Summary of NMPA's new anti-tumor drugs approved in June, domestic drugs ushered in a small outbreak

On June 22, NMPA passed the priority review and approval procedure and conditionally approved Hutchison Whampoa Pharmaceuticals (Shanghai) Co.
, Ltd.
declared a category 1 innovative drug Saivotinib tablets (trade name: Woresa) to be marketed for the treatment of interstitial -Locally advanced or metastatic non-small cell lung cancer with a jump in exon 14 of epithelial transforming factor (MET)
.

Saivotinib is a highly selective oral small molecule c-Met kinase inhibitor independently developed by Hutchison Whampoa.
It has global intellectual property rights.
The indications under global development include a variety of c-Met abnormal solid tumors, such as non-small cell lung cancer, renal cancer, gastric cancer and the like of colorectal cancer
.

This approval is based on the data support of an open-label Phase II registration study
.
The results showed that in all 70 patients, the objective response rate was 42.
9%, the disease control rate was 82.
9%, the median response time was 1.
4 months, and the median duration of response was 8.
3 months.
Among them, 7 patients (10%) ) The duration of remission has reached at least 12 months
.
The median progression-free survival of patients was 6.
8 months, and the 6-month and 12-month progression-free survival rates were 52% and 31.
9%, respectively
.
The median overall survival time was 12.
5 months
.

Drug name: Akirensai injection (trade name: Yikaida, research and development code: FKC876)

R&D company: Fosun Kate

Indications: Large B-cell lymphoma

On June 22, the NMPA official website showed that Fosun Kate’s CAR-T cell therapy product Akilunsai injection (trade name: Yikaida, R&D code: FKC876) was officially approved for the treatment of two-line or more systemic Relapsed or refractory large B-cell lymphoma after treatment, including diffuse large B-cell lymphoma (DLBCL) unspecified type, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and follicular lymphoma Fosun Kate has the commercialization rights of tumor-transformed DLBCL in China, including Hong Kong and Macau, and localized production in China (excluding Hong Kong, Macao and Taiwan)
.

Based on research data at home and abroad, the ORR of Akirensai injection in the treatment of relapsed and refractory large B-cell lymphoma (LBCL) is 83%, the complete remission (CR) rate is 58%, and the median overall survival (OS) ) Was 25.
8 months, with a median follow-up of 51.
1 months, and the OS rate could reach 44%
.

In recent years, the number of new anti-tumor drugs independently developed in China has shown an increasing trend year by year.
It can be said that a small outbreak ushered in in June this year
.
However, there is still a lot of room for advancement in the field of domestic anti-tumor drugs.
Compared with international companies, they still need to make persistent efforts
.

  Reference materials:

1.
Retrieved June 09, 2021, from https://

2.
Management of Non-small Cell Lung Cancer Patients with MET Exon 14 SkippingMutations.
CurrTreat Options Oncol.
2020;21(4): 33;

3.
http://