Fifteen Class 1 Innovative Drugs Receive IND Approval in China

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 (January 12th to January 17th), there are 151Class Innovative DrugFirst obtained clinical trial implied permission (IND) in China.These products coverSmall molecules, cyclic peptide-targeted radiopharmaceuticals, antibodies, ADCs, cell therapies, circular mRNA drugsEtc.

EpigenicEpigenic: EPI-003 Injection

Mechanism of Action: Epigenetic Therapy

Indications: Chronic Hepatitis B

Epigenic's New Drug Class 1 EPI-003 Injection Approved for Clinical Trials, Intended for Development to Treat Chronic Hepatitis B. Public information indicates that EPI-003 is an intravenously injected antiviral drug.This drug, through the LNP delivery system, precisely delivers mRNA encoding epigenetic regulatory proteins and guide RNA targeting HBV genes to liver cells, directly inducing durable epigenetic modifications on cccDNA and integrated DNA.Thereby suppressing the generation of all viral products from the transcription source. Preclinical studies have shown that EPI-003 can significantly and continuously reduce hepatitis B surface antigen (HBsAg) and HBV DNA levels, maintaining long-term efficacy after discontinuation of the drug, demonstrating the potential to achieve functional cure or even complete cure of hepatitis B.

Coremed Biotech: cmRNA1210 Injection

Mechanism of Action: IL-12 Circular mRNA Drug

Indications: Advanced Solid Tumors

CureMed Bio's Class 1 new drug cmRNA1210 injection has been approved for clinical trials and is expected to be developed for the treatment of advanced solid tumors (such as melanoma, colorectal cancer, etc.). According to public information, this isIntratumoral Injection of IL-12 Circular mRNA Based on Circular mRNA PlatformA Class 1 therapeutic biological product for the treatment of unresectable and advanced solid tumors. It encodes a single-chain human interleukin-12 (IL-12), which, after local injection at the tumor site, is taken up by cells and expresses high concentrations of IL-12. IL-12 enhances the cytotoxic effects of CD8 T cells and NK cells in the tumor microenvironment, activating the body's anti-tumor immunity.

Sanofi: SAR445399

Mechanism of Action: Monoclonal Antibody Targeting IL-1R3

Indications: Moderate to Severe Hidradenitis Suppurativa in Adults

Sanofi's SAR445399 (also known as MAB212) has been approved for clinical trials, intended for the development of treatment for moderate to severe hidradenitis suppurativa in adults. Public information indicates that this is a potential "first-in-class" drug.IL-1R3 Antagonist IgG4 Monoclonal Antibody, IL-1R3 is a co-receptor required for IL-1, IL-33, and IL-36 signal transduction.

Chengdu Easton Bio Pharmaceuticals Co., Ltd., Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Zhongke Zhongshan Institute of Drug Innovation: EP-0226 Tablets

Mechanism of Action: New Chemical Drug

Indications: Neuropathic Pain

EP-0226, a Class 1 new drug jointly developed by Chengdu Easton Bio Pharmaceuticals Co., Ltd., Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Zhongshan Institute of Drug Innovation, Chinese Academy of Sciences, has been approved for clinical trials and is expected to be developed for treatment.Neuropathic pain. According to the application number, this is a new chemical drug.

Saie Biologics: Human Umbilical Cord Mesenchymal Stem Cell Injection

Mechanism of Action: Human Umbilical Cord Mesenchymal Stem Cells

Indications: Diabetic Foot Ulcer

Saiyi Biologics' Application for a Class 1 New Drug, Human Umbilical Cord Mesenchymal Stem Cell Injection, Approved for Clinical Trials, Intended for the Treatment of Diabetic Foot Ulcers. Public information indicates that this is a ready-to-use (shelf-type) stem cell product after cryopreservation and revival, with the main active ingredient being human umbilical cord mesenchymal stem cells.

Qilu Pharmaceutical: QL2401 for Injection, QLS7305 Injection

Mechanism of Action: New Chemical Drugs, New Biologics

Indications: Metabolic dysfunction-associated steatohepatitis with moderate to severe hepatic fibrosis (F2-F3); Primary membranous nephropathy, Paroxysmal nocturnal hemoglobinuria

Two Class 1 new drugs from Qilu Pharmaceutical have been approved for IND in China for the first time, among which injectable QL2401 is a new biologic drug intended for development to treatMetabolic dysfunction-associated steatohepatitis with moderate to severe hepatic fibrosis (F2-F3); QLS7305 injection is a new chemical drug under development for treatment.Primary Membranous Nephropathy (PMN), Paroxysmal Nocturnal Hemoglobinuria (PNH).

Arno Pharmaceuticals: AN9025 Capsule

Mechanism of Action: Small Molecule Pan-RAS(ON) Inhibitor

Indications: RAS-mutated advanced solid tumors

Arno Pharmaceuticals' Class 1 new drug AN9025 capsule has been approved for clinical trials, intended for the development of treatment for advanced or metastatic solid tumors carrying RAS mutations (including but not limited to non-small cell lung cancer and melanoma). Public information indicates that this is an orally administered pan-RAS(ON) inhibitor with potent broad-spectrum anti-tumor activity, designed to targetRASMultiple Tumor Types with Mutations.This product utilizes a new generation of molecular glue technology, which induces the formation of RAS protein ternary complexes, reducing RAS protein function or protein levels from the source and systematically regulating the signaling output of the entire KRAS, NRAS, and HRAS family.This mechanism does not rely on a single mutation site, thus providing a higher barrier to drug resistance. Preclinical studies have shown that AN9025 is effective against pancreatic cancer, lung cancer, and colorectal adenocarcinoma, among others.RASMutant mouse tumor models exhibit potent and lasting inhibitory effects.

Hengrui Medicine: SHR-1049 Injection

Mechanism of Action: New Biologics

Indications: Solid Tumors

Hengrui Medicine's Class 1 New Drug SHR-1049 Injection Approved for Clinical TrialsIntended for the treatment of solid tumors. Based on the acceptance number, this is a new biologic drug.

Shanghai Pharmaceutical Group: B023 Cell Injection

Mechanism of Action:New Biologics Drug

Indications: Solid Tumors

Shanghai Pharmaceutical Group's Application for New Drug B023 Cell Injection, a Class 1 Biological Product, Approved for Clinical Trials, Intended for Use inLocally advanced or metastatic solid tumors that are inoperable, have failed standard treatments, and have no effective treatment options.

Crystal Core Biologics: Lutetium [177Lu] JH040182 Injection

Mechanism of Action: Cyclic Peptide-Targeted Radiopharmaceuticals

Indications: FAP-positive advanced solid tumors

Crystal Core Biologics' Class 1 New Drug Lutetium [177Lu] JH040182 Injection (Pipeline Code: JH04) Approved for Clinical Trials, Intended for Development to Treat Patients with Advanced Solid Tumors Positive for Fibroblast Activation Protein (FAP). Public information indicates that JH04 is aCyclic Peptide Targeted Radioisotope TherapeuticsIt "targets" by binding to the overexpressed FAP on the surface of tumor cells, precisely delivering therapeutic radioisotopes such as Lu-177 or Ac-225 into the tumor lesion. This achieves precise molecular-level destruction of tumor cells while causing minimal or no damage to surrounding normal tissues. The product exhibits higher tumor accumulation and faster renal clearance.

Zelif Biotech: ZL-65 Tablets

Mechanism of Action:NLRP3 Inflammasome Inhibitor

Indications: Cryopyrin-Associated Periodic Syndromes

Zelif Bio's Class 1 New Drug ZL-65 TabletsApproved for clinical trials, intended for treatment developmentCryopyrin-Associated Periodic Syndromes（CAPS）. According toZhe Ling Bio Public Information, this isAA New Generation of Highly Brain-Penetrant, Orally Available NLRP3 Inflammasome Inhibitor。CAPS is related toNLRP3A group of rare inflammatory diseases related to genetic defects.NLRP3Patients with gene mutations continuously overproduce IL-1β molecules, leading to inflammation.

DualityBio: DB-1317 for Injection

Mechanism of Action: ADAM9-Targeted ADC

Indications: Advanced/Metastatic Malignant Solid Tumors

DualityBio's New Class 1 Drug DB-1317 Injection Approved for Clinical Trials, Intended for Development to Treat Advanced/Metastatic Malignant Solid Tumors. According to publicly available information from DualityBio, this is aADAM9-Targeted Antibody-Drug Conjugate (ADC) with a payload of topoisomerase I inhibitor. Its target, ADAM9, is highly expressed in various gastrointestinal tumors such as gastric cancer, colorectal cancer, and pancreatic cancer, while showing low expression in normal tissues.Preclinical data show that DB-1317 demonstrates significant anti-tumor activity in various gastrointestinal tumor models, including gastric cancer and colorectal cancer.

Nuo Lun Jie Bio: NRG-103 Injection

Mechanism of Action: In Situ Transdifferentiation Tumor Therapy

Indications: Recurrent or progressive high-grade glioma

Newron Therapeutics' Novel Class 1 Drug NRG-103 Injection Approved for Clinical Trials, Aiming to Treat Recurrent or Progressive High-Grade Glioma. According to public information, NRG-103 Injection is an innovative therapy independently developed by Newron Therapeutics based on its in vivo direct reprogramming technology innovation platform.The product is designed with a triple mechanism of "in vivo in situ cell transdifferentiation + oncolytic virus + immune enhancement": Based on the selective replication of a new generation of recombinant oncolytic viruses to kill glioma cells and the use of cytokines to enhance immune killing ability, the in vivo in situ transdifferentiation technology is further employed to convert residual/escaped tumor cells into non-proliferating cells.Combination of multiple mechanisms to enhance the therapeutic efficacy of high-grade gliomas, aiming to fundamentally address the challenges of tumor escape and recurrence.

Hengdong Biopharmaceuticals: CS01 Monoclonal Antibody Injection

Mechanism of Action: Monoclonal Antibody

Indications: Advanced Solid Tumors

Hengdong Biopharmaceuticals' Application for the New Drug CS01 Monoclonal Antibody Injection Approved for Clinical Trials. According to the announcement, the clinical study applied for this time is Phase 1/2.Phase Clinical Trial Protocol, with the proposed indication for advanced solid tumors.

We look forward to the smooth progress of subsequent clinical development processes for these investigational new drugs, which will bring new treatment options to patients as soon as possible.

References:

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