Six Class 1 Innovative Drugs Receive First-in-China IND Approval from Companies Including Qilu Pharmaceutical and Chia Tai Tianqing

According to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) and publicly available information, this week (October 13th ~ October 18th), there were6 Products 1Class Innovative DrugFirst obtained Investigational New Drug (IND) approval in China.These products coverSmall molecule targeted drugs, protein degradation therapy, cell therapyetc.。

Qilu Pharmaceutical: QLS2309 Injection

Mechanism of Action: New Biologics

Indications: Hematologic Malignancies

Qilu Pharmaceutical's申报的1类新药QLS2309注射液has been approved for clinical trials, intended for the development of treatment for hematological malignancies. Public information indicates that this is a novel biological product. Qilu Pharmaceutical has registered a Phase 1 clinical study to evaluate the product.CD70+Patients with Relapsed/Refractory Hematologic MalignanciesTolerability, safety, and preliminary antitumor activity.

CHIATAI TIANQING: TQB3142 for Injection

Mechanism of Action: PROTAC Drugs Targeting Bcl-xL Protein Degradation

Indications: Advanced Malignant Tumors

CHIATAI TIANQING's Class 1 new drug TQB3142 for injection has been approved for clinical trials, intended for the treatment of advanced malignant tumors. Public information shows that TQB3142 isA PROTAC (Proteolysis Targeting Chimera) drug targeting Bcl-xL protein degradation specifically degrades Bcl-xL protein through the ubiquitin-proteasome system, relieving its inhibition of tumor cell apoptosis and inducing programmed death in tumor cells.Public data shows that traditional Bcl-xL small molecule inhibitors have encountered obstacles in clinical development due to dose-limiting toxicity causing thrombocytopenia. New drugs developed based on PROTAC technology can achieve highly efficient degradation at lower compound concentrations, becoming a breakthrough direction for research and development.

Zion Pharma: ZN-F-6418 Capsule

Mechanism of Action: New Chemical Drug

Indications:KRAS G12DMutant Advanced Solid Tumors

Zion Pharma's Application for the New Drug ZN-F-6418 Capsules Approved for Clinical Trials, Intended for Development to Treat Advanced Solid Tumors with KRAS G12D Mutation. From the application number, it can be seen that this is a new chemical drug.

Novartis: PKN605 Tablets

Mechanism of Action: New Chemical Drug

Indications: Atrial Fibrillation

Novartis' Class 1 new drug PKN605 tablets have been approved for clinical trials, intended for the development of atrial fibrillation treatment. Internationally, this product is undergoing a Phase 2 clinical study, with atrial fibrillation as the indication.

Exegen Pharma: EGFNASA Capsule

Mechanism of Action: New Chemical Drug

Indications: Endometriosis

ExoMed's Class 1 new drug EGFNASA capsule has been approved for clinical trials, intended for the development of treatment for endometriosis. The specific mechanism of action of this product cannot be found through public channels at present. From the acceptance number, it is known to be a chemical new drug.

Help Stem Cell Innovations Co., Ltd.: HiCM388 Injection

Mechanism of Action: Human Umbilical Cord MesenchymalStem Cells

Indications: Patients with acute ST-segment elevation myocardial infarction after vascular recanalization treatment

Help Stem Cell Innovations Co., Ltd.'s Application for a Class 1 New Drug, Injectable Human Umbilical Cord Mesenchymal Stem Cells (HiCM388), Approved for Clinical Trials, Intended for Development to Treat Patients with Acute ST-Segment Elevation Myocardial Infarction After Revascularization. Acute Myocardial Infarction (AMI) is the "number one killer" leading to death in patients with cardiovascular diseases, and Acute ST-Segment Elevation Myocardial Infarction (STEMI) represents the most critical and high-risk type among AMI cases.

We look forward to the smooth progress of subsequent clinical development processes for these drugs under research, and hope they can bring new treatment options to patients as soon as possible.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Oct 18, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c