According to information compiled from the official website of China's Center for Drug Evaluation (CDE) and public sources, 14 Class 1 innovative drugs received their first clinical trial approval in China during the week of April 27 to May 2. These products encompass a variety of modalities, including small molecules, peptides, antibodies, and antibody-drug conjugates (ADCs).

CF Pharmtech (02652): ICF004 Inhalation Powder Mechanism of Action: Undisclosed Indication: Interstitial Lung Disease CF Pharmtech's ICF004 inhalation powder has been approved for clinical trials, intended for the treatment of interstitial lung disease. According to the company's press release, ICF004 is being developed for Progressive Fibrosing Interstitial Lung Disease (PF-ILD), a category that includes severe, life-threatening conditions such as Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). The drug is designed as an inhalation powder to deliver the medication directly to the affected areas of the lungs, aiming to enhance local exposure while minimizing systemic exposure, thereby optimizing the balance between efficacy and safety. ICF004 is positioned as a candidate combining mechanistic exploration with formulation innovation, with ongoing research focused on fibrosis-related pathological processes, including inflammation, oxidative stress, and fibroblast activation.

Jiuyuan Gene Engineering: JY54 Injection Mechanism of Action: Long-acting Amylin Analog Indication: Weight Management for Obesity or Overweight Jiuyuan Gene Engineering's JY54 injection has received clinical trial approval for weight management in individuals with obesity or who are overweight. JY54 is a long-acting amylin analog developed by the company. Natural amylin is secreted by pancreatic beta cells and works with insulin to regulate blood glucose and energy metabolism. JY54 mimics the mechanism of natural amylin by binding to amylin receptors, exerting multiple biological effects such as inhibiting glucagon secretion, delaying gastric emptying, and reducing appetite, thereby aiding in blood glucose control and weight management.

Hansoh Pharma: HS-10522 Tablets Mechanism of Action: Undisclosed (New Chemical Entity) Indication: Primary Aldosteronism, Uncontrolled Hypertension HS-10522 tablets, jointly declared by Hansoh Pharma, have been approved for clinical trials for the treatment of primary aldosteronism and uncontrolled hypertension. Based on the application number, this is a new chemical entity.

Johnson & Johnson: JNJ-79635322 Mechanism of Action: Next-Generation Trispecific Antibody (targeting BCMA, GPRC5D, and CD3) Indication: Multiple Myeloma Johnson & Johnson's JNJ-79635322 has been approved for clinical trials. It is intended for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Public information indicates that JNJ-79635322 (JNJ-5322) is a novel, next-generation trispecific antibody capable of targeting two myeloma antigens with a single molecule. It contains binding domains for B-cell maturation antigen (BCMA), G protein-coupled receptor class C group 5 member D (GPRC5D), and CD3. By simultaneously binding to both BCMA and GPRC5D, JNJ-5322 increases binding affinity and may enhance efficacy by overcoming clonal heterogeneity and preventing antigen escape.

Yingli Pharma: YL-18319 Tablets Mechanism of Action: Novel PARG Inhibitor Indication: Solid Tumors Yingli Pharma's YL-18319 tablets have been approved for clinical trials for the treatment of solid tumors. YL-18319 is an oral small-molecule chemical drug co-developed by Yingli Pharma and Akarra Therapeutics. It is a novel poly(ADP-ribose) glycohydrolase (PARG) inhibitor that selectively kills tumor cells with specific DNA damage repair defects via a synthetic lethality mechanism. Preclinical studies show that YL-18319 significantly inhibits the growth of various cancer cells, including breast, ovarian, lung, pancreatic, prostate, endometrial, gastric, and colorectal cancers. It has demonstrated tumor regression in various cancer models, including those with BRCA mutations, homologous recombination deficiency (HRD), and resistance to PARP inhibitors.

Zai Lab: ZL-6201 for Injection Mechanism of Action: ADC targeting LRRC15 Indication: Sarcoma and Selected Epithelial-derived Solid Tumors Zai Lab's ZL-6201 for injection has been approved for clinical trials for the treatment of sarcoma and selected epithelial-derived solid tumors. ZL-6201 is an antibody-drug conjugate (ADC) targeting Leucine Rich Repeat Containing 15 (LRRC15), intended for various solid tumors. LRRC15 is a type I transmembrane protein overexpressed in various mesenchymal tumors (such as sarcoma, glioblastoma, and melanoma) and in cancer-associated fibroblasts of many other tumor types, making it an attractive therapeutic target.

Humanwell Healthcare: RFUS-188 Injection Mechanism of Action: Undisclosed (New Chemical Entity) Indication: Treatment of Acute Pain Humanwell Healthcare's RFUS-188 injection has been approved for clinical trials for the treatment of acute pain. Based on the application number, this is a new chemical entity.

Duoxi Biotech: DEC003M for Injection Mechanism of Action: ADC (specific target undisclosed) Indication: Advanced Prostate Cancer Duoxi Biotech's DEC003M for injection has been approved for clinical trials for the treatment of advanced prostate cancer. Public information indicates this is a new ADC drug.

3SBio: SSS68 Injection Mechanism of Action: Bispecific Antibody targeting the APRIL/BAFF pathway Indication: Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Primary Membranous Nephropathy (pMN) 3SBio's SSS68 injection has been approved for clinical trials for the treatment of Immunoglobulin A Nephropathy, Lupus Nephritis, and Primary Membranous Nephropathy. This is an innovative long-acting bispecific antibody drug targeting the APRIL/BAFF pathway for the treatment of autoimmune kidney diseases. SSS68 is an innovative tetravalent bispecific antibody developed using 3SBio's internal antibody discovery platform. It can simultaneously and specifically bind to and neutralize the two key cytokines BAFF and APRIL. By inhibiting B-cell activation, proliferation, differentiation, and plasma cell survival at the source, it reduces the production of autoantibodies, enabling comprehensive, efficient, and precise regulation of the relevant autoimmune disease pathways.

Hengrui Pharma (01276): SHR-3079 Injection Mechanism of Action: Undisclosed (New Biological Product) Indication: Intended for the treatment of B-cell Non-Hodgkin Lymphoma Hengrui Pharma's SHR-3079 injection has been approved for clinical trials for the treatment of B-cell Non-Hodgkin Lymphoma. Based on the application number, this is a new biological product.

Hengrui Pharma: SHR-5421 for Injection Mechanism of Action: Undisclosed (New Biological Product) Indication: Multiple Myeloma Hengrui Pharma's SHR-5421 for injection has been approved for clinical trials for the treatment of multiple myeloma. Based on the application number, this is a new biological product.

Sciwind Biosciences: SIM0613 for Injection Mechanism of Action: Novel ADC targeting LRRC15 Indication: Locally Advanced/Metastatic Solid Tumors Sciwind Biosciences' SIM0613 for injection has been approved for clinical trials for the treatment of locally advanced or metastatic solid tumors. SIM0613 is a novel ADC targeting LRRC15. After binding to LRRC15, it is internalized into tumor cells, releasing a cytotoxic payload to kill the tumor cells while having minimal impact on normal cells. SIM0613 is specially designed to penetrate deeply into tumors and tumor-associated fibroblasts, demonstrating significant anti-tumor activity in various preclinical in vivo models.

Biosigh: BXOS116 for Injection Mechanism of Action: Peptide Drug Indication: Treatment of Acute Ischemic Stroke Biosigh's BXOS116 for injection has been approved for clinical trials for the treatment of acute ischemic stroke. Public information indicates this is a peptide drug for neurovascular unit regeneration in the acute phase of stroke.

89bio: Pegozafermin Injection Mechanism of Action: FGF21 Analog Indication: MASH 89bio's Pegozafermin injection has been approved for clinical trials for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH) with liver fibrosis, as well as compensated cirrhosis due to MASH. Pegozafermin is an analog of Fibroblast Growth Factor 21 (FGF21). FGF21 is an endogenous metabolic hormone that regulates energy expenditure, glucose, and lipid metabolism. Pegozafermin utilizes 89bio's GlycoPEGylation technology to extend the half-life of natural FGF21 and optimize its biological activity.

There is anticipation for the successful progression of these investigational drugs through subsequent clinical development stages, hoping they will soon provide new treatment options for patients.