赛恺泽® I期临床试验更新结果已于多伦多时间2025年9月17日早上，在第22 届IMS年会上进行壁报展 示，标题为"复发╱难治性多发性骨髓瘤患者接受 zevor-cel治疗的长期随访"("Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma")。 赛恺泽®是一种用于治疗多发性骨髓瘤(MM)的全人抗自体BCMA CAR-T细胞产品。国家药品监督管理 局于2024年2月23日批准赛恺泽®新药上市申请，用于治疗复发或难治性多发性骨髓瘤成人患者，既往 经过至少3线治疗后进展(至少使用过一种蛋白酶体抑制剂及免疫调节剂)。泽沃基奥仑赛注射液于2019 年获得美国 FDA的再生医学先进疗法(RMAT)及孤儿药称号。 科济药业-B(02171)发布公告，赛恺泽®(泽沃基奥仑赛注射液，产品编号： CT053，一种靶向BCMA的 自体CAR-T细胞产品)的长期随访更新结果已在第 22届国际骨髓瘤学会年会上进行壁报展示。 ...

Core Insights - The company Kintor Pharmaceutical announced the long-term follow-up results of its CAR-T cell product, Zevor-cel, at the 22nd International Myeloma Society (IMS) annual meeting [1] Group 1 - The long-term follow-up results of the Phase I clinical trial for Zevor-cel were presented in a poster session at the IMS annual meeting [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

Core Viewpoint - The long-term follow-up results of the CAR-T cell product Zevor-cel (赛恺泽®) for treating relapsed/refractory multiple myeloma were presented at the 22nd International Myeloma Society Annual Meeting [1] Group 1: Product Information - Zevor-cel is an autologous CAR-T cell product targeting BCMA, specifically designed for the treatment of multiple myeloma (MM) [1] - The product received approval from the National Medical Products Administration on February 23, 2024, for use in adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - Zevor-cel was granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation by the FDA in 2019 [1] Group 2: Clinical Trial Updates - The updated results of the Phase I clinical trial were presented on September 17, 2025, at the IMS annual meeting, focusing on long-term follow-up for patients treated with Zevor-cel [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

Core Viewpoint - Huadong Medicine reported steady growth in its financial performance for the first half of 2025, driven by the successful launch of innovative products and a strategic shift from traditional generic drugs to innovative pharmaceuticals [1][2]. Financial Performance - The company achieved total revenue of 21.675 billion yuan, a year-on-year increase of 3.39% [1]. - The net profit attributable to shareholders reached 1.815 billion yuan, up 7.01% year-on-year, while the net profit after deducting non-recurring gains and losses was 1.762 billion yuan, reflecting an 8.40% increase [1]. - The core subsidiary, China-U.S. Huadong, reported revenue of 7.317 billion yuan, a 9.24% increase, and a net profit of 1.580 billion yuan, up 14.09% [5]. Innovative Product Growth - Sales and agency service revenue from innovative products reached 1.084 billion yuan, with a significant year-on-year growth of 59% [1]. - The CAR-T product, Zekai Ze® (注射液), has completed certifications in over 20 provinces and has received more than 111 valid orders, with over 100 insurance projects covering it [5][6]. - The company is also commercializing PARP inhibitor, Senapali capsules (派舒宁®), and has established a presence in over 600 medical institutions [6]. Market Dynamics and Competition - The competitive landscape is intensifying, with multinational pharmaceutical companies accelerating localization in China and domestic biotech firms potentially shortening Huadong's first-mover advantage [2]. - The company needs to continue investing in R&D and strengthen its commercialization network to address price wars and market share competition [2]. Research and Development Focus - Huadong Medicine is focusing on ADC and GLP-1 as its main research directions, with several ADC drugs in advanced clinical trials [8][9]. - The company has received orphan drug designation for its ADC drug HDM2005 and has initiated clinical trials for multiple innovative drugs targeting various diseases [8][9]. Future Outlook - Analysts predict that GLP-1 products will become the largest drug category globally in the next 3 to 5 years, although recent market expectations have been adjusted downward [10]. - The company's short-term stability is expected to remain strong, but its long-term competitiveness will depend on its ability to launch successful products in oncology and metabolic diseases [10].

Financial Performance - In the first half of 2025, the company achieved total revenue of CNY 21.675 billion, a year-on-year increase of 3.39% [2] - Net profit attributable to shareholders was CNY 1.815 billion, up 7.01% year-on-year [2] - The second quarter revenue reached CNY 10.939 billion, with a year-on-year growth of 3.65% [2] Pharmaceutical Sector Performance - The core subsidiary, China Medical East, reported revenue of CNY 7.317 billion, a 9.24% increase year-on-year, and a net profit of CNY 1.580 billion, up 14.09% [3] - The pharmaceutical industrial segment's innovative product sales reached CNY 1.084 billion, with a significant growth of 59% [3] Research and Development - The company invested CNY 1.484 billion in R&D, a 33.75% increase, with direct R&D expenses at CNY 1.174 billion, up 54.21% [4] - The R&D expenditure accounted for 15.97% of the pharmaceutical industrial revenue [4] - Over 80 innovative drug pipelines are currently under development, focusing on endocrine, autoimmune, and oncology fields [5][6] Product Pipeline and Innovations - The company is advancing several ADC products, including HDM2005 and HDM2012, with clinical trials ongoing [7][8] - In the autoimmune sector, candidates like HDM3018 and HDM4002 are in IND development, targeting conditions such as inflammatory bowel disease and IgA nephropathy [10][11] - The oral GLP-1 receptor agonist HDM1002 has completed patient enrollment for its clinical trials [15][20] Market Outlook and Strategic Initiatives - The company plans to distribute a cash dividend of CNY 614 million, representing 33.83% of the net profit [5] - The innovative product revenue is expected to continue rising, with a current contribution of nearly 15% to the pharmaceutical industrial revenue [14] - The newly established pharmaceutical investment fund will focus on innovative drugs, medical aesthetics, and health-related projects [19]

Core Viewpoint - Huadong Medicine reported steady performance in the first half of 2025, with revenue of 21.675 billion yuan, a year-on-year increase of 3.39%, and a net profit of 1.815 billion yuan, up 7.01% [2] Financial Performance - The company achieved a non-deductible net profit of 1.762 billion yuan, reflecting an 8.40% year-on-year growth [2] - The core subsidiary, China-U.S. Huadong, generated revenue of 7.317 billion yuan, a 9.24% increase, and a net profit of 1.580 billion yuan, up 14.09% [3] - In Q2 2025, revenue reached 3.696 billion yuan, with a 12.04% growth, and net profit was 737 million yuan, increasing by 16.34% [3] Innovation Product Growth - The innovative product segment saw significant growth, with sales and agency service revenue totaling 1.084 billion yuan, a 59% increase year-on-year [2] - The CAR-T product, Zekai Ze® (泽沃基奥仑赛注射液), has completed certification in over 20 provinces and has received more than 111 valid orders [4] - The product has been included in reimbursement programs by over 100 insurance and welfare projects, indicating a strong growth trajectory [4] Commercialization and Market Strategy - The company is focusing on the commercialization of innovative products, including PARP inhibitor Senaparib capsules (派舒宁®) and somatostatin analog Elahere® (爱拉赫®) [5] - Elahere® has achieved sales of approximately 30 million yuan in the Guangdong-Hong Kong-Macao Greater Bay Area and is set for formal commercialization in Q4 2025 [5] - The CSO business is highlighted as a key growth area, driven by increasing demand from Biotech companies and the need for specialized commercialization services [6] Competitive Landscape - The competitive environment is intensifying, with multinational pharmaceutical companies accelerating localization in China and domestic Biotech firms advancing in similar target research [3] - The ADC (Antibody-Drug Conjugate) market is projected to grow significantly, with a compound annual growth rate of 39.1% from 2018 to 2023, reaching a market size of 66.2 billion dollars by 2030 [7] - Huadong Medicine is focusing on differentiated competition through self-developed products, particularly in ADC and GLP-1 areas [7][8] Future Outlook - Analysts predict that GLP-1 products will become the largest drug category globally in the next 3 to 5 years, despite recent adjustments in market expectations [9] - The company's ability to launch successful products in oncology and metabolic diseases will be crucial for its long-term competitiveness [10]

Financial Performance - In the first half of 2025, the company achieved total revenue of 21.675 billion yuan, a year-on-year increase of 3.39% [2] - The net profit attributable to shareholders reached 1.815 billion yuan, up 7.01% year-on-year, while the net profit after deducting non-recurring gains and losses was 1.762 billion yuan, reflecting an 8.40% increase [2] - The company plans to distribute a dividend of 614 million yuan, accounting for 33.83% of the net profit attributable to shareholders for the first half of 2025 [2] Product Commercialization - The core subsidiary, Sinopharm East China, reported revenue of 7.317 billion yuan, a 9.24% increase year-on-year, and a net profit of 1.580 billion yuan, up 14.09% [3] - The innovative product business has seen significant growth, with sales and agency service revenue reaching 1.084 billion yuan, a 59% increase year-on-year [3] - The CAR-T product, Zekai Ze® (泽沃基奥仑赛注射液), has received positive clinical feedback and has expanded its market coverage, with over 111 effective orders placed [3] R&D and Pipeline Development - The company invested 1.484 billion yuan in R&D in the first half of 2025, a 33.75% increase, with direct R&D expenses of 1.174 billion yuan, up 54.21% [5] - The company is advancing over 80 innovative drug pipelines, focusing on oncology, endocrinology, and autoimmune diseases, with several first-in-class drugs already launched [5] - The company has established a "golden product combination" for psoriasis treatment, offering a range of options for patients [5] Strategic Collaboration and Market Expansion - The company is collaborating with Qianxin Biotech on the innovative drug HDM3016, which is currently in Phase III clinical trials for two indications [5][6] - The company is also expanding its medical aesthetics segment, with 40 international products, 26 of which have been launched globally [7] - The medical commercial sector achieved revenue of 13.947 billion yuan, a 2.91% increase year-on-year, while the industrial microbiology sector is enhancing its international competitiveness [7]

Core Viewpoint - Kintor Pharmaceutical's H1 financial results show a significant reduction in net loss, driven by increased product sales, particularly from its CAR-T therapy, with a focus on the upcoming NDA submission for its CT041 product targeting solid tumors [1][2]. Financial Performance - Kintor reported revenues of approximately 51 million yuan in H1 2025, a substantial increase from 6.34 million yuan in the same period of 2024, primarily due to sales growth from its product, Sai Ke Zai [1]. - The gross profit for the period was around 29 million yuan, with a net loss of 75 million yuan, which is a reduction of 277 million yuan compared to the previous year [1]. Product Development and Market Position - The company submitted a New Drug Application (NDA) for CT041, which is the first and only CAR-T cell product submitted for treating solid tumors globally [1]. - CEO Li Zonghai indicated that the review process for CT041 is proceeding normally, with optimistic expectations for approval in Q1 or Q2 of next year [2]. Market Strategy and Opportunities - Kintor is actively exploring commercial opportunities both domestically and internationally, including partnerships with overseas pharmaceutical companies [2]. - The company is focusing on expanding its market presence in the post-operative treatment of gastric cancer, which currently lacks effective therapies beyond chemotherapy [2]. Insurance and Pricing Strategy - Kintor is engaged in discussions regarding the inclusion of its products in the commercial insurance innovation drug directory, which could enhance patient access [3]. - The company is considering the implications of pricing strategies if its products are included in insurance coverage, emphasizing a comprehensive approach beyond simple price reductions [3].