The world's first subcutaneous PD-L1 envolimab is approved for marketing in China

Recently, according to the latest announcement by the National Medical Products Administration (NMPA) of China, Corning Jereh, Siddi Medicine, and Simcere Pharmaceuticals have reached a strategic cooperation with Class 1 biological drug Envolimab Injection (KN035) that has been qualified.
Approved for the treatment of advanced microsatellite instability (MSI-H) advanced rectal cancer and MSI-H advanced gastric cancer and advanced solid tumors with defective DNA mismatch repair (dMMR)
.

 This drug is jointly developed by Sidi Medicine, Corning Jerry, and Simcere Pharmaceuticals.
It is an anti-PD-L1 monoclonal antibody that can be used for subcutaneous injection
.

Envolimab is the first domestically approved PD-L1 monoclonal antibody, and it is also the first domestically approved immunotherapy for MSI-H/dMMR solid tumors
.

 The approved indications for envolimab include: suitable for the treatment of unresectable or highly metastatic microsatellite instability (MSI-H) or mismatch repair gene defect (dMMR) adult patients with advanced solid tumors, Including patients with advanced colorectal cancer who have progressed after treatment with fluorouracil, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have progressed after previous treatment and have no satisfactory alternative treatment plan
.

 Envolimab is a monospecific antibody consisting of a single domain antibody (sdAb) and an Fc segment.
Its molecular weight is half the molecular weight of a complete antibody, which gives it enhanced penetration and complete antigen binding capacity.

.

In addition, Fc-mediated effector functions are impaired in Envolimab to limit its exposure to the immune system and avoid unexpected unwanted immune responses
.

 In addition, Envoli is an anti-PD-L1 monoclonal antibody that can be used for subcutaneous injection.
Compared with intravenous injection, it is not only faster, but also less likely to have adverse reactions.

.

At present, the PD-(L)1 treatment on the market requires frequent intravenous injections, which can not meet the convenience of patients' medication needs, and will also affect patients' compliance with medications
.

With envolimab, the patient can complete the administration process without intravenous injection, which greatly shortens the patient's administration time and can complete the administration within 30 seconds
.

What's more worth mentioning is that Envolimab has the potential of home self-administration, which can effectively improve the quality of life of patients
.

 In contrast, Envolimab has significant advantages in terms of safety, convenience and compliance.
It is a very good treatment option for patients who cannot use intravenous injection for various reasons
.

 This marketing application is based on data from a single-arm open-label phase 2 key clinical trial.
In this study, envolimab was used as a single agent to treat patients with advanced solid tumors in MSI-H/dMMR.
The overall population (n=103) The confirmed objective remission rate evaluated by the Independent Review Committee (BIRC) reached 42.
7%
.

The data in patients with colorectal cancer (CRC), gastric cancer (GC) and other solid tumors were 43.
1%, 44.
4%, and 40%, respectively
.

The median time to response (DOR) of the overall population was not reached, and the 12-month DOR rate was 92.
2%; the median progression-free survival (PFS) was 11.
1 months; the median survival (OS) was not reached, and the 12-month OS rate was not 74.
6%
.

 The incidence of grade 3/4 treatment-related adverse events observed in the study was 16%, and the incidence of grade 3/4 immune-related adverse events was 8%
.

Overall, this study demonstrates the therapeutic effect and safety of envolimab
.

End reference materials: [1]https://#H3598112821[2]https://pdf.
dfcfw.
com/pdf /H2_AN201911170053444075_1.
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