China: NMPA Approves New Therapies | 2026

Badari Andukuri
Aug 26
3 min read

Rexobin Approved for Pustular Psoriasis Flares

The NMPA has authorized Rexobin injection, submitted by Shanghai Huatai Biological Pharmacy, through the priority review pathway.

The treatment is intended for adults weighing at least 40 kilograms who experience flare-ups of generalized pustular psoriasis. The approval introduces an additional therapy for patients affected by this rare and severe inflammatory skin condition.

The authorization was announced on July 29, 2026.

Tengotinib Receives Conditional Clearance

August 11, 2026

The NMPA granted conditional marketing approval to tengotinib tablets, submitted by Jieentai Nanjing Technology.

The medicine is a Class 1 innovative therapy for adults with advanced, metastatic, or unresectable cholangiocarcinoma. It is intended for patients whose disease has progressed after systemic treatment and therapy targeting FGFR, provided their tumors carry FGFR2 fusions or rearrangements.

The application was reviewed under China’s priority approval process. The conditional authorization gives eligible patients another treatment option after earlier therapies have failed.

Enhertu Combination Approved in HER2 Positive Breast Cancer

August 12, 2026

The NMPA has also approved Enhertu together with pertuzumab as an initial treatment for adults with HER2-positive metastatic breast cancer.

The decision was supported by findings from the Phase 3 DESTINY-Breast09 study. In the trial, the Enhertu and pertuzumab combination reduced the risk of disease progression or death by 44% compared with taxane, trastuzumab, and pertuzumab, commonly referred to as THP.

Patients receiving the combination achieved a median progression-free survival of 40.7 months. The corresponding figure for the THP regimen was 26.9 months.

The treatment effect was observed across the predefined patient subgroups, and results from participants in China were consistent with the overall study findings.

Response Rates and Disease Control

The confirmed objective response rate reached 85.1% among patients treated with Enhertu and pertuzumab. This included a complete response rate of 15.1% and a partial response rate of 70%.

In the THP group, the objective response rate was 78.6%. Complete responses accounted for 8.5%, while partial responses represented 70% of cases.

The median duration of response was 39.2 months with the Enhertu combination, compared with 26.4 months for THP.

The DESTINY-Breast09 findings were presented at the 2025 annual meeting of the American Society of Clinical Oncology and later published in The New England Journal of Medicine.

Growing Availability in China

The latest decision represents the fourth approval for Enhertu in China in less than 12 months. The medicine is now authorized for eight indications in the country.

Enhertu is an antibody drug conjugate designed to target HER2. It was discovered by Daiichi Sankyo and is being developed and commercialized jointly by Daiichi Sankyo and AstraZeneca.

Together, the latest regulatory actions demonstrate China’s continued use of priority review pathways to accelerate access to therapies for serious diseases and patient groups with limited treatment choices.

NMPA approved Fenzalotuzumab for Multiple Myeloma

The NMPA has approved fenzalotuzumab injection, marketed as Jingfei, from I-Mab Biopharma Hangzhou.

The medicine is intended to be used with lenalidomide and dexamethasone in adults with multiple myeloma who have already received at least one previous treatment line.

Multiple myeloma is a blood cancer that develops in plasma cells within the bone marrow. It can return after treatment and often requires multiple lines of therapy as the disease progresses.

The approval gives physicians an additional combination regimen for patients whose disease has been treated previously.

Tengotinib Receives Conditional Approval for Cholangiocarcinoma

The NMPA has also conditionally authorized tengotinib tablets, known as Jieentai, from Jieentai Nanjing Technology.

The medicine is a Class 1 innovative drug and was reviewed through China’s priority approval pathway.

Tengotinib is intended for adults with advanced, metastatic, or unresectable cholangiocarcinoma whose disease has progressed after systemic treatment and therapy directed at FGFR.

The approval applies to patients whose tumors carry FGFR2 fusions or rearrangements. These genetic changes can help identify people who may benefit from treatments designed to target the FGFR pathway