Core Viewpoint - Baiotai has received FDA approval for BAT2206 (Ustinumab) injection, indicating a significant milestone for the company in the biopharmaceutical sector [1] Group 1: Product Approval - The FDA has approved BAT2206 (Ustinumab) injection, marketed in the U.S. as STARJEMZA [1] - The drug is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn's disease, and moderate to severe active ulcerative colitis in both adults and children [1] Group 2: Commercialization Efforts - Baiotai is actively pursuing the commercialization of BAT2206 in multiple global regions [1] - The company has submitted marketing authorization applications to the NMPA in China and the EMA in Europe [1]

智通财经5月8日电，百奥泰(688177.SH)在投资者关系活动上表示，公司会努力争取BAT2206在今年下 半年和明年初在主要市场（中美欧）获得批准上市。BAT5906首个III期适应症wAMD研究的揭盲时间在 2025年的二季度末，DME临床在开展中，公司已有计划针对CNV和CRVO开展注册临床研究，正在筹 备阶段。托珠单抗皮下的开发及托珠欧洲的合作都在推进中，公司会尽快推进已经批准的静脉给药在欧 洲销售。公司正在加紧准备BAT8006临床项目，估计本月开始入组受试者。 百奥泰：公司正在加紧准备BAT8006临床项目 估计本月开始入组受试者 ...

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]