FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 麗珠醫藥集團股份有限公司 呈交日期: 2026年2月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01513 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 299,807,117 | RMB | | 1 RMB | | 299,807,117 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 299,807,117 | RMB | | 1 RMB | | 299,807,117 | | 2. 股份分類 | 普通股 | 股份類別 | A | | ...

Core Viewpoint - The company adopts a "dual-track" strategy for its international expansion, focusing on both licensing out innovative products to mature markets and direct exports to emerging markets to establish a global sales network [1] Group 1: Licensing Strategy - The company is currently focusing on overseas rights cooperation for its core product, Lecanemab, in the self-immune field, which has attracted attention from multiple overseas pharmaceutical companies due to its clinical efficacy and low dosing frequency [1] - The partnership with XinKang allows for shared overseas rights, enhancing the product's market potential [1] Group 2: Export Strategy - The company has systematically laid out its export strategy since 2022, prioritizing Southeast Asia and South America as key emerging markets [1] - The decision is based on three core considerations: 1. Regional driving effect, using Vietnam and Brazil as pivotal points to accelerate market expansion due to their robust drug regulatory systems [1] 2. Registration synergy, as Southeast Asian countries generally recognize or can reference Chinese clinical research data, speeding up the approval process [1] 3. Market growth potential, with Vietnam's pharmaceutical market maintaining double-digit growth and Brazil being the largest pharmaceutical market in Latin America [1] Group 3: Implementation Measures - In Southeast Asia, the company is building a localized production and sales platform through the acquisition of the Vietnamese listed company IMP [1] - In South America, the focus is on Brazil, actively promoting product registration and channel development, leveraging its efficient review process to accelerate product entry [1] - The company expects that through 2-3 years of strategic layout and cultivation, its overseas formulation business will gradually scale up and contribute positively to financial performance in the future [1]

证券日报网1月22日讯，丽珠集团（000513）在接受调研者提问时表示，丽珠生物是健康元（600380） 和丽珠集团共同唯一的生物药平台，拥有三大主要业务板块：自免领域、生殖领域和疫苗领域。 ...

Core Viewpoint - Lijun Group's research indicates significant advancements in its biopharmaceutical platform, focusing on autoimmune, reproductive, and vaccine sectors, with key products nearing approval and promising clinical results [1][4][5] Group 1: Autoimmune Sector - Lijun Biopharmaceutical's core product, Lakanqita monoclonal antibody, shows a PASI100 response rate of 49.5% in severe psoriasis, outperforming the control group at 40.2%, and is expected to receive approval by the end of this year [1][6][7] - The company has completed Phase III clinical trials for ankylosing spondylitis, with approval anticipated next year, and significant sales growth for another product, tocilizumab, is expected in 2025 [1][4] Group 2: Reproductive Sector - The recombinant human follicle-stimulating hormone injection is expected to be approved within this year, reinforcing the company's leading position in the assisted reproductive field [1][4] Group 3: Vaccine Sector - The quadrivalent influenza recombinant protein vaccine, the first of its kind with an adjuvant, has completed Phase I safety trials and is expected to enter Phase II clinical trials in March [5] Group 4: Overseas Expansion Strategy - The company adopts a "dual-track" strategy for international expansion, focusing on licensing its innovative pipeline to mature markets and exporting formulations to emerging markets [2][9] - In Southeast Asia, the company is building a localized platform through the acquisition of IMP in Vietnam, while in South America, it is prioritizing registration and channel development in Brazil [9] Group 5: Cardiovascular Pipeline - H001, an oral direct thrombin inhibitor, is the fastest progressing project in its category in China, showing comparable efficacy to enoxaparin with a lower bleeding risk, and is preparing for Phase III trials [3][10] Group 6: GnRH Pipeline - The GnRH pipeline covers all indications and various formulations, with key products like the three-month formulation of leuprolide expected to be approved this year [11][12] Group 7: Chemical Preparation Sector - The chemical preparation sector generated 47.2 billion yuan in revenue from January to September 2025, accounting for 51.8% of the company's total revenue, serving as a core revenue support [13][14] - Future growth will be driven by product upgrades, innovative product launches, and deepening market penetration in core therapeutic areas [14][15][16]

Core Viewpoint - The company, Lizhu Group, has announced that its core product, Lakanqita monoclonal antibody, has outperformed Secukinumab in the primary endpoint of a Phase III head-to-head clinical trial for moderate to severe psoriasis, with a PASI 100 response rate at week 12 [1] Group 1 - The product is the first IL-17A/F dual-target inhibitor in China, offering advantages such as less frequent dosing, convenient administration, and excellent safety profile [1] - The company has submitted for market approval and has been included in the CDE's priority review, with the earliest expected approval by the end of 2026 [1] - Cost competitive barriers have been established through the localization of raw materials and process optimization, laying a foundation for future market access and commercialization [1]

Business Overview - Lizhu Biopharmaceuticals operates three main business segments: autoimmune, reproductive, and vaccine fields [2][3] - The core product in the autoimmune field, Lakanqita monoclonal antibody, has shown superior efficacy in clinical trials compared to competitors [4][5] Autoimmune Field - Lakanqita monoclonal antibody targets IL-17A/F dual sites, with a PASI100 response rate of 49.5% in clinical trials, outperforming the control group at 40.2% [4] - The product is expected to receive approval by the end of 2026, with significant market potential due to its unique characteristics [5] Reproductive Field - The recombinant human follicle-stimulating hormone (r-FSH) injection is anticipated to be approved within the year, reinforcing the company's leadership in assisted reproduction [3] Vaccine Field - The quadrivalent recombinant protein influenza vaccine is the first of its kind with an adjuvant, having completed Phase I trials and expected to enter Phase II in March [3] International Expansion Strategy - The company adopts a dual-track strategy for international expansion, focusing on licensing out innovative pipelines and direct exports to emerging markets [5][6] - Key markets include Southeast Asia and South America, with Vietnam and Brazil as strategic hubs for regulatory advantages and market growth [6] Cardiovascular Pipeline - H001, an oral direct thrombin inhibitor, is the fastest progressing project in its category, aimed at preventing venous thromboembolism (VTE) post-orthopedic surgeries [7] - The product has shown comparable efficacy to standard therapies and is preparing for Phase III trials [8] GnRH Pipeline - The GnRH pipeline covers all related indications and various formulations, making it the most comprehensive in China [9] - Key products include leuprolide with multiple formulations expected to launch soon, enhancing market presence [9] Chemical Preparation Segment - The chemical preparation segment generated revenue of 4.72 billion CNY, accounting for 51.8% of the company's total revenue in the first nine months of 2025 [10][11] - Growth drivers include product upgrades, innovation, and a focus on core therapeutic areas [11][12]

Policy Developments - The State Administration for Market Regulation has approved the national standard for "Classification and Determination of Traditional Chinese Medicine Constitution," which will be implemented from April 1. This standard categorizes nine basic types of TCM constitution and aims to enhance health literacy and optimize health service models [2]. Medical Device Approvals - Opcon Vision's application for the registration of "soft hydrophilic contact lenses" has been accepted by the National Medical Products Administration, currently in the acceptance phase [4]. - Livzon Pharmaceutical announced that its clinical trial application for injectable brexpiprazole microspheres for treating schizophrenia has been accepted by the National Medical Products Administration [5]. Capital Markets - AstraZeneca will acquire the remaining 50% equity of Westman Biotech's GPC3 armored CAR-T therapy in China, with a potential payment of up to $630 million, including upfront and milestone payments [7]. - Aote Biological's controlling shareholder has proposed a share buyback plan using funds from its IPO, with a total amount between RMB 100 million and RMB 200 million [8]. Industry Developments - Alibaba Health has launched its self-developed AI medical model "Hydrogen Ion," which is now in practical application, targeting clinical and research fields. This move complements Alibaba's existing health service strategies [10][11]. - Jiangzhong Pharmaceutical has changed its name to "China Resources Jiangzhong Pharmaceutical Co., Ltd." and will also change its stock abbreviation to "China Resources Jiangzhong," while keeping the stock code unchanged [12]. Shareholder Actions - Liaoning He Eye Hospital Group has received a notice from a major shareholder planning to reduce its stake by up to 3,106,074 shares, representing 1.97% of the total share capital, between February 7 and May 6, 2026 [14].

Core Viewpoint - The 2025 China Enterprise ESG "Golden Responsibility Award" aims to recognize companies and institutions that have made significant contributions to ESG initiatives in China, reflecting a shift from voluntary practices to compliance requirements in ESG performance [1][12]. Group 1: ESG Development and Awards Overview - By 2025, China's ESG development has transitioned from "setting standards" to "strengthening regulations," with a comprehensive disclosure standard system being established [1][12]. - The award selection attracted over 5,000 companies, with results based on ESG performance, online voting, and professional evaluations [2][12]. Group 2: Award Categories and Winners - The award categories include Excellent Environmental Responsibility Award, Excellent Social Responsibility Award, Excellent Corporate Governance Responsibility Award, Excellent Responsibility Initiative Award, Excellent Sustainable Development Award, and various responsibility investment awards [1][12]. - Notable winners of the Excellent Environmental Responsibility Award include Great Wall Motors, Hikvision, and China Petroleum [7][24]. - The Excellent Social Responsibility Award was awarded to companies such as YF Communication, ZTE, and Ningde Times [7][24]. - Winners of the Excellent Corporate Governance Responsibility Award include China Petroleum, Hikvision, and WuXi AppTec [7][24]. - The Excellent Responsibility Initiative Award was given to companies like ZTE, Sunlight Power, and Industrial and Commercial Bank of China [7][24]. - The Excellent Sustainable Development Award included companies such as WanHua Chemical, China Bank, and China Petroleum [7][24]. Group 3: Responsibility Investment Awards - The Responsibility Investment Excellent Bank Award was given to institutions like CITIC Bank and Minsheng Bank [5][21]. - The Responsibility Investment Excellent Securities Company Award included firms such as Shenwan Hongyuan and CITIC Securities [5][22]. - The Responsibility Investment Excellent Insurance Company Award recognized companies like New China Life and AIA [5][26]. - The Responsibility Investment Excellent Fund Company Award included firms such as Xinhua Fund and Harvest Fund [5][27]. - The Responsibility Investment Excellent Asset Management Institution Award recognized institutions like Ping An Asset Management and Sunshine Asset Management [5][28]. Group 4: Call to Action and Future Directions - The award committee encourages more Chinese enterprises to integrate ESG principles into their operations and strategic planning, emphasizing the importance of balancing commercial and social values [10][29].

Group 1: Product Development and Market Positioning - The company is advancing the IL-17A/F monoclonal antibody project, targeting psoriasis and ankylosing spondylitis, with a New Drug Application (NDA) submitted for psoriasis, expected approval by Q4 2026 [2][3] - The product has received priority review status from the National Medical Products Administration (NMPA) and aims to participate in the 2027 national health insurance negotiations [2] - The company has secured production and commercialization rights for ankylosing spondylitis in China, with Phase III clinical trial data expected to be finalized by mid-2026 [2] Group 2: Competitive Advantages - The product's differentiation lies in head-to-head clinical efficacy against a positive control drug, showing superior efficacy in key indicators such as PASI100 and PASI75 [3] - Cost advantages are noted due to the localization of key materials and a lower administration frequency compared to competitors, allowing for flexible pricing strategies [3] Group 3: Target Market Strategy - The primary focus post-launch will be on new psoriasis patients, as the current penetration of biological drugs in this market is low, indicating significant growth potential [3] - The company also targets patients who do not respond well to existing IL-17A inhibitors [3] Group 4: Sales and Marketing Strategy for Aripiprazole Microspheres - Aripiprazole microspheres were launched in May 2025 and included in the 2025 health insurance directory at a price of 850 RMB per bottle, effective January 1, 2026 [4] - The company plans to leverage a nationwide psychiatric sales team and marketing network to promote the product [4] - Strategies include real-world studies to evaluate efficacy and safety, aiming for rapid market penetration in 80% of psychiatric hospitals in 2026 [4] Group 5: GnRH Product Line Development - The company has developed a comprehensive product matrix for GnRH drugs, covering all indications and offering various dosage forms [5][6] - Key products include Leuprolide and Triptorelin, with Leuprolide microspheres expected to be approved in H2 2026 for breast cancer and prostate cancer [5] - The oral GnRH antagonist is in Phase II clinical trials, showing promise for infertility treatments [5][6] Group 6: Innovation in Neurology - The company is developing NS-041, a selective potassium channel activator for epilepsy and depression, with ongoing Phase II clinical trials [7] - NS-041 aims to avoid safety risks associated with previous similar drugs and is positioned as a best-in-class candidate in the market [7]

Group 1 - The core viewpoint of the article emphasizes the growing importance of ESG (Environmental, Social, and Governance) as a key metric for high-quality corporate development and a vital link between corporate value and social value [1][2] - The "2025 China Enterprise ESG Top 100" list was released by Sina Finance, evaluating over 5,000 A-share listed companies and mainland companies listed in Hong Kong using 18 industry ESG evaluation models and over 150 ESG indicators [1][2] - The list serves as a benchmark for industry development and provides valuable decision-making references for investors [1][2] Group 2 - Lijun Group was recognized for its outstanding ESG performance, ranking 35th on the "2025 China Enterprise ESG Top 100" list, highlighting its commitment to sustainable development practices [2] - The release of the list is seen as an authoritative recognition of the sustainable development practices of the listed companies and promotes the core values of ESG across the industry [2] - Companies are encouraged to integrate ESG principles into their strategic planning, operations, and supply chain collaboration to achieve a symbiotic relationship between commercial and social value [2] Group 3 - The list includes top companies such as China Construction Bank, China Mobile, Agricultural Bank of China, Tencent, and Bank of China, all receiving a five-star rating in their respective industries [4][5] - The ranking reflects the companies' commitment to ESG practices and their role as leaders in promoting sustainable development within their sectors [4][5]