The National Healthcare Security Administration (NHSA) has released a preliminary list of drugs that have passed the initial formal review stage for potential inclusion in the National Reimbursement Drug List (NRDL) for this year, with a public feedback period open until August 18, 2024. The NHSA received a total of 626 applications between July 1st and 14th, with 570 unique drugs by molecule name being put forward for consideration. This initial selection phase saw 440 molecules advance, marking a slight increase from the previous year’s review.
The shortlist includes 244 drugs that have never been listed on the NRDL before, including 225 Western medicines and 19 traditional Chinese patent medicines, with 33 of these being candidates for rare disease treatments. Additionally, 196 drugs already listed on the NRDL, consisting of 153 Western medicines and 43 traditional Chinese medicines (TCMs), are under review.
The review saw seven PD-1/L1 related preparations pass, such as Sino Bio’s Andewei (benmelstobart), CSPC’s Enshuxing (enlonstobart), Akeso Bio’s cadonilimab and penpulimab, Gloria Pharma’s zimberelimab, Lee’s Pharma’s socazolimab, and Akeso Bio’s Yidafang (ivonescimab). Notably, CStone’s Cejemly (sugemalimab), the only new PD-1 drug that passed the formal review last year, did not participate this time.
Four CAR-T therapies also passed the review, including Fosun Kite Bio’s Yescarta (axicabtagene ciloleucel) and JW Therapeutics’ Carteyva (relmacabtagene autoleucel), which were unsuccessful in their previous attempts, as well as Juventas Cell Therapy’s inaticabtagene autoleucel and CARsgen Therapeutics’ zevorcabtagene autoleucel, both newly filed this year. Antibody-drug conjugates (ADCs) such as Gilead’s Trodelvy (sacituzumab govitecan), Roche’s Polivy (polatuzumab vedotin), and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) also passed the review stage. However, Pfizer’s Besponsa (inotuzumab ozogamicin) was not on the list.
The preliminary formal review’s approval of some drugs with higher price tags indicates their eligibility for the next round. They will have to undergo rigorous review and negotiations or price bidding to ultimately secure a place on the NRDL.- Flcube.com
