Latest! Two Innovative Cancer Drugs: Zongertinib Tablets & Zemetostat Tablets Officially Approved by NMPA

August 29, 2025 – Beijing – The National Medical Products Administration (NMPA) of China has officially announced the approval of two Category 1 innovative drugs:

• Zongertinib Tablets (Boehringer Ingelheim) – a HER2 tyrosine kinase inhibitor
• Zemetostat Tablets (Hengrui Pharmaceuticals) – an EZH2 inhibitor

Boehringer Ingelheim – Zongertinib Tablets

Mechanism: Irreversible HER2 Tyrosine Kinase Inhibitor
Indication: Non-Small Cell Lung Cancer (NSCLC)

The NMPA granted conditional approval under the priority review pathway for Zongertinib Tablets (generic name: zongertinib) as monotherapy for adult patients with unresectable locally advanced or metastatic NSCLC harboring HER2 (ERBB2) activating mutations, who have previously received at least one systemic therapy.

• Clinical Data (Beamion LUNG-1 Study):
  • ORR of 75% in patients previously treated with platinum-based chemotherapy but without prior HER2-targeted therapy (58% had DOR ≥6 months).
  • ORR of 44% in patients previously treated with HER2-targeted ADCs (27% had DOR ≥6 months).
  • Disease control rate (DCR) reached 93%.
  • Intracranial activity was observed, with confirmed responses in patients with asymptomatic brain metastases (ORR 33–40%).

Zongertinib had already received FDA accelerated approval (August 9, 2024) for similar indications in the U.S. Its favorable safety profile is linked to its lack of binding to wild-type EGFR.

In April 2024, China Biopharma partnered with Boehringer Ingelheim to co-develop and commercialize zongertinib and other oncology assets in mainland China.

Hengrui Pharmaceuticals – Zemetostat Tablets (SHR2554)

Mechanism: Oral EZH2 Inhibitor
Indication: Relapsed or Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

The NMPA conditionally approved Zemetostat Tablets for adult patients with R/R PTCL who have received at least one prior systemic therapy.

• Key Clinical Findings (EHA 2025 Presentation):
  • Enrolled 67 patients across PTCL subtypes.
  • Overall response rate (ORR): 64.2%, with 32.8% CR and 31.3% PR.
  • ORR by subtype:
    • AITL: 70.3%
    • PTCL-NOS: 57.1%
    • ENKTL-NT: 50.0%
    • ALCL (ALK-): 42.9%
  • Median DoR: 18.7 months
  • Median PFS: 10.0 months
  • Median OS: Not yet reached
  • Safety profile: manageable and overall well-tolerated

Researchers concluded that SHR2554 demonstrated promising efficacy and controllable safety in patients with relapsed/refractory PTCL.

DengYueMed Comment

The approval of Zongertinib and Zemetostat highlights China’s accelerated progress in oncology innovation, providing new treatment options for HER2-mutated NSCLC and R/R PTCL.

At HK DengYueMedicine, we view these milestones as a strong sign of how priority review with conditional approval is driving faster access to innovative therapies, addressing urgent clinical needs and improving patient outcomes

📌 Sources: NMPA official website