Chipscreen Biosciences Announces NMPA IND Approval for NW001, a PD — L1 — Targeted Epigenetic Immune — Modulating Antibody Conjugate

For best results when printing this announcement, please click on link below: Chipscreen Biosciences Announces NMPA IND Approval for NW001, a PD-L1-Targeted Epigenetic Immune-Modulating Antibody Conjugate 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.

About Chipscreen Biosciences Founded in March 2001, Chipscreen Biosciences is a pioneer in innovative drug development based in China. The company is committed to providing affordable medicines with novel mechanisms of action and transformative efficacy that address urgent clinical needs. With its AI-enabled Chemical Genomics Platform (AI-ChemGen), Chipscreen Biosciences supports the full process from basic research to clinical translation. The company has successfully developed two first-in-class medicines: Epidaza® (chidamide) for oncology and Bilessglu® (chiglitazar sodium) for type 2 diabetes.

These products are marketed for multiple indications worldwide. Chipscreen Biosciences has built an R&D pipeline spanning from early discovery to late-stage clinical development across oncology, metabolic diseases, autoimmune diseases, and neurodegenerative diseases. Eleven products are currently in clinical development, three of which are undergoing concurrent clinical studies in China and the United States. The company continues to advance a range of differentiated, globally competitive R&D programs.

About Chipscreen Newway Biosciences Chengdu Chipscreen Newway Biosciences Co., Ltd. (“Chipscreen Newway Biosciences”) is an associate company of Chipscreen Biosciences, established as part of Chipscreen Biosciences’ strategic expansion into innovative large-molecule drug development. The company aims to address urgent clinical needs by applying new discoveries and technologies at the forefront of life sciences. It has an R&D team with more than 50 members and a 3,000 m² laboratory that integrates small-molecule and large-molecule drug discovery.

Chipscreen Newway Biosciences has established world-leading technology platforms for ADC development. These include a platform that combines three approaches to high-throughput antibody discovery based on precision immunization strategies with AI-assisted protein engineering; the DSHL (DAR homogeneous Site-specific Hydrophilic Linker) platform; and an innovative cytotoxic payload platform featuring novel mechanisms of action and dual-payload designs with complementary mechanisms of action.

With a focus on immuno-oncology and ADCs (IO + ADC), the company is developing molecules with novel mechanisms of action, including ADCs directed at novel targets, bispecific ADCs and dual-payload ADCs. It is committed to continually advancing differentiated drug candidates to address unmet clinical needs. A number of its innovative products are currently in clinical or preclinical development. View source version on.com: pr@chipscreen.com (mailto:pr@chipscreen.com)