Chipscreen Biosciences Announces NMPA IND Approval for NW001, a PD-L1-Targeted Epigenetic Immune-Modulating Antibody Conjugate
SHENZHEN, China, October 16, 2026--Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") (SSE: 688321) today announced that NW001, a first-in-class epigenetic immune-modulating antibody conjugate (EIMAC) co-developed with Chengdu Chipscreen Newway Biosciences Co., Ltd., has obtained IND approval from China's National Medical Products Administration (NMPA). The Phase 1 trial will assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NW001 in patients with advanced tumors.
Although immune checkpoint inhibitors have reshaped the treatment landscape for many advanced cancers, immunologically "cold" tumors and primary or acquired resistance remain major clinical challenges. Improving the efficacy of immunotherapy and overcoming resistance are therefore key priorities in developing next-generation immuno-oncology (IO) drugs.
NW001 is an epigenetic immune-modulating antibody conjugate (EIMAC). Its antibody component is a humanized anti-PD-L1 monoclonal antibody, conjugated to a novel histone deacetylase inhibitor (HDACi) payload. Upon binding to cell-surface PD-L1, NW001 is internalized and undergoes intracellular cleavage, releasing the HDACi payload to exert antitumor activity through combined epigenetic and immune modulation. This design aims to enable precise release of the epigenetic modulator payload inside tumor cells and reduce systemic exposure. It has the potential to overcome limitations of current immunotherapies and marks a key milestone in Chipscreen Biosciences' IO 2.0 strategy.
Preclinical studies show that NW001 exhibits marked antitumor activity in models refractory or resistant to PD-1/PD-L1 inhibitors. In responsive models, it also demonstrates greater antitumor activity than that of PD-L1 inhibitors. NW001 shows favorable pharmacokinetic properties and is well tolerated in non-human primates.
Through its work on chidamide, the world's first approved oral, subtype-selective HDAC inhibitor, the company has extensively explored the interplay between epigenetics and tumor immunology, accumulating substantial preclinical and clinical evidence. The combination of chidamide and immune checkpoint inhibitors has met the primary efficacy endpoint in a global Phase 3 study in melanoma. A Phase 3 study in colorectal cancer conducted in China has completed patient enrollment.
Built on the clinically validated epigenetic immune-modulating mechanism, NW001 is designed to widen the therapeutic window; it therefore has the potential to offer superior efficacy to that of current immunotherapies, and to overcome treatment limitations in immunologically "cold" tumors and tumors resistant to immunotherapy.