Skip to main content

Biocytogen Announces FDA IND Clearance for Partner NEOK Bio's NEOK002 Targeting Solid Tumors

Biocytogen Announces FDA IND Clearance for Partner NEOK Bio's NEOK002 Targeting Solid Tumors

Source: Businesswire India

You are reading a free article with opinions that may differ from the recommendation given by Kalkine in its paid research reports. Become a Kalkine member today to get access to our research reports, in-depth technical and fundamental research. Learn More

Business Wire India

 

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner NEOK Bio, Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for NEOK002, an EGFR/MUC1-targeting ADC program for solid tumors. NEOK Bio plans to initiate a Phase 1 clinical study in the second quarter of 2026 and expects to report initial data in 2027.

 

This IND clearance marks an important milestone for NEOK002, an EGFR/MUC1-targeting ADC candidate developed by NEOK Bio and built on a bispecific antibody originally developed by Biocytogen and licensed in 2024. According to NEOK Bio, NEOK002 is being advanced for solid tumors and may offer differentiated efficacy and safety compared with monospecific ADC approaches directed at either target alone.

 

 

Dr. Yuelei Shen, President and CEO of Biocytogen, said: “We are pleased to see one of our partnered molecules reach this important stage of development. This milestone further validates the quality, developability, and therapeutic potential of fully human bispecific antibodies discovered using our RenLite® platform, which features a common light chain design. We look forward to the continued clinical advancement of the program.”

 

 

About Biocytogen

 

 

Biocytogen (SSE: 688796; HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen has established a dual-engine platform combining a fully human antibody library with an extensive target-humanized mouse model portfolio, enabling a systematic approach to accelerating global drug discovery and development.

 

 

Biocytogen has independently developed its proprietary RenMice® (RenMab®/RenLite®/RenNano®/RenTCR™/RenTCR mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, hu-VHH discovery, and TCR mimic antibody discovery, and has established a sub-brand, RenSuper™ Biologics, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. "As of December 31, 2025, more than 350 agreements for therapeutic antibodies and clinical assets—spanning co-development, out-licensing, and transfers—have been established globally, including landmark partnerships with leading multinational pharmaceutical companies (MNCs)."Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen, Jiangsu, Shanghai), the USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

 

 

 

 

 


Unlock Premium Articles for Exclusive Insights!

DISCLAIMER

The content and services provided by Kalkine Consultancy India Private Limited (Research Analyst License No: INH000017727, hereinafter referred to as “Kalkine”) are for informational purposes only. The content, including but not limited to articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, charts, animations, and videos (collectively, “Content”), is a service of Kalkine Consultancy India Private Limited and is available for personal and non-commercial use only. Kalkine does not provide personalized financial advice and does not endorse or recommend any individuals, investment products, or services as suitable for specific financial situations. Investors are advised to consult a qualified financial planner or adviser to assess their risk tolerance and portfolio suitability before making any investment decisions. Kalkine accepts no liability for investment losses or any other financial detriment arising from reliance on the Content. Some of the Content on this website may be sourced from third-party providers. Kalkine does not claim ownership over such third-party content and does not guarantee its accuracy, completeness, or reliability. Kalkine shall not be held liable for any errors, omissions, or inaccuracies in third-party content or for any damages or losses resulting from its use. Any images, music, or videos used in the Content are either sourced from publicly available materials, paid subscriptions, or credited to their respective owners where applicable. Kalkine does not claim ownership of third-party media unless explicitly stated. This disclaimer is subject to change without notice. Users are advised to review it periodically for updates.