{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T18:10:15Z","timestamp":1779127815620,"version":"3.51.4"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T00:00:00Z","timestamp":1771200000000},"content-version":"vor","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Chongqing Claruvis"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Conventional botulinum toxin type A (BoNT\/A) products include non-therapeutic accessory proteins vary in composition and manufacturing processes, which may contribute to differences in purity and biochemical characteristics. YY001 (Retoxin\u00ae) is a novel recombinant BoNT\/A manufactured via E. coli expression to reduce impurities, improve purity, and minimize immunogenic risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the efficacy, safety, and immunogenicity of YY001, a recombinant botulinum toxin type A (Chongqing Claruvis Pharmaceutical Co., Ltd., Chongqing, China), in the treatment of moderate-to-severe glabellar lines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicenter, randomized, double-blind, vehicle- and active-controlled Phase III trial, 529 adults aged 18-65 with moderate to severe glabellar lines were randomized 4:2:1 to receive a single 20\u2005U injection of YY001, Botox\u00ae(Allergan Pharmaceuticals Ireland, Westport, Ireland), or vehicle. The primary endpoint was composite response rate (CRR) at Week 4, defined as a \u22652-grade improvement of glabellar line severity assessed by both investigator and participant. Secondary endpoints included onset time, duration, satisfaction, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>YY001 achieved a CRR of 86.7% at Week 4, significantly outperforming Botox\u00ae (66.7%, P &amp;lt; .0001) and vehicle (1.3%, P &amp;lt; .0001). It showed faster onset, longer median duration (97 days), and high participant satisfaction. Adverse events were mild and comparable across groups. Only one case of anti-drug antibody was observed; no neutralizing antibodies were detected. A 12-week follow-up and ethnically homogenous population may limit generalizability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>YY001 demonstrated strong efficacy and a favorable safety profile than Botox\u00ae. Longer-term and multicenter studies are needed to assess durability, immunogenicity, and applicability across broader populations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence: 1 (Therapeutic)<\/jats:title>\n                    <jats:p>For image description, please refer to the figure legend and surrounding text.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/asj\/sjag042","type":"journal-article","created":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T12:46:03Z","timestamp":1770900363000},"page":"672-679","source":"Crossref","is-referenced-by-count":0,"title":["Therapeutic Efficacy and Safety of Recombinant Botulinum Toxin Type A for Moderate to Severe Glabellar Lines: A Randomized, Controlled, Double-blind, Phase III Trial in Chinese 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