On October 19, 2025 Novartis reported new Pluvicto (lutetium (177Lu) vipivotide tetraxetan) data from the Phase III PSMAddition trial in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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Pluvicto plus standard of care (SoC) (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), reducing the risk of radiographic progression or death by 28% (HR 0.72; 95% CI: 0.58, 0.90) versus SoC alone in patients with prostate-specific membrane antigen (PSMA)+ metastatic hormone-sensitive prostate cancer (mHSPC)1.

Results also show an early positive trend in overall survival (OS) in patients treated with Pluvicto plus SoC (HR 0.84; 95% CI: 0.63, 1.13); follow-up will continue until data are mature1. More patients achieved a complete response versus SoC alone (57.1% vs. 42.3%) and the overall response rate (ORR) was numerically higher in the Pluvicto plus SoC arm (85.3% vs. 80.8%)1. Pluvicto delayed time to progression to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.70; 95% CI: 0.58, 0.84)1. The rPFS benefit was consistent across pre-specified subgroups1.

"In metastatic prostate cancer, choosing the most efficacious treatment early is crucial, even at initial diagnosis," said Scott T. Tagawa, MD, a professor of medicine at Weill Cornell Medicine and a medical oncologist at NewYork-Presbyterian/Weill Cornell Medical Center. "These findings suggest that combining 177Lu-PSMA-617 with standard of care hormonal therapy offers patients more time without disease progression, a safety profile with adverse events that are most often low grade and managed with supportive care, and an encouraging trend in overall survival."

"These results reinforce the potential for Pluvicto, a radioligand therapy that delivers treatment directly to target cells, to change how we treat metastatic prostate cancer," said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. "With significant benefit now shown across multiple disease stages, Pluvicto is redefining the standard of care. The strength of these results reflects our deep commitment to patients with prostate cancer and our leadership in radioligand therapy."

The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION1,4,5. Grade ≥3 adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone1. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia1.

PSMAddition marks the third positive Phase III trial with Pluvicto1,4,5. Building on the significant benefit demonstrated in PSMAfore, which led to the US Food and Drug Administration (FDA) approval in pre-taxane mCRPC in March 2025, these new results strengthen the evidence base for Pluvicto and demonstrate its potential to improve outcomes in an even earlier stage of metastatic prostate cancer1,4,6. Novartis plans to submit these data to regulatory authorities before end of year.

About unmet need in mHSPC
Approximately 172,000 men are diagnosed with mHSPC each year across the US, China, Japan, France, Germany, Italy, Spain and the United Kingdom1. Most patients progress to mCRPC, typically within 20 months2,3,7,8. Progression to mCRPC is associated with significantly worse outcomes, including increased patient burden, worse quality of life and life expectancy less than two years9,10. More than 80% of patients with prostate cancer highly express the PSMA biomarker, making it a promising therapeutic target11-15.

About PSMAddition
PSMAddition (NCT04720157) is a Phase III, open-label, prospective, 1:1 randomized study comparing the efficacy and safety of Pluvicto in combination with SoC (ARPI + ADT) vs. SoC alone in adult patients with PSMA+ mHSPC16. The primary endpoint is rPFS, defined as the time to radiographic progression by PCWG3-modified RECIST V1.1 (as assessed by BIRC) or death16. The key secondary endpoint of OS is defined as time to death due to any cause16. The study remains ongoing and a total of 1,144 patients with mHSPC across 20 countries have been randomized in the trial16.

About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)5,17. After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein5,17. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death17.

Pluvicto is the only PSMA-targeted agent approved for PSMA+ mCRPC and is the first RLT to demonstrate a clinical benefit for patients with PSMA+ mHSPC in a Phase III trial1. Novartis is investigating Pluvicto in oligometastatic prostate cancer, an earlier stage of disease, in the PSMA-DC trial (NCT05939414).

(Press release, Novartis, OCT 19, 2025, View Source [SID1234656773])

On October 19, 2025 NETRIS Pharma, a clinical-stage biotechnology company pioneering novel therapies targeting Netrin-1 to overcome resistance to chemotherapy and immunotherapy, reported the presentation of the first results from its ongoing Phase 2 clinical trial IMMUNONET. The Study evaluates NP137 in combination with anti–PD-1/PD-L1 therapies with advanced solid tumors. The data will be shared in a poster session at the upcoming ESMO (Free ESMO Whitepaper) Oncology Congress 2025 in Berlin, Germany.

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Resistance to Immune Checkpoint Inhibitors (ICI) remains a major challenge in the treatment of solid tumors such as non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). Netrin-1, an embryonic guidance factor re-expressed in various cancers, contributes to tumor resistance and epithelial-to- mesenchymal transition (EMT). NP137, a first-in-class monoclonal antibody targeting Netrin-1, has demonstrated the ability to inhibit EMT and modulate the tumor microenvironment, thereby potentially restoring sensitivity to immunotherapy.

IMMUNONET (NCT05605496) was designed to evaluate whether NP137 was able to (re)-sensitize solid tumors to ICI. Patients who had progressed under a prior anti–PD-1/PD-L1 were enrolled to receive NP137 as an add–on to their immunotherapy. They were enrolled in 3 distinct cohorts depending on their best response and time to progression (cohort 1, stable disease; cohort 2, primary refractory and cohort 3, secondary refractory). The study was designed as a 2-stage adaptive design. This poster reports the results of stage 1. In cohort 3 (secondary refractory) where a majority of NSCLC and HNSCC patients were enrolled, the primary endpoint of Progression-Free Rate at 12 weeks (PFR-12W) was met ahead of stage 2. These results strongly suggest the efficacy of combining NP137 with anti–PD-1/PD-L1 therapy in this difficult-to-treat population and warrant further controlled studies to confirm these findings.

Importantly, the combination of NP137 with ICI was very well tolerated. « These preliminary results are particularly encouraging » said Dr Jérome Fayette, M.D., Ph.D., Principal Investigator of the study. « Patients who have progressed after prior anti–PD-1/PD-L1 therapy represent one of the most difficult populations to treat. The encouraging efficacy and safety results observed in this study strongly support the continued clinical development of NP137. Advancing to a confirmatory randomized study will allow to further validate these findings and better define the therapeuticpotential of NP137 in combination with immune checkpoint inhibitors for patients with advanced solid tumors ».

« Observing durable disease control in this setting supports the concept that targeting Netrin-1 can re-sensitize tumors to immune checkpoint inhibition » added Dr. Sébastien Hazard, Chief Medical Officer of NETRIS Pharma. « Combining NP137 with checkpoint inhibitors may offer a new option for patients who no longer benefit from standard immunotherapy ».

Poster Details

Title: NP137 combined with anti–PD-1/PD-L1 therapy in ICI-pretreated solid tumors: Interim efficacy and safety results from the IMMUNONET study
Session: 966P
First Author: Dr. Jerome Fayette
About EIC Accelerator

The EIC Accelerator supports individual Small and Medium Enterprises (SMEs), in particular Startups and spinout companies to develop and scaleup game-changing

innovations. ImmunoNET is co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or NETRIS Pharma. Neither the European Union nor NETRIS Pharma can be held responsible for them.

(Press release, Netris Pharma, OCT 19, 2025, View Source [SID1234656772])

On October 19, 2025 The European Organisation for Research and Treatment of Cancer (EORTC) reported that the EORTC 1333/PEACE-3 trial has reached its final overall survival (OS) endpoint at the time of the final database lock on September 19, 2025.

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The EORTC 1333/PEACE-3 study is a randomized, open-label, multicentre phase III trial conducted in collaboration with Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and the French group GETUG/UNICANCER. A total of 446 asymptomatic or mildly symptomatic patients (Brief Pain Inventory score < 4) with metastatic castration-resistant prostate cancer (mCRPC) and ≥2 bone metastases were randomized 1:1 to receive either enzalutamide (160 mg daily) alone or enzalutamide plus six intravenous injections of radium-223 (55 kBq/kg every four weeks).

In the primary analysis, published in Annals of Oncology, the addition of six cycles of radium-223 to enzalutamide significantly improved the primary endpoint radiological progression-free survival (rPFS) from 16.4 months (95% CI 13.8–19.2) to 19.4 months (95% CI 17.1–25.3) (hazard ratio [HR] 0.69; 95% CI 0.54–0.87; p = 0.0009)¹, and an interim analysis at 80% of events that suggested an OS advantage for combining enzalutamide and Ra223.

The final overall survival analysis now confirms that the addition of six cycles of radium-223 to enzalutamide significantly prolongs overall survival, thereby reinforcing the findings of the interim analysis reported at the time of the primary publication.

Comprehensive results will be presented soon.

This trial is supported by an investigator driven clinical trial agreement from Bayer HealthCare Pharmaceuticals Inc. and Astellas Pharma Europe.

(Press release, EORTC, OCT 19, 2025, View Source [SID1234656768])

On October 19, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported new late-breaking data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Annual Meeting. The data demonstrated a progression-free survival (PFS) benefit for patients who experienced disease progression while on or after taking a PARP inhibitor (PARPi), a patient population with particularly poor prognosis. The presentation slides can be found here. The company also announced expansion of the Phase 2 BELLA trial in a poster session at ESMO (Free ESMO Whitepaper), found here.

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New relacorilant data presented at ESMO (Free ESMO Whitepaper) demonstrated a consistent benefit in PARPi subgroups to overcome chemotherapy resistance. Relacorilant plus nab-paclitaxel showed a PFS benefit in patients with prior PARPi treatment (hazard ratio: 0.60; p-value: 0.0035) and in patients whose disease progressed while on a PARPi (hazard ratio: 0.56; p-value: 0.0046), with a median PFS of 7.36 months for both subgroups. Relacorilant plus nab-paclitaxel was well-tolerated in the PARPi subgroups, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.

"These new ROSELLA data substantiate the significant benefit of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, an extremely difficult-to-treat cancer," said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano, European Network of Gynaecological Oncological Trial groups Principal Investigator in the ROSELLA trial and ESMO (Free ESMO Whitepaper) presenter. "These findings are especially promising for patients with an exceptionally poor prognosis and necessitate further research of relacorilant and its potential benefit in earlier treatment lines of gynecological cancers."

Corcept also announced the expansion of the recently initiated Phase 2 BELLA trial to three study arms to evaluate the efficacy and safety of: (i) relacorilant plus nab-paclitaxel and bevacizumab to treat patients with platinum-resistant ovarian cancer; (ii) relacorilant plus nab-paclitaxel and bevacizumab to treat patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARPi and (iii) relacorilant plus nab-paclitaxel to treat patients with endometrial cancer who had received one or two prior lines of therapy. Initial results are expected in late 2026.

"The ROSELLA data give us confidence to expand the BELLA trial to include patients with ovarian cancer whose disease is platinum sensitive (an earlier stage of tumor progression), as well as patients with endometrial cancer," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "With the FDA’s recent acceptance of our New Drug Application for relacorilant in platinum-resistant ovarian cancer and the expansion of our BELLA trial, we are closer than ever to bringing new and vital treatment to patients in need. We are grateful to all the patients and investigators for participating in our ongoing trials."

Corcept previously announced that ROSELLA met its primary endpoint of improved PFS, with no need for biomarker selection. Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in the risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). An interim analysis of overall survival (OS) showed that the addition of relacorilant reduced the risk of death by 31 percent, substantially lengthening patients’ lives (hazard ratio: 0.69; p-value: 0.0121).

The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns six months after receiving platinum-containing therapy have "platinum-sensitive" disease and those with disease progression of less than six months have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease and 13,000 women with platinum-sensitive disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

(Press release, Corcept Therapeutics, OCT 19, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-presents-esmo-2025-late-breaker-relacorilant [SID1234656765])

On October 18, 2025 Alphamab Oncology (Stock Code: 9966.HK) reported that the first interim analysis results of a phase III clinical trial of anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), in combination with chemotherapy as second-line or above treatment of HER2-positive gastric cancer (GC) (including gastroesophageal junction cancer (GEJ)) (Study ID: KN026-001, also known as KC-WISE), have been presented at the 2025 European Society for Medical Oncology Congress (ESMO Congress 2025) Late-Breaking Abstract (LBA) Oral Presentation Session.

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LBA Oral Presentation Session is a highly anticipated global highlight of the ESMO (Free ESMO Whitepaper) Congress. The research presented in this category is both highly topical and of significant clinical value. Their findings often herald potential impacts on current clinical practice and can even guide the future direction of entire therapeutic fields.

Title：KN026 in combination with chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Interim analysis of KC-WISE

Number: LBA 78

Speaker: Jianming Xu, Chinese PLA General Hospital

Date：Friday, 17 October 2025

METHODS

Enrolled patients in study KN026-001 (KC-WISE) with HER2-positive GC/GEJ who had disease progression after trastuzumab-based therapy were randomized to receive either anbenitamab (KN026) in combination with chemotherapy (the "Anbenitamab Group") or chemotherapy with placebo (the "Control Group"). The patients were stratified based on (i) type of chemotherapy, (ii) HER2 expression level, and (iii) number of prior lines of treatments.

RESULTS

At baseline, patient characteristics were generally well balanced between the two groups. The median age was approximately 64 in the Anbenitamab Group and 61 in the Control Group. In both groups, over 80% of patients had an ECOG PS of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment. All patients had previously received chemotherapy, most commonly taxanes (over 70%), with the remainder receiving irinotecan-based regimens.

As of April 3, 2025, the median follow-up duration was 9.7 months (95% CI, 7.2 to 11.9 months) in the Anbenitamab Group and 9.8 months (95% CI, 7.4 to 12.9 months) in the Control Group.

Efficacy as assessed by the Independent Review Committee (IRC):

● The median treatment-related adverse event (PFS) for the Anbenitamab Group was 7.1 months, compared with 2.7 months in the Control Group. The hazard ratio (HR) is 0.25 (P value is 5.44 × 10⁻¹²), corresponding to a 75% reduction in the risk of disease progression or death.

● The median overall survival (OS) for the Anbenitamab Group was 19.6 months (not mature), compared with 11.5 months in the Control Group. The HR is 0.29, representing a 71% reduction in the risk of death, and P value is 1.56 × 10⁻6, which is well below the prespecified extremely stringent alpha threshold of 0.00001.

● The objective response rate (ORR) was 55.8% in the Anbenitamab Group versus 10.8% in the Control Group, while the disease control rate (DCR) was 80.0% and 41.9%, respectively. The median duration of response (DoR) was 8.2 months and 2.9 months, respectively.

Safety:

● The median treatment duration was 6.5 cycles in the Anbenitamab Group and 3.0 cycles in the Control Group.

● The incidence of Grade 3 treatment-emergent adverse events (TEAEs) or above was 60.6% in the Anbenitamab Group and 51.6% in the Control Group, while the incidence of serious adverse events (SAEs) was 31.9% and 33.3%, respectively.

● The most frequently observed Grade 3 treatment-related adverse events (TRAEs) or above in the Anbenitamab Group included neutropenia (29.8%), leukopenia (21.3%), anemia (18.1%), diarrhea (8.5%) and asthenia (8.5%), while the most frequently observed Grade 3 TRAEs or above in the Control Group included leukopenia (24.7%), neutropenia (21.5%), anemia (10.8%), diarrhea (7.5%) and thrombocytopenia (5.4%). The incidence of cardiotoxicity in both groups were both 3.2%, indicating fewer cardiac concerns.

CONCLUSIONS

The interim analysis demonstrated that anbenitamab achieved superior efficacy in second-line or third-line HER2-positive gastric cancer patients who had been previously treated with trastuzumab. The study met both its primary endpoints of PFS and OS with statistically significant and clinically meaningful improvements, indicating its potential to change clinical practice guidelines for the treatment of second-line or above gastric cancer. Compared with the recently published DESTINY-Gastric04 results of DS-8201 in second-line gastric cancer, anbenitamab demonstrates potential advantages in both efficacy and safety.

Prompted by these encouraging results of anbenitamab, we are preparing to expand clinical development into first-line and perioperative gastric cancer through new registrational trials, aiming to extend benefits to more patients. Meanwhile, JSKN003, an ADC built upon KN026, has demonstrated high-security profile and distinctive advantages. With multiple registrational studies currently advancing as planned, we anticipate even more outstanding performance from JSKN003 in the future.

About Anbenitamab (KN026)

Anbenitamab (KN026) is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade.

Results from multiple clinical studies showed that KN026 has promising efficacy for the treatment of HER2-positive solid tumors, both in the first-line and in patients previously treated with trastuzumab. Currently, several pivotal trials of KN026 for second-line or above HER2-positive GC/gastroesophageal junction cancer (GEJ), first-line HER2-positive BC, neoadjuvant treatment of HER2-positive BC are being conducted. KN026 for the treatment of patients with HER2-positive GC who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA). KN026 for the treatment of HER2-positive or low expressing GC was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). In September 2025, the first New Drug Application (NDA) for anbenitamab injection has been accepted by the NMPA for use in combination with chemotherapy in patients with HER2-positive locally advanced, recurrent, or metastatic GC/GEJ who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).

In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

(Press release, Alphamab, OCT 18, 2025, View Source [SID1234656997])