Workflow
贝伐珠单抗
icon
Search documents
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。 ...
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
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)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(研究编号:JSKN033- 202)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: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
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)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(研究编号:JSKN033-202)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。 ...
华兰生物:公司参股公司开展创新药和生物类似药的研发、生产
Zheng Quan Ri Bao· 2025-12-25 12:45
证券日报网讯 12月25日,华兰生物在互动平台回答投资者提问时表示,公司参股公司开展创新药和生 物类似药的研发、生产。贝伐珠单抗已于2024年11月取得药品注册证书,开始正式生产和销售;利妥昔 单抗、地舒单抗分别于2024年11月、2025年12月完成临床研究并递交药品注册上市许可申请并被受理; 阿达木单抗、曲妥珠单抗、伊匹木单抗、帕尼单抗、重组抗Claudin18.2全人源单克隆抗体注射液、重组 抗PD-L1和TGF-β双功能融合蛋白注射液、重组抗BCMA和CD3双特异性抗体注射液等已取得临床批 件,正在开展相关临床研究,为公司培育新的利润增长点,丰富公司的产品梯队。 (文章来源:证券日报) ...
STTT:王洁团队发现肺癌脑转移治疗新靶点——LCN2
生物世界· 2025-12-24 04:21
撰文丨王聪 编辑丨王多鱼 排版丨水成文 脑转移 ( Brain metastasis ) 是 肺癌 患者死亡的主要原因。大脑独特的微环境在 脑转移瘤 (BM) 的发生和发展中发挥着关键作用,然而,其中肿瘤与微环 境相互作用的分子机制仍知之甚少。 2025 年 12 月 24 日,中国医学科学院肿瘤医院 王洁 教授团队在 Signal Transduction and Targeted Therap 期刊发表了题为: Lipocalin-2 drives brain metastatic progression through reciprocal tumor-microenvironment interactions in lung cancer 的研究论文。 该研究发现, LCN2 通过肺癌中肿瘤-微环境的相互作用,驱动脑转移进展。 这一发现突显了 LCN2 在驱动脑转移中的核心作用,并提出了脑转移性肺癌的一种 潜在治疗靶点。 论文链接 : https://www.nature.com/articles/s41392-025-02514-2 总的来说,这一发现突显了 LCN2 在驱动脑转移中的核心作用,并提 ...
全球首个EGFR ADC背后的"中国速度",解码东曜药业(1875.HK)的隐形秘钥
Ge Long Hui· 2025-12-22 02:22
随着一年即将进入尾声,回望今年港股市场,创新药板块表现最为亮眼。富途行情数据显示,截至12月 9日,生物医药B类股年内涨幅达119%,51只成分股中涨幅超过1倍的多达25只。 近期广发证券发布研报称,CDMO行业业绩已触底回升,基于新签订单及新分子的旺盛研发需求,各公 司2026年有望延续业绩优秀增长的趋势。其同时看好基本面强劲产能优势显著伴随行业复苏及新分子业 务高景气度受益的企业,以及伴随产能利用率提升带动盈利能力改善利润弹性空间大的公司。 ADC被誉为"生物导弹",其生产工艺之复杂、技术门槛之高,对企业的商业化生产能力及质量体系提出 了相当高的要求。在乐普生物这一项目中面临着供应链整合、时间紧迫及合规上市等多重挑战,东曜药 业能够助力客户突破重围,正是得益于其构建的三大核心能力矩阵。 首先,作为国内少有的ADC一站式CDMO开发企业,东曜药业在此次项目中凭借其预先构建的一站式 ADC服务平台,提供了从单抗原料药生产、ADC 偶联原液制备到制剂生产的端到端覆盖,实现了全流 程的无缝衔接与高效协同,为项目的成功推进奠定了坚实基础。 遵循这一方向笔者留意到东曜药业近期利好不断。此前,公司成功助力合作伙伴乐普生 ...
港股异动 | 康宁杰瑞制药-B(09966)再涨近5% JSKN003已获FDA授予突破性疗法认定
智通财经网· 2025-12-19 03:41
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a nearly 5% increase in stock price, attributed to the announcement of FDA granting Breakthrough Therapy Designation (BTD) for JSKN003, a treatment for specific types of ovarian cancer in patients previously treated with bevacizumab [1][1][1] Group 1: Company Developments - JSKN003 has received BTD from the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adults who have previously undergone bevacizumab treatment [1][1] - Prior to this, JSKN003 was approved by the FDA to conduct a Phase II clinical trial for treating PROC regardless of HER2 expression levels [1][1] - The drug has also received BTD from the National Medical Products Administration (NMPA) for PROC and colorectal cancer (CRC), as well as Fast Track designation and orphan drug status from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1][1][1] Group 2: Market Reaction - Following the announcement, Corning Jereh Pharmaceutical-B's stock price rose by 4.87%, reaching HKD 11.19, with a trading volume of HKD 8.53 million [1][1]
中国生物医药二级市场分析:从千金药业看千金不换的妇科药如何开辟增长新路径
Tou Bao Yan Jiu Yuan· 2025-12-01 11:56
Investment Rating - The report does not explicitly provide an investment rating for the gynecological drug industry in China. Core Insights - The biopharmaceutical industry in China is experiencing structural optimization, valuation recovery, and confidence rebuilding, particularly in the Hong Kong market, where the 18A system supports enterprise value discovery [2][3]. - Gynecological drug companies are characterized by specialized positioning and differentiated competition, focusing on areas such as traditional Chinese medicine, innovative treatments for gynecological tumors, and hormone drugs, showcasing strong professional images and commercialization capabilities [2][3]. Summary by Sections Capital Market Performance of China's Biopharmaceutical Sector - The A-share market has shifted from a focus on scale to sustainable development, while the Hong Kong market has attracted international capital through the 18A system, leading to a gradual rebuilding of long-term confidence in the biopharmaceutical sector [3][25]. - The A-share biopharmaceutical sector has seen a total fundraising amount of 787 billion yuan from January to October 2025, with a peak of 2,451 billion yuan in 2021, indicating a transition from a capital overheating phase to a rational development phase [13][18]. - In the Hong Kong market, the total fundraising amount reached 789 billion HKD from January to October 2025, with a peak of 1,833 billion HKD in 2020, reflecting a significant improvement in the financing environment [27][28]. Market Position Assessment of Chinese Gynecological Drug Companies - The competitive landscape of gynecological drug companies is marked by a focus on specialized fields such as innovative gynecological tumor drugs and hormone treatments, with companies establishing differentiated competitive advantages [40]. - Qianjin Pharmaceutical is recognized as a leading player in the gynecological drug market, with a strong market presence in oral gynecological inflammation traditional Chinese medicine [40]. - Heng Rui Pharmaceutical is noted for its robust pipeline in gynecological tumor treatments, with eight drugs in development as of 2024 [40]. - Xianju Pharmaceutical specializes in hormone treatments, with a focus on steroid drugs, establishing a strong professional image in the gynecological field [40]. Introduction to Representative Listed Chinese Gynecological Drug Companies - Qianjin Pharmaceutical has a significant market share of 25.8% in oral gynecological inflammation traditional Chinese medicine, demonstrating strong sales performance even in challenging market conditions [45]. - Heng Rui Pharmaceutical's research and development pipeline includes multiple innovative treatments for gynecological tumors, indicating a solid commitment to this therapeutic area [52][53]. - Xianju Pharmaceutical leverages its expertise in steroid drugs to maintain a competitive edge in the gynecological drug market, with a focus on cost-effective production and high-quality formulations [58][61].
百奥泰业绩会:预计未来两年会有更多产品加速进入海外市场
Core Viewpoint - 百奥泰 reported a revenue of 684 million yuan for the first three quarters of 2025, representing a year-on-year growth of 17.57%, while the net loss narrowed to 224 million yuan, indicating improved financial performance [1] Group 1: Financial Performance - The company achieved a revenue of 684 million yuan in the first three quarters, marking a 17.57% increase year-on-year [1] - The net loss for the same period was 224 million yuan, showing a reduction in losses compared to the previous year [1] Group 2: Product Development and Approvals - Several products have been approved for sale, including Adalimumab and Tocilizumab in China and other regions, and Bevacizumab in multiple countries [1] - BAT1806 (Tocilizumab) and BAT2206 (Ustekinumab) have been approved in Europe, with sales managed by partners [2][3] - The company is advancing its innovative drug pipeline, with BAT5906 and BAT4406F expected to submit applications for market approval soon [2][3] Group 3: Market Expansion and Strategy - The company is preparing for participation in centralized procurement, optimizing production capacity and supply chain to enhance competitiveness [2] - New guidelines in the EU and the US for biosimilars are expected to lower R&D costs, providing a competitive advantage for the company [2] Group 4: Clinical Trials and Research - BAT6026 is currently in Phase II clinical trials for atopic dermatitis, while BAT8008 is set to begin Phase III trials for cervical cancer and HER2-negative breast cancer in mid-2026 [3] - Ongoing clinical research for BAT8008 in combination with BAT1308 has shown positive efficacy signals, leading to an expansion of the sample size [3] - BAT7111 is in Phase I dose escalation studies, progressing smoothly with three doses explored [3]