On 21 November, Luye Pharma announced that its pipeline asset LY03010, a once-monthly, long-acting injectable (LAI) form of paliperidone, had achieved the primary endpoint in a pivotal trial (NCT04922593) and demonstrated comparable bioavailability with Johnson & Johnson’s Invega Sustenna at steady state. If approved, LY03010 will be used as an alternative LAI and create more options for patients and physicians in the management of schizophrenia. GlobalData has forecast LY03010 to launch in the US in Q2 2024 and generate sales of $63.5m by 2031.

Prior to starting the monthly injection cycles, Invega Sustenna requires an initiation dosing regimen, in which patients receive treatment on Days 1 and 8. In contrast, LY03010 optimises the initial dosing protocol such that treatment on Day 8 is not required. Despite this difference, in the randomised, multiple-dose, open-label, parallel-group pivotal trial, the exposure levels in the LY03010 treatment group were found to be comparable to Invega Sustenna at Week 1. The steady-state bioequivalence of the two products was comparable in patients with schizophrenia and schizoaffective disorder. In addition, LY03010 was well-tolerated, with no unexpected treatment-emergent adverse events. As LAIs must be administered by a healthcare professional, the optimised initial dosing protocol offered by LY03010 could be more convenient for physicians and patients.

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Although a useful addition to the schizophrenia treatment arsenal, the uptake of LY03010 is anticipated to be limited as the market is crowded with LAIs that are reformulations of popular antipsychotics such as aripiprazole, risperidone and paliperidone. In particular, Johnson & Johnson is a major player, with four paliperidone products having a wide range of dosing frequencies, including a daily oral tablet and injectables administered monthly (Invega Sustenna), quarterly (Invega Trinza) or biannually (Invega Hafyera). Furthermore, key opinion leaders previously interviewed by GlobalData were unanimous in their preference to prescribe established LAIs over the new pipeline products, especially if the pipeline agents are anticipated to have premium pricing.

Although Luye Pharma currently markets Rykindo (risperidone ER) in China for the treatment of schizophrenia, the company is not very well-established in the schizophrenia market and may have trouble making inroads with psychiatrists. Should LY03010 receive FDA approval, Luye Pharma will need to provide solid marketing and competitive pricing to set LY03010 apart from competitors and convince payers to reimburse it. Completing a head-to-head study investigating improvements to treatment adherence through the LY03010 dosing regimen could also help differentiate it from Johnson & Johnson’s portfolio of paliperidone products.

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