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]

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 ...

Core Viewpoint - Luye Pharma's subsidiary, Luye Geneora, has issued exchangeable preferred shares worth approximately $150 million, which can be exchanged for up to 100 million shares of Boan Biologics, potentially affecting its subsidiary status [1] Group 1: Company Actions - Luye Geneora issued 4.75% exchangeable preferred shares to Bluebell Asset [1] - The funds raised will be used for general operational purposes of the group [1] Group 2: Market Reaction - Following the announcement, Luye Pharma's stock fell by 3.58% to HKD 2.96 [1] - Boan Biologics' stock also declined by 2.92% to HKD 10.63 [1] Group 3: Potential Impact - If all preferred shares are exchanged, Boan Biologics will no longer be a subsidiary of Luye Pharma [1]

Core Viewpoint - Luye Pharma's subsidiary, Luye Geneora, has issued exchangeable preferred shares amounting to approximately $150 million, which can be exchanged for up to 100 million shares of Boan Biologics, potentially affecting its subsidiary status [1] Group 1 - Luye Pharma's stock price decreased by 3.58%, trading at HKD 2.96 [1] - Boan Biologics' stock price fell by 2.92%, trading at HKD 10.63 [1] - The funds raised from the issuance will be used for general operational purposes of the group [1] Group 2 - The exchangeable preferred shares have a coupon rate of 4.75% [1] - If fully exchanged, Boan Biologics will no longer be a subsidiary of Luye Pharma [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) announced the issuance of exchangeable preferred shares worth $150 million, which will be exchanged for shares of Boan Biologics (600201) under specific terms outlined in the subscription agreement [1] Group 1: Financial Details - The total subscription price for the exchangeable preferred shares is $150 million [1] - The proceeds from the subscription will be used for general working capital purposes of the group [1] Group 2: Strategic Implications - The issuance of exchangeable preferred shares provides the company with immediate cash funding while maintaining strategic flexibility [1] - The exchange mechanism allows the company to monetize its investment in Boan Biologics over a longer period at a price above the current market level, which is expected to yield better results compared to bulk disposals at discounted prices [1] Group 3: Investor Information - The subscriber is a company registered under the laws of the Cayman Islands, with RRJ Capital Master Fund IV, L.P. as its direct shareholder, holding 100% of the issued share capital [1] - The main business of the subscriber is investment holding activities [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) announced the issuance of exchangeable preferred shares worth $150 million, which will provide immediate cash flow while maintaining strategic flexibility [1] Group 1: Issuance Details - The company has entered into a subscription agreement with a subscriber for the issuance of exchangeable preferred shares, with a total subscription price of $150 million [1] - The exchangeable preferred shares can be converted into shares of Boan Biotechnology according to the terms outlined in the subscription agreement [1] Group 2: Strategic Implications - The board believes that issuing exchangeable preferred shares will allow the company to obtain cash funding immediately while retaining strategic flexibility [1] - The exchange mechanism enables the company to monetize its investment in Boan Biotechnology over a longer period at a price above the current market level, which is expected to yield better results compared to bulk disposals at discounted prices [1] Group 3: Use of Proceeds - The proceeds from the subscription will be used for the general working capital purposes of the group [1] Group 4: Subscriber Information - The subscriber is a company incorporated under the laws of the Cayman Islands and is a wholly-owned subsidiary of RRJ Capital Master Fund IV, L.P., which holds 100% of the issued share capital of the subscriber [1] - The primary business of the subscriber is investment holding activities [1]