Core Viewpoint - The company has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Drug Information - Drug Names: Injection Karilizumab (injection) and Apalutamide capsules (capsule) [1] - The application is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide to platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for recurrent or metastatic cervical cancer patients [1]

Core Viewpoint - Heng Rui Medicine (01276) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1: Drug Development - The application for market approval is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide against platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] Group 2: Efficacy and Safety - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for patients with recurrent or metastatic cervical cancer [1]

Core Viewpoint - Heng Rui Medicine has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1: Drug Development - The application for market approval is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide to platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] Group 2: Efficacy and Safety - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for patients with recurrent or metastatic cervical cancer [1]

注射用卡瑞利珠单抗已在国内获批多个适应症，分别为：2020年3月获批用于既往接受过索拉非尼治疗 和/或含奥沙利铂系统化疗的晚期肝细胞癌患者的治疗。苹果酸法米替尼胶囊已于2025年5月获批，适应 症为联合注射用卡瑞利珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移 性宫颈癌患者。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司及子公司苏州盛迪亚生物医药有限公司 收到国家药品监督管理局(简称"国家药监局")下发的《受理通知书》，公司创新药注射用卡瑞利珠单抗 联合苹果酸法米替尼胶囊用于复发或转移性宫颈癌患者一线治疗的药品注册上市许可申请获受理。 ...

恒瑞医药（600276）(600276.SH)发布公告，近日，公司及子公司苏州盛迪亚生物医药有限公司收到国 家药品监督管理局(简称"国家药监局")下发的《受理通知书》，公司创新药注射用卡瑞利珠单抗联合苹 果酸法米替尼胶囊用于复发或转移性宫颈癌患者一线治疗的药品注册上市许可申请获受理。 注射用卡瑞利珠单抗已在国内获批多个适应症，分别为：2020年3月获批用于既往接受过索拉非尼治疗 和/或含奥沙利铂系统化疗的晚期肝细胞癌患者的治疗。苹果酸法米替尼胶囊已于2025年5月获批，适应 症为联合注射用卡瑞利珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移 性宫颈癌患者。 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection of Carrelizumab combined with Apalutamide capsules, intended for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., are involved in the development of innovative drugs [1] - The acceptance of the drug registration application marks a significant step towards potential market entry for the treatment of cervical cancer [1]

Core Event - Heng Rui Medicine received the acceptance notice from the National Medical Products Administration for the marketing authorization application of the innovative drug injection of Carrelizumab combined with Apalutamide capsules for first-line treatment of recurrent or metastatic cervical cancer patients [1] Clinical Trial Data - Trial Design: Phase III randomized controlled multicenter study involving 45 domestic centers with 443 patients enrolled [2] - Trial Results: The trial met its primary endpoint, with the experimental group showing significantly better progression-free survival (PFS) and overall survival (OS) compared to the control group [2] Market Background - Indication: Cervical cancer has the highest incidence and mortality rates among female reproductive system tumors in China, indicating an unmet clinical need [2] - Competitive Landscape: The global sales of anti-PD-1 antibodies are projected to reach approximately $41.546 billion in 2024 [2] R&D Investment - Cumulative R&D investment in Carrelizumab is approximately 3.026 billion yuan [2] - Cumulative R&D investment in Apalutamide is approximately 258 million yuan [2]

人民财讯9月30日电，恒瑞医药（600276）9月30日公告，公司收到国家药监局核准签发关于HRS-2329 片的《药物临床试验批准通知书》；子公司苏州盛迪亚生物医药有限公司收到国家药监局核准签发关于 SHR-4298注射液的《药物临床试验批准通知书》。恒瑞医药同日公告，公司及子公司苏州盛迪亚生物 医药有限公司收到国家药监局下发的《受理通知书》，公司创新药注射用卡瑞利珠单抗联合苹果酸法米 替尼胶囊用于复发或转移性宫颈癌患者一线治疗的药品注册上市许可申请获受理。 ...

Group 1: Drug Approval and Indications - Jiangsu Hengrui Medicine Co., Ltd. announced the conditional approval of its innovative drug SHR-A1811 for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy [1][2] - SHR-A1811 is the first antibody-drug conjugate (ADC) approved in China for HER2-mutant NSCLC patients, highlighting a significant advancement in targeted cancer therapy [1][3] - The drug's approval is based on the HORIZON-Lung study, which reported an objective response rate (ORR) of 74.5% and a median progression-free survival (mPFS) of 11.5 months in treated patients [3][4] Group 2: Market Context and Competitors - The global market for similar products, including Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), is projected to reach approximately $6.557 billion in 2024 [5] - The approval of SHR-A1811 positions the company competitively within the ADC market, which has seen limited options for HER2-mutant NSCLC treatment [5] Group 3: Additional Drug Approvals - The company also received approval for HR20013, a combination drug for preventing acute and delayed nausea and vomiting in adults undergoing highly emetogenic chemotherapy (HEC), marking it as China's first ultra-long-acting compound antiemetic injection [8][9] - HR20013 offers a significant advantage with a half-life of nearly 8 days, allowing for a single administration per chemotherapy cycle, thus improving patient compliance and quality of life [9][10] Group 4: Research and Development Investment - The cumulative R&D investment for SHR-A1811 has reached approximately 117 million yuan, while HR20013 has seen an investment of about 18.216 million yuan [5][10] - The company is actively exploring the therapeutic potential of SHR-A1811 in various cancer types beyond lung cancer, with multiple indications recognized by the National Medical Products Administration [3][10]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [4]. Core Insights - The upcoming 2025 ASCO conference highlights the impressive presence of Chinese innovative pharmaceutical companies, with over 70 research projects selected, indicating a robust growth in domestic drug development [2][22]. - The report emphasizes the structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: hospital payments, out-of-pocket payments, and overseas payments [3]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 1.78%, outperforming the CSI 300 index by 1.96 percentage points and the ChiNext index by 2.83 percentage points, ranking first among 31 sub-industries [1][16]. - The Hong Kong Hang Seng Medical Health Index increased by 5.54%, surpassing the Hang Seng National Enterprises Index by 4.18 percentage points [1][16]. Company Research Progress - Recent developments include the IND application for HS-10510 by Haosen Pharmaceutical and ongoing clinical trials for several drugs from companies like Hengrui Medicine and BeiGene [35]. Key Company Highlights - Hengrui Medicine has 69 research projects selected for the ASCO conference, covering various cancer types, showcasing its leadership in innovative drug development [23][26]. - Innovent Biologics will present clinical data for IBI363 and IBI343 at ASCO, indicating its strong pipeline in cancer immunotherapy [27][28]. - Rongchang Biopharmaceutical has over 20 clinical progress reports accepted for presentation at ASCO, focusing on ADC therapies for various cancers [30][31]. Investment Recommendations - The report recommends focusing on companies such as Hengrui Medicine, Mindray Medical, United Imaging Healthcare, and Yuyue Medical, based on their strong market positions and growth potential [3].