Core Viewpoint - The recent advancements in the clinical trials of STC3141 and TLX591 have significantly boosted the stock price of Yuan Da Pharmaceutical, reflecting the company's strong position in the global nuclear medicine market and its innovative product pipeline [1][5]. Group 1: Company Developments - Yuan Da Pharmaceutical's stock surged over 13% following the announcement of progress in the domestic Phase II clinical trials for STC3141, with a total increase of over 70% since the end of January [1]. - The company has received formal acceptance from the National Medical Products Administration for its application to initiate international multicenter Phase III clinical trials for TLX591, a radiolabeled drug for prostate cancer [1][4]. - Yuan Da has established a comprehensive industry chain covering research, production, sales, and regulatory qualifications, positioning itself as a leading global player in nuclear medicine [4]. Group 2: Product Pipeline and Innovation - The company has a robust pipeline with 15 innovative products in the nuclear medicine field, targeting various cancers including liver, prostate, kidney, and brain cancers [2][4]. - TLX591 is designed to treat metastatic castration-resistant prostate cancer (mCRPC) and is expected to significantly improve patient compliance due to its shorter treatment cycle compared to existing therapies [5][6]. - The unique targeting mechanism of TLX591 reduces exposure to non-target organs, minimizing common side effects and improving the quality of life for patients [6][9]. Group 3: Market Potential - The prostate cancer treatment market is projected to grow from $15.2 billion in 2021 to $24.9 billion by 2030 globally, with China's market expected to reach approximately 30.3 billion yuan in 2023, reflecting a year-on-year growth of 15.07% [8][9]. - The increasing incidence of prostate cancer, with an estimated 440,000 patients in China by 2025, highlights the urgent need for effective treatment options like TLX591 [8][9]. - Yuan Da aims to leverage its existing hospital resources to promote TLX591 rapidly upon approval, potentially establishing it as a key product in its portfolio [9].

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 本集團全球創新放射性核素偶聯藥物 TLX591 加入國際多中心 III 期臨床試驗的申請已獲中國藥監局受理 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，本集團用於治療前列腺癌的全球創新放射性核素偶聯藥物(「RDC」) TLX591 (177Lu- HuJ591)加入國際多中心 III 期臨床試驗的申請，近日已獲得中華人民共 和國國家藥品監督管理局(「中國藥監局」)正式受理，這是本集團在核藥抗腫瘤診療領 域的重要研發進展。本集團高度重視核藥產業全球化發展戰略，積極推進創新核藥產品 的全球化開發及註冊進程，並將持續深化本集團核藥產品管線的全球化拓展。 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。 該研究是一項前 ...

Group 1 - Zhengrong Real Estate (06158.HK) has appointed joint liquidators by its controlling shareholder, and trading of its shares will resume from 9 AM on Wednesday, with business operations continuing as usual [1] - XPeng Motors (09868.HK) plans to hold a board meeting on May 21 to approve its first-quarter results [1] - Xiehe New Energy (00182.HK) reported a total equity generation of 3,330.69 GWh in the first four months, a year-on-year decrease of 2.24%, with April's generation at 809.84 GWh, down 6.48% year-on-year [1] Group 2 - Touyun Biotechnology (01332.HK) plans to sell 70% of its stake in Weidao International for 13 million yuan [1] - Gilead Sciences (01672.HK) will present early research findings on its obesity candidate drug ASC47 at the 32nd European Congress on Obesity (ECO 2025) through oral and poster presentations [1] - Yuanda Pharmaceutical (00512.HK) has successfully reached clinical endpoints in its Phase II clinical study of the global innovative product STC3141 for the treatment of sepsis in China [1] Group 3 - Shanggao New Energy (01250.HK) reported a cumulative operational generation of approximately 1.0196 million MWh in the first two months, representing a year-on-year increase of about 13.1% [1]

遠大醫藥集團有限公司* 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 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毒症治療邁入一個新紀元。 -1- 該研究是一項評估靜脈輸注 STC3141 注射液在膿毒症患者中的療效、安全性 ...

Core Viewpoint - The successful completion of the Phase II clinical trial for STC3141 by YuanDa Pharmaceutical marks a significant advancement in the treatment of sepsis, demonstrating both efficacy and safety, and positioning the company at the forefront of global sepsis research [1][2][3]. Clinical Development - STC3141 is a novel small molecule compound developed by YuanDa Pharmaceutical, targeting the immune dysregulation in sepsis through a unique mechanism [2][3]. - The Phase II trial involved 180 sepsis patients and assessed the efficacy, safety, and pharmacokinetics of STC3141, with primary endpoints focusing on changes in the SOFA score [2][3]. - Results showed a significant reduction in SOFA scores in the treatment group compared to the placebo, particularly in the high-dose group, indicating both statistical and clinical significance [3]. Market Potential - Sepsis is a major global health challenge, with a high mortality rate of 25%-60%, and approximately 50 million cases annually worldwide, leading to over 11 million deaths [4]. - The global market for sepsis treatment is projected to grow from approximately $3.814 billion in 2024 to $5.967 billion by 2031, with a CAGR of 6.7% from 2025 to 2031 [4]. - In China, there are about 2.5 million sepsis patients annually, with over 700,000 deaths, highlighting a significant unmet clinical need [4]. Competitive Landscape - Currently, there are no specific drugs available for sepsis treatment, presenting a unique opportunity for pharmaceutical companies to develop targeted therapies [5]. - YuanDa Pharmaceutical has established a strong position in the critical care sector, with a comprehensive product portfolio and ongoing research in unmet clinical needs [6][9]. Future Outlook - The successful trial of STC3141 not only reinforces YuanDa Pharmaceutical's R&D capabilities but also positions the product as a potential breakthrough therapy in sepsis treatment [3][9]. - The company plans to engage with regulatory authorities to expedite the approval process for STC3141, aiming to address the urgent clinical needs of sepsis patients [3][9].

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 ...