Exclusive: Enorna Biotechnology Raises Over RMB 100 Million to Upgrade Its End-to-End LNP-Powered mRNA CRDMO Services and Global Capabilities

Recently, Jiangsu Enorna Biotechnology Co., Ltd. (hereinafter "Enorna Biotechnology") announced that it had closed an angel round and a Pre-A round within a single year, with total proceeds exceeding RMB 100 million. The rounds were co-led by Addor Capital and Tenykin Capital, with participation from Luxin Venture Capital and several other well-known investment institutions, while Pi Sheng Capital served as the exclusive financial advisor to the transaction. The proceeds will focus on continuous upgrades to its LNP delivery technology platform, expansion of GMP capacity and development of its overseas business, further consolidating the company's core competitiveness in mRNA and delivery systems worldwide.

Enorna Biotechnology is an mRNA CRDMO company built around LNP delivery technology. It provides end-to-end solutions for mRNA vaccines and therapeutics, from sequence design to commercial manufacturing, covering key steps including plasmid, mRNA drug substance, LNP/tLNP formulation, fill-finish and lyophilization.

Building on its mRNA drug CRDMO business, Enorna focuses on differentiated barriers in lipids such as LNP delivery systems, and is actively expanding its overseas channels and business. The company has entered deep collaborations with more than 100 domestic and international companies, including several MNCs and large pharmaceutical companies, and has completed delivery of 150-plus GMP-grade batches, with quality and turnaround highly recognized by customers.

In gene editing, the company helped a customer obtain IND approvals from the US FDA and China's NMPA. The drug is the world's first LNP-delivered epigenetic modulation therapy cleared for clinical trials by regulators in both China and the US, and its global multicenter Phase I trial is now proceeding smoothly.

In the in vivo CAR field, the company has made a forward-looking push into antibody-conjugated tLNP core technology and built a technology system covering multiple antibody conjugation strategies. On that platform it has worked with more than 30 customers and delivered over 100 projects, completing the manufacture and delivery of more than ten GMP clinical batches. All samples have passed clinical safety validation, demonstrating excellent in vivo targeting and safety, and several programs have entered the clinical filing stage.

For the small-batch, highly individualized production needs of PCVs, Enorna has equipped a dedicated independent GMP production zone along with customized TFF, small-scale LNP encapsulation equipment and end-to-end automated production equipment, supporting single-patient dose batches as low as 20 mg and completely eliminating cross-contamination. It has delivered IIT drug products for dozens of patients, with encouraging clinical benefit observed in lung cancer and pancreatic cancer patients; meanwhile, multiple IND programs and Phase I/II GMP sample production are advancing in parallel.

To address storage and transport pain points, Enorna has built lyophilization capabilities at every level from research grade to GMP grade, enabling long-term stable storage of products at 2-8°C. The platform has accumulated experience in developing, scaling up and filing more than 25 novel cationic lipids, and has lyophilization process capabilities for more than 10 different lipid formulations. The company has delivered more than 10 GMP-grade lyophilized products for an infectious disease vaccine program and helped that program complete its IND filing.

Enorna has established collaborations with a number of international pharmaceutical and biotechnology companies and built a complete Bench to Clinic service chain, using a China-specific pathway to help global customers accelerate clinical translation. It has successfully supported one overseas customer's mRNA protein replacement program from IIT through to FDA Phase II. This milestone fully confirms that the company's service capabilities and quality system are aligned with international standards, laying a solid foundation for deeper participation in the global nucleic acid drug supply chain.

Drawing on systematic technology accumulation, Enorna's integrated service capabilities now cover frontier fields including lyophilized vaccines, gene editing, personalized cancer vaccines (PCV), in vivo CAR-T, in vivo TCE and protein replacement. The company can provide highly customized full-process CRDMO solutions tailored to the differentiated needs of various emerging modalities, precisely breaking through industrialization bottlenecks and continuously empowering global innovative drugmakers to accelerate their pipelines to market.