来源：问董秘 投资者提问： 你好。1.HIE是由新生儿脑组织缺氧和脑血流量减少引起的一种新生儿脑损伤疾病，对发育中的大脑有 严重影响，并可能导致显著的死亡率和长期神经系统后遗症，如脑瘫、癫痫、智力障碍等，给家庭社会 带来沉重负担。目前，全球尚无获批的HIE治疗药物。亚低温（therapeutic hypothermia，TH）是目前唯 一被批准的HIE神经保护治疗，用于中重度HIE，但效果有限。WP103可以为全球患儿提供一种全新的 主动干预手段。 2.HIE是一个需求广阔的蓝海市场。全球范围每年约有数十万婴儿罹患中重度HIE，市 场容量有望达到百亿美金。WP103已获得FDA的孤儿药（ODD）和罕见儿科疾病（RPDD）双认定，不 仅体现了创新价值，也意味着药物上市后可能获得7年的市场独占权、新药申请的优先评审、注册费用 免除等一系列政策支持，为后续商业化提供了有力保障。 3.近期完成的大动物药效学研究显示，WP103 在多个关键指标上表现出良好的治疗效果，同步改善行为学、神经评分及脑组织病理变化。试验动物与 人类大脑有相似的生理结构和脑回，提示WP103有望对HIE患儿降低残疾水平、改善认知、记忆损伤。 4 ...

Core Insights - Wanbangde's innovative drug WP103 has made significant progress in treating neonatal hypoxic-ischemic encephalopathy (HIE), receiving both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA, indicating its potential clinical value and market demand [1][2] - The successful development of WP103 is expected to revolutionize the treatment landscape for HIE, with the company aiming to complete clinical trials and enter the market by 2026-2027, potentially capturing a significant share of the global HIE treatment market [3] Company Developments - WP103 is developed by Wanbangde's wholly-owned subsidiary, Wanbangde Pharmaceutical Group, and has received FDA approval for clinical trials, marking a milestone in the company's innovative drug development capabilities [1][3] - The drug has shown promising results in preclinical studies, demonstrating a 100% reduction in seizure incidence compared to the control group, indicating its protective effects on vulnerable neonatal brains [2] Industry Context - The market for treatments related to HIE is projected to be worth tens of billions to over a hundred billion dollars, with a significant demand for breakthrough therapies due to the limited effective treatment options currently available [3] - HIE affects approximately 10,000 infants annually in the U.S. and around 750,000 globally, leading to severe neurological impairments and high mortality rates, highlighting the urgent need for effective treatments [2]

Core Insights - WP103 is an innovative drug developed by the company for treating neonatal Hypoxic-Ischemic Encephalopathy (HIE) and has received FDA approval for clinical trials starting in January 2025 [1][2] - The drug has shown promising results in large animal non-clinical pharmacodynamic trials, demonstrating effectiveness in reducing brain injury risk, accelerating neurological recovery, and reversing behavioral deficits [1] - WP103 has received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA, indicating its innovative value and potential clinical demand in the neonatal HIE treatment space [2] Company Developments - The company has conducted pre-trial communications with the FDA and is preparing for key registration clinical studies for HIE in neonates [1] - The large animal trials serve as a critical bridge between basic research and clinical application, providing reliable data for safety evaluations in neonatal drug development [1] - The dual designation from the FDA offers the company various policy supports, including market exclusivity, exemption from new drug application fees, and expedited review processes, which will aid in global clinical development and commercialization of WP103 [2] Regulatory Considerations - The company must conduct a series of clinical trials in compliance with U.S. drug registration laws and regulations before WP103 can be marketed, indicating a structured pathway to commercialization [2] - The short-term impact on the company's operational performance is expected to be minimal as it navigates the regulatory landscape [2]

Core Insights - WP103 is an innovative drug developed by the company for treating neonatal Hypoxic-Ischemic Encephalopathy (HIE) and has received FDA approval for clinical trials starting in January 2025 [1] - The drug has shown promising results in preclinical studies, demonstrating effectiveness in reducing brain injury risk, accelerating neurological recovery, and reversing behavioral deficits [1] - WP103 has received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA, indicating its innovative value and potential clinical demand in the neonatal HIE treatment space [2] Company Developments - The company has conducted large animal non-clinical pharmacodynamic trials to support the initiation of critical registration clinical studies for HIE, which are essential for bridging basic research and clinical application [1] - The dual designation of RPDD and ODD provides the company with various policy supports, including market exclusivity, exemption from new drug application fees, and expedited review processes, which will facilitate global clinical development and commercialization of WP103 [2] - The company plans to engage in further discussions with the FDA regarding trial results and must conduct a series of clinical trials in compliance with U.S. drug registration regulations before the drug can be marketed [2]

Core Viewpoint - The company reported a 12.66% year-on-year increase in net profit attributable to shareholders, reaching 55.44 million yuan, and achieved a positive operating cash flow of 120 million yuan in 2024, highlighting significant improvements in its financial performance [1] Financial Performance - The company's net profit attributable to shareholders increased by 12.66% year-on-year, amounting to 55.44 million yuan [1] - Operating cash flow turned positive, achieving 120 million yuan in 2024 [1] - The medical device segment significantly reduced losses by 42.49%, while the South African business turned profitable with a year-on-year net profit growth of 211.68% [1][2] Business Segments - The South African business segment achieved profitability after years of effort, marking a key highlight in the company's operational performance [2] - The company has established a strong presence in the medical device sector, with multiple orthopedic implant products certified by the FDA and CE, and a robust pipeline of new products under development [2] - The company has been focusing on the South African market for medical device distribution and maintenance services, building a stable customer base and market reputation [2][3] Innovation and R&D - The company has made significant breakthroughs in new drug development, particularly in the field of neurological drugs, with a focus on the development of the huperzine A series and methionine preparations [1][4] - As of the end of the reporting period, the company had seven new drug pipelines under research, with five of them being dual-filed in China and the U.S., indicating high-quality pipeline development [4] - The company has received FDA clinical trial approvals for WP107 and WP103, both of which are based on huperzine A, a potent cholinesterase inhibitor [4][6] Future Outlook - The company plans to enhance its international strategy by increasing the export of domestic medical devices, aiming to create a new profit contribution point [3] - The company is committed to advancing its R&D capabilities by leveraging artificial intelligence in drug development and production quality control [7] - The company aims to become a leading enterprise in the pharmaceutical and health industry through technological innovation and collaboration with academic institutions [7]