Orient Securities: In Vivo CAR-T Field Gains Momentum with Multiple Domestic Pipelines Expected to Drive BD Prospects and Valuation Upside This Year

Stock News
04/22

Orient Securities has released a research report stating that Eli Lilly's recent acquisition of Kelonia, following its purchase of Orna in February, fully validates the strategic value and commercial potential of in vivo CAR-T as a next-generation cell therapy technology. Both mainstream technological pathways are considered significant for development, with multinational corporations showing increasing attention and investment. This year, multiple domestic pipelines are expected to report initial clinical data intensively. Positive data, combined with validated platforms possessing differentiated advantages, could lead to business development expectations and valuation increases. The main points of Orient Securities' view are as follows:

On April 20, Eli Lilly announced the acquisition of in vivo CAR-T company Kelonia Therapeutics. The total transaction value is up to $7 billion, including a $325 million upfront payment and subsequent milestone payments. The deal is expected to be completed in the second half of 2026. This substantial acquisition further confirms the growing strategic importance global giants place on in vivo CAR-T technology.

Complementing the lentiviral vector pathway, Eli Lilly has achieved comprehensive coverage. Kelonia's core technology is its in vivo gene placement system (iGPS). Its in vivo gene delivery technology utilizes advanced modifications to the envelope of lentiviral vector particles to enhance in vivo gene transduction efficiency and employs targeting molecules to promote tissue-specific delivery. In February, Eli Lilly acquired Orna Therapeutics for a total of $2.4 billion. Orna primarily uses LNP carrier technology to develop in vivo CAR-T therapies. Thus, within two months, Eli Lilly has comprehensively positioned itself across the two main technological pathways of in vivo CAR-T through two major acquisitions.

Positive data for KLN-1010 shows prominent safety advantages. Kelonia's core pipeline, KLN-1010, is an in vivo CAR-T therapy using lentiviral vector transduction, which generates anti-BCMA CAR-T cells within the patient's body. The vector's envelope contains a modified Vesicular Stomatitis Virus (VSV) glycoprotein fusion protein and an anti-CD3 scFv, enabling the virus to enter cells via CD3 on the T-cell surface. Phase I clinical results presented at ASH 2025 showed that among four R/R MM patients treated with KLN-1010, the Objective Response Rate (ORR) and MRD negativity rate both reached 100%. Furthermore, no instances of ICANS or Grade 3 or above Cytokine Release Syndrome (CRS) occurred, indicating a safety profile significantly superior to EsoBiotec's same-target product ESO-T01, which AstraZeneca previously acquired for $1 billion.

The field is heating up, presenting a catalytic window for domestic pipelines. According to incomplete statistics, since the beginning of 2025, there have been over 10 transactions in the in vivo CAR-T field, with multinational corporations involved in 8 of them (including 6 acquisitions), indicating extremely high attention. This recent transaction significantly sets a new record for total deal value. Currently, among the four leading overseas in vivo CAR-T companies in terms of clinical progress, all except Umoja have been acquired by multinational corporations, significantly increasing the scarcity of global in vivo CAR-T targets.

Beyond the leading group, most clinical-stage in vivo CAR-T pipelines are domestic. This year, multiple domestic pipelines are expected to disclose clinical data for the first time. Orient Securities believes that if the clinical data are positive and the platforms are validated with differentiated competitive advantages, these pipelines could encounter business development opportunities.

Risk warnings include the potential for innovative drug研发失败, intensifying market competition, and risks associated with the commercialization of innovative drugs.

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