Medical Consumables and Lab Consumables OEM Manufacturer
Medical Consumables and Lab Consumables OEM Manufacturer

News & Events

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...
20 2022.06
Hillgene Completed the Pre-A+ Round Funding up to Tens of Millions of Dollars Again Constant Enhancing the Capability of CQDMO Services in the Industry of Cellular Therapy Product
Jiangsu Puxin Biopharmaceutical Co., Ltd. ("Puxin Bio" or "the Company") has continued to attract capital attention within two months after the completion of the Pre-A round of fin...
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...
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...