Core Viewpoint - Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration for the new indication application of its innovative drug Ruoxinlin, aimed at treating generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] Group 1: Drug Development and Clinical Research - Ruoxinlin is expected to be the first SNDRI (serotonin, norepinephrine, and dopamine reuptake inhibitor) for generalized anxiety disorder in China, potentially benefiting a larger patient population [1] - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating an efficacy rate exceeding 80% and a remission rate of approximately 50% [1] - The safety profile of Ruoxinlin is favorable, with low incidences of adverse effects such as drowsiness, insomnia, fatigue, and sexual dysfunction, most of which are mild to moderate and tend to improve over time [1] Group 2: Market Context and Demand - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million affected individuals, and generalized anxiety disorder has a lifetime prevalence of about 4.1%-6.6% among adults [2] - Current first-line treatments for generalized anxiety disorder, SSRIs and SNRIs, show limited efficacy with overall effectiveness rates of 67.7% and remission rates of only 39.7%, alongside significant side effects that affect patient compliance [2] - The market for SSRIs and SNRIs is projected to reach 4.83 billion yuan in 2024, with no new innovative drugs approved in the last 20 years, highlighting a significant gap in the treatment landscape [2] Group 3: Company Strategy and Product Portfolio - Green Leaf Pharmaceutical has established a long-term strategic focus on the central nervous system treatment field, with a diverse product portfolio addressing various conditions including schizophrenia, bipolar disorder, and Alzheimer's disease [4] - The company’s product lineup includes Ruoxinlin, which has served nearly 190,000 patients since its launch, and has been recognized as one of the fastest-growing antidepressants in China [3] - The company is actively developing next-generation innovative drugs, with several candidates in clinical stages targeting multiple mechanisms [4]

Core Viewpoint - Fosun Pharma is focusing on unmet clinical needs in the central nervous system treatment area by investing a total of 1.41 billion yuan in Green Valley Pharmaceutical to enhance its innovative product pipeline and market layout [1] Group 1: Investment Details - Fosun Pharma's subsidiary plans to invest 143 million yuan to acquire 20.15 million yuan of registered capital from existing shareholders [1] - An additional investment of 1.27 billion yuan will be made to subscribe for 200.87 million yuan of new registered capital [1] Group 2: Shareholder Arrangements - The target company will first pay relevant buyback amounts to certain employees, with existing shareholders transferring 8.67 million yuan of registered capital to a newly established SPV at a nominal price [2] - After the completion of the acquisition, Fosun Pharma will hold a combined 53% stake in the target company, which will be included in the consolidated financial statements [2] Group 3: Product Information - The target group specializes in the research, production, and sales of drugs for neurodegenerative diseases, with its main product, Ganluo Sodium Capsule, conditionally approved for Alzheimer's treatment [3] - The drug has shown significant cognitive improvement in patients with mild to moderate Alzheimer's disease, particularly in moderate cases, based on clinical trial results [3] - Commercial production of the drug is currently on hold due to the expiration of its registration certificate, pending the completion of post-marketing confirmatory clinical trials [3]

Core Viewpoint - Fosun Pharma aims to enhance its product pipeline in the central nervous system treatment area by acquiring a controlling stake in Green Valley Pharmaceutical for a total investment of 1.412 billion yuan [1] Group 1: Acquisition Details - Fosun Pharma's subsidiary plans to invest 1.412 billion yuan to gain control over Green Valley Pharmaceutical [1] - Following the acquisition, Green Valley Pharmaceutical will become a subsidiary of Fosun Pharma, and its core drug, mannitol sodium capsules, will be included in Fosun's innovative drug pipeline [1] Group 2: Product Information - Mannitol sodium capsules are primarily used for the treatment of mild to moderate Alzheimer's disease [1] - Due to the expiration of the registration approval, commercial production of mannitol sodium capsules will not commence until November 2024, pending the completion of post-marketing confirmatory clinical trials and approval from the national drug review authority [1] - As of the announcement date, the post-marketing confirmatory clinical trials are currently underway [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]

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]