Group 1: Brain-Computer Interface Standards - The National Standard for Non-Invasive Medical Devices Using Brain-Computer Interface Technology is open for public consultation, aiming to establish performance indicators and testing methods for such devices [1] - The standardization is expected to enhance international cooperation and improve regulatory efficiency, addressing the rapid development in the non-invasive neural modulation sector [1] Group 2: Pharmaceutical Industry Innovation - The head of the National Medical Products Administration emphasized the importance of supporting drug and medical device R&D innovation to strengthen China's pharmaceutical industry [2] - Key strategies include early intervention, tailored guidance for enterprises, and promoting international multi-center clinical trials to synchronize the development and approval of innovative drugs and devices [2][3] Group 3: Clinical Trials and Approvals - Shenzhou Cell announced that its product SCTB39G received approval for clinical trials in advanced solid tumors [4] - Hanyu Pharmaceutical's subsidiary received approval for the listing of the raw material drug Acetate Degarelix, which is used for treating advanced prostate cancer [6] Group 4: Market Expansion and IPOs - Kangzhe Pharmaceutical plans a secondary listing in Singapore, reflecting a trend of pharmaceutical companies expanding into Southeast Asian markets [7] - Lianya Pharmaceutical's IPO application has been accepted, focusing on complex drug formulations and high-end generic drugs [9] Group 5: Strategic Collaborations - Bayer and Tsinghua University signed a strategic cooperation agreement to enhance research in various medical fields, aiming to accelerate drug innovation [11][12] Group 6: Clinical Trial Developments - Fuhong Hanlin announced the first patient enrollment in a bridging clinical trial for its drug H, which is approved for first-line treatment of small cell lung cancer in multiple countries [13] Group 7: Corporate Leadership Changes - Fosun Pharma held a shareholder meeting to elect new board members, appointing Chen Yuqing as chairman and Liu Yi as CEO [14]

邮箱：xuyl@csco.com.cn 公司具备证券投资咨询业务资格 证券研究报告 医药生物 G 国产创新药闪耀 ASCO [Table_ReportType] 医药生物行业周报（4 月第 4 周） [Table_S 行业ummary 观点：] 请务必阅读文后重要声明及免责条款 [Table_ReportDate] 2025 年 04 月 28 日 [Table_Author] 分析师：王俐媛 执业证书号：S1030524080001 电话：0755-83199599 邮箱：wangly1@csco.com.cn 研究助理：徐伊琳 电话：0755-23602217 [Table_Industry] [Table_BaseData] 1) 周度回顾。上周（4 月 21 日-4 月 25 日）医药生物收 涨 1.16%，跑赢 wind 全 A（1.15%）和沪深 300（0.38%）。 从板块来看，医疗研发外包（6.34%）和原料药（4.72%） 部分个股一季报表现亮眼，涨幅居前，血液制品（- 3.26%）和疫苗（-6.38%）延续上周跌势。从个股来看， 永安药业（31.4%）、舒泰神（28.4%）和尔康制药（2 ...

H药目前已在欧洲、东南亚和中国等30多个国家获批上市。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，复宏汉霖（2696.HK）于近日公布了产品最新进展。2月5日，公司宣布，H药汉 斯状（斯鲁利单抗，欧洲商品名：Hetronifly）获欧盟委员会（EC）批准上市，用于联合卡铂和依 托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，H药成为了首个且唯一在欧盟获 批上市用于ES-SCLC治疗的抗PD-1单抗。截至目前，H药已在欧洲、东南亚和中国等30多个国家 获批上市，惠及超过90,000位患者。 此外，公司在研的Perjeta（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）也于近日 获FDA受理。目前Perjeta已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2 阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助 治疗等。 迄今为止，复宏汉霖已有已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别 获中国药监局、美国FDA和欧盟EMA受理。 突破差异化临床需求，H ...