Core Viewpoint - The recent announcement by the company regarding the completion of patient enrollment for the GPN00884 clinical trial marks a significant step in the development of a new treatment for childhood myopia, potentially transforming the management of this condition in the future [1] Group 1: Company Developments - The company's stock price increased by 6.42%, reaching HKD 8.79, with a trading volume of HKD 101 million [1] - The GPN00884 drug, aimed at delaying the progression of myopia in children, has entered a critical phase of clinical research in China, focusing on dosage exploration and preliminary efficacy assessment [1] - The successful launch of the OC-01 nasal spray in mainland China represents a significant innovation in the treatment of dry eye disease, transitioning from external substitutes to internal awakening therapies [1] Group 2: Industry Impact - The completion of the GPN00884 trial's first patient enrollment is expected to pave the way for new treatment options for childhood myopia, which could have a substantial impact on pediatric ophthalmology [1] - The OC-01 launch at the national conference highlights a shift in the treatment paradigm for dry eye patients, emphasizing advancements in therapeutic approaches within the ophthalmic industry [1]

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 Insights - The company, Yuan Da Pharmaceutical Group, has made significant progress in the field of myopia prevention for children with its innovative ophthalmic drug GPN00884, which has entered the important phase of exploring dosage and assessing preliminary efficacy after completing patient enrollment in a Phase IIa clinical study in China [1][2] Group 1: Clinical Development - GPN00884 has completed patient enrollment for its Phase I clinical study in China by August 2024 and is expected to complete the study by March 2025 [2] - The ongoing Phase IIa clinical trial is a randomized, double-blind, placebo-controlled study aiming to enroll over 80 myopic participants aged 6 to 12 years to evaluate the drug's effectiveness and safety [2] Group 2: Market Potential - The global market for myopia treatment drugs is projected to reach nearly $5 billion by 2033, with the Chinese market accounting for approximately $1.7 billion [1] - There is a significant unmet clinical need for effective myopia treatments, as current options like low-concentration atropine eye drops have high incidences of side effects, affecting patient compliance [1] Group 3: Strategic Focus - Yuan Da Pharmaceutical is focusing on ophthalmology as a key strategic development area, continuously innovating in ophthalmic drugs to enhance its industry position and market competitiveness [2] - The company has established a comprehensive product system for innovative drugs, combining partnerships and in-house research to develop treatments for various eye conditions, including dry eye syndrome and myopia [2][3] Group 4: Recent Achievements - The company has recently achieved significant clinical advancements with three products this year, including an innovative nasal spray for dry eye syndrome and treatments for other eye conditions [3] - Multiple innovative products are expected to be approved for market launch in the next three years [3]

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].

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 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。 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 ...

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 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 ...