氘可来昔替尼

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益方生物-U(688382):深耕小分子创新药赛道 BD合作持续赋能
Xin Lang Cai Jing· 2025-06-18 10:38
Core Insights - The article highlights the long-term value of Yifang Biotech, a leading domestic small molecule drug development company, focusing on high-barrier targeted therapies in oncology, autoimmune diseases, and metabolism [1][2]. Group 1: Product Pipeline and Approvals - As of March 2025, the company has two drugs approved for market: the third-generation EGFR-TKI, Befotnib, and the KRAS G12C inhibitor, Gsorese [1]. - Befotnib is the fourth approved third-generation EGFR-TKI in China, indicated for EGFR mutation-positive NSCLC in 1st and 2nd line treatments, with mPFS of 22.1 months, significantly extending the duration compared to the control group [1][2]. - Gsorese is the second KRAS G12C inhibitor in China, expected to be approved in November 2024 for treating KRAS G12C mutation NSCLC patients, with an ORR of 52% and DCR of 88.6% in Phase II trials [2]. Group 2: Strategic Collaborations - The company has partnered with Betta Pharmaceuticals for the commercialization of Befotnib, leveraging Betta's established operational and sales capabilities to enhance market penetration [1]. - An exclusive licensing agreement was signed with Zhengda Tianqing for Gsorese, which may accelerate its growth potential in the market [2]. Group 3: Research and Development Potential - The company is advancing several promising candidates, including the oral TYK2 inhibitor D-2570, which has shown strong efficacy in treating moderate to severe plaque psoriasis with a PASI75 response rate of 85.0%-90.0% [2][3]. - The oral SERD D-0502 for HR+/HER2- breast cancer is in critical Phase III clinical trials, indicating its potential to be a best-in-class (BIC) therapy [3]. - The URAT1 inhibitor D-0120 for hyperuricemia and gout has completed Phase IIb clinical trials, showcasing its promising drug development potential [3]. Group 4: Financial Projections - The company forecasts revenues of 191 million yuan, 255 million yuan, and 399 million yuan for the years 2025, 2026, and 2027, respectively, indicating a positive growth trajectory [3].
百时美施贵宝(BMY.US)公布小分子新药突破性数据
智通财经网· 2025-06-13 13:37
百时美施贵宝的科学家们设计氘可来昔替尼来选择性地靶向TYK2,从而抑制IL-23、IL-12和 I型干扰素 (IFN)的信号传导,而这些细胞因子都是参与多种免疫介导疾病发病机制的关键细胞因子。氘可来昔替 尼通过与TYK2的调节结构域结合实现高度选择性,促成对TYK2及其下游功能的变构抑制。在生理浓 度范围内,氘可来昔替尼可选择性地抑制 TYK2。在治疗剂量下,氘可来昔替尼不会抑制JAK1、JAK2 或JAK3。氘可来昔替尼已在全球多个国家和地区获批,用于治疗成年中重度斑块状银屑病患者。 智通财经APP获悉,6月12日,百时美施贵宝(BMY.US)公布了POETYK PsA-1(IM011-054)这一关键3期 试验的积极结果。该试验旨在评估氘可来昔替尼在治疗既往未接受过生物制剂类改善病情抗风湿药物 (bDMARD)的活动性银屑病关节炎成人患者中的疗效和安全性。试验达到了主要终点,即治疗16周时, 氘可来昔替尼治疗组患者的ACR20(疾病体征和症状至少改善20%)应答比例显著高于安慰剂组(分别为: 54.2% vs. 34.1%)。 16周治疗期间,氘可来昔替尼的安全性特征与其此前的临床试验项目中观察到的结果一 ...