Bharat Biotech's Nucelion to Manufacture VeGen Bio's Dual-Target Myeloma CAR-T in Hyderabad, Targeting a 2028 Launch

Nucelion Therapeutics, the cell and gene therapy manufacturing subsidiary of Bharat Biotech, has signed on as the exclusive manufacturing partner for VL-2511, a dual-target CAR-T therapy for multiple myeloma being developed by Hyderabad-based VeGen Bio. The companies announced the partnership on October 21, 2026.

The deal is one of the first to put an Indian contract manufacturer behind a clinical-stage CAR-T therapy that did not originate in India. It also tests whether the country can make cell therapies at a price Indian patients can afford.

The therapy

According to the companies, as reported by Business Standard, Telangana Today and The News Mill, VL-2511 is a Phase II clinical-stage, first-in-class, dual BCMA/CD19 autologous CAR-T therapy for multiple myeloma.

In plain terms:

• Autologous means each dose is made from the patient's own T-cells. The cells are collected, genetically modified to carry a chimeric antigen receptor (CAR), expanded in a clean-room facility and infused back into the same patient.
• BCMA (B-cell maturation antigen) is the main target of the CAR-T therapies already approved for myeloma.
• Adding CD19 as a second target is meant to reach cell populations that BCMA-only products can miss. VeGen Bio reports promising clinical activity in patients with extramedullary disease, where myeloma spreads outside the bone marrow and is notoriously hard to treat.

The therapy has been in clinical development in China and is also being developed in the United States, according to the reports. Press coverage notes that VL-2511 has not yet been shown to work better than existing treatments, and the extramedullary claims still need to be checked against detailed published data.

What the deal covers

This is a manufacturing arrangement, not a marketing or distribution deal. Nucelion will provide:

• technology transfer of VeGen Bio's process,
• process development to adapt and scale it, and
• GMP manufacturing at its single-site facility in Genome Valley, Hyderabad, which the companies say is designed to meet CDSCO, US FDA and EMA standards.

The partners plan to take VL-2511 into Phase 1/2 clinical trials in India and are targeting commercialisation by 2028, subject to regulatory approvals. They have said the main aim is to cut production costs and make advanced cell therapy more accessible in India.

Raghu Malapaka, Nucelion's chief business officer, described Nucelion in Business Standard's report as one of India's first dedicated cell and gene therapy CRDMOs, and said the partnership builds the capacity India needs to bring these therapies to more patients. VeGen Bio was represented by its director, Prashant Bhavar.

Who Nucelion is

Bharat Biotech, best known for its vaccines, launched Nucelion in November 2025 as a wholly owned subsidiary and a contract research, development and manufacturing organisation (CRDMO) dedicated to cell and gene therapies. At launch it said its GMP facility could make plasmid DNA, viral and non-viral vectors, autologous and allogeneic cell therapies, and handle aseptic fill and finish.

Nucelion has said it runs with independent leadership, governance and information systems, and deals with every sponsor, Bharat Biotech included, on arm's-length commercial terms. The VeGen Bio contract is an early sign of that third-party business model at work.

Why manufacturing is the bottleneck

Most of the cost of CAR-T therapy comes from making it. Every patient's dose is a separate batch, made under strict sterile conditions with expensive viral vectors, reagents and quality testing. In the US and Europe the approved products are list-priced in the hundreds of thousands of dollars, which puts them out of reach for almost all Indian patients.

India has already shown that local production can bring costs down sharply. ImmunoACT, an IIT Bombay spin-out, won CDSCO approval for its CD19-directed NexCAR19 in 2023 at a fraction of Western prices, and other Indian groups such as Immuneel are working on the same problem. A dedicated CRDMO that can take in therapies developed elsewhere, make them to multi-regulator standards, and support Indian trials adds a missing piece to that ecosystem.

For Bharat Biotech, the move extends its manufacturing know-how from vaccines into a much more complex field. For Hyderabad's Genome Valley, it adds advanced-therapy capacity to a cluster built on vaccines and generic drugs.

What to watch

• Regulatory path in India: the timing and design of the Phase 1/2 study, and how CDSCO weighs the data generated in China.
• Tech-transfer success: autologous CAR-T processes are hard to move between sites. Comparable product quality at Nucelion will be the first real milestone.
• Pricing: no price has been indicated. Whether the partners can match or beat the price of India's existing CAR-T therapies will decide how many patients benefit.

Sources

• Business Standard — https://www.business-standard.com/companies/news/nucelion-vegen-bio-car-t-manufacturing-multiple-myeloma-126102100640_1.html
• Telangana Today — https://telanganatoday.com/bharat-biotech-arm-nucelion-partners-with-vegen-bio-on-car-t-therapy
• The News Mill — https://thenewsmill.com/2026/10/bharat-biotechs-nucelion-therapeutics-partners-with-vegen-bio-to-manufacture-dual-target-myeloma-car-t-therapy/
• NewsMeter — https://newsmeter.in/science-health/hyderabads-healthcare-sector-gets-a-boost-two-firms-partner-on-advanced-blood-cancer-therapy-777807
• GK Today — https://www.gktoday.in/nucelion-therapeutics-and-vegen-bio-partner-on-car-t-therapy/
• BioSpectrum India (Nucelion launch, 2025) — https://biospectrumindia.com/news/102/26866/bharat-biotech-launches-next-gen-cell-and-gene-therapy-crdmo-nucelion.html