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SYS6010:广谱抗肿瘤大品种,早期NSCLC数据优异
KAIYUAN SECURITIES· 2025-06-15 11:45
医药生物 2025 年 06 月 15 日 投资评级:看好(维持) 行业走势图 数据来源:聚源 -19% -10% 0% 10% 19% 29% 2024-06 2024-10 2025-02 医药生物 沪深300 相关研究报告 《关注 Protac 自免赛道积极进展—行 业周报》-2025.6.8 《重视Pharma估值重塑的机会—行业 周报》-2025.6.2 《经营拐点显现,动保业务有望贡献 较大业绩弹性,推荐国邦医药—行业 周报》-2025.5.25 SYS6010:广谱抗肿瘤大品种,早期 NSCLC 数据优异 ——行业周报 | 余汝意(分析师) | 余克清(分析师) | 聂媛媛(联系人) | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | nieyuanyuan@kysec.cn | | 证书编号:S0790523070002 | 证书编号:S0790525010002 | 证书编号:S0790124050002 | SYS6010(EGFR ADC):广谱抗肿瘤大品种,早期 NSCLC 数据优异 截至 2025 年 6 月,全 ...
创新药ETF国泰大涨4.39%点评
Mei Ri Jing Ji Xin Wen· 2025-06-12 14:20
每经编辑|彭水萍 此外,预计6月下旬2025年ESMO(欧洲肿瘤内科学会)摘要发布。ESMO作为全球顶级肿瘤学术会议,是展示创新药临床数据的重要舞台,预计中国创新 药将公布更多国际化临床数据,覆盖NSCLC、胃癌、肝癌等高发瘤种。市场重点关注头部公司数据,例如,恒瑞医药PD-1/VEGF双抗(AK112)联合疗法 在非小细胞肺癌(NSCLC)的III期临床数据更新,若PFS(无进展生存期)超预期,可能成为下一个重磅品种。百济神州BTK抑制剂泽布替尼在欧洲人群中 的长期生存数据,进一步巩固其在淋巴瘤领域的全球地位。ADC领域,荣昌生物、科伦博泰等企业将公布新一代ADC药物的临床进展,关注毒副作用改善 及疗效突破。(风险提示:个股仅供行业基本面说明,非个股推荐。) 创新药ETF国泰(517110)单日涨幅达4.39%。 上涨驱动因素分析 消息层面,6月12日,继三生制药双抗天价BD给辉瑞、石药集团预告三项BD正在路上之后,中国生物制药在美国迈阿密举行的第46届高盛全球医疗健康年 会上透露,多个产品从年初就收到了合作意向。中国生物制药表示,"近期,这些资产中将会产生一个标志性的重磅对外授权交易,我们非常期待向市场披 ...
ADC Therapeutics Announces $100 Million Private Placement Extending Expected Cash Runway into 2028
Prnewswire· 2025-06-12 10:45
LAUSANNE, Switzerland, June 12, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that it has entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $100.0 million private investment in public equity ("PIPE") financing. In the PIPE, ADC Therapeutics is selling 13.0 million common shares at $3.53 per share and pre-funded warrants ...
ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress
Prnewswire· 2025-06-12 10:30
ZYNLONTA® in combination with glofitamab (COLUMVI®) in patients with r/r DLBCL demonstrated clinically meaningful benefit with overall response rate (ORR) of 93.3% and a complete response (CR) rate of 86.7% across 30 efficacy evaluable patients25 of 26 patients achieving CR remained in CR as of the data cut-offInitial data show the combination is generally well tolerated with a manageable safety profileCompany expanding enrollment for LOTIS-7 to 100 patients at 150 µg/kg doseCompany to host conference call ...
广发证券:首予康宁杰瑞制药-B(09966)“买入”评级 合理价值12.89港元
智通财经网· 2025-06-12 07:12
Group 1 - The core viewpoint of the report is that Guangfa Securities is optimistic about the differentiated biopharmaceutical platform of CStone Pharmaceuticals-B (09966) and the development potential of its ADC drugs, which have shown preliminary clinical efficacy [1] - The company was established in 2015 and focuses on the development, production, and commercialization of innovative anti-tumor biologics, with a highly differentiated internal pipeline covering anti-tumor drugs at various research stages [1] - The first product, KN035 (Envafolimab injection), was launched in November 2021, marking the company's entry into the commercialization phase [1] Group 2 - CStone Pharmaceuticals has developed several globally leading biopharmaceutical technology platforms, including glycoengineered conjugation platform, linker payload platform, bispecific antibody platform, and subcutaneous high-concentration formulation platform, which have differentiated therapeutic advantages [1] - The glycoengineered conjugation platform reduces the production cost of ADC drugs while effectively minimizing toxin release in the circulatory system, enhancing drug safety [1] - Products developed based on this platform, JSKN003 and JSKN016, have entered clinical stages, and the company has upgraded the dual payload technology platform with corresponding products expected to enter clinical trials [1] Group 3 - The HER2 bispecific antibody KN026 is undergoing registration clinical studies for second-line gastric cancer, first-line breast cancer, and neoadjuvant therapy, with a promising path to market [2] - The HER2 bispecific ADC JSKN003 is in phase III clinical trials for breast cancer and platinum-resistant ovarian cancer, demonstrating competitive efficacy in early clinical studies [2] - The HER3/TROP2 bispecific ADC JSKN016 has initiated clinical trials for lung cancer and breast cancer, indicating a broad potential market, while new generation ADCs like JSKN021 (dual payload) and JSKN022 are expected to advance to clinical stages quickly [2]
13亿BD交易仅是序幕,明慧医药藏了多少“金矿”?
Ge Long Hui· 2025-06-12 01:33
明慧医药这家新锐生物科技公司正在加速崛起: 5月9日,明慧医药将MHB088C(B7-H3 ADC)在大中华区的权益授权给齐鲁制药,有望获得高达13.45亿元的交易总金额(其中首付款2.8亿元); 5月25日,明慧医药启动了IGF-1R抗体MHB018A治疗甲状腺眼病的Ⅲ期临床试验; 5月31日,明慧医药的外用JAK抑制剂伊托法替布软膏(MH004)的上市申请获国家药监局受理,适应证为特应性皮炎(AD)。 这一系列迅猛进展,不仅彰显研发管线与商业价值的共振,还充分证明了明慧医药巨大的发展潜力。 01 目前,明慧医药已经打造了丰富且差异化的管线矩阵,药物类型覆盖单抗、双抗、ADC、软膏,包括IGF-1R抗体MHB018A、PD-L1/VEGF双抗MHB039A、 全球首创的外用JAK抑制剂MH004软膏,以及ADC管线矩阵(MHB088C、MHB036C、MHB118C、MHB042C、MHB009C、MHB048C),覆盖B7-H3、 TROP2、IGF-1R、c-MET、B7-H4、PSMA等多个差异化靶点。 新锐Biotech不简单 可见,明慧医药虽为新锐Biotech,但研发实力却不容小觑。尤其在ADC ...
Zymeworks(ZYME) - 2025 FY - Earnings Call Transcript
2025-06-11 19:00
Zymeworks (ZYME) FY 2025 Conference June 11, 2025 02:00 PM ET Speaker0 Good afternoon, everyone. Thanks so much for being here. My name is Laura Khan. I'm a Vice President in our Healthcare Investment Banking Group. And I'm joined today by Ken Galbraith, CEO of ZymWorks. Ken, thanks so much for being here. Let's go ahead and dive right in. It's of course been an exciting year at ZymWorks. A ton of progress with BTC approval in November for Zahira, and significant progress made on continuing to advance the p ...
科伦博泰今年累计大涨110%,核心肺癌药物获突破性疗法认定
Zheng Quan Shi Bao Wang· 2025-06-11 14:07
科伦博泰(06990.HK)今天公告,核心产品芦康沙妥珠单抗(SAC-TMT)联合PD-L1单抗塔戈利单抗作为一 线疗法,治疗无驱动基因突变的局部晚期或转移性非鳞状非小细胞肺癌,获中国国家药品监督管理局 (NMPA)药品审评中心(CDE)授予突破性疗法认定。据介绍,突破性疗法认定授予那些证明较现有治疗 手段具有明显临床优势的治疗选项,旨在加快研究、开发及推广创新治疗方案,以应对临床急需的医疗 需求。 这是芦康沙妥珠单抗获国家药品监督管理局授予的第五项突破性疗法认定。作为科伦博泰的核心产品, 芦康沙妥珠单抗是一款拥有自主知识产权的新型抗体偶联药物(ADC),主要针对非小细胞肺癌、乳腺 癌、胃癌、妇科肿瘤等晚期实体瘤。 截至目前,科伦博泰已在中国开展8项注册性临床研究。默沙东已启动14项芦康沙妥珠单抗作为单药疗 法或联合帕博利珠单抗2或其他药物用于多种类型癌症的全球性3期临床研究,这些研究由默沙东申办并 主导。2022年5月,科伦博泰授予默沙东在大中华区以外的所有地区开发、使用、制造及商业化芦康沙 妥珠单抗的独家权利。 6月5日,科伦博泰公告,与两家配售代理签订配售协议,计划配售591.8万股H股股份,每股配售价 ...
第一三共(DSNKY.US)重磅ADC新药“德曲妥珠单抗”胃癌适应症拟纳入优先审评
Zhi Tong Cai Jing· 2025-06-11 03:24
6月10日,中国国家药监局药品审评中心(CDE)官网公示,第一三共(DSNKY.US)申报的注射用德曲妥珠 单抗(T-DXd,DS-8201a)拟纳入优先审评,拟定适应症为:单药适用于治疗既往接受过一种治疗方案的局 部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者。 基于DESTINY-Gastric01、DESTINY-Gastric02等多项2期研究结果,德曲妥珠单抗作为HER2阳性转移性 胃癌的二线和三线治疗策略已得到证实。因此,德曲妥珠单抗在多个国家或地区获批用于治疗既往接受 过曲妥珠单抗治疗的HER2阳性转移性胃癌或胃食管结合部腺癌。 根据第一三共公开资料介绍,DESTINY-Gastric04是德曲妥珠单抗治疗HER2阳性晚期胃癌的首个3期研 究。该研究总体阳性结果表明,与雷莫西尤单抗+紫杉醇相比,德曲妥珠单抗为HER2阳性(IHC3+或 IHC2+/ISH+)转移性胃或胃食管结合部(GEJ)腺癌患者带来具有显著统计学差异和临床意义的总生存期 (OS)改善。 今年6月,《新英格兰医学杂志》(NEJM)发表了DESTINY-Gastric04研究结果,显示在HER2阳性转移性 胃癌或胃食管结合 ...
华东医药:白马药企转型创新,开启发展新阶段-20250610
Soochow Securities· 2025-06-10 00:23
证券研究报告·公司深度研究·化学制药 华东医药(000963) 白马药企转型创新,开启发展新阶段 2025 年 06 月 09 日 买入(维持) | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入(百万元) | 40,624 | 41,906 | 45,915 | 49,414 | 52,228 | | 同比(%) | 7.71 | 3.16 | 9.57 | 7.62 | 5.69 | | 归母净利润(百万元) | 2,839 | 3,512 | 4,032 | 4,555 | 5,154 | | 同比(%) | 13.59 | 23.72 | 14.81 | 12.96 | 13.17 | | EPS-最新摊薄(元/股) | 1.62 | 2.00 | 2.30 | 2.60 | 2.94 | | P/E(现价&最新摊薄) | 27.06 | 21.88 | 19.05 | 16.87 | 14.91 | [Table_Tag] [Tabl ...