Fosun Kite's Axicabtagene Ciloleucel and GSK's GSK3228836 Granted CDE Breakthrough Therapy Designation

On August 9, according to the latest announcement on the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration, Fosun Kite's Axicabtagene Ciloleucel Injection and GSK's GSK3228836 Injection were simultaneously proposed for inclusion in the Breakthrough Therapy Drug List.

Screenshot from CDE

Axicabtagene Ciloleucel Injection

Proposed Indication：Relapsed or refractory indolent non-Hodgkin lymphoma following second-line or subsequent systemic therapy, including follicular lymphoma (FL) and marginal zone lymphoma (MZL)

Company: Fosun Kite

Screenshot from CDE

Axicabtagene ciloleucel injection is an autologous CAR-T cell therapy product targeting CD19, introduced by Fosun Kite from Kite Pharma, a subsidiary of Gilead Sciences, under the Yescarta technology license, and authorized for localized production in China. Under the agreement, Fosun Kite holds the commercialization rights for the product in China, including Hong Kong and Macau. Yescarta is an anti-CD19 CAR-T cell therapy that, through genetic engineering, modifies autologous T cells to express molecules targeting the B-cell tumor antigen CD19, thereby mediating tumor cell killing via activated T cells. It is indicated for the treatment of refractory or relapsed large B-cell lymphoma and non-Hodgkin lymphoma.

Notably, in June this year, axicabtagene ciloleucel injection was officially approved by the National Medical Products Administration for marketing in China,For the treatment of adult patients with relapsed or refractory large B-cell lymphoma, including the treatment of diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma, becoming the first CAR-T product approved for marketing in China.

In addition to its indication for relapsed or refractory large B-cell lymphoma, Fosun Kite announced that it has received clinical trial approval in China for the development of axicabtagene ciloleucel for non-Hodgkin lymphoma, which will become its second approved indication in China.

GSK3228836 Injection

Proposed Indication：Chronic Hepatitis B

Company:GSK

Screenshot from CDE

GSK3228836 is an antisense oligonucleotide drug co-developed by GSK and Ionis Pharmaceuticals,Aims to achieve a functional cure for chronic hepatitis B by inhibiting viral replication and viral proteins.. Among them, antisense oligonucleotides, as single-stranded nucleic acid polymers, can modulate gene expression through multiple mechanisms. In hepatitis B virus (HBV)-infected livers, GSK3228836 specifically recognizes the viral mRNA used to synthesize viral antigens (disease-causing proteins), and by recruiting endogenous hepatic enzymes, degrades the viral mRNA, thereby reducing the levels of the viral protein HBsAg.

According to published data from GSK, GSK3228836 has demonstrated positive results in a Phase 2a clinical trial for patients with chronic hepatitis B. Among patients receiving a 300 mg dose of GSK3228836, hepatitis B surface antigen (HBsAg) levels decreased in both previously nucleotide analog (NA)-treated and NA-naïve patient groups.

To date, hepatitis B virus (HBV) infection remains the most common severe liver infection worldwide. While existing nucleotide/nucleoside analogue (NUCs) antiviral therapies can suppress HBV replication, they require patients to take medication for life. However, based on the results of the global Phase 2a clinical trial of GSK3228836, the drug demonstrates potential in inhibiting the hepatitis B virus and holds promise for achieving a "functional cure" for hepatitis B.