ADHD New Drug Granted Priority Review in China; Positive Early Data Reported for Tetravalent TCE and Janssen's Dual-Target CAR-T Therapy

Recently,CDE Official Website Announcement: The new drug application (NDA) for AK0901, a compound capsule of serdexmethylphenidate/dexmethylphenidate developed by Ark Bio, has been formally accepted and included in the priority review. The proposed indication is for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and above.

Company data shows that this drug is currently the only one containing immediate-release dexmethylphenidate (d-MPH) and the prodrug serdexmethylphenidate (SDX), is a "Best-in-Class" innovative treatment for ADHD patients. It was approved for marketing in the United States in March 2021 and is the first methylphenidate-class drug approved by the FDA in nearly 20 years.

Recently, at the annual meeting of the European Hematology Association,Molecular Partners Discloses Updated Positive Data from Phase Ⅰ/Ⅱa Clinical Trial of MP0533, a Tetravalent T-cell Engager, for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). The data demonstrates the impact of MP0533 on drug exposure levels and clinical response after implementing an "accelerated dose-escalation regimen" in Cohort 8, providing a basis for the further optimized dosing regimen being used in Cohort 9.

TheData from 8 cohorts showed that, among 8 evaluable patients, 3 exhibited clinical responses after the first treatment cycle: 1 achieved complete remission (CR), and 2 achieved complete remission with partial hematologic recovery (CRh). Responses in 2 patients lasted over 3 months, with 1 patient still on treatment as of the data cutoff date (April 14, 2025) and maintaining remission for more than 6 months.

Company information shows,MP0533 is a novel tetravalent DARPin therapy targeting CD3, CD33, CD123, and CD70.

Recently, Johnson & Johnson disclosed its dual-targetThe First Clinical Data of CAR-T Cell Therapy JNJ-90014496 (hereinafter referred to as JNJ-4496). This therapy is a CD19/CD20-targeted CAR-T therapy currently being studied in a Phase Ib trial for the treatment of relapsed or refractory large B-cell lymphoma (R/R LBCL) patients who have not previously received CAR-T therapy.

Data shows that, in the recommendedIn the Phase 2 dose evaluation, 22 patients were included in the efficacy analysis study, with a median follow-up time of 4 months. Among them, patients who had received one prior treatment (n=10) achieved an objective response rate (ORR) of 100%, and a complete response rate (CRR) of 80% (95% CI: 69-100); for patients who had received two or more prior treatments (n=12), the ORR was 92%, and the CRR was 75% (95% CI: 62-100).