Zhangjiang Pharma Valley's CGT Industry: From Pioneering CAR-T Approvals to Global Firsts in Solid Tumor and Gene Therapy

Jul 03, 2026 21:16 CST Updated 21:16

Fosun Kairos

Developer of Tumor Immune Cell Therapy Technologies and Products

June 22, 2021Fosun KairosThe axicabtagene ciloleucel injection (brand name: Yikaida®) developed by the company has been approved for market launch, becoming China’s first approved CAR-T cell therapy product. This marks a historic breakthrough from “0” to “1” in China’s cell therapy field, officially ushering in the inaugural year of CAR-T therapy in China.

June 22, 2026Legend BiotechThe self-developed Shu Rui Ji Ao Lun Sai Injection (brand name: Kailimei®) has been approved for marketing, indicated for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma that is CLDN18.2-positive, HER2-negative, and has failed at least two prior lines of therapy. This marks the world’s first CAR-T cell therapy product approved for solid tumors.

Cell Therapy: Diversification of Technologies,Breakthroughs from Hematologic Malignancies to Solid Tumors

(Image source: Fosun Kairos)

As China’s first CAR-T cell therapy product, Yikaida® has treated over 1,500 patients with relapsed/refractory lymphoma since its market launch. More than 200 high-standard Yikaida® treatment centers have been established across 29 provinces (autonomous regions and municipalities) in China, enabling patients to access high-quality CAR-T therapy services locally.

In June 2023, Yikaida® received approval for a new indication, making it available for the treatment of adult patients with large B-cell lymphoma who are refractory to first-line immunochemotherapy or who relapse within 12 months after completing first-line immunochemotherapy. Gao Tianyou (pseudonym), an 18-year-old who was diagnosed with diffuse large B-cell lymphoma (DLBCL) after his college entrance examination, became one of the beneficiaries.

(Image source: Fosun Kairos)

Currently, Yikaida®’s third indication (relapsed or refractory indolent non-Hodgkin lymphoma) is in the bridging clinical trial phase in China and has been included in the Breakthrough Therapy Designation program by the Center for Drug Evaluation of the National Medical Products Administration.

While expanding indications and significantly improving the convenience of medical care for patients,Fosun KairosThe company is also committed to improving drug accessibility by innovatively launching a pay-for-performance model and simultaneously working to include its products in the national commercial insurance formulary.

Compared with hematologic malignancies, solid tumors represent a “hard nut to crack” for CAR-T therapy due to the scarcity of specific targets, tumor barriers that hinder infiltration, and an immunosuppressive microenvironment. Given the substantial R&D challenges, the vast majority of global CAR-T pipelines for solid tumors remain in early-stage development.

CARsgen TherapeuticsGlobally pioneered the identification and validation of Claudin18.2 as a CAR-T therapy target for solid tumors, with nearly a decade of dedicated research, achieving a groundbreaking leap from "0 to 1."

(Image source: Shanghai Science and Technology)

The First Approval for Solid Tumor CAR-T Therapy Grants Carsgen Therapeutics Entry into a New Phase of Exploration. Currently, Carsgen is attempting to shift the timing of treatment earlier, moving from patients with gastric cancer who have failed second-line therapy to earlier stages. Their goal is transitioning from “life-saving in late-stage disease” to “curative intent in early-stage disease,” while simultaneously seizing opportunities presented by technological upgrades and iterations to bring hope for recovery to more patients.

The leadership of Zhangjiang Pharma Valley is not only reflected in a single track, but also inin vivo CAR-T, Treg, TIL and other cutting-edge cell therapies are also extensively developed.

?In the field of in vivo CAR-T,Weitao BiotechGT801 Demonstrates Rapid and Efficient In Vivo CAR-T Cell Generation. GT801 utilizes lipid nanoparticle (LNP) delivery technology targeting T cells to achieve T-cell transfection in patients, enabling the in vivo generation of CD19 CAR-expressing CAR-T cells without the need for ex vivo cell manufacturing or lymphodepleting preconditioning.

Origin BiologicsThe independently developed dual-target in vivo CAR-T product has also initiated exploratory clinical studies, validating the technical potential of “off-the-shelf CAR-T.”

Yimufeng BiotechIMV102 demonstrated durable and significant anti-tumor activity in multiple myeloma models, providing a novel pathway to overcome the accessibility bottlenecks of traditional CAR-T therapies.

(Image source: Novabio Saierxin)

?In the field of regulatory T cells (Treg),Sai'erxin Biotechautologous polyclonal Treg cell injection, accepted by the NMPA on June 30, 2026, for the treatment of Huntington's disease. This marks another key advancement in the domestic layout of Treg cell therapy in the field of neurodegenerative diseases.

Gene Therapy: Comprehensive In Vivo and Ex Vivo Strategy to Compete Globally

In the field of gene therapy, enterprises in Pudong have also achieved comprehensive coverage, ranging from ex vivo to in vivo editing and from rare genetic disorders to common metabolic diseases.

(Image source: Wen Hui Bao)

Zhengxu BiologyThe base-editing drug CS-101 injection, developed based on the company’s proprietary transformer Base Editor (tBE), has successfully cured nearly twenty patients with β-thalassemia and sickle cell disease both in China and abroad. In April 2026, clinical results of Boao Biopharma’s ex vivo base-editing drug pipeline were published in the main journal of Nature, a top-tier international academic publication, demonstrating that the innovation and breakthroughs of China’s original gene-editing technology in clinical translation have gained international recognition.

For metabolic disorders such as persistent chylomicronemia and hypertriglyceridemia, Zhengxu Bio has developed an in vivo gene-editing therapeutic, CS-121 injection. As the world’s first base-editing drug targeting APOC3, CS-121 holds promise to deliver a transformative treatment option for patients with metabolic conditions including hyperlipidemia.

(Image source: Yaotang Biotechnology)

Yaotang BiotechnologyFocusing on in vivo gene editing, the company has six pipelines in clinical development, making it the company with the largest number of in vivo gene editing pipelines in clinical stages globally. Among them, YOLT-203 has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, becoming the first in vivo gene-editing therapy for primary hyperoxaluria type 1 (PH1) worldwide to receive this designation.

In March 2026, Phase I clinical data for YOLT-101, an in vivo base-editing therapy developed by Yaotang Biotechnology for the treatment of familial hypercholesterolemia, were published in Nature Medicine. At 24 weeks after a single intravenous infusion, PCSK9 levels decreased by an average of 74.4%, and low-density lipoprotein cholesterol (LDL-C) levels showed a sustained reduction of 52.3%. The treatment was generally well tolerated, with no serious adverse events reported. This marks the first in vivo base-editing therapy targeting PCSK9 to have its clinical data published as a peer-reviewed original article in a top-tier medical journal. Previously, the rights to YOLT-101 in China were licensed to Salubris Pharmaceutical for RMB 1.035 billion.

In May 2026, Yaotang Biotechnology completed its Series C financing round of nearly RMB 500 million.

VGR-R01 Mechanism of Action Diagram

(Image source: Tianze Yuntai official website)

Tianze YuntaiIt has three gene therapy pipelines nearing commercialization: the Phase III enrollment for VGN-R09b in the indication of AADC deficiency was completed in July 2025, the enrollment for VGR-R01 in the indication of crystalline retinal degeneration was completed during the same period, and the Phase I/II clinical trials for VGN-R09b in the indication of Parkinson’s disease have been completed.

In June 2026, the domestic marketing authorization application for the gene therapy product VGR-R01, submitted by Taichang Biology, a wholly-owned subsidiary of Tianze Yuntai, was accepted by the NMPA and included in the priority review and approval program. It is expected to be approved for marketing in China in 2027. VGR-R01 is the first therapeutic agent worldwide to enter the registrational clinical stage for Bietti crystalline dystrophy (BCD), and has received Orphan Drug Designation from the U.S. FDA and Priority Medicines (PRIME) designation from the European Medicines Agency.

Meanwhile, Tianze Yuntai’s application for an initial public offering (IPO) on the STAR Market was officially accepted by the Shanghai Stock Exchange on June 17, 2026, with a planned fundraising target of RMB 2.503 billion.

With the implementation of Decree No. 818, the Regulations on the Administration of Clinical Research and Clinical Translation Application of New Biomedical Technologies, and Decree No. 828, the Implementing Regulations of the Drug Administration Law of the People's Republic of China, the CGT industry has entered a fast track of development.As the earliest region in China to launch the CGT industry, Pudong has established a complete industrial ecosystem and leveraged institutional innovation to accelerate product commercialization. From piloting the Marketing Authorization Holder (MAH) system for drugs, to facilitating customs clearance for R&D materials via a “white list,” and currently advancing reforms in supplementary commercial medical insurance and researching management systems for the domestic transfer of imported production, a series of innovative measures have provided comprehensive empowerment for technological upgrading and achievement transformation, offering broad development space for cell therapy enterprises.

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