今日晚间重要公告抢先看——11天7板顺灏股份：太空数据中心面临强烈辐射等因素可能导致项目商业 化进度和效益晚于和低于预期；古鳌科技实控人变更为徐迎辉，股票12月15日复牌；浦东金桥董事长王 颖因工作调动离任。 【重大事项】 11天7板顺灏股份：太空数据中心面临强烈辐射等因素可能导致项目商业化进度和效益晚于和低于预期 顺灏股份发布股票交易异常波动公告称，公司现有业务未与轨道辰光的业务产生协同效应；轨道辰光业 务受宏观经济、行业政策、市场环境变化等因素的影响，亦存在产业化、商业化落地周期较长以及不达 预期的风险。轨道辰光的"天数天算"业务可能在未来5年内才有明确的商业价值，太空数据中心的"地数 天算"业务可能在未来5-10年才逐步具备与地面数据中心进行竞争的优势。太空数据中心面临强烈辐 射、轨道维护困难、碎片危害以及与数据治理和太空交通相关的监管问题等障碍，包括但不限于上述各 类因素均可能导致项目商业化进度和效益晚于和低于预期。 浦东金桥：董事长王颖因工作调动离任 浦东金桥公告，董事长王颖因工作调动，不再担任公司董事、董事长以及董事会战略委员会主任委员、 提名委员会委员职务，另有任用。 嘉泽新能：下属公司拟投资建 ...

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].

重大事项： 复宏汉霖(02696)：汉斯状®联合化疗用于胃癌新辅助/辅助治疗的上市注册申请获国家药监局受理，并 已纳入优先审评 众安在线(06060)前11个月原保险保费收入总额约为329.04亿元 越秀地产(00123)前11个月累计合同销售金额约972.18亿元 诺诚健华(09969)：奥布替尼治疗系统性红斑狼疮的IIb期临床试验取得积极结果并启动III期临床试验 德林控股(01709)在选定海外矿场部署高效挖矿硬件 继续积极发展及扩展机构级比特币挖矿业务 粉笔(02469)与华图订立战略合作协议 巩固双方在行业的领导地位 经营业绩： 富力地产(02777)前11个月总销售收入约 127 亿元 同比增长24.63% 碧生源(00926)加码投资ERX维持3%持股 支持非GLP-1减肥疗法创新研发 石药集团(01093)：多恩益®(盐酸伊立替康脂质体注射液)的新适应症获上市批准 中远海能(01138)就建造一艘乙烯船和十八艘油轮订立造船合约，总代价78.82亿元 华润置地(01109)前11个月累计合同销售金额约1926亿元 同比减少15.9% ...

Investment Rating - The report does not explicitly provide an investment rating for the biopharmaceutical sector [5]. Core Insights - The biopharmaceutical sector is experiencing significant activity with multiple companies focusing on innovative drug development, particularly in the area of siRNA targeting INHBE, which shows promise for fat reduction without muscle loss [3][24]. - The report highlights the recent performance of new drug stocks, with notable gains from companies such as Saint Nor Pharmaceutical (+30.88%) and Dongyao Pharmaceutical (+16.37%), while companies like Kexin Pharmaceutical (-14.19%) and Rongchang Biotechnology (-10.09%) faced declines [1][15]. - There is an expectation of multiple catalysts in the sector, including academic conferences and data releases, which could drive further interest and investment [2]. Weekly New Drug Market Review - From December 8 to December 14, 2025, the new drug sector saw significant stock movements, with the top five gainers and losers listed [1][15]. - The report notes that there were no new drug approvals during this week, but 11 new drug applications were accepted [4][31]. Weekly New Drug Industry Analysis - Wave Life Sciences has reported promising initial data for its siRNA drug WVE-007, which targets INHBE and demonstrates potential for reducing visceral fat while preserving muscle mass [3][24]. - The report indicates that several companies, both globally and domestically, are actively developing siRNA drugs targeting INHBE, with five drugs already in clinical development [27][28]. Weekly New Drug Approval & Acceptance Status - No new drug or new indication approvals were reported this week, but 11 new drug applications were accepted [4][31]. - A total of 55 new drug clinical applications were approved, and 47 new drug clinical applications were accepted during the week [9][34]. Key Events in Domestic Market - Significant events include the approval of new drugs by companies such as Zhengda Tianqing and Nuo Cheng Jian Hua, which received approval for their respective new drugs [10][11]. Key Events in Overseas Market - Noteworthy overseas events include Eli Lilly's announcement of positive results from its TRIUMPH-4 Phase 3 trial and the FDA's approval of a gene therapy by Fondazione Telethon [11].

智通财经APP讯，诺诚健华(09969)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。 IIb期临床结果展示，在接受治疗48周的SLE患者中，奥布替尼展现了卓越的有效性和良好的耐受性和安 全性。本次研究共入组187例患者，按1:1:1随机分成三组，即奥布替尼每日一次75毫克和奥布替尼每日 一次50毫克两个剂量组，以及一个安慰剂组。 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，每日一次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%, p < 0.05)，达到主要终点。此外，每日一次75 毫克和每日一次50毫克奥布替尼治疗SLE的疗效呈剂量依赖性趋势。 奥布替尼是首个在SLE II期临床试验中展示显著疗效的BTK抑制剂，奥布替尼治疗SLE的IIa期临床数据 此前在欧洲风湿病学大会(EULAR)以最新重磅口头报告发布。奥布替尼有望成为治疗SLE的同类首创口 服BTK抑制剂。 本公司将继续致力于 ...

智通财经APP讯，诺诚健华(09969)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。 本公司将继续致力于加速奥布替尼的临床开发，为自身免疫性疾病患者带来创新、可及的治疗方案。 奥布替尼(宜诺凯®)为一款处于后期临床阶段、具有潜在同类最佳优势的高中枢神经系统渗透性、选择 性、不可逆口服小分子布鲁顿酪氨酸激酶(BTK)抑制剂。在SLE领域，奥布替尼已通过IIb期试验展现出 积极成果，其临床获益与良好安全性特征获得验证。SLE的III期试验已获准启动，预计于2026年第一季 度首例患者入组(FPI)。在其他自身免疫疾病领域，其在中国针对免疫性血小板减少症(ITP)的III期注册 性试验已完成患者入组，计划于2026年上半年提交新药上市申请。本公司保留奥布替尼在大中华区及东 南亚地区针对SLE及其他自身免疫适应症的相关权益，其他国际权益已授予Zenas。 在多发性硬化症(MS)领域，原发进展型多发性硬化症(PPMS)的III期试验已在 2025年第三季度启动，继 发进展型多发 ...

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。 ...