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港股异动 | 康宁杰瑞制药-B(09966)涨超6% 近日SKN033的一项II期临床试验IND申请获受理
智通财经网· 2026-01-08 02:37
JSKN033-202是一项开放、多中心、II期临床试验,旨在评估JSKN033联合铂类化疗联合或不联合贝伐 珠单抗一线治疗晚期宫颈癌患者的安全性、有效性及药代动力学╱药效学特征。所有患者将接受 JSKN033联合顺铂或卡铂联合或不联合贝伐珠单抗的治疗。铂类药物的选择和是否联用贝伐珠单抗将由 研究者根据患者的具体情况决定。 康宁杰瑞制药-B(09966)涨超6%,截至发稿,涨6.76%,报10.89港元,成交额1041.75万港元。 消息面上,近日,康宁杰瑞制药-B发布公告,JSKN033(一种由抗人表皮生长因子受体2(HER2)双特异性 抗体偶联药物(ADC(s))与程序性死亡配体1(PDL1)免疫检查点抑制剂组成的高浓度皮下注射复方制剂)联 合铂类化疗联合或不联合贝伐珠单抗一线治疗晚期宫颈癌的一项II期临床试验的新药临床试验(IND)申 请,已获国家药品监督管理局药品审评中心(CDE)正式受理。 ...
康宁杰瑞制药-B涨超6% 近日SKN033的一项II期临床试验IND申请获受理
Zhi Tong Cai Jing· 2026-01-08 02:16
消息面上,近日,康宁杰瑞制药-B发布公告,JSKN033(一种由抗人表皮生长因子受体2(HER2)双特异性 抗体偶联药物(ADC(s))与程序性死亡配体1(PDL1)免疫检查点抑制剂组成的高浓度皮下注射复方制剂)联 合铂类化疗联合或不联合贝伐珠单抗一线治疗晚期宫颈癌的一项II期临床试验的新药临床试验(IND)申 请,已获国家药品监督管理局药品审评中心(CDE)正式受理。 康宁杰瑞制药-B(09966)涨超6%,截至发稿,涨6.76%,报10.89港元,成交额1041.75万港元。 JSKN033-202是一项开放、多中心、II期临床试验,旨在评估JSKN033联合铂类化疗联合或不联合贝伐 珠单抗一线治疗晚期宫颈癌患者的安全性、有效性及药代动力学╱药效学特征。所有患者将接受 JSKN033联合顺铂或卡铂联合或不联合贝伐珠单抗的治疗。铂类药物的选择和是否联用贝伐珠单抗将由 研究者根据患者的具体情况决定。 ...
趋势研判!2026年中国双特异性抗体药物行业政策、产业链、市场规模、应用分布、竞争格局及未来展望:中国市场规模有望增至15亿美元,约占全球5.60%[图]
Chan Ye Xin Xi Wang· 2026-01-08 01:34
Core Viewpoint - The bispecific antibody drug market is rapidly expanding, with significant applications in cancer treatment, autoimmune diseases, and infections, and is projected to reach a global market size of $19.1 billion by 2025 and $26.8 billion by 2026 [1][5]. Group 1: Market Overview - The global bispecific antibody drug market is expected to grow to $19.1 billion by 2025, with China's market size projected at approximately $800 million, accounting for about 4.19% of the global market [5]. - By 2026, the global bispecific antibody drug market is anticipated to reach $26.8 billion, with China's market size expected to be around $1.5 billion, representing about 5.60% of the global market [5]. - Nearly 80% of the drug pipeline for bispecific antibodies is concentrated in the cancer treatment sector, particularly in solid tumors [7]. Group 2: Industry Definition and Mechanism - Bispecific antibodies, also known as bispecific or dual-function antibodies, can bind to two different antigens or two different epitopes of the same antigen, enhancing therapeutic effects and reducing adverse reactions [3][4]. - The primary mechanisms of bispecific antibodies include mediating immune cell killing, blocking dual-target signals, and promoting the formation of functional protein complexes [5]. Group 3: Industry Chain - The upstream of the bispecific antibody industry chain involves raw materials such as cell culture media, chromatography media, and key equipment like bioreactors and detection devices [9]. - The midstream focuses on the research and production of bispecific antibody drugs, while the downstream is primarily composed of medical institutions, especially large hospitals specializing in oncology and autoimmune diseases [9]. Group 4: Competitive Landscape - Major global players in the bispecific antibody field include Roche, Amgen, Johnson & Johnson, and several others, while domestic companies include BeiGene, Innovent Biologics, and others [11]. - The development of bispecific antibodies is still in progress, with ongoing exploration of target combination strategies and production technologies [11]. Group 5: Future Outlook - The future of bispecific antibodies lies in their application in cancer treatment and tissue regeneration, with a focus on addressing multiple targets in pathological processes to enhance therapeutic efficacy [14]. - New strategies and clinical trials are emerging, indicating a potential for new bispecific antibody drugs to be approved for market entry soon [14].
康宁杰瑞制药(09966) - 截至二零二五年十二月三十一日止月份之股份发行人的证券变动月报表
2026-01-06 09:00
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 康寧傑瑞生物製藥 呈交日期: 2026年1月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,100,000,000 | USD | | 0.000002 USD | | 50,200 | | 增加 / 減少 (-) | | | | 0 | | USD | | 0 | | 本月底結存 | | | 25,100,000,000 | USD | | 0.000002 USD | | 50,200 | 本月底法定/註冊股本總額: USD 5 ...
康宁杰瑞制药-B(09966.HK)12月31日回购50.00万股,耗资483.35万港元
康宁杰瑞制药-B回购明细 | 日期 | 回购股数(万股) | 回购最高价(港元) | 回购最低价(港元) | 回购金额(万港元) | | --- | --- | --- | --- | --- | | 2025.12.31 | 50.00 | 9.870 | 9.500 | 483.35 | | 2025.12.01 | 23.60 | 10.480 | 10.250 | 245.73 | | 2025.11.17 | 35.00 | 9.860 | 9.640 | 341.98 | | 2025.11.07 | 56.00 | 9.520 | 9.240 | 526.10 | | 2025.10.28 | 32.00 | 11.970 | 11.530 | 376.84 | | 2025.10.16 | 40.00 | 13.820 | 13.520 | 548.30 | | 2025.10.14 | 29.30 | 13.830 | 13.030 | 396.69 | | 2025.10.13 | 10.80 | 13.800 | 13.690 | 148.60 | (文章来源:证券时报网) 证券时报·数 ...
康宁杰瑞制药-B(09966)12月31日斥资483.35万港元回购50万股
Zhi Tong Cai Jing· 2025-12-31 09:20
Group 1 - The company Corning Jereh Pharmaceutical-B (09966) announced a share buyback plan [1] - The company will spend HKD 4.8335 million to repurchase 500,000 shares [1] - The buyback is scheduled to be completed by December 31, 2025 [1]
康宁杰瑞制药-B(09966.HK)12月31日耗资483.35万港元回购50万股
Ge Long Hui· 2025-12-31 09:13
格隆汇12月31日丨康宁杰瑞制药-B(09966.HK)发布公告,2025年12月31日耗资483.35万港元回购50万 股,回购价格每股9.5-9.87港元。 ...
康宁杰瑞制药(09966) - 翌日披露报表
2025-12-31 08:57
翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 康寧傑瑞生物製藥 呈交日期: 2025年12月31日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份(不包括庫存股份)數 目 | | 佔有關事件前 ...
康宁杰瑞制药-B(09966):JSKN033的一项II期临床试验的IND申请获CDE正式受理
智通财经网· 2025-12-29 04:25
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]
康宁杰瑞制药-B:JSKN033的一项II期临床试验的IND申请获CDE正式受理
Zhi Tong Cai Jing· 2025-12-29 04:24
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for treating patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]