Hengrui Medicine's adebelimumab application for listing domestic PD-L1 has entered an outbreak period

On January 19, the CDE official website showed that Hengrui Medicine's PD-L1 monoclonal antibody "adbelimumab" was accepted for marketing
.

This is the fifth domestic PD-L1 monoclonal antibody to be declared for marketing

On October 27, 2021, Hengrui Medicine announced the randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial of adebelimumab (R&D code: SHR-1316) combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer The primary endpoint of the study (SHR-1316-III-301) reached the protocol-preset superiority standard
.

The results of the study show that SHR-1316 combined with chemotherapy can significantly prolong the survival (OS) of patients compared with placebo combined with chemotherapy

SHR-1316 (Adebrelimab) is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui.
It can specifically bind to PD-L1 molecules to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance.
Reactivate the anti-tumor activity of the immune system to achieve the purpose of treating tumors
.

Its registrational Phase 3 clinical SHR-1316-III-301 study is a randomized, double-sided trial evaluating the efficacy and safety of SHR-1316 injection or placebo in combination with etoposide and carboplatin for the first-line treatment of extensive-stage small cell lung cancer.
Blind, phase III controlled clinical study, with Professor Cheng Ying from Jilin Cancer Hospital and Professor Wang Jie from Cancer Hospital of Chinese Academy of Medical Sciences as the principal investigators, and 49 centers across the country participated in the study.
The primary endpoint of the study was overall survival (OS), secondary The endpoints to be studied include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and safety
.

A total of 462 subjects were enrolled in the study, who were randomized 1:1 to receive SHR-1316 injection or placebo combined with etoposide and carboplatin, administered once every 3 weeks for 4-6 cycles After combination therapy, enter SHR-1316 injection or placebo maintenance therapy until disease progression, unacceptable toxicity, or other conditions that require discontinuation of therapy
.

According to the Insight database, Hengrui's SHR-1316 project has entered the Phase 3 clinical stage as early as 2018
.

At present, Hengrui has launched 11 clinical trials for SHR-1316 in China

Phase III clinical trials for SHR-1316 registration

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

According to Hengrui's official information, as of October 27 last year, the accumulated R&D expenses of SHR-1316 related projects were about 218.
37 million yuan
.

At present, five PD-L1 mAbs have been approved for marketing worldwide, including AstraZeneca's durvalizumab (Imfinzi), Roche's atezolizumab (Tecentriq), Merck/Pfizer's Avelumab (Bavencio), as well as two domestic PD-L1 mAbs that have just been approved at the end of 2021, Corning Jereh/Sidedi's nvolumab and CStone's sugelimab
.

According to public data, the total global sales of the first three PD-L1 models in 2020 are about 5.

In China, although PD-L1 is less competitive than PD-1, it will gradually enter an outbreak period from 2021
.

In a short period of time, the first echelon of nvolimab and sugelimab have been approved successively, followed by Li's pharmaceutical company's first injection of limumab and Kelun Pharmaceutical's tetlimumab.

According to statistics, in the Phase 3 clinical stage, Chia Tai Tianqing's TQB2450 and Zhixiang Jintai's GR1405 are expected to launch a sprint to the market
.

Chia Tai Tianqing TQB2450 has also launched two head-to-head Phase 3 clinical trials in combination with Anlotinib in 2021, comparing the K drug pembrolizumab and BeiGene's tislelizumab

Domestic PD-L1 mAb with rapid progress

Insight database sorting (Insight medical intelligence assistant)

Today, PD-L1 mAbs have gradually demonstrated their therapeutic potential in areas where PD-1 has not broken through
.

Recently, AstraZeneca PD-L1 achieved the first OS breakthrough in immunotherapy for first-line cholangiocarcinoma, and Roche PD-L1 became the first immunotherapy approved for adjuvant treatment of NSCLC.