News & Events - Hillgene Biopharma Co., Ltd.

19 2021.11

Another Award | Hillgene Was Awarded the TOP 5 Annual Pharmaceutical CXO Companies

From November 13 to 14, 2021, the 2021 Third Annual Bioprocess Industry Summit was successfully held in Shanghai. With the theme of "Latecomers Arrive Faster, Great Things Will Come", many e...

19 2021.11

Good News | Hillgene Won the Title of “Star of Tomorrow” among the China Biopharmaceutical CDMO Companies in Star Awards-2021 BPID

On October 11-12, 2021, the BPID Biopharmaceutical Industry Development Conference and the 2021 Life and Health Industry Summit Forum were successfully concluded in Shanghai. The conference discussed ...

18 2021.10

Contributing to the “Wuzhong Highland” in Biopharmaceutical Industry丨Hillgene Joined the “Innovative Pharmaceutical CXO Alliance in the Yangtze River Delta Region”

From October 13 to 16, 2021, the "First China (Suzhou) Taihu Pharmaceutical Innovation Conference" hosted by the Wuzhong District People's Government of Suzhou City and undertaken by the...

09 2021.09

Hillgene Reached a Strategic Cooperation with Biotheus in Climbing to New Heights in China for CAB-T Cell Therapy Products

On August 14, 2021, Jiangsu Spectrum Biopharmaceutical Co., Ltd. (hereinafter referred to as "Spectrum Bio") and Promis Biotech Co., Ltd. (hereinafter referred to as "Promis") reac...

27 2021.07

European Medicines Agency updates Reflection Paper on GMP Responsibilities of MAHs

On July 27, the European Medicines Agency (EMA) released a reflection paper on GMP and MAH, "Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders", which stipu...

12 2021.07

Live丨Writing a New Chapter for Cellular and Gene Therapies, Paving the Road to an Innovatively Developed and Industrialized Future

Cell and gene therapy technology is undoubtedly one of the most popular biotechnology fields at present, and is also regarded as the next generation of innovative therapies for disease treatment. In t...

12 2021.07

NMPA issued the “Measures for the Administration of Drug Inspection (Interim)”, and abolished the original drug administrative measures for GMP and GSP certification!

Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People&#...

10 2021.02

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products (Interim)” (No. 14, 2021)

In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the techn...

31 2020.12

[IIT] Announcement on Public Comment Soliciting on the “Administrative Measures for Investigator Initiated Clinical Trials by Medical and Health Institutions (Draft for Comments)”

Measures for the Administration of Clinical Research Initiated by Medical and Health Institutions(Draft for Comments)Chapter I General ProvisionsArticle 1 (Purpose) In order to standardize the managem...

14 2020.09

Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Gene Therapy Products (Draft for Comments)”

Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products(Draft for Comments)ForewordIn recent years, with the continuous advancement of gene delivery systems and editin...

06 2020.07

Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Draft for Comments)”

In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the techn...

30 2020.03

Newly Revised “Provisions for Supervision and Administration of Drug Manufacturing”

Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administra...