康宁杰瑞 20250703 摘要 康宁杰瑞计划于 2025 年申报 KN026 用于二线及以上 HER2 阳性胃癌 适应症，预计 2026 年二季度末或三季度初获批上市，该药联合化疗的 二期临床试验数据显示出较强竞争力，ORR 超过 40%，PFS 超过 8.6 个月。 康宁杰瑞正在开发多个新分子，包括 022、027 和 021，计划于 2025 年或 2026 年一季度申报 IND，并进行中美双报，这些新分子旨在提升 治疗效果并扩大适应症范围，其中 022 靶向 PDL1 整合素 6，是多功能 ADC。 026 一线乳腺癌三期临床试验已完成入组，样本量接近 900 人，预计 2026 年进行完整数据解读。026 在乳腺癌领域具有竞争力，一线使用 接受度更高，且从生命周期管理角度看，更能延长患者生命周期。 康宁杰瑞的 HER2 ADC 药物 GSK003 正在进行针对 HER2 阳性乳腺癌 的三期临床试验，预计 2025 年完成入组，并计划于 2026 年申报上市， 该试验对照组为 TDM-1，样本量设计为 228 例。 Q&A 康宁杰瑞公司近期有哪些重要进展？ 康宁杰瑞公司在近期取得了显著的进展，特别是在 ...

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]

太平洋证券医药组研究观点分享 文章转自2025年5月17日太平洋医药团队报告 ，分析师： 谭紫媚/ 张懿 投资要点 以下文章来源于谭谈药市 ，作者谭紫媚 张懿 谭谈药市 . 恩必普和明复乐促进神经系统领域稳健增长 公司一方面通过医院渠道加大患者教育，另一方面在零售药店大力推广恩必普胶囊剂型，提升卒中患者出院后持续用药的可及性，促进恩必普继续保持稳健增 长。 2024年2月，明复乐获批第二项新适应症，用于急性缺血性卒中患者的溶栓治疗（发病<4.5h）。通过学术推广和医院开发，有望快速增长贡献增量。 在102例EGFR突变非鳞NSCLC患者中，ORR为39.2%，DCR达93.1%； 其中单纯EGFR-TKI耐药的EGFR敏感突变非鳞NSCLC（n=19）：ORR高达63.2%，DCR为 94.7% ；而EGFR-TKI和含铂化疗双耐药的EGFR敏感突变非鳞NSCLC（n=78）：ORR为33.3%，DCR为92.3%。SYS6010在EGFR-TKI耐药NSCLC患者中展现的高 缓解率，验证其有望克服TKI耐药问题。 2024年8月26日，公司启动了SYS6010联合奥希替尼一线治疗EGFR突变型局部晚期或转移 ...

Group 1 - The Hang Seng Index fell by 0.49%, losing 114 points, while the Hang Seng Tech Index dropped by 1.03%, with a trading volume of 105.5 billion HKD in the morning session [1] - Nvidia's CEO Jensen Huang stated that the company is reassessing its strategy in the Chinese market due to U.S. government restrictions on the export of the Hopper architecture H20 chip to China, and will not launch the Hopper series chips in the future [1] - Semiconductor stocks rose against the market trend, with Hua Hong Semiconductor increasing over 4% and SMIC rising more than 1.8% [1] Group 2 - Fubo Group saw an increase of over 4% following the release of the "Digital China Construction 2025 Action Plan," which aligns with the company's AI service layout [2] - Four Seasons Pharmaceutical surged over 16% after receiving drug registration approval for two indications of its Pyrotinib tablets [3] - Xiansheng Pharmaceutical rose over 7% as the resurgence of COVID-19 raised attention, with its product Xianoxin being the first oral COVID-19 drug in China to receive regular approval [4] Group 3 - CanSino Biologics saw an increase of over 6% after collaborating with CSPC to develop KN026, which has reached the primary endpoint of the PFS [5] - Giant Legend surged over 12% as the show "Travel Diary 3" gained popularity, leading to the company's IP business revenue surpassing its new retail business for the first time [5] - Guming increased over 3% after being included in the Hang Seng Composite Index, with CICC optimistic about its same-store sales growth maintaining a high year-on-year level in Q2 [6] Group 4 - Aimee Vaccine rose over 9% as both the U.S. and China approved clinical trials for the iterative mRNA shingles vaccine [7] - Apple-related stocks collectively declined, with notable drops including Highgreat Electronics down 3.89%, Sunny Optical down 3.95%, and BYD Electronics down 1.7% [7] - Alibaba's stock continued to fall over 4% after its fourth fiscal quarter revenue fell short of expectations, and reports indicated that its AI collaboration plan with Apple is under U.S. review [8]

Market Overview - The Hong Kong stock market opened higher on May 2, with significant gains in the new energy vehicle and AI sectors, leading the Hang Seng Technology Index to rise over 3% at one point [2] - As of the report, the Hang Seng Index increased by 1.33%, while the Hang Seng Technology Index rose by 2.71% [2] AI Sector Developments - On April 30, Xiaomi launched its first open-source inference model, Xiaomi MiMo, which has 7 billion parameters and surpassed OpenAI's closed-source model o1-mini and Alibaba's Qwen model in mathematical reasoning and coding competitions [4] - Following this announcement, Xiaomi Group's stock rose over 4%, and Kingsoft's stock increased by nearly 5% [4] - The AI sector remained active, with Alibaba-W rising over 3%, and SenseTime-W, JD Group-W, and Tencent Holdings all gaining over 2% [4] New Energy Vehicle Sales - The new energy vehicle sector experienced a significant surge, with the Hang Seng Technology Index climbing over 3%, led by XPeng Motors, whose stock rose over 7% [5] - XPeng Motors reported delivering 35,000 new vehicles in April, a year-on-year increase of 273% and a month-on-month increase of 5.5%, marking six consecutive months of deliveries exceeding 30,000 units [8] - Li Auto delivered 33,900 new vehicles in April, reflecting a year-on-year growth of 31.6% [8] - Leap Motor achieved a record high with 41,000 deliveries in April, representing a year-on-year increase of 173% [8] Notable Stock Movements - On May 2, the stock of CanSino Biologics surged over 21% following positive interim results from a clinical study of its HER2 bispecific antibody KN026 for treating HER2-positive gastric cancer [9][11] - The study showed significant improvement in progression-free survival (PFS) compared to existing standard treatments, with a trend towards overall survival (OS) benefits [11] - The product's domestic rights have been sold to CSPC Pharmaceutical Group, with a total upfront and milestone payment of 1 billion yuan and a double-digit sales share [11]