FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 第 2 頁 共 11 頁 v 1.3.0 公司名稱： 麗珠醫藥集團股份有限公司 呈交日期： 2025年7月29日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01513 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股 ...

Investment Rating - The industry investment rating is "Overweight (Maintain)" [1] Core Viewpoints - The report highlights that the National Medical Insurance Administration's clarification on not using the lowest price as a reference for centralized procurement is expected to continue promoting and optimizing procurement policies, enhancing the participation of pharmaceutical and medical device companies, and balancing quality and innovation in procurement [7] - LZM012 from Livzon Pharmaceutical has successfully reached its primary research endpoint in Phase III clinical trials, showcasing a dual blockade mechanism that comprehensively inhibits inflammatory responses, providing a new solution for achieving deep clearance of skin lesions and sustained relief [7] Summary by Sections Industry Overview - The report focuses on the pharmaceutical and biotechnology industry, emphasizing the recent developments in centralized procurement and the impact on drug pricing and market dynamics [3][4] Clinical Research Highlights - Livzon Pharmaceutical's LZM012 is the first IL-17A/F dual-target inhibitor to complete Phase III clinical trials in China, demonstrating faster onset and superior efficacy compared to the benchmark drug, Secukinumab [4][6] - Key findings from the clinical trial include: - LZM012 achieved a PASI 75 response rate of 65.7% at week 4, outperforming Secukinumab's 50.3% [4] - At week 12, the PASI 100 response rate for LZM012 was 49.5%, compared to 40.2% for Secukinumab, indicating significant efficacy [4] - Long-term efficacy was sustained, with PASI 100 response rates of 75.9% and 62.6% at week 52 for LZM012 under different dosing regimens, surpassing Secukinumab's 61.6% [4] - Safety profiles were comparable between LZM012 and the control group, with similar rates of adverse events [6] Investment Recommendations - The report suggests focusing on companies such as China National Pharmaceutical Group, Hengrui Medicine, and Livzon Pharmaceutical due to their promising developments and the favorable regulatory environment [7]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 麗珠醫藥集團股份有限公司 呈交日期： 2025年7月28日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01513 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | | 佔有關 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 麗珠醫藥集團股份有限公司 呈交日期： 2025年7月28日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01513 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | 佔有關事件 ...

Group 1 - The core viewpoint of the news is that Kangmand Capital has conducted research on Lijuz Group, highlighting the promising clinical data of its IL-17A/F project (LZM012) for psoriasis, which shows superiority over Secukinumab and rapid onset of action [1] - Lijuz Group plans to develop LZM012 for ankylosing spondylitis and pyoderma gangrenosum, and aims to advance overseas licensing [1] - The company is establishing a small nucleic acid technology platform, starting with a gout project, to build a research and development system and production line [1] - In 2024, Lijuz Group intends to introduce six new drug projects to strengthen its leading position in chronic disease areas and expand its innovative drug pipeline [1] - The small nucleic acid project LZHN2408 and products with global revenue-sharing mechanisms are expected to facilitate overseas licensing [1] - The acquisition of Vietnam's IMP Company aims to establish a presence in the Southeast Asian market, integrate production capabilities, and promote overseas sales [1] - Lijuz Group is enhancing research and development efficiency through strategic research deployment, improved management structure, and strengthened project evaluation and adjustment management [1]

Group 1: Key Research Projects - LZM012 targets IL-17A/F for moderate to severe psoriasis and ankylosing spondylitis, showing superior efficacy compared to control in Phase III trials, with PASI100 as the primary endpoint [2][5] - LZHN2408 for gout with hyperuricemia has received clinical approval, currently in Phase I trials, focusing on safety and efficacy [2] - H001, an anticoagulant for post-operative venous thromboembolism, has completed Phase II trials, showing comparable efficacy to enoxaparin with lower bleeding risk [3][7] - NS-041, a new generation KCNQ2/3 activator for epilepsy, has completed Phase I and is moving to Phase II, with no similar drugs on the market [3] - SG1001 for invasive fungal infections has completed Phase I trials, addressing drug resistance issues [3] - JP-1366, a P-CAB for gastrointestinal disorders, has completed Phase III trials and is preparing for market application [3] Group 2: Market Potential and Commercialization - The global market for psoriasis treatments is significant, with ustekinumab sales exceeding $6 billion in 2022, and UCB's bimekizumab projected to grow from $150 million in 2023 to over $600 million in 2024 [6][7] - LZM012 is expected to receive approval by mid-2027, aligning with the annual medical insurance negotiations [7] Group 3: Safety and Efficacy Data - LZM012's 52-week safety data shows a lower adverse reaction rate compared to ustekinumab, with no additional safety concerns identified [5] - H001's Phase I results indicate good safety profiles with no gastrointestinal bleeding, and preliminary data shows its anticoagulant effect is comparable to enoxaparin [7]

R&D Progress and Key Projects - LZM012, targeting IL-17A/F, is the first IL-17A/F inhibitor to complete Phase III clinical trials in China, showing a PASI100 response rate of 49.5%, outperforming the control group at 40.2% [6][7] - LZHN2408, for gout with hyperuricemia, has received clinical approval and is currently in Phase I trials, demonstrating safety and efficacy in preclinical studies [3][8] - H001, an anticoagulant for post-surgical venous thromboembolism, has completed patient enrollment in Phase II trials, showing comparable efficacy to enoxaparin with lower bleeding risks [3][4] New Drug Development - NS-041, a new generation KCNQ2/3 activator for epilepsy, has completed Phase I trials and is set to enroll over 280 patients in Phase II, with no similar drugs currently on the market [4] - SG1001, targeting invasive fungal infections, has completed Phase I trials and is expected to address drug resistance issues [5] - JP-1366, a P-CAB product, has completed Phase III trials and will soon submit for market approval, filling a gap in the domestic P-CAB injection market [5] Strategic Initiatives - The company plans to introduce 6 new drug projects in 2024, with 5 being innovative drugs, focusing on consolidating its leading position in gastrointestinal and neurological fields [9][10] - The acquisition of Vietnam's IMP Company aims to enhance market presence in Southeast Asia, leveraging local production capabilities and distribution networks [11] Clinical Data and Market Potential - LZM012's Phase III data indicates a low adverse reaction rate compared to the control drug, with ongoing evaluations for additional indications and potential overseas licensing [7][10] - The small RNA technology platform is being developed to enhance drug delivery systems, with a focus on the gout project as a leading initiative [8] Efficiency Improvements - The company has reformed its R&D system to improve efficiency through strategic project management and resource allocation, focusing on high-quality advancements in key therapeutic areas [11]

Core Viewpoint - LZM012, a humanized monoclonal antibody injection targeting IL-17A/F developed by the company, has successfully met its primary endpoint in Phase III clinical trials for moderate to severe plaque psoriasis, showing non-inferiority and superiority compared to Secukinumab [1][2] Group 1: Clinical Trial Results - The primary endpoint of the Phase III trial was the proportion of subjects achieving PASI 100 at week 12, with LZM012 showing a PASI 100 response rate of 49.5% compared to 40.2% for Secukinumab [2] - The secondary endpoint at week 4 showed a PASI 75 response rate of 65.7% for LZM012 versus 50.3% for Secukinumab, indicating a faster onset of action and good safety profile for LZM012 [2] Group 2: Market Landscape - The IL-17 market remains competitive, with only three IL-17 inhibitors approved overseas: Novartis' Secukinumab, Eli Lilly's Efalizumab, and UCB's Bimekizumab [1] - In 2024, projected sales for these drugs are $6.14 billion for Secukinumab, $3.26 billion for Efalizumab, and $630 million for Bimekizumab [1] Group 3: Future Prospects - The company has submitted a pre-application for marketing authorization to the CDE, with expectations for continued growth as its pipeline products enter the market [1] - Profit forecasts indicate net profits of 2.2 billion, 2.5 billion, and 2.8 billion yuan for 2025-2027, reflecting an optimistic outlook on business structure optimization and accelerating growth [2]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative price increase of over 20% compared to the benchmark index within the next six months [6][12]. Core Insights - The company has successfully completed the Phase III clinical trial for its IL-17A/F monoclonal antibody, LZM012, demonstrating superior efficacy compared to the control group, Secukinumab, in treating moderate to severe plaque psoriasis [3][4]. - LZM012 achieved a PASI 100 response rate of 49.5% at week 12, compared to 40.2% for Secukinumab, indicating a significant therapeutic advantage [4]. - The company is positioned to capitalize on the growing market for biologics in psoriasis treatment, with an estimated 6-7 million patients in China and increasing penetration of targeted biologic therapies [5]. Financial Projections - The company is projected to achieve net profits of 2.372 billion, 2.683 billion, and 3.046 billion yuan for the years 2025, 2026, and 2027, respectively, with corresponding P/E ratios of 16.74, 14.79, and 13.03 [6][9]. - Revenue is expected to grow from 11.812 billion yuan in 2024 to 14.695 billion yuan in 2027, reflecting a compound annual growth rate of approximately 8.6% [9][10]. - The EBITDA is forecasted to increase from 3.373 billion yuan in 2024 to 4.429 billion yuan in 2027, indicating strong operational performance [9][10].

Core Viewpoint - The path of domestic innovative drugs in China is becoming clearer, with companies like Livzon Pharmaceutical demonstrating the potential to lead in the market through differentiated treatment mechanisms and successful clinical trials [1][4]. Group 1: Clinical Trial Success - Livzon Pharmaceutical's LZM012, a recombinant anti-IL-17A/F humanized monoclonal antibody, achieved its primary endpoint in a Phase III clinical trial for moderate to severe plaque psoriasis, outperforming Novartis's Cosentyx (secukinumab) [1][3]. - The trial results showed a PASI 100 response rate of 49.5% for LZM012 compared to 40.2% for the control group (secukinumab) at week 12, indicating superior efficacy [3]. - LZM012 also demonstrated faster onset of action with a PASI 75 response rate of 65.7% at week 4, compared to 50.3% for secukinumab [3]. Group 2: Market Potential - The psoriasis drug market in China reached 13.9 billion yuan in 2023 and is projected to grow to 89.4 billion yuan by 2032, with a compound annual growth rate of 59.1% [5]. - The impending patent expiration of secukinumab presents an opportunity for LZM012 to capture market share [5][6]. Group 3: Competitive Landscape - LZM012 faces competition from several other IL-17 targeted therapies already approved in China, including Eli Lilly's etanercept and others, which may impact its market entry [5][6]. - The competitive landscape is further complicated by the aggressive pricing strategies of established products like secukinumab, which has seen significant price reductions since its launch [6]. Group 4: Company Performance - Livzon Pharmaceutical reported a revenue decline of 4.97% in 2024, with net profit increasing by 5.5%, indicating challenges in core business growth despite cost-cutting measures [7]. - The company has successfully reduced sales, management, and R&D expenses, leading to improved net profit margins [7]. Group 5: Strategic Challenges - The success of innovative drugs like LZM012 hinges not only on clinical efficacy but also on navigating the complexities of commercialization, including market competition and pricing strategies [9]. - Livzon Pharmaceutical must maintain strategic focus to effectively respond to market dynamics and ensure the successful launch of its new products [9].