Keyi Pharmaceuticals Secures $2.135 Billion Global Licensing Deal for First-in-Class Dual-Target BCMA/CD19 CAR-T Therapy KQ-2003

On July 22, 2025, Novatim entered into an exclusive overseas licensing agreement with U.S.-based biopharmaceutical company ERIGEN LLC, granting ERIGEN global rights outside of Greater China for KQ-2003, the world’s first dual-targeted CAR-T cell therapy product with enhanced parallel targeting (targeting BCMA/CD19).

According to the agreement, Novatim will receive a near-term development milestone payment of 15 million US dollars and is eligible to receiveUp toUSD 1.32 billion in R&D, registration, and commercialization milestone payments, and based on net salesHighest$800 Million in Sales Revenue。

Novatim retains the full rights to this universal product in Greater China, laying the foundation for subsequent co-development and regional commercialization. This collaboration is not only a significant milestone in the internationalization of China's innovative drugs but also marks a crucial step forward in the journey of dual-target CAR-T therapy toward conquering multiple myeloma.

The core value of KQ-2003 lies in itsWorld's First Dual-Target Parallel Design. Unlike traditional single-target CAR-T, it can simultaneously target two key antigens, BCMA (B-cell maturation antigen) and CD19. Through a parallel structural design and signal domain optimization, this product significantly enhances the performance of CAR-T cells.Persistence and Antitumor Activity, while reducing the common risk of relapse after traditional CAR-T treatment. This design directly addresses the pain point of multiple myeloma treatment—disease recurrence caused by tumor cell antigen escape.

Data presented at the 2024 ASH Annual Meeting included 23 patients, of which 5 had no hematological indicators, and the remaining 18 evaluable patients achieved an ORR of 100%. However, sCR/CR was observed in 14 cases (77.8%), and VGPR in 4 cases (22.2%). The 12-month PFS rate of KQ-2003 was 75.3%, higher than that of similar products.

The field of CAR-T therapy for multiple myeloma is highly competitive. In June 2023, IASO Biotherapeutics' fully human BCMA CAR-T therapy, Equecabtagene Autoleucel, was approved for marketing in China. It achieved an overall response rate of 96% in 103 patients, with 74.3% reaching stringent complete response. In January 2025, the product also submitted a marketing application in Singapore.

Novatim's KQ-2003, as a dual-target product, is expected to address the recurrence issue after single-target treatment. At the 2024 ASH Annual Meeting, CARsgen Therapeutics announced the publication of its product, Cilta-cel.® CR rate is71.6%. RootAccording to the PharmaCube database, in the global BCMA/CD19 dual-target CAR-T development pipeline, KQ-2003 ranks third, just behind a similar product from Gracell Biotechnologies, a subsidiary of AstraZeneca.

Novatim PassesPhased Revenue ModelSignificantly reduced R&D risks — a recent payment of $15 million ensures the continuity of R&D investment, while$1.32 Billion in Milestone Payments and $800 Million in Sales RoyaltiesThe combination maximizes long-term value, totaling $2.135 billion (approximately 15.372 billion RMB).

In terms of regional division, the agreement adoptsPrecise Regional Differentiation Authorization StrategyERIGEN obtains global rights outside Greater China, while Novatim retains the rights in Greater China. This model is gradually becoming a trend in recent international cooperation of China's innovative pharmaceutical companies.

One clause in the agreement that is easily overlooked but holds significant strategic value is: ERIGEN's acquisitionUseKQ-2003 Key Patent Structure and Sequence Development for "Universal CAR-T Cell Therapy" RightsIf the development of off-the-shelf products is successful, the cost can be reduced to100,000Dollar/Course of treatment(Traditional CAR-T costs $400,000), significantly improving accessibility. This arrangement opens the door for Novatim to enter the cutting-edge field of off-the-shelf cell therapy, allowing it to share in the future technological benefits without having to independently invest in high-risk platform development.

Novatim is a biopharmaceutical company focused on the research and development of innovative drugs for cancer immunotherapy and autoimmune diseases, relying onThree Core Technology Platforms——IRAE bispecific antibody platform, TPEBEN nano-bispecific ADC platform, and K2 CAR-T platform (enhanced dual-target CAR-T), building a differentiated product pipeline covering multiple therapeutic areas such as oncology and autoimmune diseases.

R&D Pipeline (Excerpt from the official website)

1. Enhanced Dual-TargetCAR-T Platform: Overcoming the Challenge of Blood Tumor Recurrence

Core Products:KQ-2003 (BCMA/CD19 Dual-Target CAR-T)

· Technological Breakthrough: Adopting the world's firstParallel Structure Dual-Target Design, Synchronous TargetingBCMA and CD19 antigens, with enhanced T cell persistence through signal domain optimization, reducing the risk of relapse caused by tumor antigen escape.

· Clinical Progress：

o POEMS Syndrome: Pivotal clinical trials are ongoing, as the world's first for this indication.CAR-T Therapy.

o Systemic Lupus Erythematosus with Lupus Nephritis (SLE-LN）: In the preclinical research stage.

Other pipelines

· KQ-2002 (CD19/CD22 Dual-Target CAR-T)：Accepted by CDE for IND in August 2024, intended for the treatment of high-grade B-cell lymphoma.

· RD27 (BCMA/GPRC5D Dual-Target CAR-T): Preclinical stage, expanding multiple myeloma target combinations。

II.IRAE Bispecific Antibody Platform: Activating Immune Response in Solid Tumors

Core Products:KY-0118 (PD-1/Mutant IL-2 Fusion Protein)

· Mechanism Innovation: The fastest progressing in ChinaOne of the βγ-biased PD-1/IL-2 fusion proteins。

· R&D Progress：

o Monotherapy: Chinese ClinicalPhase Ⅰb (Advanced Solid Tumors), U.S. IND Approved.

o Combination Therapy: AndPD-L1 monoclonal antibody (Atezolizumab) combination in Phase I trial to explore synergistic potential.

· Global Status: The R&D progress ranks second globally, only behind Roche's similar product.。

3.TPEBEN Nano Bispecific ADC Platform: Breaking Through the Bottleneck of Targeted Delivery in Solid Tumors

Core Products:KY-0301 (c-MET/EGFR Nano Bispecific ADC)

· Technical Highlights：

o The World's First Nano Bispecific Antibody to Enter Clinical TrialsOne of the ADCs。

o Technological Breakthrough：DAR4 (Drug-to-Antibody Ratio) purity reaches 98% (the highest in the industry), significantly reducing the risk of off-target toxicity.

· Preclinical Data：

o InTumor establishment in 4 CDX models and 2 PDX modelsComplete regression, drug delivery capability of traditional bispecific antibodiesTwice that of ADC.

o Toxicology data surpasses similar products, with outstanding safety advantages.

· Clinical Progress：

o December 2024: FDA IND Approval Obtained(United StatesPhase Ⅰ), China IND approval is imminent.

Although Novatim is not yet listed, its financial strategy can be analyzed through industry benchmarks and transaction structures.Cash Flow ReserveDependent on the $15 million upfront payment from KQ-2003, which is higher than the average upfront payment in the cell therapy field in 2023 ($12 million, McKinsey white paper), it is sufficient to support the recent pipeline advancement.Light-Asset Operation ModelIts core strategy is to transfer the high-cost global development risks through overseas licensing. Novatim's phased revenue model, a light-asset approach, significantly reduces cash flow pressure, allowing financial room for the clinical advancement of KY-0118 and the nano-ADC.

The treatment field for multiple myeloma has become a red ocean, with domestic competitors including Legend Biotech's BCMA CAR-T, IASO Biotherapeutics' Equecabtagene Autoleucel, and Novatim's Saikaze®.

There are still many challenges in clinical, regulatory, and cost aspects: The dual-target design of Novatim's KQ-2003 theoretically addresses the recurrence issue caused by antigen escape, but Phase III large-scale trials are required to verify the sustainability of the early 100% remission rate (current data originates from investigator-initiated trials). According to the 2024 FDA "Cell Therapy Guidelines," regulatory recommendations suggest that dual-target products provide a scientific basis for target contribution, though it is not a mandatory requirement. The median out-of-pocket cost for CAR-T therapy patients is $180,000 (commercial insurance typically covers 90%+, but Medicare only covers 65%).

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