Plerixafor

汇宇制药诚邀您携手美法仑、塞替派，共促血液肿瘤治疗发展！ 导读： 近年来，我国血液肿瘤发病率呈现上升趋势，治疗需求日益增长。与此同时，血液肿瘤有效治疗手段——造血干细胞移植（HSCT）技术日益成熟，挽救了无数患者生命。2023年，我国造血干细胞移植人数突破2万余例，并以约15%的年增长率持续攀升。而预处理是造血干细胞移植技术体系中的重要环节，对于预后有至关重要的影响。美法仑和塞替派作为烷化剂，都是HSCT预处理方案中常用的药物。据米内网数据显示，2024年上半年中国城市公立医院烷化剂类（注射剂型）销售额达7.4亿元，增长20.26%。 依托在肿瘤治疗领域的研发积累，汇宇制药推出了汇芙安®注射用盐酸美法仑、汇立泰®注射用塞替派，致力于为血液肿瘤治疗领域提供更多选择。我们诚挚地邀请全国医药界同仁携手合作，共同探索血液肿瘤治疗的进步之路。 汇芙安®注射用盐酸美法仑 临床需求 多发性骨髓瘤(MM)占所有恶性肿瘤的1%，占所有血液肿瘤的10%，是常见且多发的血液肿瘤，MM不可治愈，自体造血干细胞移植（ASCT）仍是MM患者根治的主要治疗方式，为患者的生存带来多方面获益。而美法仑是多发性骨髓瘤患者自体造血干细胞移植预处理方案中使用最多的药物，美法仑200mg/㎡被推荐为MM患者的标准预处理方案。美法仑等药物可及后，极大促进了我国ASCT的蓬勃发展。当前ASCT高速发展，市场亟待更优质的美法仑，点亮更多生命希望！ 产品规格 50mg（按C13H18Cl2N2O2计） 适应症 用于多发性骨髓瘤患者造血干细胞移植前的高剂量预处理治疗； 用于不适合口服剂型治疗的多发性骨髓瘤患者的姑息治疗。 市场规模 米内网数据显示，注射用美法仑自2019年国内上市后销量增速平稳，2023年市场近2亿元，同比增长27.54%；2024年上半年期销售额超过8600万元，同步增长9.19%。 • 产品优势 国内外权威指南推荐：美法仑为自体造血干细胞移植预处理的金标准。 • 品牌优势 ①国内首仿的Captisol®技术的美法仑； ②通过国家一致性评价； ③相较于丙二醇美法仑，稳定性好，安全性高。 • 市场优势 ①价格亲民，有助于提高患者用药的可及性； ②与汇涞®普乐沙福注射液强强联合，聚焦HSCT领域，市场影响力广； ③短期内无集采风险； ④造血干细胞移植预处理必选用药，移植市场增长迅速，前景好。 产品卡片 汇立泰®注射用塞替派 临床需求 淋巴造血系统肿瘤是我国常见的恶性肿瘤，且发病率逐年上升，严重危害人民健康。造血干细胞移植是急性白血病、原发性中枢神经系统淋巴瘤、重型β-地中海贫血、非霍奇金淋巴瘤、多发性骨髓瘤等血液疾病重要治疗手段。在临床中，塞替派作为一种血脑屏障通过率极高的烷化剂，是造血干细胞移植预处理的优选药物之一，同时因为其广谱的抗瘤作用和良好的耐受性，在实体瘤的治疗中也得到了广泛应用。 产品规格 ①15mg ②100mg 适应症 本品适用于重型β-地中海贫血儿童（＜18周岁）异基因造血干细胞移植（allo-HSCT）前预处理。 市场规模 米内网数据显示，塞替派2024年上半年销售额近超过1.12亿元，同比增长29.88%。 • 产品优势 ①急性白血病优选药物，原发性中枢神经系统淋巴瘤指南一线推荐药物，覆盖异基因/自体移植领域主要患者人群，是移植预处理的重要药物； ②产品易透过血脑屏障，对原发/继发中枢肿瘤有独特的治疗效果，且耐受性较好； ③在实体瘤领域也有广泛的临床应用，同时覆盖血液/实体肿瘤，患者人群广泛； ④国内外多指南共识推荐，临床应用时间长，观念成熟。 • 品牌优势 ①获批适应症聚焦临床主要治疗领域——造血干细胞移植预处理； ②大小双规格，同时满足血液/实体肿瘤患者需求，使用便捷； ③中欧共线，质控标准优于USP、原研，24个月长效期 。 • 市场优势 ①医保甲类，准入更具优势； ②价格亲民，有助于提高患者用药的可及性； ③通用名市场份额以35%速度快速增长，处于成长期，潜力较大。 产品卡片 汇宇制药始终秉承“为全球患者提供疗效确切、质量精湛、价格合理的药品，让癌症成为一种可以控制的疾病”的使命。作为深耕肿瘤领域的药企，汇宇制药致力于与医药同仁携手，为血液肿瘤治疗领域提供更多选择，共同助力患者改善生活质量。 声明： 1.本文仅供医疗卫生专业人士参考，非广告用途； 2.医疗卫生专业人士在做出任何与治疗相关的决策时，应充分考虑患者的具体情况，并根严格遵照药品说明书的各项规定； 3.文中数据来源：米内网。

- Reports meaningful progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare diseases - - Executed license agreement with Ayrmid Pharma Ltd. for APHEXDA® (motixafortide) with $10 million upfront payment, up to $87 million in commercial milestones, and high double-digit royalties on net sales - - Completed financings raising combined gross proceeds of $19 million and reduced operating expense run rate by 70%, extending the Company's cash runway through H2 2026 - - Management to host conference call today, March 31st, at 8:30 am EDT - TEL AVIV, Israel, March 31, 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 audited financial results for the year ended December 31, 2024, and provided a corporate update. "It has been just over four months since we implemented a major strategy shift, highlighted by the transformational exclusive licensing agreement that we entered into with Ayrmid Ltd., granting it the rights to commercialize APHEXDA® (motixafortide) in all non-solid-tumor indications and all territories other than Asia," said Philip Serlin, Chief Executive Officer of BioLineRx. "Since then, we implemented cost efficiencies across the Company, including the shutdown of our U.S. commercial operations, that have resulted in an approximate 70% reduction in our operating expense base, which, together with recent financings, have put us on a firm footing with a cash runway through the second half of 2026." "As we return to our roots as a lean drug development company, with a highly validated development platform focused on oncology and rare diseases, we believe these actions help ensure that we remain nimble and capable of seizing the opportunities in front of us. Our strategy moving forward is to in-license additional assets over the next year that we can advance through clinical proof-of-concept, funded in part by milestones and royalties from our out-licensing transactions. To that end, I am pleased to report that we are evaluating numerous promising candidates. This process is methodical and steady to ensure that our due diligence is thorough as we look for new chemical entities. Based on our deep and validated experience in drug development, I believe we are well positioned to create sustained value for our shareholders. I am excited about what the future holds for our Company this year and beyond," Mr. Serlin concluded. Corporate Updates Executed license agreement with Ayrmid Pharma Ltd. to develop and commercialize APHEXDA® (motixafortide) in all indications except solid tumors, and across all territories except Asia - License agreement included a $10 million upfront payment, up to $87 million in potential commercial milestones, and royalties on net sales ranging from 18% to 23% Announced receipt of a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) for a patent, titled "Composition of BL-8040," which strengthens BioLineRx's robust intellectual property (IP) estate and extends its patent protection on motixafortide (BL-8040) in the U.S. through December 2041 Financial Updates Completed two financings in past few months which raised combined gross proceeds of $19 million Reduced operating expense run rate by approximately 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 Q424, as well as additional headcount and other operating expense reductions Significantly reduced outstanding debt and restructured the remainder on favorable terms to the Company APHEXDA 2024 Performance Update Aphexda achieved 10 percent market share of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications BioLineRx generated more than $6 million in net product sales year-to-date through the November 2024 completion of the Ayrmid out-licensing transaction Clinical Updates Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Additional trial sites activated for the CheMo4METPANC Phase 2b clinical trial being led by Columbia University. Full enrollment in the randomized trial targeting 108 patients is anticipated in 2027, with a prespecified interim futility analysis planned when 40% of PFS events are observed Sickle Cell Disease (SCD) & Gene Therapy First patient dosed in 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. Oral presentation delivered at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition detailing initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in SCD. Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle. Financial Results for the Year Ended December 31, 2024 Revenues for the year ended December 31, 2024 were $28.9 million, an increase of $24.1 million, or 502.1%, compared to $4.8 million for the year ended December 31, 2023. The revenues in 2024 primarily reflect a portion of the up-front payment received, and a milestone payment achieved, under the Gloria license, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid license and $6.0 million of net revenues from product sales of APHEXDA in the U.S. The revenues in 2023 (all of which were recorded in the fourth quarter of 2023) primarily reflect a portion of the up-front payment received under the Gloria license of $4.6 million, as well as $0.2 million of revenues from product sales of APHEXDA in the U.S. Cost of revenues for the year ended December 31, 2024 were $9.3 million, an increase of $5.6, or 151.4%, compared to $3.7 million for the year ended December 31, 2023. The cost of revenues in 2024 primarily reflects amortization of intangible assets, Biokine's share of the up-front payment received under the Ayrmid license, sub-license fees accrued on a milestone payment recorded under the Gloria license, as well as royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. The cost of revenues in 2023 primarily reflects Biokine's share of the up-front payment received under the Gloria license and of the net sales. Research and development expenses for the year ended December 31, 2024 were $9.2 million, a decrease of $3.3 million, or 26.4%, compared to $12.5 million for the year ended December 31, 2023. The decrease resulted primarily from lower expenses related to motixafortide NDA supporting activities, termination of the development of AGI-134 and a decrease in payroll and share-based compensation. Sales and marketing expenses for the year ended December 31, 2024 were $23.6 million, a decrease of $1.7 million, or 6.7%, compared to $25.3 million for the year ended December 31, 2023. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license. General and administrative expenses for the year ended December 31, 2024 were $6.3 million, similar to the year ended December 31, 2023. Net non-operating income amounted to $18.4 million for the year ended December 31, 2024, compared to net non-operating expenses of $10.8 million for the year ended December 31, 2023. Non-operating income for the year ended December 31, 2024 primarily relates to non-cash, fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in the Company's share price, offset by warrant offering expenses. Non-operating expenses for the year ended December 31, 2023 primarily relate to non-cash, fair-value adjustments of warrant liabilities on the Company's balance sheet. Net financial expenses amounted to $7.3 million for the year ended December 31, 2024, compared to net financial expenses of $0.1 million for the year ended December 31, 2023. Net financial expenses for both periods primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to the loan agreement with BlackRock, partially offset by investment income earned on bank deposits. Net loss for the year ended December 31, 2024 was $9.2 million, compared to $60.6 million for the year ended December 31, 2023. As of December 31, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $19.6 million (approximately $29.0 million on a pro-forma basis, following the financing completed at the beginning of January 2025). A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the U.S. Securities and Exchange Commission at and posted on the Company's investor relations website at Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected]. 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 April 2, 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, manufacturing and commercialization 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. Contacts: United States Irina Koffler LifeSci Advisors, LLC [email protected] Israel Moran Meir LifeSci Advisors, LLC [email protected] Logo - 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