Sihuan, Junshi, Hengrui and other pharmaceutical companies have been approved for clinical trials

 Since March, a number of pharmaceutical companies have announced the progress of drug research and development, and said that the company's related products have been approved for clinical trials
.
For example, Sihuan Pharmaceutical announced that the class 1 macromolecule innovative drug HER2 double anti-XZP-KM 257 was approved for clinical trials, Junshi Biopharmaceuticals for nasopharyngeal cancer injection was approved for clinical trials, and Hengrui Medicine SHR0302 tablets were approved for clinical trials
.
Sihuan Pharmaceutical's innovative drug HER2 dual anti-XZP-KM257 was approved for clinical trials Sihuan Pharmaceutical recently announced that a class 1 innovative drug XZP-KM257 (recombinant anti-HER2 domain II and A clinical trial application for IV Bispecific Antibody Injection) (“KM257”) for the treatment of advanced solid tumors with medium and high expression of HER2+ has been successfully approved by the China National Medical Products Administration
.
This time, the approval of Xuanzhu Bio's KM257 for clinical trials marks that Xuanzhu Bio's first macromolecule drug has entered the clinical development stage
.
According to the disclosure, KM257 is a HER2/HER2 product developed by Xuanzhu Biotechnology relying on the Mebs-lg (antibody editing bispecific antibody) platform and Mab-Edit (antibody editing) technology platform independently developed by Xuanzhu Kangming, its macromolecule innovative drug company.
Bispecific antibodies, innovative mechanism, bispecific antibodies targeting two different domains of HER2 (domain II and domain IV) are highly innovative
.
It inhibits the proliferation of tumor cells or induces apoptosis by preventing the heterodimerization of HER2 protein and other HER family members, thereby preventing the effective transmission of signals
.
Junshi Biotech's Clinical Trial Approved for Nasopharyngeal Carcinoma Injection Junshi Biotech has recently announced that it has received a notification from the State Drug Administration that JS001sc injection (project code "JS001sc") has been approved for clinical trial application for advanced nasopharyngeal carcinoma treatment
.
JS001sc injection is a subcutaneous injection preparation developed by the company on the basis of the marketed product toripalimab injection (trade name: Tuoyi, product code: JS001).

.
JS001sc targets human PD-1, binds PD-1 with high affinity, selectively blocks the binding of PD-1 to ligands PD-L1 and PD-L2, thereby activating T lymphocytes, improving lymphocyte proliferation and cell proliferation.
factor secretion
.
The preclinical in vivo efficacy test showed that JS001sc showed significant tumor-inhibiting effect in animal models by subcutaneous injection.
At the dose level of 0.
3 mg/kg, subcutaneous injection of JS001sc and intravenous injection of Terry The antitumor effect of plimumab was comparable, and no significant difference was found
.
Furthermore, JS001sc was well tolerated by animals
.
Hengrui Medicine SHR0302 Tablets Approved for Clinical Trials Hengrui Medicine recently announced that the company has received the approval from the State Drug Administration ("NMPA") to issue the "Drug Clinical Trial Approval Letter" for SHR0302 Tablets, which will be released in the near future.
Conduct clinical trials
.
According to the announcement, SHR0302 is a highly selective JAK1 inhibitor, which can exert anti-inflammatory and immunosuppressive biological effects by inhibiting JAK1 signaling.
It is clinically planned for the treatment of active radiologically negative axial spondyloarthritis
.
After review, the SHR0302 tablets accepted on December 17, 2021 met the relevant requirements for drug registration, and the clinical trial of this product in adults with active radiology-negative axial spondyloarthritis was approved
.
It is reported that up to now, SHR0302-related research and development projects have invested about 411.
45 million yuan in research and development
.
Luoxin Pharmaceutical Group Co.
, Ltd.
(referred to as "Luoxin Pharmaceutical") has recently obtained the approval for the clinical trial of the new indication of Tigorasan Tablets by Luoxin Pharmaceutical Group Co.
, Ltd.
The Drug Administration approved the new indication for the eradication of Helicobacter pylori (Hp) infection in adults with appropriate antibacterial therapy
.
Based on the approval, Luoxin Pharmaceutical plans to conduct a multicenter, randomized, double-blind, double-dummy Phase III clinical study to evaluate the eradication of bismuth quadruple therapy with tigorasan versus esomeprazole Efficacy and safety of Helicobacter pylori
.
A relevant person from Luoxin Pharmaceutical said: The field of digestive system diseases is one of the core disease areas that Luoxin Pharmaceutical continues to pay attention to and has obvious advantages
.
As one of the key products in the digestive field of Luoxin Pharmaceutical, the Phase III clinical trial of the new indication of tigolasheng tablet was approved by the State Drug Administration, which represents another important progress made by the company in the field of digestive system diseases
.
Motivated by this, the R&D team of Luoxin Pharmaceutical is accelerating the R&D process of tigola raw tablets, striving to bring better treatment options to patients as soon as possible
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.