The fifth domestic PD-L1 has been declared for listing, and market competition may usher in new changes

The huge market prospect of PD-1/PD-L1 is undoubtedly the key to attracting various enterprises to grab the beach.
Anti-injection (Tuoyi) and Sintilimab Injection (Daboshu) of Cinda Biosciences have market sales of more than 2 billion yuan
.
With the considerable market prospects, foreign and domestic pharmaceutical companies have also begun to enter the PD-1/PD-L1 track in an attempt to seize more market share
.
However, it is worth noting that from an overall point of view, the current PD-1/PD-L1 track is indeed fighting fiercely, but in comparison, pharmaceutical companies are more concerned about the PD-1 field
.
In China, no domestically-produced drug for PD-L1 monoclonal antibody has been approved yet, and those that are making rapid progress are still in the stage of submitting applications for marketing
.
For example, on September 28, Li’s Pharmaceuticals announced that its subsidiary, China Cancer Medical Co.
, Ltd.
, has been approved by the CDE to submit the anti-PD-L1 monoclonal antibody Socazolimab (R&D code: ZKAB001) as a new drug for the treatment of recurrent or metastatic cervical cancer.
Apply
.
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
.
It is understood that 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
.
Among them, the two PD-L1 products that have been approved for marketing each have their own differentiated characteristics.
Envolimab is the world's first subcutaneous injection of PD-L1; and suglizumab has major indications and differentiated indications.
Both are true
.
However, in recent years, as the country has vigorously promoted pharmaceutical innovation and the PD-1 track is becoming increasingly crowded, more and more pharmaceutical companies have begun to pay attention to the PD-L1 field
.
It is reported that there are many pharmaceutical companies are aspects of PD-L1 expanded layout, including the cornerstone of medicine, CTTQ, HRH medicine and so on
.
Among them, Cornerstone announced in June this year that Shuglizumab intends to submit a new drug listing application for stage III non-small cell lung cancer to NMPA.

.
Combining with November 2020, Cornerstone has already applied to NMPA for combined chemotherapy with NMPA for the first-line treatment of advanced (stage IV) squamous and non-squamous non-small cell lung cancer (acceptance number: CXSS2000056).
The indications have been approved, and Shuglizumab may become the world's first PD-L1 monoclonal antibody to simultaneously cover the entire population of locally advanced/unresectable (stage III) and metastatic (stage IV) non-small cell lung cancer
.
In addition to CStone Pharmaceuticals, Corning Jerry, Chia Tai Tianqing, and Hengrui Pharmaceuticals are conducting clinical developments for NSCLC indications and are making progress
.
The layout of its indications is also relatively wide, ranging from operable NSCLC to late metastatic NSCLC
.
In general, there are not a few pharmaceutical companies that have laid out the PD-L1 track, but it is too early to discuss the price war of PD-L1 drugs, and the approval of more indications in the future is expected to become the key to corporate development
.
In addition, with the continuous sinking of medical resources, the accessibility of PD-L1 is getting higher and higher, and the market below the county level may become the main position for future competition.
Can it be stored at room temperature without cold chain transportation? Perfect safety and other details may also become the key points that determine the success or failure of the development of pharmaceutical companies
.