YolTech Sells China Rights to Cholesterol Gene Therapy to Salubris for $29M

In a significant development in the field of gene editing, Chinese biotechnology company YolTech Therapeutics has entered into a substantial deal with Salubris Pharmaceuticals, granting the latter the local rights to YolTech’s cholesterol disease-focused candidate, YOLT-101. The deal, valued at 205 million Chinese yuan (approximately $28.7 million), marks a notable step forward in the treatment of cholesterol-related conditions.

YOLT-101 is an innovative in vivo liver base editing therapy designed to address three major cholesterol-related conditions: heterozygous familial hypercholesterolemia (FH), established atherosclerotic cardiovascular disease, and uncontrolled low-density lipoprotein cholesterol (LDL-C). Earlier this year, in April, YolTech initiated a phase 1 clinical trial of YOLT-101 with the first patient dosed. The focus of this trial is individuals suffering from FH, a genetic disorder that leads to elevated cholesterol levels.

YOLT-101 operates by permanently inhibiting the PCSK9 gene in the liver. This gene editing approach has shown promising results, particularly in non-human primate models, where it has been demonstrated to reduce LDL-C levels for nearly two years. This could potentially represent a one-time, long-lasting treatment for patients with cholesterol disorders.

As part of the agreement, Salubris Pharmaceuticals has obtained the rights to develop and commercialize YOLT-101 exclusively in Mainland China. The initial 205 million yuan payment comprises both an upfront fee and a development milestone. Should YOLT-101 successfully reach the Chinese market, Salubris may be required to pay up to an additional 830 million yuan ($116 million) in commercial milestones, along with tiered royalties based on sales performance.

The collaboration delineates clear responsibilities: YolTech, based in Shanghai, will continue its preclinical development of YOLT-101. Meanwhile, Salubris, headquartered in Shenzhen, will take charge of preparing and conducting human trials and subsequent stages of development.

Yuxiang Ye, Chairman of Salubris, emphasized the significance of this collaboration, stating, “In vivo gene editing represents a paradigm shift in medical treatment, enabling precise interventions for complex diseases, including cardiovascular disorders.” He added that this partnership with YolTech is a strategic move to harness advanced gene editing technologies, aiming to go beyond the limitations of conventional therapies. Ye highlighted that the alliance is aimed at fostering innovation and positioning both companies for long-term success in providing transformative treatments.

YolTech is not limiting its gene editing endeavors to YOLT-101 alone. The company is also advancing another candidate, YOLT-201, which is an in vivo gene editing therapy currently in a phase 1 trial for hereditary transthyretin amyloidosis. This indicates YolTech’s broader ambition in the realm of gene editing therapies.

Salubris Pharmaceuticals, for its part, possesses a diverse pipeline of drugs. Among these is enadostat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor that has received approval in China for the treatment of non-dialysis adults with chronic kidney disease. This extensive pipeline reflects Salubris's commitment to addressing a wide range of medical conditions through innovative therapies.

The partnership between YolTech and Salubris thus represents a confluence of cutting-edge gene editing technology and strategic pharmaceutical development, aimed at addressing some of the most challenging conditions related to cholesterol management. This collaboration could potentially pave the way for groundbreaking treatments that offer long-lasting benefits to patients.