Group 1 - The core viewpoint of the report is that the company, InnoCare Pharma-B (09606), is rated as outperforming the industry, with a reasonable market value of HKD 37.9 billion and a target price of HKD 430, indicating a potential upside of 20.1% from the current stock price [1] - The ADC (Antibody-Drug Conjugate) market is one of the most promising and fastest-growing drug forms globally, with an estimated market size of approximately USD 10.4 billion in 2023, projected to reach USD 115.1 billion by 2032 [2] - InnoCare Pharma has established four unique ADC technology platforms and has secured licensing agreements with multinational pharmaceutical companies, with a total transaction value exceeding USD 6 billion [3] Group 2 - The first ADC is expected to submit a listing application in 2025, with notable pipelines including DB-1303 for endometrial cancer and breast cancer, DB-1311 showing potential in prostate cancer, and advancements in dual-antibody ADCs [4] - The report highlights a key difference from market sentiment, emphasizing the investment value of the company as a validated platform innovator in the ADC field, which may incubate more valuable pipelines in the long term [5]

中国生物制药(01177)发布公告，公司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)"在澳洲开展的I期临床试验已顺利完成首例患者入 组，标志着这一创新疗法正式进入临床开发阶段。 LM-350是基于礼新医药新一代ADC技术平台LM-ADCTM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-350在多个异种移植模型中表现出显著的抗肿瘤活 性，尤其在对MMAE耐药或伊立替康耐药的结直肠癌细胞中效果突出。 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。 本次临床研究为一项LM-350在晚期实体肿瘤患者中的安全性、耐受性、药代动力学特 ...

智通财经APP讯，中国生物制药(01177)发布公告，公司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)"在澳洲开展的I期临床试验已顺 利完成首例患者入组，标志着这一创新疗法正式进入临床开发阶段。 LM-350是基于礼新医药新一代ADC技术平台LM-ADCTM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-350在多个异种移植模型中表现出显著的抗肿瘤活 性，尤其在对MMAE耐药或伊立替康耐药的结直肠癌细胞中效果突出。 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。 本次临床研究为一项LM-350在晚期实体肿瘤患者中的安全性、耐 ...

Core Viewpoint - The stock of Valiant Biopharma-B (09887) rose over 5% following the announcement of successful patient enrollment in a clinical study for its drug LBL-024, a dual-specific antibody targeting PD-L1 and 4-1BB, which is aimed at treating advanced melanoma and potentially lung neuroendocrine cancer [1] Company Developments - Valiant Biopharma announced the successful enrollment of the first patient in an Ib/II clinical study (NCT07099430) for LBL-024, which will explore its efficacy as a monotherapy or in combination for first-line treatment of advanced melanoma [1] - LBL-024 is noted as the first targeted therapy for the 4-1BB receptor to reach the registration clinical stage globally, with the potential to become the first approved drug for advanced lung neuroendocrine cancer [1] Industry Insights - CMB International released a report highlighting Valiant Biopharma's focus on developing immunotherapies involving immune checkpoint inhibitors and co-stimulatory agonists, while also expanding into other areas such as CD3T cell connectors and antibody-drug conjugates (ADC) [1] - The company has developed proprietary platforms, LeadsBody and X-body, which serve as engines for continuous drug discovery [1] - The report expresses optimism regarding Valiant Biopharma's development of PD-L1/4-1BB and TCE as next-generation immuno-oncology therapies [1]

Group 1 - The Hang Seng Index Company announced the inclusion of InnoCare Pharma-B (09606) into the Hang Seng Composite Index, effective after market close on September 5, 2025, with trading starting on September 8, 2025 [1] - InnoCare Pharma-B is likely to be included in the Hong Kong Stock Connect due to meeting various criteria such as market capitalization, liquidity, and listing duration [1] - The company's key product, DB-1310, has received Fast Track designation from the FDA for treating adult patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed on prior EGFR TKI therapy and platinum-based chemotherapy [1] Group 2 - DB-1310 is a next-generation ADC product targeting HER3, developed using the company's proprietary DITAC technology platform [2] - Initial results from the Phase I/IIa clinical trial (NCT05785741) of DB-1310 were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showing encouraging efficacy and manageable safety in patients with advanced solid tumors who failed standard treatments [2]

Core Viewpoint - Fuhong Hanlin (02696) has seen a significant stock price increase following the announcement of a strategic partnership with Qide Pharmaceutical for the development and commercialization of the innovative HER2-targeted antibody-drug conjugate (ADC) GQ1005 in China and select overseas markets [1] Group 1: Strategic Partnership - Fuhong Hanlin has entered into a strategic collaboration with Qide Pharmaceutical to obtain exclusive rights for the development and commercialization of GQ1005, which is currently in Phase III clinical trials for HER2-positive breast cancer [1] - GQ1005 is developed using Qide Pharmaceutical's proprietary enzyme-mediated site-specific conjugation technology, showing comparable anti-tumor activity to Trastuzumab in preclinical studies [1] Group 2: Market Position and Product Pipeline - Breast cancer is a core therapeutic area for Fuhong Hanlin, which has established a diversified product pipeline covering the entire disease course and molecular subtypes of breast cancer [1] - The company has built a global commercialization network through its own commercial team and partnerships with overseas collaborators, aiming to continuously unlock the commercial value of its breast cancer pipeline [1]

Core Insights - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has developed an innovative drug LM-302, which has been included in the Breakthrough Therapy Designation (BTD) program by the National Medical Products Administration (NMPA) for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody [1][2] - LM-302 is a potential first-in-class antibody-drug conjugate (ADC) targeting CLDN18.2, showing clinical efficacy in patients with gastric cancer, pancreatic cancer, and biliary tract cancer, with benefits observed even in patients with low expression of Claudin18.2 and PD-L1 [1] - Recent data presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicated an overall response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients, with ORR of 71.9% and DCR of 96.9% in 32 patients with CLDN18.2 expression ≥25% [1] Clinical Development - LM-302 is currently undergoing Phase III clinical trials in China for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma after progression on two or more lines of systemic therapy [2] - The inclusion in the Breakthrough Therapy Designation program is expected to expedite the approval process for LM-302, providing innovative treatment options for more CLDN18.2 positive gastric cancer patients [2]

Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has developed the innovative drug LM-302, which has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody [1][2] Group 1: Drug Development and Clinical Trials - LM-302 is a first-in-class antibody-drug conjugate (ADC) targeting CLDN18.2, showing clinical efficacy in patients with gastric cancer, pancreatic cancer, and biliary tract cancer [1] - The latest research data presented at the 2025 ASCO annual meeting indicates an overall response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients [1] - In patients with CLDN18.2 expression ≥25%, the ORR was 71.9% and the DCR was 96.9%, demonstrating good anti-tumor activity and controllable safety in CLDN18.2 positive patients [1] Group 2: Regulatory and Market Implications - LM-302 is currently undergoing Phase III clinical trials in China for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma after progression on second-line or higher systemic therapy [2] - The inclusion in the Breakthrough Therapy Designation program is expected to accelerate the market entry of LM-302, providing innovative treatment options for more CLDN18.2 positive gastric cancer patients [2]

康宁杰瑞制药-B(09966)再涨超7%，截至发稿，涨6.56%，报9.59港元，成交额3218.92万港元。 消息面上，康宁杰瑞制药将于8月28日召开董事会会议以审批中期业绩。公司此前预计，上半年取得利 润不少于人民币2000万元，去年同期亏损约人民币4490万元。公司于报告期内转亏为盈，主要基于三项 授权合作的里程碑收入和商业化产品的销售收入。 此外，康宁杰瑞制药近日公告，公司自主研发的程序性死亡配体1(PD-L1)/整合素αvβ6双特异性抗体偶 联药物(ADC)JSKN022的新药临床试验申请已获中国国家药品监督管理局药品审评中心正式受理。公司 计划开展用于治疗晚期恶性实体瘤的JSKN022首次人体临床研究。目前全球范围内尚无靶向整合素αvβ6 或PD-L1的ADC上市，相关在研药物均处于临床研究阶段。 ...

MRG004A的作用机制十分精准：首先通过抗体部分识别并结合癌细胞表面过度表达的TF抗原，随后抗原-抗体复合物 通过受体介导的内吞作用进入癌细胞内部，在溶酶体内经蛋白酶降解释放出细胞毒素MMAE，进而导致癌细胞死亡。 这种"生物导弹"式的靶向递送机制能够最大限度提高药物在肿瘤部位的浓度，同时减少对正常组织的毒性。 8月1日，国家药品监督管理局药品审评中心(CDE)最新公示，乐普生物-B(02157)自主研发的靶向组织因子(TF)的抗体 偶联药物(ADC)MRG004A正式启动针对胰腺癌的三期临床试验。这一重要进展标志着这款创新药物距离上市又迈出了 关键一步，也为胰腺癌这一"癌王"的治疗带来了新的希望。 | 登记号 CTR20253026 | | | --- | --- | | 相关建记号 CTR20221675 | | | 药物名称 MRG004A | | | 药物类型 生物制品 | | | 临床申请受理号 企业选择不公示 | | | 适应症 晚期胰腺癌 | | | 试验专业题目 | MRG004A联合最佳支持治疗对比安慰剂联合最佳支持治疗在晚期脚腺癌中的随机对照,双盲、多中心Ⅲ期临床研究 | | 试验通俗题 ...