Group 1: Company Developments - The company has received FDA approval for its innovative drug SIR-Spheres® for treating unresectable hepatocellular carcinoma (HCC) [1] - The company’s nasal spray product OC-01 for dry eye syndrome has been approved in mainland China and has begun commercial prescriptions [1][3] - OC-01 is the only nasal spray approved for treating dry eye syndrome in China, providing a new treatment option for patients [1] Group 2: Market Insights - The dry eye syndrome market in China is estimated to have around 360 million patients, with a prevalence rate of approximately 21.0% to 52.4% [3] - The overall dry eye syndrome market in China has a compound annual growth rate (CAGR) of 1.6% from 2017 to 2021, with moderate growth expected in the coming years [4] - The global dry eye syndrome market is projected to reach $25.48 billion in 2024, expanding at a CAGR of 3.4% to $33.26 billion by 2033 [6] Group 3: Product Advantages - OC-01 utilizes a nasal delivery method that enhances tear secretion and improves tear film stability, potentially increasing patient compliance compared to traditional eye drops [7] - The product has shown strong commercial potential, with over 97,000 prescriptions in the U.S. within its first year and approximately $42 million in sales revenue in 2023 [7] - The company has a comprehensive pipeline of innovative ophthalmic products, including treatments for various eye conditions, which are expected to contribute to future revenue growth [11][14] Group 4: Competitive Landscape - The ophthalmic drug market in China has grown from 15.1 billion RMB in 2016 to 18.8 billion RMB in 2020, with a projected market size of 44 billion RMB by 2025 [8] - The company is strategically positioned in the competitive ophthalmic market, focusing on innovative product development to maintain its leading position [10] - The company has established a professional marketing team and a nationwide distribution network to support its ophthalmic product sales [14]

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 ...

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 本集團全球創新眼科藥物 CBT-001 国际多中心 III 期臨床試驗完成全部患者入組 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，本集團用於治療翼狀胬肉的全球創新眼科藥物 CBT-001（GPN00153） 開展的國際多中心 III 期臨床試驗，近日完成了全球中心全部患者入組。該研究是一項 隨機、雙盲、安慰劑平行對照的 III 期臨床試驗，擬入組 660 例 12 周歲及以上的翼狀胬 肉伴結膜充血患者，旨在評估 CBT-001 滴眼液在減少結膜充血和預防翼狀胬肉進展方 面的安全性和有效性。此次，該產品臨床研究全部患者入組是本集團在五官科領域眼科 方向的又一次重 ...

Core Viewpoint - The recent advancements in innovative nuclear medicine products by the company, particularly the Yttrium-90 microsphere injection, have garnered significant international recognition, showcasing the clinical potential of its nuclear medicine pipeline [1][4][9]. Group 1: Product Developments - The innovative nuclear medicine product, Yttrium-90 microsphere injection, has been highlighted at major international conferences, indicating its clinical value and potential in treating liver cancer [4][5]. - The company has successfully launched a global innovative ophthalmic drug for treating demodex blepharitis, which is expected to enhance its market presence in the Greater Bay Area and mainland China [3][9]. - The Yttrium-90 microsphere injection has achieved a disease control rate of 90.9% and an objective response rate of 87.8% in clinical studies, establishing it as a leading treatment for hepatocellular carcinoma (HCC) [7][8]. Group 2: Financial Performance - The company's stock price has surged over 50% since early May, reaching a historical high of 9.19 HKD, with a year-to-date increase of over 130% [3]. - The Yttrium-90 microsphere injection has treated nearly 2,000 patients and is projected to generate approximately 500 million HKD in sales revenue for 2024, reflecting a year-on-year growth rate exceeding 140% [7][8]. Group 3: Research and Clinical Impact - The Yttrium-90 microsphere injection has become a focal point in global HCC treatment, with multiple studies presented at the ASCO and APPLE conferences [5][6]. - The company has trained over 1,100 doctors across 70 hospitals to enhance the clinical application of its products, indicating a commitment to improving treatment accessibility [8][9]. Group 4: Infrastructure and Future Plans - The company is establishing a "zero-radiation" intelligent nuclear medicine factory in Chengdu, which will serve as a comprehensive platform for research, production, and sales, enhancing its operational capabilities [13][16]. - The factory is set to be the first of its kind globally, with a planned investment exceeding 3 billion RMB, focusing on isotope production and automated manufacturing processes [16][18].

Core Viewpoint - The stock price of Yuan Da Pharmaceutical has surged nearly 50% in May, reaching a historical high of 9.20 HKD, driven by positive news regarding its innovative ophthalmic drug GPN01768, which has been approved for market in Macau [1][3]. Group 1: Product Development and Market Potential - GPN01768 is the first and only FDA-approved drug for treating Demodex blepharitis, with exclusive rights for development, production, and commercialization in Greater China [3]. - The approval of GPN01768 in Macau is expected to facilitate its future launch in the Guangdong-Hong Kong-Macau Greater Bay Area and further promote its entry into mainland China [3]. - The global prevalence of Demodex blepharitis is significant, with an estimated 468 million patients in 2021, projected to increase to approximately 506 million by 2030 [4][6]. - GPN01768 has shown strong market penetration in the U.S., generating $180 million in revenue in 2024 and achieving $78.3 million in sales in Q1 2025, reflecting an 18% increase from the previous quarter [6][7]. Group 2: Clinical Need and Competitive Advantage - There is currently no specific treatment for Demodex blepharitis, highlighting the urgent need for effective therapies, which GPN01768 aims to address [6]. - GPN01768 acts as a selective non-competitive antagonist of the GABA-Cl channel in Demodex mites, leading to their paralysis and death, thus providing a targeted treatment option [6]. - The domestic market for blepharitis treatment is estimated to be around 1.85 billion RMB in 2023, indicating substantial commercial potential for GPN01768 in China [7]. Group 3: Innovation and Strategic Positioning - Yuan Da Pharmaceutical has established a comprehensive innovation framework across multiple business segments, particularly in ophthalmology, positioning itself as a "hidden leader" in the domestic market [8]. - The company has a robust pipeline of innovative products targeting various eye conditions, with several expected to receive approval in the next three years [8]. - The company’s nuclear medicine division has also made significant advancements, with a new facility set to enhance its production capabilities and meet growing market demands [14][15]. Group 4: Market Sentiment and Future Outlook - The capital market has recognized the company's innovative transformation, with multiple research institutions raising the stock price expectations, including a target price increase to 9.6 HKD by CICC and 10.15 HKD by Huatai Securities [14]. - The ongoing development of innovative products across various segments is anticipated to drive sustained growth and performance for the company [15].

Core Viewpoint - The approval of GPN01768 (TP-03) for the treatment of Demodex blepharitis by the Macau government marks a significant advancement for the company in the field of ophthalmic innovation, laying the groundwork for future approvals in the Greater Bay Area and potentially facilitating its entry into mainland China [1][2]. Group 1: Product Details - GPN01768 is a selective non-competitive antagonist of the GABA-Cl channel, specifically targeting Demodex mites, leading to their paralysis and death, thus treating Demodex blepharitis [2]. - The product has shown promising sales in the U.S., generating approximately $180 million in revenue in 2024, with about 163,000 bottles sold, and $78.3 million in Q1 2025, reflecting an 18% increase from Q4 2024 [2]. - The company has secured exclusive rights for the development, production, and commercialization of GPN01768 in Greater China, following a strategic partnership with Tarsus Pharmaceuticals [2]. Group 2: Market Need - Demodex blepharitis is a common chronic inflammatory disease, accounting for over two-thirds of all blepharitis cases, with more than 40 million patients in China, highlighting a significant unmet clinical need for effective treatments [3]. - Additionally, over 70 million patients in China suffer from meibomian gland dysfunction, which is a risk factor associated with Demodex mites, further emphasizing the necessity for targeted therapies like GPN01768 [3]. Group 3: Strategic Focus - The company is committed to the ophthalmic sector as a key strategic development area, focusing on innovation in ophthalmic drugs and enhancing its market competitiveness [4]. - The company has developed a comprehensive product portfolio targeting various ophthalmic conditions, including myopia, dry eye syndrome, and Demodex-related disorders, with multiple innovative products expected to receive approval in the next three years [4][5]. - The company has established a professional marketing team and a nationwide distribution network, aiming to strengthen its core product promotion and brand building in the ophthalmic field [5]. Group 4: Innovation and Development Strategy - The company emphasizes the importance of innovation and advanced technology in product development, focusing on unmet clinical needs and increasing investment in global innovative products [6]. - A dual-circulation development strategy is being implemented to enhance domestic and international operations, leveraging the company's industrial advantages and research capabilities [6].

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) 瞼緣炎是一種常見的眼科疾病。蠕形蟎瞼緣炎是蠕形蟎感染瞼緣所致的慢性炎性反應性 疾病，約佔所有瞼緣炎病例的三分之二以上，主要累及瞼緣皮膚、睫毛囊和腺體以及瞼 板腺，以眼瞼搔癢、眼異物感、眼幹、瞼緣充血、鱗屑及睫毛根部袖套狀分泌物等為典 型臨床表現，嚴重者可引起結膜及角膜併發症。中國目前有超過 4,000 萬蠕形蟎瞼緣炎 患者，且並未有針對蠕形蟎瞼緣炎的藥物上市，臨床上急需一款起效快且可直接針對病 因的安全有效的治療藥物，GPN01768 則有望填補該臨床空白。 此外，蠕形蟎也是瞼板腺功能障礙的危險因素之一，蠕形蟎導致的瞼板腺功能障礙患者 常出現眼瞼邊緣發炎和視力模糊，並可能導致瞼板腺堵塞和/或瞼脂液分泌的減少，若 不及時接受治療，可能會導致淚膜永久性改變 ...