Ophthalmic Drugs

We are primarily developing two ophthalmic drug product candidates QA102 and QA108, which are under clinical development for treating dry age-related macular degeneration (AMD).

QA102: A potentially first-in-class, orally-administered, small molecule drug candidate for the treatment of dry AMD

AMD is a common disease of the central area in the ocular posterior segment, which is essential for the vision of fine details and image resolution, with the symptoms of blurring, vision distortion, central scotoma and the occurrence of blind spots.

QA102 is a small molecule drug that potentially treats dry AMD by killing or inhibiting the growth of intraocular bacteria, based on the association of intraocular bacteria and the degenerative process of macular tissues which was firstly discovered by our scientific team and reported in Cell Discovery, a peer-reviewed scientific journal, in 2021.

In November 2021, we completed the Phase I clinical trial of QA102 for the treatment of dry AMD in the United States to evaluate its safety, tolerability and pharmacokinetics in healthy young and older participants. There were no severe adverse events reported in any participants at all dose levels administered, suggesting that QA102 has a favorable safety profile and was well tolerated among healthy participants. Based on the satisfactory safety and tolerability results from the Phase I clinical trial, we submitted an IND application to the FDA in April 2022 for a Phase II clinical trial of QA102 to assess its safety, tolerability and efficacy in patients with intermediate to advanced dry AMD. We initiated the Phase II clinical trial in May 2022.

QA102 is the first dry AMD drug candidate developed by a China-based company and approved by the FDA for clinical trials, according to Frost & Sullivan. QA102 is regulated as a novel drug by the FDA. Designed as an orally-administered drug, we believe that QA102 could be conveniently administrated to patients, and therefore could potentially improve the patient compliance and alleviated the burdens associated with drug administration through ocular operations on patients or the healthcare system in general.

QA108: An innovative traditional Chinese medicine candidate in granule form for oral administration for the treatment of dry AMD

We initiated the development of QA108 in 2018. The investigator-initiated trial of QA108 demonstrated a favorable safety and efficacy profile of QA108 to treat dry AMD. The NMPA waived the requirement for us to conduct a Phase I clinical trial for QA108 in China. We submitted an IND application to the NMPA in November 2021 for a Phase II clinical trial and received its approval in January 2022. We began the patient enrollment for the Phase II clinical trial in June 2022 and has completed the last patient out (LPO) for the Phase II clinical study. QA108 is classified as a Class 1.1 traditional Chinese medicine by the NMPA.