From Oncology to Autoimmunity: Nearly 30% of China's 30 NK/CAR-NK Companies Have Entered Clinical Trials

CAR-TCell Therapy andTILCell therapies have been successfully launched, but it can be seen that the pricing remains high.NKCell TherapyHas the potential to be developed into a universal cell therapy，With a great cost advantage, it is highly expected in the industry. Globally, the layoutNKSeveral companies in the cell therapy field have entered the clinical trial stage and published relevant clinical research results.

There are various ways to develop NK cell therapy, mainly including screening based on natural NK cells, gene editing of NK cells, and iPSC-CAR-NK, etc. Most companies in China are also laying out their strategies according to these three methods. Currently, there are 30 companies in China that have explicitly disclosed their NK/CAR-NK cell therapy projects.(If there are any omissions, please feel free to add them. The order is not ranked.)。

▲ NK/CAR-NK Companies Under Research in China (Source: MedMerck Collation)

Overall,An increasing number of companies have entered the clinical research stage., and some companies have already entered the IND sprint stage. In terms of indications, it is no longer limited to the field of oncology,Some companies have expanded their indications to the field of autoimmune diseases.; In terms of vectors, it can be seen that companies have chosen both viral and non-viral vectors; in terms of technology, companies have established their own technical platforms, incorporating technologies such as iPSC and gene editing.

In China, 2023 was a breakthrough year for the NK cell therapy track, moving from the preclinical stage to the clinical stage. Since 2024, multiple advancements have been announced, with expectations to maintain this momentum while exploring more possibilities.In April 2024, the Phase I clinical trial initiation meeting for IBR733, a CD33/CLL1 dual-target antibody-conjugated NK cell candidate product developed by Yingbai Rui for the treatment of acute myeloid leukemia, was successfully held at Zhongda Hospital affiliated with Southeast University. IBR733 is the world's first CAR-NK cell candidate product with dual targeting of CD33/CLL1 for the treatment of acute myeloid leukemia.

March 2024,Shanghai Jingshan Biotechnology Co., Ltd.The"GCK-01 Cell Injection" Obtains CDEClinical TrialImplicit approval has been granted to initiate a clinical trial for the treatment of relapsed or refractory follicular lymphoma. According to the disclosure, this is an off-the-shelf allogeneic peripheral blood-derived CAR-NK cell product targeting CD20.

2024February,SimnovaThe CD19-targeted CAR-NK has officially received the clinical trial approval from CDE, with the indication for moderate to severe refractory systemic lupus erythematosus (SLE). This marks the first off-the-shelf NK product approved for IND in China for SLE indication, and its clinical progress is expected to become a global leader. In March, Simnova...Simnova Announces Completion of RMB 200 Million Series A+ Financing.

January,Enkaice PharmaceuticalsSimnova's Non-Gene-Modified NK Cell Therapy NK010 Receives FDA ApprovalEntering the clinic,It is the first non-gene-modified allogeneic peripheral blood NK cell therapy in China to receive FDA approval.In the same month, the three clinical applications of Medton Pharmaceuticals' "PB103 Allogeneic Natural Killer (NK) Cell Formulation" were accepted by the CDE.

However, NK/CAR-NK cell therapy still faces many challenges. How can NK cells be rapidly expanded in large quantities? How can the persistence of NK cell therapy be enhanced? How can cytotoxic activation issues be overcome? What are the similarities and differences in the clinical development of NK cell therapy in China and abroad, and what insights do they offer?

To further address the bottlenecks currently facing the industry and promote common development.MedCareerWill be held onJune 14-15, 2024Held in Nanjing2024 IBI EXPO Biologics Innovation Conference`, and convene`"6th Symposium on Tumor Immunotherapy and Cell Therapy Technologies"`, Explore`"Progress in the Clinical Development of NK Cell Therapy"This hotly debated topic. This conference will invite pioneers and leaders in the field to focus on the latest research trends and advancements, and to deeply explore and forecast the future development trends of cell therapy.

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