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科济药业-B(02171.HK):于2025年第22届IMS年会上呈列的赛恺泽?的研究成果更新
Ge Long Hui· 2025-09-18 00:25
Core Insights - Company Kogei Pharmaceuticals-B (02171.HK) announced the long-term follow-up results of its product Zevor-cel (CT053), a targeted BCMA autologous CAR-T cell therapy, which were presented at the 22nd International Myeloma Society (IMS) annual meeting [1] Group 1 - The updated results of the Phase I clinical trial for Zevor-cel were showcased in a poster presentation at the IMS annual meeting held on September 17, 2025, in Toronto [1]
科济药业-B(02171)于2025年第22届IMS年会上呈列的赛恺泽?的研究成果更新
Zhi Tong Cai Jing· 2025-09-18 00:18
Core Viewpoint - The long-term follow-up results of the CAR-T cell product Zevor-cel (CT053) 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 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 under the title "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" at the IMS annual meeting on September 17, 2025 [1]
科济药业-B(02171)于2025年第22届IMS年会上呈列的赛恺泽的研究成果更新
智通财经网· 2025-09-18 00:09
Core Insights - 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 (IMS) annual meeting [1] - Zevor-cel is an autologous CAR-T cell therapy targeting BCMA, approved by the National Medical Products Administration (NMPA) in China for adult patients with relapsed or refractory multiple myeloma who have undergone at least three lines of treatment [1] - The product received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status in 2019, indicating its potential significance in treating rare diseases [1] Company Overview - 科济药业-B (02171) is focused on developing innovative therapies for hematological malignancies, with Zevor-cel being a key product in its pipeline [1] - The company aims to address unmet medical needs in the treatment of multiple myeloma, a challenging condition with limited effective therapies available [1] Clinical Development - The Phase I clinical trial results of Zevor-cel were updated and showcased at the IMS annual meeting, highlighting the ongoing commitment to research and development in the field of CAR-T therapies [1] - The long-term follow-up data is crucial for understanding the efficacy and safety profile of Zevor-cel in a real-world patient population [1]
科济药业-B于2025年第22届IMS年会上呈列的赛恺泽 的研究成果更新
Zhi Tong Cai Jing· 2025-09-18 00:07
Core Viewpoint - The long-term follow-up results of the CAR-T cell therapy product Zevor-cel for treating relapsed/refractory multiple myeloma have been presented at the 22nd International Myeloma Society (IMS) Annual Meeting [1] Group 1: Product Information - Zevor-cel (CT053) is a fully human anti-BCMA CAR-T cell product designed for the treatment of multiple myeloma (MM) [1] - The National Medical Products Administration approved Zevor-cel for marketing on February 23, 2024, for adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - The product has received the Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status from 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 of 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]
科济药业-B(02171.HK):于2025年第22届IMS年会上呈列的赛恺泽®的研究成果更新
Ge Long Hui· 2025-09-18 00:06
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]
科济药业-B(02171)于2025年第22届IMS年会上呈列的赛恺泽®的研究成果更新
智通财经网· 2025-09-18 00:06
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]
破译生命密码、挑战衰老极限……AI如何重塑未来人类健康
Ke Ji Ri Bao· 2025-09-18 00:00
Core Insights - The article discusses the transformative role of artificial intelligence (AI) in understanding and manipulating biological processes, particularly in the context of human health and disease management [2][4][6]. Group 1: AI in Biological Research - AI is redefining biology by interpreting protein sequences as a language, enabling the identification of patterns within amino acid chains [2]. - Companies like Dyno are utilizing AI to design viral capsids for safer and more efficient gene therapies, potentially leading to personalized treatments for rare diseases [2]. - Wake Bio is developing technology for whole-body cryopreservation using machine learning to create cryoprotectants that maintain cell integrity during freezing and thawing [3]. Group 2: Accelerating Scientific Discovery - The organization "Future House" aims to accelerate scientific research through AI agents that can autonomously analyze biological data, generate hypotheses, and validate them through digital experiments [4][5]. - Their AI models can significantly reduce the time and cost associated with scientific research, exemplified by the identification of a new candidate drug for age-related macular degeneration [4]. Group 3: Aging and Health - Retro Bio is focused on using AI to understand the aging process, particularly how proteins function and interact, which is crucial for addressing age-related diseases [6]. - The collaboration with OpenAI has led to advancements in cellular reprogramming techniques, potentially allowing for biological rejuvenation and the reversal of aging effects [6]. Group 4: Challenges and Future Outlook - The integration of AI in medicine raises concerns about the "black box" nature of AI decision-making, which can create unease among stakeholders [6]. - As AI continues to permeate the medical field, it is expected to become an essential tool for extending life and improving health outcomes, shifting perceptions from skepticism to acceptance [6].
轩竹生物通过港交所聆讯 首款获批产品KBP-3571已取得商业化收入
Zhi Tong Cai Jing· 2025-09-17 23:24
Core Viewpoint - Xuan Bamboo Biotechnology Co., Ltd. is undergoing a listing hearing on the Hong Kong Stock Exchange, with CICC serving as its sole sponsor [1] Company Overview - Xuan Bamboo Biotechnology is an innovative Chinese biopharmaceutical company focused on improving patient health and addressing unique clinical needs in the Chinese pharmaceutical industry [4] - The company has established a comprehensive internal R&D platform since its acquisition by Sihuan Pharmaceutical Holdings Group in 2008, supporting a diverse and balanced pipeline [4] Product Pipeline - As of September 10, 2025, the company has over ten drug assets actively in development, targeting diseases such as digestive system disorders, tumors, and non-alcoholic fatty liver disease (NASH) [4] - The pipeline includes three core products: - KBP-3571, an NDA-approved innovative proton pump inhibitor (PPI) for digestive system diseases - XZP-3287, an NDA-approved CDK4/6 inhibitor for breast cancer - XZP-3621, an NDA-approved ALK inhibitor for non-small cell lung cancer (NSCLC) [4][6] Drug Development and Commercialization - The company has demonstrated exceptional speed and execution in drug development, having obtained a total of 20 IND approvals [5] - The first approved product, KBP-3571, achieved sales of RMB 32.7 million since commercialization until March 31, 2025, showcasing the company's commercialization capabilities [6] - The company is expanding the indications for its core products and has several other oncology drug assets in various stages of clinical trials [7] Financial Performance - For the three months ending March 31 in 2023, 2024, and 2025, the company's revenues were RMB 29,000, RMB 30.094 million, and RMB 2.559 million, respectively [8] - R&D expenses for the same periods were approximately RMB 239.061 million, RMB 186.395 million, and RMB 53.044 million [8] - The company reported a pre-tax loss of RMB 300.556 million, RMB 556.424 million, and RMB 65.455 million for the respective periods [8]
新股消息 | 轩竹生物通过港交所聆讯 首款获批产品KBP-3571已取得商业化收入
智通财经网· 2025-09-17 23:23
Core Viewpoint - XuanZhu Biotechnology Co., Ltd. is undergoing a listing hearing on the Hong Kong Stock Exchange, with CICC as its sole sponsor [1] Company Overview - XuanZhu Biotechnology is an innovative Chinese biopharmaceutical company focused on improving patient health and addressing unique clinical needs in the Chinese pharmaceutical industry [4] - The company has established a comprehensive internal R&D platform since its acquisition by Sihuan Pharmaceutical Holdings Group in 2008, supporting a diverse and balanced pipeline [4] Product Pipeline - As of September 10, 2025, the company has over ten drug assets actively in development, targeting diseases such as digestive system disorders, tumors, and non-alcoholic fatty liver disease (NASH) [4] - The pipeline includes three core products: KBP-3571 (NDA approved for digestive system diseases), XZP-3287 (NDA approved for targeted breast cancer treatment), and XZP-3621 (NDA approved for targeted non-small cell lung cancer treatment) [4][6] Drug Development and Commercialization - The company has demonstrated exceptional speed and execution in drug development, having obtained a total of 20 IND approvals [5] - KBP-3571 has generated sales of RMB 32.7 million since its commercialization, indicating the company's capability in commercialization [6] - The company is expanding the indications for its core products and has several other oncology drug assets in various stages of clinical trials [7] Financial Performance - For the three months ending March 31 in 2023, 2024, and 2025, the company's revenues were RMB 29,000, RMB 30.094 million, and RMB 2.559 million, respectively [8] - R&D expenses for the same periods were approximately RMB 239.061 million, RMB 186.395 million, and RMB 53.044 million [8]
杭州嘉因生物:做出惠及大众的划时代创新药
Mei Ri Shang Bao· 2025-09-17 22:23
Core Viewpoint - Gene therapy is emerging as a revolutionary treatment method in the biopharmaceutical field, with companies like Hangzhou Jiayin Biotechnology aiming to make it more accessible and affordable for patients [6][10]. Company Overview - Hangzhou Jiayin Biotechnology, established in 2019, focuses on gene therapy and has developed multiple research pipelines in ophthalmology and neurology [6][8]. - The company has successfully advanced three projects to clinical stages within five years, emphasizing innovation as a key driver [11]. Product Development - The company’s gene therapy product EXG102-031 has received FDA approval for clinical trials in the U.S. and is currently in Phase III trials after completing Phase II in China [7][8]. - EXG102-031 targets age-related macular degeneration, offering a single injection solution that can effectively express therapeutic proteins to prevent abnormal blood vessel formation [8]. - Another product, EXG001-307, is aimed at treating spinal muscular atrophy (SMA) and has shown promising results in clinical trials, with all treated patients surviving without respiratory support [9][10]. Innovation and Infrastructure - The company has established a GMP production platform covering over 12,000 square meters, which supports the entire gene therapy production chain and aims to reduce costs through optimized processes [11][12]. - A highly qualified research team, with over 50% holding master's degrees or higher, drives the company’s innovation efforts [12]. Industry Context - The gene therapy market in China is still in its infancy, with few participants, but is expected to grow significantly as companies like Hangzhou Jiayin Biotechnology push forward [11]. - The company believes that private enterprises play a crucial role in technological innovation, particularly in the biopharmaceutical sector, due to their agility and collaborative capabilities [12].