Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 165

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 165
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. In July 2024, NDA was accepted by NMPA with Priority Review for r/r≥2L EZH2m FL.

We are developing and plan to seek approval for tazemetostat in various hematological and solid tumors in China. We are participating in Ipsen’ s SYMPHONY-1 (EZH-302) study, leading it in China.

Tazemetostat Mechanism of Action

EZH2 is one member of a class of histone methyltransferases (“ HMTs”). It catalyzes the methylation of histone H3 at lysine 27 (H3K27) which controls expression of various genes and in turn plays a role in the normal physiology of many cell types. Dysregulation of EZH2 has been seen in a wide range of cancers and is associated with poor clinical prognosis and outcomes. Tazemetostat inhibits EZH2 which allows transcription of genes involved in functions such as cell cycle control and terminal differentiation and thus inhibits cancer cell proliferation.

Tazemetostat Clinical Development

  Treatment                                         Trial Name, Patient Focus                Sites       Phase            Status/Plan                                      NCT #        
  Monotherapy                                       r/r ≥ 3L EZH2m/EZH2w FL                  China       II Bridging      NDA accepted July 2024                           NCT05467943  
  Tazemetostat+ lenalidomide + rituximab (R 2)      SYMPHONY-1: r/r ≥ 2L EZH2m/EZH2w FL      Global      Ib/III           Phase III ongoing Phase Ib data at ASH 2023      NCT04224493  
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Phase II bridging study of tazemetostat in r/r≥3L FL (NCT05467943)

In July 2022, we initiated a China Phase II open-label, two-cohort bridging study of tazemetostat in r/r≥3L FL intended to support conditional registration in China. Patients received 800mg of tazemetostat BID. The primary objective is to evaluate ORR in patients with EZH2m (Cohort 1). The secondary objectives are to evaluate DoR, PFS and OS in patients with EZH2m and EZH