本周新药行业重点分析： 维立志博即将于下周 2025 年 7 月 25 日正式在港交所主板挂牌上市。 目前公司创新药管线有约 14 款候选药物，有 6 款已在临床开发阶段， 其中核心产品二代 IO 产品 PD-L1/4-1BB 双抗 LBL-024 已在治疗肺外 神经内分泌瘤后线的关键注册临床阶段，后续进展值得关注。 目前全球范围已有多个 PD-L1/4-1BB 双抗在研，进度最快的为 Genmab 的 Acasunlimab，已开展治疗 PD-L1 阳性 NSCLC 二线的 3 期临床研 究；其次维立志博 LBL-024 已开展治疗肺外神经内分泌瘤后线的关键 注册临床研究。 从 PD-L1/4-1BB 双抗已披露的早期数据来看，维立志博 LBL-024 已 在 SCLC 一线展示优异的 ORR 数据，Genmab Acasunlimab 已在 PD-L1 阳性 NSCLC 二线展示出优异的生存数据，中国生物制药的 FS222 已 在黑色素瘤后线展示优异的 ORR 数据。 本周新药上市申请获批准&受理情况： 2025 年 07 月 20 日 生物医药Ⅱ 新药周观点：维立志博 IPO 在即，二代 IO 产品 P ...

百奥泰公告，公司近日收到BAT2506(戈利木单抗)注射液生物制品许可申请(BLA)获得美国食品药品监 督管理局(美国FDA)受理的通知。该药物为戈利木单抗生物类似药，原研药为美国强生公司的Simponi (欣普尼 )，2024年全球销售额为21.9亿美元。百奥泰已与多家公司合作，开展BAT2506(戈利木单抗)注 射液在多个地区的商业化进程。药品上市许可申请已获得中国NMPA、美国FDA、欧洲EMA、巴西 ANVISA受理。 ...

Investment Rating - The report does not explicitly state an investment rating for the medical device sector, but it highlights positive developments and opportunities for investment in high-end medical devices and domestic medical equipment companies. Core Insights - The medical and biological sector saw a weekly increase of 1.2%, outperforming the Wind All A index (-1.17%) and the CSI 300 index (-1.37%) during the week of March 31 to April 3, 2025. Key performers included offline pharmacies (4.15%), chemical preparations (3.92%), and medical consumables (1.66%) [2][7]. - A new policy from the National Medical Products Administration aims to support innovation in high-end medical devices, including surgical robots and AI medical devices, through ten key measures that enhance the regulatory framework and promote international standards [2][12]. - The acceleration of centralized procurement for large medical devices in regions like Guangxi is expected to benefit domestic medical equipment companies, allowing them to capture a larger market share as the industry recovers [2][12]. Market Weekly Review - The medical and biological sector increased by 1.2%, with offline pharmacies leading the gains at 4.15%, followed by chemical preparations at 3.92% and medical consumables at 1.66%. Conversely, medical research outsourcing (-3.19%), medical devices (-1.48%), and hospitals (-0.15%) experienced declines [2][7]. - The top three gaining stocks were Duorui Pharmaceutical (56.3%), Weisi Medical (31.8%), and Hasanlian (31.3%), while the largest declines were seen in Dongfang Biological (-11.1%), Dongfang Ocean (-9.2%), and Nengte Technology (-9.1%) [2][10]. Industry News and Key Company Announcements - The National Medical Products Administration is seeking opinions on measures to optimize lifecycle regulation for high-end medical devices, which includes support for innovation and the application of new technologies in healthcare [2][12]. - Guangxi's public resource trading center announced the initiation of centralized procurement for large medical devices for 2025, encouraging participation from both government and non-government medical institutions [2][12]. - Amgen announced FDA approval for a new indication of its CD19 antibody Inebilizumab, targeting a rare autoimmune disease with a patient population of approximately 20,000 to 40,000 in the U.S. and EU [2][12].

Core Viewpoint - Bio-Thera Solutions and Dr. Reddy's Laboratories have entered into exclusive commercialization and license agreements for two proposed biosimilars, BAT2206 and BAT2506, targeting Southeast Asia and Colombia [1][2][3] Group 1: Agreements and Responsibilities - Bio-Thera will handle the development, manufacturing, and supply of BAT2206 and BAT2506, while Dr. Reddy's will seek regulatory approvals and manage commercialization in Southeast Asia, including countries like Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam [2][3] - Dr. Reddy's will also gain exclusive commercial rights to BAT2206 in Colombia [2] Group 2: Product Information - BAT2206 is a proposed biosimilar to Stelara®, targeting conditions like Crohn's disease and ulcerative colitis, and is currently approved in the EU for multiple indications including moderate to severe plaque psoriasis and active psoriatic arthritis [4] - BAT2506 is a proposed biosimilar to Simponi®, which is used for moderate to severe rheumatoid arthritis and carries a Boxed Warning for serious infections and malignancy [5] Group 3: Company Background - Bio-Thera Solutions is a biopharmaceutical company based in Guangzhou, China, focused on developing innovative therapies and biosimilars for various diseases, including cancer and autoimmune disorders [6][7] - Dr. Reddy's Laboratories, headquartered in Hyderabad, India, is a global pharmaceutical company committed to providing access to affordable medicines, with a diverse portfolio including APIs, generics, and biosimilars [8]