For melanoma, the new indication of Lepu Bio PD-1 ptalizumab was approved for marketing

On September 29, according to the official website of the NMPA, the new indication of Lepu Bio PD-1 monoclonal antibody putlizumab was approved for listing, and the indication is melanoma
.

From: NMPA website

Previously, in July, "Putlizumab" has been approved for marketing (acceptance number: CXSS2101041) for the treatment of patients with advanced solid tumors who have previously received first-line and above system treatment failures of highly microsatellite unstable type (MSI-H) or mismatched repair defective type (dMMR), becoming the 10th PD-1 monoclonal antibody
in China.

The domestic PD-1/L1 track is now seriously coiled, but according to the differentiation of antibody design, indication development and combination therapy development, there may still be a chance to kill a bloody road
in this field.

Putlizumab (R&D code: HX008) is a PD-1 product obtained by Lepu Bio acquired Taizhou Hanzhong in 2018, which is a humanized monoclonal antibody with differentiated design, and introduces S254T, V308P, N434A mutations in IgG4's Fc to extend the half-life
.

According to the Insight database, ptalizumab was first approved for clinical use in China in September 2017, first publicized for clinical trials in January 2018, and first declared for marketing in July 2021 for the treatment of advanced melanoma at the second line and above, and was approved for marketing
today.

Overview of domestic projects in ptalizumab

From: Insight Database Web (http://db.
dxy.
cn/v5/home/)

Previously, data disclosed at the 2021 ASCO meeting showed that HX008 had ORR and DCR of 18.
5% and 44.
5%
in Phase II clinical trials against melanoma, respectively.

NCT04749485 Clinical trial results

From: Insight Database Web

In addition to the above two approved indications, according to the Insight database, butlizumab is expanding the development
of gastric cancer, non-small cell lung cancer, breast cancer and other tumors.
At present, 19 clinical trials have been initiated, and the fastest progressing second-line gastric cancer indications are already in the Phase 3 registered clinical stage
.
In addition, stage II clinical involvement also involves high-risk non-muscularly invasive bladder cancer, thyroid undifferentiated carcinoma, and first-line treatment of advanced hepatocellular carcinoma
.

Domestic development progress of putlizumab Gantt chart

From: Insight Database Web