News & Events - Hillgene Biopharma Co., Ltd.

07 2022.06

CDE issued “Guidelines on Clinical Trial Statistics of Drug Products for Rare Diseases (Interim)”

In order to encourage the development of drugs for rare diseases and guide applicants to improve R&D efficiency from the perspective of clinical research methodology, the Drug Evaluation Center or...

01 2022.06

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022)

In order to standardize and guide the pharmaceutical research and development, production and registration of in vivo gene therapy products, under the deployment of the National Medical Products Admin...

01 2022.06

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)” (No. 29, 2022)

In order to standardize and guide the pharmaceutical research of in vitro gene modification systems, under the deployment of the National Drug Administration, the Drug Evaluation Center organized the ...

01 2022.06

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)” (No. 30, 2022)

In order to standardize and guide the pharmaceutical research and development, production and registration of immune cell therapy products, under the deployment of the National Medical Products Admini...

31 2022.05

Hillgene Winning the Bid on the First Contract Manufacturing Order for Commercial CAR-T Cell Therapy in China

It is reported that Shanghai Xianbo Biotechnology Co., Ltd. and Jiangsu Puxin Biopharmaceutical Co., Ltd. have reached a strategic cooperation agreement, entrusting Puxin Bio to carry out the second p...

31 2022.05

[GMP revised] Appendix for “Investigational Drugs (Interim)” issued and taking effect as of July 1!

In accordance with Article 310 of the Good Manufacturing Practice for Pharmaceuticals (Revised in 2010), the Appendix to the Drugs for Clinical Trial Use (Trial) is hereby issued as a supporting docum...

20 2022.05

Establishment of the Judge Workshop at the Industrial Park, Bridging the Court and the Enterprises

On May 11, the unveiling ceremony of the "Judges' Studio in the Park" of Wuzhong District People's Court was held in Suzhou (Taihu) Software Industrial Park. Dong Qihai, Party Secret...

17 2022.05

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Evaluation of Immune-related Adverse Events in Antitumor Therapy” (No. 25, 2022)

Tumor immunotherapy is a hot topic in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and judgment of immune-related...

31 2022.03

The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”

In order to strengthen the supervision and management of drug marketing authorization holders (hereinafter referred to as holders), supervise the holders to fulfill the quality management responsibili...

21 2022.03

Who will become the leading “water supplier” during the “gold rush” of the cellular therapy industry?

2022 marks the 10th anniversary of Emily Whitehead, the world's first child with leukemia cured by CAR-T cell immunotherapy, achieving cancer-free survival.In 2012, Emily, who suffered from acute ...

16 2022.03

Leading Enterprise of Professional and Dedicated CDMO for Cellular Therapy Products - Hillgene Completed the Pre-A Round Funding up to Hundreds of Millions of Dollars

Recently, Jiangsu Puxin Biopharmaceutical Co., Ltd. ("Puxin Bio" or "the Company") completed a Pre-A round of financing of nearly 100 million yuan. This round of financing was led ...

29 2022.01

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Risk Management Plan for Marketing Application of Chimeric Antigen Receptor T cell (CAR-T) Therapy Pro

Chimeric antigen receptor CAR-T cells (CAR-T) refer to a type of T cell that can recognize a specific antigen by introducing vectors such as viruses into autologous or allogeneic T cells through gene ...