Over 3 Years Tumor-Free Survival with Novel TIL Therapy, CSPC's $4.3B-In-Licensed Bispecific ADC, and Multiple PD-1 Bispecifics Achieve Clinical Progress – CDE Weekly Update
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
August 5, 2025
eMedClub News
According to the Center for Drug Evaluation of China's National Medical Products Administration（CDE）According to incomplete statistics from the official website and publicly available information, last week(July 28 - August 3), Recently30 Innovative Drugs Granted Clinical Trial Approval/IND Application AcceptedCAR-T, TIL, Stem Cells, Bispecific ADC, PD-(L)1 bispecific antibodies, etc., with indications mainly focused on advanced solid tumors。
TIL/CAR-T/Stem Cell/Gene Therapy Breakthroughs
This week, the CGT field has made multiple advances, involving TIL, CAR-T, gene therapy, and stem cells.(hUC-MSC, iPSC)Multiple tracks, from companies such as Juncell Therapeutics, SinoBio, Sanofi, and Ruojian Pharmaceutical Technology. The following will list the therapies with more disclosed information on their progress.
Juncell Therapeutics: The World's First Without Lymphodepletion,
Natural TIL Without IL-2 Injection
Juncell Therapeutics Autologous Natural Tumor-Infiltrating Lymphocyte Injection（GC101 TIL）Approved for clinical trials, intended to be combined with pembrolizumab for the treatment of advanced solid tumors. This therapy is Juncell Therapeutics' fastest progressing TIL pipeline and also...The World's FirstNatural TIL Therapy Without Lymphodepletion or IL-2 Injection. Clinical data shows that GC101 has an objective response rate against various types of advanced solid tumors. (ORR) Over 35%, Multiple Patients Have Achieved Complete Remission (CR) Efficacy, with the longest tumor-free survival time exceeding 3Years. Currently, GC101 for advanced melanoma has entered a critical II Phase of clinical stage.
New Targets, Bispecific ADCs Lead the New Trend in ADCs
In the ADC field, AbbVie's global first c-MET targeted ADC, B7H3/CLDN18.2/CDH17 targeted ADC, and others have achieved new IND progress. Moreover, bispecific ADCs, through "dual-target" or "dual-epitope" designs, can simultaneously block two signaling pathways, enhance tumor specificity, overcome drug resistance, significantly improve internalization, and reduce damage to normal cells, becoming a new trend in ADCs. Examples include康宁杰瑞's HER2 dual-epitope ADC and PD-L1/ITGB6/8 bispecific ADC.
Minghui Pharmaceuticals/Qilu Pharmaceuticals: B7H3-Targeted ADC
Minghui Pharmaceuticals/Qilu Pharmaceutical's Injectable MHB088C Granted Clinical Tacit Approval, to Be Used in Combination with Injectable MHB039A for the Treatment of Patients with Advanced Solid Tumors. Public data shows that MHB088C is a B7H3-targeted ADC developed based on Minghui Pharmaceuticals' proprietary SuperTopoi™ ADC platform. It consists of a humanized anti-B7H3 monoclonal antibody conjugated to Minghui’s proprietary DNA topoisomerase I inhibitor via a cleavable linker. The antibody also demonstrates stronger antigen binding affinity and higher endocytosis efficiency.
In May this year, Qilu Pharmaceutical reached a potential totalRMB 1.345 billionIntroducing its exclusive rights in the Greater China region. Information disclosed at the 2024 ASCO conference showed that, in 3 small cell lung cancer patients, the ORR was100.0%, one of which reachedCRAnd all small cell lung cancer patients showed remission in the first tumor assessment.
Alphamab Oncology: HER2 Bispecific ADC
JSKN003 for injection is independently developed by Alphamab Oncology using its proprietary glycan-based site-specific conjugation platform.HER2 Dual-Epitope ADC, with a DAR value of approximately 4. In 2024, Alphamab Oncology and CSPC Pharmaceutical Group reached a deal worth up toRMB 3.08 billionThe exclusive authorization and retains its exclusive production rights. Currently, JSKN003 is being developed for the treatment of HER2-low breast cancer, platinum-resistant ovarian cancer, and HER2-positive breast cancer in threeⅢ Phase clinical studies and multiple exploratory Phase II clinical studies are proceeding smoothly.
Biotech's First ARC Submits for Clinical Trial
If ADCs have the potential to replace chemotherapy, then RDCs, with their unique mechanisms of action, possess the potential to strongly complement or even replace traditional radiotherapy and some ADC application scenarios.
This week, Baili Tianhe's first ARC(Antibody Radionuclide Conjugates, a type of RDC)[177Lu]-BL-ARC001 Injection for Clinical Application. According to the previous prospectus, this therapy utilizes similar tumor antigen-specific targeting molecules to identify cancer cells but employs a radioactive isotope payload instead of a cytotoxic payload to attack cancer cells, which can be considered as targeted radiotherapy.
PD-(L)1 Continues to Gain Momentum
This week, there are multiple PD-(L)1/c-MET Targeted Multi-Antibody and Other IND Updates. Among them, PD-(L)1 Bispecific antibodies or fusion proteins by simultaneously targeting PD-(L)1 Synergistic enhancement and precise regulation with other immune-modulating pathways are expected to become the next-generation development direction for cancer immunotherapy. This week, new IND progress was made for bispecific antibodies involving combinations such as PD-L1/VEGF, PD-L1/EGFR, PD-1/IL-2α-bias, PD-1/PD-L1, and PD-1/TGF-β.
Innovent Biologics: PD-1/IL-2α-bias
Innovent Biologics' IBI363 Receives Clinical Approval for Two Indications, Proposed Indications Include Combination with Bevacizumab for Advanced Solid Tumors（EGFR Advanced mutant non-small cell lung cancer, platinum-resistant ovarian cancer)And neoadjuvant therapy for non-squamous non-small cell lung cancer.
According to publicly available data, IBI363 is a globally pioneering PD-1/IL-2 bispecific antibody therapy developed by Innovent Biologics, which is used in combination with bevacizumab.(Targeting VEGF), closing in on Kangfang's PD-1/VEGF bispecific antibody therapy AK112. At the 2025 ASCO Conference, IBI363 showed promise in squamous non-small cell lung cancer resistant to immunotherapy. 9.3Months of Surpassing PFS Data.
BeiGene: EGFR/MET Tri-specific Antibody
According to publicly available information from BeiGene, BG-T187 is a trispecific antibody targeting EGF/MET, utilizing a differentiated approach.MET Dual EpitopeDesign. Dual targeting of EGFR and MET can be used to treat a large number ofEGFRMutant non-small cell lung cancer population and others EGFROr METMutated populations, such as colorectal cancer, etc.
According to the information from the Drug Clinical Trial Registration and Information Disclosure Platform, a study exploring BG-T187 as a monotherapy and in combination with other therapeutic agents for the treatment of advanced...A Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity in Patients with Solid Tumors is Currently Underway.
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