Financial Data and Key Metrics Changes - The company has submitted its Biologics License Application (BLA) on November 7, with a potential PDUFA date expected in July, indicating a significant milestone in its regulatory process [2][3] - The company is well-capitalized with an estimated $400 million to $500 million in resources and access to an additional $500 million, totaling approximately $1 billion for the upcoming launch year [51] Business Line Data and Key Metrics Changes - The lead product candidate, Atakicept, has shown positive phase three data in treating IgA nephropathy, a significant unmet medical need, with a patient population of about 160,000 in the U.S. [3][4] - The company is the only program approaching an autoinjector for Atakicept, which is expected to enhance patient convenience and adherence [4] Market Data and Key Metrics Changes - There are currently five drugs approved for IgA nephropathy, with only one targeting B cell signaling, highlighting the competitive landscape [24] - The company has a unique position with two-year GFR data, which may differentiate it from other approved therapies [24] Company Strategy and Development Direction - The corporate strategy focuses on establishing leadership in IgA nephropathy before expanding into adjacent glomerular diseases such as membranous nephropathy and FSGS [35][36] - The company is also exploring broader applications of Atakicept in various autoimmune diseases, indicating a long-term vision beyond nephrology [35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of Atakicept, emphasizing its efficacy and safety profile compared to traditional therapies [9][12] - The management team is confident in their commercial strategy and readiness for the drug launch, having built a strong leadership team with experience in successful drug launches [27][53] Other Important Information - The company has initiated a long-term open-label program called Origin Extend to capture data on patients treated with Atakicept, which will aid in understanding the drug's long-term impact [20] - The guideline process in nephrology is evolving, with a strong motivation from KDIGO to update guidelines in a timely manner following new drug approvals [30][33] Q&A Session Summary Question: What is the safety profile of Atakicept compared to other B cell modulators? - The management highlighted that Atakicept modulates B cells without causing significant immunosuppression or opportunistic infections, differentiating it from traditional therapies [10][12] Question: How does the company plan to position Atakicept in the market? - The company plans to position Atakicept as a foundational therapy for IgA nephropathy, complemented by other medications like ACE inhibitors and SGLT2 inhibitors [58][59] Question: What is the expected timeline for data from the Pioneer study? - The company plans to share data from the Pioneer study at academic congresses in the first half of 2026, focusing on broader IgA-mediated diseases [43][46]

Core Insights - Nocera Biopharma announced the completion of the first patient dosing in the global Phase II clinical trial of its novel TYK2 inhibitor Soficitinib (ICP-332) for the treatment of nodular prurigo [1][2] - Soficitinib is a highly selective oral TYK2 inhibitor developed for various T-cell related autoimmune diseases, with a strong focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The global market for nodular prurigo treatment is projected to grow from $2 billion in 2024 to $3 billion by 2034, with approximately 10 million patients affected worldwide [1] Company Developments - Nocera Biopharma's product pipeline covers ten autoimmune diseases, with a significant emphasis on dermatological diseases [2] - Soficitinib has demonstrated excellent efficacy and safety in Phase II clinical studies for moderate to severe atopic dermatitis, and the related research was featured in a prominent oral presentation at the American Academy of Dermatology annual meeting [2] - The company is accelerating global clinical development to provide innovative treatment solutions for more autoimmune patients [2]

Core Insights - Nocare Biopharma announced the completion of the first patient dosing in the global Phase II clinical trial of its novel TYK2 inhibitor, Soficitinib, for the treatment of nodular prurigo [1][2] - Soficitinib is designed to treat various T-cell related autoimmune diseases, with a strong focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The global market for nodular prurigo treatment is projected to grow from $2 billion in 2024 to $3 billion by 2034, with approximately 10 million patients affected worldwide [1] Company Developments - Nocare Biopharma's product pipeline covers ten autoimmune diseases, with a significant emphasis on dermatological diseases [2] - Soficitinib has demonstrated excellent efficacy and safety in Phase II clinical studies for moderate to severe atopic dermatitis, and the research was selected for a prominent oral presentation at the American Academy of Dermatology annual meeting [2] - The company is accelerating its global clinical development to provide innovative treatment solutions for more autoimmune patients [2]

Core Viewpoint - Shanghai Baoji Pharmaceutical Co., Ltd. has passed the listing hearing on the Hong Kong Stock Exchange, with its core product SJ02 receiving NDA approval from the National Medical Products Administration in August 2025, and two candidate drugs KJ103 and KJ017 entering late-stage trials or NDA registration in China [1][4]. Company Overview - Baoji Pharmaceutical, established in 2019, focuses on four strategic therapeutic areas: (i) large-volume subcutaneous administration, (ii) antibody-mediated autoimmune diseases, (iii) assisted reproduction, and (iv) recombinant biopharmaceuticals. The company has a pipeline of 12 self-developed products, including three core products (KJ017, KJ103, and SJ02), four other clinical-stage candidates, and five preclinical assets [4][5]. Product Pipeline - The core products include: - SJ02 (Shengnuowa®), a long-acting recombinant human follicle-stimulating hormone CTP fusion protein, approved for controlled ovarian stimulation [4][6]. - KJ017, a recombinant hyaluronidase in NDA stage for large-volume subcutaneous administration and fluid loss treatment [4][6]. - KJ103, an innovative recombinant immunoglobulin G (IgG) degrading enzyme in Phase III development for treating desensitization prior to kidney transplantation and various autoimmune diseases [4][6]. Market Potential - According to Frost & Sullivan, the clinical addressable market for the company's four strategic therapeutic areas in China is projected to reach approximately RMB 50 billion by 2033, driven by segments such as large-volume subcutaneous administration and autoimmune diseases [5]. Financial Performance - The company's revenue for the six months ending June 30 for 2023, 2024, and 2025 was RMB 6.93 million, RMB 6.16 million, and RMB 41.99 million, respectively. R&D expenses for the same periods were approximately RMB 133 million, RMB 251 million, and RMB 111 million [7][8].

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]