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Author: Forest
On December 8, 2021, the world's first subcutaneous injection of PD-L1 antibody drug Envida® (Envolimab injection) was first prescribed in various provinces and cities
On the same day, Hengrui Medicine registered a phase 1 clinical trial on the drug clinical trial registration and information disclosure platform website for subcutaneous injection of PD-1 antibody SHR-1901
Source: Drug Clinical Trial Registration and Information Disclosure Platform
SHR-1901 is the second PD-1 antibody developed by Hengrui Pharmaceuticals.
This launch is a non-randomized, open, single-arm Phase 1 clinical trial in China, which aims to evaluate the safety of SHR-1901 in subjects with advanced malignant tumors
In-depth layout PD-1/PD-L1
In-depth layout PD-1/PD-L1Up to now, 11 PD-1/PD-L1 antibodies have been approved for marketing in China, and there are more than 100 PD-1/PD-L1 clinical registrations.
Some people think that China's PD-1 has no future, but the author believes that although the PD-1/PD-L1 track is rolling, unmet clinical needs still exist
Data source: Yaozhi data
For tumor treatment, PD-1/PD-L1 is a rare target in a century, and it is also the most successful signal pathway, and its efficacy has been verified
Hengrui's approved carrelizumab is the domestically produced PD-1 antibody with the highest sales, but it was returned to overseas rights by Incyte due to hematoma toxicity
At this time, the development of the second PD-1 monoclonal antibody can achieve rapid progress with the help of Hengrui's excellent medical team and the experience accumulated in the past development of PD-1; on the other hand, it can break through the barriers through subcutaneous injections.
Compared with intravenous injection, subcutaneous injection formulations can improve patient compliance and save medical resources; provide new options for patients with vascular restriction; and reduce side effects of subcutaneous injection formulations
Moreover, the oral dosage form of PD-L1 is already on the way, and the convenience will be further improved
Obviously, despite the internal volume, PD-1/PD-L1 has not become the abandoned child of pharmaceutical companies.
Accumulate and gain autonomy
Accumulate and gain autonomyAs we all know, the research and development of original drugs has high risk, large investment and long cycle
Although the process of innovation and R&D is not easy, Hengrui still insists on independent innovation and strives to "hold the destiny in our own hands
Hengrui has entered the harvest period of innovative drugs after many years of deployment
Henry has established a number of new drugs in the form of new technology platforms, including PROTAC, ADC, double-antibody / polyclonal antibodies, RNA drugs, gene therapy and so on
In terms of PROTAC, a new type of E3 ligase ligand has been developed, and a number of PROTAC drugs are under development
.
In terms of ADC, new ADC technologies such as antibody coupling to TLR7/8 agonist coupling and antibody coupling to Eribulin have been developed
.
There are more than 22 models in the study of new drugs, new drugs which 6 ADC has been applied clinically, including second generation HER2 ADC, Trop2 ADC, Claudin 18.
2 ADC like
.
In terms of double antibodies, a new HOT-Ig double antibody technology platform has been established
.
Hengrui Medicine has declared the PD-L1/TGFβ double antibody, and the double antibodies under development include PD-L1/CD47 double antibody (SIRPγ fusion), GCGR/GLP-1R double antibody (antibody fusion GLP-1), VEGF/Ang2 Double antibodies, PD-L1/4-1BB double antibodies, PD-1/TGFβ double antibodies, CEA/CD3 double antibodies, PVRIG/TIGIT double antibodies
.
Hengrui also has a layout in terms of tumor vaccines, RNA drugs, and gene therapy
.
In addition, since the beginning of this year, Hengrui Medicine has announced a number of cooperation projects, including Wanchun Medicine’s GEF-H1 activator prinabulin, Tianguangshi’s CD20 monoclonal antibody MIL62, and Yingli Pharmaceutical’s PI3kδ inhibitor YY-20394.
, CS1002 injection of CTLA-4 mAb from CStone Pharmaceuticals
.
On December 8, Hengrui Medicine announced that it had signed a strategic cooperation agreement with France Iktos on the AI new drug development platform
.
However, Hengrui is not all smooth sailing, and it can even be said to be ups and downs
.
In terms of BD, the cooperation between Hengrui Medicine and Wanchun Medicine has not progressed smoothly
.
In terms of internationalization, progress has been slow
.
Although Hengrui made up its mind to go global at the beginning of this year, Hengrui has actually been deploying overseas markets many years ago, but the effect is not obvious
.
At present, it is difficult to find Hengrui overseas whether it is a generic drug or an innovative drug
.
Only by insisting on independent innovation and possessing excellent core technology can we take our destiny in our own hands
.
Those who have perseverance will succeed.
I hope Hengrui can make up for its shortcomings, give full play to its strengths, and become a first-class pharmaceutical company
.