Industry News - Hillgene Biopharma Co., Ltd.

01 2022.12

NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration”

In order to improve the efficiency of drug review and approval, the National Medical Products Administration has decided to implement electronic submission of drug registration application materials. ...

30 2022.11

MAH issued“Provisions for Supervision and Administration of Drug Quality (Interim)”

On November 29, the State Food and Drug Administration publicly solicited opinions on the "Regulations on the Supervision and Management of Drug Quality by Drug Marketing Authorization Holders&qu...

03 2022.11

Big News: Newly released “Good Manufacturing Practice for Cellular Therapy Products (Interim)”!

On October 31, 2022, in order to guide the drug MAH to standardize the production and quality management of cell therapy products, the National Bureau Verification Center issued the "Guidelines f...

17 2022.10

Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”

Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (October 2022)On October 13, 2022, the FDA (CDER and CBER) issued the...

23 2022.06

CDE: Notification of Public Comment Soliciting on “Technical Guideline for the Clinical Research and Development of New Drug Products for Chronic Lymphocytic Leukemia (Draft for Comments)”

Chronic lymphocytic leukemia (CLL) is a mature B lymphocyte clonal proliferation tumor that mainly occurs in the middle-aged and elderly population. Its overall incidence rate is increasing due to the...

08 2022.06

Important Report from CDE! The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021)

In order to fully grasp the progress of clinical trials for new drug registration in China, use information technology to improve drug regulatory capabilities, and timely disclose clinical trial progr...

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...