Two Domestic CGT Therapies Accelerate Toward Market Launch with NDA Submissions

According to incomplete statistics from the CDE website and public information, from June 15 to 21, 2026, approximately 10 Class 1 innovative drugs were proposed for priority review or received implied clinical trial approval, covering novel TIL cell therapies, gene therapies, ADCs, bispecific/multispecific antibodies,PROTACs, radiopharmaceuticals, and other therapeutic areas. Among these, multiple candidates have entered clinical trials as “global first-in-class” or “China’s first,” including two CGT therapies."Sprint" to IPO。

The following are representative Class 1 innovative drugs with extensive public information:

Vitalgen’s Subsidiary’s Self-Developed Recombinant AAV Gene Therapy VGR-R01 Intravitreal Injection Proposed for Priority Review for the Treatment of Adult Crystalline Retinal Dystrophy（BCD）Bietti crystalline dystrophy (BCD) is a severe blinding retinal degenerative disease characterized by extensive intraretinal crystalline deposits scattered throughout the fundus. Most patients with BCD develop symptoms such as night blindness and visual acuity decline between the ages of 20 and 40, progressing to legal blindness by the age of 50 to 60.

VGR-R01 employs a gene replacement therapy strategy, utilizing an AAV8 vector to deliver CYP4V2 Gene Delivery to the Retinal Pigment Epithelium（RPE）nucleus, thereby expressing the CYP4V2 protein to correct fatty acid metabolism disorders, preserve residual visual function, and delay vision deterioration.

Based on the evidence from Phase I/II clinical studies, best-corrected visual acuity in 2/3 of patients following administration of VGR-R01（BCVA）Significant Improvement（≥-0.3 logMAR）, with no patients experiencing significant vision deterioration, VGR-R01 received PRIME designation from the European Medicines Agency.

Previously, this therapy was included in the CDE’s “Care Program” and the list of breakthrough therapies, and was granted Orphan Drug Designation by the U.S. FDA. On June 23, itsNew Drug Application Accepted by CDE。

Grit Biotherapeutics’ Two TIL Therapies, GT201 and GT101 Injections, Both Receive Implicit Clinical Approval from the CDE; Proposed Indications Are Combination with PD-1 Inhibitors for Advanced Solid Tumors and First-Line Combination with PD-1 Inhibitors for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, Respectively.

GT201 is a next-generation tumor-infiltrating lymphocyte (TIL) therapy developed on the company’s proprietary StaViral retroviral vector platform, which enhances TIL cells through stable expression of membrane-bound IL-15. Compared with conventional TIL therapies, GT201 not only demonstrates stronger antitumor activity and more durable in vivo persistence, but also has the potential to reduce dependence on IL-2, as validated by preclinical and early clinical data. Currently, a Phase I clinical study evaluating GT201 for the treatment of recurrent or metastatic solid tumors has been initiated.

GT101 is the first TIL therapy approved for clinical registration in China and has currently entered pivotal Phase II clinical trials, with expectations toSubmit marketing authorization application for cervical cancer this year. In the Phase I clinical trial presented at the 2025 ASCO Annual Meeting, GT101 achieved an objective response rate of 45.5%.（ORR）, Disease Control Rate（DCR）reaching 90.9%, with one patient maintaining a complete response for over 14 months.

HLX3902 Injection, jointly submitted by Henlius Biopharma, has received its first clinical trial approval in China, intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors. Prostate cancer typically exhibits characteristics of “immunologically cold tumors”—sparse T-cell infiltration, low antigen-presenting capacity, and an abundance of immunosuppressive factors—which limits the efficacy of immune checkpoint inhibitors such as PD-1 inhibitors.

HLX3902 is a STEAP1/CD3/CD28 trispecific antibody that simultaneously activates CD3 and CD28 to enhance the cytotoxicity of T cells against STEAP1-expressing tumor cells, and through the first signal of T cell activation（CD3）and the second signal（CD28）optimization, enhancing T cell activation, proliferation, and survival, prolonging the duration of anti-tumor immune responses, and enabling robust anti-tumor activity even in environments with low T cell infiltration. STEAP1 is highly expressed in over 85% of prostate tumors, whereasBarely expressed in normal tissues。

Shunjing Biologics’ SGT003 Injection Receives First Implicit Clinical Trial Approval from the CDE, Intended for the Treatment of Advanced Solid Tumors

Publicly available information indicates that SGT003 injection is a novel bispecific antibody candidate drug, with its core innovation lying inClearing Regulatory T Cells in the Tumor Microenvironment（Tregs）, thereby activating anti-tumor immunity. This mechanism not only precisely targets tumor tissues and modulates the tumor microenvironment to activate the body’s endogenous immune response against tumor cells, but also reduces CTLA-4-mediated immune activation-related toxicities. It effectively addresses the broad population of patients with extensive solid tumors who are resistant to or unresponsive to conventional therapies, holding promise as a cornerstone therapeutic agent in cancer immunotherapy.

Nuoyu Biologics’ Kit for the Preparation of ⁶⁸Ga-NYM096 Injection Receives First Implicit Clinical Approval from the CDE, Intended for PET Imaging to Characterize Indeterminate Renal Masses by Differentiating Clear Cell Renal Cell Carcinoma from Non-Clear Cell Renal Cell Carcinoma. Public information indicates that NYM096 is a small-molecule RDC drug that specifically binds to CAⅨ and can be labeled with ⁶⁸Ga and ¹⁷⁷Lu, demonstrating higher affinity and favorable anti-tumor efficacy.

Tide Pharmaceutical’s TRD209 for Injection Receives Implicit Clinical Approval from the CDE for the Treatment of Advanced Solid Tumors, Marking Its Second IND Approval Following Adult Acute Myeloid Leukemia. Public Information Indicates That This Is a SHP2-TargetingBispecific Protein Degradation Therapy。

Bispecific protein degradation therapy can specifically recognize target proteins by leveraging the intracellular ubiquitin-proteasome system（UPS）Degradation of target proteins to achieve therapeutic effects. TRD209 is a bispecific protein degrader targeting SHP2, designed to treat acute myeloid leukemia and small cell lung cancer by correcting abnormal differentiation in hematologic malignancies and inhibiting the growth of small cell lung cancer.

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