Around 20 Class 1 New Drugs Receive IND Approval in China, Including Candidates from Hengrui Medicine, Roche, Shanghai Pharmaceuticals, and Others

▎Edited by the WuXi AppTec content team

According to the official website data of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China, there are approximately 20First-in-class new drugObtained tacit approval for clinical trials.Through combing, these new drugsCoverMultiple antibody-drug conjugates (ADCs), radiopharmaceuticals, antibody-based drugs, cell therapy drugs, and small molecule drugsetc., intended for the treatment of psoriasis, pulmonary arterial hypertension, depression, growth hormone deficiency in children, type 2 diabetes, overweight or obesity, and various types of cancer, etc.。This article will provide a brief introduction to some of these products for readers' reference only.

Hengrui Pharma: HRS9531 Tablet

Mechanism of Action: GIPR and GLP-1R Dual Agonist

Indications: Overweight or Obesity, Type 2 Diabetes

According to public data from Hengrui Pharma, HRS9531 tablets are a new type of oralDual Agonist of Peptide GIPR and GLP-1R, intended for the treatment of type 2 diabetes and weight loss. HRS9531Injectable FormulationsHas entered the Phase 3 clinical research stage in China for the treatment of overweight or obesity. This productTablet FormulationApproved for clinical trials in China, intended for the treatment of overweight or obesity and type 2 diabetes. Notably, just a few days ago (May 16), Hengrui Pharma announced a deal exceeding $6 billion with U.S.-based Hercules Company.CooperationThe latter will obtain exclusive rights to develop, manufacture, and commercialize the GLP-1 portfolio globally, excluding Greater China, which includes HRS9531 injection and oral products.

MediLink: Injectable YL211,YL205 for Injection

Mechanism of Action: ADC Targeting c-Met, TargetADC Targeting NaPi2b

Indications: Advanced Solid Tumors, Advanced Solid Tumors

According to the public information from MediLink, YL211 isNovel ADC Specifically Targeting c-MET, adopting MediLink's next-generation, tumor microenvironment-activatable novel toxin linker platform technology. In January this year, MediLink has reached a deal exceeding 1 billion US dollars with Roche.CooperationThe latter obtained exclusive global rights for the development, manufacturing, and commercialization of the YL211 project. The drug has been approved for clinical trials in China and is being developed for the treatment of advanced solid tumors.

YL205YesNext-Generation Antibody-Drug Conjugate (ADC) Specifically Targeting NaPi2b, with a novel topoisomerase I inhibitor as the payload. NaPi2b is a sodium-dependent phosphate transporter located on the cell surface.，It is expressed in various cancers such as high-grade serous epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer, while its expression in normal tissues is limited. Therefore, it has the potential to serve as a target for cancer treatment.

AbbVie: ABBV-400 for Injection Powder

Mechanism of Action: ADC Targeting c-Met

Indications: Locally Advanced/Metastatic Colorectal Cancer

According to public information from AbbVie, ABBV-400 is ac-Met-targeted ADC, with TOP1i as the payload, is being developed for the treatment of c-Met positive solid tumors. The product is currently undergoing Phase 1 clinical trials internationally, and the indication approved for clinical use in China this time is unresectable locally advanced/metastatic colorectal cancer.

Servier: Vorasidenib Tablets

Mechanism of Action: IDH1/2 Inhibitor

Indications: Astrocytoma or Oligodendroglioma

Public information shows that vorasidenib tablets are aOrally administered dual inhibitor with brain permeability and selectivity can inhibit mutations.Susceptible Gene Isocitrate Dehydrogenase (IDH1/2 protein. The indication approved for clinical use this time is: for adults and children aged 12 years and above with post-surgical intervention.IDH1/2Treatment of patients with non-enhancing predominant astrocytoma or oligodendroglioma mutations. Notably, in February this year, vorasidenib was used to treatIDHPatients with mutant gliomaNew Drug Application (NDA)Has been accepted by the U.S. FDA and granted priority review status.

SINOVAC: GB08 Injection

Mechanism of Action: Long-Acting Growth Hormone

Indications: Growth Hormone Deficiency in Children

According to previous announcements from SINOVAC, GB08 injection is independently developed by the company.Fc Fusion Protein Long-Acting Growth HormoneThe indication approved for clinical use this time is pediatric growth hormone deficiency. SINOVAC, through DNA recombinant technology, has linked the human growth hormone (hGH) gene with the IgG4 subtype Fc segment gene for expression, significantly enhancing the product's safety and the convenience and compliance of patient medication.

SPH: SPH7450 Tablet (I040)

Mechanism of Action: Small Molecule Compounds

Indications: Depression

According to the announcement by SPH, I040 is a small molecule compound, and the approved clinical indication this time is for depression. Preclinical studies have shown that it can improve core symptoms in multiple animal models of depression, with good safety.

Yantai Lannacheng Biotechnology Co., Ltd.:¹⁷⁷Lu-LNC1010 Injection

Mechanism of Action: Radiolabeled Somatostatin Analog

Indications: Gastrointestinal Pancreatic Neuroendocrine Tumors

According to the public information from Yantai Lannacheng Biotechnology Co., Ltd.,¹⁷⁷Lu-LNC1010 InjectionA radiopharmaceutical for targeted therapy directed at somatostatin receptor 2 (SSTR2)In the field of nuclear medicine development, the development of radiopharmaceuticals targeting somatostatin receptors (SSTR) represents a significant advancement.The Internalization Properties of Somatostatin Analog Peptides Enable the Delivery of Radioisotopes to Tumor Cells。¹⁷⁷Lu-LNC1010 Injection Approved for Clinical Use in Treating SSTR2-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Xindou Biotechnology: DGPR1008 Injection

Mechanism of Action: Targeted Fluorescent Contrast Agents

Indications: Prostate Cancer

According to the press release from Xindou Biotechnology, DGPR1008 Injection is the company's first product.Targeted Fluorescent Contrast Agents, for prostate cancer,Can light up tumors in real time during surgeryThe product achieves real-time fluorescence imaging during surgery by targeting tumor cells, which can assist doctors in accurately determining positive margins, achieving complete removal of tumor lesions, and significantly reducing damage to normal tissues. The drug has been approved for clinical use in prostate cancer surgery patients as an auxiliary means for intraoperative identification of malignant lesions.

Beijing Continent Pharmaceuticals Co., Ltd.: F230 Tablet

Mechanism of Action: Selective Endothelin Receptor Antagonist

Indications: Pulmonary Arterial Hypertension

Public information shows that Beijing Continent Pharmaceuticals Co., Ltd. was established in 2002 as a subsidiary of Gyre Therapeutics in the United States, focusing on developing innovative drugs for organ fibrosis diseases. According to the company's official website, F230 is aSelective Endothelin Receptor (ETA) Antagonist, aiming to develop a treatment for the rare disease pulmonary arterial hypertension. Selective blockade of ETA can block endothelin-induced vasoconstriction, exerting a hypotensive effect, improving hemodynamics and exercise capacity, thereby treating pulmonary arterial hypertension. The latter is a rare, progressive, life-threatening vascular disease characterized by constriction of the small pulmonary arteries and elevated blood pressure in the pulmonary circulation.

Ningbo Yinuo Pharmaceutical Co., Ltd.: INNA1605 Ointment

Mechanism of Action: Small Molecule MyD88 Inhibitor

Indications: Psoriasis

According to the press release from Ningbo Yinuo Pharmaceutical Co., Ltd., INNA1605 ointment is a product independently developed by the company.Small Molecule MyD88 Inhibitor, plans to develop various types of dermatitis caused by autoimmune issues, such as psoriasis, atopic dermatitis, and allergic dermatitis, etc. The indication for which this drug has been approved for clinical trials isPsoriasisMyD88 inhibitors are a class of small molecule inhibitors targeting the TLR/MyD88 signaling pathway in the innate immune system. MyD88 is at the origin of the human immune system and plays a crucial role in the onset and development of numerous immune-related diseases.

Genentech: Vixarelimab Injection

Mechanism of Action: Anti-OSMRβ Monoclonal Antibody

Indications: Ulcerative Colitis

According to public information,vixarelimab（RG6536）It is a potential "first-in-class" fully human monoclonal antibody that blocks oncostatin M receptor β (OSMRβ), developed by Genentech, a subsidiary of Roche. It can block OSM and IL-31 signaling while preserving signaling through the LIFR pathway. The product's indication for prurigo nodularis-related itching has previously been granted Breakthrough Therapy Designation by the FDA. The drug's approved clinical indication in China this time is ulcerative colitis.

Enkaisai Pharmaceuticals: NK042 Cell Injection

Mechanism of Action: Universal Gene-Modified NK Cell Injection

Indications: Advanced Solid Tumors

According to the press release from Enkaicell, NK042 isAllogeneic Peripheral Blood-Derived Universal Genetically Modified NK Cell Injection, with the potential to treat solid tumors, hematological malignancies, and non-cancerous diseases. The Phase 1 clinical trial approved this time targets advanced solid tumors.

Shunxi Regenerative Medicine: SCM-181 Injection

Mechanism of Action: Human Placental Chorionic Mesenchymal Stem Cell Injection

Indications: Idiopathic Pulmonary Fibrosis

According to the press release from Shunxi Regenerative Medicine, SCM-181 Injection is a type of mesenchymal stem cell (hPC-MSC) derived from human placental chorion. Compared with mesenchymal stem cells from other sources, placental chorionic mesenchymal stem cells have advantages such as abundant sources, convenient collection, low immunogenicity, and higher proliferation capacity. The product has been approved for clinical trials for the indication of idiopathic pulmonary fibrosis.

In addition to the aforementioned products, other Class 1 new drugs were approved for clinical trials this week, or received approval to conduct clinical research for new indications. Due to space limitations, they will not be elaborated here one by one.We hope that the subsequent clinical research of these Class 1 new drugs will proceed smoothly, achieve breakthroughs as soon as possible, and benefit patients.

[2] Official websites of various companies and publicly available information