Zhimeng Pharmaceutical ZM-H1505R tablets, Yilian Biotech's injection grade YL201, and Xinda Biotech's IBI343 were all included in the breakthrough treatment list on January 16th; On January 9th, the Ruiqiolon injection of WuXi AppTec was included in the list of breakthrough treatment varieties; Lepu Biotech's CG0070 injection is planned to be included in the list of breakthrough treatment varieties, with a public announcement period from January 14, 2025 to January 21, 2025.

 

 

 

ZM-H1505R of Zhimeng Pharmaceutical is a HBV nucleocapsid inhibitor, which can prevent the replication of hepatitis B virus and effectively block the formation of HBV cccDNA by interfering with the normal formation of viral nucleocapsid and blocking the packaging of pregenomic RNA (PgRNA). The indication for breakthrough treatment included in this study is chronic hepatitis B.

 

 

 

It is reported that in November 2024, Zhimeng Pharmaceutical announced the mid-term clinical analysis results of ZM-H1505R in Phase IIa at the 2024 American College of Hepatology Annual Meeting (AASLD 2024). The results showed that ZM-H1505R had good overall tolerability with ETV adjuvant therapy and could effectively reduce HBV DNA to below 10 IU/mL. The combination of ZM-H1505R and ETV can enhance the virus inhibition effect.

 

 

 

YL201 for injection by Yilian Biotech is a B7-H3 ADC that utilizes Yilian Biotech's novel toxin linker platform technology (TMALIN) ®) Developed. The indications for breakthrough therapy included in this study are recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with PD - (L) 1 inhibitors and at least second-line chemotherapy. It is reported that there is currently no B7-H3 ADC approved for market worldwide, but three products have entered phase III clinical trials, namely from Ifinatamab deruxtecan, Hanson Pharmaceuticals (HS-20093), and YL201.

 

 

 

The IBI343 from Xinda Biotechnology is an ADC targeting CLDN18.2, utilizing fixed-point coupling technology with a DAR value of 4, exhibiting high stability and potent killing effects. The indications included in this breakthrough treatment are advanced pancreatic ductal adenocarcinoma (PDAC) with Claudin (CLDN) 18.2 positive expression that has received at least one systemic treatment. It is reported that currently there is no CLDN18.2 ADC approved for market worldwide. There are four models that have entered the Phase III clinical stage, namely IBI343 (Xinda Biotechnology), TPX-4589 (Lixin Biotechnology), SHR-A1904 (Hengrui Pharmaceutical), and CMG901 (Lepu Biotechnology).

 

 

 

WuXi AppTec injection is an autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product targeting CD19. It has been approved for three indications, including the treatment of r/rLBCL, relapsed or refractory follicular lymphoma (r/rFL), and relapsed or refractory mantle cell lymphoma (r/rMCL). The indication included in this breakthrough treatment is for second-line treatment of relapsed or refractory adult large B-cell lymphoma (r/rLBCL). This determination is based on efficacy and safety studies on adult r/rLBCL patients who are not suitable for autologous stem cell transplantation after first-line treatment failure, supported for the first time by clinical trial data from Chinese patients.

 

 

 

CG0070 from Lepu Biotechnology is an oncolytic virus immunotherapy with a dual mechanism of action. This therapy targets the Rb-E2F pathway and selectively replicates and lyses tumor cells in Rb regulated deficient tumor cells. Two encoding genes are embedded in CG0070: tumor selective promoter E2F-1 and human granulocyte macrophage colony-stimulating factor (GM-CSF) gene. The E2F-1 promoter ensures specific replication of the virus in tumor cells, while the GM-CSF gene can stimulate systemic anti-tumor immune responses. The indication to be included in the disruptive therapy this time is to treat high-risk patients with non muscle invasive bladder cancer (NMIBC) who do not respond to BCG.