Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码：09969）12月14日宣布，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。 临床IIb期结果展示，在接受治疗48周的患者中，奥布替尼展现了卓越的有效性以及良好的耐受性和安 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。 奥布替尼显示出良好的耐受性和安全性，安全性特征与BTK抑制剂的作用机制和SLE的疾病生物学相一 致。 第48周时，每天一次75毫克奥布替尼剂量组的SRI- ...

Group 1 - Anbotong plans to issue H-shares and list on the Hong Kong Stock Exchange, with the board authorizing management to start preparations within 12 months [1] - Xiangsheng Medical proposes a cash dividend of 3 yuan per 10 shares for the first three quarters of 2025 [2] - Junshi Biosciences receives FDA approval for clinical trials of JS212, a dual-specific antibody-drug conjugate for treating advanced solid tumors [3] Group 2 - Zhonghuan Environmental plans to raise up to 300 million yuan by issuing shares to a specific entity, with funds allocated for working capital and bank loan repayment [4] - Guao Technology announces a change in actual control to Xu Yinghui, with stock resuming trading on December 15 [5] - Jiaze New Energy intends to invest approximately 3.557 billion yuan in a green hydrogen and methanol project in Heilongjiang [6] Group 3 - Shanghai Airport reports a 15.47% year-on-year increase in passenger throughput at Pudong International Airport for November [7] - Innovent Biologics achieves primary endpoint in a Phase IIb study of Obinutuzumab for systemic lupus erythematosus, with plans for a Phase III trial [8] - Saiyi Information leads a national major science and technology project on intelligent manufacturing systems and robotics [9] Group 4 - Yipin Hong's Qinxing Qingjie oral solution is approved as a national second-level protected traditional Chinese medicine [10] - Yipin Hong's stake in US-based Arthrosi Therapeutics is set to be acquired by Sobi for a total of up to 950 million USD [11] - Pudong Jinqiao announces the resignation of Chairman Wang Ying due to job transfer [12] Group 5 - Jiaze New Energy plans to invest in two wind power projects with a total estimated investment of approximately 2.366 billion yuan [13] - Jinpan Technology receives approval from the CSRC for issuing convertible bonds to unspecified investors [14] - Zoli Pharmaceutical intends to acquire a multi-trace element injection asset group for 356 million yuan [15] Group 6 - Jiuan Medical's US subsidiary receives pre-market notification from the FDA for multiple testing products [16][17] - Changfei Optical Fiber's subsidiary plans to participate in establishing an investment fund with a total subscription amount of 830 million yuan [18] - Chenfeng Technology's shareholder plans to reduce holdings by up to 3% of the company's shares [19][20][21][22]

Core Viewpoint - Multiple pharmaceutical companies announced positive developments, including FDA approvals and clinical trial advancements, indicating a favorable environment for the sector. Group 1: FDA Approvals and Clinical Trials - Ji'an Medical announced that its U.S. subsidiary received pre-market notification from the FDA for its quadrivalent home test kits for influenza A, influenza B, COVID-19, and RSV, allowing for normal sales in the U.S. market [1] - Junshi Biosciences reported that its EGFR/HER3 bispecific antibody-drug conjugate for treating advanced solid tumors received FDA approval for clinical trial application [1] - Innovent Biologics disclosed that its self-developed BTK inhibitor, Orelabrutinib, achieved the primary endpoint in a Phase II study for systemic lupus erythematosus and has been approved for Phase III registration clinical trials [1] Group 2: Strategic Partnerships and Product Developments - Yipinhong announced that its Qinxing Qingjie oral solution was approved as a national second-level protected traditional Chinese medicine. Additionally, the company secured a deal with Swedish pharmaceutical giant Sobi for $950 million (approximately 6.713 billion RMB) upfront and up to $550 million (approximately 3.887 billion RMB) in additional payments for a new URAT1 inhibitor, which has shown strong efficacy in dissolving gout stones and has received FDA fast track designation, with key Phase III clinical trials completed [1]

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。 登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 诺诚健华医药有限公司（以下简称"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（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，现将主要情况公告如下： 一、奥布替尼临床试验进展情况 近日，公司自主研发的BTK抑制剂奥布替尼治疗SLE的IIb期临床研究达到主要终点，并获CDE批准开展 III期注册性临床试验。该III期研究将评估每日一次（QD）75毫克的给药方案，该方 ...

Group 1 - Multiple pharmaceutical stocks announced positive news, including Jiuan Medical's FDA pre-market notification for home test kits for influenza and COVID-19, allowing normal sales in the U.S. market [1] - Junshi Bioscience received FDA approval for clinical trials of its EGFR/HER3 bispecific antibody drug for treating advanced solid tumors [1] - Innovent Biologics' BTK inhibitor, Orelabrutinib, reached primary endpoints in a Phase II trial for systemic lupus erythematosus and has been approved for Phase III trials [2] Group 2 - The Chinese innovative drug industry is at a critical turning point, with over $100 billion in licensing deals in the first three quarters of 2025, indicating significant potential for domestic innovative drugs [3] - Major collaborations between Chinese companies and multinational corporations include a $12 billion deal between Hengrui and GSK, and a $114 billion potential deal between Innovent and Takeda [3] - The Chinese innovative drug sector is expected to show a compound annual growth rate of 20.2% from 2024 to 2028, with the market size projected to reach 26.9 billion yuan by 2028 [1][4] Group 3 - The pharmaceutical industry is anticipated to thrive by 2025, with the Hang Seng Index expected to double in value [4] - The innovative drug sector's listed companies achieved a total revenue of 48.83 billion yuan in the first three quarters of 2025, a 22% year-on-year increase, marking the first quarterly profit since inception [4] - The investment landscape is shifting from a focus on academic backgrounds and preclinical data to a stronger emphasis on companies' tangible strengths and product quality [4]

Core Insights - Multiple pharmaceutical companies have recently announced positive developments, indicating a potential growth phase in the industry [1][2][4]. Group 1: Company Announcements - Jiuan Medical's U.S. subsidiary received pre-market notification from the FDA for its home testing kits for multiple viruses, including COVID-19, allowing for normal sales in the U.S. market [1]. - Junshi Bioscience's dual-specific antibody drug for treating advanced solid tumors has received FDA approval for clinical trials [1]. - Innovent Biologics announced that its BTK inhibitor, Orelabrutinib, has met primary endpoints in a Phase II study for systemic lupus erythematosus and has been approved for Phase III trials [1]. - Yipinhong's Qinxiang Qingjie oral solution has been approved as a national secondary protected traditional Chinese medicine, and the company is set to receive up to $15 billion (approximately 67.13 billion RMB) from Sobi for a new URAT1 inhibitor [2]. Group 2: Market Trends - The Chinese innovative drug sector is experiencing a significant turnaround after a challenging period from 2021 to 2024, with total external licensing amounts surpassing $100 billion in the first three quarters of 2025 [4]. - Major collaborations between Chinese innovative drug companies and multinational corporations (MNCs) are on the rise, exemplified by significant deals such as the $12 billion partnership between Hengrui Medicine and GSK [4]. - The speed and cost-effectiveness of Chinese drug development are becoming competitive advantages, with drug discovery processes being 2-3 times faster than international counterparts [4]. Group 3: Financial Performance - The innovative drug sector in China reported a total revenue of 48.83 billion RMB in the first three quarters of 2025, reflecting a year-on-year growth of 22% [5]. - The sector achieved its first quarterly profit since its inception, with a net profit of 1.1 billion RMB in the third quarter [5]. Group 4: Investment Landscape - The capital market for Chinese innovative drugs is undergoing a transformation, shifting from a focus on academic backgrounds and preclinical data to a stronger emphasis on tangible product capabilities [6].

登录新浪财经APP 搜索【信披】查看更多考评等级 A股代码：688428 A股简称：诺诚健华 公告编号：2025-040 港股代码：09969 港股简称：诺诚健华 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在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 诺诚健华医药有限公司（以下简称"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（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，现将主要情况公告如下： 一、奥布替尼临床试验进展情况 近日，公司自主研发的BTK抑制剂奥布替尼治疗SLE的IIb期临床研究达到主要终点，并获CDE批准开展 III期注册性临床试验。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 ...

Core Viewpoint - Multiple pharmaceutical companies have announced positive developments, including FDA approvals and significant clinical trial milestones, indicating a robust growth trajectory in the pharmaceutical sector. Group 1: Company Announcements - Jiuan Medical announced that its U.S. subsidiary received FDA pre-market notifications for its four-in-one and three-in-one home testing kits for influenza and COVID-19, enhancing its product line in the IVD field [1][3]. - Junshi Biosciences reported that its dual-specificity antibody-drug conjugate (JS212) for treating advanced solid tumors received FDA approval for clinical trials [4]. - Innovent Biologics disclosed that its BTK inhibitor, Obutinib, achieved primary endpoints in a Phase II clinical trial for systemic lupus erythematosus and received approval for Phase III trials [4]. - Yipinhong announced that its Qinxing Qingjie oral solution was approved as a national secondary protected traditional Chinese medicine, which will strengthen its market position [5]. Group 2: Market Trends and Insights - The Chinese innovative drug industry is expected to experience rapid growth, with over $92 billion in outbound BD transactions in the first three quarters of 2025, indicating a significant opportunity for Chinese companies in the global market [7]. - The first version of the commercial health insurance innovative drug directory was released, highlighting the competitive landscape and the inclusion of several high-efficacy domestic drugs, which signals a positive trend for innovative drug development [8]. - Analysts suggest that the integration of innovative drugs into both medical insurance and commercial insurance will lead to rapid revenue growth for these products, benefiting patients and companies alike [8].

在基线疾病活动度BILAG ≥1A 或≥2B的亚组患者中，每天一次 75 毫克奥布替尼剂量组相较于安慰剂 组，SRI-4 应答率提高了 35%。在基线疾病活动度 BILAG ≥1A 或 ≥2B 且临床SLEDAI-2K评分 ≥4 的亚 组患者中，每天一次75毫克奥布替尼剂量组的SRI-4应答率较安慰剂组提高 43%。 诺诚健华联合创始人、董事长兼CEO崔霁松博士说："系统性红斑狼疮存在巨大的未被满足的临床需 求，患者往往需要长期甚至终身服药，极大影响他们的生活质量。非常高兴看到奥布替尼在治疗SLE的 IIb期研究中达到主要终点，展示优异疗效，并获批开展III期注册临床试验。我们将加速推进临床开 发，为SLE等自身免疫性疾病患者带来更好的治疗选择。" 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。 SLE是一种全身性自身免 ...