CD Biopharma

What CD Biopharma does

CD Biopharma (legally CD (Suzhou) Biopharma Co., Ltd. / 乘典(苏州)生物医药有限公司) is a privately held, clinical-stage biotechnology company founded in April 2021 in Suzhou, China, with a co-located research presence in Beijing. The company develops next-generation immunotherapies for oncology, with stated pipeline extensions into viral infections and autoimmune diseases. Its core technology is a proprietary Bispecific Fusion Protein (BsFP) platform combining anti-PD-1 antibodies with engineered cytokines — most notably an IL-21 mutant — to selectively expand tumor-reactive CD8+ T cells while blocking PD-1 immunosuppressive signaling. The BsFP platform comprises three sub-technologies: ImmuX for antibody-cytokine discovery and dual-target drug construction; FusionX for computer-aided molecular design and affinity/stability optimization; and IME Cell, which engineers CAR-T cells (CD19-, BCMA-, HER2-directed) to secrete PD-1Ab/IL-21 fusion proteins in vivo.

The lead clinical asset, CD-001, is a PD-1/IL-21 bi-targeting fusion protein that received FDA IND clearance in September 2024 and NMPA IND approval for solid tumors in December 2024, with first patient dosed in January 2025 at Tianjin Medical University Cancer Institute & Hospital and WuXi Clinical acting as CRO. NMPA subsequently cleared CD-001 for hematologic malignancy trials in March 2025. IIT-generated clinical evidence in the CAR-T program includes 100% complete remission (10/10) in relapsed/refractory B-cell lymphoma patients treated with PD-1Ab21-CD19CAR-T, including patients with prior allogeneic transplant failure and CNS involvement, plus a 3-year sustained remission in the first lymphoma patient treated.

The company's business model is licensing- and royalty-oriented at the platform and program level, targeting eventual out-licensing of the BsFP platform and CD-001 to pharmaceutical partners and co-development arrangements; the company is explicitly pre-revenue with no disclosed commercial products. The go-to-market motion today is enterprise/B2B partnership development led by CEO Dr. Jian Xu, conducted via scientific conferences (AACR, Bio International), peer-reviewed publications, and direct investor outreach rather than traditional sales channels. Capital has come from Proximal Ventures (比邻星创投) as sole disclosed investor across three rounds (2021 seed, 2023 pre-A, 2024 pre-A+), and a November 2025 strategic partnership with UK-based BioCorteX was added for solid tumor co-development using Carbon Mirror computational technology.

Name

CD Biopharma

Legal name

CD (Suzhou) Biopharma Co., Ltd.

Website

https://cdbiopharma.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

CD Biopharma is a Suzhou-based, clinical-stage Chinese biotech founded in 2021 that develops next-generation PD-1/IL-21 bispecific fusion protein immunotherapies for solid tumors and hematologic malignancies, with lead asset CD-001 in Phase I trials under both FDA and NMPA IND clearances.

Ownership category

akta.pro rank

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical R&D and Licensing: Pre-revenue clinical-stage biotech company. Revenue expected through out-licensing of proprietary BsFP platform technology and CD-001 program to pharmaceutical partners, co-development deals, and eventual product commercialization upon regulatory approval.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

CD Biopharma is a clinical-stage biotechnology company that develops novel tumor immunotherapy drugs based on its proprietary Bispecific Fusion Protein (BsFP) platform. Its lead candidate CD-001 is a PD-1/IL-21 bi-targeting fusion protein designed to selectively expand tumor-reactive CD8+ T cells while blocking PD-1 immunosuppressive signaling, and the company is also developing enhanced CAR-T cell therapies (PD-1Ab21-CAR-T) for hematologic malignancies and solid tumors.

Product overview

CD Biopharma is a clinical-stage biotech company developing next-generation immunotherapies through its proprietary Bispecific Fusion Protein (BsFP) platform. The core product, CD-001, is a novel PD-1/IL-21 fusion protein that blocks PD-1 immunosuppressive signaling while selectively expanding tumor-reactive CD8+ T cells. Supporting the BsFP platform are three key technologies: ImmuX for BsFP discovery and design, FusionX for BsFP optimization, and IME Cell for clinical feasibility exploration. The company also develops enhanced CAR-T cell therapies (PD-1Ab21-CAR-T) that secrete bispecific fusion proteins, including Anti-CD19 CAR-T and Anti-BCMA CAR-T programs.

Differentiator

Problem solved

Functional benefit

Products and services

• CD-001 CD-001 is a novel IL-21 fusion protein combining PD-1 blockade with engineered IL-21 mutant, designed to target PD-1 positive CD8+ T cells. It selectively expands tumor-reactive CD8+ T cells while blocking PD-1 immunosuppressive signaling to enhance immunotherapy efficacy. CD-001 has received IND approvals from both FDA and NMPA for solid tumors, with additional NMPA approval for hematologic malignancies. First patient was dosed in January 2025.
• Bispecific Fusion Protein (BsFP) Platform Proprietary technology platform enabling the development of bispecific fusion proteins by combining antibodies with cytokines for dual targeting and immune modulation. The platform comprises three core technologies: ImmuX for discovery and design, FusionX for optimization, and IME Cell for clinical feasibility.
• PD-1Ab21-CAR-T Enhanced CAR-T cell therapy that secretes PD-1 antibody and IL-21 fusion protein (PD-1Ab21), designed to block PD-1 immunosuppressive signaling on CAR-T cells, promote CAR-T proliferation, and activate the patient's endogenous anti-tumor immune response. Demonstrated 100% complete remission in 10 patients with relapsed/refractory B-cell malignancies.
• Anti-BCMA CAR-T CAR-T cell therapy targeting BCMA antigen, enhanced with PD-1Ab21 fusion protein secretion for treatment of multiple myeloma. Developed using IME Cell technology platform.
• Anti-CD19 CAR-T CAR-T cell therapy targeting CD19 antigen, enhanced with PD-1Ab21 fusion protein secretion capability for treatment of CD19-positive hematologic malignancies including B-cell lymphomas and leukemias. Requires approximately 1/10 the cell dose of commercialized CD19CAR-T products.

Quantifiable outcome

• 100% complete remission rate in 10 patients with relapsed/refractory B-cell malignancies treated with PD-1Ab21-CD19CAR-T
• +3 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core and major.

• BioCorteXcoreStrategic or Co-development Partner · 11 November 2025Strategic partnership announced November 11, 2025 to jointly develop next-generation immunotherapy drugs for solid tumors. Combines CD Biopharma's BsFP platform and CD-001 with BioCorteX's Carbon Mirror technology for computational drug development. BioCorteX, a UK-based biotech backed by Draper and Sofinnova, brings expertise in clinical translation and de-risking drug development across geographies. CD-001 already has regulatory approvals and ongoing clinical trials.
• WuXi ClinicalmajorImplementation/ SI/ Consulting PartnerContract research organization (CRO) partner for CD-001-CT101 Phase I clinical trial at Tianjin Medical University Cancer Institute & Hospital. WuXi Clinical demonstrated exceptional operational efficiency, completing process from project establishment to site activation within 30 days.
• Tianjin Medical University Cancer Institute & HospitalcoreStrategic or Co-development PartnerLead clinical trial site for CD-001 Phase I first-in-human study for solid tumors. Principal Investigator Professor Jihui Hao (President) and Professor Jun Yu (Director of Pancreatic Center and Clinical Trial Office) provide scientific expertise and implementation assurance. The study was officially initiated January 2, 2025.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Akeso, Inc. Chinese clinical-stage biotech developing novel bispecific antibodies for oncology immunotherapy (e.g., cadonilimab, PD-1/VEGF). Directly comparable to CD Biopharma as a Chinese bispecific immuno-oncology developer pursuing novel antibody-based mechanisms, though at a more advanced clinical stage.
• Fosun Kite Biotechnology: Shanghai-based joint venture between Fosun Pharma and Gilead's Kite Pharma developing and commercializing CAR-T therapies in China (axicabtagene ciloleucel). Comparable to CD Biopharma in Chinese CAR-T cell therapy development but backed by major multinational pharma with commercial-stage capabilities.
• JW Therapeutics: Hong Kong-listed Chinese cell therapy company commercializing CAR-T products including Carteyva (relmacabtagene autoleucel) for lymphoma. Directly comparable to CD Biopharma as a Chinese CAR-T developer with overlapping hematologic malignancy focus, but at commercial stage versus CD Biopharma's IIT/Phase I.
• Carsgen Therapeutics: Hong Kong-listed Chinese CAR-T developer with multiple autologous CAR-T programs targeting BCMA, CD19, and Claudin18.2 across solid tumors and hematologic malignancies. Comparable to CD Biopharma as a China-based CAR-T platform company with similar target portfolio (BCMA, CD19) and overlapping indications.

Broad incumbents

• BeiGene: Global oncology biotech with approved PD-1 inhibitor tislelizumab and broad hematology portfolio (zanubrutinib). Comparable to CD Biopharma in PD-1 immuno-oncology focus but operates globally with multiple approved products and a substantially larger pipeline.
• Innovent Biologics: Hong Kong-listed Chinese biotech with multiple approved biologics including PD-1 inhibitor sintilimab (Tyvyt) and a broad oncology pipeline. Comparable to CD Biopharma in PD-1-based immunotherapy development but at significantly larger scale and commercial stage.
• Junshi Biosciences: Shanghai-listed Chinese biopharma with the first approved Chinese PD-1 antibody (toripalimab) and an extensive oncology pipeline including bispecifics. Comparable to CD Biopharma in PD-1/immuno-oncology focus but operates as a broader, more advanced incumbent with commercial products.

Emerging players

• Genor Biopharma: Hong Kong-listed Chinese biotech developing immuno-oncology biologics including monoclonal and bispecific antibodies. Comparable to CD Biopharma as a China-headquartered emerging immuno-oncology developer with similar stage and Chinese market focus.
• Harbour BioMed: Clinical-stage biopharma with heavy focus on immuno-oncology, including antibody-based therapies targeting tumor microenvironment. Comparable to CD Biopharma as a China-rooted immuno-oncology developer with similar clinical-stage profile and antibody-engineering approach.
• Elpiscience Biopharmaceuticals: Chinese clinical-stage immunotherapy biotech developing bispecifics and antibody-cytokine fusion proteins for oncology. Highly comparable to CD Biopharma as a China-based developer of next-generation immuno-oncology biologics using bispecific/cytokine modalities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cd-biopharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds1 record

Investors1 record

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CD Biopharma