Good news this month!

Since April, there has been continuous news about the clinical approval of domestic drugs, including Kangyuan Pharmaceutical’s Zaobai Anshen Granules for chronic insomnia, Betta Pharmaceuticals’ new indication for NSCLC postoperative adjuvant therapy, Guilin Sanjin Holdings Sun Company's anti-tumor drug BC008 antibody injection, Cinda's VEGF/ANG-2 double antibody for the treatment of diabetic macular edema, Xiangxue Pharmaceutical Sun Company's Xiangxue Life Science TCR-T therapeutic product TAEST1901 injection,
etc.
In addition, there is good news that a batch of pharmaceutical products have been approved for clinical use overseas
.
Huadong Medicine: Its holding subsidiary, DR10624 for injection, was approved for clinical use in New Zealand.
HDEC), and launched a phase I clinical trial of DR10624 for injection in the local area for the treatment of type 2 diabetes, obesity, metabolic syndrome,
etc.
It is reported that DR10624 for injection is one of the key innovative drugs under research and development by Doyle
.
The product is a global first-in-class long-acting triple-target agonist targeting GLP-1 receptor (GLP-1R), GCG receptor (GCGR) and FGFR1c/Klothoβ (FGF21R)
.
Preclinical animal studies have shown that DR10624 has obvious curative effects on hypoglycemic, lipid-lowering, and weight loss
.
At present, there is no long-acting triple-target agonist drug that simultaneously targets GLP-1R, GCGR and FGF21R ​​in the world
.
Junshi Bio: Anti-CD112R Monoclonal Antibody Approved in the United States On April 3, Junshi Bio announced that its self-developed anti-CD112R monoclonal antibody injection (project code: TAB009/JS009) is used in clinical trials for the treatment of advanced solid tumors The trial application has been approved by the US FDA
.
It is reported that CD112R is a brand-new immune checkpoint pathway, and no product targeting CD112R has been approved for marketing in the world
.
JS009 is a recombinant humanized IgG4 monoclonal antibody targeting CD112R independently developed by Junshi Bio for the treatment of advanced malignant tumors.

.
Preclinical research results show that the drug can specifically bind CD112R with high affinity, effectively block the CD112R and its ligand CD112 signaling pathway, thereby promoting the activation and proliferation of T cells and NK cells, and enhancing the ability of the immune system to kill tumor cells
.
Haisco: BTK protein degrader approved for clinical use in the United States On April 18, Haisco announced that the US clinical trial application (IND) of the company's BTK protein degrader HSK29116 was approved by the FDA
.
This clinical trial is evaluating the safety, tolerability and pharmacokinetics/pharmacodynamics of the drug in subjects with relapsed or refractory B-cell malignancies
.
It is reported that HSK-29116 is an oral PROTAC small molecule antitumor drug that targets BTK (Bruton's tyrosine kinase) independently developed by Hisco, and is intended to be developed for the treatment of B-cell lymphoma
.
This product has dual anti-tumor effects: on the one hand, it can directly inhibit BTK activity by specifically binding to BTK; Growth and proliferation of B-cell lymphoma cells
.
By selectively blocking BTK kinase activity and regulating signaling pathways to interfere with B cell development, HSK-29116 is expected to control the progression of various B cell malignancies
.
In addition to the clinical deployment in the United States, HSK29116 is currently undergoing clinical dose escalation trials in China and Australia, and has been carried out to the fourth dose group with good progress
.
Haisco said that HSK29116 is the first BTK-PROTAC drug in China and the second in the world to enter clinical research
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.