GMP Nadroparin Calcium

2021-08-18 15:27:49

A few days ago, Genetron Health (Nasdaq: GTH), a partner of CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616), announced that it and CStone Pharmaceuticals developed the Taijihua® companion diagnostic kit-human PDGFRA gene The D842V mutation detection kit (PCR-fluorescent probe method) received priority approval from the National Medical Products Administration (NMPA), becoming the first domestic companion diagnostic kit to enter the priority approval process.

It is understood that the "Medical Device Priority Approval Procedure" aims to set up priority approval channels for qualified domestic and foreign medical device registration applications to ensure the clinical use of medical devices and benefit patients as soon as possible. For medical devices listed in priority approval, the Approval Center will give priority to their technical review, and conduct efficient communication with the company to speed up the review process. The provincial food and drug regulatory authorities will prioritize their registration quality management system verification, and the national drug The Supervision and Administration Bureau will also give priority to administrative approval.

GIST patients with PDGFRA gene mutations have always lacked effective treatment drugs, and Taijihua® has shown excellent anti-tumor activity and safety in Chinese unresectable or metastatic GIST patients with PDGFRA exon 18 mutations (including D842V mutations) Good sex and tolerability. As the original companion diagnostic product of Taijihua® (that is, its clinical effectiveness research is associated with the clinical efficacy data of new drug development), the kit can be used to detect the PDGFRA gene in patients with gastrointestinal stromal tumors (hereinafter referred to as "GIST") Mutations provide accurate companion diagnosis for drug use, so as to strive for more opportunities for benefit for the majority of patients as soon as possible, and provide safer medication protection for clinically applicable populations.

Product recommendation: GMP Nadroparin Calcium

Indications:

1. It has the effect of chondroitin sulfate sodium salt;

2. It can reduce the intake of sodium;

3. It can inhibit bone resorption caused by periodontal bacterial endotoxin;

4. It can be used as root canal filling and bone filling;

5. It can inhibit bone calcium loss caused by estrogen deficiency;

6. As a colon-targeted delivery carrier; maintain blood calcium balance and prevent heart palpitations