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About

What We Do

Shaping the Future of Biopharmaceuticals

Fortvita Biologics was founded with a clear purpose: to expand the reach of innovative biologics with the goal of addressing critical health needs around the world. Building on a strong legacy of scientific achievement and therapeutic innovation, Fortvita was established to bring advanced treatments to patients beyond its origins in China.

With expertise in oncology and plans to expand into cardiovascular and metabolic medicine, autoimmune diseases, and ophthalmology, Fortvita aims to contribute meaningful solutions to the healthcare needs of today. This global mission reflects a commitment to making groundbreaking science accessible and improving health outcomes for all.

Our Mission

Transforming research breakthroughs into therapeutic excellence

We’re a biopharma company based in the San Francisco Bay Area with a global presence, specializing in antibody discovery and engineering. Our clinical trials span Australia, China, and the U.S., showing promising efficacy in treating challenging cancers, including lung, pancreatic, and gastroesophageal cancers. Driven by a commitment to improving patient outcomes, we focus on delivering targeted solutions that aim to improve the lives of patients and their communities.

Our Story

Where we’ve been and where we’re going

Fortvita Biologics builds on a strong foundation of biopharmaceutical innovation and success in China, where a pioneering approach to drug development and commercialization helped accelerate access to advanced therapies. Now expanding onto the global stage, Fortvita is leveraging that experience to develop next-generation biologics through a growing portfolio of clinical trials. With established R&D capabilities, strategic partnerships, and scalable manufacturing, Fortvita is focused on delivering transformative medicines to patients worldwide.

Core Capabilities

Antibody Innovation

Currently focused on oncology, with plans to expand into cardiovascular and metabolic and autoimmune treatment areas

End-to-end R&D from target discovery to global clinical trials

Global Clinical Trials

Team of 100 leading scientists with international expertise

Integrated platforms for preclinical screening and clinical development

Innovation for Drug Development

Strategic partnerships expanding our reach and enhancing our ability to investigate novel therapeutics worldwide

AI-driven molecular design accelerating next-generation drug candidates

R&D Pipeline

Advancing Next-Generation Immunotherapies

Flagship Oncology Programs:

FT363: a bispecific antibody targeting PD-1 and IL-2 in non-small cell lung cancer, melanoma, and colorectal cancer

FT343: a TOPO1-inhibitor and claudin 18.2-targeting ADC in pancreatic and gastric cancers

FT3009: a DLL3-targeted ADC in small cell lung cancer and other neuroendocrine tumors

FT389: a bispecific antibody targeting CLDN18.2 and CD3 in pancreatic and gastroesophageal tumors

Expanding pipeline

While oncology remains a core focus, Fortvita is broadening its pipeline to address unmet needs in autoimmune diseases and metabolic disorders. Several early-stage clinical candidates are currently in development across these therapeutic areas.

Strategic collaboration driving global impact

In December 2024, Fortvita became a key collaborator in a landmark partnership with Roche to co-develop IBI3009, a novel DLL3-targeting antibody-drug conjugate for advanced small cell lung cancer. Leveraging a strong foundation in oncology biologics and cross-border development capabilities, Fortvita is contributing to early-stage clinical development, while Roche leads global commercialization. With IND clearances in both the U.S. and China, this alliance reflects Fortvita’s strategic focus on accelerating globally impactful therapies.

Vision & Commitment

Guided by the vision of creating greater health through innovation, Fortvita is committed to:

Technological Breakthroughs

Advancing ADC targeting efficiency and precision gene-editing technologies.


Clinical Acceleration

Implementing a dual BLA/NDA submission strategy in China and the U.S. to expedite regulatory approvals.


Global Network Expansion

Strengthening open innovation partnerships with pharmaceutical leaders and academic institutions.

Leadership

Our leadership team combines deep scientific and operational expertise with a bold vision to transform antibody therapeutics.

Hui Zhou, MD, PhD

President

Raj Dhodda, PhD

Head of Regulatory Affairs

David M. Cohan, MD/FACS

Vice President, Global Oncology Clinical Development

Robert J. Pelham, PhD

Executive Director and Head of Clinical Biomarkers and Companion Diagnostics

William Liu, MD

Head of Clinical Operations

Fred Medick, JD

General Counsel

Michael Zhang, PhD

Head of IT & Data Sciences

Leah Tong

Head of Fortvita US Office