December 07,2025
On December 7, 2025, the 2025 High-Quality Development Conference for Innovative Drugs was held in Guangzhou, where the 2025 National Reimbursement Drug List (NRDL) for Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance was released. Epidaza® (Chidamide Tablets), a first-in-class drug independently developed by Chipscreen Biosciences, has been included in the NRDL as a regular Category B drug. Its approved indications include: patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic chemotherapy, and previously untreated patients with diffuse large B-cell lymphoma (DLBCL) who are positive for MYC and BCL2 expression. The new version of the list will officially take effect on January 1, 2026.
Supporting Genuine Innovation
As early as 2017, chidamide was included in the NRDL as one of the first 36 exclusive drugs, significantly improving patient access to treatment for R/R PTCL. In 2024, its new DLBCL indication was successfully included, making it the only oral first-in-class drug currently listed for first-line treatment of DLBCL. This inclusion in the NRDL as a regular Category B drug is a solid measure by the national medical insurance system to support genuine innovation and benefit a wide range of patients, bringing long-term, stable medication security and hope for life to countless families. It also signifies full recognition of chidamide's outstanding clinical value and patient benefit.
From Originating in China to Global Exploration
Chipscreen Biosciences continues to explore new mechanisms combining HDAC inhibitor-based epi-immunotherapy with immunotherapy (IO). Currently, Phase III trials of chidamide for colorectal cancer and melanoma are advancing rapidly, both domestically and internationally, with both trials using active standard therapies as comparators. Furthermore, NW001, a next-generation epigenetic immunomodulatory ADC drug developed by Chipscreen Biosciences, has entered preclinical studies, with broad application prospects for a wide range of immunologically refractory tumors. As the world's first subtype-selective histone deacetylase (HDAC) inhibitor and China's first original anti-tumor chemical new drug, chidamide has been approved for 3 indications in China (covering mainland China and the Taiwan region): PTCL, breast cancer, and DLBCL; and for 2 indications in Japan: adult T-cell leukemia and PTCL. Against the backdrop of ongoing support from national medical insurance policies for innovation and development in the biopharmaceutical industry, Chipscreen Biosciences will remain focused on addressing unmet clinical needs globally, committed to benefiting a broader patient population through China's original achievements.
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