Core Viewpoint - The approval of the III phase clinical trial for Obutinib in treating systemic lupus erythematosus (SLE) marks a significant advancement for the company, supported by strong data from the IIb phase trial demonstrating efficacy and safety [1][2][3] Group 1: Clinical Trial Results - The III phase trial will evaluate a daily dose of 75 mg of Obutinib, building on solid data from the IIb phase trial [1] - In the IIb trial, 187 SLE patients were randomized into three groups, with the 75 mg dose showing a significant SLE response index-4 (SRI-4) response rate of 57.1% compared to 34.4% in the placebo group at 48 weeks (p < 0.05) [1] - The 75 mg dose also demonstrated a dose-dependent efficacy trend, with significant improvements in SRI-6 and British Isles Lupus Assessment Group (BILAG) response rates compared to the placebo group (p < 0.05) [1] Group 2: Subgroup Analysis - In patients with baseline BILAG ≥ 1A or ≥ 2B, the SRI-4 response rate for the 75 mg dose improved by 35% compared to the placebo group [2] - Among patients with baseline BILAG ≥ 1A or ≥ 2B and clinical SLEDAI-2K scores ≥ 4, the SRI-4 response rate increased by 43% for the 75 mg dose compared to the placebo [2] Group 3: Future Development Plans - The company aims to accelerate the clinical development of Obutinib, which is a selective, irreversible oral BTK inhibitor with potential best-in-class advantages [3] - The III phase trial is expected to enroll the first patient in Q1 2026, with ongoing trials for immune thrombocytopenic purpura (ITP) and multiple sclerosis (MS) also in progress [3] - Obutinib has already gained significant clinical recognition and market penetration in the hematological malignancies sector, having been included in China's National Reimbursement Drug List (NRDL) [4]

InnoCare Pharma Limited 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的內容概不負責，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 因依賴該等內容而引致的任何損失承擔任何責任。 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） 自願公告 奧布替尼治療系統性紅斑狼瘡的IIb期 臨床試驗取得積極結果並啟動III期臨床試驗 本公告乃由諾誠健華醫藥有限公司（「本公司」）自願作出，以告知本公司股東 及潛在投資者有關本公司的最新業務進展。 董事會（「董事會」）欣然宣佈，藥品審評中心(CDE)批准啟動奧布替尼治療系統 性紅斑狼瘡(SLE)的III期臨床試驗。在IIb期臨床試驗堅實數據的強力支持下，III 期研究將評估每日一次75毫克給藥的方案。 IIb期臨床結果展示，在接受治療48週的SLE患者中，奧布替尼展現了卓越的有 效性和良好的耐受性和安全性。本次研究共入組187例患者，按1:1:1隨機分成 三組，即奧布替尼每日一次75毫克和奧布替尼每日一次50毫克兩個劑量組，以 及一個安慰劑組 ...

Group 1: InSilico Medicine and Eli Lilly Collaboration - InSilico Medicine announced a strategic partnership with Eli Lilly for AI-driven drug development, leveraging InSilico's Pharma.AI platform and Eli Lilly's expertise in drug development [1] - The collaboration is valued at over $100 million, including upfront payments, milestone payments, and royalties from future drug sales [1] - This partnership builds on a previous software licensing agreement established in 2023, enhancing the relationship between the two companies [1] Group 2: Fourth Paradigm Financial Performance - Fourth Paradigm reported a revenue of RMB 4.402 billion for the first three quarters of 2025, representing a year-on-year growth of 36.8% [2] - The company's gross profit reached RMB 1.621 billion, with a gross margin of 36.8%, indicating a significant improvement in profitability [2] - The core product, the Xianzhi AI platform, saw explosive growth with revenues of RMB 3.692 billion, up 70.1% year-on-year, contributing to the company's accelerated performance [2] Group 3: Yipinhong Legal Dispute - Yipinhong is facing a lawsuit from Huiyou International, claiming ownership of a patent and seeking RMB 528 million in damages [3][4] - The lawsuit stems from a 2014 cooperation agreement regarding the development of a specific drug, with Yipinhong holding a 52% stake in the joint venture [3][4] - Huiyou International asserts that the original valuation of the disputed intellectual property is RMB 88 million, leading to the substantial compensation claim [4] Group 4: North Medical's Leadership Changes - North Medical announced that its chairman and president, Xu Xiren, has been arrested for alleged criminal activities, impacting his ability to perform duties [6] - The company's board operations remain normal, with other executives temporarily assuming leadership roles [6] - There has been no change in the company's control, and its financial and operational management is reported to be stable [6] Group 5: Aidi Kang's Acquisition Plans - Aidi Kang plans to acquire Crown Bioscience for $204 million, aiming to enhance its global laboratory service platform [7] - The acquisition will allow Crown Bioscience to operate as an independent entity under Aidi Kang, focusing on drug discovery and clinical research [7] - The deal includes performance-based payments, with potential additional payments based on adjusted EBITDA [7] Group 6: Nuo Cheng Jian Hua's Revenue Growth - Nuo Cheng Jian Hua reported a revenue increase of 59.8% to RMB 1.12 billion for the first three quarters of 2025, driven by sales of its core product, BTK inhibitor Aobutini [8] - Aobutini's sales reached RMB 1.01 billion, reflecting a 45.8% year-on-year increase, attributed to new indications and market expansion [8] - The company's losses narrowed significantly by 74.8% to RMB 70 million, indicating improved cost efficiency alongside revenue growth [8]

Group 1 - Shimai Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor. The company, founded in 2017, is a pioneer in next-generation T cell engagers (TCE) aimed at utilizing the human immune system to combat cancer. It has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors, with four self-developed clinical-stage candidates currently in its pipeline [1] - The listing will accelerate research and development, allowing the company to seize market opportunities in the growing TCE sector [1] Group 2 - Gilead Sciences announced that its new generation of once-monthly GLP-1 receptor agonist ASC36 and dual-target agonist ASC35 has entered clinical development. The company expects to submit clinical trial applications to the FDA for ASC36 and ASC35 for obesity treatment by the second quarter of 2026 [2] - ASC36 and ASC35 are proprietary long-acting formulations with superior physicochemical stability, designed to treat metabolic diseases including obesity. ASC36 is positioned as a cornerstone therapy with potential efficacy and tolerability advantages over existing GLP-1 therapies [2] Group 3 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by sustained sales growth of its core product, the BTK inhibitor Orelabrutinib, and upfront payments from licensing agreements [4] - The revenue from Orelabrutinib increased by 45.8% year-on-year, surpassing last year's total revenue. The company's losses narrowed by 74.8% to 70 million yuan, indicating a potential turning point in profitability [4] Group 4 - InnoCare's revenue growth and reduced losses are attributed to the expansion of Orelabrutinib's indications and additional licensing income, which will accelerate the advancement of its innovative pipeline and strengthen its position in the BTK field [4] Group 5 - Ying'en Biopharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors. This drug is an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of this ADC aims to address treatment bottlenecks in resistant solid tumors and enhance the company's pipeline competitiveness, providing new options for solid tumor treatment [3]

Core Insights - Nuo Cheng Jian Hua reported a significant revenue increase of 59.8% year-on-year for the first three quarters of 2025, reaching 1.12 billion yuan, primarily driven by the sales growth of its core product, the BTK inhibitor Aobutini (Yinokai®) [2][5] - The company expects to achieve breakeven for the entire year of 2025, two years ahead of its profitability target, supported by strong revenue growth and improved cost efficiency [2][5] Financial Performance - Aobutini's revenue for the first three quarters increased by 45.8% year-on-year, totaling 1.01 billion yuan, surpassing the total revenue for the previous year [2] - The company's loss narrowed significantly by 74.8%, down to 70 million yuan, due to rapid revenue growth and enhanced cost management [2] Globalization Strategy - Nuo Cheng Jian Hua is accelerating its globalization efforts, having completed two major licensing agreements this year, including a significant deal with Zenas for Aobutini and other autoimmune pipeline products [3][4] - The agreement with Zenas includes an upfront payment of 100 million USD and potential milestone payments, with the total deal value exceeding 2 billion USD [3] Product Pipeline and Market Position - The company is strengthening its leadership in the hematological oncology market with Aobutini, Tanshizhu Single Antibody (Mingnuokai®), and Mesutoclax, covering multiple indications [6] - Aobutini has been approved for first-line treatment of CLL/SLL, enhancing its market position [6][7] - Tanshizhu Single Antibody has been fully commercialized in China, providing a new treatment option for R/R DLBCL patients [8] Clinical Development - Mesutoclax is undergoing multiple clinical trials, showing significant potential in treating CLL/SLL and AML, with promising efficacy and safety data [9][10] - The company is advancing several Phase III clinical trials for autoimmune diseases, including Aobutini for primary progressive multiple sclerosis (PPMS) and immune thrombocytopenic purpura (ITP) [12][14] Innovation and R&D - Nuo Cheng Jian Hua is committed to innovation, with a 9.9% increase in R&D expenses, reaching 680 million yuan in the first three quarters of 2025 [19] - The company plans to submit 5 to 7 clinical trial applications for new drug candidates in 2026, focusing on oncology and autoimmune diseases [20]

Core Insights - The company reported a 59.8% year-on-year increase in total revenue for the first three quarters of 2025, reaching 1.12 billion RMB, driven by the continued growth in sales of its core product, BTK inhibitor Oubatinib (Yinokai®), and an upfront payment from a licensing agreement with Prolium [1] Revenue Performance - Oubatinib's revenue for the first three quarters increased by 45.8% year-on-year, amounting to 1.01 billion RMB, surpassing the total revenue of the previous year, attributed to the expanding market for its exclusive indication of marginal zone lymphoma (MZL) and the approval of new indications for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) [1] Loss Reduction - The company's losses significantly narrowed by 74.8%, reducing to 0.07 billion RMB, primarily due to rapid revenue growth and improved cost efficiency [1]

Core Insights - The company, Nuo Cheng Jian Hua (688428.SH), reported a significant revenue increase of 59.85% year-on-year for the first three quarters of 2025, reaching 1.115 billion yuan [1] - Despite the revenue growth, the company recorded a net loss attributable to shareholders of 64.41 million yuan [1] - The revenue growth was primarily driven by the continued sales increase of its core product, Oubutini (Yinokai®), and the recognition of upfront payment income from a licensing agreement with Prolium [1]