科济药业 20250702 摘要 科济药业 CT041 已递交 NDA 上市申请并获 CDE 受理，预计 2026 年 商业化，该产品在胰腺癌和胃癌术后辅助治疗中显示出 100%的 ORR， 并在 ASCO 会议和《柳叶刀》上公布了显著疗效的关键二期数据。 CT041 的临床试验采用随机对照设计，结果显示使用 CT041 的患者中 位生存期为 9.9 个月，显著高于未使用者的 3.98 个月，生存时间延长 约 6 个月，体现了 CAR-T 疗法的显著疗效。 科济药业计划自主商业化新产品，基于其在实体瘤市场的领先地位和独 占优势，以及与华东医药合作积累的经验，预计在国内市场拥有更灵活 和自主的定价策略。 科济药业的通用型 CAR-T 虽然成本显著降低，但疗效与自体 CAR-T 相 比仍有差距，公司正致力于通过技术平台优化（如 3Q Plus）提高疗效， 并开发新产品如 0,596 和 2,219。 BCM 通用型 CAR-T 数据显示，科济药业的 0,590 项目在 DOR 方面表 现突出，部分患者达到完全缓解且缓解持续时间长达 20-23 个月，优于 竞品 Besayda 和艾乐哲的 7-8 个月。 Q&A ...

Core Viewpoint - Shuyou Shen's subsidiary, Beijitai, has received priority review status from the National Medical Products Administration (NMPA) for its product STSP-0601, which is intended for the treatment of bleeding in adult patients with hemophilia A or B with inhibitors, marking a significant advancement in the drug's approval process [2][3]. Company Developments - Shuyou Shen's stock price surged nearly 190% over a 10-day period, reaching a peak of 34.49 yuan per share, the highest since 2016, following the announcement of the priority review [4]. - The company has 13 major R&D projects in clinical research stages, focusing on unmet therapeutic needs, including monoclonal antibodies and protein drugs [4]. - The capitalized R&D expenditure for STSP-0601 (with inhibitors) is reported at 85.16 million yuan, while for STSP-0601 (without inhibitors) it stands at 10.89 million yuan [3]. Industry Context - The NMPA has also granted priority review status to other companies, including He Yu and Ke Ji Pharmaceuticals, indicating a broader trend in the industry towards expedited drug approvals [5][6]. - He Yu's drug ABSK021 has received multiple recognitions, including breakthrough therapy designation from the NMPA and FDA, and has seen a significant revenue increase due to licensing agreements [6][7]. - Ke Ji's product, a CAR-T cell therapy candidate, has also been recognized by the NMPA and FDA, highlighting the growing focus on innovative cancer treatments within the industry [7].

科济药业 20250601 摘要 科济药业 CT041 在晚期胃食管结合部腺癌的二期临床试验中，主要终 点无进展生存期（PFS）显著延长，疾病进展或死亡风险降低 63%，实 际输注人群中位 PFS 翻倍，绝对值延长 2.5 个月。 CT041 临床试验安全性良好，仅 4.5%的患者出现 3 级细胞因子释放综 合征（CRS），未观察到 4~5 级 CRS 或神经毒性事件，常见不良反应 如血液学毒性、清零和 CRS 等可控。 在意向治疗（ITT）人群中，CT041 组的总生存期（OS）显示明显延长 趋势，在 MITT 人群中生存获益更明显，总生存时间翻倍，为 9.17 个月 对比 3.98 个月。 CT041 覆盖 Claudin 18.2 表达阳性（表达强度≥两个加号且表达百分 数≥40%）的胃癌患者，范围较 Claudin 18.2 ADC 疗法更广，且 CAR-T 疗法提供长期生存优势。 科济药业计划在美国、日本、韩国、新加坡和中国香港等地申请 CT041 上市，并与海外药厂探讨授权合作，同时与 FDA 沟通注册策略。 Q&A 在意向治疗（ITT）人群中，本实验主要疗效终点达成：CT041 显著降低疾病 进 ...

Core Viewpoint - The recent developments in the innovative drug sector, particularly the record-breaking licensing deal and the upcoming ASCO conference, highlight the growing competitiveness and potential of Chinese pharmaceutical companies in the global market [4][5]. Group 1: Market Performance - The Hong Kong Innovative Drug ETF (159570) opened high but closed lower, experiencing a 1% pullback after four days of gains last week, with trading volume reaching 300 million, indicating strong liquidity [1]. - Major component stocks of the ETF mostly declined, with notable drops including a more than 4% decrease for 3SBio and over 3% for both WuXi AppTec and Rongchang Biopharmaceutical [2]. Group 2: Licensing Deal - A historic licensing agreement was reached where Pfizer will pay a $1.25 billion upfront fee to Chinese companies for the PD-1/VEGF dual antibody SSGJ-707, with potential total payments reaching $4.8 billion [4]. - This deal sets a new record for Chinese innovative drugs entering the international market and is expected to enhance market valuation expectations for the innovative drug sector [4]. Group 3: ASCO Conference Insights - The upcoming ASCO conference is anticipated to showcase the global competitiveness of Chinese pharmaceutical companies, with numerous clinical studies being presented [5]. - Key highlights include the performance of domestic drugs that have shown potential to outperform established treatments, such as the combination of Bemarituzumab and Anlotinib against Keytruda in NSCLC [5]. - CAR-T therapies are also making significant strides, with Kintor Pharmaceuticals presenting promising data for their CLDN18.2 CAR-T therapy [5]. Group 4: Innovative Drug ETF Characteristics - The Hong Kong Innovative Drug ETF (159570) has a high concentration in innovative drugs, with over 85% of its weight in this category, making it the highest among all pharmaceutical indices [6]. - The ETF features a low valuation, with a five-year price-to-sales ratio at the 48.5th percentile, indicating potential undervaluation in the innovative drug sector [6].