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Technology and Cooperation

Listing permit holder (MAH)

On June 6, the general office of the state council released the highly anticipated pilot program of the drug listing permit holder system, which will be carried out in 10 provinces (cities) including Beijing, tianjin, hebei, Shanghai, jiangsu, zhejiang, fujian, shandong, guangdong and sichuan from now until November 4, 2018. One of the highlights of this pilot program is that drug research and development institutions or researchers in the pilot administrative region can serve as drug registration applicants, submit drug clinical trial applications and drug listing applications, and applicants who obtain drug listing licenses and drug approval document Numbers can become drug listing license holders. The company will be listed license holders as the focus of later development, screening a number of drugs for independent development of 2 types of improved new drugs and 3 types of exclusive generic drugs.

Drug licensee development program

 

name

classification

Dosage form

Research and development phase

Project Jane interface

ZC-01

2class

Slow-release gel

preclinical

Traditional medicine supported by corpus luteum of artificial assisted reproductive technology. Rapid absorption after intramuscular injection, without liver metabolism, high bioavailability, definite efficacy, patented technology, external slow-release gel, once a day.

ZC-02

3class

injection

preclinical

The treatment of acute heart failure is characterized by low dose, quick onset and small side effects.

ZC-03

3class

4/5000 Sustained-release suppository

preclinical

Traditional medicine supported by corpus luteum of artificial assisted reproductive technology. Rapid absorption after intramuscular injection, without liver metabolism, high bioavailability, definite efficacy, patented technology, external slow-release suppository, once a day.

ZC-04

3class

lozenges

 

Prophylaxis to reduce the incidence of immunocompromised patients including chemotherapy, radiotherapy, oral infection with candida oropharyngitis, as well as corticosteroid therapy for leukemia, tumors, or kidney transplant adjuvant drugs, administered three times a day, one tablet at a time, until the steroids are reduced to normal levels.

ZC-05

3class

Vaginal tablet

 

Used for candidiasis vulvovaginosis.

 

ZC-06

3class

4/5000 Sustained-release suppository

preclinical

Europe and the United States as an important cancer radiotherapy antiemetic drugs, once a day.