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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
Core Insights - Bristol-Myers Squibb (BMY.US) announced positive results from the pivotal Phase 3 trial POETYK PsA-1 (IM011-054) for deucravacitinib in treating adult patients with active psoriatic arthritis who have not previously received bDMARDs [1] - The trial met its primary endpoint, showing a significant difference in ACR20 response rates at 16 weeks between the deucravacitinib group (54.2%) and the placebo group (34.1%) [1] - The safety profile of deucravacitinib during the 16-week treatment period was consistent with previous clinical trials, including the Phase 3 POETYK PsA-2 trial and trials for moderate to severe plaque psoriasis [1] Group 1 - Deucravacitinib is a selective TYK2 inhibitor with a unique mechanism of action, targeting IL-23, IL-12, and type I interferon signaling pathways, which are critical in the pathogenesis of various immune-mediated diseases [2] - The drug achieves high selectivity by binding to the regulatory domain of TYK2, leading to allosteric inhibition of TYK2 and its downstream functions [2] - Deucravacitinib has been approved in multiple countries for the treatment of adult patients with moderate to severe plaque psoriasis [2]