Core Viewpoint - The launch of OC-01, a novel nasal spray for treating dry eye syndrome, marks a significant advancement in the treatment landscape for dry eye patients in China, transitioning from external substitutes to internal stimulation of tear production [1][6]. Group 1: Product Launch and Market Impact - OC-01 was officially launched in mainland China during the 11th Global Dry Eye Academic Conference, indicating a new era in dry eye treatment [1]. - The product is expected to capture a significant share of the dry eye medication market, which is projected to reach 180 billion yuan, providing effective and convenient treatment for millions of dry eye patients [7]. Group 2: Clinical and Market Validation - OC-01 has shown promising results in the U.S. market, with over 97,000 prescriptions written within a year of its approval and approximately $42 million in sales revenue in 2023 [6]. - The product's innovative mechanism, which stimulates natural tear production through nasal administration, addresses the limitations of traditional eye drops, enhancing patient compliance and treatment efficacy [6][5]. Group 3: Industry Context and Future Prospects - The dry eye syndrome is a prevalent condition, affecting 21.0%-52.4% of the population in China, with a notable increase in younger patients, particularly those aged 18-35, whose incidence has risen by 400% over the past decade [5]. - The broader ophthalmic market in China is expected to grow significantly, with projections estimating the eye care drug market to reach 440 billion yuan by 2025 and 1,084 billion yuan by 2030 [9]. Group 4: Company Pipeline and Innovation Strategy - The company has developed a comprehensive pipeline of innovative ophthalmic products, including treatments for dry eye syndrome, meibomian gland dysfunction, and other eye conditions, enhancing its market position [9][12]. - Recent approvals and clinical advancements in the company's pipeline indicate a strong commitment to innovation and market expansion, with multiple products expected to be launched in the coming years [13].

Core Insights - The company has made significant progress in the field of pediatric myopia prevention with its innovative ophthalmic drug GPN00884 entering the important IIa clinical trial phase in China [1][2][3] Group 1: Clinical Development - GPN00884 has completed patient enrollment for its IIa clinical trial, which aims to evaluate the drug's efficacy and safety in delaying myopia progression in children aged 6 to 12 [3] - The IIa trial is a randomized, double-blind, placebo-controlled study involving over 80 participants, marking a major milestone for the company in the ophthalmology sector [3] - Previous phases of clinical trials have shown that GPN00884 has good safety and tolerability profiles, with linear pharmacokinetic characteristics [3] Group 2: Market Opportunity - Myopia is a significant public health issue globally, with 2.6 billion people affected as of 2020, including 312 million under the age of 19, particularly prevalent in high-income Asia-Pacific countries [2] - China has the highest number of myopia cases globally, with a reported prevalence rate of 51.9% among children and adolescents in 2022 [2] - There are currently very few sustainable and effective treatments available for myopia, and GPN00884's lack of adverse effects such as photophobia could enhance patient compliance [2] Group 3: Competitive Advantage - The company is focusing on ophthalmic drug innovation as a key strategic direction, aiming to enhance its market position and competitiveness [4] - GPN00884 is part of a broader portfolio of innovative ophthalmic products, which includes treatments for dry eye syndrome, meibomian gland dysfunction, and other eye conditions [4] - The company has a comprehensive product pipeline and anticipates multiple product approvals in the next three years, which could significantly contribute to its growth [5][6] Group 4: Recent Developments - The company has recently achieved major clinical advancements with three products, including a preservative-free nasal spray for dry eye treatment and a drug for treating demodex blepharitis, indicating a robust pipeline [6][7] - The company’s hormone nano-suspension eye drops for anti-inflammatory pain relief have received FDA approval and are expected to revitalize the domestic market for steroid eye preparations [7] - The ongoing "Go Global" strategy is expected to facilitate international market expansion for its innovative products, driving sustained growth and enhancing corporate value [7]

Core Viewpoint - Recently, Yuan Da Pharmaceutical (00512) made significant progress in the important field of children's myopia prevention and control, with the initiation of the IIa clinical study for its innovative ophthalmic drug GPN00884 in China, marking a crucial step towards exploring dosage and assessing preliminary efficacy [1][2]. Group 1: Market Context - Myopia is one of the most severe public health issues globally, with 2.6 billion people affected as of 2020, including 312 million under the age of 19 [2]. - China has the highest number of myopia cases worldwide, with a reported prevalence rate of 51.9% among children and adolescents in 2022 [2]. - The global market for myopia treatment products is expected to reach nearly $5 billion by 2033, with the Chinese market projected to be around $1.7 billion [2]. Group 2: Product Development - GPN00884 is designed to delay the progression of myopia without causing adverse effects such as photophobia or accommodation decline, which are common with existing treatments like low-concentration atropine eye drops [3]. - The IIa clinical trial for GPN00884 aims to enroll over 80 myopic participants aged 6 to 12, focusing on evaluating its efficacy and safety [3][4]. - The product has already shown good safety and tolerability in previous phases, with linear pharmacokinetic characteristics [3]. Group 3: Competitive Advantage - With the successful initiation of the IIa clinical study, Yuan Da Pharmaceutical's differentiated competitive advantage in the myopia prevention field is further highlighted, addressing the urgent need for safe and effective solutions for children and adolescents [4]. - The company has established a comprehensive product system in the ophthalmic field, focusing on innovation and professional development, which enhances its market competitiveness [5]. Group 4: Pipeline and Future Prospects - Yuan Da Pharmaceutical has a robust pipeline of innovative ophthalmic products, with three products achieving significant clinical progress this year, including treatments for dry eye and meibomian gland dysfunction [8][9]. - The company anticipates multiple innovative products to be approved for market entry in the next three years, which could significantly contribute to its revenue growth [8].

Core Viewpoint - The recent progress of Yuan Da Pharmaceutical in the field of myopia prevention and control is significant, with the initiation of the IIa clinical trial for the innovative ophthalmic drug GPN00884, which aims to delay the progression of myopia in children [1][3]. Group 1: Market Context - Myopia is a major public health issue globally, with 2.6 billion people affected as of 2020, including 312 million under the age of 19 [2]. - China has the highest number of myopia cases in the world, with a reported prevalence rate of 51.9% among children and adolescents in 2022 [2]. - The Chinese government has prioritized myopia prevention as a national strategy, implementing various plans and guidelines to combat the issue [2]. Group 2: Product Development - GPN00884 is positioned as a potential breakthrough in myopia treatment, as it does not cause adverse effects such as photophobia or pupil dilation, which are common with existing treatments like low-concentration atropine eye drops [3]. - The IIa clinical trial for GPN00884 will involve over 80 participants aged 6 to 12, focusing on evaluating its efficacy and safety in delaying myopia progression [3]. - Previous phases of clinical trials for GPN00884 have shown good safety and tolerability profiles, indicating its potential for successful market entry [3]. Group 3: Competitive Advantage - The successful initiation of the IIa clinical trial enhances Yuan Da Pharmaceutical's competitive edge in the myopia prevention market, addressing the urgent need for safe and effective treatment options for children [4]. - The company has established a comprehensive product pipeline in the ophthalmic sector, focusing on innovative drug development to strengthen its market position [5]. - Yuan Da Pharmaceutical's strategy includes a combination of in-house development and partnerships to create a diverse range of ophthalmic products, enhancing its competitive differentiation [5]. Group 4: Future Prospects - The company anticipates significant growth in its ophthalmic product pipeline, with multiple innovative products expected to receive regulatory approval in the coming years [8]. - Recent advancements include the launch of OC-01 for dry eye treatment and TP-03 for demodex blepharitis, both of which are expected to contribute to the company's revenue growth [8][9]. - The ongoing development of these products not only showcases Yuan Da Pharmaceutical's competitive capabilities but also aligns with its "Go Global" strategy, potentially expanding its market reach internationally [9].

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]

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].

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。 本集團獲得治療乾眼症的全球首創創新產品的獨家開發及商業化權益 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，本集團與箕星藥業香港有限公司(「箕星」)達成產品引進戰略 合作協議。根據協議，在相關條件滿足後，本集團將獲得用於治療乾眼症的全球首創創 新產品酒石酸伐尼克蘭鼻噴霧劑「( OC-01」)及 OC-02（Simpinicline）鼻噴霧劑「( OC-02」) 在大中華區（中國大陸、中國香港特別行政區、中國澳門特別行政區、台灣地區）的獨 家開發及商業化權益。此次戰略合作將進一步深化本集團在眼科領域的創新產品佈局。 箕星是一家總部位於美國和中國的生物科技公司，致力於將創新科學和藥物帶給罹患嚴 重危及生命健康的全球患者，其重磅產品 OC-01 和 OC-02 是兩種高選擇性的乙醯膽鹼 能受體激動劑，可通過啟動三叉神經副交感神經 ...

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* ( 於百慕大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 GPN00833 完成國內ⅠⅠⅠ期臨床研究並達到了臨床終點 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，近日，本集團用於眼科術後抗炎鎮痛的激素納米混懸滴眼液 GPN00833 完成了在中國開展的 III 期臨床研究並成功達到了臨床終點，是本集團在五官科領域眼 科方向的又一次重大里程碑進展。 GPN00833 為抗炎鎮痛類激素納米混懸滴眼液，其主要活性成分丙酸氯倍他索是一種強 效的糖皮質激素，具有高效的局部抗炎活性和較強的毛細血管收縮作用，同時其獨特的 納米製劑工藝有效解決了激素產品低水溶性導致的生物利用度低及安全性風險。該產品 於二零二三 ...