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的內容概不 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 的全部或任何部份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。 LUYE PHARMA GROUP LTD. 綠葉製藥集團有限公司 （於 百 慕 達 註 冊 成 立 之 有 限 公 司） （股 份 代 號：02186） 自願性公告 本集團五款新產品成功納入 2025年國家醫保藥品目錄或商保創新藥目錄 瑞百萊® （棕 櫚 酸 帕 利 哌 酮 注 射 液（Ⅱ））是全球首個且唯一實現「首 月 僅 需1針」給 藥 方 案 的 帕 利 哌 酮 長 效 針 劑，在 中 國 獲 批 的 適 應 症 為 用 於 精 神 分 裂 症 急 性 期 和 維 持 期 的 治 療。該 產 品 同 時 也 已 在 美 國 獲 批 上 市。相 較 於 傳 統 的 帕 利 哌 酮 長 效針劑首月需要注射2次的給藥方案（第1天和第8天各注射1次），瑞 百 萊®僅 需 單 次351mg起 始 劑 量 即 可 完 成 初 始 治 療，簡 化 用 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 绿叶制药集团有限公司 呈交日期: 2025年12月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02186 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | USD | | 0.02 | USD | | 200,000,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 10,000,000,000 | USD | | 0.02 | USD | | 200,000,000 | ...

Core Insights - The pharmaceutical industry is witnessing a shift in Alzheimer's disease (AD) drug development, with Chinese companies increasingly entering the field while multinational corporations face setbacks [1][2][3] Group 1: Current Developments in Alzheimer's Drug Research - Novo Nordisk announced that its two large Phase III trials for Semaglutide in treating Alzheimer's disease did not meet primary endpoints [1] - Chinese pharmaceutical companies, such as Green Leaf Pharmaceutical and Kangfang Biotech, are advancing their own AD drug candidates, with Green Leaf's LY03017 recently receiving FDA approval for clinical trials [1][2] - The number of drugs under development for AD in China ranks second globally, following the United States, indicating a growing interest and investment in this area [2] Group 2: Challenges Faced by Multinational Corporations - Major multinational companies like Pfizer, Roche, and Johnson & Johnson have faced failures in AD drug development due to unclear disease mechanisms and ineffective clinical trial results [2][3] - Notably, Biogen's Aducanumab is set to exit the AD treatment landscape due to conflicting Phase III trial results, while other drugs like Lecanemab and Donanemab have received limited approval [3] Group 3: Factors Driving Chinese Companies' Confidence - Chinese companies are motivated by advancements in diagnostic technologies and a significant unmet clinical need in the AD space [4] - The integration of biomarker testing and advanced imaging techniques has improved diagnostic accuracy, addressing previous challenges in the field [4] - Green Leaf Pharmaceutical is exploring multiple indications for its LY03017 drug, indicating a strategic approach to capitalize on the unmet needs in AD and related disorders [4]

Core Insights - The pharmaceutical industry is witnessing a shift in Alzheimer's disease (AD) drug development, with Chinese companies increasingly entering the field while multinational corporations face setbacks [1][2][3] Group 1: Current Developments in AD Drug Research - Novo Nordisk announced that its two large Phase III trials for Semaglutide in treating Alzheimer's did not meet primary endpoints, indicating challenges in the AD drug development landscape [1] - Chinese pharmaceutical companies, such as Green Leaf Pharmaceutical and Kangfang Biotech, are advancing their own AD drug candidates, with Green Leaf's LY03017 recently receiving FDA approval for clinical trials [1][2] - The number of drugs under development for AD in China ranks second globally, following the United States, highlighting the growing interest and investment in this area [2] Group 2: Challenges Faced by Multinational Corporations - Major multinational companies like Pfizer, Roche, and Johnson & Johnson have faced failures in AD drug development due to unclear disease mechanisms and ineffective clinical trial results [2][3] - Notably, Biogen's Aducanumab is set to exit the AD treatment space due to contradictory Phase III trial results, while other drugs like Lecanemab and Donanemab have received mixed responses from regulatory bodies [3] Group 3: Factors Driving Chinese Companies' Confidence - Chinese companies are motivated by advancements in diagnostic technologies and a significant unmet clinical need in the AD space, particularly for psychiatric symptoms associated with the disease [4] - The combination of improved diagnostic methods and a large patient population with unmet needs is driving the confidence of Chinese firms in pursuing AD drug development [4] - Green Leaf Pharmaceutical is exploring multiple indications for its LY03017, indicating a strategic approach to address various aspects of AD and related disorders [4]

Core Viewpoint - Green Leaf Pharmaceutical (02186.HK) has seen its stock price increase by over 3%, currently trading at 3.2 HKD with a trading volume of 28.3181 million HKD [1] Group 1 - The stock price of Green Leaf Pharmaceutical rose by 3.22% [1] - The current trading price is 3.2 HKD [1] - The trading volume reached 28.3181 million HKD [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) has seen a stock increase of over 3% following the announcement of FDA approval for clinical trials of its new drug LY03017, aimed at treating various psychiatric disorders associated with Alzheimer's and Parkinson's diseases [1] Company Summary - Green Leaf Pharmaceutical's LY03017 is a new generation 5-HT2AR agonist and 5-HT2CR antagonist, which has received FDA permission to initiate clinical trials [1] - The drug is intended for the treatment of Alzheimer's Disease Psychosis (ADP), Parkinson's Disease Psychosis (PDP), and Negative Symptoms of Schizophrenia (NSS) [1] - The FDA has waived the single ascending dose (SAD) trial phase for the Phase I clinical trial, allowing the company to proceed directly to multiple ascending dose (MAD) trials and subsequent clinical phases [1] - LY03017 is developed based on the company's new molecular entity/novel therapeutic entity technology platform and is being developed simultaneously in China and the U.S. [1] - Currently, LY03017 is in Phase I clinical trials in China [1] Industry Summary - There is only one drug globally approved by the FDA for the treatment of PDP, which has not yet been approved in China [1] - No drugs have been approved for the treatment of ADP either domestically or internationally [1] - Only a few drugs have shown efficacy for NSS, but their effectiveness is considered inadequate, indicating a significant unmet medical need in these therapeutic areas [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) has seen a stock increase of over 3% following the announcement of FDA approval for clinical trials of its new drug LY03017, aimed at treating various psychiatric disorders associated with Alzheimer's and Parkinson's diseases [1] Company Summary - Green Leaf Pharmaceutical's LY03017 is a new generation 5-HT2AR inverse agonist and 5-HT2CR antagonist, which has received FDA permission to initiate clinical trials [1] - The drug is intended for the treatment of Alzheimer's Disease Psychosis (ADP), Parkinson's Disease Psychosis (PDP), and Negative Symptoms of Schizophrenia (NSS) [1] - The FDA has waived the single ascending dose (SAD) trial phase of the Phase I clinical trial, allowing the company to proceed directly to multiple ascending dose (MAD) trials and subsequent clinical phases [1] - LY03017 is developed based on the company's new molecular entity/new therapeutic entity technology platform and is being developed simultaneously in China and the U.S. [1] - Currently, LY03017 is in Phase I clinical trials in China [1] Industry Summary - There is currently only one drug approved by the FDA for the treatment of PDP, which has not yet been approved in China [1] - No drugs have been approved for the treatment of ADP in both domestic and international markets [1] - For NSS, only a few drugs show efficacy, but their effectiveness is limited, indicating a significant unmet medical need in these three indications [1]

Core Viewpoint - Green Leaf Pharmaceutical has received FDA approval to conduct clinical trials for its new generation 5-HT2A receptor inverse agonist and 5-HT2C receptor antagonist, LY03017, aimed at treating psychiatric disorders associated with Alzheimer's disease, Parkinson's disease, and negative symptoms of schizophrenia [1] Group 1: Clinical Development - LY03017 is based on the company's new molecular entity technology platform and is being developed simultaneously in China and the United States for central nervous system treatments [1] - The FDA has waived the single-dose escalation trial phase in the Phase I clinical trial, allowing the company to directly initiate multiple-dose escalation and subsequent clinical trials [1] - LY03017 is currently in Phase I clinical trials in China as well [1] Group 2: Market Opportunity - There is currently only one drug approved by the FDA for the treatment of Parkinson's disease psychosis (PDP), which has not yet been approved in China [1] - No drugs have been approved for the treatment of Alzheimer's disease psychosis (ADP) in both domestic and international markets [1] - Only a few drugs are effective for negative symptoms of schizophrenia (NSS), but their efficacy is suboptimal, indicating a significant unmet medical need in these three indications [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) has received FDA approval to conduct clinical trials for its innovative drug LY03017, targeting psychiatric disorders associated with Alzheimer's disease, Parkinson's disease, and negative symptoms of schizophrenia [1][2]. Group 1: Drug Development and Clinical Trials - LY03017 is a dual-target innovative drug that acts as a reverse agonist for the 5-HT2AR receptor and an antagonist for the 5-HT2CR receptor, showing potential in treating hallucinations and delusions in patients with PDP and ADP, as well as improving negative symptoms of schizophrenia [2]. - The FDA has waived the single ascending dose (SAD) trial phase for LY03017's Phase I clinical trial, allowing the drug to proceed directly to multiple ascending dose (MAD) trials and subsequent clinical studies [1]. - LY03017 is currently in Phase I clinical trials in China, and it is developed based on the company's new molecular entity/new therapeutic entity technology platform [1]. Group 2: Market Opportunity and Competitive Landscape - There is currently only one drug approved by the FDA for treating Parkinson's disease psychosis (PDP), which has not yet been approved in China; no drugs have been approved for treating Alzheimer's disease psychosis (ADP) domestically or internationally; and only a few drugs have shown limited efficacy for negative symptoms of schizophrenia (NSS) [1]. - The unmet medical needs for the three targeted indications present significant market opportunities for LY03017 [1]. Group 3: Strategic Focus and Product Portfolio - The central nervous system treatment area is a core strategic focus for the company, which has developed a differentiated product portfolio addressing various diseases, including depression, schizophrenia, bipolar disorder, and Alzheimer's disease [3]. - The company has several approved products, including Erzofri and Rykindo in the U.S., and various formulations in Europe, Japan, and China, alongside ongoing development of next-generation innovative drugs [3]. - Additional innovative drugs in clinical stages include LY03015, LY03020, and LY03021, targeting multiple receptors for enhanced therapeutic effects [3].

Core Insights - Green Leaf Pharmaceutical has received FDA approval to conduct clinical trials for its new generation 5-HT2AR inverse agonist and 5-HT2CR antagonist, LY03017, aimed at treating Alzheimer's disease psychotic disorder (ADP), Parkinson's disease psychotic disorder (PDP), and negative symptoms of schizophrenia (NSS) [1][2] - LY03017 is designed to target both 5-HT2AR and 5-HT2CR receptors, showing significant preclinical efficacy and safety advantages over existing and investigational drugs for the same indications [2] Group 1: Product Development - LY03017 is based on the company's new molecular entity platform and is being developed simultaneously in China and the U.S., currently in Phase I clinical trials in both regions [1] - The FDA has waived the single ascending dose (SAD) trial phase for LY03017, allowing the company to proceed directly to multiple ascending dose (MAD) trials and subsequent clinical studies [1] Group 2: Market Opportunity - There is currently only one FDA-approved drug for treating PDP, which has not yet been approved in China; no drugs are approved for ADP treatment, and only a few have limited efficacy for NSS, indicating a significant unmet medical need in these areas [1] - The central nervous system treatment sector is a core strategic focus for the company, with a diverse product portfolio addressing various mental health conditions, including depression, schizophrenia, and bipolar disorder [3] Group 3: Pipeline and Innovation - The company is actively developing next-generation innovative drugs, with several first-in-class candidates in clinical stages, including LY03015, LY03020, and LY03021, targeting multiple receptors [3]