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]

Group 1 - Vitasoy International (00345) reported a 6% year-on-year decrease in revenue and a 7% decrease in gross profit for the six months ending September 30, 2025, primarily due to weak market conditions in mainland China [1] - Shandong Xinhua Pharmaceutical (00719) saw a rise of over 2% after receiving approval from the National Medical Products Administration for the registration of a drug [1] - China Biologic Products (01177) increased by over 2% following the publication of positive Phase II clinical trial results for TQB2102 in HER2-positive breast cancer in a prestigious journal [1] - GDS Holdings (09698) rose over 4% after reporting a net income of 2.887 billion RMB for Q3, a 10.2% year-on-year increase, and a net profit margin of 25.2% [1] Group 2 - GaYa Optical (00907) surged by 49.12% after announcing a profit forecast of 8.8 million to 9.6 million HKD for the six months ending September 30, 2025, a significant turnaround from a loss of 13.8 million HKD in the same period last year [2] - Green Leaf Pharmaceutical (02186) rose nearly 2% after announcing FDA approval for clinical trials of a new drug [2] - Hengrui Medicine (01276) increased by over 5% after receiving approval for clinical trials of two drugs [2] - Meituan-W (03690) saw a 6% rise as Alibaba's CFO announced increased investment in Taobao Flash Purchase [2] Group 3 - Alibaba Group (09988) experienced a nearly 2% drop after reporting a 5% year-on-year revenue increase for Q2, but a significant 78% decline in adjusted EBITA [3] - Junshi Biosciences (01877) rose nearly 4% after announcing successful Phase III trial results for a drug in treating non-small cell lung cancer [4] Group 4 - Abercrombie & Fitch (ANF.US) surged by 37.54% after reporting Q3 earnings that exceeded expectations with an adjusted EPS of $2.36 and a 7% year-on-year sales increase [5] - Symbotic (SYM.US) rose by 39.36% after reporting Q4 revenue of $618 million despite a net loss [5] - Novo Nordisk (NVO.US) increased by 4.65% following positive results for a new weight loss and diabetes drug [5] - Kohl's (KSS.US) saw a 42.53% increase after exceeding Q3 earnings expectations and raising full-year guidance [6] - Alibaba (BABA.US) rose by 2.31% after reporting a 5% year-on-year revenue increase, although adjusted net profit fell by 72% [6] - Pony.ai (PONY.US) increased by 5.88% after announcing profitability for its seventh-generation Robotaxi [6]

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 ...

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]