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]

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]

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]

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita Monoclonal Antibody (LZM012/XKH004) for the treatment of plaque psoriasis [2] Group 1: Product Development - Lakanqita Monoclonal Antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [4] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has exclusive rights for the global development, registration, production, sales, and sublicensing of this product [4] Group 2: Clinical Trial Results - In July, Lijun Pharmaceutical announced that Lakanqita Monoclonal Antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [4] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [4] - The overall safety profile of Lakanqita Monoclonal Antibody was good, with the incidence of common adverse events comparable to that of the control group [4]

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita monoclonal antibody (LZM012/XKH004) for the treatment of plaque psoriasis [1] Group 1: Product Development - Lakanqita monoclonal antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [2] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has obtained exclusive rights for the global development, registration, production, sales, and sublicensing of this product [2] Group 2: Clinical Trials - In July, Lijun Pharmaceutical announced that Lakanqita monoclonal antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [3] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [3] - The overall safety profile of Lakanqita monoclonal antibody was good, with the incidence of common adverse events comparable to that of the control group [3]