Core Viewpoint - The stock price of Yuan Da Pharmaceutical (00512) has experienced a strong upward trend, achieving a four-day consecutive rise and over 20% increase within the week, driven by significant innovations in various fields [1]. Group 1: Innovations and Clinical Trials - The company has reached clinical endpoints in the Phase II trial of its innovative drug STC3141 for treating sepsis and has received acceptance for the Phase III clinical trial application of its radiopharmaceutical TLX591 for oncology [1][7]. - Yuan Da Pharmaceutical has a robust pipeline with 15 innovative products in the registration phase, covering multiple cancer types and offering integrated diagnostic and therapeutic solutions [3][5]. Group 2: Financial Performance - The nuclear medicine oncology segment is projected to generate approximately HKD 589 million in revenue for 2024, reflecting a year-on-year growth of nearly 177%, with the core product contributing nearly HKD 500 million [3]. - The company has seen its core product, Yttrium-90 microsphere injection, achieve over 140% year-on-year sales growth for two consecutive years [3]. Group 3: Strategic Developments - Yuan Da Pharmaceutical has established a comprehensive industrial layout, including R&D, production, sales, and regulatory qualifications, with a new radioactive drug R&D and production base in Chengdu expected to commence operations soon [6]. - The company is investing approximately HKD 3 billion in this facility, which aims to become a global hub for innovative nuclear medicine [6]. Group 4: Market Potential - The global market for sepsis treatment drugs is expected to grow from USD 12.54 billion in 2024 to USD 19.37 billion by 2032, with a compound annual growth rate of 5.58% [7]. - Yuan Da Pharmaceutical is positioned to fill a significant clinical gap in sepsis treatment with STC3141, which is anticipated to be a groundbreaking therapy [7]. Group 5: Eye Care Sector - The company has developed a comprehensive product system in the ophthalmology field, focusing on various eye diseases and has several innovative products in the pipeline [10][13]. - Yuan Da Pharmaceutical is recognized as a leader in the eye care sector, with a strong marketing network and a commitment to addressing unmet clinical needs [10][13].

Core Viewpoint - The recent clinical successes of the innovative drugs STC3141 and TLX591 by the company have significantly boosted its stock price and market recognition, indicating strong potential in the global sepsis and nuclear medicine markets [1][2][13]. Group 1: Clinical Developments - The company has successfully reached clinical endpoints in the Phase II trial of STC3141 for sepsis treatment and has received acceptance for the Phase III trial application of TLX591 for prostate cancer by the National Medical Products Administration [1][8]. - STC3141 is a novel small molecule with a unique mechanism that addresses the lack of targeted therapies for sepsis, showing promising clinical benefits [4][7]. - TLX591 is a groundbreaking radiopharmaceutical for treating metastatic castration-resistant prostate cancer (mCRPC), utilizing a dual-targeting approach to enhance treatment efficacy while minimizing off-target effects [8][9]. Group 2: Financial Performance - The company reported a revenue of approximately HKD 11.64 billion for 2024, reflecting a year-on-year growth of about 12.8%, with a net profit of approximately HKD 2.47 billion, up 34.0% year-on-year [3]. - The nuclear medicine segment has seen a substantial revenue increase of nearly 177%, driven by the core product Yttrium-90 microspheres, which contributed nearly HKD 500 million in revenue with a growth rate exceeding 140% [3]. Group 3: Market Position and Future Outlook - The company is positioned as a leader in the nuclear medicine sector, with a robust pipeline of 147 projects, including 47 innovative projects, and is recognized for its comprehensive product offerings in both diagnostic and therapeutic areas [3][11]. - The establishment of a global R&D and production base for radiopharmaceuticals in Chengdu, with an investment of approximately HKD 3 billion, aims to enhance the company's capabilities and market reach [12]. - The company's strategic focus on technological innovation and globalization is expected to sustain its growth trajectory and enhance shareholder value, as reflected in the recent target price upgrade by investment banks [2][13].

Industry Overview - The nuclear medicine market is experiencing robust growth due to increasing health awareness and rapid advancements in medical technology [1] - As of July 4, 2024, 88 radioactive new drugs have been approved globally, with only 18 for treatment purposes [1] - From 2021 onwards, China's policies have strongly supported the nuclear medicine industry, which is expected to drive its development [1] - According to Ping An Securities, the nuclear medicine market in China is projected to grow from 5 billion yuan to 26 billion yuan at a CAGR of 26.6% from 2023 to 2030 [1] Company Highlights - Yuan Da Pharmaceutical (00512) is a notable player in the nuclear medicine sector, with a successful Phase II clinical trial for its global innovative product STC3141 [2] - CICC maintains profit forecasts for Yuan Da Pharmaceutical at 2.131 billion yuan for 2025 and 2.235 billion yuan for 2026 [2] - The company has received approval for its innovative drug ITM-11 to conduct Phase III clinical trials, targeting neuroendocrine tumors [3] - China Tongyuan (01763) is a leading enterprise in the nuclear medicine industry, dominating the market for radioactive pharmaceuticals and being the largest supplier of radiation source products in China [4] - In October 2023, China Tongyuan began mass production of a new dual-spiral CT radiation therapy platform, marking a significant advancement in domestic high-end radiation therapy products [4]

Core Viewpoint - The report from CICC maintains the profit forecast for Yuan Da Pharmaceutical (00512) at 2.131 billion yuan for 2025 and 2.235 billion yuan for 2026, following the successful achievement of clinical endpoints in the Phase II trial of the global innovative product STC3141 for sepsis treatment [1][2]. Group 1: Market Potential and Clinical Need - The theoretical market space for sepsis drugs is vast, with approximately 49 million new cases annually and over 20% mortality rate among patients, contributing to around 20% of global deaths [2]. - In China, the incidence of sepsis in intensive care units ranges from 20.6% to 50.8%, with about one-third of patients experiencing in-hospital mortality [2]. - The average treatment cost for sepsis patients in high-income countries exceeds $32,000, highlighting the significant unmet clinical needs due to the complex pathophysiology of the disease [2]. Group 2: STC3141 Clinical Trial Success - STC3141 is an innovative drug developed by the company, designed to reverse organ damage caused by excessive immune responses in sepsis by neutralizing extracellular histones and neutrophil extracellular traps [3]. - The Phase II clinical trial (CTR20233109) involved 180 sepsis patients receiving standard treatment, with results showing a significant decrease in the Sequential Organ Failure Assessment (SOFA) score by day 7 in the treatment group, particularly in the high-dose group, demonstrating statistical significance and clinical relevance [3]. - The safety and tolerability of STC3141 were found to be good, and the company is encouraged to monitor the complete data readout and publication [3]. Group 3: Strategic Implications - STC3141 is expected to fill the clinical gap in sepsis treatment, offering a differentiated mechanism focused on immune homeostasis, which could provide significant clinical benefits [4]. - The company has a well-established product line in respiratory and critical care, and the commercialization of STC3141 is anticipated to synergize with its existing pipeline [4].

Group 1 - The company YuanDa Pharmaceutical Group has received formal acceptance from the National Medical Products Administration for its innovative radiopharmaceutical drug TLX591, aimed at treating metastatic castration-resistant prostate cancer (mCRPC) [2] - TLX591 is set to be evaluated in a global Phase III clinical trial involving over 500 patients across multiple countries, including China, the USA, Australia, and New Zealand, comparing its efficacy and safety against standard treatment [2] - Prostate cancer is a common malignancy among elderly men, ranking second in incidence and fifth in mortality among male cancers globally, and sixth and seventh in China respectively [2] Group 2 - The global prostate cancer treatment market was estimated at $15.2 billion in 2021 and is projected to grow to $24.9 billion by 2030 [3] - Traditional radiotherapy for prostate cancer in China has high cumulative radiation doses, leading to complications that significantly affect patients' quality of life, indicating a clinical need for lower radiation exposure treatment options [3] - YuanDa Pharmaceutical is focusing on the global development strategy of nuclear medicine for oncology, aiming to expedite the registration and commercialization of innovative nuclear drugs, with TLX591 potentially becoming a significant product for the company [3]

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].