Evening Brief: World’s First In Vivo Gene Editing Therapy Succeeds in Phase III; Corheart’s Fully Magnetically Levitated Pediatric Artificial Heart Trial Approved by FDA

1. The world's first in vivo gene editing therapy Phase III study succeeds

On April 27, Intellia Therapeutics announced positive results from the global Phase III HAELO study of its in vivo gene-editing therapy Lonvo-z (NTLA-2002), developed using CRISPR/Cas9 technology, for the treatment of hereditary angioedema (HAE). The study enrolled 80 patients and showed that the frequency of HAE attacks in the Lonvo-z group was reduced by 87% compared to the placebo group. Additionally, 62% of patients remained attack-free and did not require further treatment within six months, with good safety and tolerability. Lonvo-z aims to achieve disease remission by knocking out the KLKB1 gene and has the potential to become the world's first drug capable of functionally curing HAE with a single injection. The company plans to submit a rolling BLA application to the FDA, expected to be completed in the second half of 2026, with commercialization anticipated in the first half of 2027 in the United States.

2. BrioHealth Solutions' World's First Fully Magnetically Levitated Artificial Heart for Children Clinical Trial Approved by U.S. FDA

BrioHealth Solutions, the wholly-owned U.S. subsidiary of BrioHealth Solutions, announced that the company has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate clinical evaluation of the BrioVAD® system for pediatric patients with advanced heart failure. The Brio4Kids trial, an extension of the INNOVATE trial into the pediatric field, will be conducted under the latter's Investigational Device Exemption (IDE). This trial is not only the first prospective clinical trial of a fully magnetically levitated artificial heart in the pediatric field but also marks the first time that the same left ventricular assist device (LVAD) has been evaluated in parallel clinical trials for both adult and pediatric populations, filling a critical gap in the treatment of pediatric heart failure.

3. Hexaell Biotech Completes Nearly 100 Million Yuan in Additional B+ Round Financing, Accelerating Clinical and Industrialization of Bioartificial Liver

Artery Network learned that Hexaell Biotech Co., Ltd. (hereinafter referred to as "Hexaell Biotech"), an innovative biopharmaceutical company focusing on liver disease cell therapy and regenerative medicine, has recently successfully completed an additional financing of nearly 100 million yuan in its B+ round. This additional round of financing was jointly participated by Fuhui Venture Capital, Yueke Financial, Shenzhen Capital, Cuihong Innovation, and Zhongshan Venture Capital. The funds will be mainly used for the clinical development, process optimization, and subsequent pipeline development of its core product, the HepaCure Bioartificial Liver, further solidifying the company's global leading position in the field of liver disease treatment.

End-stage liver diseases such as liver failure represent a significant unmet clinical need. As the most promising treatment approach, bioartificial liver has become an industry focal point. Hexaell Biotech has been deeply committed to this field for many years, leveraging internationally leading hepatocyte-like cell transdifferentiation technology (hiHep technology) to establish a differentiated technical barrier. This core technology originates from the research team of Professor Lijian Hui at the Center for Excellence in Molecular Cell Science, Chinese Academy of Sciences, which achieved the world’s first direct transdifferentiation from somatic cells into hepatocyte-like cells. Related research findings have been published in top-tier international journals such as *Nature* and *Cell Stem Cell*, providing a solid foundation of original innovation for product development.

The core product HepaCure Bioartificial Liver, developed based on this technology, has now entered Phase II clinical research, making it the fastest-progressing product of its kind globally. Existing clinical data shows that HepaCure excels in safety and efficacy, significantly improving the survival rate of patients with liver failure and bringing new hope to the patient population suffering from liver failure.

4. Layer浪 Bio Completes Tens of Millions in Financing, Strengthens Core Competitiveness of Chinese Production, and Accelerates the Implementation of Globalization Strategy

Recently, Beijing Cenlang Biotechnology Co., Ltd. (hereinafter referred to as "Cenlang Biotech"), a well-known enterprise in China's flow cytometry field, announced the completion of a multi-million yuan financing round. This round of financing was exclusively invested by Sunshine Ronghui Capital, with StarBridge Capital serving as the exclusive financial advisor. This marks the second time Cenlang Biotech has gained capital market favor following its March 2024 financing, demonstrating the industry's widespread recognition of the innovation capability and commercial prospects of high-end, China-produced flow cytometry technology.

5. Brain-Computer Interface Rehabilitation Leader Sirun Medical Completes Tens of Millions in Financing, Building a Full-Chain Brain-Computer Interface Rehabilitation Product Line

Cerebral Interface Rehabilitation Leader, Xirun Medical, Announces Completion of Tens of Millions in Financing; This Round Exclusively Invested by Wuxi Liangxi Science and Innovation Industry Fund. This financing marks the capital market's high recognition of Xirun Medical’s technical barriers, clinical transformation capabilities, and full-chain industrialization in the cerebral interface rehabilitation field.

Sirun Medical Layouts Full-Stack Brain-Computer Interface Technology, Building Core Barriers. The company owns more than 80 patents, and its products have passed the triple international certifications of NMPA, CE, and FDA, leading the industry in technical maturity and compliance. The company has built an open brain-computer platform that supports multi-protocol transmission and cross-device compatibility, achieving a full-process closed loop of "signal acquisition-intent recognition-rehabilitation intervention."

6. "Xunming Bio" Completes $35 Million Series A+ Financing, First Antibody Drug to Enter Clinical Trials Soon

On April 28, 2026, Aureka Biotechnologies completed a $35 million Series A+ financing round. This round was led by Sequoia Capital China, with participation from Matrix Partners and Boyuan Capital, while existing shareholders such as 5Y Capital, Qiming Venture Partners, and New Alliance Capital continued to increase their investments. Aureka Biotechnologies stated that the proceeds from this round will be used to advance the development of its self-developed innovative functional antibody design platform AuraIDE™, enhance foundational model and intelligent agent capabilities, improve high-throughput and high-content experimental platform facilities, and further streamline key processes for intelligent agents from project initiation, molecular design, to implementation.