New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial
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A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations.
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The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment.
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Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.
Chinese University of Hong Kong (CUHK) medical researchers announced on Monday that a mainland-developed cancer drug has demonstrated significant efficacy in treating multiple types of cancer in a multinational clinical trial.
The drug, D3S-001, developed by pharmaceutical company D3Bio, showed promising results in a phase 1 trial involving patients with non-small-cell lung cancer, colorectal cancer, and pancreatic cancer driven by KRAS-G12C gene mutations.
According to the research team, more than 70 percent of the 42 patients who received the inhibitor for the first time experienced significant tumor shrinkage or complete disappearance. This response rate indicates substantial potential for the novel therapy in addressing cancers with limited treatment options.
Dr. Herbert Loong Ho-fung, an associate professor at CUHK's department of clinical oncology, highlighted the drug's advantages over existing treatments.
"It does inhibit KRAS-G12C at a quicker rate and most likely at a longer duration as well compared with a first-generation inhibitor," Dr. Loong explained. "This is demonstrated in the laboratory and certainly in our clinical trials. We're also seeing signals of this in our patients."
The KRAS-G12C mutation has been a challenging target in cancer therapy, with limited therapeutic options currently available. D3S-001 represents a next-generation approach to targeting this specific mutation, which is found in approximately 13% of non-small-cell lung cancers, 3% of colorectal cancers, and 2% of pancreatic cancers.
The mutation acts as an oncogenic driver, meaning it plays a crucial role in tumor development and progression. Effectively targeting this mutation could potentially halt or reverse cancer growth in patients with these specific genetic profiles.
Professor Tony Mok, who chairs CUHK's department of clinical oncology, indicated that further research is already being planned to advance the drug's development.
"We are actually looking into a phase three development, most likely we would like to see this compound as a first-line medication," Professor Mok stated.
The progression to phase 3 trials would represent a significant step toward potential regulatory approval and wider clinical use. First-line designation would position the drug as an initial treatment option for newly diagnosed patients with KRAS-G12C mutations, potentially improving outcomes from the earliest stages of treatment.
The research team noted that their findings have been published in the prestigious Nature Medicine journal, underscoring the scientific significance of the discovery. This publication in a high-impact peer-reviewed journal provides important validation of the study's methodology and results.
The multinational nature of the trial also highlights growing international collaboration in cancer drug development, with Chinese pharmaceutical innovation increasingly contributing to the global oncology landscape.
As research continues, oncologists and patients alike will be watching closely to see if D3S-001 can maintain its promising efficacy profile in larger trials and potentially become a standard treatment option for patients with KRAS-G12C-mutated cancers.

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