Hexaminolevulinate Hydrochloride

As of the date of this publication, APL-1702 has not been approved for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL); APL-1706 has not been approved for the diagnosis or surgical treatment of bladder cancer in China. This article is intended to disclose the latest development of these products, not to serve as a promotional advertisement for the products. The relevant information is not intended for patients but is provided solely for the reference of healthcare professionals. If you like to learn more about these diseases, please consult healthcare professionals. SHANGHAI, Aug. 28, 2024 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2024 Semi-Annual Report, showcasing a strong growth momentum. The launch of its blockbuster product APL-1702 is progressing smoothly, while the Commercial Team continues to enhance revenue-generating capabilities. The company's pipeline is advancing and broadening, currently with 13 major products and 18 ongoing research projects. As of the end of this reporting period, Asieris had approximately RMB 2.024 billion in cash, cash equivalents, and financial assets held for trading, ensuring ample capital for the company's continued growth and expansion. Advancing Launch of APL-1702 to Meet Strong Demand for Non-Invasive Treatment of Precancerous Cervical Lesions The new drug application for APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly. APL-1702 is a groundbreaking product that combines innovative, clinical, and social value. As a first-in-class treatment to be debuted in China, backed by proven efficacy in an international phase III trial, it is poised to become the world's first non-invasive therapy for HSIL. Clinically, APL-1702 is set to redefine the treatment paradigm of precancerous cervical lesions, moving beyond the one-size-fits-all approach of cervical resection. It aims to reverse disease progression while preserving the cervix, avoiding damage from resection, and supporting long-term management and recurrence prevention. From a societal perspective, managing HSIL patient is a crucial step in the "early diagnosis and early treatment" of cervical cancer. APL-1702 combines the value of early cervical cancer intervention and the promotion of a fertility-friendly society, and it is expected to contribute to the success of the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030) and the Healthy China Initiative. To support the commercialization of APL-1702, the company formally established the Women's Health Business Unit in early 2024. This unit is responsible for the domestic commercialization of APL-1702 in the Chinese market and expanding the company's gynecological pipeline. Key members, including the BU head and teams for marketing, government affairs, and regional commercialization, have already come on board, all bringing extensive experience in gynecology and multinational pharmaceutical companies. In the first half of this year, the Women's Health Business Unit conducted thorough market and industry research, developed a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the product's rapid market availability following its approval. The company has also convened three expert consultation meetings focusing on key topics such as review and dissimilation of phase III clinical data of APL-1702, the current state of HSIL diagnosis and treatment, and clinical needs. The meetings garnered strong endorsements from the principal investigators and leading national gynecologists, highlighting the innovation and clinical value of APL-1702. With this expert backing, the Women's Health Business Unit is pursuing strategic partnerships with government departments and industry associations to advance cervical cancer control and help shape a long-term management framework for precancerous lesions. Preparations are well underway, and a cooperation agreement is expected to be signed and implemented in the second half of the year. Given the scarcity of innovative drugs in gynecology, APL-1702 stands out with its solid clinical evidence and proven efficacy. Moving forward, the company will leverage APL-1702 and its drug-device combination platform to build a robust gynecological portfolio through external partnerships, indication expansion, and proprietary second-generation products. Commercial Capabilities Continue to Strengthen: Operating Revenue Increased by 130.98% from Q1 to Q2 During this period, the company's commercial team's revenue-generating capabilities continued to strengthen. In the first half of 2024, the Oncology Business Unit optimized its marketing strategies and execution quality despite a shifting competitive landscape and policy environment. While effectively controlling sales expenses, the company generated operating revenue of RMB 80.4934 million yuan in the first half of 2024, with RMB 56.1739 million earned in the second quarter, a 130.98% increase from the previous quarter. Alongside strong commercialization performance, the Oncology Business Unit is actively preparing for the launch of new products. The new drug application for APL-1706, a diagnostic and management agent for bladder cancer, was accepted in November 2023. Currently, APL-1706 is the world's only imaging agent approved to assist bladder cancer diagnosis or surgery. It has passed inspection by the Center for Food and Drug Inspection (CFDI), with NMPA approval expected by the end of June 2025. The Oncology Business Unit is refining a launch plan for APL-1706, exploring opportunities beyond surgical applications, such as outpatient examinations and strategic partnerships. The aim is to broaden market reach and benefit more patients. The team is developing strategies for post-launch access, pricing, expert endorsement, clinical collaboration, and dealer networks. Additionally, the company will build on its strong brand positioning with a strategy that combines in-house research and in-licensing, will actively pursue external partnerships to further enhance its commercial competitiveness and strengthen its position in oncology. Commit to Innovation and Drive Pipeline Expansion and Development Worldwide Guided by its strategy, Asieris has made significant strides in multiple clinical development programs in the first half of the year, with a strong push for global presence. In the field of women's health, following the positive results of the international phase III trial for APL-1702 and recognizing the substantial unmet clinical needs, Asieris plans to submit a pre-submission to the European Medicines Agency (EMA) in the fourth quarter of 2024. It also aims to be in discussion with the US Food and Drug Administration (FDA) this year on the design of a pivotal clinical program for the North American market and will apply for a phase III trial in due course. The company has also begun development of the HPV clearance indication. In the field of genitourinary tumors, the interim analysis for the phase II trial of APL-1202 with tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer has been completed, thus moving to the next evaluation stage. Data read-out from the phase II trial is expected in September 2024. The company's preclinical pipeline includes APLD-2304, AT-014, AT-020, AT-017, AT-018, and AT-021, with active R&D efforts underway. Notably, APL-2302 has advanced to the IND-enabling phase and is expected to receive IND approval within 2024. Compared to major competitors, APL-2302 offers potential advantages such as superior pharmacokinetics, a lower onset dose, and an optimal safety profile, supporting higher safe doses in humans. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "We remain optimistic and confident about the future of Asieris. The launch of our two core products, APL-1702 and APL-1706, is on track and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products. We also saw strong growth in commercialization, reduced operational costs, and increased efficiency in the first half, showcasing our ability to meet strategic goals. Looking ahead, we will remain focused on genitourinary tumors and women's health, aiming to deliver even greater value to both society and our shareholders." SOURCE Asieris

说明： 截至发稿日期，APL-1702尚未获批用于治疗宫颈高级别鳞状上皮内病变；APL-1706尚未在国内获批用于膀胱癌诊断或手术。本文用于披露公司最新进展，并非产品推广广告。相关信息并非针对患者，仅供医疗卫生专业人士参考之用。如您想了解更多疾病信息，请咨询医疗卫生专业人士。 上海 2024年8月28日 /美通社/ -- 今日，亚虹医药发布的2024年半年报显示，公司展现出了锐意前行的态势：重磅产品APL-1702的上市进程有序进行；商业化"造血"能力持续增强；创新管线积极推进。截至目前，公司主要产品管线拥有13个产品、18个在研项目。报告期末货币资金与交易性金融资产约20.24亿元，资金储备充足，为公司发展提供保障。 全力推进 APL-1702上市工作，满足癌前病变无创治疗需求 亚虹医药用于非手术治疗宫颈高级别鳞状上皮内病变（High-Grade Squamous Intraepithelial Lesion，HSIL）的光动力药器组合产品APL-1702的新药上市申请于2024年5月获得国家药品监督管理局（NMPA）受理。公司正在积极推进该产品的上市审评审批工作，目前进展顺利。 APL-1702是一款同时满足创新价值、临床价值与社会价值的产品：其创新价值尤为突出，是全球首创、中国首发，并且具有高等级的临床证据支持，有望成为全球首个经国际Ⅲ期临床验证、疗效确切的HSIL无创疗法；在临床价值方面，APL-1702有望重新定义宫颈癌前病变的治疗目标，让HSIL治疗不再只能一刀切（宫颈切除术），而是有望在保留完整宫颈的前提下，逆转疾病进程，避免推迟宫颈切除术带来的宫颈损伤，有助于疾病的长期管理，更好应对复发；此外，从社会价值角度来看，HSIL患者管理是宫颈癌"早诊早治"的关键环节，APL-1702兼具消除宫颈癌早期干预和建设生育友好型社会的价值，有望助力《加速消除宫颈癌行动计划（2023-2030年）》和健康中国战略的早日实现。 为了更好地推进APL-1702的商业化进程，公司已于2024年初设立女性健康事业部，并由该事业部负责APL-1702的国内商业化以及扩大在妇科的产品管线。目前，事业部负责人、市场部、政府事务部、区域上市团队等核心成员已完成招聘，成员均具备妇科领域丰富工作经验和跨国药企背景。今年上半年，女性健康事业部深入调研市场与行业需求，已经完成了APL-1702关键上市策略的制定，并积极规划商业化供应方案，确保产品获批后能迅速投放市场。 此外，公司目前已就APL-1702的Ⅲ期临床数据、HSIL的诊疗现状及临床需求等关键课题成功召开3次专家咨询会，赢得了主要研究者和全国顶级妇科领域专家对APL-1702的创新性和临床价值的高度认可。在相关领域专家支持下，女性健康事业部还在积极寻求与政府部门和相关行业协会的战略合作，以推动宫颈癌防控及癌前病变长期管理路径的建立，相关准备工作已就绪，预计下半年将签署合作协议并推进落地执行。 鉴于妇科领域创新药物的稀缺，APL-1702作为妇科领域具有临床证据且疗效确切的创新产品，显得尤为重要。未来，公司计划依托APL-1702及药械联用平台，通过外部合作、拓展适应证及开发自研二代产品，构建有梯度和深度的妇科产品线。 商业化能力持续增强，二季度营收环比增长 130.98% 同期，公司商业化团队"造血"能力也在持续增强。2024年上半年，肿瘤事业部商业化团队在多变的竞争形势和政策环境下，不断优化市场策略及落地执行质量，在有效控制销售费用支出的前提下，公司实现营业收入8049.34万元，其中第二季度实现5617.39万元，环比增长130.98%。 在商业化实现强劲增长的同时，肿瘤事业部还在积极为新产品上市做准备。公司膀胱癌诊断和管理药物APL-1706的新药上市申请于2023年11月获得受理，该产品是目前全球唯一获批的辅助膀胱癌诊断或手术的显影剂类药物。目前，APL-1706已顺利通过了国家药品监督管理局食品药品审核查验中心（CFDI）核查，并期望于2025年6月底前获得上市批准。 肿瘤事业部正在持续完善APL-1706的上市规划，在原来手术治疗场景的基础上，积极探索门诊检查场景、第三方战略合作等方式，以期进一步拓展APL-1706的商业机会，惠及更多患者；并逐步规划和落实产品上市后准入、定价、专家支持、临床合作及经销商体系搭建。 另外，在不断夯实品牌定位的基础上，公司基于自研结合引进策略，还将积极寻求外部合作，以期进一步强化公司在肿瘤领域商业化的竞争能力和优势。 坚持创新研发 积极推进管线布局及海外开发 在公司战略引导下，亚虹医药今年上半年在临床开发方面取得了多项进展，包括全球临床布局也正在高效推进中。 在女性健康领域，基于APL-1702国际多中心Ⅲ期研究的优异结果，以及潜在的巨大未被满足的临床需求，公司拟于2024年第四季度向欧洲药品管理局（EMA）提交该产品上市申请前的沟通申请（Pre-submission）；期望于2024年与美国食品药品监督管理局（FDA）沟通交流在北美市场的注册临床方案设计，并适时递交在北美开展注册三期临床研究的申请。同时，公司目前已启动HPV病毒清除适应证的开发。 在泌尿系统肿瘤领域，APL-1202与替雷利珠单抗联合新辅助治疗肌层浸润性膀胱癌已完成Ⅱ期临床试验期中分析，并已进入下一阶段的评估，预计将于2024年9月读出Ⅱ期试验的数据。 此外，公司处于临床前研发阶段的产品主要包括APLD-2304、AT-014、AT-020、AT-017、AT-018、AT-021等，公司正积极推进这些新药的研发进程。其中，APL-2302已进入IND enabling阶段，期望于2024年获得临床试验批准。相比于主要竞对产品，APL-2302表现出更好的药代动力学性质、更低起效剂量、理想的安全窗等潜在差异化竞争优势，有望支持更高的人体安全用药剂量。 亚虹医药创始人、董事长、首席执行官潘柯博士表示： 我们对亚虹的未来发展始终保持乐观和信心。公司两款填补治疗领域空白的核心产品APL-1702、APL-1706的上市工作均在有序推进中，这不仅体现了公司以临床价值为导向的理念，而且随着这两款产品商业化的临近，有望让创新成果早日惠及患者。同时，我们在今年上半年实现了商业化的强劲增长和运营的降本增效，这些都突显了亚虹实现战略目标的能力。展望未来，我们将继续聚焦泌尿生殖系统肿瘤及女性健康领域，期望能够为社会和股东创造更多价值。