君实生物 20250827 摘要 君实生物 2025 年上半年研发费用 7.06 亿元，同比增长 29%，销售费 用率降至 50%以下，管理费用同比下降 19%。归母净亏损同比下降 36%，并完成近 10 亿元港股配售，资金状况良好，为未来研发和业务 拓展提供保障。 特瑞普利单抗国内新增一线治疗黑色素瘤和联合贝伐珠单抗一线治疗晚 期肝细胞癌两项适应症，并已在包括美国、欧盟等 40 个国家和地区获 批上市，商业化网络覆盖全球 80 多个国家。 PD-1/VEGF 双抗 GS207 正处于二期临床研究阶段，探索联合治疗多种 瘤种。BTLA 单抗联合 PD-1 用于小细胞肺癌的全球多中心三期临床研究 预计 2026 年完成入组。克瑞普利皮下注射剂有望 2025 年内读出关键 数据并申报上市。 JT002 是一种 CPG 寡聚脱氧核苷酸，通过激活 TLR9 信号通路治疗过敏 性鼻炎，是唯一通过调节免疫系统治疗该疾病的新机制药物，已提交三 期关键注册研究申请，具有出海潜力。 Q&A 君实生物 2025 年上半年业绩表现如何？ 2025 年上半年，君实生物的营业收入达到 11.68 亿元，同比大幅增长 49%。 其中，核 ...

HRS-6093片是一种新型、高效、选择性的口服KRAS G12D抑制剂，能够特异性结合KRAS G12D突变 蛋白，发挥抗肿瘤作用。经查询，国内外尚无同类产品获批上市。截至目前，HRS-6093片相关项目累 计研发投入约2984万元。 恒瑞医药（600276）(01276)发布公告，近日，公司收到国家药品监督管理局("国家药监局")核准签发关 于HRS-6093片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

格隆汇8月25日丨恒瑞医药(01276.HK)发布公告，近日，公司收到国家药品监督管理局核准签发关于 HRS-6093片的《药物临床试验批准通知书》，将于近期开展临床试验。HRS-6093片是一种新型、高 效、选择性的口服KRAS G12D抑制剂，能够特异性结合KRAS G12D突变蛋白，发挥抗肿瘤作用。 ...

Core Viewpoint - The company, Valiant Biopharma (09887), has seen its stock price increase by over 5%, currently trading at 72.5 HKD, following the completion of patient enrollment in a pivotal clinical study for its drug, Opalizumab (LBL-024), a dual-targeting antibody for treating EP-NEC [1] Group 1 - The pivotal clinical study for Opalizumab (LBL-024), a PD-L1 and 4-1BB dual-targeting antibody, has completed enrollment of all participants [1] - Opalizumab is the first dual-targeting molecule in a pivotal clinical stage aimed at the 4-1BB co-stimulatory receptor, potentially becoming the first approved drug for treating EP-NEC [1] - The 4-1BB agonist can reactivate apoptotic T cells and significantly expand their numbers, making it particularly suitable for treating PD-1/PD-L1 resistant or ineffective cold tumors [1] Group 2 - Besides EP-NEC, Opalizumab has received approval to conduct clinical studies in several cancer types with high unmet clinical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), liver cancer (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma [1] - Encouraging clinical results have already been observed in SCLC, BTC, and OC, indicating the potential of Opalizumab as an effective anti-tumor drug with a broad range of indications [1]

Core Viewpoint - 康宁杰瑞制药-B expects to achieve a profit of no less than RMB 20 million for the six months ending June 30, 2025, compared to a loss of approximately RMB 44.9 million in the same period of 2024, indicating a turnaround from loss to profit driven by milestone revenues from three licensing collaborations and sales from commercialized products [1][1][1] Group 1 - Following the announcement, 康宁杰瑞制药-B's stock rose over 3%, currently trading at HKD 9.42 with a transaction volume of HKD 10.1093 million [1][1] - 广发证券 highlights the company's robust proprietary technology platform in ADC, bispecific antibodies, and multifunctional protein engineering, suggesting a strong differentiation in its internal pipeline [1][1] - The company’s pipeline includes various anti-tumor drugs at different stages of development, showcasing its potential for growth in the biopharmaceutical sector [1][1]

Core Viewpoint - The company has received an acceptance notification from the National Medical Products Administration for its IND application of HSK47977, a new oral small molecule anti-tumor drug aimed at treating lymphoma, marking a significant step in its drug development pipeline [1] Group 1 - HSK47977 is a self-developed drug with no other drugs targeting the same pathway currently in clinical stages globally [1] - Preclinical studies show that HSK47977 exhibits significant proliferation inhibition on human lymphoma cell lines in vitro and effectively suppresses tumor growth in in vivo xenograft models [1] - The drug demonstrates strong target selectivity and an ideal safety window, potentially providing new treatment options for lymphoma patients [1]