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On September 28, Li's Pharmaceuticals announced that its subsidiary, China Cancer Medical Co.
, Ltd.
, has been approved by the CDE to submit an application for the listing of a new drug for the treatment of recurrent or metastatic cervical cancer, the anti-PD-L1 monoclonal antibody Socazolimab (R&D code: ZKAB001)
.
In January of this year, ZKAB001 was included in the breakthrough therapy program for recurrent and metastatic cervical cancer that has failed or cannot tolerate the first-line platinum-containing regimen
This is the fifth domestic PD-L1 monoclonal antibody that has submitted a marketing application
.
Up to now, only two imported PD-L1 monoclonal antibodies in China have been approved for marketing, and no domestic PD-L1 has been approved
Socazalimab: Certified as a breakthrough therapy
Socazalimab: Certified as a breakthrough therapySocazolimab is a fully human PD-L1 monoclonal antibody (mAb) for tumor immune checkpoints imported from Sorrento Therapeutics of the United States by Lee's Pharmaceutical Company
.
The antibody binds to the PD-L1 protein to block the interaction between the PD-L1 protein and its receptor PD-1, thereby releasing the inhibition of T cells by the PD-1 or PD-L1 signaling pathway, and enhancing the killing of T cells by T cells Role
Socazolimab is a fully human anti-PD-L1 monoclonal antibody screened using Sorrento's patented G-MAB™ library platform
.
Compared with competitors, it has the following potential advantages: as a fully human antibody, it has low immunogenicity; compared with other PD-L1, the dose required for curative effect is smaller; at the same time, it has dual immune checkpoint suppression and antibody-dependent cellular cytotoxicity (ADCC).
According to the Insight database, the research and development process of the Socazolimab project in China began with the first clinical application in May 2017
.
In June 2018, Socazolimab was registered for the first time in CDE and started clinical trials.
ZKAB001 registered clinical trial
From Insight database (http://db.
dxy.
cn/v5/home/)
The clinical study of Socazolimab in the treatment of recurrent and metastatic cervical cancer monotherapy was led by Director Wu Lingying.
It was carried out in two phases, first the open-label 3+3 dose escalation phase, and then the key expansion phase research
.
A total of 91 patients participated in the key part of the study.
In addition to the PD-L1 monoclonal antibody Socazolimab, the company also has a number of new drug assets in clinical development.
The oral multikinase inhibitor Zotiraciclib is currently undergoing phase I clinical trials for glioblastoma; topoisomerase I inhibitors Gimatecan is currently undergoing phase I clinical trials for ovarian cancer and phase Ib/II clinical trials for small cell lung cancer in China; the oncolytic virus Pexa-vec is currently undergoing phase Ib clinical trials for renal cell carcinoma worldwide
.
Domestic PD-L1 each shows its magical powers
Domestic PD-L1 each shows its magical powersAlthough PD-1 is fighting fiercely at present, no domestically-produced drug has been approved for PD-L1 monoclonal antibody
.
The two PD-L1 products that have been submitted for marketing have their own differentiated features.
Fast-developing domestic PD-L1 monoclonal antibody
Insight database collation
Envolimab (R&D code KN035, generic name: Envafolimab) is a PD-L1 single-domain antibody Fc fusion protein independently developed by Corning Jereh.
It has been jointly developed with Sidi Medicine in 2016; in March 2020, Simcere Industry obtained the exclusive marketing rights for KN035 tumor indications in Mainland China
.
As a stable subcutaneous injection at room temperature, Envolimab has advantages in terms of safety, convenience and compliance.
Suglizumab is a fully human full-length anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals
.
On the one hand, the unique indications of extranodal NK cell/T-cell lymphoma (R/RENKTL) have won CDE breakthrough therapy approval.
Both locally advanced/unresectable (stage III) and metastatic (stage IV) non-small cell lung cancers have been declared for marketing
.
Socazolimab takes the lead with the second-line indications for cervical cancer, this cancer is still lacking in immunotherapy, only K drug has been approved for this cancer
.
There are more than 100,000 new cases of cervical cancer in China each year, and nearly 30,000 women die of cervical cancer.
The recurrence rate after first-line treatment is extremely high.
China and the world have an urgent medical need for new standard treatment methods
.
At present, more and more PD-1 clinical studies have been initiated for cervical cancer, but the domestic same indication of PD-L1 has only Tianqing TQB2450, which has carried out relevant clinical trials for PD-L1 positive groups
.
The information disclosed by Li's Pharmaceutical Factory shows that regardless of the expression status of PD-L1, Socazolimab has shown improvements in ORR, PFS, and OS, so it is expected to cover a wider group of patients
.
Among the products that have entered Phase III clinical trials, Hengrui's adebrelimab (SHR-1316) entered Phase III clinical trials at the earliest, for the perioperative treatment of extensive-stage small cell lung cancer, limited-stage small cell lung cancer, and non-small cell lung cancer that can be excised; Tianqing The TQB2450 of TQB2450 mainly joined forces with its own product Anlotinib to attack multiple cancer types, and recently launched a head-to-head K drug Phase 3 clinical trial; Zhixiang Jintai’s GR1405 just entered Phase 3 clinical trials in May this year
.
