Novatim Immune Therapeutics

What Novatim Immune Therapeutics does

Novatim Immune Therapeutics (Zhejiang) Co., Ltd. is a privately held Chinese biotechnology company founded in 2018 that develops first-in-class (FIC) and best-in-class (BIC) tumor immunotherapies across three modalities: bifunctional antibodies, nano bispecific ADCs, and dual-target CAR-T cell therapies. The company operates three proprietary technology platforms — IRAE (Inhibition Removal and Activation Enhancement) for bifunctional antibodies, TPEBEN (Tumor Penetration Enhancement By Engineered Nanobody) for nano bispecific ADCs with industry-leading ~98% DAR4 purity, and K2 for enhanced dual-target CAR-T. Its clinical pipeline includes KY-0118 (China's first βγ-biased PD1/IL2 fusion protein), KY-0301 (world's first nano bispecific cMET/EGFR ADC), KQ-2003 (BCMA/CD19 CAR-T and world's first CAR-T for POEMS syndrome), KQ-2002 (CD19/CD22 CAR-T), and earlier-stage assets KY-0601, KY-0901, and KQ-2512 (autoimmune). As of December 2024, Novatim had secured eight clinical trial approvals across China and the United States, and KQ-2003 had advanced to Phase II by 2026.

Novatim's business model rests on three revenue streams: (1) drug product sales expected post-approval in China; (2) upfront payments, development/regulatory/commercial milestones, and tiered royalties from ex-Greater China licensing partners — including Erigen LLC (KQ-2003, up to USD 2.12B), Radiance Biopharma (KY-0301, up to USD 1.165B), and VRise Therapeutics (KQ-2003 India) — totaling over USD 2.5 billion in aggregate disclosed deal value across 2025; and (3) contract research and technical services through regional testing centers in Shanghai, Anji, and Weifang, targeting over 200 million yuan in revenue. The company retains Greater China rights across its portfolio and pursues global development through MNC and biotech out-licensing, while operating an enterprise field sales motion anchored on licensing deals and a sales-led model for technical services to domestic pharma/biotech customers.

The company is headquartered in Shanghai with primary operations and a new GMP manufacturing base under construction in Anji County, Zhejiang Province (>50,000 sqm of facilities, with annual capacity for 2,000 CAR-T cases plus 40 batches each of antibody/ADC/lentiviral vector/plasmid products). Novatim is led by founder and Chairman Wu Guoxiang, with Chief Scientific Advisor Dianwen Ju (Fudan University professor), and is preparing for an IPO following the 2023 shareholding system reform and 2023 NASDAQ filing initiation.

Name

Novatim Immune Therapeutics

Legal name

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Website

https://en.novatim-zj.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

101–250 employees

Short description

Novatim Immune Therapeutics is a private Chinese biotechnology company developing first-in-class and best-in-class tumor immunotherapies — bifunctional antibodies, nano bispecific ADCs, and dual-target CAR-T cell therapies — out-licensed globally for ex-Greater China commercialization while retaining China rights.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

CAR-T & TCR-T Therapies (HLAAABAC)

akta.pro secondary industries

Bispecific & Multispecific Antibodies (HLAAAAAF), Cytokines, Interferons & Immunomodulatory Proteins (HLAAAAAC), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Tumor immunotherapy drugs
• Bispecific antibody platforms
• CAR-T cell therapy
• Antibody drug conjugates
• Oncology biologics

Headquarters

HQ city

Anji

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Drug product sales: Revenue from commercialization of novel oncology immunotherapy drugs (CAR-T, bispecific antibodies, ADCs) upon regulatory approval in China and global markets.
2. Licensing and milestone payments: Novatim receives upfront payments, development and regulatory milestone payments, and commercial milestone payments from global licensing partners. Deal values have exceeded USD 2.5 billion in aggregate across multiple partnerships (KQ-2003 with Erigen: up to USD 2.12B; KY-0301 with Radiance: up to USD 1.165B).
3. Royalty income: Tiered royalties based on annual net sales in licensed territories, from high single-digit to double-digit percentages (KQ-2003/India deal: high single-digit to double-digit royalties).
4. Technical services: Contract research and testing services provided to other pharmaceutical and biotech companies, including in vivo/vitro efficacy studies, toxicity and safety evaluation, FDA/NMPA filing support, and Phase I/II clinical trial services. The company has established testing centers in Shanghai, Anji (Zhejiang), and Weifang (Shandong). Target: over 200 million yuan in sales revenue.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Novatim Immune Therapeutics develops novel tumor immunotherapy drugs spanning three modalities: bifunctional antibodies (KY-0118 PD1/IL2 fusion protein), nano bispecific antibody-drug conjugates (KY-0301 cMET/EGFR ADC, KY-0601, KY-0901), and autologous CAR-T cell therapies (KQ-2003 BCMA/CD19, KQ-2002 CD19/CD22, KQ-2512). The pipeline targets relapsed/refractory hematological malignancies (rrMM, POEMS syndrome, B-ALL, B-NHL), advanced solid tumors, and autoimmune diseases. The company additionally operates a contract research and testing services business providing efficacy, toxicity, and clinical trial support to other pharmaceutical and biotech firms.

Product overview

Novatim Immune Therapeutics operates three core technology platforms: the IRAE Bifunctional Antibody Platform, the TPEBEN Nano Bispecific ADC Platform, and the K2 Enhanced Dual Target CAR-T Platform. The product portfolio includes macromolecular drugs (KY-0118 PD1/IL2 fusion protein, KY-0301 nano bispecific ADC, KY-0601 and KY-0901 ADCs) and CAR-T cell therapies (KQ-2003 BCMA/CD19 for rrMM and POEMS syndrome, KQ-2002 CD19/CD22 for B-cell malignancies, KQ-2512 for autoimmune diseases). The company develops first-in-class and best-in-class tumor immunotherapy drugs through its proprietary technology platforms.

Differentiator

Problem solved

Functional benefit

Products and services

• KY-0118 Injection China's first βγ-biased PD1/IL2 fusion protein for locally advanced or metastatic solid tumors. KY-0118 selectively delivers IL-2 to PD-1-positive T cells, preferentially activating tumor-specific T cells. Available in intravenous and subcutaneous formulations. Monotherapy showed 67% DCR and 33% ORR in the 64 μg/kg dose group, with 100% DCR in melanoma patients and only 4% Grade ≥3 drug-related TEAE rate.
• KY-0301 World's first nano bispecific ADC (cMET/EGFR BsNb-ADC) developed on the TPEBEN platform. Demonstrates superior tumor tissue penetration and drug delivery capacity (~2x traditional bispecific ADCs), achieves 98% DAR4 product purity, and showed complete tumor regression in CDX and PDX animal models. Targets lung cancer and head and neck cancer.
• KQ-2003 CAR-T Cell Therapy BCMA×CD19 parallel dual-target autologous CAR-T cell therapy (parallel architecture) developed on the K2 platform. World's first CAR-T for POEMS syndrome and first for rrMM with extramedullary involvement. Demonstrated 94.4% ORR with 77.8% CR in 18 evaluable rrMM patients, 100% ORR in CAR-T-naïve patients, longest PFS of 21 months, and no Grade ≥3 CRS. Indications include rrMM, POEMS syndrome, B-ALL, and B-NHL.
• KQ-2002 CAR-T Cell Therapy CD19×CD22 enhanced dual-target autologous CAR-T cell therapy for adult relapsed/refractory acute B lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL). Targets combined CD19 and CD22 antigens for comprehensive B-cell malignancy coverage.
• KY-0601 (double toxin) B7H3-cMET nanobispecific ADC with dual toxin payloads (first-in-class) at CMC stage. Targets colorectal cancer and esophageal cancer.
• KY-0901 (double toxin) Bispecific nanobody drug conjugate with dual payloads (first-in-class) at PCC stage. Targets pancreatic cancer, cholangiocarcinoma, and other advanced solid tumors.
• KQ-2512 BCMA×CD19 in vivo CAR-T cell therapy for autoimmune diseases including systemic lupus erythematosus (SLE), currently at PCC stage.
• Contract Research and Technical Services Contract research and testing services for domestic pharmaceutical and biotech companies, including in vivo/in vitro efficacy studies, toxicity and safety evaluation, FDA/NMPA filing support, and Phase I/II clinical trial services. Delivered through testing centers in Shanghai, Anji (Zhejiang), and Weifang (Shandong).

Quantifiable outcome

• KQ-2003 achieved 100% complete response (CR) rate in all 15 CAR-T-naïve efficacy evaluable patients across REDEEM-1 and POEMS-1 Phase 1 trials (rrMM and POEMS syndrome)
• +4 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core, major and supporting.

• VRise TherapeuticscoreOEM/ Whitelabel/ Licensing Partner · 28 September 2025Novatim signed an exclusive license agreement with VRise Therapeutics for KQ-2003 (parallel dual-target BCMA/CD19 CAR-T) in India. VRise plans to evaluate KQ-2003 in both oncology (rrMM) and autoimmune diseases (subject to regulatory approvals). Novatim receives upfront payment, development/regulatory/commercial milestones, and tiered royalties from high single-digit to double-digit percentages.
• Radiance BiopharmacoreOEM/ Whitelabel/ Licensing Partner · 3 September 2025Novatim granted Radiance Biopharma (Boston, MA) exclusive rights to develop, register, and commercialize KY-0301 — the world's first nanobody bispecific cMET/EGFR ADC — outside Greater China. Novatim receives USD 15 million upfront, up to USD 150 million in development/regulatory milestones, over USD 1 billion in commercial milestones, and tiered royalties on net sales. The asset is renamed RB-601 by Radiance.
• Erigen LLC (affiliate of Factor Bioscience)coreOEM/ Whitelabel/ Licensing Partner · 23 July 2025Novatim entered an exclusive global licensing agreement with Erigen LLC for KQ-2003 (first-in-class BCMA/CD19 dual-target CAR-T) excluding Greater China/India/Turkey/Russia. Deal terms: near-term USD 15 million development milestone, up to USD 1.32 billion in development/regulatory/commercial milestones, and up to USD 800 million in tiered sales-based royalties. Erigen also gains rights to use key patent structures for universal CAR-T development, with Novatim retaining full rights in Greater China.
• 3D Medicines (1244.HK)majorStrategic or Co-development Partner · 22 February 2024Novatim and 3D Medicines signed a strategic cooperation agreement to explore combination therapy of Novatim's KY-0118 (PD1-IL2 fusion protein) with 3D Medicines' Envidra (Envovalimab), the world's first approved subcutaneous PD-L1 inhibitor. In animal models, combination achieved 100% tumor regression vs. 69.2% for KY-0118 alone and 65.7% for PD-L1 alone. Parties also discussed potential cooperation on dual-target CAR-T product rights and global clinical trial research.
• Tigermed (Contract Research Organization)supportingImplementation/ SI/ Consulting PartnerTigermed, a contract research organization (CRO), supports Novatim's clinical trials as CRO partner for KQ-2003 Phase I/IIa studies at multiple clinical trial centers across China.

Scale indicators8 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Akeso: Akeso is a Chinese biotech known for cadonilimab (PD-1/VEGF bispecific) and a broad bispecific antibody pipeline, comparable to Novatim's IRAE bifunctional antibody platform and novel immuno-oncology pipeline.
• RemeGen: RemeGen is a Chinese ADC biotech with disitamab vedotin and a deep ADC pipeline, directly comparable to Novatim's TPEBEN nano bispecific ADC platform (KY-0301, KY-0601, KY-0901).
• Legend Biotech: Legend Biotech developed Carvykti (ciltacabtagene autoleucel), a BCMA-directed CAR-T partnered with Janssen, making it a direct cell therapy peer to Novatim's KQ-2003 BCMA/CD19 CAR-T program in multiple myeloma.
• Innovent Biologics: Innovent is a Chinese biotech with IBI363 (PD-1/IL-2α-biased), a near-direct competitor to Novatim's KY-0118 βγ-biased PD1/IL2 fusion protein, alongside a broader oncology bispecific pipeline.
• JW Therapeutics: JW Therapeutics is a leading Chinese CAR-T company with Carteyva (relmacabtagene autoleucel) approved for lymphoma, making it the most direct Chinese-market competitor in cell therapy commercialization and clinical development.
• Carsgen Therapeutics: Carsgen Therapeutics developed zevorcabtagene autoleucel, an approved Chinese BCMA CAR-T for multiple myeloma, making it a direct BCMA CAR-T competitor to Novatim's KQ-2003 in the China market.

Broad incumbents

• Roche: Roche pioneered the PD-1/IL-2v fusion protein class globally (benchmark for KY-0118) and operates one of the largest oncology biologics and bispecific antibody pipelines, serving as the benchmark incumbent in the same therapeutic space.
• Bristol-Myers Squibb: BMS markets Abecma (idecabtagene vicleucel), an approved BCMA CAR-T, alongside a broad immuno-oncology portfolio, making it the incumbent benchmark for the BCMA CAR-T market KQ-2003 targets.
• BeiGene: BeiGene is a large Chinese-listed biotech with a diversified oncology pipeline spanning antibodies, bispecifics, and ADCs, comparable as a broader incumbent Chinese oncology platform with similar modalities to Novatim's three platforms.
• Junshi Biosciences: Junshi Biosciences is a major Chinese immuno-oncology biotech with toripalimab (PD-1) and an emerging bispecific/ADC pipeline, comparable as a Chinese PD-1/IO incumbent that intersects with Novatim's PD-1/IL-2v and ADC strategies.

Market position

Strengths6 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/novatim-immune-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Novatim Immune Therapeutics