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宜明昂科-B:IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
Zhi Tong Cai Jing· 2025-09-29 15:04
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of China, marking a significant step in the development of a novel dual-targeting bispecific molecule for cancer treatment [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-Fc RIIa and Fc-Fc RIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving therapeutic outcomes [1] Group 2: Intellectual Property and Commercialization - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]
宜明昂科(01541) - 自愿公告 - IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
2025-09-29 14:54
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 由本集團獨立研發的IMM0306是一種靶向分化簇47(CD47)及分化簇20(CD20)的 雙特異性分子,是全球首個進入臨床階段的CD47和CD20雙靶向雙特異性分子。 IMM0306透過抑制CD47-SIRPα相互作用來阻斷「別吃我」訊號,增強Fc-FcɣRIIa 和Fc-FcɣRIIIa相互作用來激活巨噬細胞和NK細胞,並優先結合CD20而非CD47, 以有效消除惡性B細胞,同時將毒性降至最低,從而可改善治療效果。 – 1 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 宜明昂科生物醫藥技術(上海)股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1541) 自願公告 IMM0306治療濾泡性淋巴瘤的III期臨床試驗申請 本公告由宜明昂科生物醫藥技術(上海)股份有限公司(「本公司」,連同其附屬 公司統稱「本集團」)自願作出,以告知本公 ...
港股医药股多数走强 宜明昂科-B涨18.98%
Mei Ri Jing Ji Xin Wen· 2025-09-29 07:03
Group 1 - The Hong Kong pharmaceutical stocks showed a strong performance on September 29, with most companies experiencing significant gains [1] - Yiming Anke-B (01541.HK) increased by 18.98%, reaching HKD 13.48 [1] - Chuangxin Biotechnology-B (02509.HK) rose by 12.11%, trading at HKD 32.96 [1] - Jingtai Holdings (02228.HK) saw an increase of 8.55%, priced at HKD 13.2 [1] - Gakosi-B (01167.HK) gained 7.58%, with a price of HKD 9.94 [1] - Rongchang Biotechnology (09995.HK) experienced a rise of 6.37%, reaching HKD 108.5 [1]
医药股多数走强 特朗普药品关税影响有限 机构称四季度BD事件值得期待
Zhi Tong Cai Jing· 2025-09-29 06:53
Group 1 - The pharmaceutical stocks have shown a strong performance, with notable increases in share prices for companies such as Yiming Anke-B (up 18.98%), Quansheng Biotechnology-B (up 12.11%), and others [1] - On September 25, Trump announced a 100% tariff on patented and branded drugs, with the only exemption for companies that are "IS BUILDING" pharmaceutical factories in the U.S. [1] - According to CMB International, the impact on China's innovative drug industry chain is limited, and there is no need for excessive concern [1] Group 2 - Guojin Securities noted recent fluctuations in the innovative drug sector due to a lack of authoritative academic conferences in July and August, leading to a decrease in business development (BD) events [2] - Historically, significant BD transactions tend to cluster towards the end of the year, and upcoming authoritative academic meetings in October, such as the ESMO conference, are expected to boost BD events [2] - The outlook remains positive for the global competitiveness of Chinese innovative drugs, driven by operational improvements and an increase in BD collaborations [2]
港股异动 | 医药股多数走强 特朗普药品关税影响有限 机构称四季度BD事件值得期待
智通财经网· 2025-09-29 06:50
Group 1 - The pharmaceutical stocks have shown strong performance, with notable increases in share prices for companies such as Yiming Anke-B (up 18.98%), Quansheng Biotechnology-B (up 12.11%), and others [1] - On September 25, Trump announced a 100% tariff on patented and branded drugs, with the only exemption for companies that are "IS BUILDING" pharmaceutical factories in the U.S. [1] - According to CMB International, the impact on China's innovative drug industry chain is limited, and there is no need for excessive concern [1] Group 2 - Guojin Securities noted recent fluctuations in the innovative drug sector due to a lack of authoritative academic conferences in July and August, leading to a decrease in BD events [2] - The firm anticipates that with the upcoming ESMO conference in October, there will be an increase in BD events, which are expected to enhance the global competitiveness of Chinese innovative drugs [2] - The industry trend indicates improvements in operational performance and a concentration of BD collaborations [2]
港股午评|恒生指数早盘涨1.35% 中资券商板块回暖
智通财经网· 2025-09-29 04:06
Market Overview - The Hang Seng Index rose by 1.35%, gaining 352 points to close at 26,480 points, while the Hang Seng Tech Index increased by 1.31%. The early trading volume in Hong Kong reached HKD 160 billion [1]. Brokerage Sector - Chinese brokerage stocks showed recovery in early trading, with optimistic third-quarter performance expectations. Institutions predict a further increase in year-on-year growth rates. Dongfang Securities surged over 8%, Huatai Securities rose over 6%, and CITIC Securities increased by over 7% [1]. Semiconductor Sector - Chip stocks experienced a rise, with leading companies accelerating their listings. Institutions maintain a solid long-term outlook for domestic substitution. Hua Hong Semiconductor increased by 3.8%, SMIC rose by 1.4%, and Shanghai Fudan gained 1% [1]. Metals Sector - The non-ferrous metals sector was active, supported by a growth stabilization plan for the industry. Institutions are optimistic about the continued rise in industrial metal prices. Ganfeng Lithium rose by 6.01%, China Aluminum International increased by 5%, Zhaojin Mining gained 3.4%, and Luoyang Molybdenum rose by 3.44% [1]. Energy Storage Sector - Ruipu Lanjun saw a significant increase of over 17% after signing a supply agreement with Energy Vault for a 3GWh energy storage system [1]. PCB Sector - Jiantao Laminates rose over 7%, with institutions indicating that product upgrades and rising copper foil prices are expected to contribute to performance growth [1]. Gaming Sector - Gaming stocks continued their recent upward trend, with Amax Holdings increasing by 5.7%. The number of tourists in Macau during the National Day holiday is expected to exceed last year’s figures [1]. Biotechnology Sector - Rongchang Bio increased by 4.7% as its drug Taitasip was proposed for priority review, achieving the primary endpoint in Phase III trials for IgA nephropathy [2]. AI and Pharmaceutical Collaboration - Jingtai Holdings rose over 6% as it collaborates with Baicheng Pharmaceutical to advance AI drug development, seeking strategic synergy with China Merchants Group [2]. Education Sector - New Oriental Education rose over 5%, with overall business development stabilizing and an increase in shareholder return ratios potentially acting as a positive catalyst [2]. Fuel Cell Sector - Yihua Tong surged over 10% as it participated in the EPC bidding for a large-scale wind-hydrogen integration project, promoting the large-scale application of fuel cell vehicles [2]. Robotics Sector - Yunzhihui Technology increased by over 17% after announcing potential collaboration with UBTECH in the humanoid robot business [2]. Clinical Trials - Yiming Anke-B rose over 15% after submitting two Phase III registration clinical trials for IMM2510 [2]. Material Sector - Global New Materials International rose over 6%, with institutions stating that the consolidation of Merck's Susonity business in the second half of the year will contribute to the company's performance growth [2].
港股异动 | 宜明昂科-B(01541)涨超12% IMM2510两项III期注册临床试验已递...
Xin Lang Cai Jing· 2025-09-29 02:52
值得一提的是,国元国际指出,公司在2025年世界肺癌大会上公布IMM2510单药在晚期肺鳞状非小细 胞肺癌(sq-NSCLC)患者中的初步疗效与安全性数据,数据来源于I期临床研究的剂量递增及队列扩展阶 段。IMM2510此次公布单药治疗的ORR为35.3%,PFS为9.4个月,临床数据优秀,安全性良好。 消息面上,据动脉网报道,近日,宜明昂科自主研发的VEGF×PD-L1双特异性抗体IMM2510,已向国 家药品监督管理局药品审评中心递交两项针对不同类型肺癌的III期注册临床试验的EOP2沟通交流申 请,标志着其临床开发进入关键阶段。 据介绍,IMM2510基于"mAb-Trap"技术平台研发,通过多重机制发挥抗肿瘤作用。I期临床研究显示, IMM2510治疗经免疫治疗的晚期鳞状非小细胞肺癌客观缓解率达35.3%,疾病控制率为76.5%,中位无 进展生存期为9.4个月,安全性可控;II期初步数据显示联合化疗一线治疗NSCLC效果显著。基于积极结 果,宜明昂科计划在III期临床试验中进一步验证IMM2510的疗效和安全性。 来源:智通财经网 宜明昂科-B(01541)涨超12%,截至发稿,涨12.27%,报12 ...
港股宜明昂科-B涨超12%
Mei Ri Jing Ji Xin Wen· 2025-09-29 02:52
每经AI快讯,9月29日,港股宜明昂科-B(01541.HK)涨超12%,截至发稿,涨12.27%,报12.72港元,成 交额2390.9万港元。 ...
港股异动 | 宜明昂科-B(01541)涨超12% IMM2510两项III期注册临床试验已递交EOP2
Zhi Tong Cai Jing· 2025-09-29 02:52
据介绍,IMM2510基于"mAb-Trap"技术平台研发,通过多重机制发挥抗肿瘤作用。I期临床研究显示, IMM2510治疗经免疫治疗的晚期鳞状非小细胞肺癌客观缓解率达35.3%,疾病控制率为76.5%,中位无 进展生存期为9.4个月,安全性可控;II期初步数据显示联合化疗一线治疗NSCLC效果显著。基于积极结 果,宜明昂科计划在III期临床试验中进一步验证IMM2510的疗效和安全性。 值得一提的是,国元国际指出,公司在2025年世界肺癌大会上公布IMM2510单药在晚期肺鳞状非小细 胞肺癌(sq-NSCLC)患者中的初步疗效与安全性数据,数据来源于I期临床研究的剂量递增及队列扩展阶 段。IMM2510此次公布单药治疗的ORR为35.3%,PFS为9.4个月,临床数据优秀,安全性良好。 (原标题:港股异动 | 宜明昂科-B(01541)涨超12% IMM2510两项III期注册临床试验已递交EOP2) 智通财经APP获悉,宜明昂科-B(01541)涨超12%,截至发稿,涨12.27%,报12.72港元,成交额2390.9万 港元。 消息面上,据动脉网报道,近日,宜明昂科自主研发的VEGF×PD-L1双特异 ...
宜明昂科-B涨超12% IMM2510两项III期注册临床试验已递交EOP2
Zhi Tong Cai Jing· 2025-09-29 02:42
Group 1 - The stock of Yiming Oncology-B (01541) increased by over 12%, reaching HKD 12.72 with a trading volume of HKD 23.9 million [1] - Yiming Oncology has submitted two EOP2 communication requests for its self-developed VEGF×PD-L1 bispecific antibody IMM2510 to the National Medical Products Administration for Phase III clinical trials targeting different types of lung cancer, marking a critical stage in its clinical development [1] - The IMM2510 is developed based on the "mAb-Trap" technology platform and demonstrates antitumor effects through multiple mechanisms [1] Group 2 - Phase I clinical trials showed that IMM2510 achieved an objective response rate (ORR) of 35.3% and a disease control rate of 76.5% in patients with advanced squamous non-small cell lung cancer (sq-NSCLC), with a median progression-free survival (PFS) of 9.4 months and manageable safety [1][2] - Preliminary data from the Phase I clinical study presented at the 2025 World Lung Cancer Conference indicated excellent clinical data and good safety for IMM2510 as a monotherapy in advanced sq-NSCLC patients [2] - Based on positive results, Yiming Oncology plans to further validate the efficacy and safety of IMM2510 in Phase III clinical trials [1]