Gemcitabine Hydrochloride

8月12日，药物临床试验登记与信息公示平台显示，正大天晴自主研发的1类创新药TQB2868（（PD-1/TGF-β双功能融合蛋白）启动了首个Ⅲ期临床试验，为联合安罗替尼及化疗一线治疗转移性胰腺导管腺癌（mPDAC）。该联合方案有望成为免疫检查点抑制剂在胰腺癌领域的首个一线治疗方案，打破“癌中之王”胰腺癌严峻的治疗现状，并以“免疫+靶向+化疗”三重机制联合的创新疗法为“免疫冷肿瘤”的治疗提供可借鉴的创新范式。 在全球肿瘤治疗领域，胰腺癌是公认恶性程度最高的肿瘤之一，因极低的五年生存率（不足10%）和迅猛的疾病进展被称为“癌中之王”，转移性胰腺癌占确诊患者80%以上。近年来，免疫治疗在临床中得到广泛应用，但单一的免疫检查点抑制剂（ICI）对胰腺癌并没有起到良好的抗肿瘤作用。研究显示，胰腺癌微环境中存在致密的基质成分，并有广泛的免疫抑制细胞浸润，会抑制肿瘤细胞的免疫应答，造成免疫逃逸，从而影响免疫治疗效果[1-3]。胰腺癌因此被认为是一种免疫学上的“冷肿瘤”。 TQB2868是正大天晴自主研发的PD-1/TGF-β双功能融合蛋白，可阻断PD-1/PD-L1通路，并中和肿瘤微环境中的TGF-β，兼具免疫检查点抑制与肿瘤微环境重塑的双重作用。PD-1和TGF-β信号的共同抑制可带来比任一单独途径抑制更加有效的抗肿瘤免疫应答，从而达到提高抗肿瘤临床获益目的。 同时，治疗方案为联合安罗替尼与化疗，以独特的“免疫-靶向-化疗”三重协同机制，直击胰腺癌“冷肿瘤”特性，为破解免疫逃逸提供了全新路径： ● TQB2868通过阻断PD-1与其配体PD-L1之间的结合，解除肿瘤细胞对T细胞的抑制作用，从而激活T细胞对肿瘤的攻击； ● TGF-β可抑制机体的免疫功能, 帮助肿瘤细胞免疫逃逸，TQB2868通过中和TGF-β信号可逆转肿瘤细胞免疫逃逸； ● 联合方案中，安罗替尼具有抑制肿瘤血管新生、抑制肿瘤生长、调控免疫微环境的作用； ● AG化疗直接杀伤肿瘤细胞并释放抗原，增强免疫应答。 在今年5月的ASCO 2025大会上，正大天晴公布了TQB2868联合安罗替尼和化疗一线治疗mPDAC的Ⅱ期研究数据，以“中国原创方案”影响全球胰腺癌治疗格局[4-7]: ● 客观缓解率（ORR）达63.9%，为传统方案的2-3倍； ● 疾病控制率（DCR）达100%，是传统方案的1.6倍； ● 中位无进展生存期（mPFS）尚未达到，6个月PFS率达86%，是传统方案的2倍； ● 中位生存期（mOS）尚未达到，预期有望超过1年； ● 安全耐受性良好，3级及以上不良反应发生率为52.5%（传统方案为68.1%-77%）。 点击链接回顾精彩数据： 基于其优异的探索数据，6月，该方案获中国国家药品监督管理局药品审评中心（CDE）批准开展Ⅲ期临床研究。TQB2868是全球首个进入III期临床阶段的PD-1/TGF-β双功能融合蛋白。 本次启动的Ⅲ期研究是一项随机、双盲、平行对照、多中心临床试验（n=568），旨在评估TQB2868联合安罗替尼和化疗对比安慰剂联合化疗一线治疗转移性胰腺导管腺癌的有效性和安全性，主要终点为总生存期（OS）。 随着研究推进，该联合疗法有望成为免疫检查点抑制剂在胰腺癌的首个一线治疗方案，公司也将持续投入创新，秉承“健康科技，温暖更多生命”的品牌理念，与医生、院方强强联手，为胰腺癌患者的总生存期、生活质量带来根本性改善。 参考文献： [1] Skelton RA, Javed A, Zheng L, et al. Overcoming the resistance of pancreatic cancer to immune checkpoint inhibitors [J]. J Surg Oncol, 2017, 116(1): 55-62.  [2] Amedei A, Niccolai E, Prisco D. Pancreatic cancer: role of the immune system in cancer progression and vaccine-based immunotherapy [J]. Hum Vaccin Immunother, 2014, 10(11): 3354-3368.  [3] Steele CW, Karim SA, Leach JDG, et al. CXCR2 Inhibition Profoundly Suppresses Metastases and Augments immunotherapy in Pancreatic Ductal Adenocarcinoma [J]. Cancer Cell, 2016, 29(6): 832-845. [4] D, El-Maraghi RH, Hammel P, et al. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst.2015;107(2): dju413. [5] Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-25. [6] Wainberg ZA, Melisi D, Macarulla T, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-81. [7]Si Shi, Xianjun Yu,Xiaobing Chen, et al. TQB2868 combined with anlotinib and nab-paclitaxel plus gemcitabine as first-line treatment for metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase 2 study.2025 ASCO(#4159). 声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。  ● 中国生物制药访问香港理工大学 擘画AI医药创新合作蓝图 ● 谢承润参加香港特区行政长官李家超施政报告咨询会并发言 ● 十五载攻坚，如何铸就救命通道？ ● 抗肿瘤管线再扩容！正大天晴2款1类新药首次临床获受理

- Reports continued progress in the evaluation of assets for potential pipeline expansion in the areas of oncology and rare disease; transaction targeted for 2025 -- Provides updated and extended cash runway guidance into H1 2027 -- Management to host conference call today, August 14th , at 8:30 am EDT - TEL AVIV, Israel , Aug. 14, 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 June 30, 2025 , and provided a corporate update. "Since our last quarterly update, we have been acutely focused on evaluating a broad range of potential pipeline expansion opportunities where we can leverage our clinical and regulatory expertise, and track record of drug approval success, to drive new innovation in areas of need," said Philip Serlin , Chief Executive Officer of BioLineRx . "Today, I am pleased to report that discussions with potential partners continue to progress. Our balance sheet is strong, our organization is lean, and we are seeing promising opportunities that fit well within our criteria - most notably a clear and efficient development pathway. I remain confident that we could potentially execute a transaction this year that will expand our pipeline and provide fresh opportunities for clinical success and long-term value creation." Financial Updates With $28.2 million on its balance sheet as of June 30, 2025 , BioLineRx is guiding to a cash runway into the first half of 2027. This represents an improvement as compared to the Company's previous cash runway guidance into the second half of 2026. Clinical Updates Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Enrollment activities continue in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University , and supported by both Regeneron and BioLineRx . The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel). A prespecified interim analysis is 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 was presented at the 2025 ASCO Annual Meeting in May. Key highlights include: - Four of 11 patients remained progression-free after more than one year.- Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent 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 Ongoing Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress. The trial is sponsored by Washington University School of Medicine in St. Louis , and results are anticipated in the second half of 2025. A second study, sponsored by St. Jude Children's Research Hospital , continues to enroll patients. The study is a 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). APHEXDA Performance Update APHEXDA generated sales of $1.7 million in the second quarter of 2025, providing royalty revenue to the Company of $0.3 million . Financial Results for the Quarter Ended June 30, 2025 Total revenues for the second quarter of 2025 were $0.3 million , reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024 . Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of $0.9 million for the second quarter of 2024. Cost of revenues in 2025 are not comparable to the same period in 2024, which included cost of sales from direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024 . Research and development expenses for the second quarter of 2025 were $2.3 million , compared to $2.2 million for the second quarter of 2024. The increase resulted primarily from certain one-time costs associated with the PDAC study at Columbia University , offset by 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 second quarter of 2025, compared to $6.4 million for the second quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid transaction. General and administrative expenses for the second quarter of 2025 were $0.2 million , compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, 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 expenses for the second quarter of 2025 were $1.9 million , compared to net non-operating income of $7.8 million for the second quarter of 2024. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price Net financial income for the second quarter of 2025 was $0.2 million , compared to net financial expenses of $1.6 million for the second quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024 , following the transaction with Ayrmid. Net loss for the second quarter of 2025 was $3.9 million , compared to net income of $0.5 million for the second quarter of 2024. As of June 30, 2025 , the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million , sufficient to fund operations, as currently planned, into the first half of 2027. 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 August 16, 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, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia ) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University . In addition, BioLineRx is in discussions to expand its pipeline in the areas of oncology and/or rare diseases, where the Company can utilize its end-to-end expertise in drug development, regulatory affairs and manufacturing to bring life-changing innovation from bench to bedside. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, 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, expectations regarding pipeline expansion, 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 IR@biolinerx.com Israel Moran Meir LifeSci Advisors , LLC moran@lifesciadvisors.com CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) December 31 , June 30 , 2024 2025 in USD thousands Assets CURRENT ASSETS Cash and cash equivalents 10,436 7,189 Short-term bank deposits 9,126 20,970 Trade receivables 2,476 78 Prepaid expenses 443 572 Other receivables 1,478 203 Inventory 3,145 2,850 Total current assets 27,104 31,862 NON-CURRENT ASSETS Property and equipment, net 386 197 Right-of-use assets, net 967 800 Intangible assets, net 10,449 10,408 Total non-current assets 11,802 11,405 Total assets 38,906 43,267 Liabilities and equity CURRENT LIABILITIES Current maturities of long-term loan 4,479 4,479 Accounts payable and accruals: Trade 5,583 3,465 Other 3,131 2,767 Current maturities of lease liabilities 522 408 Warrants 1,691 4,360 Total current liabilities 15,406 15,479 NON-CURRENT LIABILITIES Long-term loan, net of current maturities 8,958 6,718 Lease liabilities 1,081 998 Total non-current liabilities 10,039 7,716 COMMITMENTS AND CONTINGENT LIABILITIES Total liabilities 25,445 23,195 EQUITY Ordinary shares 38,097 71,819 Share premium 353,693 327,475 Warrants 5,367 3,686 Capital reserve 17,547 17,148 Other comprehensive loss (1,416) (1,416) Accumulated deficit (399,827) (398,640) Total equity 13,461 20,072 Total liabilities and equity 38,906 43,267 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three months ended June 30 , Six months ended June 30 , 2024 2025 2024 2025 in USD thousands In USD thousands REVENUES: License revenues 3,550 304 9,481 559 Product sales, net 1,843 - 2,767 - Total revenues 5,393 304 12,248 559 COST OF REVENUES (897) (72) (2,352) (106) GROSS PROFIT 4,496 232 9,896 453 RESEARCH AND DEVELOPMENT EXPENSES (2,225) (2,326) (4,719) (3,949) SALES AND MARKETING EXPENSES (6,415) - (12,757) - GENERAL AND ADMINISTRATIVE EXPENSES (1,629) (209) (3,015) (1,198) OPERATING LOSS (5,773) (2,303) (10,595) (4,694) NON-OPERATING INCOME (EXPENSES), NET 7,807 (1,851) 12,297 5,793 FINANCIAL INCOME 535 490 1,100 784 FINANCIAL EXPENSES (2,085) (276) (3,014) (696) NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) 484 (3,940) (212) 1,187 in USD In USD EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED 0.00 (0.00) (0.00) 0.00 WEIGHTED AVERAGE NUMBER OF SHARES USED INCALCULATION OF EARNINGS )LOSS( PER ORDINARY SHARE 1,197,582,901 2,369,687,536 1,142,221,033 2,294,127,662 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED) Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss Accumulated deficit Total in USD thousands BALANCE AT JANUARY 1, 2024 CHANGES FOR SIX MONTHS ENDED JUNE 30, 2024: 31,355 355,482 1,408 17,000 (1,416) (390,606) 13,223 Issuance of share capital and warrants, net 3,056 (3,056) - - - - - Employee stock options expired - - - (66) - - (66) Share-based compensation - - - 1,036 - - 1,036 Comprehensive loss for the period - - - - - (212) (212) BALANCE AT JUNE 30, 2024 34,411 352,426 1,408 17,970 (1,416) (390,818) 13,891 Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss Accumulated deficit Total in USD thousands BALANCE AT JANUARY 1, 2025 CHANGES FOR SIX MONTHS ENDED JUNE 30, 2025 : 38,097 353,693 5,367 17,547 (1,416) (399,827) 13,461 Issuance of share capital, pre-funded warrants and warrants, net 25,664 (20,988) 501 - - - 5,177 Pre-funded warrants exercised 8,058 (5,876) (2,182) - - - - Employee stock options expired - 646 - (646) - - - Share-based compensation - - - 247 - - 247 Comprehensive income for the period - - - - - 1,187 1,187 BALANCE AT JUNE 30, 2025 71,819 327,475 3,686 17,148 (1,416) (398,640) 20,072 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Six months ended June 30 , 2024 2025 in USD thousands CASH FLOWS - OPERATING ACTIVITIES Comprehensive income (loss) for the period (212) 1,187 Adjustments required to reflect net cash used in operating activities (see appendix below) (25,226) (3,955) Net cash used in operating activities (25,438) (2,768) CASH FLOWS - INVESTING ACTIVITIES Investments in short-term deposits (20,559) (24,818) Maturities of short-term deposits 28,660 12,926 Sale (purchase) of property and equipment (59) 11 Net cash provided by (used in) investing activities 8,042 (11,881) CASH FLOWS - FINANCING ACTIVITIES Issuance of share capital and warrants, net of issuance costs 5,565 13,554 Net proceeds from loan 19,223 - Repayments of loan (1,547) (2,240) Repayments of lease liabilities (256) (262) Net cash provided by financing activities 22,985 11,052 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 5,589 (3,597) CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD 4,255 10,436 EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (221) 350 CASH AND CASH EQUIVALENTS - END OF PERIOD 9,623 7,189 BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Six months ended June 30 , 2024 2025 in USD thousands Adjustments required to reflect net cash used in operating activities: Income and expenses not involving cash flows: Depreciation and amortization 1,373 341 Exchange differences on cash and cash equivalents 221 (350) Fair value adjustments of warrants (12,845) (6,410) Warrant issuance costs 642 702 Share-based compensation 970 247 Interest on short-term deposits 201 48 Interest on loan 1,997 - Exchange differences on lease liabilities 189 110 (7,252) (5,312) Changes in operating asset and liability items: Decrease (increase) in trade receivables (2,821) 2,398 Decrease (increase) in prepaid expenses and other receivables (359) 1,146 Decrease (increase) in inventory (1,681) 295 Decrease in accounts payable and accruals (5,633) (2,482) Decrease in contract liabilities (7,480) - (17,974) 1,357 (25,226) (3,955) Supplemental information on interest received in cash 931 583 Supplemental information on interest paid in cash 971 694 Supplemental information on non-cash transactions: Changes in right-of-use asset and lease liabilities 58 45 Warrant issuance costs 207 - Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2025-financial-results-and-provides-corporate-update-302530015.html SOURCE BioLineRx Ltd. +972-8-6429100