Over 10 Domestic Innovative Drugs Enter Clinical Trials for the First Time, Led by He Yuan Bio, Dingcheng Peptide Source, Xiangxue Life Sciences, Everest Medicines, and BeiGene-Biotech

The following will introduceFor the first timeRepresentative Class 1 Innovative Drugs Approved/Submitted for Clinical Trials

Dingcheng Peptide Source, a holding company of Northeast Pharmaceutical, has received clinical approval for its DCTY0801 injection, which is being developed to treat recurrent or progressive high-grade glioma positive for EGFRvIII. DCTY0801 is a targetedEGFRvIIICAR-T targeting mutant antigens, the target EGFRvIII is only present in tumor cells and has a mutation rate of nearly30%. The clinical indications approved this time areHighly malignant and difficult-to-treat tumor subtypes in the central nervous system, PatientThe median survival time is often less than 1 year., Currently, there are still very limited immunotherapy drugs targeting this site. DCTY0801 was granted Orphan Drug Designation by the U.S. FDA in May 2023.

Juventas' self-developed HY001N cell injection IND application has been accepted, intended for the treatment of autoimmune hemolytic anemia that has failed at least three lines of therapy.（AIHA）Patient.

HY001N is the first candidate product developed on Juventas' innovative rapid preparation NexT technology platform, which is expected to reduce the production time of CAR-T cells in the workshop.Shortened from 6~8 days to within 2 days, Patient Waiting TimeReduce by 50%, which can reach 8-10 days, significantly reduces production costs based on existing preparation technologies. At the same time, the proportion of T naïve cells in the rapidly prepared CAR-T final product is increased to25%The above lays the foundation for its efficacy and safety.

Alphamab Oncology's JSKN022 for Injection Approved for Clinical Trials, Aiming to Develop Treatment for Advanced Solid Tumors. JSKN022 is a drug developed by Alphamab Oncology based on its glycosylation site-specific conjugation platform.World's First Dual-Target ADC, which can simultaneously recognize and bind to PD-L1 and αvβ6 integrin on the surface of tumor cells. After binding to either target, this ADC is internalized into lysosomes through target-mediated endocytosis. The cleavable linker is then broken down by proteolytic enzymes such as cathepsin B, releasing the cytotoxic topoisomerase I inhibitor at the designated site.（T01）, which can not only directly induce apoptosis in antigen-positive cells but also penetrate the cell membrane to trigger a bystander effect in antigen-negative cells, achieving a dual anti-tumor effect.

Lutetium [177Lu]-BL-ARC001 Injection Submitted by Belie Tianheng's Subsidiary(abbreviation: BL-ARC001)Approved for clinical use, intended to treat locally advanced or metastatic solid tumors, including but not limited to those that have failed standard treatment or are unable to receive standard treatment.

BL-ARC001 is a HIRE-ARC platform-based antibody radionuclide conjugate drug independently developed by Baili Tianheng.（ARC）The first Class I innovative drug in the field. Compared with traditional radiolabeled conjugates, BL-ARC001 utilizes antibody-mediated precise targeted delivery technology and the powerful tumoricidal capacity of radionuclides, offering significant advantages.Stronger target specificity, higher tumor enrichment, and expected to exhibit better anti-resistance properties.。

Preclinical data shows that JSKN022 has anti-tumor activity against tumor cells positive for integrin αvβ6 and/or PD-L1, with the potential to benefit PD-1/PD-L1.Cancer patients with inhibitor resistance or ineffective treatmentProvide a brand-new treatment option.

EVM14 Injection, submitted by Everest Medicines, has been approved for clinical trials. It is intended for the treatment of patients with squamous non-small cell lung cancer and squamous cell carcinoma of the head and neck. EVM14 is a drug that targets 5 tumor-associated antigens.（TAA) A universal off-the-shelf therapeutic cancer vaccine, which is also Everest Medicines' first mRNA therapeutic cancer vaccine approved in both China and the U.S. It is formulated by encapsulating mRNA encoding TAAs in a lipid system. The vaccine has several advantages, including no need for HLA screening, being readily available as an off-the-shelf product, lower production costs compared to personalized neoantigen vaccines, and applicability across multiple types of cancer.

In preclinical studies, EVM14 induced immunological memory and demonstrated the ability to effectively reduce tumor recurrence, offering the potential to help patients achieve the benefit of "long-term cancer-free survival."

HS_SW01 Cell Injection, a Class 1 new drug developed by Huishan Bio, has been approved for clinical trials for the treatment of ankylosing spondylitis. According to official information, HS_SW01 is a human umbilical cord MSC.

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New Product Trial Application

Event Time: September-October

Baolai Bio's Human Umbilical Cord Mesenchymal Stem Cell Injection Approved for Clinical Trials, Aiming to Treat Spontaneous Acute Supratentorial Intracerebral Hemorrhage. This disease, caused by acute intracerebral bleeding due to cerebrovascular pathology, ranks high in disability and mortality among cerebrovascular disorders.

Rongrui Pharmaceuticals' OVV-01 Injection has been approved for clinical trials, intended for the development of treatments for advanced solid tumors and advanced soft tissue sarcoma. Public information indicates that this is a recombinant vesicular stomatitis virus carrying the NY-ESO-1 TAA.（VSV）OVV-01 can specifically replicate in tumor cells, lyse tumor cells, and release various tumor antigens. It also expresses the highly immunogenic NY-ESO-1 antigen, modulates the tumor immune microenvironment, induces tumor-specific immune responses, promotes T cell activation, expansion, recruits infiltrating T cells, and regulates immunosuppression within the tumor to kill tumor cells.

Kadgene Bio's KDTV001 Injection Approved for Clinical Trials, Aiming to Treat High-Grade Squamous Intraepithelial Lesions of the Cervix Positive for HPV16 and/or HPV18 and/or HPV52（HSIL）. Public InformationDisplay,KDTV001 It is a therapeutic biologic product for active immunization against HPV based on a recombinant human adenovirus type 5 vector. Its mechanism of action involves stimulating robust cellular and humoral immune responses in the body to precisely target and eliminate cells infected with HPV16/18/52, thereby clearing the virus and reversing disease progression.

Mabwell's 7 MW4911 Injection Approved for Clinical Trials, Aiming to Develop Treatment for Advanced Solid Tumors. 7 MW4911 is a Cadherin-17 Targeted Drug.（CDH17）The ADC innovative drug adopts CDH17 high-specificity monoclonal antibody Mab0727, a novel cleavable linker, and a proprietary DNA topoisomerase I inhibitor MF-6 payload designed to overcome multidrug resistance mechanisms. Among these, MF-6 significantly enhances anti-tumor activity through excellent plasma stability, controllable drug release, and a potent bystander effect. Published in July this year inCell Reports Medicine The preclinical research results systematically confirmed that 7 MW4911 achieves tumor-selective cytotoxic payload release through CDH17-mediated efficient internalization.

HDM2017 for injection, filed by Sinopharm Huadong, has been approved for clinical trials and is under development for the treatment of advanced malignant solid tumors. HDM2017 is a CDH17-targeted ADC composed of a monoclonal antibody against CDH17 conjugated with a topoisomerase I inhibitor through a cleavable linker, with a DAR of 4.

For more IND progress of new drugs, please refer to the table.

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