中国生物制药(01177)涨超4%，截至发稿，涨2.87%，报7.16港元，成交额1.74亿港元。 消息面上，11月25日，注射用TQB2102单药用于HER2阳性乳腺癌新辅助治疗的Ⅱ期临床研究结果，获 国际著名期刊《临床肿瘤学杂志》(Journal of Clinical Oncology，IF43.4)在线发表。TQB2102是中国生物 制药旗下正大天晴自主研发的一种靶向HER2两个非重叠表位ECD2及ECD4的抗体偶联药物(ADC)。该 项研究由复旦大学附属肿瘤医院邵志敏教授团队领衔，为首个证实双表位HER2ADC TQB2102在乳腺癌 新辅助治疗阶段具有良好疗效和安全性的研究，Ⅲ期注册临床研究正在开展中。 ...

映恩生物首席科学官兼美国总经理邱杨博士表示，DB-2304作为全球首个进入临床的靶向BDCA2的免疫 调节ADC，其Ⅰ期健康受试者数据验证了我们基于生物学的药物设计理念，我们将加快推进该创新药 在SLE及CLE患者中的临床开发进度，期待早日为自身免疫疾病治疗带来ADC新突破。 消息面上，2025年第53界秋季免疫学会议(AIC2025)在美国芝加哥举办，映恩生物在会议上以口头报告 形式公布了首创BDCA2靶向免疫调节抗体偶联药物(ADC)DB-2304的Ⅰ期随机对照研究数据。研究结果 显示，DB-2304在健康受试者中整体安全耐受性良好，药代动力学(PK)特征呈线性，并可有效结合靶 点，验证了其药理机制。 映恩生物-B(09606)早盘涨近9%，截至发稿，涨7.17%，报349.6港元，成交额1.18亿港元。 ...

物的全球市场同样有望强劲增长。其中，TED市场预计将从2024年的34亿美元以13.2%的复合年增 长率增至2035年的134亿美元，全球特应性皮炎治疗药物市场则将从2024年的149亿美元扩大至 2035年的295亿美元。值得注意的是，在靶向疗法普及度提升的驱动下，中国市场增长尤为迅猛。 管线产品具备成为潜在同类最佳(BIC)及/或同类首创(FIC)。 本文为IPO早知道原创 作者｜ Stone Jin 微信公众号｜ipozaozhidao 据IPO早知道消息，明宇制药有限公司（以下简称"明慧医药"）于2025年11月24日正式向港交所递 交招股说明书，拟主板挂牌上市，摩根士丹利、美银及中信证券担任联席保荐人。 成立于2018年的明慧医药作为一家接近商业化的生物技术创新企业，具有双重增长引擎：其一、基 于专有抗体偶联药物(ADC)平台和一款新型PD-1/VEGF双特异性抗体(bsAb)搭建的临床阶段肿瘤产 品组合；其二、向商业化推进的已处于临床后期的自身的免疫资产。 | 項目 | 肥益 | 陈特斯型 | 喷圆在 | 厚盛/ 群合 | ■床的 | 1月 | 田岸 | 田駒 | NDA/BLA | 雷前妖感／东 ...

智通财经APP讯，中国生物制药(01177)发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的国家1类创新药LM-350"CDH17抗体偶联药物(ADC)"已获得中国国家药品监督管理局 (NMPA)的临床试验批准。 CDH17在多种肿瘤侵袭转移中发挥重要作用，并在约99%的结肠癌、86%的胃腺癌、79%的食管腺癌、 50%的胰腺导管腺癌中高表达。消化道肿瘤(包括结直肠癌、胃癌、胰腺癌、食管癌等)是全球发病率和 死亡率最高的癌症种类之一，2022年全球新发患者数量超过400万人，存在巨大的尚未被满足的临床需 求。 此前，LM-350已获得美国食品药品监督管理局(FDA)的IND批件，并于2025年9月在澳大利亚完成首例 患者入组。随着此次中国临床试验申请的获批，礼新医药将加速推进中国临床研究，致力于尽早为患者 提供全新的治疗选择。 LM-350是基于礼新医药新一代LM-ADC™平台开发的一款靶向CDH17的ADC，能够高度选择性地结合 CDH17，具有很强的内化能力。LM-350采用IgG1野生型构型，同时具备抗体依赖细胞介导的细胞毒性 作用(ADCC)活性。临床前研究显示，LM-3 ...

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for BlissBio Inc. regarding its overseas listing application, focusing on operational management and financial details [1][2]. Group 1: Regulatory Requirements - CSRC has requested BlissBio Inc. to clarify the actual operation of its management and the significant influence on the management team [1]. - Specific inquiries include the pricing basis and tax implications related to the acquisition of CCCBio, as well as the tax situation during the capital reduction process in Hangzhou [1][2]. - The CSRC also seeks explanations regarding the reasons for not recognizing certain individuals as joint actual controllers and the rationale behind the stock incentive plans [2]. Group 2: Company Overview - BlissBio Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation antibody-drug conjugates (ADCs) to address unmet needs in cancer treatment [2]. - The company's core product, BB-1701, targets HER2 and is aimed at treating breast cancer, non-small cell lung cancer, and other HER2-expressing cancers [2]. Group 3: Financial Performance - For the fiscal years 2023 and 2024, BlissBio Inc. reported revenues of approximately 180 million RMB and 22.59 million RMB, respectively [3]. - The company incurred losses of about 206 million RMB and 55.7 million RMB for the same periods [3].

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for BlissBio Inc. as part of its overseas listing application process, highlighting the need for detailed explanations regarding the company's management operations and financial transactions [1][2]. Group 1: Regulatory Requirements - The CSRC has requested BlissBio Inc. to provide clarifications on several financial and operational aspects, including the pricing basis for the acquisition of CCCBio and tax implications for the involved parties [1]. - Specific inquiries include the tax situation related to the capital reduction process in Hangzhou, the relationship between shareholders, and compliance with foreign exchange management regulations [1][2]. - The CSRC also seeks to understand the reasons behind the lack of simultaneous capital reduction for the Shenyang entity and the implications of the acquisition of equity in Hangzhou [1][2]. Group 2: Company Overview - BlissBio Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation antibody-drug conjugates (ADCs) to address unmet needs in cancer treatment [2]. - The company's lead product, BB-1701, targets the human epidermal growth factor receptor 2 (HER2) and is primarily aimed at treating breast cancer, non-small cell lung cancer, and other HER2-expressing cancers [2]. Group 3: Financial Performance - For the fiscal years 2023 and 2024, BlissBio Inc. reported revenues of approximately 180 million RMB and 22.591 million RMB, respectively, while incurring losses of about 206 million RMB and 55.7 million RMB during the same periods [3].

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced significant clinical research results from its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., at the 2025 European Society for Medical Oncology (ESMO) conference, highlighting advancements in targeted antibody-drug conjugates (ADCs) for various cancers [1]. Group 1: Clinical Research Results Overview - Two studies on sac-TMT (LKB5) were selected for Late Breaking Abstract (LBA) oral presentations, demonstrating its efficacy in treating EGFR mutation-positive non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer (BC) [2][3]. - In the OptiTROP-Lung04 study, sac-TMT showed a median progression-free survival (PFS) of 8.3 months compared to 4.3 months for chemotherapy, reducing the risk of disease progression or death by 51% [2][3]. - The OptiTROP-Breast02 study reported a median PFS of 8.3 months for sac-TMT versus 4.1 months for investigator's choice chemotherapy, with a hazard ratio (HR) of 0.35 [4][5]. Group 2: Safety and Efficacy - Both studies indicated similar rates of treatment-related adverse events (TRAEs) between sac-TMT and chemotherapy, with no TRAEs leading to treatment discontinuation in the sac-TMT group [3][5]. - The objective response rate (ORR) for sac-TMT was 60.6% in NSCLC and 41.5% in BC, significantly higher than the chemotherapy groups [2][5]. - The studies support the approval of sac-TMT by the National Medical Products Administration (NMPA) for specific cancer treatments [3][5]. Group 3: Additional Research and Drug Information - The study on SKB315, targeting Claudin18.2 in advanced solid tumors, showed an ORR of 37.5% and a median PFS of 8.2 months [6]. - The innovative drugs sac-TMT and botu-tuzumab (舒泰莱) are designed to target specific cancer types, with sac-TMT being the first TROP2 ADC approved for lung cancer indications [8][10]. - Kelun Botai has initiated multiple clinical studies for these drugs, indicating a robust pipeline for cancer treatment [9][11].

Core Viewpoint - The stock of Deqi Pharmaceutical-B (06996) rose over 6% following the announcement of positive clinical trial results for its ADC ATG-022 at the ESMO 2025 conference, indicating strong safety and anti-tumor activity across various patient groups [1] Group 1: Clinical Research Results - Deqi Pharmaceutical presented the latest findings from the I/II phase clinical study of ATG-022, an antibody-drug conjugate targeting CLDN18.2, at the ESMO 2025 conference in Berlin [1] - ATG-022 demonstrated good safety and significant anti-tumor activity in patients with gastric cancer (GC) and gastroesophageal junction cancer (GEJC) across different levels of CLDN18.2 expression [1] - Preliminary efficacy was also observed in other non-gastrointestinal tumors, with further data expected to be presented at upcoming academic meetings [1] Group 2: Dosage and Safety Data - The safety data for the 2.4 mg/kg dosage group was reported to be good, while the 1.8 mg/kg dosage group showed even better safety and tolerability [1] - These findings support the potential for ATG-022 to be combined with immune checkpoint inhibitors and chemotherapy in frontline treatment, significantly expanding its clinical applicability and commercialization potential [1] Group 3: Ongoing Development - The I phase dose expansion study of ATG-022 is progressing smoothly in mainland China and Australia [1] - The company is actively preparing for clinical research on combination therapies involving ATG-022 to further advance its clinical development process [1]

Core Viewpoint - Kolon Biotech Inc. (06990) experienced a significant increase in stock price, rising by 5.37% to HKD 483, with a trading volume of HKD 1.5939 million, following the announcement of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1]. Group 1 - Kolon Biotech announced the presentation of several clinical research results at the ESMO conference [1]. - The research included data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (佳泰莱), A166 (舒泰莱), and SKB315 [1]. - The focus of the studies was on TROP2, HER2, and Claudin18.2 [1].

Core Insights - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., presented multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1 - The clinical research results included data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (Jiatailai®), targeting trophoblast cell surface antigen 2 (TROP2) [1] - The results also covered data on A166 (Shutailai®), a HER2-targeted ADC [1] - Additionally, data on SKB315, a Claudin18.2 (CLDN18.2) ADC, was presented [1]