On September 19, Hengrui Pharmaceutical announced that its subsidiary, Shanghai Hengrui Pharmaceutical Co.
, Ltd.
, received the "Notice of Approval of Drug Clinical Trial" on SHR-A2102 injection approved by the State Food and Drug Administration, and will carry out clinical trials
in the near future.
SHR-A2102 binds to the target antigen on the surface of tumor cells, so that the drug is endocytosized into the cells and releases small molecule toxins to kill tumor cells, and is clinically intended for the treatment
of malignant tumors.
After inquiry, at present, no similar products in China have been approved for listing, and there is no relevant sales data
.
Up to now, SHR-A2102 injection related projects have invested a total of about 26.
2 million yuan in research and development costs.
It is worth noting that in addition to SHR-A2102 injection, Hengrui Pharmaceutical recently issued an announcement that it received the "Drug Clinical Trial Approval Notice" approved by the State Food and Drug Administration on HRS-6209 capsules, and will carry out clinical trials
in the near future.
It is understood that HRS-6209 is a selective cell cycle blocker, which can induce tumor cells to undergo G0/G1 stage block, and then exert anti-tumor effects, and is clinically intended for the treatment
of advanced malignant tumors.
After inquiry, no similar products have been approved for listing at home and abroad, and there is no relevant sales data
.
Up to now, HRS-6209 capsule related projects have invested about 30.
14 million yuan in research and development costs.
In addition, on the evening of August 2, Hengrui Pharmaceutical also announced that it received a clinical notice approved by the State Food and Drug Administration on the approval of the anti-tumor drug HRS-4642 injection, and will carry out clinical trials
in the near future.
HRS-4642 injection inhibits tumor cell proliferation and is used to treat advanced solid tumors with KRAS G12D mutations and exert antitumor effects
.
In addition to the above drugs, since the beginning of this year, Hengrui Pharmaceutical has 20 Class 1 new drugs approved for clinical practice, including HRS-4642 injection, HRS-8427 for injection, SHR-A1811 for injection, HRS-1167 tablets, etc.
, 10 small molecule chemical drugs and 10 macromolecular biological drugs, and a number of Class 1 new drugs have been approved to carry out combination therapy clinical trials
.
For Hengrui Pharmaceutical in many drug fields, especially in the field of new drugs for tumors, and a number of studies have been internationally recognized, industry analysis believes that this is mainly related
to its continuous increase in R&D investment in recent years.
It is understood that in the past 2021, the company's cumulative R & D investment reached 6.
203 billion yuan, an increase of 24.
34% year-on-year, R & D investment accounted for 23.
95% of sales revenue, setting a record high for the company, only HRS-4642 injection related projects have invested 41.
11 million yuan.
It is worth mentioning that in the first half of this year, Hengrui Pharmaceutical's cumulative R&D investment reached 2.
909 billion yuan, another record high
.
At present, with large-scale investment, Hengrui Pharmaceutical's research and development pipeline has been very rich
.
From the perspective of the layout of the innovative R&D pipeline, Hengrui Pharmaceutical re-warehoused tumors, involving sub-fields including traditional kinase inhibitors, emerging antibody drug conjugates (ADCs), tumor immunology, hormone receptor regulation, DNA repair and epigenetics and tumor supportive therapy
.
In general, Hengrui's R&D varieties have basically covered the high-incidence tumors in China, especially lung cancer and breast cancer
.
Of course, in addition to the field of oncology, Hengrui Pharmaceutical has also achieved a forward-looking layout in many therapeutic fields such as autoimmune diseases, pain, cardiovascular, metabolic diseases, infectious diseases, respiratory diseases and neurological diseases, and its research and development pipeline has been very diversified
.
Industry analysts believe that from the current progress of Hengrui Pharmaceutical's R&D pipeline, it is speculated that Hengrui Pharmaceutical will have more than 20 pipelines applying for NDA in the next 3 years, which will benefit more patients
.
