Eight CGT Therapies, Four PD-1 Bispecifics, and Two TCEs Receive IND Approvals in China – CDE Weekly Update

According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）Incomplete statistics from the official website and publicly available data last week(June 16 - June 22)，Approximately 28 Class 1 Innovative DrugsProposed inclusion in breakthrough therapy category/IND approved for clinical trial by default/IND application accepted.(Note: This article only counts new molecular type innovative drugs such as bispecific antibodies, ADCs, CAR-T, small nucleic acids, and oncolytic viruses.)

Due to limited publicly available information, LNF2102 Injection by New Era Pharmaceutical for advanced solid tumors, ABBV-324 Injectable Powder by AbbVie for adult hepatocellular carcinoma or squamous cell non-small cell lung cancer, and HX001 Injection by HouXian Bio, among other Class 1 innovative drugs, were not included in the above table. Below, some Class 1 innovative drugs with more extensive public information will be introduced.

HuaDao CAR-Tcell's Application for New Drug Class 1 HD006 Cell Injection Granted Clinical Trial Approval, Intended for Treating Advanced Solid Tumors Positive for GUCY2C Expression. HD006 is the company's ___ approved clinical candidate.TwoSolid Tumor CAR-T, also the first product developed based on the company's self-developed accessible cell drug intelligent manufacturing and sharing technology platform. 5A CAR-T therapy. The CAR-T developed based on the aforementioned platform is expected to reduce the market price of millions of yuan for CAR-T toRMB 200,000Left and right, greatly improving treatment accessibility.

According to the press release from HuaDao CAR-Tcell, HD006 genetically modifies the patient's autologous T cells, enabling the T cells to express a CAR structure that can recognize GUCY2C. This allows the T cells to specifically identify and attack GUCY2C-positive tumor cells, exerting an anti-tumor effect. For more information, see:HuaDao CAR-Tcell's Second Solid Tumor CAR-T Approved for Clinical Trial, Poised to Break the Accessibility Barrier of Expensive CAR-T Therapy

KN5501 is a CAR-NK cell therapy candidate developed by Rui Therapeutics targeting the CD19 antigen. It utilizes a unique HTAS-RV™ delivery system and NK cell expansion cryopreservation technology, featuring "universal" and "off-the-shelf" characteristics.

KN5501Aiming to achieve deep depletion of CD19+B cells by targeting the CD19 antigen, inducing immune reconstitution in subjects, enabling patients to discontinue long-term steroid and immunosuppressant treatments, and achieving long-term deep or complete disease remission. European Alliance of Associations for Rheumatology 2025.（EULAR）The information published at the annual meeting indicated that, among the 13 systemic lupus erythematosus subjects with follow-ups reaching over 12 months, the SRI-4 response rate...100%, LLDAS response rate 76.9%, Doris remission rate 69.2%; the longest follow-up time for subjects achieving Doris remission exceeded21months, still maintaining remission without recurrence.

SA102-CAR-T Injection is a CS1/BCMA dual-target CAR-T independently developed by SiAn Medical.In 2023, 3SBio introduced SA102-CAR-T for development and commercialization rights in Greater China.Dual-target design is expected to significantly reduce the risk of tumor antigen escape, providing patients with relapsed/refractory multiple myeloma a more durable treatment option. Multiple studies have found that an important reason for relapse after CAR-T treatment in myeloma is the loss of antigen caused by the cleavage of the BCMA target.

Hengrui Yuanzheng's Multi-Antigen Autologous Immune Cell Injection（MASCT-I）It is an investigational immunotherapy product made by culturing human lymphocytes in vitro, which includes loading15 TypesMature Dendritic Cells with Specific Tumor Antigens(DC Cells)And activated and expanded effector T cells in vitro, which exert anti-tumor effects through multiple infusions.

2024ASCO ConferencePublic data shows that MASCT-I, used alone or in combination with immunotherapy and chemotherapy, has good safety and tolerability. Encouraging therapeutic effects were observed in patients with advanced metastatic or recurrent urothelial carcinoma who achieved clinical benefit after first-line chemotherapy, whether treated with MASCT-I alone or MASCT-I combined with Camrelizumab.

AZD6621 is a CD8-biased TCE developed by AstraZeneca, using 0.5+1+2 Structure, where 0.5 is targeting the CD8 site. At the 2025 AACR, AstraZeneca unveiled its TCE therapy for prostate cancer for the first time.（AZD6621）Preclinical research data. By targeting new targets（STEAP2）Optimizing the affinity of the CD3 binding domain and integrating the CD8 binding domain improved the therapeutic index. Studies have shown that this CD8-biased design effectively achieves CD8 T-cell specific activation, with significantly lower cytokine release compared to traditional 1+2 conformation TCEs.

Innovent Biologics' IBI343 Granted Breakthrough Therapy Designation for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer with CLDN18.2 Expression Who Have Received at Least Two Systemic Therapies. No ADC targeting this site has been approved globally.

IBI343 is a recombinant human anti-CLDN18.2 targeted ADC developed by Innovent Biologics, based on Lonza Synaffix’s ADC technology platform. The antibody affinity is an order of magnitude higher than that of Zolbetuximab, with silenced Fc design. The toxin is Exatecan, utilizing Synaffix glyco-conjugation technology, with a DAR value of 4. As an innovative TOPO1i-type ADC, IBI343 has demonstrated manageable safety and encouraging efficacy signals in Phase I clinical studies.

Data released at this year's ASCO conference showed that, as of the data cutoff date, among 44 subjects in the 6 mg/kg dose group with CLDN18.2 1+2+3+≥60%, the disease control rate（DCR）For81.8%`, Median Progression-Free Survival`（PFS）For 5.4 Months; Median Overall Survival（OS）For9.1months.

PM1300, a Class 1 new drug in lyophilized injection form developed by Primus Bio/BioNTAb, has been granted clinical trial approval in China for the potential treatment of advanced solid tumors. According to publicly disclosed data from the 2024 AACR Annual Meeting, PM1300 is a humanized anti-EGFR/HER3 bispecific antibody-drug conjugate (ADC). This ADC forms an asymmetric 1+1 structure through charge-based HC-HC and HC-LC heterodimerization, followed by conjugation with a topoisomerase 1 inhibitor payload via a cleavable linker. The affinity of PM1300 for EGFR and HER3 has been optimized to broaden the therapeutic window.

QLS32015 is a novel humanized IgG1 T-cell redirecting bispecific antibody independently developed by Qilu Pharmaceutical, targeting GPRC5D/CD3, intended for the development of treatment for multiple myeloma.

QLS32015 can bridge T cells expressing CD3 and tumor cells expressing GPRC5D, independent of the major histocompatibility complex.（MHC）And Specific T-Cell Receptor（TCR）The combination pathway forms an immunological synapse, activates T cells, and induces T cell-mediated cytotoxicity against tumor cells. QLS32015 for the treatment of relapsed/refractory multiple myeloma.For the first timeClinical trial results in humans indicate that it is well-tolerated in patients with relapsed/refractory multiple myeloma and exhibits excellent anti-tumor activity.

Eli Lilly's LY4101174 for Injection Approved for Clinical Trials, Intended as Monotherapy for Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors. Public data shows that LY4101174 (ETx-22) As an Nectin-4-targeted ADC, it was acquired by Eli Lilly in 2023 for approximately 4.7 Acquired for billions of dollars from Emergence. LY4101174 contains a humanized IgG1 fc-silenced monoclonal antibody linked to the topoisomerase I inhibitor exatecan via a maleimide-β-glucuronide multi-sarcosine linker, with a DAR value of 8。

Nurit Medical's 177Lu-NRT6020 Injection and 68Ga-NRT6020 Injection have been approved for clinical use, intended for FAP-positive advanced malignant solid tumors and for selecting patients with advanced malignant solid tumors suitable for treatment with 177Lu-NRT6020 Injection, respectively. According to publicly available data from Nurit Medical, these are two "theranostic" radioligand therapies developed by the company, which can specifically bind to FAP (Fibroblast Activation Protein)Combination, Diagnosis and Treatment of Advanced Solid Tumors with Positive FAP Expression.

Huiyu Pharma's wholly-owned subsidiary Huiyu Haiyue's application for the clinical trial of HY0001a, a Category 1 new drug injection, has been approved for use in patients with advanced solid tumors. According to publicly available information, this is HY0001a.For the first timeApproved for clinical use.

HY0001a is a CDCP1-targeted ADC independently developed by Huiyu Haiyue. Currently, no drugs targeting the same point have been approved for marketing domestically or internationally. CDCP1 is highly expressed in various tumors such as gastric cancer, breast cancer, lung cancer, colorectal cancer, and pancreatic cancer, while showing no or low expression in normal tissues, making it a promising target for development. Preclinical studies have shown that HY0001a exhibits excellent anti-tumor effects in multiple solid tumor models with good safety.

Amgen's AMG 133（MariTide）It is a GLP-1R agonist/GIPR antagonist, with a lower administration frequency compared to semaglutide and tirzepatide, allowing for once-monthly or even longer dosing intervals. As an antibody-peptide conjugate drug with a long half-life and dual mechanism of action.（RPC）MariTide can reduce the likelihood of weight regain after discontinuation. In a Phase 2 clinical trial, for obese or overweight patients without type 2 diabetes, treatment with MariTide at Week 52 resulted in an average weight loss.20%。

Zelgen's injectable ZG006 has been granted clinical tacit approval for use in combination with ZG005, intended for the treatment of advanced small cell lung cancer or neuroendocrine carcinoma. ZG006 is a trispecific TCE targeting two distinct DLL3 epitopes and CD3, which bridges tumor cells and T cells, drawing T cells closer to tumor cells to enable T cell-specific killing of tumor cells.

Preclinical study results show that ZG006 can lead to a significant proportion of tumor regression in mouse tumor models.Complete RegressionThe data of ZG006-002 study disclosed at the 2025 ASCO Conference shows that, in subjects with small cell lung cancer（n=48）In China, the ORR for the 10 mg and 30 mg groups were respectively 62.5%and 58.3%, DCR were 70.8% And 66.7%.

MEDI5752 is a bispecific antibody targeting PD-1/CTLA-4 developed by AstraZeneca for the treatment of advanced clear cell renal carcinoma. MEDI5752 is a monovalent bispecific antibody composed of the CTLA-4 monoclonal antibody tremelimumab and a PD-1 monoclonal antibody. Compared to bivalent bispecific antibodies, it does not induce receptor homodimerization and exhibits stronger targeting.

MEDI5752, developed based on the DuetMab technology platform, features a modified Fc domain carrying L234F, L235E, and P331S mutations, which eliminates antibody-dependent cellular cytotoxicity (ADCC) effects. Preclinical studies have shown that MED15752 not only mediates the internalization of CTLA-4 but also facilitates the internalization and degradation of PD-1, a function not observed with other PD-1-related antibodies. In the phase 1 clinical study involving patients with advanced renal cell carcinoma, treatment-naïve subjects were included in the expansion cohort.（1L）In patients, the objective response rate was 58.3%.(Including 1 case of complete remission and 6 cases of partial remission)。

OncoImmune's AI-081 Injection, a Class 1 new drug, has been approved for clinical trials in China, intended for the treatment of advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and extensive-stage small cell lung cancer. Previously, AI-081 received FDA approval for clinical trials and initiated a Phase 1/2 clinical study for solid tumors in the first quarter of this year.（NCT06635785）。

Public information shows that AI-081 is a bispecific antibody targeting PD-1/VEGF. It is composed of proprietary, high-affinity clinical-stage anti-PD-1. (AI-025) And Anti-VEGF(AI-011) Antibody Composition. AI-081 adopts a tested and validated head-and-tail bispecific format designed to achieve stronger synergy and utilizes additional Fc silent mutations to protect immune effector cells.

Fangtuo Bio's FT-001 Injection Proposed for Inclusion in Breakthrough Therapy Designation, Indication for...RPE65Biallelic Mutation-Associated Retinal Degeneration. According to official information from Frontier Bio, FT-001 Injection is an AAV gene therapy for biallelic RPE65 mutation-associated inherited retinal degeneration, which was launched in 2023.2 Phase clinical trial.

IMM-003, developed by ImmingAngke, has been approved for clinical trials for the treatment of pulmonary arterial hypertension. IMM-003 is an activin receptor IIA-Fc fusion protein targeting the ActRIIA signaling pathway.

IMC-003 ActRIIA Receptor Extracellular Domain Functional Region Enhanced Through Genetic Engineering to Strengthen Binding and Blocking Activity with Ligand Activin A, While Improving Drug Quality Uniformity. The mechanism of action of IMC-003 allows it to fundamentally improve vascular smooth muscle cell homeostasis and vascular remodeling from the pathogenic mechanism, thereby reversing the patient's condition from the root cause. Existing studies have shown that IMC-003 hasHigh SelectivityEnabling it to exhibit differentiated advantages over the marketed drug sotatercept with the same mechanism of action.

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