The second domestic company, Junshi PD-1 urothelial carcinoma was approved for listing by NMPA

Recently (April 12, 2021) Junshi Biotech announced that its PD-1 drug, Tereprizumab, has been conditionally approved by the National Medical Products Administration (NMPA) of China for use in the local development of previous treatments.
Or patients with metastatic urothelial carcinoma (UC), this is the third indication approved for teriprizumab.

The marketing application for this new indication is based on a clinical study called POLARIS-03, which is the first pivotal clinical study conducted in a non-selected population of advanced urinary tract cancer that has failed standard treatment in China.

To evaluate the safety and effectiveness of teriprizumab in patients with locally advanced or metastatic bladder urothelial cancer after failure of standard therapies.

As assessed by the Independent Review Committee (IRC), the overall objective response rate (ORR) of teriprizumab in this category of patients was 27.
2%, the disease control rate (DCR) was 46.
3%, and the median overall survival (mOS) To reach 14.
6 months.

Going abroad, teriprizumab is a recombinant humanized anti-PD-1 monoclonal antibody for injection.

Through the optimization of multiple R&D steps, especially the discovery and efficient identification of new molecular entities, humanization of mouse antibodies, functional evaluation of antibody production in vivo, and the construction of productive and stable cell lines, Trap Lizumab has become an innovative drug with unique therapeutic advantages.

Teriprizumab is the first domestic monoclonal antibody drug targeting PD-1 approved for marketing in China.

In December 2018, NMPA conditionally approved teriprizumab for the second-line treatment of unresectable or metastatic melanoma.

Two months ago, teriprizumab was approved for the second indication in China, the second-line treatment of patients with recurrent/metastatic nasopharyngeal carcinoma.

In addition to the clinical development of various indications carried out in China, now, the internationalization of triprizumab has also been paved.
On March 3, 2021, the company submitted a rolling submission of tripril to the U.
S.
FDA.
The monoclonal antibody is used for the treatment of recurrent or metastatic nasopharyngeal carcinoma in the Biological Products Licensing Application (BLA).
This is also the first domestic anti-PD-1 monoclonal antibody to submit a marketing application to the FDA.

Junshi Biotech stated at the time that tereprizumab is expected to become the first domestic anti-PD-1 monoclonal antibody to be commercialized in overseas markets.

U.
S.
Dilemma Urothelial cancer has attracted special attention recently in the U.
S.
market.

In less than a month, the labels of two PD-1/L1 drugs, Imfinzi and Tecentriq, for second-line treatment of urothelial cancer were withdrawn in the United States.

On February 23, 2021, in a phase III clinical study called DANUBE, after Imfinzi failed to show an extension of the overall survival of patients with advanced bladder cancer treated with platinum-based chemotherapy, AstraZeneca announced its voluntary withdrawal from the United States Imfinzi is an indication for the second-line treatment of urothelial carcinoma.

Immediately after March 8, Roche also announced the withdrawal of its PD-L1 antibody Tecentriq from the United States for the second-line treatment of urothelial cancer.

At the oncology drug advisory committee's expert meeting to be held at the end of this month, Tecentriq and Keytruda urothelial cancer first-line treatment labels (through accelerated approval but failed to meet post-marketing requirements) will also discuss and decide to stay.

With the FDA's comprehensive liquidation for accelerated approval, there are few PD-1 drugs left for urothelial cancer.

Domestically, in addition to Junshi, NMPA has previously approved tislelizumab for the treatment of locally advanced or metastatic urothelial cancer.

The editor concludes that immunotherapy has rewritten the treatment of advanced urothelial cancer.
However, in China, treatment options for patients with advanced urothelial cancer after failure of standard treatments are still limited, and the approval of teriprizumab as a single agent Add a treatment option for domestic patients.

Recommended reading 1.
The world's first immunological drug for the treatment of nasopharyngeal cancer was officially launched, PD-12 from Junshi Bio.
The first domestic PD-1- to submit a marketing application to the FDA--Junshi Bio-Treplimumab Reference Source: 1.
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