Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [4][11]. Core Insights - The company has shown significant growth with a revenue of 2.375 billion yuan in 2025, marking a year-on-year increase of 135.27%. The net profit reached 644 million yuan, a substantial increase from the previous year, indicating the first annual profit for the company [3][11]. - The revenue structure is shifting from a single product focus to a dual-driven model of commercial sales and technology licensing, with drug sales contributing approximately 60.73% and technology licensing accounting for about 38.07% of total revenue [3][11]. - The core product, Acalabrutinib, continues to see rapid commercialization, achieving sales of 1.41 billion yuan, a year-on-year growth of 40.99%. The product's inclusion in medical insurance has significantly improved patient accessibility [3][6][11]. Financial Performance - In 2025, the company reported a net cash flow from operating activities of 84 million yuan, and R&D expenses were 952 million yuan, reflecting a year-on-year increase of 16.82% [3][11]. - The company expects revenues of 2.106 billion yuan, 2.633 billion yuan, and 3.258 billion yuan for 2026, 2027, and 2028 respectively, with a projected net profit of -0.85 million yuan, 116.56 million yuan, and 377.17 million yuan for the same years [11][13]. Product Development - The company has initiated commercialization of Tafasitamab and received NMPA approval for Zolbetuximab, expanding its product matrix and opening new revenue streams [6][10]. - The BCL-2 inhibitor Mesutoclax is progressing through clinical trials and is expected to become a strategic pillar in the hematology sector, with multiple key trials underway [7][11]. - The company is also deepening its layout in the autoimmune disease field, with ongoing clinical developments for Acalabrutinib and TYK2 products across various indications [8][9]. Market Position and Future Outlook - The company is enhancing its commercialization capabilities, which is expected to support revenue growth in the hematology sector and strengthen its long-term global value [6][11]. - The ADC platform is showing significant progress, with multiple candidates in clinical development, providing a continuous growth engine for the company [10][11].

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [3][4]. Core Insights - The company has shown significant growth with a total revenue of 2.375 billion yuan in 2025, representing a substantial year-on-year increase of 135.27%. The net profit reached 644 million yuan, marking a turnaround from losses in the previous year [3][11]. - The revenue structure is evolving from a single product focus to a dual-driven model of commercial sales and technology licensing, with drug sales contributing approximately 60.73% and technology licensing accounting for about 38.07% of total revenue [3][11]. - The core product, Aobutinin, continues to experience rapid growth, achieving commercial revenue of 1.41 billion yuan, a year-on-year increase of 40.99%. The internationalization of Aobutinin is also progressing, with approvals in Singapore and submissions in Australia [3][6]. Financial Performance - In 2025, the company achieved a net profit of 644 million yuan, a significant increase from a loss of 10.97 million yuan in the previous year. The operating cash flow turned positive at 84 million yuan [3][11]. - The company expects revenues of 2.106 billion yuan, 2.633 billion yuan, and 3.258 billion yuan for 2026, 2027, and 2028 respectively, with corresponding net profits projected at -0.85 million yuan, 116.56 million yuan, and 377.17 million yuan [11][13]. Product Development and Pipeline - The company has initiated commercialization of Tafasitamab and received NMPA approval for Zolbetuximab, expanding its product matrix and revenue potential [6][10]. - The BCL-2 inhibitor Mesutoclax is progressing through clinical trials and is expected to become a strategic pillar in the hematology field, with multiple key trials underway [7][11]. - The company is also deepening its layout in the autoimmune disease sector, with ongoing clinical developments for Aobutinin and TYK2 products across various indications [8][9]. Market Position and Future Outlook - The company is positioned to leverage its growing commercial capabilities and product pipeline to sustain revenue growth in the hematology sector and expand into solid tumors [6][10]. - The strategic focus on multiple innovative projects, including small molecules and ADCs, is expected to solidify the company's long-term growth trajectory [11][10].

Investment Rating - The report assigns a positive investment rating to the company, indicating a favorable outlook for the next six months [1]. Core Insights - The company has turned profitable for the first time, with a reported net profit of 642.47 million HKD in 2025, marking a significant increase of 245.81% compared to the previous year [7]. - The revenue for 2025 reached 2.37491 billion HKD, reflecting a growth rate of 135.27% [2]. - Strong sales growth of the drug Aobutini, which generated 1.41 billion HKD in 2025, up by 41% [7]. - The company has successfully licensed Aobutini to Zenas BioPharma, with a total transaction amount exceeding 2 billion USD, setting a record for external licensing in China's small molecule field [7]. - The company’s pipeline is entering a harvest phase, with multiple potential products progressing through clinical trials [7]. Financial Summary - The projected revenues for 2026, 2027, and 2028 are estimated at 20.2 billion HKD, 24.4 billion HKD, and 28.4 billion HKD respectively [9]. - The expected earnings per share (EPS) for 2026, 2027, and 2028 are 0.26 HKD, 0.29 HKD, and 0.32 HKD respectively [2]. - The net asset return (ROE) is projected to be 5.53% in 2026, increasing to 6.18% by 2028 [2]. - The price-to-earnings (PE) ratio is expected to decrease from 48.37 in 2026 to 38.21 in 2028 [2]. Product Pipeline and Development - Aobutini is expected to submit a market application for ITP in the first half of 2026, with several other clinical trials for various indications also underway [7]. - The company has two TYK2 inhibitors, with ongoing clinical trials for multiple conditions, including moderate to severe atopic dermatitis and vitiligo [7]. - The company is advancing multiple antibody-drug conjugate (ADC) projects, with IND approvals and clinical trials planned for 2026 [7].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 海外監管公告 本公告乃諾誠健華醫藥有限公司（「本公司」）根據香港聯合交易所有限公司證 券上市規則第13.10B條作出。 茲載列本公司於上海證券交易所網站刊登之《董事會決議公告》、《2025年年度 報告》、《2025年年度報告摘要》、《2025年度審計報告》、《2025年度非經營性資 金佔用及其他關聯資金往來情況的專項說明》、《2025年度持續督導現場檢查報 告》、《2025年度內部控制評價報告》、《內部控制審計報告》、《2025年度「提質 增效重回報」行動方案的年度評估報告及2026年度「提質增效重回報」行動方案》、 《董事會審核委員會2025年度履職報告》、《董事會關於會計師事務所履職情況 的評估報告》、《董事會審核委員會對會計師事務所履行監督職 ...

Core Insights - The company, Nocera Biopharma-U (688428), is making significant progress in clinical research, partnerships, and product commercialization in 2026. Clinical Development Progress - ICP-488 (highly selective TYK2 inhibitor) has completed patient enrollment for its Phase III clinical trial for psoriasis, with a total of 383 patients enrolled, marking a key clinical milestone [2] - Soficitinib (TYK2 inhibitor) has completed patient enrollment for its Phase III registration trial for moderate to severe atopic dermatitis, with accelerated trials for indications like vitiligo and nodular prurigo [2] - Obinutuzumab (BTK inhibitor) has completed its Phase III clinical study for idiopathic thrombocytopenic purpura (ITP) and is expected to submit a New Drug Application (NDA) in the first half of 2026; a Phase IIb study for systemic lupus erythematosus (SLE) has met its primary endpoint, with a Phase III trial set to begin soon [3] - BCL2 inhibitor (Mesutoclax/ICP-248) is advancing two registration Phase III clinical studies in the hematological malignancies field [3] Collaboration and International Expansion - The partnership with Zenas BioPharma, established in October 2025, plans to initiate a global Phase III clinical trial for Obinutuzumab targeting secondary progressive multiple sclerosis (SPMS) in the first quarter of 2026; Zenas will also advance two preclinical molecules from Nocera Biopharma into clinical stages in 2026. The total potential value of this collaboration exceeds $2 billion, including milestone payments and royalties [4] Commercialization and Product Pipeline - Newly approved drugs, Tansimod (Mingnuokai) and Zolbetuximab (Yinuoxin), which were approved in 2025, are now on the market and expected to contribute to revenue growth alongside Obinutuzumab. The new indications for Obinutuzumab (such as first-line treatment for CLL/SLL) are anticipated to drive continued sales growth [5] - The company achieved profitability for the first time in 2025, with revenue of approximately 2.37 billion yuan and a net profit of about 630 million yuan. Management indicates that the company will enter a phase of sustainable profitability starting in 2025, focusing on global expansion and pipeline diversification to solidify performance [5]

Core Viewpoint - The company Nocera Biopharma (09969) has seen a significant increase in stock price following the release of its earnings forecast, projecting substantial revenue growth and a return to profitability by 2025 [1] Financial Performance - Nocera Biopharma expects to achieve revenue of 2.37 billion yuan in 2025, representing a year-on-year increase of approximately 134% [1] - The company anticipates a net profit attributable to shareholders of around 630 million yuan in 2025, marking its first return to profitability [1] Product Development - The core product, Orelabrutinib, is expected to contribute significantly to revenue growth [1] - The approval of Tansimertinib in May 2025 is anticipated to further diversify the company's revenue sources [1] Clinical Trials - Nocera Biopharma has completed patient enrollment for its Phase III clinical trial of the novel TYK2 inhibitor ICP-488 for the treatment of psoriasis, with a total of 383 patients enrolled [1] - This clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of ICP-488 as a monotherapy for adult patients with moderate to severe plaque psoriasis [1]

Core Viewpoint - Nocera Biopharma (09969) has seen a significant stock price increase following its earnings forecast, projecting a revenue of 2.37 billion yuan in 2025, representing a year-on-year growth of approximately 134% [1] Group 1: Financial Performance - The company anticipates achieving a net profit of around 630 million yuan in 2025, marking its first profit after losses [1] - The core product, Orelabrutinib, is expected to contribute significantly to revenue growth [1] - Two business development (BD) transactions completed in the year are also expected to be key drivers for rapid revenue growth in 2025 [1] Group 2: Clinical Development - Nocera Biopharma has completed patient enrollment for its Phase III clinical trial of the novel TYK2 inhibitor ICP-488 for the treatment of psoriasis, with a total of 383 patients enrolled [1] - This clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of ICP-488 as a monotherapy for adult patients with moderate to severe plaque psoriasis [1] - The completion of patient enrollment marks a significant clinical advancement for ICP-488, potentially offering a new oral treatment option for psoriasis patients [1]

Investment Rating - The report maintains a "Recommendation" rating for the company, indicating an expectation that the stock will outperform the market by 10% to 20% over the next six months [10]. Core Insights - The company is expected to achieve a revenue of 2.371 billion yuan in 2025, representing a year-on-year growth of approximately 134%. Additionally, it is projected to turn a profit with a net profit of around 630 million yuan, primarily due to the continued commercialization of products and income from business development [4][8]. - The company has multiple products in the market, including Obinutuzumab, which is seeing increasing sales. The company is also expanding its global collaboration efforts, having secured two licensing agreements in 2025, which will provide upfront payments and milestone revenues [7][8]. Financial Summary - Revenue projections for the company are as follows: - 2023: 739 million yuan - 2024: 1.009 billion yuan - 2025: 2.371 billion yuan - 2026: 2.575 billion yuan - 2027: 2.732 billion yuan - Year-on-year growth rates are projected at 18.1% for 2023, 36.7% for 2024, and 134.9% for 2025, followed by 8.6% and 6.1% for 2026 and 2027 respectively [6][8]. - The company is expected to achieve a gross margin of 98.0% in 2025, with a net margin of 27.4% [6][8]. - The company's total assets are projected to reach 10.888 billion yuan by 2025, with total liabilities of 3.491 billion yuan [9].

Group 1 - The company expects to achieve total operating revenue of approximately RMB 2.365 billion in 2025, representing a growth of around 134% compared to the previous year [1] - The company anticipates turning a profit in 2025, with a net profit attributable to shareholders of approximately RMB 633 million, an increase of about RMB 1.074 billion compared to the same period last year [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses is expected to be around RMB 534 million, an increase of approximately RMB 974 million compared to the previous year [1] Group 2 - In 2024, the company reported an operating revenue of RMB 1.009 billion, with a total profit of RMB -453 million and a net profit attributable to shareholders of RMB -441 million [2] - The company experienced significant growth in pharmaceutical revenue due to the approval of new indications for its drug, Acalbrutinib, in April 2025, which contributed to rapid sales growth [3] - Business development (BD) revenue also played a crucial role in the revenue increase, with two BD transactions completed in 2025, including a licensing agreement with Prolium Bioscience Inc. and an authorization agreement with Zenas BioPharma, Inc. [4]

Core Viewpoint - The company, Nocera Biopharma (688428.SH), is expected to achieve profitability for the first time in 2025, with a projected net profit of approximately 633 million yuan, an increase of about 1.074 billion yuan compared to the same period last year [1] Group 1: Financial Performance - The net profit attributable to the parent company is projected to be around 633 million yuan, marking a significant increase of approximately 1.074 billion yuan year-on-year [1] - The company anticipates rapid growth in drug sales revenue for 2025, driven by new approvals and existing product performance [1] Group 2: Product Approvals - In April 2025, the drug Obutinib received approval for a new indication for first-line treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) [1] - Obutinib is the first and only BTK inhibitor approved in China for the indication of Marginal Zone Lymphoma (MZL) [1] - In May 2025, the application for the combination of Tanshizhuo monoclonal antibody and Lenalidomide for the treatment of adult patients with relapsed/refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) was approved by NMPA [1] Group 3: Business Development - Business Development (BD) revenue is another key factor contributing to the rapid growth of operating income in 2025 [2] - The company achieved two BD transactions in 2025, including a licensing collaboration with Prolium Bioscience Inc. regarding the CD20×CD3 bispecific antibody ICP-B02 (CM355) in January [2] - In October 2025, the company entered into a licensing agreement with Zenas BioPharma, Inc. concerning Obutinib and two preclinical molecular-related rights [2]