Novatim and VRise enter exclusive licensing agreement for dual-target CAR-T therapy KQ-2003 in India

September 27, 2025, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. ("Novatim") today announced a strategic collaboration with U.S. biopharmaceutical company VRise Therapeutics ("VRise"). Under the agreement, Novatim grants VRise the exclusive rights to develop, register, and commercialize KQ-2003—the world's first parallel-enhanced dual-targeting CAR-T cell therapy product (targeting BCMA/CD19) independently developed by Novatim—in India.

Pursuant to the agreement, Novatim will receive an upfront payment, and is eligible to receive development, regulatory, and commercial milestone payments. Additionally, Novatim is eligible to receive tiered royalties ranging from high-single-digit to low-double-digit percentages based on annual net sales of KQ-2003 in the licensed territory of India.

Since the introduction of the first Chimeric Antigen Receptor T-cell (CAR-T) therapy product, Kymriah (tisagenlecleucel), in 2017, CAR-T therapy has achieved breakthroughs in the field of hematologic malignancies. However, traditional single-target CAR-T therapies often face challenges such as high relapse rates and insufficient durability of response. Taking multiple myeloma (MM) as an example, although BCMA-targeted CAR-T therapies demonstrate very high initial response rates, most patients still relapse within 1–2 years, with limited long-term cure rates.

Novatim's KQ-2003 is designed to simultaneously target two antigens strongly associated with the pathogenesis and progression of multiple myeloma: BCMA (B-cell maturation antigen) and CD19. Furthermore, leveraging its parallel-enhanced design with optimized signaling domains and a parallel structure, KQ-2003 maintains potent tumor-killing efficacy while significantly enhancing T-cell persistence, thereby reducing the risk of relapse.

According to publicly disclosed company information and clinical trial registry data, KQ-2003 has initiated or submitted registration/clinical studies for relapsed/refractory multiple myeloma (rrMM) and POEMS syndrome. In investigator-initiated trials (IIT) conducted to date, KQ-2003 has demonstrated a 100% Objective Response Rate (ORR) in patients with relapsed/refractory multiple myeloma, indicating promising therapeutic efficacy.

Founded in 2018, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. is a biotechnology company focused on innovative immuno-oncology drugs and clinical translation. Centered on unmet clinical needs and differentiated R&D, Novatim has built three core technology platforms: a bi-functional antibody platform, a nanobody bispecific ADC platform, and an enhanced dual-target CAR-T platform, with over ten internally discovered, potentially FIC/BIC programs. Representative assets include China’s first βγ-biased PD-1/IL-2 fusion protein, the world’s first nanobody bispecific ADC, and a parallel enhanced dual-target CAR-T.

In addition to the licensed KQ-2003, Novatim is advancing its ADC pipeline. KY-0301 received U.S. FDA clinical trial approval in December 2024 and obtained implicit approval from China's National Medical Products Administration (NMPA) in January 2025, achieving simultaneous submissions and approvals in both China and the United States. In the biologics domain, KY-0118 (a biased IL-2 bifunctional fusion protein targeting PD-1) has entered the clinical stage and is exploring combination strategies with PD-L1 monoclonal antibodies.

Overview of Novatim's Pipeline

Meanwhile, VRise Therapeutics, the partner for the KQ-2003 licensing agreement in India, is an innovation-driven biotechnology company founded in 2021, committed to bringing breakthrough therapies to cancer patients. The management team at VRise possesses extensive experience in the discovery, clinical development, and commercialization of multiple First-in-Class (FIC) oncology drugs. Its Scientific Advisory Board comprises leading authorities in the field of oncology. Leveraging an international collaboration network, the company is advancing global research, development, and clinical programs.

For an innovative biopharmaceutical company that has not yet gone public, R&D investment often significantly outpaces revenue growth. Novatim's frequent licensing activities over the past two years reflect the company's strategic balancing of funding needs and global development objectives.

Since 2025, Novatim has granted regional rights for KQ-2003 to multiple international partners: Erigen holds rights for all global markets except Greater China, India, Turkey, and Russia, while VRise holds exclusive rights for the Indian market. This partitioned licensing model not only enables rapid access to upfront and milestone payments, alleviating financial pressure from R&D, but also leverages partners' local clinical and market resources to reduce barriers to entry in unfamiliar markets.

Deeper underlying rationale involves risk hedging. Compared to a one-time global licensing agreement, partitioning rights by region allows the company to retain autonomy in key markets while exploring diverse clinical and commercial pathways across different regions.

From a global perspective, licensing collaborations for CAR-T therapies have become an industry trend. Against this backdrop, Chinese companies have also been active in international licensing within the CAR-T field. For instance, AstraZeneca acquired China-based Gracell Biotechnologies for up to $1.2 billion, with the transaction completed in February 2024, gaining access to its dual-target CAR-T therapy GC012F. In November 2024, Roche announced the acquisition of U.S.-based Poseida Therapeutics for up to $1.5 billion, further expanding its non-viral CAR-T therapy portfolio.

From a macro perspective, this case reflects two pathways for Chinese innovative biopharmaceutical companies going global: first, achieving differentiated technological innovation to overcome the limitations of traditional therapies; second, adopting flexible licensing strategies to strike a balance between capital and market demands. Novatim is advancing both pathways simultaneously and accelerating their implementation through frequent licensing collaborations.

For investment institutions and industry observers, whether KQ-2003 can achieve successful commercialization first in India will serve as a key indicator for validating both its technological merits and business model.