News
Reducing the backlog of drug registration radically is good for some enterprises

Reducing the backlog of drug registration radically is good for some enterprises

At night of July 31st, 2015, CFDA released an “Announcement about soliciting opinions on policies of reducing the backlog of drug application registration” (No.140, 2015) (hereinafter referred to as “Soliciting opinions” After CFDA released an “Announcement about self-checking drug clinical trial data” on July, 22nd, they take a second movement on revolution of drug registration. According to “Soliciting opinions”, on the one hand CFDA will actively support R & D and application of innovative drug, children’s drug, clinical urgent need and shorted drug, and rob imitation drugs, on the other hand they will no longer tolerate on drugs with problems of safety, effectiveness, and quality. It will not work to change preparation or acid root. The drug with clinical value or urgent needed is in priority. Fight for resource with high quality will be more violent.

28

2015

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08

Drug appraisal enters into an era of four colors of light, and which color is yours?

Drug appraisal enters into an era of four colors of light, and which color is yours?

The Drug Appraisal, Examine and Approve Institutional Reform Working Conferenced was hold in Shanghai. Bi Jingquan, the Director of CFDA, and Wu Zhen, the Deputy Director of CFDS were present at the conference. The conference is about polices of dealing with appraisal backlog, classify “global new” innovative drugs into district with “no color light”, classify drug that is clinical needed or good for industrial transformation into district with “green light”, classify repeated declared imitation drug into district with “yellow light”, classify restricted appraisal drug into district with “red light”, and release catalogue of restricted appraisal drug in time.

27

2015

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08

Warmly congratulations to establishment of Hartmut Michel Institute of (Jiangyin) Biomedical Research

Warmly congratulations to establishment of Hartmut Michel Institute of (Jiangyin) Biomedical Research

In the morning of November 18th, 2014, ProteLight together with the Noble Prize Winner Professor Hartmut Michel together established Hartmut Michel Institute of (Jiangyin) Biomedical Research, which is the third Noble Prize Winner research in Jiangyin. Zhou Tiegen, a member of Wuxi Municipal Committee and the secretary of Jiangyin Municipal Committee, Zhu Jinsong, a member of Wuxi Municipal Committee and minister of Wuxi Organization Department, and Shen Jian, the Vice-secretary of Jiangyin Municipal Committee and the Mayor of Jiangyin, attended this ceremony and made an important speech there. Before the meeting starts, together with the President of ProteLight, Dr. Yuxin Chen, the Secretary Zhou Tiegen, the Minister Zhu Jinsong and the Mayor Shen Jian had a face to face meeting with Professor Michel.

24

2014

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11

Congratulate ProteLight got the title of “the most potential seed corporation” granted by 2014 EY Fudan in China

Congratulate ProteLight got the title of “the most potential seed corporation” granted by 2014 EY Fudan in China

The most Potential Corporation Award Ceremony of the Fourth Ernst & Young Fudan in China was held on September 16, 2014, in Shanghai. This selection was hold jointly by Ernst & Young, one of the world’s four largest accounting firms in economic area, and School of Management, Fudan University’s, one of the top universities. After expert team’s careful assessment and strict selection, the winning companies were selected out in the end.

23

2014

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09

Two New Drugs of National Category 1.1 Got Clinical Acceptance Notification

Two New Drugs of National Category 1.1 Got Clinical Acceptance Notification

In May 2014, the clinical trial application of ProteLight’s two national category 1.1 new drugs, antimicrobial peptide PL-5 active pharmaceutical ingredient and its preparation accepted by Jilin FDA, and we got the notification of application acceptance for drug registration, that means the two drugs were in the process of registration application. Antimicrobial peptide PL-5 has clear intellectual property right protection, and is applicable to most of skin infections (including stubborn infectious disease initiated by drug resistant bacteria, such as diabetic foot and bed sore),. It is defined as a project of “12th five-year plan” key innovative new drug manufacture projects in 2012 and got support as“Science and Technology Innovation Fund (growth type)” project of Ministry of Science and Tehcnology.

04

2014

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06

The Nobel Prize winner, Dr. Hartmut Michel came to visit and cooperate with our company

The Nobel Prize winner, Dr. Hartmut Michel came to visit and cooperate with our company

On April 27th, 2017, the Nobel Prize winner of 1998, Dr. Hartmut Michel came to visit Jiangsu ProteLight and talk about cooperation. Dr. Hartmut Michel is a biochemist, majors in membrane protein and membrane polypeptide research for a long time, and gets outstanding achievements in applying protein and polypeptide to pharmaceutical area. During the visit, Dr. Michel visited the work shop and Products Exhibition Hall, negotiated about cooperation, and met with leaders from Jiangyin Municipal Government and National Hi-Tech District.

14

2014

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05

WTO release the first Global Antibiotics Resistant Report

WTO release the first Global Antibiotics Resistant Report

On May 5th, 2014, a new report released by WTO makes us examine global antibiotics resistant for the first time, which indicates that the severe threat of antibiotics resistant is no longer a forecast for the future, it is happening all around the world, and it has the potential to affect everyone no matter what age or nationality. When mutation happens to bacteria, antibiotic is no longer effective to people who need it for treatment, that is called antibiotic resistant, which has formed a great threat to public health.

06

2014

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05

Most of diabetic foot are gram positive bacteria

Most of diabetic foot are gram positive bacteria

Liu Jianfeng from Guangzhou Red Cross Hospital published a paper, by analysis 87 strains of pathogenic bacteria and MTT colorimetric assay trends that separated from exudate of 69 patients’ diabetic foot merging ulcer surface, that were received and cured by this hospital from January of 2003 to December of 2010, the results indicates that gram positive bacteria is the majority of pathogenic bacteria that infected diabetic foot ulcer, and the drug-resistant situation is severe. It is necessary to strengthen bacilli culture and MTT colorimetric assay check of diabetic foot ulcer exudate, and to use antibiotics appropriately, so as to improve cure efficiency and improve patients’ prognosis.

13

2012

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07

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