Core Viewpoint - YuanDa Pharmaceutical's innovative strategy in the ophthalmology sector has achieved a significant milestone with the completion of patient enrollment for the global Phase III clinical trial of CBT-001, a novel eye drop treatment for pterygium [1][2]. Group 1: Product Development and Clinical Trials - CBT-001 has completed patient enrollment for a Phase III clinical trial involving 660 patients aged 12 and above, aimed at assessing its safety and efficacy in reducing conjunctival congestion and preventing pterygium progression [1][2]. - The product is a modified version of Nintedanib, the active ingredient in OFEV, and has shown high safety and clinical efficacy in inhibiting pterygium growth [2][6]. - The global market for pterygium treatment is projected to reach $540 million by 2028 and approximately $3.11 billion by 2033, with a compound annual growth rate (CAGR) of 42.1% [3]. Group 2: Market Opportunity and Patient Demographics - Pterygium affects around 900 million patients globally, with approximately 150 million in China, highlighting a significant unmet clinical need for effective treatments [2][3]. - Current treatment options are limited, with no approved specific drugs for pterygium, leading to reliance on off-label medications and surgical interventions, which carry risks and high costs [3][6]. - The prevalence of pterygium is notably high in rural China, reaching 33%, and increases with age, with a 13.4% prevalence in individuals aged 40 and above [2]. Group 3: Commercialization and Future Prospects - YuanDa Pharmaceutical has established a comprehensive pipeline of innovative ophthalmic products, focusing on various conditions including myopia and dry eye syndrome, with multiple products expected to be approved in the next three years [7][14]. - The company has built a professional marketing team and a stable distribution network, positioning itself well for the commercialization of its innovative products [14]. - The recent approval of GPN01768 for treating demodex blepharitis and the anticipated launch of OC-01 for dry eye syndrome further validate the company's growth potential in the ophthalmology market [11][12][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。 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 ...

Group 1 - The core issue involves allegations of product fraud against Juzhi Biotechnology, which the company has denied by stating that multiple tests show collagen content greater than 0.1% [1] - Juzhi Biotechnology's swift response to the allegations aims to clarify the situation and restore consumer confidence, indicating the importance of effective public relations management [1] - The incident highlights the need for companies to maintain transparency and manage public sentiment to protect brand reputation and stock stability in the long term [1] Group 2 - Jinhua Co., Ltd.'s chairman, Xing Yajiang, is under investigation for failing to disclose significant information in a timely manner, which raises concerns about corporate governance and transparency [2] - The regulatory actions against the chairman, including a warning and a fine of 3.5 million yuan, may lead to a loss of investor trust and potential stock price volatility [2] - The ongoing investigation by the China Securities Regulatory Commission introduces uncertainty for the company, which could face further regulatory measures if major violations are confirmed [2] Group 3 - Yuanda Pharmaceutical has received approval from the Macau Drug Regulatory Authority for its innovative ophthalmic drug GPN01768, indicating a significant market opportunity [3] - The drug, which has already generated approximately $180 million in revenue in the U.S. market, demonstrates strong commercial potential and market demand [3] - The approval in Macau marks a critical step for Yuanda Pharmaceutical in expanding its product offerings and capturing market share in the ophthalmic sector [3] Group 4 - Rongchang Biotechnology has responded to a regulatory inquiry from the Shanghai Stock Exchange, affirming that its financial data aligns with industry standards and that its R&D expenses are accurately accounted for [4] - The company's clarification regarding its financial practices is expected to alleviate market concerns and bolster investor confidence [4] - This response reflects a commitment to regulatory compliance and sound financial management, which is essential for future fundraising and market expansion efforts [4]

Core Insights - The company, YuanDa Pharmaceutical Group, has showcased significant clinical potential for its innovative nuclear medicine product, Yttrium-90 microsphere injection, at major oncology conferences [1][2] - The product is the only one globally approved for selective internal radiation therapy (SIRT) for colorectal cancer liver metastases and has been used by over 150,000 patients across more than 50 countries since its launch in May 2022 [1][2] Conference Highlights - The ASCO and APPLE conferences are recognized as authoritative platforms in the oncology field, with ASCO being the largest and most prestigious clinical oncology meeting globally [1] - At the ASCO conference, the Yttrium-90 microsphere injection was highlighted in two studies from leading Chinese research teams, indicating its prominence in hepatocellular carcinoma (HCC) treatment [2] Market Position and Financials - YuanDa Pharmaceutical is one of only four companies worldwide to have successfully commercialized nuclear medicine [2] - By the end of 2024, the Yttrium-90 microsphere injection is expected to have treated nearly 2,000 patients, generating approximately HKD 500 million in sales revenue [2] Future Development Plans - The company plans to enhance its nuclear medicine oncology treatment segment by expanding its product pipeline, which currently includes 15 innovative products across various radioactive isotopes targeting multiple cancer types [2] - The focus will be on establishing a product cluster centered around the Yttrium-90 microsphere injection to solidify its leadership position in the global nuclear medicine oncology market [2]

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 ...

Core Viewpoint - The company, Yuan Da Pharmaceutical, has made significant breakthroughs in nuclear medicine for tumor diagnosis and treatment, as well as in sepsis, leading to a surge in its stock price, which reached a historical high of 9.20 HKD, an increase of over 130% from its low this year [1] Group 1: Product Launch and Clinical Application - The NeoNova transcatheter mitral valve repair system, developed independently in China, has officially commenced its first commercial implantations across multiple centers nationwide [1][3] - NeoNova offers a minimally invasive solution for patients with mitral valve regurgitation, enhancing heart function while reducing surgical trauma and recovery time [3] - The product has been successfully implanted by several top cardiac centers, showcasing its clinical advantages and effectiveness in treating severe mitral valve regurgitation [5][12] Group 2: Clinical Advantages and Innovations - NeoNova features several innovative designs, including a unique "one-line" structure to minimize chordae tendineae entanglement, an "elastic self-locking" mechanism to protect valve leaflets, and a small radius curvature to lower puncture height requirements [6][8] - Clinical trials have demonstrated significant improvements in patients' conditions, with reductions in regurgitation severity and cross-valve pressure [10][12] - The product's design allows for efficient and safe procedures, with some surgeries completed in as little as 35 minutes, highlighting its operational convenience [8][12] Group 3: Strategic Development and Future Outlook - The company is committed to advancing high-end medical device research and aims to establish a leading global platform for precise interventional diagnosis and treatment in cardiovascular and cerebrovascular fields [15][18] - Yuan Da Pharmaceutical has a robust pipeline with 27 products in development, including five innovative products, and is actively pursuing regulatory approvals for various devices [15][18] - The company emphasizes the importance of innovation and advanced technology, planning to increase investments in global product development to enhance its product offerings and market presence [18]

Core Insights - The recent announcement of former US President Biden's prostate cancer diagnosis has brought attention to prostate cancer, the second most common malignancy among men globally [2] - The incidence and mortality rates of prostate cancer in China are rising, with 134,200 new cases and 47,500 deaths reported in 2022 [2] - The treatment landscape for prostate cancer is evolving, with numerous innovative pharmaceutical companies developing new therapies, enhancing treatment options for patients [2][4] Market Dynamics - The global prostate cancer treatment market was valued at $35.3 billion in 2022 and is projected to grow to $56.4 billion by 2028, with a compound annual growth rate (CAGR) of 8.3% [4] - Major pharmaceutical companies are competing in this lucrative market, with Pfizer and Astellas' enzalutamide generating $5.926 billion in global sales in 2023, ranking sixth among oncology drugs [3][4] - Chinese pharmaceutical companies are transitioning from generic to innovative drug development, with Heng Rui Medicine's new drug, Rivelutamide, set to launch in December 2024 [4] Treatment Advances - Treatment options for prostate cancer have expanded significantly, with survival rates improving from 2-3 years to over 5 years due to advancements in therapies such as new anti-androgens and PARP inhibitors [3] - The introduction of targeted therapies, such as Novartis' Pluvicto, which achieved $271 million in its first year, indicates a shift towards precision medicine in prostate cancer treatment [3][4] Screening Challenges - Early detection of prostate cancer remains a challenge, with many patients diagnosed at advanced stages due to the disease's asymptomatic nature in early stages [5][6] - The five-year survival rate for prostate cancer patients in China is approximately 66.4%, significantly lower than over 95% in developed countries, highlighting the need for improved screening practices [5] - PSA testing is the primary screening method, and initiatives are underway to increase screening coverage in China, aiming for 40% coverage in the next five years [7]