远大医药公告，集团全资附属公司Grand Medical Pty Ltd.开发的全球创新药物STC3141在中国开展的用 于治疗脓毒症的II期临床研究成功达到临床终点。该临床研究入组了180名接受标准治疗和护理的脓毒 症患者，持续给药5天，并随访至第28天。研究的主要临床终点指标为第7天序贯器官衰竭评估(SOFA) 评分较基线的变化值，次要终点包括第7天SOFA评分较基线下降幅度达到25%的受试者比例、第3天和 第5天SOFA评分较基线的变化值、28天全因死亡率等。结果显示，药物治疗组第7天SOFA评分较基线均 有明显下降，尤其是高剂量组，降幅明显大于安慰剂组。此外，STC3141安全性、耐受性良好，药代动 力学特征也符合预期。 ...

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任何責任。 自願性公告 本集團全球創新產品 STC3141 在中國開展的 II 期臨床研究成功達到臨床終點 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之 董事會(「董事會」)自願刊發。 董事會欣然公告，本集團全資擁有附屬公司 Grand Medical Pty Ltd.（一間本集團在 澳洲設立的創新藥研發中心）開發的全球創新藥物 STC3141，在中國開展的用於治 療膿毒症的 II 期臨床研究成功達到臨床終點，該臨床研究進度處於全球膿毒症研究 領域前列，這是本集團在危重症領域的又一重大研發進展。同時，STC3141 是全球 首個以重新構建免疫穩態為核心的膿毒症治療方案，實現了治療維度的重大升級， 在現有的抗感染、液體復蘇和維持器官運轉等對症支持治療的基礎上，針對機體免 疫失調這個核心病因加以精准調節，幫助身體恢復平衡，填補了當前膿毒症針對病 因治療的臨床空白。這次臨床研究的成功有望推動膿 ...

Policy Developments - The State Council, led by Premier Li Qiang, has discussed and approved the draft of the Medical Security Law, aiming to enhance the medical security policy system and protect the rights of insured individuals [2] - The draft emphasizes the need for stricter supervision of medical insurance funds and the establishment of mechanisms to combat fraudulent medical practices [2] Legislative Updates - The third review of the Infectious Disease Prevention Law revision has been conducted, which includes provisions for timely clarification of false or incomplete infectious disease information by health authorities [3] - The revision also calls for strengthening the disease prevention and control capabilities of medical institutions [3] Regulatory Actions - The National Medical Products Administration (NMPA) has suspended the import of digoxin raw materials from VITAL LABORATORIES PVT. LTD. due to discrepancies in production processes and quality management [4] - The NMPA has mandated that any products made with the affected raw materials must not be released into the market [4] Company Announcements - Weishinkang has received a drug registration certificate for its compound amino acid injection, which is intended for patients with renal insufficiency [6] - Yiling Pharmaceutical's subsidiary has received approval for the listing of letrozole, a drug used in breast cancer treatment [7] Financial Reports - Yixin Tang reported a 79.23% decline in net profit for 2024, with revenues of 18 billion yuan and a net profit of 114 million yuan [9] - Kexing Pharmaceutical's net profit for Q1 2025 increased by 106.21%, with revenues of 354 million yuan [10] - Shengda Bio's Q1 2025 net profit surged by 469.35%, reaching 21.71 million yuan [11] Capital Market Developments - Synaire has completed a multi-million yuan angel round of financing, which will be used for product development and global brand expansion [13] Industry News - The NMPA has identified 10 batches of cosmetics containing banned ingredients, prompting investigations and required corrective actions from involved companies [15] - Tsinghua University has established an AI hospital, aiming to integrate AI with medical services and education [16] - Yuan Da Pharmaceutical's early detection product for urinary tumors has received FDA breakthrough device designation and has commenced clinical application [17] Shareholder Actions - Shareholders of Xiangsheng Medical plan to reduce their holdings by up to 1.72% of the company's shares [19]

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 ...

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任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號: 00512) 持續關連交易 商業合作協議 商業合作協議 2025 年 4 月 25 日，本公司間接非全資附屬公司成都社泰與 Sirtex Medical US 訂立 商業合作協議，據此，各方可交替聘用另一方提供與醫療器械產品及放射性藥物產 品研發有關的若干服務，包括(i)按逐個項目提供諮詢及服務；和/或 (ii) 贊助研究和 開發項目，和/或 (iii) 招聘和員工。根據業務合作協議的對價每年不得超過 120 萬 美元。 上市規則之含義 於本公告日期，CDH Genetech 為一間於開曼群島成立之公司，其主要業務為投資控 股，由 CDH Fund V, L.P. （一間根據開曼群島法律成立之有限合夥企業）全資擁有， 其普通合夥人為 CDH V Holdings ...

Core Viewpoint - The announcement by the company regarding the approval of its fluticasone propionate nasal spray marks a significant step in breaking the market monopoly of foreign products in the domestic allergic rhinitis treatment sector [2]. Group 1: Product Development and Market Position - The fluticasone propionate nasal spray is the first domestic generic product to be launched in China and has been included in the national medical insurance and essential drug lists [2]. - The company has established itself as one of the leading firms in the domestic market for allergic rhinitis treatments, with a comprehensive product pipeline [2]. - The respiratory and critical care segment generated approximately HKD 1.71 billion in revenue last year, reflecting a nearly 27% year-on-year growth [2]. Group 2: Future Development Strategy - The company plans to continue its strategy of independent research and global expansion, focusing on developing a comprehensive product cluster for chronic airway diseases and critical care [3].

Core Viewpoint - The announcement of the approval of the fluticasone propionate nasal spray by Yuan Da Pharmaceutical marks a significant milestone for the company, as it is the first domestic generic version in China, expected to disrupt the market dominated by foreign products and provide more affordable treatment options for patients with allergic rhinitis [1][4]. Group 1: Market Opportunity - The fluticasone propionate nasal spray is a preferred treatment for allergic rhinitis in China, which has a high prevalence of approximately 17.6% among adults, translating to nearly 250 million patients [4][5]. - The nasal preparation market in China is projected to reach nearly 3.5 billion RMB in 2023, with a compound annual growth rate (CAGR) of 10.4% from 2019 to 2023 [4]. - The market for fluticasone propionate nasal spray is expected to reach 2.46 billion RMB by 2025, indicating substantial growth potential [4]. Group 2: Competitive Landscape - The current market for nasal corticosteroids is largely dominated by foreign companies, with Pfizer and Merck holding about half of the market share in 2023, highlighting a significant opportunity for domestic alternatives [5]. - Yuan Da Pharmaceutical's successful launch of the budesonide nasal spray, another first generic product, demonstrates the potential for domestic products to gain market share and disrupt foreign dominance [5][6]. Group 3: Product Pipeline and Innovation - Yuan Da Pharmaceutical has a comprehensive pipeline for allergic rhinitis treatments, including the upcoming Ryaltris® combination nasal spray, which is expected to meet the needs of patients with varying severity of allergic rhinitis [7][8]. - The company is also developing STC3141, an innovative product targeting sepsis, which has shown promising clinical results and addresses a significant unmet medical need in a market projected to reach 5.627 billion USD by 2030 [9]. - The focus on both self-developed and globally expanded research and development aims to solidify the company's position in the respiratory and critical care sectors [9].

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任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 本集團中國首仿的丙酸氟替卡松鼻噴霧劑獲批上市 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事會 (「董事會」)自願刊發。 董事會欣然公告，本集團開發的用於治療過敏性鼻炎的丙酸氟替卡松鼻噴霧劑近日獲得 中華人民共和國國家藥品監督管理局(「藥監局」)頒發的藥品註冊證書，該產品為中國首 仿上市產品，且已被納入國家醫保目錄和國家基本用藥目錄，此次，該產品的獲批上市是 本集團在呼吸及危重症領域的又一次重大研發進展。 中國是世界上過敏性鼻炎發病率最高的國家之一。根據中國相關流行病學調查結果，中國 成人過敏性鼻炎患病率約 17.6%，患病群體已近 2.5 億人口，患者群體龐大。中國過敏性 鼻炎診斷率僅37.3%，治療率為4 ...

Group 1 - The Hong Kong pharmaceutical ETF (513700.SH) increased by 3.14%, with major constituents such as Xintai Medical rising by 60%, Meizhong Jiahe by 26%, and Nuocheng Jianhua by 13% [1] - Yuan Da Pharmaceutical announced a milestone breakthrough in its clinical research for the innovative radioactive nuclide-conjugated drug (RDC) GPN02006 for diagnosing hepatocellular carcinoma (HCC), achieving high-quality imaging within 30 minutes of administration [1] - GPN02006 provides strong molecular imaging evidence for personalized treatment plans, addressing the clinical need for rapid diagnosis of HCC and improving early diagnosis rates and monitoring of recurrence and metastasis [1] Group 2 - Guojin Securities believes that innovative drugs in the Hong Kong stock market will be a key investment theme in 2025, driven by AI enabling shorter R&D cycles, reduced costs, and improved efficiency [2] - The recovery of investment and financing activities in the global pharmaceutical industry is beneficial for improving cash flow for innovative drug companies [2] - Anticipation of fiscal stimulus, including the imminent release of the "Class B Directory," may catalyze valuation and sentiment recovery in the sector [2]