Exegenesis Bio files for HKEX listing; pipeline of nine gene therapy candidates with core products covering wAMD and SMA type 1

NewTimeSpace News: On 28 August 2026, Exegenesis Bio Inc. filed a listing application with HKEX. The Company is a biopharmaceutical company focused on the discovery and development of gene therapies for neurological and ophthalmic diseases, with its pipeline also including oligonucleotide-based therapies. Incorporated in 2019, the Company has built a pipeline of nine candidates through its fully integrated in-house R&D platform.

According to the announcement, the Company has internally developed two core products and one key product: core product EXG102-031 is a candidate for the treatment of wet age-related macular degeneration (wAMD), EXG001-307 (SMA type 1) is a candidate for the treatment of spinal muscular atrophy (SMA) type 1; and key product EXG202 is used for the treatment of retinal neovascular diseases, including wAMD, diabetic macular edema (DME) and retinal vein occlusion (RVO).

In terms of clinical progress, for EXG102-031, the Company has conducted two clinical trials in China and the United States: in China, all subjects completed the 52-week follow-up of the Phase IIa trial in May 2026, with the Phase IIb/III trial expected to commence in the second half of 2026; in the US, the Phase I clinical trial has been completed, with the clinical database locked since 20 March 2026. For EXG001-307 (SMA type 1), the Company has completed all Phase I/II clinical trials in patients with SMA type 1, and plans to discuss the pivotal Phase III trial design with regulatory authorities in the second half of 2026.

EXG202 is currently being evaluated in two ongoing clinical trials in the United States and China: in the US, the Company obtained IND approval from the FDA in July 2025 and plans to leverage Phase I data generated in China to bypass the US Phase I study and proceed directly to Phase II; in China, the Company obtained NMPA approval in August 2025 to initiate a combined Phase I/II clinical study, with the Phase IIa trial initiated in March 2026 and the Phase IIb trial expected in the second half of 2026.

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