智通财经APP获悉，据港交所11月26日披露，上海宝济药业股份有限公司-B(以下简称：宝济药业)通过 港交所主板上市聆讯，中信证券、国泰海通为联席保荐人。截至2025年11月22日，该公司的核心产品 SJ02已于2025年8月获得国家药监局的NDA批准及两款候选药物(即核心产品KJ103及KJ017)已于中国进 入后期试验或NDA注册阶段。 该公司的核心产品包括：(i)SJ02(晟诺娃®)，是一种长效重组人卵泡刺激素羧基末端肽融合蛋白(FSH- CTP)，作为辅助生殖，用于进行控制性卵巢刺激、促进多囊泡发育及诱发排卵，于2025年8月获得国家 药监局NDA批准;(ii)KJ017，是一种处于NDA阶段的重组人透明质酸酶，用于大容量皮下给药(联合治 疗)、由于各种原因导致的体液流失(单药治疗)、辅助皮下补液(联合治疗);及(iii)KJ103，是一种处于III 期开发阶段的创新重组免疫球蛋白G(IgG)降解酶，用于治疗肾脏移植前脱敏及病理性IgG介导自身免疫 性疾病。 根据弗若斯特沙利文的资料，到2033年，该公司的四个战略性治疗领域在中国的临床可触及市场规模合 计将约达人民币500亿元，包括：(i)大容量皮下 ...

Core Viewpoint - Nuo Cheng Jian Hua is optimistic about its future development, expecting to achieve breakeven in 2025, two years ahead of its profitability target, supported by strong revenue growth and a significant licensing deal with Zenas [1][2]. Financial Performance - The company reported a 59.8% year-on-year increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, primarily driven by the sales of its core product, the BTK inhibitor Aobutini [1]. - Aobutini's revenue for the same period rose by 45.8% to 1.01 billion yuan, surpassing last year's total revenue [1]. - The company's losses narrowed significantly by 74.8%, down to 70 million yuan, due to rapid revenue growth and improved cost efficiency [1]. Strategic Partnerships - The licensing agreement with Zenas, valued at over 2 billion USD, is expected to enhance Nuo Cheng Jian Hua's financial performance and support its global expansion efforts [2][3]. - Zenas is advancing global Phase III clinical trials for Aobutini targeting primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) patients, with trials set to start in Q1 2026 [2]. Product Pipeline and Market Potential - Nuo Cheng Jian Hua is focusing on three key therapeutic targets: BTK, CD19, and BCL2, to strengthen its position in the hematological oncology market [4]. - The CD19 monoclonal antibody, Tanshizhuo, has been commercially launched in China, filling a gap in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [5]. - The BCL2 inhibitor, Mesutoclax, is undergoing multiple clinical trials, showing promise in treating various hematological malignancies [6][7]. Expansion into Autoimmune Diseases - The global market for autoimmune diseases is projected to reach 185 billion USD by 2029, with Nuo Cheng Jian Hua actively advancing multiple Phase III clinical trials for its pipeline products [8]. - Aobutini is the first BTK inhibitor to show efficacy in systemic lupus erythematosus (SLE) in Phase II trials, with data expected to be released in Q4 2025 [8]. Research and Development - The company has increased its R&D expenditure by 9.9% year-on-year to 680 million yuan, with plans to submit 5 to 7 clinical trial applications for new drug candidates by 2026 [10][11]. - Nuo Cheng Jian Hua is developing a new ADC drug, ICP-B794, which has completed its first patient dosing, and aims to leverage its ADC platform for further innovations [10][11].

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received acceptance for the market approval application of ZORYVE® 0.15% cream for treating mild to moderate atopic dermatitis in patients aged 6 and above, marking a significant milestone in the product's development [1][4] Group 1: Product Development and Market Potential - The acceptance of the ZORYVE® 0.15% cream application signifies a critical advancement in Huadong Medicine's research and development process, enhancing its core competitiveness in the treatment of autoimmune skin diseases [1][4] - ZORYVE® is a non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which helps reduce inflammation by inhibiting the enzyme that increases pro-inflammatory mediators [2] - The atopic dermatitis market in China is projected to grow significantly, with an estimated market size of approximately $970 million in 2022, expected to reach $7.07 billion by 2030, reflecting a compound annual growth rate (CAGR) of 28.2% [2] Group 2: Strategic Positioning and Product Portfolio - ZORYVE® has received full recognition from the FDA in the United States, with a mature product matrix covering multiple age groups and indications, including treatments for atopic dermatitis and psoriasis [3] - Huadong Medicine is focusing on autoimmune diseases as one of its three core development directions, continuously enhancing its product introduction and independent research and development capabilities [3] - The company has a comprehensive range of products and pipeline candidates addressing various autoimmune diseases, positioning itself as one of the most diversified pharmaceutical companies in this field in China [3]

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was $73.5 million, an increase of 8% from $67.8 million in Q3 2024. Excluding a one-time milestone payment in 2024, total revenue increased by 27% year-over-year [4][5] - Net product sales of LUPKYNIS were $70.6 million, up 27% from $55.5 million in 2024 [4] - Net income was $31.6 million, up 119% from $14.4 million in 2024, with diluted earnings per share at $0.23, up 130% from $0.10 in 2024 [4] - Cash flows from operating activities were $44.5 million, up 162% from $17 million in 2024 [4] Business Line Data and Key Metrics Changes - LUPKYNIS sales grew at a rate of 27% year-over-year, prompting the company to raise its sales guidance for 2025 to $265 million-$270 million [3][6] - For the nine months ended September 30, 2025, net product sales of LUPKYNIS were $197.2 million, up 24% from $158.6 million in 2024 [5] Company Strategy and Development Direction - The company is focused on advancing its Atenercept program toward clinical studies in two autoimmune diseases, following positive phase one results [3][12] - The strategy includes sharpening commercial focus on high-volume prescribers, particularly rheumatologists, to drive growth in LUPKYNIS sales [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth, citing positive momentum from the ACR guidelines and consistent performance in sales [26][49] - The company anticipates further details on the APRIL/BAF program to be disclosed in early 2026, indicating ongoing development and strategic planning [25][42] Other Important Information - The company filed a complaint against Dr. George Tidmarsh regarding statements about BacloSporin, which is pending in court [2] - New analyses of LUPKYNIS data reinforce its clinical profile, showing a 53% reduction in the risk of renal-related events or death [8] Q&A Session Summary Question: Insights on prescriber habits and LUPKYNIS usage - Management noted consistent growth in rheumatology prescribers and emphasized the positive impact of ACR guidelines on treatment practices [16][19] Question: Trends into Q4 and confidence in growth - Management expressed confidence in continued positive momentum for LUPKYNIS and plans to disclose more about the APRIL/BAF program in early 2026 [26][25] Question: FDA information request details - Management could not specify the trigger for the FDA's information request but emphasized the favorable data presented [32][41] Question: Persistence trends for LUPKYNIS - Management reported an upward trend in patient persistence on LUPKYNIS, supported by positive clinical data [55] Question: Atenercept dosing in clinical trials - Management confirmed that 150 mg dosing will be used in future studies, with further details to be disclosed in 2026 [62]

Core Insights - The company announced a global exclusive licensing agreement with Dianthus Therapeutics, Inc. to jointly advance the novel anti-BDCA2-TACI bispecific fusion protein LBL-047 [1] - LBL-047 has received IND approval for clinical trials in the United States and is under IND review in mainland China [1] Financial Terms - Dianthus will obtain exclusive rights for the research, development, and commercialization of LBL-047 outside Greater China [1] - The company will receive an upfront payment of up to $38 million, potential near-term milestone payments, and up to $1 billion in potential milestone payments related to clinical development, regulatory, and commercialization [1] - The company will also receive tiered royalties on net sales outside Greater China [1] Product Potential - LBL-047 targets BAFF/APRIL and BDCA2, showing therapeutic potential for various autoimmune diseases [1] - The drug is designed to reduce dosing frequency and improve patient compliance through glycosylation modifications and Fc region engineering [1]

Core Viewpoint - The company has entered into a global exclusive licensing agreement with Dianthus Therapeutics to advance the clinical asset LBL-047, a novel anti-BDCA2-TACI bispecific fusion protein, which has received IND approval in the US and acceptance in mainland China [1][2]. Group 1: Licensing Agreement Details - The agreement grants Dianthus exclusive rights to develop, manufacture, and commercialize LBL-047 outside of Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive an upfront payment of up to $38 million, along with potential milestone payments totaling up to $1 billion related to clinical development, regulatory, and commercialization achievements [1]. - The company will also earn tiered royalties on net sales outside of Greater China, with rates ranging from single digits to low double digits [1]. Group 2: Strategic Importance - The collaboration with Dianthus, recognized for its leadership in developing transformative therapies for severe autoimmune diseases, is expected to enhance the company's commitment to advancing innovative drug candidates into clinical stages [2]. - The agreement aligns with the overall best interests of the company and its shareholders [2]. Group 3: Mechanism and Potential of LBL-047 - LBL-047 targets BAFF/APRIL and BDCA2, aiming to simultaneously inhibit the activity of plasmacytoid dendritic cells (pDC) and the differentiation and activation of B cells and plasma cells [3]. - The drug shows strong therapeutic potential for autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, IgA nephropathy (IgAN), and Sjögren's syndrome [3]. - LBL-047 is designed with glycosylation modifications to enhance its efficacy and broaden its immunosuppressive effects, while Fc region modifications extend its half-life, reducing dosing frequency and improving patient compliance [3].

Core Viewpoint - The company has entered into a global exclusive licensing agreement with Dianthus Therapeutics, Inc. to jointly advance the clinical asset LBL-047, which has received IND approval in the U.S. and acceptance in China [1][2] Group 1: Licensing Agreement Details - The agreement grants Dianthus exclusive rights to develop, manufacture, and commercialize LBL-047 outside of Greater China [1] - The company will receive an upfront payment of up to $38 million, along with potential milestone payments totaling up to $1 billion for clinical development, regulatory, and commercialization milestones [1] - The company will also earn tiered royalties on net sales outside of Greater China, with rates ranging from single digits to low double digits [1] Group 2: Collaboration Significance - The collaboration with Dianthus, a recognized leader in transformative therapies for severe autoimmune diseases, is expected to enhance the company's commitment to advancing innovative drug candidates into clinical stages [2] - This partnership aligns with the overall best interests of the company and its shareholders [2] Group 3: Mechanism and Potential of LBL-047 - LBL-047 targets BAFF/APRIL and BDCA2 to simultaneously inhibit the activity of plasmacytoid dendritic cells (pDC) and the differentiation and activation of B cells and plasma cells [3] - The drug shows strong therapeutic potential for autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, IgA nephropathy (IgAN), and Sjögren's syndrome [3] - LBL-047 is designed to have an extended half-life through Fc region modification, which may reduce dosing frequency and improve patient compliance [3]

Core Insights - Nuo Cheng Jian Hua has signed a global licensing agreement with Zenas BioPharma worth over $2 billion, which includes an upfront payment of up to $100 million and milestone payments [1][2] - Zenas will gain global rights to Nuo Cheng Jian Hua's core product, Obexelimab, in the field of multiple sclerosis, along with rights to new oral IL-17AA/AF inhibitors and oral TYK2 inhibitors [2] - Obexelimab is a highly selective BTK inhibitor with strong CNS penetration, already commercialized since 2021 and included in the national medical insurance directory in 2022 [3] Financial Performance - Nuo Cheng Jian Hua reported a revenue of 731 million yuan in the first half of 2025, a year-on-year increase of 74.3%, with revenue from Obexelimab reaching 637 million yuan, up 52.8% [4] - The company narrowed its net loss to 30 million yuan in the first half of 2025, compared to a loss of 262 million yuan in the same period last year [4] - As of June 30, 2025, Nuo Cheng Jian Hua had cash and cash equivalents totaling 7.7 billion yuan [4]

Core Insights - 诺诚健华 and Zenas BioPharma have entered into a significant licensing agreement, granting Zenas global development and commercialization rights for 奥布替尼 in multiple sclerosis and other non-oncology indications outside Greater China and Southeast Asia [1][2] - The total transaction value exceeds $2 billion, including an upfront payment of up to $100 million, milestone payments, and the issuance of 7 million shares of Zenas common stock [1][2] - 奥布替尼 is a potential best-in-class oral BTK inhibitor with strong CNS penetration, aimed at addressing challenges in the progression of multiple sclerosis [2][3] Company Developments - Zenas will initiate a Phase III clinical trial for 奥布替尼 in primary progressive multiple sclerosis (PPMS) in Q1 2026, following a successful Phase II trial that demonstrated significant efficacy [2][3] - The collaboration is seen as a crucial milestone for 诺诚健华 in its globalization efforts, with expectations of enhancing the clinical and commercial value of 奥布替尼 [3][4] - Zenas aims to advance two additional preclinical molecules, a novel oral IL-17AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor, into clinical development by 2026 [1][4] Market Potential - 奥布替尼 has shown promising clinical data, significantly reducing the number of new lesions in patients with relapsing-remitting multiple sclerosis (RRMS) [3][4] - The strategic partnership is expected to accelerate the clinical development of 奥布替尼 and maximize its market potential, particularly in the underserved areas of PPMS and secondary progressive multiple sclerosis (SPMS) [3][4] - Zenas is positioned to become a global, integrated biopharmaceutical company focused on the development and commercialization of treatments for autoimmune diseases, leveraging its collaboration with 诺诚健华 [3][4]

Core Insights - Orelabrutinib is a potential best-in-class oral small molecule BTK inhibitor with strong CNS penetration, currently in global Phase III clinical development for progressive forms of multiple sclerosis (MS) [1][2][3] - A Phase III trial for primary progressive MS (PPMS) has been initiated, while a trial for secondary progressive MS (SPMS) is expected to start in Q1 2026 [1][2][6] - Zenas BioPharma has entered a significant licensing agreement with InnoCare Pharma, acquiring global rights for Orelabrutinib in MS and other non-oncological indications outside Greater China and Southeast Asia [1][11] Clinical Development - The Phase III trial for PPMS is a global, multicenter, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Orelabrutinib at a daily dose of 80 mg [2][6] - The SPMS Phase III trial is also designed as a global, multicenter, randomized, double-blind, placebo-controlled study, expected to start in Q1 2026 [6][14] - Previous Phase II trials demonstrated significant reductions in Gd+ T1 MRI brain lesions at 12 and 24 weeks, with sustained effects up to 96 weeks [2][4] Strategic Collaboration - The collaboration between InnoCare and Zenas is seen as a milestone in global development, enhancing the clinical and commercial value of Orelabrutinib [3][4] - Zenas aims to leverage this partnership to advance its pipeline, including two additional preclinical molecules: a novel oral IL-17AA/AF inhibitor and a CNS-penetrant oral TYK2 inhibitor, both expected to enter clinical trials in 2026 [3][7][8] Financial Terms - Under the licensing agreement, Zenas will pay InnoCare up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion [11] - Zenas will also issue 7 million shares of common stock to InnoCare, along with tiered royalties based on annual net sales of the licensed products [11] Company Profiles - InnoCare Pharma is a biopharmaceutical company focused on innovative drug development for oncology and autoimmune diseases, with a strong pipeline of products at various stages [16] - Zenas BioPharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for autoimmune diseases, with a focus on Orelabrutinib and Obexelimab [17][18]