Core Viewpoint - Multiple pharmaceutical companies have announced positive developments, indicating a growing momentum in the industry and potential investment opportunities. Company Announcements - Jiuan Medical announced that its U.S. subsidiary received pre-market notifications from the FDA for several home and professional testing kits for influenza A, influenza B, COVID-19, and RSV, enhancing its product line in the IVD sector [2][3]. - Junshi Biosciences reported that its dual-specificity antibody-drug conjugate (JS212) for treating advanced solid tumors received FDA approval for clinical trials, marking a significant step in its oncology pipeline [4]. - Innovent Biologics disclosed that its BTK inhibitor, Orelabrutinib, achieved primary endpoints in a Phase IIb study for systemic lupus erythematosus and has been approved to proceed to Phase III trials, positioning it as a potential first-in-class treatment [4]. - Yipinhong announced that its Qinxing Qingjie oral solution has been approved as a national secondary protected traditional Chinese medicine, which will enhance its market competitiveness in pediatric medicine [5]. Industry Insights - The Chinese innovative drug industry is expected to experience rapid growth, with over $92 billion in outbound business development transactions in the first three quarters of 2025, indicating a significant expansion into the global market [6]. - The first commercial health insurance drug directory has been released, highlighting the competitive landscape for new drugs, with only 19 out of 121 new drugs passing the review, emphasizing the importance of clinical efficacy and innovation [7]. - The inclusion of innovative drugs in both medical insurance and commercial insurance is anticipated to lead to rapid revenue growth for these products, benefiting patients and driving growth for related pharmaceutical companies [7].

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]

Core Viewpoint - The approval of the III phase clinical trial for Obutinib in treating systemic lupus erythematosus (SLE) marks a significant advancement in the company's clinical development efforts, supported by strong data from the IIb phase trial [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 phase trial, 187 SLE patients were randomized into three groups, with the 75 mg dose showing a significant SLE Responder Index-4 (SRI-4) response rate of 57.1% compared to 34.4% in the placebo group (p < 0.05) [1] - The 75 mg dose also demonstrated a dose-dependent efficacy trend, with significant improvements in SRI-6 and 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 group [2] - The study indicates that Obutinib has good tolerability and safety characteristics consistent with the mechanism of action of BTK inhibitors and the underlying biology of SLE [2] Group 3: Future Development Plans - The company is committed to accelerating the clinical development of Obutinib, which is a selective, irreversible oral BTK inhibitor with potential best-in-class advantages [3] - The III phase trial for SLE is expected to enroll the first patient in Q1 2026, while a III phase trial for immune thrombocytopenic purpura (ITP) has completed patient enrollment, with a new drug application planned for submission in H1 2026 [3] - In the multiple sclerosis (MS) field, the III phase trial for primary progressive MS (PPMS) is set to start in Q3 2025, and the trial for secondary progressive MS (SPMS) is expected to begin in Q1 2026 [3] Group 4: Market Recognition - Obutinib has gained significant clinical recognition and market penetration in the hematological malignancies sector since its launch in mainland China [4] - The drug was included in the National Reimbursement Drug List (NRDL) in 2022, covering adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) patients who have received at least one prior treatment [4] - In 2024, the coverage will expand to include adult marginal zone lymphoma (MZL), making Obutinib the first and only BTK inhibitor approved for relapsed/refractory MZL in China [4]

格隆汇12月14日丨诺诚健华(09969.HK)发布公告，药品审评中心(CDE)批准启动奥布替尼治疗系统性红 斑狼疮(SLE)的III期临床试验。在IIb期临床试验坚实数据的强力支持下，III期研究将评估每日一次75毫 克给药的方案。 ...

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 ...

Core Viewpoint - InnoCare Pharma announced that the phase IIb clinical study of its BTK inhibitor orelabrutinib has successfully met its primary endpoint in treating systemic lupus erythematosus (SLE) and has received approval for a phase III trial [1][8]. Clinical Study Results - Orelabrutinib showed significant efficacy and a well-tolerated safety profile in SLE patients after 48 weeks of treatment, with 187 patients enrolled in the study [2][6]. - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was achieved with the 75 mg QD group showing a response rate of 57.1% compared to 34.4% in the placebo group (p < 0.05) [3]. - The 75 mg QD group also demonstrated better efficacy than the 50 mg QD group, indicating a dose-dependent improvement [3]. Secondary Endpoint and Subgroup Analysis - At week 48, the 75 mg QD group met secondary endpoints with significantly higher SRI-6 and BICLA response rates compared to placebo (p < 0.05) [4]. - In patients with baseline BILAG ≥1A or ≥2B, the placebo-adjusted difference in SRI-4 response rate for the 75 mg QD group was 35%, and for those with a clinical SLEDAI-2K score ≥4, it was 43% [5]. Safety Profile - Orelabrutinib was well tolerated among SLE patients, with a safety profile consistent with BTK inhibition and the disease's biology [6]. Market Potential and Company Overview - Orelabrutinib is the first BTK inhibitor to show significant efficacy in a phase II clinical trial for SLE, with expectations to become a first-in-class oral treatment [7]. - SLE affects approximately 8 million people globally, with around 1 million patients in China, highlighting a significant unmet medical need [8]. - InnoCare is focused on developing first-in-class and best-in-class drugs for cancer and autoimmune diseases, with operations in multiple locations including China and the United States [9].

北京商报讯（记者 丁宁）12月14日晚间，诺诚健华（688428）发布公告称，公司自主研发的BTK抑制 剂奥布替尼治疗系统性红斑狼疮（以下简称"SLE"）的 IIb期临床研究达到主要终点，并获国家药品监 督管理局药品审评中心批准开展III期注册性临床试验。 诺诚健华表示，该III期研究将评估每日一次（QD）75毫克的给药方案，该方案已在IIb期临床试验中获 得有力的数据支持。这是公司致力于开发创新有效疗法，以满足SLE患者未被满足临床需求的一个重要 里程碑。 ...

财经频道更多独家策划、专家专栏，免费查阅>> 智通财经讯，诺诚健华(688428.SH)公告，公司自主研发的BTK抑制剂奥布替尼治疗系统性红斑狼疮(简 称"SLE")的IIb期临床研究达到主要终点，并获国家药品监督管理局(NMPA)药品审评中心(CDE)批准开 展III期注册性临床试验。公司将尽快启动该临床研究。 临床IIb结果展示，在接受治疗48周的患者中，奥布替尼展现了卓越的有效性、良好的耐受性和安全 性。 责任编辑：钟离 ...

责任编辑：钟离 财经频道更多独家策划、专家专栏，免费查阅>> 格隆汇12月14日丨诺诚健华(688428.SH)发布公告，公司自主研发的BTK抑制剂奥布替尼治疗系统性红 斑狼疮(以下简称"SLE")的IIb期临床研究达到主要终点，并获国家药品监督管理局(NMPA)药品审评中心 (CDE)批准开展III期注册性临床试验。公司将尽快启动该临床研究。 ...

| | | 临床 IIb 结果展示，在接受治疗 48 周的患者中，奥布替尼展现了卓越的有 效性、良好的耐受性和安全性。本次研究共入组 187 例患者，按 1:1:1 随机分成 三组，即口服奥布替尼每天一次 75 毫克和 50 毫克两个剂量组，以及安慰剂组。 本次研究的主要终点是第 48 周时的 SLE 反应指数-4（SRI-4）应答率。第 48 周时，每天一次 75 毫克奥布替尼剂量组的 SRI-4 应答率显著高于安慰剂组 （57.1%vs.34.4%），具有统计学意义（p＜0.05），达到主要终点。此外，每天一 1 次 75 毫克奥布替尼剂量组的疗效优于每天一次 50 毫克剂量组，这表明疗效呈剂 量依赖性的改善趋势。 第 48 周时，每天一次 75 毫克奥布替尼剂量组的 SRI-6 应答率和英岛狼疮评 定组复合性评估（BICLA）应答率都显著高于安慰剂组，具有统计学意义（p＜ 0.05），达到次要终点。 诺诚健华医药有限公司 自愿披露关于奥布替尼治疗系统性红斑狼疮 IIb 期 研 究 达 到 主 要 终 点 并 获 批 III 期 注 册 性 临 床 试 验 的公告 本公司董事会及全体董事保证本公告内容不存 ...