GF Securities: Vertex JPM conference updates, focus on progress in domestic enterprises' pain and kidney disease fields.

date
19/01/2025
avatar
GMT Eight
GF SEC released a research report stating that the success of Suzetrigine provides a new hope for the development of the Nav1.8 target, with its innate mechanism advantages, it is expected to bring a new, safer, and more effective therapy for pain patients. The market potential in the IgA nephropathy field is gradually emerging, with Povetacicept showing excellent therapeutic potential. The collaboration between ZAI LAB and Vertex is expected to accelerate the development process of this product domestically. It is recommended to pay attention to companies in China that have already positioned themselves in the corresponding targets or indications and have rich research and commercialization experience in the pain or nephropathy fields. Key points from GF SEC: Vertex JPM Conference Progress Update Vertex was established in 1989 and has been dedicated to innovative drug development. Recently, the Morgan Healthcare Conference was held in the United States, and Vertex provided updates on their business and research progress at the conference. According to the company's presentation at the JPM conference, five cystic fibrosis products have supported the company's revenue and profit growth in recent years. Several innovative products that have entered Phase III and later stages of evaluation are expected to enter the commercialization stage between 2024-2028, including the Nav1.8 inhibitor Suzetrigine for pain treatment and Povetacicept for kidney-related diseases. Nav1.8 has become a key target for non-addictive pain relief, with the Suzetrigine PDUFA date set for January 30, 2025. Based on its mechanistic advantages, Nav1.8 is expected to address the addictive nature of opioid drugs. According to Vertex's presentation at the JPM conference, their novel Nav1.8 inhibitor Suzetrigine (VX-548) has demonstrated excellent pain relief capabilities and tolerability in Phase III clinical trials for acute pain, and a New Drug Application has been submitted in the United States with a PDUFA date of January 30, 2025; for the PNP indication, DPN Phase III clinical trials are currently in the enrollment stage, and LSR Phase II trials have been completed, showing statistical differences compared to baseline but no differences from the placebo. The company is actively discussing Phase III clinical trial plans with the FDA. Several companies in China are following this drug closely, including Jiangsu Hengrui Pharmaceuticals' HRS-2129, which has entered clinical trials, as well as Haisco Pharmaceutical Group and Humanwell Healthcare, which are also in the preclinical stage. Vertex has partnered with ZAI LAB, with their corresponding product Povetacicept showing clinical BIC potential. According to ZAI LAB's official website and Vertex's presentation at the JPM conference, Povetacicept is a dual BAFF and APRIL antagonist, which has shown the best potential therapeutic effect in Phase II clinical trials for IgA nephropathy, with an average reduction of 66% in urine protein at week 48, and 63% of participants achieving clinical remission at week 48. This indication has entered Phase III clinical trials. ZAI LAB's collaboration with Vertex on this product is expected to accelerate the development process in China. Several domestic companies are also positioning themselves in the IgA nephropathy field. Investment recommendation: It is recommended to pay attention to companies in China that have already positioned themselves in the corresponding targets or indications and have rich research and commercialization experience in the pain or nephropathy fields. Recommended companies include Jiangsu Hengrui Pharmaceuticals (600276.SH), Haisco Pharmaceutical Group (002653.SZ), Humanwell Healthcare (600079.SH), ZAI LAB (09688), REMEGEN (09995), HANSOH PHARMA (03692), Shanghai Fosun Pharmaceutical (02196, 600196.SH), etc. Risk warning: Drug evaluation progress lower than expected, commercialization progress slower than expected, research progress not meeting expectations.

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