每经AI快讯，9月29日，港股荣昌生物(09995.HK)涨超7%，截至发稿，涨7.25%，报109.4港元，成交额 3.57亿港元。 ...

消息面上，9月28日，CDE官网显示，荣昌生物泰它西普拟纳入优先审评品种，用于治疗具有进展风险 的原发性免疫球蛋白 A(IgA)肾病成人患者，显著降低蛋白尿水平。此前8月27日，荣昌生物宣布泰它西 普治疗lgA肾病的国内III期研究达成A阶段的主要终点。研究结果显示，与安慰剂组相比，泰它西普组 患者在治疗39周时24小时尿蛋白肌酐比值(UPCR)降低了55%。 智通财经APP获悉，荣昌生物(09995)涨超7%，截至发稿，涨7.25%，报109.4港元，成交额3.57亿港元。 据了解，泰它西普是目前唯一可同时抑制B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)的药物， 而这两种细胞因子在IgA肾病患者中的水平显著高于正常人群，是疾病发生的关键驱动因素。通过抑制 这两种因子，泰它西普可减少B细胞增殖、降低浆细胞数量及异常免疫球蛋白生成，从源头阻断免疫复 合物沉积，减轻肾脏免疫炎症反应。 ...

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, currently at 109.4 HKD, with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics announced that the Phase III study of Taitasip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]

Core Viewpoint - The Hang Seng Healthcare Index fell by 1.4% this week, underperforming the market, with internet medicine, CXO, and traditional Chinese medicine sectors showing better performance [1] Group 1: Market Trends - Since September, the proportion of domestic holdings through the Hong Kong Stock Connect has remained stable, while foreign holdings have slightly decreased since mid-year [1] - Both domestic and foreign investors continue to increase their positions in innovative pharmaceutical companies, indicating a consistent long-term strategy [1] Group 2: Investment Recommendations - The report suggests focusing on companies with significant data releases at the upcoming ESMO conference in mid to late October, specifically mentioning Kangfang Biotech (09926), Kelun-Biotech (06990), and Rongchang Biotech (09995) [1] - The importance of timing and stock selection has increased following a broad rise in the innovative drug sector, with recommendations to gradually build positions during market corrections [1] Group 3: Sector Focus - For the innovative drug sector, the report highlights companies such as 3SBio (01530) and Eucure Biopharma-B (06996) as having rich short-term catalysts and undervalued core products, while companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are noted as significantly undervalued with clear long-term growth logic [1] - In the CXO sector, the report points to leading companies benefiting from high downstream demand and marginal recovery in financing, specifically mentioning WuXi AppTec (02268) [1]

Core Viewpoint - The Hang Seng Healthcare Index declined by 1.4% this week, underperforming the market, with internet medicine, CXO, and traditional Chinese medicine sectors showing better performance [1] Group 1: Market Trends - Since September, the proportion of domestic holdings through the Hong Kong Stock Connect has remained stable, while foreign holdings have slightly decreased since mid-year [1] - Both domestic and foreign investors continue to increase their positions in innovative pharmaceutical companies, indicating a consistent long-term strategy [1] Group 2: Investment Opportunities - Domestic investors are focusing on rebound opportunities, while foreign investors are increasing positions in innovative drug targets with high long-term potential and current cost-effectiveness [1] - The innovative drug guarantee model is gradually taking shape, which is expected to alleviate challenges such as hospital access and reimbursement difficulties for companies [1] Group 3: Upcoming Events - The ESMO conference will be held in mid to late October, and the report suggests focusing on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] Group 4: Stock Recommendations - The importance of timing and stock selection has increased after a broad rise in the innovative drug sector, with recommendations to gradually build positions during sector pullbacks [1] - Specific recommendations include: 1. Innovative drugs: 3SBio (01530), Eucure Biopharma-B (06996) with rich short-term catalysts and undervalued long-term growth logic [1] 2. CXO: Leaders in high-demand segments benefiting from improved financing conditions, such as WuXi AppTec (02268) [1]

Financial Performance - Revenue for the six months ended June 30, 2025, reached RMB 1,091,976 thousand, a significant increase of 47.6% from RMB 739,656 thousand in the same period of 2024[9]. - Gross profit for the first half of 2025 was RMB 921,848 thousand, up 61.5% from RMB 570,385 thousand in the prior year[9]. - RemeGen's pre-tax loss for the first half of 2025 was RMB 449,568 thousand, an improvement from a loss of RMB 780,460 thousand in the same period of 2024[9]. - The net loss for the period was RMB 449,568 thousand, an improvement from a net loss of RMB 780,460 thousand in the prior year, showing a 42.4% reduction in losses[132]. - The basic loss per share improved to RMB (0.83) from RMB (1.45) year-over-year, indicating better performance on a per-share basis[132]. - The total comprehensive loss for the period was RMB 419,557 thousand, which includes other comprehensive income of RMB 29,011 thousand[138]. Assets and Liabilities - Total assets increased to RMB 5,850,358 thousand as of June 30, 2025, compared to RMB 5,498,519 thousand as of December 31, 2024, reflecting a growth of approximately 6.4%[9]. - The total liabilities as of June 30, 2025, were RMB 3,492,867 thousand, a slight decrease from RMB 3,512,318 thousand as of December 31, 2024[9]. - The total equity increased to RMB 2,357,491 thousand as of June 30, 2025, compared to RMB 1,986,201 thousand as of December 31, 2024, representing a growth of approximately 18.6%[9]. - Cash and cash equivalents increased significantly to RMB 1,271,002 thousand from RMB 759,530 thousand, representing a 67.3% increase[135]. - The group's debt-to-asset ratio improved from 63.9% as of December 31, 2024, to 59.7% as of June 30, 2025[58]. Research and Development - Research and development expenses decreased to RMB 647,216 thousand in the first half of 2025 from RMB 806,233 thousand in the same period of 2024, indicating a reduction of approximately 19.7%[9]. - The company has developed over ten drug candidates, with seven currently in clinical development targeting more than twenty indications[10]. - The company is developing a rich pipeline of candidates, including Taitasip for various autoimmune diseases and other indications[14]. - The company is actively exploring additional indications for Taitasip, planning to initiate multiple Phase II/III clinical trials domestically[19]. Clinical Trials and Product Development - The company initiated a Phase III clinical trial for Taitasip (RC18) in China for the treatment of generalized myasthenia gravis (gMG) in the first half of 2023, with the trial expected to reach its primary endpoint by August 2024[15]. - In the Phase III trial, Taitasip demonstrated a significant reduction in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score by 5.74 points compared to a 0.91 point reduction in the placebo group, with 98.1% of patients showing improvement of ≥3 points[16]. - A licensing agreement was established with Vor Biopharma Inc. for the development and commercialization of Taitasip outside Greater China, with a total value of $125 million, including an upfront payment of $45 million[19]. - Vor Biopharma is conducting a global Phase III clinical trial for Taitasip in gMG patients, having received orphan drug designation from the FDA in October 2022[20]. - The company has developed Vidisicimab, a leading antibody-drug conjugate (ADC) candidate, which is the first domestically approved ADC in China for treating HER2-expressing solid tumors, including low-expressing types[22]. Market and Sales - The company has commercialized two products, RC18 (brand name: Tai'ai®) and RC48 (brand name: Aidiqi®), which are undergoing clinical trials in China and the United States for over twenty indications[10]. - The company aims to become a leading player in the global biopharmaceutical industry, focusing on innovative and differentiated biologics for unmet medical needs[10]. - Revenue increased from RMB 739.7 million for the six months ended June 30, 2024, to RMB 1,092.0 million for the six months ended June 30, 2025, driven by strong sales of the autoimmune product Taitasip and the oncology product Vidisizumab[42]. Shareholder and Equity Information - As of June 30, 2025, the company had a total of 563,608,243 shares, including 208,581,239 H-shares and 355,027,004 A-shares[75]. - Mr. Wang Weidong holds a 43.25% equity interest in A-shares through controlled entities, representing 27.24% of the total shares[71]. - The company has established a consortium agreement among key stakeholders to ensure unified action in management and decision-making[73]. - The company issued 54,426,301 new A-shares at RMB 48.00 per share, raising approximately RMB 2,612.4 million, with net proceeds of about RMB 2,505.9 million after deducting issuance costs[68]. Incentive Plans - The company has implemented the first H-share plan to enhance its compensation system and ensure a balance of interests among stakeholders[82]. - The second phase of the H-share plan allows for the purchase of up to 27,213,150 H-shares, representing approximately 13.05% of the total issued H-shares and about 4.83% of the total share capital as of the report date[96]. - The 2022 A-share plan aims to enhance the company's long-term incentive mechanism, attracting and retaining talent while aligning the interests of shareholders, the company, and core team members[105]. - The maximum number of shares that any incentive recipient can receive will not exceed 1% of the total shares as of the announcement date[105]. Corporate Governance - The company has complied with all applicable corporate governance codes as of June 30, 2025[122]. - The independent auditor has reviewed the interim financial information in accordance with the relevant standards, confirming compliance with applicable accounting standards and regulations[124].

每经AI快讯，9月25日，港股荣昌生物(09995.HK)早盘涨超5%，截至发稿，涨5.54%，报108.6港元，成 交额1.1亿港元。 （文章来源：每日经济新闻） ...

9月25日，荣昌生物涨5.02%，截至发稿，报110.17元/股，成交2.19亿元，换手率1.24%，总市值620.93 亿元。 资料显示，荣昌生物制药(烟台)股份有限公司位于中国(山东)自由贸易试验区烟台片区烟台开发区北京 中路58号，成立日期2008年7月4日，上市日期2022年3月31日，公司主营业务涉及公司是一家具有全球 化视野的创新型生物制药企业,自成立以来一直专注于抗体药物偶联物(ADC)、抗体融合蛋白、单抗及 双抗等治疗性抗体药物领域。公司致力于发现、开发与商业化创新、有特色的同类首创(first-in-class)与 同类最佳(best-in-class)生物药,以创造药物临床价值为导向,为自身免疫疾病、肿瘤疾病、眼科疾病等重 大疾病领域提供安全、有效、可及的临床解决方案,以满足大量尚未被满足的临床需求。主营业务收入 构成为：销售商品99.46%，出售材料0.38%，租赁服务0.16%。 从基金十大重仓股角度 数据显示，嘉合基金旗下1只基金重仓荣昌生物。嘉合锦鹏添利混合A（008905）二季度持有股数20万 股，占基金净值比例为1.69%，位居第八大重仓股。根据测算，今日浮盈赚取约105.4万 ...

据介绍，本次大会上，荣昌生物的多项重磅研究成果将集中亮相。其中，维迪西妥单抗联合治疗一线尿 路上皮癌的RC48-C016Ⅲ期临床研究入选"最新突破摘要(Late-Breaking Abstracts，LBA)"，展现了该研 究的重要学术价值。此外，公司还将展示10项多个瘤种及相关治疗策略的最新数据，呈现形式包括2项 简短口头报告和8项壁报展示，覆盖尿路上皮癌、胃癌、妇科肿瘤等领域，全面体现荣昌生物在ADC药 物联合治疗中的领先实力。 消息面上，据荣昌生物官微消息，2025年欧洲肿瘤内科学会(ESMO)年会将于当地时间10月17日至21日 在德国柏林召开，荣昌生物11项原创研究成果成功入选，其中多项临床研究数据为首次在国际公布。 荣昌生物(09995)早盘涨超5%，截至发稿，涨5.54%，报108.6港元，成交额1.1亿港元。 ...

智通财经APP获悉，荣昌生物(09995)早盘涨超5%，截至发稿，涨5.54%，报108.6港元，成交额1.1亿港 元。 据介绍，本次大会上，荣昌生物的多项重磅研究成果将集中亮相。其中，维迪西妥单抗联合治疗一线尿 路上皮癌的RC48-C016Ⅲ期临床研究入选"最新突破摘要(Late-Breaking Abstracts，LBA)"，展现了该研 究的重要学术价值。此外，公司还将展示10项多个瘤种及相关治疗策略的最新数据，呈现形式包括2项 简短口头报告和8项壁报展示，覆盖尿路上皮癌、胃癌、妇科肿瘤等领域，全面体现荣昌生物在ADC药 物联合治疗中的领先实力。 消息面上，据荣昌生物官微消息，2025年欧洲肿瘤内科学会(ESMO)年会将于当地时间10月17日至21日 在德国柏林召开，荣昌生物11项原创研究成果成功入选，其中多项临床研究数据为首次在国际公布。 ...