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 ...

12月14日，诺诚健华宣布，公司自主研发的新型BTK抑制剂奥布替尼在治疗系统性红斑狼疮（SLE）的 IIb期临床研究中达到主要终点，同时获得国家药品监督管理局（NMPA）药品审评中心（CDE）批准开 展III期注册临床试验。 ...

每经AI快讯，诺诚健华(09969.HK)涨超3%，截至发稿，涨3.24%，报14港元，成交额5105.45万港元。 ...

Core Viewpoint - The approval of the second-generation small molecule pan-TRK inhibitor, Zoltracitinib (ICP-723), by the National Medical Products Administration (NMPA) marks a significant advancement for the treatment of adult and adolescent patients with NTRK fusion gene-related solid tumors, indicating a potential growth opportunity for the company in the oncology market [1] Company Summary - NMPA has approved Zoltracitinib for treating adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] - The company plans to submit a New Drug Application (NDA) for Zoltracitinib to treat pediatric patients aged 2 to 12 years soon [1] Industry Summary - NTRK fusion genes are found in over 26 types of solid tumors, with an estimated 6,500 new cases carrying NTRK fusion genes diagnosed annually in China [1] - Patients with NTRK fusion gene-related tumors typically have a short survival period, rapid disease progression, and high disability rates, highlighting an unmet clinical need due to the low prevalence of next-generation sequencing (NGS) for diagnosis [1]

Core Viewpoint - Nocera Biopharma (09969) has seen a stock increase of over 3% following the approval of its drug, ICP-723, by the National Medical Products Administration (NMPA) for treating adult and adolescent patients with NTRK fusion gene solid tumors [1] Company Summary - Nocera Biopharma's ICP-723, a second-generation small molecule pan-TRK inhibitor, has been approved for use in patients aged 12 and older with NTRK fusion gene solid tumors [1] - The drug has been included in the NMPA's "Starlight Program," aimed at encouraging the development of pediatric oncology drugs [1] - The company plans to submit a New Drug Application (NDA) for ICP-723 to treat pediatric patients aged 2 to 12 years soon [1] Industry Summary - NTRK fusion genes are present in various tumor types, with over 26 solid tumors identified to date [1] - An estimated 6,500 new cases of tumors carrying NTRK fusion genes are diagnosed annually in China, characterized by short survival, rapid disease progression, and high disability rates [1] - The low prevalence of next-generation sequencing (NGS) as the gold standard diagnostic method has led to delayed diagnoses, indicating an unmet clinical need in this area [1]

Group 1 - Lu Kang Pharmaceutical plans to increase capital by 109 million yuan to its wholly-owned subsidiary Bio-Pesticide Company and 27 million yuan to Ze Run Company, aiming to expand its pesticide and sales sectors [1] - Hui Green Ecology intends to sell two properties in Ningbo for 12.52 million yuan, expecting a net profit impact of approximately 6.23 million yuan from the transaction [2] - Tianyuan Co., Ltd. plans to invest 185 million yuan in an intelligent upgrade project for its titanium dioxide production facilities [3] Group 2 - Metro Design has received approval from the Shenzhen Stock Exchange for its share issuance to acquire 100% equity of Guangzhou Metro Engineering Consulting Co., Ltd. for 511 million yuan [4] - South Network Energy announced a mid-term profit distribution plan for 2025, proposing a cash dividend of 0.07 yuan per 10 shares [5] - Qibin Group plans to establish two wholly-owned subsidiaries in Shenzhen with a registered capital of 100 million yuan each [6] Group 3 - All New Good received an administrative regulatory decision from the Shenzhen Securities Regulatory Bureau due to issues in financial accounting and information disclosure [7] - Luokai Co., Ltd. announced that its shareholders plan to reduce their holdings by up to 3% of the company's shares [8][9] - Jincheng Pharmaceutical's actual controller received an administrative penalty from the CSRC for stock manipulation, leading to the resignation of the chairman [10] Group 4 - Yicheng New Energy intends to acquire a 7.69% stake in Kaifeng Times for 10 million yuan, enhancing its strategic development [11] - Yujing Co., Ltd. signed a sales contract worth approximately 28.6 million USD with an overseas photovoltaic company [12] - Nuocheng Jianhua's TRK inhibitor, Zoltracitinib, has been approved for market entry in China [13] Group 5 - Nandu Power announced that its controlling shareholder is planning a change in control, leading to a temporary suspension of its stock [14] - Xinxing Casting plans to acquire 100% equity of China Resources Steel for 1.244 billion yuan to focus on special steel development [15] - Xinlitai is planning to issue H-shares and list on the Hong Kong Stock Exchange [16] Group 6 - Blue Fan Medical's subsidiary received approval for a new medical device, the coronary artery scoring balloon dilation catheter [18] - China Iron & Steel plans to establish a joint venture with several companies to provide new energy transportation solutions with a registered capital of 500 million yuan [19] - Jifeng Technology intends to sign a cooperation framework agreement with Dongtai Lianfei for a total transaction amount not exceeding 100 million yuan [20] Group 7 - Zhongwei Electronics announced a change in its actual controller, with stock resuming trading [21] - Weihong Co., Ltd. plans to reduce its holdings by up to 1.15% of the company's shares [22] - Te Fa Information received a criminal judgment related to a fraud case involving the acquisition of Shenzhen Te Fa Dongzhi Technology Co., Ltd. [23] Group 8 - Sunshine Dairy's controlling shareholder's concerted action plans to reduce holdings by up to 3% of the company's shares [24] - Meikailong reported that Taobao Holdings and New Retail Fund collectively reduced their H-shares by 30.616 million shares [25] - Xinjubang plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange [26] Group 9 - Beite Technology's application for issuing A-shares to specific objects has been approved by the Shanghai Stock Exchange [28] - Victory Energy's controlling shareholder is planning a change in control, with stock resuming trading [29] - Jiutian Pharmaceutical signed a patent and technology transfer agreement for a small molecule analgesic drug project, with a total transfer fee not exceeding 400 million yuan [29]