标的集团主要从事神经退行性疾病治疗药品的研发、生产和销售。2019年11月，标的集团的甘露特钠胶 囊获国家药监局有条件批准上市，获批适应症为"用于轻度至中度阿尔茨海默病，改善患者认知功能"； 2021年，该药品获纳入国家医保目录。 复星医药产业拟出资126,948.1633万元认缴标的公司20,086.7347万元新增注册资本(即"本次认购新增注 册资本"或"本次认购")。 此外，为妥善处理标的公司存续股权激励计划等安排中的相关退股并由投资方和创始人共同承担相应成 本，拟由标的公司先行向约定范围内的退股员工等支付相应退股款项，同时由标的公司现有股东上海耀 期九(由创始人实际控制)于本次认购交割日前以1元或法律允许的最低对价向由复星医药产业与标的公 司创始人或其关联方拟共同设立的SPV(双方分别持股51%、49%)转让所持有的标的公司866.7347万元注 册资本(即"阶段性转让");后续，创始人或其关联方有权以相当于退股实际成本51%的价格(即标的公司已 先行承担的前述退股款项总额的51%)受让复星医药产业所持有的SPV51%的股权(即"后续转让")。 不考虑其他可能影响标的公司股权结构变动的因素,本次收购( ...

北京商报讯（记者 丁宁）12月15日晚间，复星医药（600196）发布公告称，为聚焦未被满足的临床需 求，进一步丰富集团中枢神经系统治疗领域的创新产品管线矩阵、完善市场布局，打造诊疗一体、多技 术路径协同的解决方案，控股子公司复星医药产业拟出资共计14.12亿元控股投资绿谷医药。 复星医药表示，本次收购完成后，绿谷医药将成为公司控股子公司，其核心药品甘露特钠胶囊也将纳入 复星医药创新药品管线，主要用于治疗轻度至中度阿尔茨海默病。 值得一提的是，因注册批件到期，2024年11月起，甘露特钠胶囊未开展商业化生产。该药品在重新开展 商业化生产和销售前，还需（其中主要包括）补充完成上市后确证性临床试验并获得国家药品审评部门 批准。截至公告日期，该等上市后确证性临床试验已在开展中。 ...

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]

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 - The core point of the news is that Green Leaf Pharmaceutical has completed patient enrollment for the Phase III clinical trial of its innovative drug, Ruoxinlin, aimed at treating generalized anxiety disorder (GAD) [1] - The Phase III trial is a multi-center, randomized, double-blind, placebo-controlled study involving 555 patients, with the primary endpoint being the change in Hamilton Anxiety Scale (HAM-A) scores at the end of week 8 [1] - The company expects to complete the clinical trial by the end of this year and submit a marketing application for this indication [1] Group 2 - Generalized anxiety disorder is the most common mental disorder in China, affecting approximately 53.1 million people as of 2021 [1] - There have been no innovative drugs approved for the treatment of anxiety disorders globally in the past 15 years, making Ruoxinlin a potential first-in-class serotonin, norepinephrine, and dopamine reuptake inhibitor (SNDRI) for GAD [1] Group 3 - Ruoxinlin is the first independently developed innovative drug in China for treating depression, having been approved in 2022, and has shown significant clinical efficacy and safety [3] - The drug has been recognized for its ability to improve depressive symptoms without causing insomnia, sedation, or affecting sexual function, weight, and lipid metabolism [3] - Ruoxinlin has served over 80,000 patients since its launch and is the fastest-growing antidepressant in China [3] Group 4 - The demand for treatments in the central nervous system field, including depression and anxiety, is substantial, but new drug development has been relatively slow [4] - The company has received approvals for a series of competitive innovative drugs in various markets, including the US, Europe, and Japan [4] - The company is actively developing next-generation innovative drugs, with several first-class innovative drugs in clinical stages targeting multiple receptors [4]

Group 1 - Luye Pharmaceutical has launched Rotigotine Luye in the UK, a generic version of Neupro®, for treating early and advanced idiopathic Parkinson's disease and moderate to severe idiopathic restless legs syndrome [1] - Rotigotine Luye is the first generic version of Neupro® to be launched in the UK, demonstrating bioequivalence with the original product [1] - The product features a smaller patch size, 8% smaller than Neupro®, and has a lower drug load while maintaining the same release dosage [1] Group 2 - Parkinson's disease affects over 10 million people globally and is the second most common neurodegenerative disease, leading to significant mobility and mental health issues [2] - Restless legs syndrome affects approximately 3% of the global population, causing an irresistible urge to move the legs, which can severely disrupt daily activities [2] - Rotigotine, as a dopamine receptor agonist, improves both motor and non-motor symptoms in Parkinson's patients and alleviates symptoms in restless legs syndrome patients [2] Group 3 - Luye Pharmaceutical has a strong focus on the central nervous system treatment field, with a portfolio of internationally competitive innovative drugs and formulations [3] - The company has several approved products, including Erzofri® and Rykindo® in the US, and Ruoxinlin® and Jinyouping® in China [3] - Multiple first-in-class innovative drugs are in clinical stages, including LY03020, LY03021, and LY03015, targeting various mechanisms [3]