Core Viewpoint - The recent diagnosis of prostate cancer in former U.S. President Biden has highlighted the importance of early cancer screening, which aligns with the comprehensive strategies of Yuan Da Pharmaceutical in the prostate cancer sector [1][3]. Company Overview - Yuan Da Pharmaceutical has established a robust presence in the prostate cancer market with innovative medical devices and a comprehensive product portfolio that integrates diagnosis and treatment [1][2]. - The company has seen a significant stock price increase, reaching a nearly ten-year high of 9 HKD per share, with a cumulative rise of approximately 50% over the past two weeks [1]. Market Dynamics - The global prostate cancer treatment market is projected to grow from 13.5 billion USD in 2025 to 29.9 billion USD by 2034, with a CAGR of 9.2% [7]. - In China, the prostate cancer medication market was valued at approximately 30.3 billion CNY in 2023, reflecting a year-on-year growth of 15.07% [7]. Early Screening Importance - The early detection rate of prostate cancer in China is only 32%, significantly lower than the 92% in the U.S., leading to a higher incidence of late-stage diagnoses [9]. - Early-stage prostate cancer patients have a survival rate of up to 100%, while those with metastatic disease have only a 31% five-year survival rate [3]. Product Development and Clinical Trials - Yuan Da Pharmaceutical's innovative products include TLX591-CDx, which has completed patient enrollment for its Phase III clinical trial in China and is expected to submit for market approval within the year [2][10]. - The company has a pipeline of 15 innovative products in the nuclear medicine sector, covering multiple cancer types, and has achieved significant clinical milestones [16][17]. Strategic Positioning - The establishment of a global nuclear medicine R&D and production base in Chengdu, set to commence operations in June 2025, will enhance Yuan Da's capabilities in the nuclear medicine field [19]. - The company aims to create a comprehensive ecosystem for urogenital system diseases, integrating early screening and treatment solutions [15][20]. Future Outlook - Yuan Da Pharmaceutical is positioned to become a key player in the global pharmaceutical market, with a focus on innovation and expanding its market share in cancer diagnostics and treatment [20].

Core Viewpoint - Early diagnosis and intervention in cancer treatment is a primary policy direction in China, as highlighted by the "Healthy China Action - Cancer Prevention and Control Action Implementation Plan (2023-2030)" which emphasizes promoting early diagnosis and treatment of cancer and strengthening screening mechanisms [1] Company Developments - On April 27, 2023, the Hong Kong-listed innovative pharmaceutical company, Yuan Da Pharmaceutical (00512), announced the commercialization of its early detection product, Youai®, for urinary system tumors in collaboration with Beijing Xiangxin Biotechnology Co., Ltd. This product is the only approved dual-mechanism early detection product for urothelial carcinoma in China, marking a significant advancement in non-invasive tumor diagnostics [1][3] - Youai® has received multiple recommendations from authoritative guidelines, including the "2024 CSCO Urothelial Carcinoma Diagnosis and Treatment Guidelines" and the "Bladder Cancer Early Diagnosis and Treatment Expert Consensus (2024 Edition)" [3] - The product demonstrates a sensitivity of 92.5% and specificity of 95.8% based on over 1,000 clinical studies, significantly improving patient comfort compared to invasive procedures like cystoscopy [3] Market Potential - The early detection market for tumors in China is projected to grow significantly, with a compound annual growth rate of 97.9% from 2018 to 2022, reaching approximately 28.5 billion yuan by 2030 [4] - The demand for precise and non-invasive early detection of urinary system tumors is substantial, given the increasing incidence of these cancers, with over 270,000 new cases reported in 2020 [5] Product Pipeline and Innovation - Yuan Da Pharmaceutical is advancing its product pipeline in the nuclear medicine sector, with 15 innovative products under development, covering various radioactive isotopes and multiple cancer types [6][9] - The company has established a comprehensive industrial layout in the nuclear medicine field, including research, production, sales, and regulatory qualifications, aiming to solidify its position as a leader in the global nuclear medicine oncology market [9]

董事會欣然公告，近日，本集團核藥抗腫瘤診療板塊與北京橡鑫生物科技有限公司(「金 橡醫學」)合作開發的泌尿系統腫瘤早檢產品優愛®的首張商業化處方在上海復旦大學附 屬華東醫院落地，標誌著我國目前唯一獲批上市的甲基化+基因突變雙機制的尿路上皮 癌早檢產品正式進入臨床應用，為中國患者提供更精准的無創腫瘤診斷服務。 金橡醫學成立於 2018 年，依託獨家的生物標誌物發現平台，聚焦未滿足的臨床需求， 已形成「腫瘤早診早篩及監測、癌症患者精准醫學檢測、全球抗腫瘤藥企研發合作」三 大板塊業務佈局。公司核心產品優愛/優護系列產品涵蓋了尿路上皮癌早檢產品 (「優愛® 」)、尿路上皮癌複查產品(「優愛 MRD」)以及前列腺癌早檢產品(「優護」)， 三款產品均獲得了美國食品藥品監督管理局(Food and Drug Administration，FDA)突破性 醫療器械認定。本集團已獲得這三款核心產品在中國大陸的獨家商業化及聯合開發權益。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其 準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而 產生或因倚賴該等內容而引致的任何損失承擔 ...