In 2020, 1 billion treprisumab was sold, and the third indication was "taken" in China

On April 7, Junshi Biologics independently developed a recombinant humanized anti-PD-1 monoclonal antibody injection, teriplizumab (trade name: Tuoyi®) for the new indications to be marketed and approved by the State Food and Drug Administration.
It is used for the treatment of locally advanced or metastatic urothelial cancer that has failed or intolerated previously received systemic treatment.
The approval number is: National Medicine Standard S20191003.

This is the third indication that Teriplizumab has obtained in my country, and it is also the second indication that the product has obtained since 2021.

In December 2018, the State Food and Drug Administration approved the conditional marketing of teriprizumab for the treatment of locally advanced or metastatic melanoma after the failure of previous standard treatments.

In February of this year, the product was further approved for the marketing of recurrent/metastatic nasopharyngeal cancer that had previously failed second-line and above systemic treatments, becoming the world's first anti-PD-1 monoclonal antibody approved for the treatment of nasopharyngeal cancer.

Urothelial carcinoma is one of the main tumors of the urinary system, and the main release site is the bladder.

In my country, there are 82,000 new cases of bladder cancer each year, accounting for 15.
0% of the world, and 38,200 deaths, accounting for 19.
1% of the world.

In the past, the first-line treatment of advanced urothelial cancer was mainly chemotherapy, but for patients who failed the standard chemotherapy regimen, the second-line treatment options were limited.

The approval of the new indication of teriplizumab is based on an open, single-arm, multi-center, phase 2 key registration clinical study (POLARIS-03), which is also the first late-stage failure of standard treatment in China A key clinical study conducted in a non-selected population of urothelial cancer.

The results of the study showed that the objective response rate (ORR) assessed by the independent review committee was 25.
8%.

Subgroup analysis showed that the ORR of PD-L1 positive patients was as high as 41.
7%, and PD-L1 positive people and those with only lymph node metastases benefited more significantly.The median onset time was 1.
8 months, the median duration of response (DOR) was 19.
7 months, and the 12-month DoR rate reached 68.
9%.

Since the beginning of this year, Junshi Bio has reached commercial cooperation with Coherus BioSciences, AstraZeneca and other companies.
At the same time, it has also begun to submit a rolling application for Teriplizumab to the US FDA.

At present, teriprizumab has been granted 1 breakthrough therapy designation, 1 fast track designation and 3 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

As the first domestic PD-1 product approved for listing in China, Teriplimab has become the "main force" supporting Junshi Bio's revenue.

In 2020, Junshi Biotech's total revenue will be 1.
595 billion yuan, of which teriprolizumab will contribute more than 1 billion yuan.

With the approval of new indications for teriprolizumab and further promotion worldwide, the global sales share of this product in 2021 is expected.

End reference materials: [1] CSCO 2020│Professor Guo Jun and Professor He Zhisong interpret the POLARIS-03 study-a new breakthrough in the second-line treatment of advanced urothelial cancer [2] The third indication! Junshi Biologics anti-PD-1 antibody new drug approved to treat urothelial cancer