Insights

On April 19, 2023, a cooperative exchange meeting themed "Mutual Cooperation - Innovative Integration" was jointly organized by theSecond Affiliated Hospital of Suzhou University, Suzhou Biomedical Industry Park (BioBAY), and the Suzhou Clinical Research Services Platform.

From June 26th to 28th, our company's senior leadership, including CEO Mr. Yu Xu, Chairman Dr. Daniel Liu, Senior Vice President and Chief CNS Expert Dr. Ren, Senior Vice President Mrs. Sha, Operations Director of the US subsidiary Dr. Roy Feng, and Clinical Operations Manager Dr. Xue, gathered in Boston, USA, to participate in the 2023 DIA exhibition.

Recently, Lecanemab injection (Chinese trade name: Leqembi) of Eisai Inc. has been approved with the priority review and approval procedure by NMPA China for the treatment of patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease.

In order to further guide enterprises to optimize the clinical dosage of PD-1 /PD-L1 antibodies and improve patient compliance and overall quality of life, provide a technical specification that can be referred to, CDE has organized to formulate the Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer , which was issued and implemented on January 10, 2024 upon the review and approval of the NMPA.

To align the technical standards for drug registration with international standards, the NMPA has decided to adopt the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M7(R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (hereinafter referred to as M7(R2)).

To guide global standardization in drug development, leading practices in standardized clinical trials were discussed at the ICH semi-annual meeting held in Prague in 2023.