证券日报网讯12月15日，诺诚健华在互动平台回答投资者提问时表示，截至2025年11月28日公司A股股 东户数约为1.79万户。 ...

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]

Core Viewpoint - The company, Innovent Biologics, announced that its novel BTK inhibitor, Orelabrutinib, has met the primary endpoint in a Phase IIb clinical trial for treating systemic lupus erythematosus (SLE) and has received approval from the National Medical Products Administration (NMPA) to initiate Phase III registration trials [1][2]. Group 1: Clinical Trial Results - In the Phase IIb trial, 187 patients were randomized into three groups: two dosage groups of Orelabrutinib (75 mg and 50 mg once daily) and a placebo group [1]. - The primary endpoint, the SLE Response Index-4 (SRI-4) response rate at week 48, showed that the 75 mg group had a significantly higher response rate compared to the placebo group (57.1% vs. 34.4%, p<0.05) [1]. - The 75 mg dosage group also demonstrated a dose-dependent improvement in efficacy compared to the 50 mg group [1]. Group 2: Secondary Endpoints and Subgroup Analysis - At week 48, the SRI-6 response rate and the British Isles Lupus Assessment Group Composite Endpoint (BICLA) response rate for the 75 mg group were significantly higher than those of the placebo group (p<0.05) [2]. - In patients with baseline disease activity BILAG ≥1A or ≥2B, the SRI-4 response rate for the 75 mg group improved by 35% compared to the placebo [2]. - In a subgroup with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg group increased by 43% compared to the placebo [2]. Group 3: Safety and Market Potential - Orelabrutinib exhibited good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biology of SLE [2]. - Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a Phase II trial for SLE, with previous Phase IIa data presented at the European League Against Rheumatism (EULAR) conference [2]. - The company aims to accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases, addressing a significant unmet clinical need [3].

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]

Core Viewpoint - The company has achieved a significant milestone with its BTK inhibitor, Orelabrutinib, in the treatment of systemic lupus erythematosus (SLE), as the Phase IIb clinical trial met its primary endpoint and received approval from the National Medical Products Administration (NMPA) to initiate Phase III trials [1][2]. Group 1: Clinical Trial Progress - The Phase IIb clinical trial demonstrated that Orelabrutinib showed excellent efficacy, good tolerability, and safety in patients treated for 48 weeks [2]. - A total of 187 patients were enrolled in the study, randomized into three groups: Orelabrutinib 75 mg, 50 mg, and a placebo group [2]. - The primary endpoint was the SLE Response Index-4 (SRI-4) response rate at week 48, where the 75 mg group showed a significant response rate of 57.1% compared to 34.4% in the placebo group (p < 0.05) [2]. - The 75 mg dose also outperformed the 50 mg dose, indicating a dose-dependent improvement in efficacy [2]. Group 2: Efficacy in Subgroups - In patients with baseline disease activity BILAG ≥ 1A or ≥ 2B, the SRI-4 response rate for the 75 mg group showed a corrected difference of 35% compared to the placebo [3]. - For patients with baseline disease activity BILAG ≥ 1A or ≥ 2B and clinical SLEDAI-2K score ≥ 4, the corrected difference in SRI-4 response rate was 43% [3]. - Orelabrutinib demonstrated good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biological characteristics of SLE [3]. Group 3: Background on SLE - SLE is a systemic autoimmune disease that can lead to severe organ and neurological damage, and even death [4]. - The global prevalence of SLE is approximately 8 million, with around 1 million patients in China, the highest number globally [4]. - The most common SLE patients are young and middle-aged women, requiring long-term management and presenting a significant unmet medical need [4].

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].

Core Insights - The new BTK inhibitor, Oubretyn, developed by the biopharmaceutical company Nuo Cheng Jian Hua, has achieved its primary endpoint in the Phase IIb clinical trial for treating systemic lupus erythematosus (SLE) and has received approval from the National Medical Products Administration (NMPA) to initiate Phase III registration clinical trials [2][4]. Group 1: Clinical Trial Results - In the Phase IIb study, 187 patients were randomized into three groups: two dosage groups of Oubretyn (75 mg and 50 mg once daily) and a placebo group [2]. - The primary endpoint, the SLE Response Index-4 (SRI-4) response rate at week 48, showed that the 75 mg Oubretyn group had a significantly higher response rate compared to the placebo group (57.1% vs. 34.4%, p<0.05) [2]. - The 75 mg Oubretyn group also demonstrated superior efficacy over the 50 mg group, indicating a dose-dependent improvement trend [2]. Group 2: Subgroup Analysis - In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B, the SRI-4 response rate for the 75 mg Oubretyn group increased by 35% compared to the placebo group [3]. - For patients with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg Oubretyn group improved by 43% compared to the placebo group [3]. Group 3: Safety and Market Potential - Oubretyn has shown good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biology of SLE [3]. - Oubretyn is the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE, positioning it as a potential first-in-class oral BTK inhibitor for this condition [4]. - The global prevalence of SLE is approximately 8 million, with China having around 1 million patients, indicating a substantial unmet clinical need for effective treatments [4].