CDD-2103: A self-developed Chinese medicine for the treatment of Ulcerative Colitis approved by National Medical Products Administration for clinical trial

Project Description

Ulcerative colitis is characterised by symptoms such as diarrhoea, rectal bleeding, and abdominal cramps, which significantly diminish patients’ quality of life. Ulcerative colitis is generally classified into active and remission stages, with treatment goals focused on alleviating symptoms, maintaining remission, and minimising recurrence. Existing treatments, however, often fail to completely maintain remission or prevent recurrence, highlighting the urgent need for more effective therapies.

In response to this need, our research team has developed CDD-2103, a novel Chinese herbal formulation designed to help maintain remission in patients with ulcerative colitis. Drawing from years of clinical experience, CDD-2103 was tested in a clinical study in Hong Kong, where it demonstrated good tolerability with no adverse effects reported.

To ensure the highest quality, CDD-2103 has been developed in granule form, adhering to the stringent quality control standards set by the China National Medical Products Administration (NMPA). Foundational experimental studies, including preclinical pharmaceutical, pharmacological, and non-clinical safety evaluations, indicated that CDD-2103 effectively suppresses the progression of colitis by enhancing the tolerogenic immune microenvironment. Additionally, CDD-2103 has received multiple patents in both the U.S. and China.

In June 2024, we submitted an Investigational New Drug application to the National Medical Products Administration of China and received authorisation for a clinical trial in August 2024. We plan to commence a Phase II clinical trial in Chinese Mainland in 2025 to further verify the effectiveness and safety of CDD-2103 as a treatment for maintaining remission in ulcerative colitis. Our ultimate goal is to obtain new drug approval for CDD-2103, enabling it to be marketed and benefit more patients worldwide.