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Significant OS Benefit with Cadonilimab in First-Line Advanced Gastric Cancer: Final Analysis of COMPASSION-15 Presented at ESMO 2025

On October 19, 2025 Akeso (9926.HK) reported the final analysis results from the COMPASSION-15/AK104-302 study at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO 2025) . COMPASSION-15 is a Phase III clinical trial evaluating cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Professor Shen Lin, principal investigator from Peking University Cancer Hospital, presented the findings in an oral session at ESMO (Free ESMO Whitepaper) 2025.

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In this final analysis presented at ESMO (Free ESMO Whitepaper) 2025 (median follow-up: 33.9 months), the cadonilimab regimen demonstrated enhanced long-term survival benefits in first-line advanced G/GEJ adenocarcinoma. With the extended follow-up period and more mature data, the cadonilimab treatment regimen showed a further reduction in the risk of death compared to the control group. This consistent benefit was observed across all PD-L1 expression subgroups.

The interim analysis of COMPASSION-15, with a median follow-up of 18.7 months, was previously published in Nature Medicine in January 2025. The data presented at ESMO (Free ESMO Whitepaper) 2025 were analyzed using the same statistical methodology.

COMPASSION-15 2025 ESMO (Free ESMO Whitepaper) Data

In the intent-to-treat (ITT) population:

With long-term follow-up, the cadonilimab regimen demonstrated a significant 39% reduction in the risk of death (OS HR 0.61) versus the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.66).
With extended follow-up, in the PD-L1 CPS ≥5 population, the cadonilimab regimen demonstrated a significant 51% reduction in the risk of death (OS HR 0.49; p < 0.001) compared to the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.58).
With long-term follow-up, in the PD-L1 CPS <5 population, the cadonilimab regimen showed a significant 24% reduction in the risk of death (OS HR 0.76; 95% CI: 0.59-0.99; p = 0.019) versus the control group, with a strengthening trend of benefit compared to the data from the median 18.7-month follow-up (OS HR 0.75; 95% CI: 0.56-1.00).
Following extended the follow-up period, the cadonilimab combination regimen maintained a favorable safety profile, with no new safety signals emerging.
In the COMPASSION-15 study, patients with PD-L1 CPS <5 (low expression) and CPS <1 (negative expression) are 49.8% and 23%, respectively, of the ITT population. This represents a higher proportion of PD-L1 low and negative patient population in COMPASSION-15 compared to previous Phase III trials of other immune checkpoint inhibitors used in the treatment of first-line gastric cancer. Previous studies have shown limited responses to PD-1/L1 inhibitors in PD-L1 low-expression or negative patients.

Cadonilimab was approved by the NMPA in September 2024 for the first-line treatment for advanced gastric cancer, offering a new and effective immunotherapy option. Cadonilimab has been included in the 2025 CSCO Gastric Cancer Guidelines as the only Category I recommendation (Level 1A evidence) for first-line immunotherapy, regardless of PD-L1 expression, and is currently widely used in clinical practice.

(Press release, Akeso Biopharma, OCT 19, 2025, View Source [SID1234656792])

CStone Discloses Phase I Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

On October 19, 2025 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported the first disclosure of preliminary Phase I data for CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) and the Phase Ib study design for CS5001 (a ROR1-targeted Antibody-Drug Conjugate [ADC]) at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress.

Key Highlights of CS2009 Poster Presentation:

This also represents the first known clinical data publication of a PD-1/VEGF/CTLA-4 trispecific antibody to date.

CS2009-101 is a multi-regional phase Ⅰ study currently ongoing in Australia and China. The study evaluates the safety, tolerability, pharmacokinetics (PK)/ pharmacodynamics (PD), and antitumor activity of CS2009 in patients with advanced solid tumors.

Patients baseline characteristics:

As of the data cutoff date, 72 patients with advanced solid tumors treated across 6 dose levels (DL1-6, 1-45 mg/kg); 72.2% remain on treatment.
Heavily pretreated population: over 51% received prior immuno-oncology (IO) therapies. Median follow-up: only 1.9 months (range 0.1-6.7 months) at data cutoff.
Favorable safety and tolerability:

Dose escalation completed with no dose-limiting toxicity (DLT) reported; maximum tolerated dose (MTD) not reached.
No Grade 4 or 5 treatment-related adverse event (TRAE) observed. Incidence of Grade ≥3 TRAEs, immune-related AEs (irAEs), and VEGF-related TRAEs was 13.9%, 4.2%, and 2.8%, respectively.
Only 1 treatment-emergent adverse event (TEAE) leading to drug permanent discontinuation observed (at DL4 [20 mg/kg]; 1.4% incidence).
Promising antitumor activity and high disease control rate (DCR):

CS2009 demonstrated encouraging anti-tumor activities across tumor types. As of the cutoff date, the overall follow-up duration remained limited, particularly in higher-dose cohorts where the majority patients had yet to reach the protocol-specified time point of post-baseline tumor assessment:

49/72 patients underwent at least one post-baseline tumor assessment by data cutoff.
Despite limited follow-up duration, anti-tumor activity was observed across all dose levels with dose-dependent uptrend:
Among all 49 evaluable patients, overall response rate (ORR) was 12.2%; DCR was 71.4%. Efficacy data remains immature; with additional follow-up beyond the poster data cutoff, ORR was further improved to 14.3%.
Higher ORR (25.0%) at tentative recommended Phase 2 dose (RP2D, 30 mg/kg) and higher dose.
Promising efficacy signals were observed across multiple tumor types within the short follow-up period:
Non-Small Cell Lung Cancer (NSCLC): ORR: 11.8%, DCR: 82.4%; Post-ESMO update: stable disease (SD)-to-partial response (PR) conversion observed, ORR further elevated to 17.6%; In AGA-negative subgroup, ORR reached 25%;
Ovarian Cancer (OC): ORR: 16.7%, DCR: 66.7%;
Triple-Negative Breast Cancer (TNBC): ORR: 25.0%, DCR: 75.0%;
Non–Clear Cell Renal Cell Carcinoma (nccRCC): ORR: 33.3%, DCR: 100.0%;
Soft Tissue Sarcoma (STS): ORR: 11.1%, DCR: 66.7%.
Favorable PK and PD profiles:

Linear PK with half-life of 6-8 days supported every-three-week (Q3W) dosing, with no significant accumulation observed at cycle 3.
PD profile demonstrated saturated receptor occupancy and robust T-cell activation/proliferation confirming PD-1/CTLA-4 blockade and deep and sustained VEGFA neutralization.
Receptor occupancy of PD-1/CTLA-4 on peripheral T cells reached saturation throughout dosing interval at doses ≥20 mg/kg.
On cycle 1 day 8, CS2009 induced notable, dose-dependent upregulation of Ki67 (proliferation due to PD-1 and CTLA-4 blockade) and ICOS (activation due to CTLA-4 blockade) expression on both CD4+ and CD8+ T cells, collectively demonstrating effective PD-1 and CTLA-4 inhibition.
Serum-free VEGFA reduced deeply and rapidly across all dose levels, and the effect sustained throughout dose intervals.
CStone has initiated Phase Ⅱ dose expansion study in first-line patients with selected tum or types for dose optimization and to generate data supporting registration trials in first-line NSCLC and other tumors as monotherapy or in combination therapies.

CS2009 Data Review Conference Call:

CStone will host an investor meeting to discuss presented data and future clinical development plan. The Company cordially invites all investors to attend this conference call.

Chinese-language session:

Date & Time: Monday, October 20, 2025, at 2:00 p.m. (Beijing Time)/2:00 a.m. (US Eastern Time)
Registration Link: Registration is required, please sign up via the link: View Source
English-language session:

Date & Time: Monday, October 20, 2025, at 9:00 p.m. (Beijing Time)/9:00 a.m. (US Eastern Time)
Registration Link: The Zoom meeting link will be sent to you by email after registration via the below link. You may join the meeting by clicking the link in email: View Source
Key Highlights of CS5001 ePoster Presentation:

CS5001 phase Ib study aims to determine the RP2D and further evaluate the safety, tolerability, PK, and efficacy of CS5001 as a monotherapy and in combination with systemic therapies in selected tumor types.
In monotherapy cohorts, Cohorts A-D enroll patients with chronic lymphocytic leukemia and other B-cell lymphomas, and Cohort I enrolls patients with ROR1-positive solid tumors. In combination therapy cohorts (E-H), CS5001 will be administered with standard systemic therapies (R-GemOx, R2 or R-CHOP) or with sugemalimab (an anti-PD-L1 monoclonal antibody).
Patient enrollment for CS5001 Phase Ib study commenced in December 2024 and is currently advancing smoothly at 30 sites across Australia, the United States, and China.

(Press release, CStone Pharmaceauticals, OCT 19, 2025, View Source [SID1234656791])

CARsgen Presents Preliminary Results on Satri-cel for Adjuvant Therapy of Pancreatic Cancer at ESMO Congress 2025

On October 19, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the research results of the Phase Ib registrational clinical trial of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for pancreatic cancer (PC) adjuvant therapy in China (CT041-ST-05, NCT05911217) has been presented in poster session at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. The poster was titled "Adjuvant Therapy with Claudin18.2-specific CAR T Cells (Satri-cel) in High-Risk Pancreatic Cancer (CT041-ST-05)" (Poster number: 2220P). The trial represents the world’s first proof-of-concept (POC) study exploring CAR T-cell therapy for the adjuvant treatment of solid tumors. Professor Xianjun Yu from Fudan University Shanghai Cancer Center serves as the principal investigator.

Pancreatic ductal adenocarcinoma (PDAC) is characterized by a dismal prognosis even among patients who undergo surgical resection. Local recurrence and distant metastasis are common, often leading to treatment failure. Elevated carbohydrate antigen 19-9 (CA19-9) levels post resection indicate aggressive tumor biology and higher risk of recurrence. The median interval is approximately 3 months between CA19-9 elevation and radiological recurrence. [1][2] Current standard adjuvant therapies have limited effectiveness for high-risk patients, highlighting the urgent need for novel strategies.

This trial enrolled patients with Claudin18.2 positive PDAC who have undergone curative-intent resection, with abnormal CA19-9 after 3 months adjuvant chemotherapy and no evidence of recurrence. From Sep 15, 2023 to April 11, 2025 (data cut-off date), six patients received satri-cel infusion and completed at least 4 weeks of follow-up.

With a median follow-up of 6.05 months from infusion, only one patient experienced disease recurrence, while others are still under disease free. The median disease-free survival (DFS) and median overall survival (OS) were not reached (NR). The 9-month DFS rate from surgery was 83.3%. Notably, one patient who has completed 52-week follow-up post infusion is still under follow-up without disease recurrence. Moreover, significant decline in CA19-9 levels post infusion was observed in five (83.3%) patients, with reductions ranging from 51.3% to 96.1%.

All patients developed Grade 1 or 2 cytokine release syndrome (CRS) after the first satri-cel infusion. For the second infusion administered in one patient, grade 3 CRS accompanied by hypotension was observed, which was resolved within three days following tocilizumab treatment. All patients experienced gastrointestinal disorders, such as nausea and vomiting, which were all Grade 1 or 2. Only one case of Grade 3 gastritis occurred. No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are pleased to see that satri-cel has shown promising preliminary efficacy with a manageable safety profile in the highly challenging setting of pancreatic cancer adjuvant therapy. For patients at high risk of recurrence after surgical resection of pancreatic cancer, there are currently very few effective treatment options. In this trial, the sustained disease-free survival and marked declines in CA19-9 levels suggest that satri-cel, an innovative cellular immunotherapy, may clear minimal residual disease and potentially alter the disease course for these patients. Furthermore, we are actively advancing clinical trials exploring satri-cel for gastric cancer adjuvant therapy and as a sequential treatment following first-line gastric cancer therapy, with the goal of providing better curative opportunities for a broader patient population."

About Satri-cel
Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib registrational trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), an investigator-initiated trial for satri-cel as a sequential therapy following first-line treatment in patients with advanced G/GEJA (CT041-CG4011, NCT07179484), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).

The Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satri-cel for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy on June 25, 2025. It has been granted Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025 by the CDE. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA for the treatment of G/GEJA in September 2020.

(Press release, Carsgen Therapeutics, OCT 19, 2025, View Source [SID1234656790])

Antengene Presents Latest ATG-022 Clinical Data at ESMO 2025 Demonstrating Efficacy Across All CLDN18.2 Expression Levels and Exceptional Tolerability

On October 19, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that the latest results from the ongoing Phase I/II CLINCH study of ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]), were presented in a Poster Presentation at the European Society for Medical Oncology Congress 2025 (ESMO 2025) in Berlin, Germany.

Details of the Poster Presentation:
ATG-022 (CLDN18.2 antibody-drug conjugate)
Title: Phase I/II study of Claudin 18.2 ADC ATG-022 in patients with advanced gastric/ gastroesophageal junction cancer (CLINCH)
Abstract Number: 2907
Presentation Number: 2113P

ATG-022 and CLINCH Study Overview

ATG-022 is a CLDN18.2-targeted ADC with sub-nM affinity and fast internalization. Using a VC-MMAE linker-payload (DAR 4), ATG-022 has demonstrated potent activity across tumors with high, low, and ultra-low CLDN18.2 expression.
The ongoing Phase I/II CLINCH study consists of dose escalation and dose expansion phases. In dose escalation, patients with advanced solid tumors regardless of CLDN18.2 expression receive ATG-022 once every three weeks (0.3-3.0 mg/kg Q3W) to evaluate the safety, tolerability, and pharmacokinetics; CLDN18.2-positive (≥ IHC 1+, 1%) patients are treated at 1.8 mg/kg or 2.4 mg/kg in dose expansion to evaluate the efficacy and safety.
ATG-022 has been granted two Orphan Drug designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer, and in August 2025 obtained Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for treating CLDN18.2-positive, HER-2 negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received at least two prior lines of therapy.
Key Results from the CLINCH Study

Efficacy Data
Among GC/GEJC patients with moderate/high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort observed 1 complete response (CR), 11 partial responses (PRs) and 15 stable diseases (SDs), resulting in an objective response rate (ORR) of 40% (12/30) and a disease control rate (DCR) of 90% (27/30). The median progression-free survival (mPFS) was 6.97 months and the 12-month overall survival (OS) rate was 66.2%. In the 1.8 mg/kg dose cohort, there were 1 CR, 9 PRs, and 11 SDs, resulting in an ORR of 40% (10/25) and a DCR of 84% (21/25).
Among GC/GEJC patients with low/ultra low CLDN18.2 expression (IHC 2+ ≤ 20%), patients treated at the efficacious dose of 1.8-2.4 mg/kg achieved 1 CR and 5 PRs, resulting in an ORR of 33.3% (6/18) and a DCR of 50% (9/18). The patient with CR has demonstrated durable response and has been on the study for over 22 months.
To date, the study has observed three CRs, one from each of the three forementioned cohorts (two dose cohorts among CLDN18.2 mid/high expressors and the cohort of low/ultra low CLDN18.2 expressors). This broad-spectrum antitumor activity indicates ATG-022’s potential as a new treatment option for a broader population of patients).
Safety Data
At 2.4 mg/kg in the dose expansion, 45.8% of patients had ≥1 treatment-emergent adverse events (TEAEs), 60.4% of patients had grade ≥3 TEAEs. The most common grade ≥3 treatment-related adverse events (TRAEs, ≥5% of patients) were neutrophil count decrease (16.7%), decreased appetite (14.6%) and anaemia (8.3%).
In the dose-expansion phase, the 1.8 mg/kg cohort demonstrated excellent safety and tolerability, with only 13.6% of patients reporting serious TEAEs and 18.2% reporting Grade ≥3 TEAEs. The favorable safety profile of this dose level support its potential use in first-line combination regimens with chemotherapy and immune checkpoint inhibitors.
No ophthalmological toxicities or interstitial lung disease have been observed.
Conclusions and Outlook

ATG-022 demonstrated a manageable safety profile and encouraging antitumor effects in GC/GEJC adenocarcinoma patients with a broad range of CLDN18.2 expressions, thus supporting further clinical investigation in patients with variable CLDN18.2 expressions. In addition to GC/GEJC, preliminary efficacy has been observed in other non-GI tumor types which will be reported at upcoming conferences.
The 2.4 mg/kg cohort showed a favorable safety profile, while the 1.8 mg/kg cohort demonstrated even better safety and tolerability. These findings provide strong support for advancing ATG-022 in combination with immune checkpoint inhibitors and chemotherapy in first-line treatment settings, paving the way to significantly expand its clinical reach and commercial potential.
The Phase II dose expansion study of ATG-022 is going smoothly in China and Australia. In parallel, Antengene is actively preparing for combination therapy studies involving ATG-022 to further advance its clinical development.

(Press release, Antengene, OCT 19, 2025, View Source [SID1234656789])

Positive Results from Phase 3 OptiTROP-Lung04 Trial of Sacituzumab Tirumotecan Presented at ESMO Presidential Symposium and Simultaneously Published in NEJM

On October 19, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress held in Berlin, Germany, results from a Phase 3 OptiTROP-Lung04 trial of the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in EGFR-mutated non-small cell lung cancer (NSCLC) following progression on epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) was presented as an oral report by Professor Li Zhang from Sun Yat-sen University Cancer Center (Presentation # LBA5, Presidential Symposium II) and were simultaneously published in the New England Journal of Medicine (Impact Factor = 78.5).

In the OptiTROP-Lung04 trial, a total of 376 patients were randomized (1:1) to receive sac-TMT monotherapy or chemotherapy.

As at the data cut-off date July 06, 2025, the median follow-up is 18.9 months. the median Progression-Free Survival (PFS) was 8.3 months in the sac-TMT group and 4.3 months in the chemotherapy group. Sac-TMT significantly improved PFS over chemotherapy with 51% lower risk of disease progression or death (hazard ratio (HR) 0.49; 95% confidence interval (CI), 0.39-0.62; P<0.0001).

At the preplanned interim analysis of overall survival (OS), the OS was not reached (NR) in the sac-TMT group and 17.4 months in the chemotherapy group. sac-TMT significantly improved OS over chemotherapy with 40% lower risk of death (hazard ratio (HR) 0.6; 95% CI: 0.44-0.82; two-sided P=0.001). In the supplemental analysis, when censoring patients at the date of initiation of subsequent ADCs, sac-TMT significantly improved OS over chemotherapy with 44% lower risk of death (HR, 0.56; 95% CI, 0.41 – 0.77).

Sac-TMT significantly improved ORR as compared to chemotherapy (60.6% vs 43.1%)

A consistent PFS and OS benefit of sac-TMT over chemotherapy was observed across all predefined subgroups, including prior EGFR-TKI therapy, presence of liver or brain metastases, and EGFR mutation subtype.

The incidence of any grade treatment-related adverse events (TRAEs) and grade ≥3 TRAEs was similar between the two groups. The most common TRAEs for both sac-TMT and chemotherapy were hematologic toxicities. No TRAEs led to discontinuation or death, and no cases of interstitial lung disease/pneumonitis were reported in the sac-TMT group. Ocular surface toxicity: occurred in 9.6% of patients in the sac-TMT group, all of which were grade 1 – 2.

As a conclusion, sac-TMT demonstrates highly statistically significant and clinically meaningful improvements in PFS and OS compared to platinum-based chemotherapy and showed a manageable safety profile, with no unexpected safety signals identified. Several global phase 3 studies of sac-TMT monotherapy (NCT06305754, NCT06074588) and combination study with osimertinib in China (NCT06670196) in EGFR-mutant NSCLC are ongoing.

Professor Zhang Li, National Lead Principal Investigator from Sun Yat-sen University Cancer Center, commented: "Compared to platinum-based doublet chemotherapy, sac-TMT not only significantly prolonged PFS but also demonstrated a statistically significant and clinically meaningful improvement in OS within this patient population. This achievement marks a major breakthrough in global lung cancer treatment—sac-TMT, as a monotherapy, demonstrated statistically significant and clinically meaningful improvements in both PFS and OS in the Phase III trial for patients with EGFR-TKI-resistant NSCLC. This study provides highly valuable, new evidence-based guidance for lung cancer management worldwide and has the potential to reshape the therapeutic landscape for EGFR-TKI-resistant NSCLC "

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, GC, gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication applications for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, OCT 19, 2025, View Source [SID1234656788])