Group 1 - The Hong Kong stock market's biopharmaceutical sector has shown strong performance, with Rongchang Biologics rising over 14% [1] - Other companies in the sector, including Tigermed, Innovent Biologics, and WuXi Biologics, also experienced gains [1]

本文源自：智通财经网 消息面上，荣昌生物发布公告，公司自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普（RC18， 商品名：泰爱 ）用于治疗原发性干燥综合征（pSS）的Ⅲ期临床研究，达到方案设计的临床试验主要研 究终点。 智通财经获悉，荣昌生物(09995)高开近5%，截至发稿，涨4.7%，报71.35港元，成交额1184.41万港 元。 公告称，泰它西普已经在中国完成治疗原发性干燥综合征的Ⅲ期临床研究，达到方案设计的临床试验主 要研究终点。临床研究结果显示，泰它西普可持续有效改善干燥综合征患者的临床症状，显示良好的有 效性和安全性。公司将尽快向国家药品监督管理局药品审评中心(CDE)递交上市申请，详细数据将在国 际重大学术会议上公布。 ...

Core Viewpoint - Rongchang Biologics (09995) experienced a nearly 5% increase in opening price, currently up 4.7% at HKD 71.35, with a trading volume of HKD 11.84 million [1] Group 1: Clinical Research Announcement - The company announced that its self-developed BLyS/APRIL dual-target fusion protein innovative drug, Tai'aisip (RC18), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS), achieving the primary endpoint as per the study design [1] - The clinical research results indicate that Tai'aisip can sustainably and effectively improve the clinical symptoms of patients with Sjögren's syndrome, demonstrating good efficacy and safety [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) as soon as possible, with detailed data to be presented at major international academic conferences [1]

智通财经APP获悉，荣昌生物(09995)高开近5%，截至发稿，涨4.7%，报71.35港元，成交额1184.41万港 元。 消息面上，荣昌生物发布公告，公司自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普（RC18， 商品名：泰爱 ）用于治疗原发性干燥综合征（pSS）的Ⅲ期临床研究，达到方案设计的临床试验主要研 究终点。 公告称，泰它西普已经在中国完成治疗原发性干燥综合征的Ⅲ期临床研究，达到方案设计的临床试验主 要研究终点。临床研究结果显示，泰它西普可持续有效改善干燥综合征患者的临床症状，显示良好的有 效性和安全性。公司将尽快向国家药品监督管理局药品审评中心(CDE)递交上市申请，详细数据将在国 际重大学术会议上公布。 ...

Group 1 - Ruikang Pharmaceutical's executive Li Zhe has had his detention changed to a notice of investigation, indicating a shift in the investigation phase [1] - The change from detention to a notice of investigation suggests a reduced level of coercion, highlighting the importance of internal control and compliance systems in listed companies [1] Group 2 - Zhixiang Jintai has initiated a Phase III clinical trial for GR1802 injection for allergic rhinitis, following communication with the National Medical Products Administration [2] - GR1802 is slightly behind in clinical progress compared to two other approved drugs targeting the same indication, but successful commercialization could lead to competition with Dupilumab [2] Group 3 - Rongchang Biopharmaceutical's innovative drug RC18 (Taitaxip) for primary Sjögren's syndrome has met its primary endpoint in Phase III clinical trials, marking a potential first in the global market for this indication [3] - If approved, this drug could provide a breakthrough treatment for millions of patients in China and strengthen Rongchang's position in the autoimmune field [3] Group 4 - Hengrui Medicine's SHR-A2102, a targeted antibody-drug conjugate (ADC) for Nectin-4, has received approval for clinical trials in combination with Atezolizumab for recurrent/metastatic head and neck squamous cell carcinoma [4] - There is currently only one similar product on the market, Padcev, which is projected to generate $1.949 billion in sales in 2024, indicating significant market potential for this target [4] Group 5 - BeiGene has launched the first domestic Phase III clinical trial for subcutaneous Tislelizumab, a PD-1 inhibitor, for use in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [5] - The subcutaneous formulation is becoming a competitive area for PD-1/PD-L1 inhibitors, with three other subcutaneous PD-1/L1 products already approved globally [5]

Core Viewpoint - Rongchang Biopharmaceutical's innovative drug Tai'ta Xipu (RC18) has successfully met the primary endpoint in its Phase III clinical trial for treating primary Sjögren's syndrome, indicating its potential effectiveness and safety in addressing this chronic autoimmune disease [1][3]. Group 1: Clinical Research Overview - The Phase III clinical trial for Tai'ta Xipu is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the drug's efficacy and safety in patients with primary Sjögren's syndrome [1][3]. - Primary Sjögren's syndrome is characterized by chronic inflammation and damage to exocrine glands, leading to symptoms such as dry mouth and dry eyes, with a prevalence rate in China estimated between 0.3% and 0.7% [1][2]. Group 2: Mechanism of Action - Tai'ta Xipu is a recombinant dual-target fusion protein that inhibits both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which are crucial in the abnormal activation of B cells, thereby reducing pathological immune responses [2]. Group 3: Clinical Progress - The clinical trial results indicate that Tai'ta Xipu can sustainably and effectively improve the clinical symptoms of patients with primary Sjögren's syndrome, demonstrating good efficacy and safety [3]. - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [3].

荣昌生物制药（烟台）股份有限公司 自愿披露关于泰它西普治疗原发性干燥综合征Ⅲ期临床 研究达到主要研究终点的公告 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、准确性和完整性承担法律责任。 证券代码：688331 证券简称：荣昌生物 公告编号：2025-037 荣昌生物制药（烟台）有限公司（以下简称"公司"或"荣昌生物"）自主研发的 BLyS/APRIL 双靶点融合蛋白创新药泰它西普（RC18，商品名：泰爱）用于治疗原发性 干燥综合征（pSS）的Ⅲ期临床研究，达到方案设计的临床试验主要研究终点。现将情 况公告如下： 港股代码：09995 港股简称：榮昌生物 一、 基本情况介绍 本研究是一项多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究。旨在评价泰它西 普用于治疗原发性干燥综合征患者的有效性和安全性。 特此公告。 干燥综合征是一种慢性炎症性自身免疫性疾病，以淋巴细胞浸润和外分泌腺体损伤 为主要特征。除唾液腺和泪腺功能障碍导致的持续口干、眼干外，还可累及多系统器官。 我国干燥综合征的患病率为 0.3%-0.7%，且呈上升趋势，存在巨大尚未被满足的临床需 求。 研 ...

Core Insights - Telitacicept shows potential as a best-in-disease treatment for primary Sjögren's disease, achieving the primary endpoint in a Phase 3 clinical study in China [2][3] - The drug targets both BAFF and APRIL, addressing the autoimmune signaling cascade, which may allow for disease modification rather than just symptom management [3] - Vor Bio plans to submit a Biologics License Application (BLA) for telitacicept in primary Sjögren's disease, marking its fourth approved indication in China [4] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on advancing telitacicept, a dual-target fusion protein, through Phase 3 clinical development to treat autoimmune diseases [5] - The company aims to transform treatment options for serious autoantibody-driven conditions globally [5] Product Details - Telitacicept is designed to selectively inhibit BLyS (BAFF) and APRIL, reducing autoreactive B cells and autoantibody production, which are key drivers of autoimmune diseases [6] - The drug is already approved in China for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis [7] Disease Context - Primary Sjögren's disease is a chronic autoimmune condition characterized by overactive B cells, leading to inflammation and damage to moisture-producing glands [8] - The disease is often underdiagnosed, with significant impacts on patients' daily lives, and currently lacks systemic disease-modifying therapies [10]

Group 1 - The core viewpoint of the news is the performance and holdings of the Zhongyin Innovation Medical Mixed Fund C, which has shown significant growth in recent months and has a strong portfolio in the healthcare sector [1][3]. - As of August 13, 2025, the latest net value of Zhongyin Innovation Medical Mixed Fund C is 2.1969 yuan, reflecting a growth of 3.87% [1]. - The fund has achieved a return of 15.09% over the past month, ranking 1008 out of 4699 in its category [1]. - Over the last six months, the fund's return is 86.76%, ranking 26 out of 4543 [1]. - Year-to-date, the fund has returned 85.33%, ranking 30 out of 4501 [1]. - The top ten stock holdings of the fund account for a total of 62.83%, with significant positions in companies such as Innovent Biologics (8.33%), Kelun-Biotech (8.15%), and Hengrui Medicine (8.08%) [1]. Group 2 - The Zhongyin Innovation Medical Mixed Fund C was established on October 30, 2020, and as of June 30, 2025, it has a total scale of 2.686 billion yuan [1]. - The fund manager, Zheng Ning, has a background in asset management and has held various positions in the investment industry, including roles at Taikang Asset Management and Zhonggeng Fund Management [2]. - Zheng Ning has been managing the Zhongyin Innovation Medical Mixed Fund C since July 1, 2022, and has also taken on management roles for other funds within the healthcare sector [2].

Core Insights - Rongchang Biopharmaceutical (09995) announced that its self-developed dual-target fusion protein innovative drug, Tai'axi (RC18, brand name: Tai'ai®), has achieved the primary endpoint of its Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) [1][2] Group 1: Clinical Trial Details - The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Tai'axi in patients with primary Sjögren's syndrome [1] - The trial results indicate that Tai'axi can sustainably and effectively improve the clinical symptoms of patients with Sjögren's syndrome, demonstrating good efficacy and safety [2] Group 2: Disease Background and Market Potential - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Group 3: Mechanism of Action - The overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome [1] - Tai'axi is a recombinant dual-target fusion protein that inhibits the binding of BLyS and APRIL to B cell surface receptors, preventing abnormal differentiation and maturation of B cells, thereby effectively reducing pathological immune responses [1]