SinoBiocar Accelerates Domestic In Vivo CAR-T Development with First Patient Dosed in SNC116 Trial and Dual-Track Strategy Combining Lentiviral and Circular RNA Platforms

Recently,Simnova announced that its self-developed targetedCD19 in vivo CAR-T Product (SNC116) Officially Launches Clinical Research at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with the First Patient Successfully Enrolled`, is expected to provide more convenient and accessible disruptive treatment options for patients with hematologic malignancies.`

Simnova was founded inIn 2019, dedicated to bringing innovative cell therapy products to oncology and autoimmune patients,ItsSelf-developed universal off-the-shelfThe CAR-NK and BiTE CAR-T technology platforms are both in the clinical development stage. Simnova was originally a subsidiary of Simcere and was spun off into an independently operated company in 2021., itsResearch centers are located in Shanghai, China, and Boston, USA.

Figure 1:Simnova's R&D Pipeline

With a virus vector platform that has independent intellectual property rights,AndLong-term in lentivirus modification andWith the technical沉淀 in the CMC field, Simnova has launched a new generation of in vivo CAR-T therapy. This technology employs a T-cell-specific promoter and transfection system, akin to“Precision Guidance”, ensureCAR gene is expressed efficiently and specifically in vivo. The next-generation dual-target design aims to enhance the clearance of target cells, pursuing deeper therapeutic effects.Moreover, itsThe first-mover advantage in process development and scale production is significant.

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In addition to the self-developed lentiviral vector approach in vivoCAR-T（SNC116）ExternalSimnovaAlsoActively enhance its technical strength and pipeline breadth through international cooperation：

• January 2023，Simnova andOrna Therapeutics, lnc. Reaches Cooperation Agreement:Simnova is responsible for the development and commercialization in China (including Hong Kong, Macao, and Taiwan) of Orna's in vivo cell therapy products utilizing its breakthrough circular mRNA technology (oRNA) in the field of oncology., including Orna's most advanced anti-CD19 in situ chimeric antigen receptor T-cell technology (isCAR) project, named“ORN-101”。

• January 2025,In order toMake full use of both parties in the circularLeading advantages in RNA (oRNA®) technology and cell therapy fields,These two companiesAnnounce further expansion of strategic cooperation,OfficiallyBCMA (B-cell Maturation Antigen) Listed as a Designated Biological Target, Jointly Advancing the Development and Application of In Vivo CAR-T TherapyAccording to the agreement, Simnova will be responsible for the research and development and commercialization of the BCMA-targeted panCar cell therapy in vivo in China (including Hong Kong, Macao, and Taiwan), while Orna will retain all rights to research and development and commercialization in other regions globally.

This“Self-developed+Cooperation”The dual-track strategy for Simnova in the rapidly developing in vivoA differentiated competitive advantage has been established in the CAR-T field.

In recent years, in vivoCAR-T has become a breakthrough in the biopharmaceutical industry because it can fundamentally address the pain points of traditional CAR-T.“A strategic location". According to incomplete statistics, globally there are over 20 pipelines in preclinical or early clinical stages:

• Overseas Aspect，Umoja、MyeloidWait for enterprises in the bodyDeeply Cultivated in the CAR-T Field, and LikeAstellas,AstraZeneca, AbbVie, Gilead,BMSMultinational pharmaceutical companies have joined through acquisitions or collaborations.Layout this track；

• In China, except for Simnova,Legend Biotech, Everest Medicines、Jiyin BioCompanies such as Simcere are also accelerating the advancement of in vivoCAR-T Pipeline, Formation“Contending for Dominance”The competitive landscape.

Table 1: Global10 Products Entering Clinical StageIn vivoCAR-TUnder ResearchPipeline

Currently, in vivoThe mainstream technology routes of CAR-T are divided into two categories: lentiviral vectors and LNP-mRNA. Lentiviral vectors have obvious advantages in terms of expression durability and clinical validation, while LNP-mRNA shows greater potential in safety and production flexibility. The field of in vivo CAR-T is currently in a stage of rapid development, with both technologies continuously being optimized. In the future, appropriate technology routes may be selected based on indications and clinical needs.

In general,As an important evolutionary direction in the field of cell therapy, in vivoCAR-T is moving from the laboratory to clinical applications, gradually achieving“Scalability and Accessibility”The Vision. SimnovaThe clinical initiation of SNC116 not only marks a key milestone for the company itself but will also accelerate the development of China's in vivo CAR-T industry, allowing more patients to benefit from this disruptive technology.

References:

[1] Simnova Initiates Clinical Trials for Innovative In Vivo CAR-T Therapy, Enrolls First Patient. Simnova. October 24, 2025.

[2] Pharma Valley Observation | In Vivo CAR-T Gains Momentum, Domestic and Overseas Companies Collaborate. Zhangjiang Pharma Valley. June 6, 2025.

[3] In Vivo CAR-T Therapy: Technological Evolution and Regulatory Pathway Prospects. Innoforce Marketing. October 17, 2025.

[4] Where is the in vivo CAR-T race heading? bioSeedin. October 13, 2025.

[5] In Vivo CAR-T Becomes MNC "Battlefield". Amino Observation. October 13, 2025.

[6] SimnovaOfficial website, etc..