Core Insights - Green Leaf Pharmaceutical (02186) announced that five new products have been successfully included in the National Medical Insurance Drug List (2025) and the Commercial Health Insurance Innovative Drug List (2025) [1] Group 1: New Product Inclusion - The five new products include: - Mimesin (Oxycodone Naloxone Extended-Release Tablets) and Ruibailai (Paliperidone Palmitate Injection (II)) are newly included in the National Medical Insurance Drug List [1] - Zanbija (Injectable Lurbinectedin) has been successfully included in the Commercial Health Insurance Innovative Drug List [1] - Baituowei (Injectable Goserelin Microspheres) and Ruiketuo (Injectable Risperidone Microspheres (II)) have successfully renewed their contracts and continue to be included in the National Medical Insurance Drug List [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186.HK) announced the successful inclusion of five new products in the National Medical Insurance Drug List (2025) and the Commercial Health Insurance Innovative Drug List (2025) [1] Group 1: New Product Inclusion - The five new products include: - Mimesin (Oxycodone Naloxone Extended-Release Tablets) and Ruibailai (Paliperidone Palmitate Injection (II)) are newly included in the National Medical Insurance Drug List - Zanbija (Injectable Lurbinectedin) is successfully included in the Commercial Health Insurance Innovative Drug List - Baituo Wei (Injectable Goserelin Microspheres) and Ruiketuo (Injectable Risperidone Microspheres (II)) have successfully renewed their inclusion in the National Medical Insurance Drug List [1][1][1] Group 2: Strategic Importance - The company believes that the synergy between medical insurance and commercial insurance is a significant measure to support the high-quality development of innovative drugs, promoting basic healthcare and innovation [1] - The inclusion of these five products through multiple access pathways into a multi-tiered medical security system will enhance drug accessibility for patients in related disease areas, effectively reducing their treatment burden [1][1] - This strategic move is expected to accelerate market penetration and coverage of these products, laying a solid foundation for their long-term high-quality growth [1][1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) has successfully included five new products in the National Medical Insurance Drug List (2025) and the Commercial Health Insurance Innovative Drug List (2025) [1] Group 1: New Product Inclusion - The five new products include: - Mimesin® (Oxycodone Naloxone Extended-Release Tablets) and Ruibailai® (Paliperidone Palmitate Injection (II)) are newly included in the National Medical Insurance Drug List [1] - Zanbija® (Injectable Lurbinectedin) has been successfully included in the Commercial Health Insurance Innovative Drug List [1] - Baituowei® (Injectable Goserelin Microspheres) and Ruiketuo® (Injectable Risperidone Microspheres (II)) have successfully renewed their inclusion in the National Medical Insurance Drug List [1]

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]