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 本集團治療乾眼症的全球首創鼻噴產品 OC-01 正式獲批後 在中國大陸實現首批商業化處方落地 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） 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，近日，本集團全球首創用於增加乾眼症患者淚液分泌的鼻噴產品酒石 酸伐尼克蘭鼻噴霧劑(「OC-01」)，在正式獲批後於中山大學附屬第一醫院和深圳市眼科 醫院實現中國大陸首批商業化處方落地。這一裡程碑進展標誌著中國乾眼症治療迎來全 新選擇：中國目前唯一一款獲批上市的用於增加乾眼症患者淚液分泌的鼻噴產品正式投 入臨床應用，為中國乾眼症患者提供一種全新的治療方案。 OC-01 是高選擇性的煙鹼乙酰膽鹼受體激動劑，普遍認為可通過啟動三叉 ...

Core Insights - The Yttrium-90 microsphere injection, 易甘泰®, has benefited over 3,000 liver cancer patients since its launch in mainland China in 2022, showcasing its significant impact in the treatment of liver tumors [1] - The product received FDA approval for a new indication for unresectable hepatocellular carcinoma (HCC) on July 7, 2025, making it the first and only selective internal radiation therapy product approved for both unresectable HCC and colorectal cancer liver metastases [1][5] - The 15 abstracts related to Yttrium-90 microspheres presented at the 15th Asia-Pacific Primary Liver Cancer Expert Alliance (APPLE) conference highlight its clinical applicability and effectiveness across different stages of HCC [4][2] Group 1: FDA Approval and Clinical Impact - The FDA's early approval was based on the promising mid-term results of the DOORwaY90 clinical trial, which reported an objective response rate of 98.5% and a local tumor control rate of 100% [4][5] - The approval aligns with real-world data from Chinese patients, indicating broad applicability of 易甘泰® in local clinical settings [4] - The product's success is expected to accelerate its commercialization in China and reshape the treatment landscape for liver cancer [1][5] Group 2: Market Context and Future Prospects - According to GLOBOCAN 2022, liver cancer is the sixth most common cancer globally, with approximately 870,000 new cases and 760,000 deaths annually [6] - In China, liver cancer accounted for about 370,000 new cases in 2022, representing 42.5% of global cases, and the mortality rate was approximately 320,000, also the highest globally [6][8] - The Chinese liver cancer drug market is projected to grow at a compound annual growth rate (CAGR) of 12.3%, reaching 45.21 billion yuan by 2030 [8][9] Group 3: Company Development and Innovation - The company has established a comprehensive nuclear medicine industry chain, covering research, production, sales, and regulatory qualifications, with 15 innovative products in the pipeline targeting various cancers [11][17] - The newly launched Chengdu Wenjiang nuclear medicine R&D and production base, with an investment exceeding 3 billion yuan, aims to enhance production capabilities and meet domestic and international demands [17][19] - The base features advanced automation and a full-process radiation monitoring system, positioning the company as a leader in the nuclear medicine sector [18][19]

Investment Rating - The report maintains a positive outlook on the innovative drug sector, expecting significant revenue growth and potential profitability for several companies in the first half of 2025 [3][8]. Core Insights - The innovative drug sector is projected to see revenue growth of at least 40% year-on-year for companies such as BeiGene, Innovent Biologics, and others, driven by the commercialization of core products [3][8]. - The Pharma sub-sector is expected to experience a revenue growth rate of 10-15% for companies like Hansoh Pharmaceutical and China Biologic Products, while others may see growth of 5-10% [3][8]. - The medical services sector is anticipated to have a revenue growth of 15-20% for companies like GuoShengTang, with a focus on mergers and acquisitions [3][8]. Summary by Sections Innovative Drugs - Companies expected to achieve over 40% revenue growth in 1H25 include BeiGene, Innovent Biologics, and others, primarily due to the commercialization of key products [3][8]. - Some companies, such as BeiGene and Innovent Biologics, are likely to reach profitability due to increased sales volume [3][8]. - The report highlights that companies like Hutchison China MediTech may see significant profit growth due to asset disposals [3][8]. Pharma - The impact of centralized procurement is gradually diminishing, allowing for continued innovation and transformation within the sector [3][8]. - Companies projected to achieve 10-15% revenue growth include Hansoh Pharmaceutical and China Biologic Products, while others like 3SBio and United Laboratories may see 5-10% growth [3][8]. Medical Services - GuoShengTang is expected to have a revenue growth of 15-20% in 1H25, with ongoing attention to domestic and international acquisition activities [3][8].

Summary of YD Pharma Conference Call Company Overview - YD Pharma's total assets reached HKD 24.9 billion in 2024, with revenue of HKD 11.64 billion and net profit attributable to shareholders of HKD 2.47 billion, marking a 17.7% year-on-year growth in the pharmaceutical segment [2][5] - The company operates in three main areas: nuclear medicine for oncology, cardiovascular intervention technology, and formulation technology [2][6] Financial Performance - In 2024, YD Pharma's revenue grew by 12.8% year-on-year in RMB terms, with a net profit increase of 34% [4] - The company declared a dividend of HKD 910 million, with a net profit of HKD 1.76 billion excluding fair value changes [5] - The nuclear medicine and cardiovascular intervention segments saw a revenue increase of 148.3% [2][6] Business Segments Nuclear Medicine - The nuclear medicine segment has established a global integrated production and research layout, with significant revenue from the Hepatocyte Injection reaching nearly HKD 500 million [2][7] - The Chengdu production base was completed, enhancing production capabilities for all research pipeline products [7][30] Cardiovascular Intervention - The company focuses on both acute rescue and chronic disease management, with products like Coenzyme Q10 and a second-generation aldosterone receptor antagonist contributing to growth [12] Respiratory and Critical Care - The core product, Ceno, continues to lead the oral market, with plans for various inhalation formulations [9] - A new nasal spray for allergic rhinitis, Raltex, is set to launch in 2025 [9] Research and Development - YD Pharma has 15 innovative products in the registration phase, covering five collaborative projects and seven cancer types [8] - Three products are in Phase III clinical trials, with one international multi-center trial already submitted for approval [8] Sepsis Treatment - Sepsis is a major focus, with YD Pharma's product SC3,141 targeting the overactive immune response associated with the condition [10][11] - The company plans to advance research in this area, addressing a significant public health issue [10] Market Potential - The FDA approved a new indication for the 190 microsphere product for primary liver cancer, expected to significantly boost global sales, particularly in China [16][19] - The domestic sales peak for this product is projected to reach at least RMB 5 billion due to the high incidence of liver cancer in China [19][34] Future Outlook - YD Pharma anticipates a challenging year in 2025 due to the impact of the tenth batch of centralized procurement, but aims for positive revenue growth [39] - The company expects to achieve higher growth rates in 2026, potentially reaching double-digit growth [39] Additional Insights - The Chengdu production base is designed to meet high safety standards and will support the nuclear medicine segment's growth [30] - YD Pharma is exploring partnerships for global sales of its nuclear medicine products, aiming to compete with larger pharmaceutical companies [36][37]

Group 1 - Tong Ren Tang's Executive Vice President Zhang Chunyou submitted a resignation letter, effective July 8, 2025, due to work adjustments, while remaining as General Manager of Tong Ren Tang Technology [1] - The company stated that Zhang Chunyou's departure will not adversely affect daily operations, indicating limited market impact from this internal personnel adjustment [1] Group 2 - Basestone Pharmaceuticals announced an exclusive strategic partnership with Istituto Gentili for the commercialization of Sugliant in Western Europe and the UK, granting Gentili exclusive rights in 23 countries [2] - Basestone will receive up to $192.5 million in payments, including upfront, registration, and sales milestone payments, along with nearly 50% revenue sharing from net sales in the authorized region [2] - This collaboration enhances Basestone's international market recognition and strengthens investor confidence in future growth [2] Group 3 - Fosun Pharma announced guarantees for its subsidiaries, providing a maximum joint liability guarantee for a financing application not exceeding 500 million yuan with Bank of China [3] - Additionally, a guarantee was provided for a financing contract not exceeding 150 million yuan with China Construction Bank for its subsidiary Hanlin Pharmaceutical [3] - This move supports subsidiaries in obtaining funds for business expansion or R&D, although it introduces certain financial risks [3] Group 4 - Run Da Medical responded to the Shanghai Stock Exchange's inquiry regarding its 2024 annual report, addressing issues related to operating performance, goodwill, short-term solvency, and prepayments [4] - The response aims to alleviate market concerns and stabilize investor confidence, although ongoing monitoring of the company's performance improvement measures is necessary [4] Group 5 - Yuan Da Pharmaceutical announced that its joint venture Sirtex Medical Pty Ltd received FDA approval for SIR-Spheres Yttrium-90 microspheres for treating unresectable hepatocellular carcinoma (HCC) [5] - This product is the first and only FDA-approved selective internal radiation therapy for both unresectable HCC and colorectal cancer liver metastases [5] - This breakthrough enhances Yuan Da's market position in oncology and boosts investor confidence in future growth [5]

Market Overview - The A-share market opened with mixed performance, with the Shanghai Composite Index up 0.04% at 3474.63 points, while the Shenzhen Component Index and the ChiNext Index fell by 0.04% and 0.03% respectively [2][3] - The Hong Kong market saw the Hang Seng Index rise by 0.17% and the Hang Seng Tech Index increase by 0.28%, with notable gains in companies like Far East Horizon and Kingstone Pharmaceuticals [4] Sector Performance - Advanced packaging, semiconductor, and power sectors showed strength, while tax refund stores, recombinant protein, and CPO concepts opened lower [1] - The storage chip sector led gains, with companies like Jingzhida rising over 7% following news of Changxin Memory's listing guidance [1] - Shipping and port concepts also performed well, with Ningbo Ocean and Ningbo Shipping both rising over 3% amid news of Houthi attacks on Red Sea merchant ships [1] Monetary Policy - The central bank conducted a 690 billion yuan reverse repurchase operation with a rate of 1.40%, while 1310 billion yuan of reverse repos are set to mature today [5] Currency Exchange - The RMB against the USD was adjusted down by 28 basis points to a midpoint of 7.1534, with the onshore closing price at 7.1747 [6]

港股开盘，恒生指数开涨0.17%，恒生科技指数开涨0.28%；创新药概念反弹，远大医药(00512.HK)涨 超5%；芯片股回升，上海复旦(01385.HK)涨1.5%。 ...

恒生指数开盘涨0.17%，恒生科技指数涨0.28%。创新药概念反弹，远大医药涨超5%。 ...

Core Insights - The article highlights the significant milestone achieved by YuanDa Pharmaceutical with its innovative nuclear medicine product, SIR-Spheres Yttrium-90 microsphere injection, which has received FDA approval for dual indications in treating unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastases [1][2][3] Product Development and Approval - SIR-Spheres Yttrium-90 microsphere injection is the first and only selective internal radiation therapy (SIRT) product globally approved by the FDA for both unresectable HCC and colorectal cancer liver metastases, showcasing its clinical value [1][2] - The product achieved a remarkable objective response rate of 98.5% and a local tumor control rate of 100% in the DOORwaY90 clinical trial, with a median duration of response exceeding 300 days [2][3] - The FDA's early approval for the new indication of unresectable HCC, without restrictions on tumor diameter, reflects the product's significant advantages over competitors [2][3] Market Potential and Clinical Impact - The global liver cancer treatment market is projected to reach USD 9.81 billion by 2030, indicating a substantial opportunity for innovative therapies like SIR-Spheres [7] - With liver cancer being the sixth most common and the third deadliest cancer globally, and China accounting for a significant portion of new cases and deaths, the product is positioned to address a critical healthcare need [4][7] Company Positioning and Strategy - YuanDa Pharmaceutical has established a comprehensive nuclear medicine ecosystem, encompassing research, production, sales, and regulatory compliance, positioning itself as a leader in the nuclear medicine field [8][15] - The company has a robust pipeline of 15 innovative products targeting various cancers, supported by a state-of-the-art production facility that meets international standards [8][13][15] - The successful operation of the Chengdu Wenjiang nuclear medicine R&D and production base marks a strategic leap for the company, enabling it to meet global demand for therapeutic and diagnostic nuclear medicines [13][15]

Grand Pharmaceutical Group Limited 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。 本集團全球創新放射性產品 SIR-Spheres®釔[ 90Y]微球注射液 提前正式獲得 FDA 批准新增適應症 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。 ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 SIR-Spheres®釔[ 90Y]微球注射液，是一款針對肝臟惡性腫瘤的選擇性內放射治療產品， 採用全球領先的介入技術將釔[ 90Y]樹脂微球注入肝臟腫瘤血管，釋放高能量 β 放射線 殺滅腫瘤細胞，兼具了放射性藥物和精准介入治療的雙重優勢。本次新適應症的獲批是 基於一項前瞻性、多中心、開放標籤的臨床試驗（「DOORwaY90」）的中期結果。該 試驗中期數據顯示，DOORwaY90 成功達到預先設定的共同主要終點：經獨立中 ...