CORXEL Submits NDA for LNZ100 in China for Presbyopia Treatment

CORXEL Pharmaceuticals has submitted a New Drug Application (NDA) for LNZ100 (1.75% aceclidine HCl) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for the treatment of presbyopia. This regulatory milestone marks the first international NDA filing for LNZ100 outside the United States.

Strategic Partnership Between LENZ and CORXEL

The NDA submission stems from an ongoing partnership between LENZ Therapeutics and CORXEL Pharmaceuticals, established in April 2022, under which CORXEL received exclusive rights to develop and commercialize LNZ100 in Greater China. This marks the first milestone achievement under their License and Collaboration Agreement, positioning CORXEL to advance LNZ100 toward market approval in China.

Under the terms of the agreement, LENZ Therapeutics is eligible to receive up to $95 million in regulatory and commercial milestone payments, along with tiered royalties ranging from mid-single-digit to low double-digit percentages on net sales in the region.

NDA Supported by Phase 3 Clinical Data in China

The NDA is supported by positive outcomes from the JX07001 Phase 3 clinical trial, which was conducted in patients with presbyopia across China. This multicenter, randomized, double-blind, vehicle-controlled study evaluated both efficacy and safety of LNZ100. The trial included a 4-week efficacy phase followed by a 5-month safety extension, enrolling 300 participants aged 45 to 75 years, with a spherical equivalent range of –4.0 to +1.0 diopters. Participants included individuals with prior laser-assisted corneal refractive surgery and monofocal intraocular lens implantation.

The trial met both primary and key secondary endpoints, demonstrating that LNZ100 achieved three lines or more of improvement in best-corrected distance visual acuity (VA) at near, while preserving optimal distance VA, defined as no loss of five or more letters.

Ongoing Regulatory Developments for LNZ100

This regulatory development follows LENZ Therapeutics’ announcement in October 2024 that the U.S. FDA had accepted the NDA for LNZ100 for the treatment of presbyopia. It also builds on the company’s recent collaboration with Laboratoires Théa, which will pursue registration and commercialization of LNZ100 in Canada.

Executive Commentary

Eef Schimmelpennink, President and CEO of LENZ Therapeutics, expressed confidence in the progress of the global development strategy:

“This exciting milestone in our development partnership with CORXEL has come as a result of tremendous collaboration between the teams. This submission was supported by the impressive data generated from the Phase 3 clinical trial of LNZ100 in China, consistent with the data from the CLARITY trial. This is the first regulatory submission outside of the United States, further reinforcing the opportunity for LNZ100 to become a global therapy for the treatment of presbyopia.”