14 new drugs of Class 1 have been approved for clinical trials in China! From CF PHARMTECH (02652), Jiangsu Hengrui Pharmaceuticals (01276), and others.

According to the official website of the Center for Drug Evaluation of the China National Medical Products Administration (CDE) and public information, last week (April 27th to May 2nd), 14 first-class innovative drugs in China obtained the first clinical trial implied license (IND). These products cover small molecules, peptides, antibodies, antibody-drug conjugates (ADCs), and so on. CF PHARMTECH: ICF004 Inhalation Powder Mechanism of action: undisclosed Indication: Interstitial lung disease CF PHARMTECH's application for ICF004 Inhalation Powder was approved for clinical trials, intended for the treatment of interstitial lung disease. According to a CF PHARMTECH press release, ICF004 is intended for the treatment of progressive fibrotic interstitial lung disease (PF-ILD), which covers indications threatening patients' survival such as idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). ICF004 uses the inhalation powder delivery route to directly deliver the drug to the area of lung lesions to enhance local lung exposure and minimize systemic exposure, aiming to achieve a better balance between efficacy and safety. In terms of project positioning, ICF004 is a candidate project combining "mechanism exploration + dosage form innovation", and continues to conduct mechanism research and translational verification around fibrosis-related pathological processes (including inflammation, oxidative stress, and fibroblast activation). JIUYUAN GENE: JY54 Injection Mechanism of action: long-acting insulin analog Indication: Weight management for obesity or overweight JIUYUAN GENE's application for JY54 Injection was approved for clinical trials, intended for weight management for obesity or overweight. According to public information from JIUYUAN GENE, JY54 Injection is a long-acting insulin analog developed independently by the company. Natural insulin is secreted by pancreatic cells and plays a role in regulating blood glucose and energy metabolism. JY54 Injection mimics the mechanism of natural insulin, binds to insulin receptors, inhibits glucagon secretion, delays gastric emptying, reduces appetite, and helps in blood sugar control and weight management. HANSOH PHARMA: HS-10522 Tablets Mechanism of action: undisclosed (chemical new drug) Indication: Primary aldosterone excess, uncontrolled hypertension HANSOH PHARMA's joint application for HS-10522 Tablets was approved for clinical trials, intended for the treatment of primary aldosterone excess and uncontrolled hypertension. According to the acceptance number, this is a new chemical drug. Johnson & Johnson: JNJ-79635322 Mechanism of action: Novel three-specificity antibody (targeting BCMA, GPRC5D, and CD3) Indication: Multiple myeloma Johnson & Johnson's application for JNJ-79635322 was approved for clinical trials, intended for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least three previous lines of treatment (including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody). Public information shows that JNJ-79635322 (JNJ-5322) is a novel next-generation three-specificity antibody with the ability to target two bone marrow antigens in a single molecule, containing novel B-cell maturation antigen (BCMA), G-protein-coupled receptor C class 5 member D (GPRC5D), and CD3 binding domains. JNJ-5322 binds to both BCMA and GPRC5D, improves affinity, and may enhance efficacy by overcoming clone heterogeneity and preventing antigen escape. Yinyili Pharmaceuticals: YL-18319 Tablets Mechanism of action: Novel PARG inhibitor Indication: Solid tumors Yinyili Pharmaceuticals' application for YL-18319 Tablets was approved for clinical trials, intended for the treatment of solid tumors. Public information shows that YL-18319 is an orally administered small molecule chemical innovative drug developed jointly by Yinyili Pharmaceuticals and Azkarra Therapeutics. It is a novel poly ADP-ribose glycosidase (PARG) inhibitor that selectively kills tumor cells with specific DNA damage repair defects by a synthetic lethal mechanism. Preclinical studies have shown significant inhibitory effects of YL-18319 on the growth of various cancer cells, including breast cancer, ovarian cancer, lung cancer, pancreatic cancer, prostate cancer, endometrial cancer, gastric cancer, colorectal cancer, etc., and it can achieve tumor regression in various cancer models with BRCA mutations, homologous recombination defects (HRD), and resistance to PARP inhibitors. ZAI LAB: Injection ZL-6201 Mechanism of action: ADC targeting LRRC15 Indication: Sarcoma and selected epithelial tumors ZAI LAB's application for Injection ZL-6201 was approved for clinical trials, intended for the treatment of sarcomas and selected epithelial tumors. Public information shows that ZL-6201 is an ADC targeting LRRC15 intended for the treatment of various solid tumors. Leucine-rich repeat protein 15 (LRRC15) is a type I transmembrane protein that is overexpressed in cancer-associated fibroblasts in various stromal tumors (such as sarcomas, glioblastomas, and melanomas) and many other types of tumors, making it an attractive cancer treatment target. Renfu Pharmaceutical: RFUS-188 Injection Mechanism of action: undisclosed (chemical new drug) Indication: Treatment for acute pain Renfu Pharmaceutical's application for RFUS-188 Injection was approved for clinical trials, intended for the treatment of acute pain. According to the acceptance number, this is a new chemical drug. DuoXi Bio: Injection DEC003M Mechanism of action: ADC new drug (specific target undisclosed) Indication: Advanced prostate cancer DuoXi Bio's application for Injection DEC003M was approved for clinical trials, intended for the treatment of advanced prostate cancer. Public information shows that this is a new ADC drug. 3SBIO: SSS68 Injection Mechanism of action: Dual-specific targeting APRIL/BAFF pathway Indication: IgA nephropathy (IgAN), lupus nephritis (LN), primary membranous nephropathy (pMN) 3SBIO's application for SSS68 Injection was approved for clinical trials, intended for the treatment of IgA nephropathy, lupus nephritis, and primary membranous nephropathy. Public information shows that this is an innovative dual-specific antibody drug targeting the APRIL/BAFF pathway for the treatment of autoimmune kidney diseases. SSS68 is an innovative tetravalent dual-specific antibody developed by 3SBIO using an internal antibody discovery platform, which can specifically bind and neutralize both BAFF and APRIL, thus inhibiting B cell activation, proliferation, differentiation, and plasma cell survival from the source, reducing the production of autoantibodies, and achieving comprehensive, efficient, and precise regulation of pathways related to autoimmune diseases. Jiangsu Hengrui Pharmaceuticals: SHR-3079 Injection Mechanism of action: undisclosed (biological new drug) Indication: Intended for the treatment of B-cell non-Hodgkin's lymphoma Jiangsu Hengrui Pharmaceuticals' application for SHR-3079 Injection was approved for clinical trials, intended for the treatment of B-cell non-Hodgkin's lymphoma. According to the acceptance number, this is a new biological drug. Jiangsu Hengrui Pharmaceuticals: Injection SHR-5421 Mechanism of action: undisclosed (biological new drug) Indication: Multiple myeloma Jiangsu Hengrui Pharmaceuticals' application for Injection SHR-5421 was approved for clinical trials, intended for the treatment of multiple myeloma. According to the acceptance number, this is a new biological drug. Xianwei Medicine: Injection SIM0613 Mechanism of action: Novel ADC targeting LRRC15 Indication: Local advanced/metastatic solid tumors Xianwei Medicine's application for Injection SIM0613 was approved for clinical trials, intended for the treatment of local advanced/metastatic solid tumors. Public information shows that SIM0613 is a novel ADC targeting LRRC15, which, upon binding to LRRC15, enters the tumor cells through endocytosis, releases cytotoxic payloads, kills tumor cells, and minimally affects normal cells. SIM0613 is designed to infiltrate tumors and tumor-associated fibroblasts, exhibiting significant antitumor activity in various preclinical in vivo models. In December 2025, SIMCERE PHARMA reached an exclusive global licensing agreement with Ipsen, a French company, for the entire rights of this product outside the Greater China region. Baixios: Injection BXOS116 Mechanism of action: Peptide drug Indication: Treatment for acute ischemic stroke Baixios' application for Injection BXOS116 was approved for clinical trials, intended for the treatment of acute ischemic stroke. Public information shows that this is a peptide drug for the regeneration of neurovascular units in the acute phase of stroke. 89bio: Pegozafermin Injection Mechanism of action: FGF21 analog Indication: MASH 89bio's application for Pegozafermin Injection was approved for clinical trials, intended for the treatment of metabolic associated fatty liver disease (MASH) with liver fibrosis, as well as for compensated cirrhosis due to metabolic associated fatty liver disease (MASH). Public information shows that Pegozafermin is an FGF21 analog. FGF21 is an endogenous metabolic hormone that regulates energy expenditure, glucose, and lipid metabolism. By using 89bio's glycosylated pegylation technology, Pegozafermin extends the half-life of natural FGF21 and optimizes its biological activity. In September 2025, Roche announced its acquisition of 89bio for approximately $2.4 billion and acquired the in-development therapy pegozafermin in Phase 3 clinical trials. We look forward to these investigational drugs progressing smoothly in clinical development and bringing new treatment options to patients soon. This article is reproduced from the WeChat public account "Medical Observations." GMTEight Editor: Feng Qiuyi.