FREMONT, CA, April 17, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC) ('Company'), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and Oncology/Hematology, announced today that the Company, together with its affiliate Rgene Corporation entered into a comprehensive licensing agreement with OncoX, a private company registered in the British Virgin Islands that specializes in dietary supplements for Oncology.

加利福尼亚州弗里蒙特，2024年4月17日（环球通讯社）——通过NewMediaWire——ABVC BioPharma，Inc.（纳斯达克：ABVC）（“公司”），一家临床阶段的生物制药公司，开发眼科，中枢神经系统和肿瘤学/血液学的治疗方案，今天宣布该公司及其附属公司Rgene Corporation与OncoX签订了全面的许可协议，OncoX是一家在英属维尔京群岛注册的私人公司，专门从事肿瘤学膳食补充剂。

We are hopeful that this agreement will facilitate the advancement of treatments for Non-Small Cell Lung Cancer (NSCLC) since it covers the license for the clinical trial, registration, manufacturing, supply, and distribution rights of ABVC's single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer.

我们希望这项协议将有助于推进非小细胞肺癌（NSCLC）的治疗，因为它涵盖了ABVC单一草药植物药提取物的临床试验，注册，制造，供应和分销权的许可证。该提取物来自灰树花蘑菇（Grifola Frondosa）的干果体，用于治疗非小细胞肺癌。

ABVC and its affiliate are set to receive an aggregate license fee of $12,500,000 in the form of cash or shares of OncoX securities within 30 days of executing the agreement, with an additional milestone payment of $1,250,000 in cash after OncoX's next round of fundraising, of which there can be no guarantee; ABVC and its affiliate are also entitled to royalties of 5% of net sales, up to $12,500,000, after the launch of the licensed product..

ABVC及其附属公司将在签署协议后30天内以现金或OncoX证券股份的形式收到12500000美元的总许可费，并在OncoX下一轮融资后以现金形式支付1250000美元的额外里程碑付款，对此无法保证；在许可产品发布后，ABVC及其附属公司也有权获得净销售额的5%的版税，最高可达12500000美元。。

The United States Food & Drug Administration (US FDA) has approved four INDs: ABV-1501 (IND 129575) for Triple Negative Breast Cancer (TNBC), ABV-1519 (IND 161602) for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 (IND 131300) for Myelodysplastic Syndrome (MDS), and ABV-1703 (IND 136309) for Pancreatic Cancer Therapy.

美国食品和药物管理局（US FDA）已批准四种IND：用于三阴性乳腺癌（TNBC）的ABV-1501（IND 129575），用于非小细胞肺癌（NSCLC）的ABV-1519（IND 161602），用于骨髓增生异常综合征（MDS）的ABV-1702（IND 131300）和用于胰腺癌治疗的ABV-1703（IND 136309）。

The Investigational New Drug (IND) application for ABV-1519 proposed the clinical investigation of BLEX 404 as a Combination Therapy Drug with Chemotherapy. The active ingredient of BLEX 404 is the β-glucan extracted from Grifola frondosa (maitake mushrooms), an edible fungus with high medical and commercial values in Asia; it contains various bioactive constituents such as polysaccharides, pyrrole alkaloids, ergosterol, etc., and has been widely served as functional foods for a long time in daily life.1.

ABV-1519的研究性新药（IND）申请提出了BLEX 404作为联合化疗药物的临床研究。BLEX 404的活性成分是从灰树花（灰树花蘑菇）中提取的β-葡聚糖，灰树花是一种在亚洲具有很高医学和商业价值的食用菌；它含有多种生物活性成分，如多糖、吡咯生物碱、麦角固醇等，长期以来被广泛用作日常生活中的功能性食品。

Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404, a promising therapeutic agent for the treatment of NSCLC. We believe that this collaboration leverages the respective strengths of both companies to accelerate the availability of this vital treatment to patients worldwide..

根据协议条款，ABVC授予OncoX在其肿瘤学管道中的四种产品之一的独家权利，以开发，制造和商业化BLEX 404，这是一种有前途的治疗NSCLC的治疗剂。我们相信，这项合作利用了两家公司各自的优势，加速了这种重要治疗方法在全球范围内的可用性。。

'We are thrilled to finalize this licensing agreement with OncoX, an emerging frontrunner in the healthcare industry,' said Dr. Uttam Patil, ABVC's Chief Executive Officer. 'This collaboration represents a significant step forward in our mission to combat NSCLC and underscores our commitment to delivering innovative therapies to needy patients.

ABVC首席执行官乌塔姆·帕蒂尔（UttamPatil）博士说，我们很高兴能与医疗行业新兴领跑者OncoX达成这项许可协议这种合作代表着我们对抗非小细胞肺癌使命的重要一步，并强调了我们致力于为贫困患者提供创新疗法。

'He added that ABVC brings its cutting-edge research and development capabilities. With a deep understanding of NSCLC and a commitment to improving patient outcomes, ABVC will spearhead the development of BLEX 404, which has demonstrated promising results in clinical studies.'.

他补充说，ABVC拥有尖端的研发能力。随着对非小细胞肺癌的深入了解和对改善患者预后的承诺，ABVC将率先开发BLEX 404，这在临床研究中已显示出有希望的结果。”。

'OncoX is well-positioned to bring BLEX 404 to the market efficiently and effectively. Through this partnership, patients suffering from NSCLC will gain access to a treatment option that has the potential to transform their lives. This licensing agreement exemplifies ABVC and OncoX's shared dedication to advancing medical science and improving patient care.

“OncoX在将BLEX 404高效推向市场方面处于有利地位。通过这种合作关系，患有非小细胞肺癌的患者将获得有可能改变其生活的治疗选择。该许可协议体现了ABVC和OncoX共同致力于推进医学科学和改善患者护理。

Both companies are committed to working closely to ensure the successful development and commercialization of BLEX 404,' said Wen-Pin Yen, CEO of OncoX..

OncoX首席执行官严文斌说，两家公司都致力于密切合作，确保BLEX 404的成功开发和商业化。。

NSCLC often develops resistance to single-agent therapies. Thus, combining different drug classes, such as chemotherapy with targeted therapy or immunotherapy, can help overcome resistance mechanisms and improve treatment outcomes.2 We believe combination therapy often leads to higher response rates than monotherapy, particularly in aggressive or advanced NSCLC, where a robust initial response is crucial for patient outcomes.

NSCLC通常对单药治疗产生耐药性。因此，将不同的药物类别（如化疗与靶向治疗或免疫治疗）相结合，可以帮助克服耐药机制并改善治疗结果。我们认为联合治疗通常比单一治疗产生更高的缓解率，特别是在侵袭性或晚期非小细胞肺癌中，强大的初始反应对患者预后至关重要。

Synergistic effects have been shown when β-glucan is used alongside chemotherapy in cancer patients.3 Studies of patients being treated with Combination Therapy show an increase in the overall survival rate for lung cancer.4 Combination Therapy represents a promising approach to address the unmet demands in NSCLC treatment by improving efficacy, overcoming resistance, and providing patients with more personalized and targeted therapeutic options.

当β-葡聚糖与癌症患者的化疗一起使用时，已经显示出协同作用。3对接受联合治疗的患者的研究表明，肺癌的总生存率有所提高。4联合治疗代表了一种有前途的方法，可以通过提高疗效，克服耐药性，为患者提供更个性化和更有针对性的治疗选择，来解决NSCLC治疗中未满足的需求。

MSKCC, a prominent research institute in the USA, has conducted two Clinical trials to evaluate the safety of BLEX 404.5,6.

MSKCC是美国一家著名的研究机构，已经进行了两项临床试验来评估BLEX 404.5,6的安全性。

The terms of the agreement include upfront payments, milestone payments upon achievement of certain developmental milestones, and royalties on net sales of BLEX 404, which cannot be guaranteed.

该协议的条款包括预付款、实现某些发展里程碑时的里程碑付款以及BLEX 404净销售额的版税，这些都是无法保证的。

Management believes the Company's product pipeline has excellent market potential. The global cancer therapeutics market is expected to be worth around US$393.61 billion by 2032, up from US$164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.7 Lung Cancer Market is valued at US$ 29.5 billion in 2022 and is projected to grow at 11% CAGR through 2032.8.

管理层认为公司的产品线具有良好的市场潜力。到2032年，全球癌症治疗市场的价值预计将从2022年的1640亿美元增加到3936.1亿美元左右，2023年至2032年的复合年增长率为9.20%.7 2022年肺癌市场的价值为295亿美元，预计到2032.8年将以11%的复合年增长率增长。

For more information about ABVC and its subsidiaries, stay updated on the latest updates or visit https://abvcpharma.com. ABVC urges its shareholders to sign up on the Company's website for the latest news alerts: visit https://abvcpharma.com/?page_id=17707

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About ABVC BioPharma & Its Industry

关于ABVC生物制药及其行业

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development.

ABVC BioPharma是一家临床阶段的生物制药公司，正在开发六种药物和一种医疗器械（ABV-1701/Vitargus®）的活跃管道。对于其药品，该公司利用其世界知名研究机构网络中的许可技术，通过临床开发的第二阶段进行概念验证试验。

The Company's network of research institutions includes Stanford University, the University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III..

该公司的研究机构网络包括斯坦福大学、加利福尼亚大学旧金山分校和雪松西奈医学中心。对于Vitargus®，该公司打算通过第三阶段进行全球临床试验。