复发性多发性硬化 John Cunningham Virus (JCV) serology	-	Extended Interval Dosing (EID) Natalizumab	鬱遞範夢範齋繭窪鑰鑰(顧顧網醖窪構壓遞壓衊) = 鏇築淵顧蓋鏇簾艱齋憲夢蓋襯淵鑰網製積構鹽 (衊鹹壓窪蓋簾淵築壓醖 ) 更多	积极	2024-02-29
				Standard Interval Dosing (SID) Natalizumab	鬱遞範夢範齋繭窪鑰鑰(顧顧網醖窪構壓遞壓衊) = 鑰鏇餘繭襯膚醖衊衊憲夢蓋襯淵鑰網製積構鹽 (衊鹹壓窪蓋簾淵築壓醖 ) 更多
NCT05304520 (SISTER, Pubmed \| Ther Adv Neurol Disord) 人工标引	N/A	复发-缓解型多发性硬化	262	Subcutaneous natalizumab	製網顧艱餘積蓋糧願醖(衊製淵廠鬱獵壓鑰膚衊) = 鹽醖膚鏇憲築範衊積製襯觸鏇廠鏇顧範觸鏇淵 (鏇觸壓獵憲構膚簾膚鑰 )	积极	2024-01-01
				Intravenous natalizumab	製網顧艱餘積蓋糧願醖(衊製淵廠鬱獵壓鑰膚衊) = 艱糧壓鬱鹽襯廠範淵遞襯觸鏇廠鏇顧範觸鏇淵 (鏇觸壓獵憲構膚簾膚鑰 ) 更多
NOVA trial (ECTRIMS2023)	N/A	JCV+	220	Natalizumab (Extended Interval Dosing (EID))	製鹽蓋鹽夢淵願窪築獵(蓋憲積憲積網範壓鑰蓋) = One case of PML occurred in each group 繭選齋遞範鑰繭齋壓選 (範餘構壓糧網範鬱廠鏇 ) 更多	不佳	2023-09-30
				Natalizumab (Standard Dosing)
ECTRIMS2023	N/A	复发-缓解型多发性硬化	86	Natalizumab IV	獵廠淵構鹽壓淵構範廠(夢壓簾繭築餘夢艱鬱願) = 選構鏇製艱積醖醖憲範鑰觸衊繭鹹積餘憲遞積 (憲壓膚網廠鏇齋築繭鹽 ) 更多	-	2023-09-30
				Natalizumab SC	夢築鑰醖廠衊構願鏇鬱(窪選繭壓襯廠築壓齋壓) = 觸憲鏇窪鹹廠壓廠願製遞網鬱觸顧築衊廠醖艱 (餘遞糧鬱淵鑰蓋鹽範觸 )
ECTRIMS2023	N/A	anti-JCV antibodies	-	natalizumab (StratifyJCVTM testing by Unilabs)	衊餘壓選壓選夢簾鏇蓋(製鬱鹽構膚鏇積憲積夢) = 齋範艱網齋餘窪壓齋鹹簾衊廠襯糧範艱齋選鑰 (網餘獵醖醖鹹遞簾鬱壓 ) 更多	-	2023-09-30
ECTRIMS2023	N/A	多发性硬化症	414	Cladribine (CLD)	鑰構餘鹽壓鹽製鏇膚糧(選製鬱艱願餘齋築網艱) = 獵壓選鹽構廠構齋願壓醖製醖醖鏇願鹽製遞鑰 (簾觸構鏇積醖繭選廠衊 ) 更多	不佳	2023-09-30
				Alemtuzumab (ALZ)	鑰構餘鹽壓鹽製鏇膚糧(選製鬱艱願餘齋築網艱) = 齋鏇簾願構艱夢願築積醖製醖醖鏇願鹽製遞鑰 (簾觸構鏇積醖繭選廠衊 ) 更多
ECTRIMS2023	N/A	复发-缓解型多发性硬化	661	Natalizumab (NTZ)	遞繭遞構淵壓窪網網蓋(遞蓋廠醖構衊製築選壓): HR = 1.75 (95% CI, 0.88 ~ 3.48), P-Value = 0.11	-	2023-09-30
				Ocrelizumab (OCR)
ECTRIMS2023	N/A	-	76	Standard interval dosing (SID)	齋築製夢製醖築築範積(簾淵餘廠夢獵願網醖鹽) = 衊鹹積製齋鹹艱鏇窪簾蓋蓋襯選觸範夢餘艱窪 (簾網襯選廠積壓糧選構 )	-	2023-09-30
				Extended interval dosing (EID)	齋築製夢製醖築築範積(簾淵餘廠夢獵願網醖鹽) = 衊範鑰遞衊襯簾鑰獵夢蓋蓋襯選觸範夢餘艱窪 (簾網襯選廠積壓糧選構 )