- APHEXDA is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade -

-APHEXDA是十年来美国批准的多发性骨髓瘤干细胞动员的第一项创新-

- One dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ 6 million hematopoietic stem cells among a contemporary population of multiple myeloma patients -

-一剂APHEXDA加非格司亭使大多数患者能够在当代多发性骨髓瘤患者群体中实现≥600万造血干细胞的收集目标-

- Management to hold conference call on Tuesday, September 12, 2023 at 8:00 a.m. U.S. EDT -

-管理层于2023年9月12日星期二上午8:00召开电话会议-

TEL AVIV, Israel, Sept. 11, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

以色列特拉维夫，2023年9月11日/PRNewswire/-BioLineRx Ltd.（纳斯达克/塔斯：BLRX），一家专注于某些癌症和罕见疾病的商业阶段生物制药公司，今天宣布美国食品和药物管理局（FDA）已批准APHEXDA™ （motixafortide）与非格司亭（G-CSF）组合，将造血干细胞动员至外周血，用于多发性骨髓瘤患者的收集和随后的自体移植。

APHEXDA is administered by injection, for subcutaneous use..

APHEXDA通过注射给药，用于皮下使用。。

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-aphexda/

体验完整的互动多渠道新闻发布：https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-aphexda/

Multiple myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type.1 The success of ASCT depends on adequate mobilization of stem cells during the treatment process.

多发性骨髓瘤是第二常见的血液系统恶性肿瘤。自体干细胞移植（ASCT）是多发性骨髓瘤标准治疗范例的一部分，为这种癌症类型的患者提供延长的生存期.1 ASCT的成功取决于治疗过程中干细胞的充分动员。

The American Society for Transplantation and Cellular Therapy (ASTCT) guidelines recommend a collection target of 3-5 x 106 CD34+ cells/kg.2 Additionally, collection of a sufficient number of stem cells to perform two transplantations is recommended.2-5 Historically, depending on induction regimens and mobilization strategies, up to 47% of patients have had challenges collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session.6-7.

美国移植和细胞治疗学会（ASTCT）指南建议收集目标为3-5 x 106 CD34+细胞/kg.2此外，建议收集足够数量的干细胞进行两次移植.2-5历史上，取决于诱导方案和动员策略，高达47%的患者在单采血液成分术后收集目标数量的造血干细胞用于ASCT有挑战。

'Greater numbers of patients with multiple myeloma are candidates for autologous stem cell therapy; however, achieving target collection goals can be difficult in some patients given modern barriers, including the treatment of older patients and use of contemporary induction regimens,' said John DiPersio, MD, PhD, primary investigator for the GENESIS trial and.

“更多的多发性骨髓瘤患者是自体干细胞治疗的候选人；然而，在GENESIS试验的主要研究者John DiPersio博士说，鉴于现代障碍，包括老年患者的治疗和当代诱导方案的使用，某些患者难以实现目标收集目标。

Professor of Medicine, Pathology and Immunology and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine in St. Louis. 'Innovation in this area of medicine has been needed, and today's approval of APHEXDA addresses the demand for new therapies that can meet today's challenges by delivering more reliability in stem cell mobilization, versus filgrastim alone, with fewer days of apheresis sessions and fewer doses of filgrastim for people living with this cancer.'.

华盛顿大学医学院医学，病理学和免疫学教授，基因和细胞免疫治疗中心主任。路易斯这方面的医学创新是必要的，今天APHEXDA的批准解决了对新疗法的需求，这些新疗法可以通过提供更高的干细胞动员可靠性来满足当今的挑战，而单独使用非格司亭，单采血液成分治疗的天数更少，非格司亭的剂量更少为患有这种癌症的人。

The FDA approval of APHEXDA is based on results from the 2-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.

FDA批准的APHEXDA基于两部分3期GENESIS试验的结果，该试验是一项随机，双盲，安慰剂对照研究，评估APHEXDA（motixafortide）加非格司亭与安慰剂加非格司亭相比的安全性和有效性，用于动员造血干细胞用于多发性骨髓瘤患者的自体移植。

Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study.8.

第1部分是一项单中心，导入，开放标签研究，涉及12名接受motixafortide加filgrastim治疗的患者，旨在确定剂量。第2部分涉及122名在双盲，安慰剂对照，多中心研究中以2:1随机分组的患者。

The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg within two apheresis sessions, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.9 Local laboratory data were used for a sensitivity analysis.

CD34+细胞的评估由中央和地方实验室进行。中心实验室评估用于疗效结果。当地的实验室结果被用于临床治疗决策。根据中心实验室的测量，APHEXDA加非格司亭使67.5%的患者在两次单采血液成分治疗中达到≥6×106 CD34+细胞/kg的干细胞采集目标，而安慰剂加非格司亭方案为9.5%.9此外，92.5%的患者在APHEXDA组最多两次单采血液成分达到干细胞采集目标，安慰剂组达到21.4%，由当地实验室测量.9当地实验室数据用于敏感性分析。

The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted..

数据是描述性的，没有统计数据或预先指定。信息应谨慎解释。。

In GENESIS, the safety was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim, and 42 patients who received placebo plus filgrastim. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. These reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia.

在GENESIS中，对92例接受APHEXDA 1.25 mg/kg皮下加非格司亭的多发性骨髓瘤患者和42例接受安慰剂加非格司亭的患者进行了安全性评估。接受APHEXDA加非格司亭治疗的患者中有5.4%发生严重不良反应。这些反应包括呕吐，注射部位反应，超敏反应，注射部位蜂窝织炎，低钾血症和缺氧。

The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema and pruritus), pruritus, flushing, and back pain.9 .

发生最常见的不良反应（发生率>20%）是注射部位反应（疼痛，红斑和瘙痒），瘙痒，潮红和背痛。

'Given the strong efficacy data shown in the GENESIS trial, which included patients who are representative of the current multiple myeloma patient population, we believe APHEXDA will play a critical role in addressing unmet needs and introduce a new treatment paradigm for this challenging cancer,' said Philip Serlin, Chief Executive Officer of BioLineRx Ltd.

“鉴于GENESIS试验显示的强大疗效数据，其中包括代表当前多发性骨髓瘤患者群体的患者，我们相信APHEXDA将在解决未满足的需求方面发挥关键作用，并为这一具有挑战性的癌症引入新的治疗模式，”BioLineRx有限公司首席执行官Philip Serlin说。

'The company is working relentlessly to make this important innovation in stem cell mobilization available to appropriate patients, their physicians and transplant teams.'.

“该公司正在不懈地努力，为适当的患者，他们的医生和移植团队提供干细胞动员方面的这一重要创新。”。

'FDA approval of APHEXDA, the company's first approved therapeutic, is a tremendously exciting and important moment in our history and validates our drug development programs,' said Ella Sorani, PhD, Chief Development Officer of BioLineRx Ltd. 'We would like to thank all of the patients and families who have contributed to the research and development of APHEXDA.'.

BioLineRx Ltd.首席开发官Ella Sorani博士说：“FDA批准该公司首次批准的治疗药物APHEXDA是我们历史上非常令人兴奋和重要的时刻，并验证了我们的药物开发计划。”我们要感谢所有为APHEXDA的研究和开发做出贡献的患者和家属“。

Increased age, as well as exposure to lenalidomide-containing induction regimens, including 3-4 drug combination regimens, have been associated with impaired stem cell mobilization.2-3 The GENESIS study included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with ~70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.8 In this contemporary population, patients in the APHEXDA plus filgrastim arm were able to mobilize more than four times the amount of stem cells with a single dose over a 24-hour period compared with placebo plus filgrastim.8.

年龄增加以及暴露于含来那度胺的诱导方案（包括3-4种药物联合方案）与干细胞动员受损有关。2-3 GENESIS研究包括被认为代表接受ASCT的典型多发性骨髓瘤人群的患者，中位年龄为63岁，两组患者中约70%的患者接受来那度胺诱导治疗[8]。在这个当代人群中，APHEXDA加filgrastim组患者能够动员超过四倍与安慰剂加非格司亭相比，24小时内单次剂量的干细胞。

BioLineRx expects to make APHEXDA available later this month. For further information about APHEXDA, please see the Important Safety Information below and the full Prescribing Information, and visit www.APHEXDA.com.

BioLineRx预计本月晚些时候将提供APHEXDA。有关APHEXDA的更多信息，请参阅下面的重要安全信息和完整的处方信息，并访问www.APHEXDA.com。

APHEXDA Investor Conference CallThe Company will host an investor conference call on September 12, 2023 at 8:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.

APHEXDA投资者会议致电该公司将于2023年9月12日上午8:00召开投资者电话会议，主要执行官Philip Serlin发表演讲。

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.

要访问电话会议，请拨打美国的+1-888-281-1167或国际上的+972-3-918-0685。可以通过公司网站上的活动页面访问实时网络广播和通话回放。请在通话前留出额外时间访问该网站并下载任何必要的软件来听取现场广播。

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 September 14, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally..

通话重放将在实时电话会议结束后约两小时内提供。通话重放的拨号将持续到2023年9月14日；请拨打美国的+1-888-295-2634或国际上的+972-3-925-5904。。

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.10 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections. .

关于多发性骨髓瘤多发性骨髓瘤是一种无法治愈的血癌，会影响一些在骨髓中发现的称为浆细胞的白细胞。当受损时，这些浆细胞迅速扩散并取代骨髓中的正常细胞。根据美国癌症协会的数据，到2023年，估计将有超过35000人被诊断患有多发性骨髓瘤，在美国将有近13000人死于这种疾病.10虽然一些被诊断患有多发性骨髓瘤的人最初没有症状，但大多数患者是由于可能包括骨折或疼痛，红细胞计数低，疲倦，高钙水平，肾脏问题或感染。 .

About Autologous Stem Cell TransplantationAutologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., as many as 8,000 ASCTs are performed each year in patients with multiple myeloma.11 The current ASCT standard of care includes 4-6 cycles of induction therapy (an initial drug-combination regimen to position the patient for as deep a treatment response as possible).

关于自体干细胞移植自体干细胞移植（ASCT）是许多血液癌症（包括多发性骨髓瘤）标准治疗范例的一部分。在美国，多发性骨髓瘤患者每年进行多达8000例ASCT[11]。目前的ASCT护理标准包括4-6个周期的诱导治疗（初始药物联合治疗方案，以使患者尽可能深入地治疗反应）。

To begin the stem cell mobilization process, a patient will receive a daily dose of filgrastim (G-CSF) for four days. Daily doses of filgrastim will continue until the target collection goal is met with the addition of up to four daily doses of plerixafor as needed.12 For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy may be carried out followed by an additional number of apheresis sessions as necessary.2.

为了开始干细胞动员过程，患者将接受每日剂量的非格司亭（G-CSF）四天。每日剂量的非格司亭将继续进行，直到达到目标收集目标，并根据需要添加多达四个日剂量的普乐沙福.12对于在该初级动员阶段无法动员足够数量的细胞用于收获的患者，可以进行救援治疗，然后根据需要进行额外数量的单采血液成分术。

About the GENESIS Trial GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.

关于GENESIS试验GENESIS（NCT 03246529）是一项由2部分组成的3期随机双盲安慰剂对照多中心研究，评估APHEXDA（motixafortide）加非格司亭（G-CSF）的安全性和有效性安慰剂加非格司亭，用于动员造血干细胞用于多发性骨髓瘤患者的自体移植。

Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study.8.

第1部分是一项单中心，导入，开放标签研究，涉及12名接受motixafortide加filgrastim治疗的患者，旨在确定剂量。第2部分涉及122名在双盲，安慰剂对照，多中心研究中以2:1随机分组的患者。

The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session.8.

该研究的主要目的是评估一剂motixafortide加非格司亭是否优于安慰剂加非格司亭，能够在最多两次单采血液成分术中动员≥600万个CD34+细胞。该研究的一个关键次要目标是评估一次剂量的motixafortide加非格司亭是否优于安慰剂加非格司亭，以便在一次单采血液成分术中动员≥600万个CD34+细胞。

The study met the primary endpoint with a high degree of statistical significance (p<0.0001). The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions.

该研究符合主要终点，具有高度统计学意义（p<0.0001）.CD34+细胞的评估由中央和地方实验室进行。中心实验室评估用于疗效结果。当地的实验室结果被用于临床治疗决策。

APHEXDA plus filgrastim enabled 67.5% of patients to achieve the cell collection goal of ≥ 6 × 106 CD34+ cells/kg in up to two apheresis sessions with a single administration, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.13 Local laboratory data were used for a sensitivity analysis.

APHEXDA加非格司亭使67.5%的患者在单次给药的最多两次单采血液成分术中达到≥6×106CD34+细胞/kg的细胞收集目标，而安慰剂加非格司亭方案为9.5%，由中央实验室测量.9此外，根据当地实验室的测量，92.5%的患者在APHEXDA组中进行了两次单采血液成分采集，达到了干细胞采集目标，安慰剂组达到了21.4%.13当地实验室数据用于敏感性分析。

The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted..

数据是描述性的，没有统计数据或预先指定。信息应谨慎解释。。

The safety of APHEXDA was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim and 42 patients who received placebo plus filgrastim for mobilization of hematopoietic stem cells for collection and apheresis. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim.

在92名接受APHEXDA 1.25 mg/kg皮下加非格司亭的多发性骨髓瘤患者和42名接受安慰剂加非格司亭动员造血干细胞进行采集和单采血液成分分析的患者中评估了APHEXDA的安全性。接受APHEXDA加非格司亭治疗的患者中有5.4%发生严重不良反应。

Serious adverse reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema, and pruritus), pruritus, flushing and back pain.9.

严重不良反应包括呕吐，注射部位反应，过敏反应，注射部位蜂窝织炎，低钾血症和缺氧。发生最常见的不良反应（发生率>20%）是注射部位反应（疼痛，红斑和瘙痒），瘙痒，潮红和背痛。

Please see important safety information below.

请参阅下面的重要安全信息。

About APHEXDA™APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.9.

关于APHEXDA™APHEXDA（motixafortide）是一种CXCR4拮抗剂，具有长受体占有率（大于72小时），与非格司亭（G-CSF）联合使用，能够将造血干细胞动员到外周血中进行收集并随后进行自体干细胞移植。多发性骨髓瘤患者。

INDICATION AND IMPORTANT SAFETY INFORMATION

指示和重要安全信息

INDICATIONAPHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

指示APHEXDA与非格司亭（G-CSF）组合用于将造血干细胞动员至外周血以收集并随后在多发性骨髓瘤患者中进行自体移植。

IMPORTANT SAFETY INFORMATION

重要的安全信息

CONTRAINDICATIONSAPHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.

禁忌症对于有对motixafortide有严重超敏反应史的患者，禁用aPhexda。

WARNINGS AND PRECAUTIONS

警告和注意事项

Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA.

过敏性休克和超敏反应：发生过敏性休克和超敏反应。在每次剂量的APHEXDA之前约30-60分钟给所有患者预先给予包括H1抗组胺药，H2阻断剂和白三烯抑制剂的三药预给药方案。

Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs..

在人员和治疗立即可用于治疗过敏反应和其他全身反应的环境中管理APHEXDA。在APHEXDA给药后监测患者1小时并及时处理反应。在发生超敏反应的情况下，接受负性变时性药物（例如β受体阻滞剂）的患者可能更有发生低血压的风险，并且在适当时应将这些药物替换为非变时性药物。。

Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed..

注射部位反应：发生注射部位反应（73%），包括疼痛（53%），红斑（27%）和瘙痒（24%）。9%的患者发生严重反应。在每次APHEXDA剂量之前预先给予镇痛药（例如对乙酰氨基酚）。根据需要在给药后使用镇痛药和局部治疗。。

Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia..

白血病患者的肿瘤细胞动员：为了造血干细胞（HSC）动员的目的，APHEXDA可能引起白血病细胞的动员和随后的单采血液成分产品的污染。因此，APHEXDA不适用于白血病患者的HSC动员和收获。。

Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.

白细胞增多症：与非格司亭一起施用APHEXDA增加循环白细胞以及HSC群体。在APHEXDA使用期间监测白细胞计数。

Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.

肿瘤细胞动员的可能性：当APHEXDA与非格司亭联合用于HSC动员时，肿瘤细胞可以从骨髓中释放并随后收集在白细胞分离术产品中。潜在的肿瘤细胞回输的影响尚未得到很好的研究。

Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose..

胚胎胎儿毒性：根据其作用机制，APHEXDA可引起胎儿伤害。建议孕妇对胎儿有潜在风险。在开始使用APHEXDA治疗之前，验证具有生殖潜力的女性的妊娠状况，并建议在治疗期间和最终剂量后8天内使用有效的避孕措施。。

ADVERSE REACTIONSThe most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).

不良反应用APHEXDA治疗的患者最常见的不良反应（发生率>20%）是注射部位反应[73%，包括疼痛（53%），红斑（27%），瘙痒（24%）]；瘙痒（38%）；冲洗（33%）；背痛（21%）。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.

怀孕：请参阅胚胎胎儿毒性警告和注意事项中的重要信息。

Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.

哺乳期：没有关于人乳中motixafortide的存在，对母乳喂养儿童的影响或对产奶量的影响的数据。建议女性在用APHEXDA治疗期间和最终剂量后8天内不推荐母乳喂养。

Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.

儿科使用：儿科患者尚未确定APHEXDA的安全性和有效性。

Please see the accompanying full Prescribing Information.

请参阅随附的完整处方信息。

About BioLineRxBioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers 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. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside. .

关于BioLineRxBioLineRx Ltd.（纳斯达克/塔斯：BLRX）是一家商业阶段生物制药公司，致力于为某些癌症和罕见疾病寻求改变生命的疗法。该公司的第一批批准产品是APHEXDA™ （motixafortide），在美国有迹象表明干细胞动员 自体移植治疗多发性骨髓瘤。BioLineRx正在为镰状细胞病，胰腺癌和其他实体瘤患者推进一系列研究药物。该公司总部设在以色列，在美国运营，正在推动创新疗法的开发和商业化方面的端到端专业知识，确保改变生活的发现超越实验室到床边。 .

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.

了解更多关于我们是谁，我们做什么以及我们如何做 www.biolinerx.com或上 Twitter 和 LinkedIn。

Forward Looking StatementVarious 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.

前瞻性声明本版本中有关BioLineRx未来预期的各种声明构成了1995年“私人证券诉讼改革法案”含义内的“前瞻性声明”。这些陈述包括诸如“预期”，“相信”，“可以”，“估计”，“期望”，“打算”，“可以”，“计划”，“潜力”，“预测”，“项目”，“应该”，“将会”和“将会”，并描述对未来事件的看法。

These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide.

其中包括关于管理层的期望，信念和意图的声明，其中包括APHEXDA的潜在益处，APHEXDA推出的时间以及管理层对未来运营的计划和目标以及motixafortide的期望和商业潜力。

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.

这些前瞻性陈述涉及已知和未知的风险，不确定性和其他可能导致BioLineRx的实际结果，表现或成就与此类前瞻性陈述所表达或暗示的任何未来结果，表现或成就大不相同的因素。

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 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; the clinical development.

可能导致BioLineRx实际结果与此类前瞻性陈述中表达或暗示的结果大不相同的因素包括但不限于：BioLineRx临床前研究，临床试验和其他治疗候选药物开发的开始，时间，进展和结果努力；BioLineRx能够将其治疗候选药物推进临床试验或成功完成其临床前研究或临床试验；APHEXDA的临床试验结果是否可以预测现实世界的结果；BioLineRx收到其治疗候选人的监管批准，以及其他监管文件和批准的时间；临床发展。

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SOURCE BioLineRx Ltd.

SOURCE BioLineRx Ltd。