Eleven Class 1 Innovative Drugs Receive IND Approval in China: Featuring Eli Lilly, Akeso Biopharma and Others

▎WuXi AppTec Content Team Report

According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and public information, this week (August 26th ~ September 1st), there were11First-in-class innovative drug approved for the first time in ChinaObtained clinical trial implied permission (IND). After sorting out, these products includeSmall molecule drugs, radiopharmaceuticals, gene-modified stem cell drugs, AAV gene therapy drugs, siRNA drugs, bispecific antibodiesSuch types are intended for the treatment of cancer, type 2 diabetes, kidney disease, psoriasis, etc. This article will introduce relevant information about these products based on publicly available data.

Image Source: 123RF

Hinova Pharma: HP515 Tablet

Mechanism of Action: THR-β Agonist

Indications: NASH/MASH

Hinova Pharma's New Drug Application for HP515 Tablets Granted Implied Approval for Clinical Trials, Intended for Development as a TreatmentNonalcoholic Steatohepatitis（NASH，Also known as metabolic dysfunction-associated steatohepatitis, MASH）According to the press release from Hinova Pharma, this is a self-developedOral Highly Selective Thyroid Hormone Receptor Beta Subtype (THR-β) AgonistIt can directly act on THR-β to activate downstream gene transcription, thereby enhancing hepatic lipid metabolism activity, increasing liver fat metabolism, reducing lipotoxicity, and achieving an improvement effect on non-alcoholic steatohepatitis (NASH).

Wangshan Wangshui, Wuhan Institute of Virology, Chinese Academy of Sciences, Shanghai Institute of Materia Medica, Chinese Academy of Sciences: VV261 Tablets

Mechanism of Action:Nucleoside Candidate Drugs Against SFTSV

Indications:Fever with Thrombocytopenia Syndrome

VV261 Tablets, a Class 1 new drug jointly declared by Wangshan Wangshui, Wuhan Institute of Virology of the Chinese Academy of Sciences, and Shanghai Institute of Materia Medica of the Chinese Academy of SciencesApproved for Clinical Use, intended for development to treatFever with Thrombocytopenia Syndrome. Public information shows,VV261Is aNucleosidesAnti-novel Bunyavirus（SFTSV）Candidate New Drug。SFTSV is an RNA virus,Capable of infecting humans and causing fever with thrombocytopenia syndromeThe main clinical symptoms are fever, vomiting, diarrhea, and multiple organ failure, etc.VV261The active form is nucleoside triphosphate., it acts on the highly conserved active center of the viral polymerase, thus making it less prone to viral resistance issues.Preclinical study results show that the product has potent in vitro and in vivo anti-SFTSV activity.

Tongrui Bio:¹⁷⁷Lu-TR0471 Injection

Mechanism of Action: Radiopharmaceuticals

Indications: Prostate Cancer

Tongrui Biologics Submitted¹⁷⁷Lu-TR0471 Injection Approved for Clinical Use, Intended to Treat Patients Who Have Received Androgen Receptor Inhibitors but Not Taxane ChemotherapyAdult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)According to the Tongrui Biotech's official website, the company was incubated and founded in 2021, focusing on the field of radiopharmaceuticals and concentrating on major diseases such as cancer.

Akeso: AK135 Injection

Mechanism of Action: Biologics Targeting IL-1RAP

Indications: Chemotherapy-induced peripheral neuropathy

Akeso's Class 1 New DrugAK135 Approved for Clinical Trials, Intended for Treatment DevelopmentChemotherapy-Induced Peripheral Neuropathy（CIPN）。CIPN is a serious side effect caused by the potential neurotoxicity of cancer chemotherapy drugs, generally affecting more than 60% of cancer patients. According to public information from Akeso,AK135 isBiological drugs targeting IL-1RAPStudies have shown that IL-1RAP is highly involved in the inflammatory process through the interleukin 1, 33, and 36 (IL-1, IL-33, IL-36) signaling pathways and has been found to be overexpressed in tumor cells of various hematological and solid cancers.

Jiyuan Bio: Human GLP-1 and FGF21 Dual-Factor High-Expression Adipose Stem Cell Injection

Mechanism of Action: Gene-Modified Mesenchymal Stem Cell New Drug

Indications: Type 2 Diabetes

Jiyuan Bio's application for human GLP-1 and FGF21 dual-factor high-expression adipose stem cell injection has been approved for clinical trials, intended for development as a treatment.Type 2 DiabetesAccording to the press release from JiYuan Bio, this is the company's firstGene-Modified Mesenchymal Stem Cell New DrugDerived from the patient's abdominal fat, this product utilizes a stem cell technology platform and a gene modification technology platform to incorporate two metabolic disease treatment drugs, GLP-1 and FGF21, into a stem cell-based drug. It is clinically intended for the treatment of refractory type 2 diabetes.

BestBio: BN-1001 Ophthalmic Injection

Mechanism of Action: AAV Gene Therapy Drugs

Indications: wAMD

Bio-Thera Solutions' BN-1001 Ophthalmic Injection Approved for Clinical Trials, Intended for TreatmentNeovascular (Wet) Age-Related Macular Degeneration (wAMD)According to the press release from BestBio, this is an AAV gene therapy drug that can continuously and stably express anti-VEGF molecules at a lower dose, which is expected to reduce the incidence of symptoms in patients. Founded in 2020, BestBio is committed to the research and development of gene therapy drugs based on recombinant viruses for the treatment of ophthalmic diseases, neurological disorders, malignant tumors, rare diseases, and more.

Lianhuan Pharmaceutical, China Pharmaceutical University: Inhalation LH-1901

Indications: COPD

Lianhe Pharmaceuticals and China Pharmaceutical University's jointly filed inhaled LH-1901 has been approved for clinical trials, intended for development as a treatment.Chronic Obstructive Pulmonary Disease (COPD)Public data shows that China Pharmaceutical University signed a transfer contract with Lianhuan Pharmaceuticals in 2019 for the new anti-COPD drug tiotropium bromide. This is speculated to be the inhaled LH-1901 recently approved for clinical trials. Tiotropium bromide is a novel bronchodilator designed to address the clinical shortcomings of M3 receptor antagonist drugs, with the potential to be developed into a new anti-COPD drug featuring low systemic exposure, strong efficacy, and long-lasting effects.

Pugy Pharm: PG-033 Tablets

Mechanism of Action: Chemical Drug

Indications: Moderate to severe pruritus associated with neurodermatitis

PG-033 Tablets, submitted by Puqi Pharmaceutical, have been approved for clinical trials, intended for the treatment of moderate to severe itching associated with neurodermatitis. Currently, Puqi Pharmaceutical has not disclosed the specific target of this product. From the acceptance number, it can be seen that this is a new chemical drug. Public information shows that Puqi Pharmaceutical was founded in 2016, focusing on the research and development of drugs for immune-inflammatory diseases. The company has established a product pipeline characterized by topical medications, centered around immune regulation and inflammatory targets.

Xuanjing Bio: RG002C0106 Injection

Mechanism of Action: siRNA Drug Targeting Complement Factor C3

Indications: Complement-mediated primary or secondary glomerular diseases

Xuanjing Bio申报的RG002C0106 Injection Approved for Clinical UseIntended for the treatment of primary or secondary glomerular diseases mediated by complement.Xuanjing Biotech Press Release,This is its self-developed innovative small interfering nucleic acid (siRNA) drug for the treatment of complement-related diseases, targeting the complement factor C3, and also the first pipeline of Xuanjing Bio to enter the clinical trial stage.. Xuanjing Biotech was founded in 2022, focusing on the research and industrialization of innovative small nucleic acid drugs.

Eli Lilly: LY3540378 Injection

Mechanism of Action: RXFP1 Agonist

Indications: Chronic Kidney Disease (CKD)

Eli Lilly（Eli Lilly and Company）DeclaredLY3540378 InjectionApproved for Clinical Use, intended for development to treatPatients with Chronic Kidney Disease (CKD). Public information shows that LY3540378（volenrelaxin）It is being developed by Eli Lilly and Company.Long-actingEffective Agonist of Relaxin Family Peptide Receptor 1 (RXFP1), which is currently in Phase 2 clinical trials internationally. Relaxin and its receptor RXFP1 are both expressed in the kidneys and have been shown to play roles in renal vasodilation, sodium excretion, and anti-fibrosis.In a Phase 1 clinical study, the product was shown to sustainably improve renal perfusion, supporting further clinical development for chronic kidney disease and chronic heart failure.Moreover, this product has an extended half-life, making it suitable for once-weekly subcutaneous injection.

Kangyuan Pharmaceutical: KYS202004A Injection

Mechanism of Action: Bispecific Antibody Targeting TNF-α and IL-17A

Indications: Psoriasis

According to the literature, KYS202004A is aA novel bispecific fusion protein targeting TNF-α and IL-17A, designed to antagonize TNF-α and IL-17A, which play a critical role in the pathophysiology of autoimmune and inflammatory diseases.In preclinical studies of psoriasis, the product demonstrated efficacy comparable to that of other approved products when used in combination, which researchers believe could offer patients a more effective dual-target treatment approach.

[2] Official websites of various companies and public materials