On May 30, 2026 Orion Pharma reported first Phase 1 results from the ongoing Phase 1/2 multi-site, open-label, first-in-human TEADES trial evaluating the safety, tolerability and preliminary efficacy of ODM-212, a small molecule oral pan-TEAD inhibitor in patients with advanced solid tumours. According to the results, ODM-212 was well tolerated. Dose limiting toxicities (DLT) were not reported and the maximum tolerated dose (MTD) was not reached. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 7.9% of patients. Other common TRAE’s were increased lipase (15.8%) and nausea (10.5%).

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Treatment responses by RECIST 1.1 were observed across multiple doses (overall response rate1, ORR 15.6%), predominantly in patients with mesothelioma (ORR 27.8%, disease control rate2, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The new data were presented during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, United States, from May 29-June 2, 2026.

"We are encouraged by the safety profile and early signs of clinical activity observed with ODM-212, particularly in mesothelioma and EHE, where treatment options remain limited", said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion Pharma. "These results support continued clinical development of ODM-212 both as a monotherapy and in combination settings."

Phase 2 of the TEADES trial is ongoing. The trial will enroll up to 300 patients with malignant pleural mesothelioma (MPM), EHE or other solid tumours with dysfunction in Hippo pathway, and who have progressed despite available standard treatments and with limited further treatment options. Another ongoing Phase 1/2 trial TEADCO is evaluating ODM-212 in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer.

About the TEADES study
The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction in Hippo pathway. The trial will include patients who have progressed despite available standard treatments and with limited further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, MAY 30, 2026, View Source [SID1234666256])

On May 30, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, reported the presentations of two studies in non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. One study evaluated DZD6008, an investigational fourth-generation EGFR TKI, in pre-treated NSCLC patients with EGFR C797X mutations following progression on third-generation EGFR TKI treatment. The results were featured in an oral presentation. The other study reported results for golidocitinib, a JAK1-selective inhibitor, combined with an anti-PD-1 antibody as a first-line treatment for PD-L1-positive, advanced NSCLC without driver mutations.

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DZD6008: A Fourth-Generation EGFR TKI Overcomes Resistance Following Third-Generation EGFR TKI Failure

The latest findings showed that DZD6008 demonstrated strong and durable anti-tumor activity in patients relapsed from third-generation EGFR TKI with a favorable safety profile.

The majority of patients (82.1%) had tumor shrinkage following DZD6008 treatment. Higher response rate is expected with longer treatment.
Tumor response is durable, with 6 months progression free survival (PFS) rates at 70.6% and 61.8%, respectively for 40 mg and 60 mg cohorts. The median duration of response (DoR) was not reached.
Excellent blood-brain barrier (BBB) penetration was observed, including strong intracranial anti-tumor activity among patients with baseline brain metastasis.
DZD6008 demonstrated a favorable safety profile with high selectivity for wild-type EGFR, resulting in minimal adverse effects.
Patients with EGFR-mutant NSCLC whose disease progresses on or after third-generation EGFR TKI treatment often acquire resistance mutations, among which EGFR C797X is one of the most frequently reported. DZD6008 is a fourth-generation EGFR TKI designed with full BBB penetration and high selectivity over wild-type EGFR. Preclinical and clinical data support its potent activities against single, double and triple EGFR mutations (L858R/19del, T790M, C797X).

Golidocitinib: A JAK1 Inhibitor Combined with Anti-PD-1 Demonstrates Durable Clinical Benefit

Among 47 enrolled treatment-naïve patients with advanced NSCLC, golidocitinib plus sintilimab following chemo-immunotherapy demonstrated encouraging and durable anti-tumor efficacy, particularly in those with high PD-L1 expression. Profound improvement of irAE was noticed.

Dr. Xiaolin Zhang, CEO of Dizal, said: "Main reasons for patients relapsed from 3rd generation EGFR TKI treatment include acquired resistance mutations and CNS metastasis. DZD6008 was designed to address these clinical issues. The data presented confirmed that DZD6008 met our design criteria and has the potential to provide an oral safe treatment option for these patients. We are very excited by the clinical data. We look forward to collaborating with investigators worldwide to accelerate its clinical development globally."

About Golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About DZD6008

DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

(Press release, Dizal Pharma, MAY 30, 2026, View Source [SID1234666273])

On May 30, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated data from the ongoing Phase 1 trial of Padeliporfin VTP treatment in patients with unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) and from ENLIGHTED, the Company’s ongoing Phase 3 study in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29-June 2, 2026, in Chicago, IL.

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"Today’s presentations underscore the continued clinical progress across both our expanding development efforts in LA-PDAC and our pivotal Phase 3 ENLIGHTED study in LG-UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The updated early Phase 1 results in LA-PDAC, including successful resection outcomes observed to date, are encouraging and support initial validation of our VTP platform and its potential broader application in difficult-to-treat solid tumors. Given the substantial unmet need and large addressable patient population in LA-PDAC, we believe Padeliporfin VTP may offer a differentiated therapeutic option with the potential to convert these patients to surgically resectable candidates."

"In parallel, updated data from the ENLIGHTED trial continue to demonstrate compelling complete response rates, encouraging durability, and a favorable tolerability profile, reinforcing Padeliporfin VTP’s potential to offer a clinically meaningful, organ-sparing treatment option for patients with low-grade UTUC," continued Dr. Morag. "We look forward to pursuing strategic opportunities for the potential commercialization of Padeliporfin VTP in LG-UTUC, while advancing clinical development in both indications."

Key updated results from the Phase 1 study of Padeliporfin VTP in LA-PDAC:

The Phase 1 LA-PDAC trial is a three part dose-escalation and expansion study evaluating Padeliporfin VTP in patients with vascular encasement deeming them ineligible for surgical resection. As of April 24, 2026, the data cut-off for the poster presentation at ASCO (Free ASCO Whitepaper), seven patients had completed treatment across the 200 mW/cm and the 400 mW/cm dose levels without clinically significant dose-limiting toxicities (DLTs) and were evaluable for potential surgery.

Efficacy Profile:

5 of the 7 (71%) patients underwent successful surgery following Padeliporfin VTP treatment, including 4 of the 7 patients (57%) with R0 margins.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with no complications observed related to arterial injury, thrombosis, ischemia, or significant VTP-related morbidity.

Early clinical observations of Padeliporfin in LA-PDAC support advancement of the program, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates. Subject to future discussions with the U.S. Food and Drug Administration (FDA), the Company believes this program may have potential to move directly into a registrational study.

Key updated results from the Phase 3 ENLIGHTED study of Padeliporfin VTP:

The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. As of April 20, 2026, the data cut-off for the poster presentation at ASCO (Free ASCO Whitepaper), Padeliporfin VTP demonstrated a consistent efficacy profile with 50 of the 72 (70%) response-evaluable patients achieving a CR at the end of Primary Response Evaluation (PRE). 18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, reaching a current median duration of response in the treated area of 23.9 months based on available follow-up. Padeliporfin VTP treatment was well-tolerated and has demonstrated a consistent and acceptable safety profile to date.

ImPact has completed enrollment in ENLIGHTED with topline data expected in 2026. Following positive ongoing discussions with the FDA, including a recent Type C meeting which confirmed the proposed registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer, the Company is on track to submit an NDA in low-grade UTUC in 2027. ImPact is pursuing strategic partnering opportunities to support the commercialization of this program.

ASCO Presentation Details:

Poster Title: Phase I Light-Dose Escalation Study in Locally Advanced Pancreatic Ductal Adenocarcinoma: Intra-Arterial (IA) Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Nadine Abi-Jaoudeh, M.D., Professor of Clinical Radiology, University of California Irvine
Poster Number: 236a
Session Title: Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: Saturday, May 30, 2026 at 9:00 AM CT

Poster Title: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP): The ENLIGHTED Phase 3 Trial
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: 115a
Session Title: Genitourinary Cancer: Kidney and Bladder

Session Date & Time: Sunday, May 31, 2026 at 9:00 AM CT

(Press release, ImPact Biotech, MAY 30, 2026, View Source [SID1234666289])

On May 30, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported updated long-term follow-up data from the pivotal study of PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Updated durability of response data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago in a presentation titled, "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial."

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PAPZIMEOS was granted full approval by the United States Food and Drug Administration (FDA) and was subsequently granted seven-year market exclusivity, further strengthening its position as the first and only approved therapy for the treatment of adults with RRP.

Key data highlights from the ASCO (Free ASCO Whitepaper) presentation include:

15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses as of the April 30, 2026 data cutoff (see Figure 1);
Patients did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during this follow-up period;
All complete responders had at least 36 months of follow-up, with a median follow-up of 36 months (range: 36 to 51 months) and a mean follow-up of 40 months;
5 complete responders have ongoing responses beyond 4 years;
Median duration of complete response has not yet been reached; and
No new safety events were observed during long-term follow-up.
FIGURE 1: Ongoing Durability of Complete Response

"The presentation at ASCO (Free ASCO Whitepaper) marks an important maturation of the PAPZIMEOS pivotal study data, with all complete responders now followed for at least 36 months, 83% with ongoing response, including 5 patients who are surgery-free beyond 4 years," said Helen Sabzevari, PhD, President and CEO of Precigen. "For adults living with RRP, durability matters. These results continue to show that PAPZIMEOS provides sustained complete responses, reinforcing its role as the new standard of care for a disease historically managed through repeated surgeries."

About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients’ work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP.

Indication and Important Safety Information

What is PAPZIMEOS?
PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults.

What is the most important information I should know about PAPZIMEOS?
Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you’re feeling okay.

Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction:

Difficulty breathing
Widespread rash
Facial swelling
Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms:

Shortness of breath
Chest pain
Leg swelling
Persistent abdominal pain
Severe or persistent headaches
Blurred vision
What should I know before taking PAPZIMEOS?
Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including:

If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby.
If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS.
What are the most common side effects of PAPZIMEOS?
The most common side effects include:

Pain, redness, or swelling where the shot was given
Feeling tired
Chills
Fever
Muscle aches
Nausea (feeling sick)
Headache
Increased heart rate
Diarrhea
Vomiting
Sweating a lot
These are not all of the possible side effects of PAPZIMEOS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777).

Please see full Prescribing Information.

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube.

Trademarks
Precigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

(Press release, Precigen, MAY 30, 2026, View Source [SID1234666257])

On May 30, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) reported that the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱) in combination with pembrolizumab (KEYTRUDA[1], MSD’s anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), have been published in the prestigious international medical journal The Lancet (IF=88.5)[2]. The co-senior authors are: Professor Caicun Zhou from Shanghai East Hospital, Tongji University; and Dr. Junyou Ge, Director of the National Engineering Research Centre of Targeted Biologics. The co‑first authors are: Professor Anwen Xiong from Shanghai East Hospital, Tongji University; Professor Wenxiu Yao from Sichuan Cancer Hospital; Professor Wei Zheng from Shengjing Hospital, China Medical University; Professor Yan Yu from Harbin Medical University Cancer Hospital; Professor Peng Chen from Tianjin Medical University Cancer Institute and Hospital; Professor Hua Zhong from Shanghai Chest Hospital; and Dr. Junyou Ge, Director of the National Engineering Research Centre of Targeted Biologics. The study findings were also selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell).

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OptiTROP-Lung05 is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of sac-TMT in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with locally advanced or metastatic PD-L1 TPS≥1% NSCLC.

The interim analysis results show that compared with pembrolizumab monotherapy, the combination of sac-TMT and pembrolizumab significantly prolongs progression-free survival (PFS) and reduces the risk of disease progression or death, with a hazard ratio (HR) of 0.35. Consistent PFS benefits were observed across all prespecified subgroups, including by PD-L1 expression level and histological type, with PFS HRs of 0.47 and 0.28 for the PD-L1 TPS ≥50% and 1–49% subgroups, respectively, and PFS HRs of 0.28 and 0.44 for the non-squamous and squamous subgroups, respectively. A positive trend in overall survival (OS) was also observed, with an HR of 0.55. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone, and no new safety signals identified.

This is the first Phase III trial of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in the first line treatment of NSCLC, and for the first time demonstrate that "ADC+IO" combination of sac-TMT plus pembrolizumab has the potential to achieve survival benefit as first‑line therapy for NSCLC. The publication of these findings in The Lancet further signifies that the clinical and academic value of this combination therapy has received internationally recognized validation.

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, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, 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, four indications for sac-TMT have been approved and marketed in China for: 1) 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); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA).

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, MAY 30, 2026, View Source [SID1234666274])