Kerui：DN022150 has initiated a Phase III clinical trial.

On June 17, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Kerui Pharmaceutical, a subsidiary of Qingfeng Pharmaceutical, has registered a Phase III study of DN022150 monotherapy versus chemotherapy in advanced pancreatic cancer carrying the KRAS G12D mutation.

DN022150 is a novel, highly selective KRAS G12D inhibitor developed by Kerui Pharmaceutical. It specifically binds to the Switch-II pocket of the mutant KRAS G12D protein, acting on both the GDP-bound (OFF) and GTP-bound (ON) states of KRAS G12D, thereby inhibiting KRAS-mediated signal transduction and downstream RAS-MAPK pathway activation to exert anti-tumor effects. According to the Insight database, Kerui Pharmaceutical has previously initiated two clinical trials for this drug: a Phase I/IIa trial evaluating DN022150 in patients with advanced solid tumors harboring KRAS G12D mutations, and a Phase I trial evaluating DN022150 in combination with gemcitabine and nab-paclitaxel (AG regimen) as first-line treatment for locally advanced or metastatic pancreatic cancer with KRAS G12D mutations.

The results of the Phase I/IIa trial were presented as an oral presentation at the 2026 ASCO Annual Meeting. As of April 5, among 31 evaluable pancreatic cancer patients (2L+), the overall objective response rate (ORR) was 41.9% and the disease control rate (DCR) was 93.5%.

DN022150 demonstrated a favorable overall safety and tolerability profile. Among all 67 patients who underwent safety evaluation, 32.8% (22/67) experienced Grade ≥3 treatment-related adverse events (TRAEs). In the recommended Phase II dose (RP2D, 650 mg) group, 27.7% (10/36) of patients experienced Grade ≥3 TRAEs. No Grade 4-5 treatment-related adverse events were observed. Based on the available clinical data, compared with published clinical data for other oral candidates targeting the same target, DN022150 demonstrates a competitive safety profile in terms of gastrointestinal tolerability and the incidence of Grade ≥3 TRAEs, supporting its potential for long-term continuous treatment in patients.

This is the first Phase III trial initiated for this drug. It is a multicenter, open-label, randomized, controlled clinical trial designed to compare the efficacy of DN022150 for injection versus investigator’s choice of chemotherapy in second-line and later treatment of advanced pancreatic cancer with KRAS G12D mutations. The trial plans to enroll 360 participants in China, with the primary endpoints being progression-free survival (PFS) and overall survival (OS), assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria.

Buy DN022150 from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.