Five Class 1 New Drugs Receive First-in-China IND Approvals

On March 21, the CDE website showed that several Class 1 new drugs, including TCC1727, XZP-6877, and MK-3475A, were approved for clinical trials in China for the first time.

Drug: TCC1727 Tablets

Company: China Biologic Products

Indications: Advanced Solid Tumors

TCC1727 is an ataxia telangiectasia and Rad3-related protein (ATR) inhibitor. ATR belongs to the protein serine/threonine kinase family and is a core member of the DNA damage repair (DDR) pathway. ATR kinase is a key factor in resistance to various clinically important anti-tumor therapies, including platinum drugs, gemcitabine, and PARP inhibitors. TCC1727 interferes with DDR by inhibiting ATR function, causing cancer cells to die due to unrepaired DNA damage. Current data show that it exhibits significant anti-tumor activity across multiple tumor types.

According to the announcement by China Biologic Products, the clinical indications intended for development of TCC1727 include non-small cell lung cancer, small cell lung cancer, ovarian cancer, triple-negative breast cancer, and other types of cancers. It will focus on patient populations with cancers that have progressed or developed resistance to PD-1/PD-L1 therapies, platinum-based chemotherapy, and PARP inhibitors. The drug aims to fill the treatment gap where existing therapies have failed or led to drug resistance, addressing an urgent unmet clinical need.

Drug: XZP-6877

Company: Xuanzhu Biotech

Indications: Advanced Solid Tumors

XZP-6877 is a DNA-dependent protein kinase (DNA-PK) inhibitor and the first DNA-PK inhibitor in China to be submitted for clinical trials. DNA-PK is a serine/threonine kinase associated with DNA damage repair. Currently, six DNA-PK inhibitors worldwide have entered clinical stages, among which CC-115 (BMS) is the most advanced.

Drug: MK-3475A

Company: MSD

Indications: Lung Cancer

MK-3475A is a subcutaneous injection formulation of pembrolizumab developed by MSD using recombinant human hyaluronidase technology, currently in Phase III clinical trials (trial details see: ).

Drug: Dinorucimab

Company: Eternity Bio

Indications: CD19-positive relapsed or refractory diffuse large B-cell lymphoma

Dinolucel Injection (RC19D2) is a CAR-T therapy developed by Eternity Bio based on its independently owned immune cell drug development platform. It simultaneously targets CD19 and TGF-β, with the ability to recognize and kill CD19-expressing target cells while antagonizing TGF-β signaling. This function can prolong the survival time of CAR-T cells in vivo and promote CAR-T cell infiltration. Its characteristics are conducive to significantly improving the remission rate of CAR-T products for r/r DLBCL, better meeting patient needs.

The Phase I clinical trial of CAR-T-19 injection was launched in March 2021, and Eternity Biopharma expects to release its preliminary analysis and results in 2023. In December 2021, Eternity Biopharma announced that the bone marrow re-examination reports at 14 days post-infusion for the second and third patients in the first dose group showed MRD negativity, and multiple bone marrow re-examinations of the first patient over three months post-infusion also indicated complete remission with MRD negativity.

Drug: Human Umbilical Cord Mesenchymal Stem Cell Injection

Company: Intron Biotechnology

Indications: Acute Ischemic Stroke

Mesenchymal Stem Cells (MSCs) possess self-renewal, multi-directional differentiation potential, and paracrine effects, and are considered crucial seed cells in regenerative medicine for stem cell therapy. They can differentiate into various tissue cells such as osteocytes, chondrocytes, muscle cells, adipocytes, and neurons, among others. In addition to repairing and replacing damaged tissues, the therapeutic effects of MSCs are mainly attributed to their potent paracrine function. MSCs play a role in repairing damaged tissues, promoting tissue differentiation and regeneration, and modulating immunity by secreting a large number of cytokines.

The human umbilical cord is an important source of mesenchymal stem cells. Human umbilical cord mesenchymal stem cells (hUC-MSCs) have high proliferation and self-renewal capabilities, low immunogenicity, no ethical issues, and are easy to obtain, making them an effective and reliable cell source. They have gained significant attention in the medical field and provide new research directions for many medical challenges.

This product is the first in Yinguan Biotech's pipeline to be approved for clinical trials, and it is also the ninth human umbilical cord mesenchymal stem cell therapy to be approved for clinical trials in China.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account's backend or send a message, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

MedCube Reader Survey Questionnaire

Thank You for Your Support. Looking Forward to Your Feedback.

Scan the QR code to provide valuable suggestions