Southwest Securities has released a research report initiating coverage on GENFLEET-B (02595), recommending active investor attention. The report highlights the company's strategy of targeting large markets such as pancreatic cancer, non-small cell lung cancer (NSCLC), and cachexia through a comprehensive product matrix, aiming to cover first-line and subsequent lines of therapy with a globally leading development timeline. Revenue forecasts for 2026-2028 are projected at RMB 85 million, RMB 102 million, and RMB 311 million, representing year-on-year changes of -35%, +20%, and +205%, respectively.
The key investment rationale is outlined as follows: 1) Approximately 6.57 million new cancer patients with RAS mutations are diagnosed globally each year. RAS inhibitors have achieved a breakthrough from zero to one and are poised to become one of the fastest-growing segments in oncology targeted therapy over the next decade. 2) The company possesses a first-tier global RAS therapy portfolio. Its lead product, GFH925, has been included in the national reimbursement drug list (NRDL) in China, with sales growth anticipated. Its G12D monotherapy demonstrates globally leading development progress and efficacy, with two New Drug Applications (NDAs) expected to be submitted in 2027. Its Pan-RAS candidate ranks among the top three globally in terms of development stage and features a differentiated structural advantage compared to the frontrunner, RMC6236. 3) The company's pipeline is comprehensive. Beyond the RAS portfolio, it also targets indications with substantial market potential and favorable competitive landscapes, such as cachexia, peripheral artery disease (PAD), and primary biliary cholangitis (PBC), forming a differentiated competitive edge against international peers.
As a leader in RAS therapy development, the company employs a dual-engine strategy of internal R&D and business development (BD). It focuses on novel therapeutic solutions for oncology, autoimmune, and inflammatory diseases, having built a pipeline comprising 8 drug candidates. This includes one marketed drug, GFH925 (fuzereisat), and five clinical-stage assets, featuring a world-class RAS therapy matrix and a differentiated, diversified clinical pipeline in non-oncology areas.
Through its internal R&D and BD efforts, the company has established a broad international collaboration network. Its core product, GFH925, is licensed to Innovent Biologics for Greater China. Three RAS-targeting drugs, including GFH375, are licensed to Verastem for ex-China territories. GFH009 is co-developed with SELLAS for ex-China markets.
GFH375: A Best-in-Class (BIC) Potential Oral G12D Inhibitor, with Two NDAs Anticipated in 2027 The G12D mutation is prevalent in pancreatic cancer, yet no G12D-targeted therapy is currently approved. GFH375 is the most advanced oral G12D inhibitor in development. It has entered Phase 3 trials for second-line or later pancreatic ductal adenocarcinoma (2L+ PDAC). Phase 1/2a trials in a third-line or later population showed an objective response rate (ORR) of 36.2% and a median progression-free survival (mPFS) of 5.52 months, significantly outperforming comparable drugs. Subsequent studies will explore combination therapies for first-line pancreatic cancer treatment. A Phase 3 trial for second-line NSCLC (2L+NSCLC) is expected to commence in 2026, with existing data also demonstrating BIC potential. Both indications have received China's first Breakthrough Therapy Designation. The company is actively preparing for registrational trials overseas and has received FDA Fast Track designation for the treatment of 1L+ PDAC.
GFH276: A Differentiated Pan-RAS(ON) Molecular Glue Inhibitor The global population of cancer patients with RAS mutations exceeds 6.57 million across various tumor types. Pan-RAS inhibitors offer broad coverage against multiple RAS mutations and hold potential to overcome resistance to G12C inhibitors. Currently, no Pan-RAS targeted therapy is approved globally. GFH276 ranks among the top three in global development progress, with Phase 1 data expected to be presented at the 2026 ESMO congress. GFH276 utilizes a novel core structure, offering a lower effective dose and potentially improved safety profile compared to RMC6236. Multiple combination therapy regimens across various indications are planned to commence in 2026.
Lead Product GFH925: Efficacy and Commercial Validation As the world's third and China's first approved KRAS G12C inhibitor for 2L+NSCLC, GFH925's inclusion in the NRDL is expected to drive rapid sales growth leveraging Innovent's strong commercial capabilities. Overseas, a combination therapy with an EGFR monoclonal antibody for first-line NSCLC has completed Phase 2 trials. In the KROCUS trial, the regimen achieved an ORR of 80% (including 3 complete responses), a disease control rate (DCR) of 100%, and an mPFS of 12.5 months, positioning it as a potential novel first-line therapy.
Risk factors include potential delays in research and development progress, intensifying competition, and changes in industry regulations.
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