11月24日，绿叶制药发布公告称，公司自主研发的新一代5-羟色胺2A型受体反向激动剂和5－羟色胺2C 型受体拮抗剂LY03017已获得美国食品药品监督管理局(FDA)许可开展临床试验。 LY03017拟用于治疗阿尔茨海默病精神病性障碍、帕金森病精神病性障碍及精神分裂症阴性症状。FDA 此次豁免了其Ⅰ期临床试验中的单次给药剂量递增试验环节，后续可直接启动多次给药剂量递增及后续 的临床试验。 LY03017基于公司的新分子实体技术平台开发，是公司在中国和美国同步开发的中枢神经系统治疗领域 创新药。目前，LY03017在中国也处于Ⅰ期临床阶段。 公告提到，全球仅有一款药物获得美国FDA批准用于治疗PDP，该药物尚未在中国获批；在治疗ADP方 面，国内外尚无药物获批上市；在治疗NSS方面，仅有少数药物对于NSS有效但疗效欠佳；上述三种适 应症存在亟待满足的治疗需求。 ...

绿叶制药(02186)公布，该集团自主研发的新一代5-羟色胺2A型受体(5-HT2AR)反向激动剂和5-羟色胺2C 型受体(5-HT2CR)拮抗剂LY03017已获得美国食品药品监督管理局(FDA)许可开展临床试验。LY03017拟 用于治疗阿尔茨海默病精神病性障碍(ADP)、帕金森病精神病性障碍(PDP)、精神分裂症阴性症状 (NSS)。FDA本次豁免了其Ⅰ期临床试验中单次给药剂量递增(SAD)试验环节，该药物后续可直接启动 多次给药剂量递增(MAD)以及后续的临床试验。 LY03017基于集团的新分子实体╱新治疗实体技术平台开发，是集团又一款在中国和美国同步开发的中 枢神经系统治疗领域创新药。目前，LY03017也在中国处于Ⅰ期临床阶段。 目前，全球仅有一款药物获得美国FDA批准用于治疗PDP，该药物尚未在中国获批;在治疗ADP方面， 国内外尚无药物获批上市;在治疗NSS方面，仅有少数药物对于NSS有效但疗效欠佳;上述三种适应症存 在亟待满足的治疗需求。 LY03017是新一代靶向5-HT2AR和5-HT2CR的双靶点创新药，其通过5-HT2AR受体反向激动作用及5- HT2C受体拮抗作用，抑制腹侧纹状体 ...

目前，全球仅有一款药物获得美国FDA批准用于治疗PDP，该药物尚未在中国获批;在治疗ADP方面， 国内外尚无药物获批上市;在治疗NSS方面，仅有少数药物对于NSS有效但疗效欠佳;上述三种适应症存 在亟待满足的治疗需求。 LY03017是新一代靶向5-HT2AR和5-HT2CR的双靶点创新药，其通过5-HT2AR受体反向激动作用及5- HT2C受体拮抗作用，抑制腹侧纹状体多巴胺释放，促进前额叶皮层多巴胺释放，有潜力治疗PDP及 ADP患者的幻觉及妄想并可改善NSS。临床前研究显示：LY03017的体内外药效活性、组织分佈、心脏 安全性均显著优于同目标适应症的已上市和在研药物。 中枢神经系统治疗领域是该集团长期布局的核心战略领域之一。该集团围绕该领域已形成一系列具有差 异化优势的产品组合，涵盖抑郁症、精神分裂症、双相情感障碍、阿尔茨海默病等多种疾病，其中包 括：在美国获批上市的Erzofri®(棕榈酸帕利哌酮缓释混悬注射液)、Rykindo®(利培酮缓释微球注射 剂)，在欧洲多国、日本、中国获批上市的利斯的明透皮贴剂(2次╱W)，在中国获批上市的若欣林®(盐 酸托鲁地文拉法辛缓释片)、金悠平®(注射用罗替高汀微球 ...

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. ADP、PDP及NSS的 全 球 病 患 人 數 龐 大。具 體 而 言，阿 爾 茨 海 默 病 全 球 患 者 人 數 約4,500萬，其 中25%至50%會 在 疾 病 病 程 中 出 現 精 神 症 狀；帕 金 森 病 患 者 人 數 超 過850萬，其 中PDP的長期累積患病率約為60%；精 神 分 裂 症 患 者 人 數 約2,300 萬，具 有 陰 性 症 狀 的 比 例 約 為60%。 – 1 – 目 前，全 球 僅 有 一 款 藥 物 獲 得 美 國FDA批准用於治療PDP，該 藥 物 尚 未 在 中 國 獲 批；在 治 療ADP方 面，國 內 外 尚 無 藥 物 獲 批 上 市；在 治 療NSS方 面，僅 有 少 數 藥物對於NSS有 效 但 療 效 欠 佳；上 述 三 種 適 應 ...

Group 1 - Tianfeng Securities has revised down the revenue forecasts for Green Leaf Pharmaceutical for 2025 and 2026 from 8.529 billion and 10.279 billion to 6.638 billion and 7.447 billion respectively, with an expected revenue of 8.162 billion in 2027 [1] - The net profit estimates have also been reduced from 1.373 billion and 1.678 billion to 672 million and 831 million for 2025 and 2026, with an expected net profit of 916 million in 2027 [1] - In the first half of 2025, the company reported a revenue of 3.181 billion, a year-on-year increase of 3.5%, while the net profit attributable to the parent company was 313 million, a year-on-year decrease of 19.3% [1] Group 2 - The company focuses on two major therapeutic areas: CNS and oncology, with multiple new products beginning commercialization and the sales proportion of new products increasing by 32% year-on-year [1] - In the oncology treatment sector, revenue reached 1.295 billion, a year-on-year increase of 13.5%, while CNS treatment revenue was 868 million, up 5.4%. Cardiovascular treatment revenue was 693 million, down 9.2%, and metabolic treatment revenue was 180 million, down 7.9% [1] Group 3 - The company has successfully commercialized two major products in the CNS field, with Ruxinlin being the first domestically developed antidepressant included in the 2024 medical insurance catalog, achieving over fourfold sales growth in the first half of 2025 [2] - ERZOFRI, a treatment for schizophrenia, was commercialized in the U.S. in April 2025, marking it as the first drug of its kind developed by a Chinese company with independent intellectual property rights [2] - The company has a rich pipeline of innovative drugs in development, including LY03017 for treating Parkinson's disease psychosis and Alzheimer's disease psychosis, with expected completion of Phase I trials in China by the end of 2025 [3]

Core Viewpoint - Tianfeng Securities has revised down the revenue and net profit forecasts for Green Leaf Pharmaceutical for 2025 to 2026 due to intense market competition and centralized procurement impacts, while maintaining a "Buy" rating [1] Group 1: Financial Performance - The revenue forecast for Green Leaf Pharmaceutical has been adjusted from 85.29 billion and 102.79 billion to 66.38 billion and 74.47 billion for 2025 and 2026 respectively, with an expected revenue of 81.62 billion for 2027 [1] - The net profit forecast has been revised down from 13.73 billion and 16.78 billion to 6.72 billion and 8.31 billion for 2025 and 2026 respectively, with an expected net profit of 9.16 billion for 2027 [1] - In the first half of 2025, the company reported revenue of 31.81 billion, a year-on-year increase of 3.5%, while the net profit attributable to the parent company was 3.13 billion, a year-on-year decrease of 19.3% [1] Group 2: Business Focus and Product Development - The company is focusing on two major areas: CNS (Central Nervous System) and oncology, with multiple new products beginning commercialization and an increasing sales proportion of new products (up 32% year-on-year) [1] - In the oncology treatment sector, revenue reached 12.95 billion, a year-on-year increase of 13.5%, while CNS treatment revenue was 8.68 billion, up 5.4%. Cardiovascular treatment revenue was 6.93 billion, down 9.2%, and metabolic treatment revenue was 1.80 billion, down 7.9% [1] Group 3: New Product Commercialization - The company has successfully commercialized two major products in the CNS field, with Ruxinlin being the first domestically developed antidepressant included in the 2024 medical insurance directory, showing over 4 times year-on-year sales growth [2] - ERZOFRI, a product for treating schizophrenia, entered the U.S. market in April 2025, being the first of its kind developed by a Chinese company with independent intellectual property rights [2] - ERZOFRI has a long patent period until 2039 and is currently in a favorable competitive landscape with only two companies in the market [2] Group 4: Innovation Pipeline - The company has a rich pipeline of innovative drugs in development, actively seeking business development collaborations with multinational corporations [3] - LY03017, aimed at treating Parkinson's disease psychosis and Alzheimer's disease psychosis, is expected to complete Phase I clinical trials in China by the end of 2025, with IND approval anticipated in Q3 2025 [3] - Other innovative drugs, including LY03015 for tardive dyskinesia and Huntington's disease, are in Phase II clinical trials, with data expected in the first half of 2026 [3]