Seven Innovative Drugs Receive First-in-Class IND Approvals or Submissions in China – CDE Weekly Update
Geek Gene
Developer of Immune Cell Therapy Products
November 11, 2025
eMedClub News
According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）According to incomplete statistics from the official website and publicly available information, last week(November 3 - November 9)Approximately 30 Class 1 innovative drugs received clinical trial approval/IND application acceptance, covering fields such as immune cells, stem cells, small nucleic acids, ADCs, and bispecific antibodies.
The following will introduce the first Class 1 innovative drugs approved for clinical trials/filed for clinical trials.
Yuekang Innovation, Tianlong Pharmaceutical:
Hepatitis B siRNA
Yuekang Sci-Tech Medicine and Liaoning Tianlong Pharmaceutical Co., Ltd. jointly submitted the YKYY013 injection for clinical approval, intended for the development of treatment for chronic hepatitis B virus infection. YKYY013 is a conjugated N-acetylgalactosamine.（GalNAc）Chemically synthesized double-stranded siRNA ligands effectively silence mRNA transcribed from the HBV genome through RNA interference, thereby inhibiting the production of hepatitis B pathogenic proteins, suppressing HBV replication, and creating conditions for host immune reconstitution, ultimately achieving functional cure of hepatitis B. Previously, YKYY013 has been approved for clinical trials by the U.S. FDA.
Suzhou Geek Gene Technology Co., Ltd.:
Autologous TRT
Suzhou Geek Gene Technology Co., Ltd.'s "GK01 Cell Injection" Approved for Clinical Trial, Intended Indication for Advanced Malignant Solid Tumors. GK01 is an autologous tumor-reactive T-cell product.（TRT）Therapy: By isolating infiltrating T cells from the patient's tumor tissue and utilizing Suzhou Geek Gene Technology Co., Ltd.'s self-developed cell fate reprogramming technology for in vitro functional optimization. This technology analyzes the aging and exhaustion mechanisms of T cells through single-cell multi-omics data, combined with artificial intelligence models, enabling T cells to regain a "youthful state" and significantly enhancing their tumor recognition and killing capabilities.
New Product Trial
6-well/24-well/100ml culture tank
Application for New Product Trial
Event Time: November
Wanchun Hongji Pharmaceutical, Renfu Likang Pharmaceutical:
RBM39-Targeting Molecular Glue Degrader
Wanchun Hongji Pharmaceutical and Renfu Likang Pharmaceutical's jointly submitted ST-01156 capsule has been approved for clinical trials, intended for development to treat advanced or metastatic malignant solid tumors. ST-01156 is aOral, Blood-Brain Barrier Penetrable RBM39-Targeted Molecular Glue DegraderBy specifically binding to the RBM39 protein and E3 ubiquitin ligase, it induces the ubiquitination and proteasomal degradation of RBM39. RBM39 is an important RNA splicing and transcriptional regulatory factor that is overexpressed in various cancers and is essential for the growth and survival of these cancer cells. Degradation of this protein can disrupt RNA processing and gene expression in tumor cells, thereby inhibiting tumor growth. Previously, ST-01156 has been approved by the FDA for clinical trials, intended for the treatment of advanced solid tumors and hematologic malignancies.
Taimirensheng Bio:
Autologous NK Cells
Taimrs Bio's IND Application for Autologous NK Cell Injection Accepted for Development of Malignant Solid Tumor Treatment. This therapy extracts NK cells from the patient’s own body, activates and expands them in vitro, and then infuses them back into the body, fundamentally avoiding the risk of immune rejection. The candidate product is produced and tested at a GMP-compliant production base. Taimrs Bio has established a "dual guarantee" of authoritative certification and commercial insurance, reaching a strategic cooperation with PICC to ensure every cell product with a standardized system.
Lilly:
ANGPTL3-Targeting siRNA
Lilly's Solbinsiran Injection IND Application Accepted. This injection is a GalNAc-conjugated siRNA targeting ANGPTL3. In March this year, a Phase II clinical study published in The Lancet on treating patients with mixed hyperlipidemia showed that, at day 180 of treatment, 400 mg of solbinsiran reduced apolipoprotein B.14.3%, while the other five lipid-related indicators — triglycerides, LDL-C, non-HDL-C, very low LDL-C, and HDL-C levels — were reduced respectively.50.3%、16.8%、25.5%、50.1%and16.4%, patients overall tolerance was good.
Biogen: ASO
BIIB115 Injection by Biogen（salanersen，ION306）IND Application Accepted. BIIB115 is an investigational antisense oligonucleotide.（ASO）, is currently conducting research on spinal muscular atrophy（SMA）Clinical research. It is conducted among SMA patients who have previously received gene therapy. Ⅰ Positive interim results from Phase I clinical study,Once a year administrationBoth the 40 mg and 80 mg dose groups showed good tolerability, and a significant reduction in neurodegeneration was confirmed by the decrease in neurofilament levels.
Crystal Core Biologics:
FAP-Targeted RDC
Crystal Core Biotech's Lutetium [177Lu]JH040182 Injection IND Application Accepted. This injection is a FAP-targeted(Fibroblast Activation Protein)Antibody-radionuclide conjugates（RDC）FAP is highly expressed in various tumor-associated fibroblasts and plays a critical role in the tumor microenvironment of solid tumors such as pancreatic cancer, breast cancer, and colorectal cancer.
For more IND progress of new drugs, please refer to the table.
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