• Screens 595 carefully selected genes associated with childhood-onset conditions where early intervention may improve outcomes
• Designed for maternity hospitals, obstetrics practices, newborn care providers, pediatric clinics and families seeking earlier genetic insights from birth
• Expands 3billion’s precision medicine platform from rare disease diagnosis into proactive newborn health management

SEOUL, South Korea and AUSTIN, Texas, June 1, 2026 /PRNewswire/ — 3billion, a global AI-powered genomic diagnostics company, today announced the launch of 3B-NEO, a premium genomic newborn screening (gNBS) service designed to identify genetic risks before symptoms appear and support earlier medical intervention.

3B-NEO was developed in response to growing demand from international healthcare providers and global partners as genomic newborn screening gains momentum worldwide. The service is intended for all newborns and clinically actionable genetic insights focused on conditions where early medical intervention, monitoring, or treatment may meaningfully improve outcomes. Rather than expanding the number of genes analyzed, 3B-NEO was designed to prioritize actionable findings that can support real-world clinical decision-making for physicians and families.

Traditional newborn screening programs primarily rely on biochemical markers and typically assess a limited number of conditions. In contrast, 3B-NEO analyzes 595 carefully selected genes associated with serious childhood-onset disorders where treatment, monitoring, or medical management may improve outcomes. By identifying genetic risks before symptoms emerge, the test can support earlier diagnosis, proactive monitoring, and timely intervention.

The 595 genes panel focuses on conditions that are likely to present during childhood and may benefit from early medical action. These include inherited metabolic disorders, immunologic disorders, neuromuscular diseases, cardiovascular conditions, and other clinically significant pediatric genetic disorders. The service was designed to prioritize actionable information over exhaustive genetic findings, enabling healthcare providers to focus on risks that may influence patient management during infancy and early childhood.

3B-NEO is available in two testing options: a Whole Exome Sequencing (WES)-based standard test and a Whole Genome Sequencing (WGS)-based premium test. Results are typically delivered within approximately two weeks after sample receipt.

The service is designed for hospitals, obstetrics practices, pediatric clinics and families seeking earlier genetic insights for newborns. Healthcare providers can offer 3B-NEO without establishing in-house genomic testing infrastructure, while parents may request testing through participating healthcare providers subject to clinical review and approval.

As genomic newborn screening continues to gain clinical validation through large-scale research initiatives and pilot programs in the United States, Europe, and other regions, demand for earlier genetic risk assessment is growing. 3billion plans to collaborate with healthcare providers globally, including markets where access to advanced genetic testing remains limited but the need for early diagnosis and preventive healthcare continues to increase.

“Genomic newborn screening creates the greatest value when it enables action before symptoms appear,” said Changwon Keum, CEO of 3billion. “Advances in genomic medicine are making it increasingly possible to identify health risks early and prepare appropriate medical interventions before irreversible complications develop. Through 3B-NEO, we aim to help healthcare providers and families make earlier, more informed decisions that can improve long-term health outcomes.”

The launch of 3B-NEO represents an important step in expanding 3billion’s precision medicine platform beyond rare disease diagnosis and into proactive genomic healthcare across the life cycle.

Founded in 2016, 3billion provides AI-powered genomic interpretation and rare disease diagnostic services to healthcare professionals in more than 75 countries and over 800 partner institutions worldwide. The company is expanding its global precision medicine platform from diagnosis toward therapeutic discovery and development.

As part of its U.S. growth strategy, 3billion established its U.S. subsidiary in Austin, Texas, and is preparing local laboratory operations to further support healthcare providers and patients across the United States.

About 3billion

3billion is a global precision medicine company specializing in AI-powered genomic interpretation and rare disease diagnostics. By combining large-scale genomic data with proprietary artificial intelligence technologies, 3billion helps healthcare providers deliver faster and more accurate genetic diagnoses and supports the broader adoption of genomic medicine worldwide.

For more information, visit: 3billion.io/neo and connect with us on LinkedIn, and Instagram.

Media Contact:
ir@3billion.io

Sales Contact:
support@3billion.io

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Lilly licenses Hanmi’s sonefpeglutide (LAPSGLP-2 analog) for multiple indications

SEOUL, South Korea, June 1, 2026 /PRNewswire/ — Hanmi Pharm. Co., Ltd. (“Hanmi”) today announced that they have entered into a license agreement for the development, manufacturing and commercialization of Hanmi’s biologic drug candidate sonefpeglutide (^LAPSGLP-2 analog) with Eli Lilly and Company (“Lilly”).

Sonefpeglutide is a novel drug candidate incorporating Hanmi’s proprietary long-acting platform technology, LAPSCOVERY™. Hanmi has previously received FDA marketing approval for a biologic incorporating its LAPSCOVERY platform and is currently conducting additional global clinical trials for five other programs utilizing the same platform.

Hanmi has focused on the biological functions of glucagon-like peptide 2 (GLP-2) – including the promotion of intestinal growth, reduction of inflammation, and protection and regeneration of the intestinal mucosa – and has demonstrated these effects through a range of non-clinical studies. The company has also presented the therapeutic potential of ^LAPSGLP-2 across multiple indications at major scientific conferences. Hanmi is currently conducting a global Phase 2 clinical trial in short bowel syndrome (SBS).

Hanmi will continue to conduct the ongoing global Phase 2 trial in SBS through completion while Lilly will explore additional clinical trials for sonefpeglutide based on its nonclinical and clinical data.

Through this agreement, Lilly will obtain exclusive rights to develop, manufacture and commercialize sonefpeglutide worldwide, excluding Korea.

Juhyun Lim, Vice Chairman of Hanmi, stated, “It is highly meaningful that Lilly—one of the most closely watched innovators globally—has highly recognized the development potential for sonefpeglutide.” She added, “Hanmi will continue to advance innovative drug development, guided by our mission of ‘Respect for People and Value Creation.'”

Under the agreement, Hanmi will receive an upfront payment of USD 75 million and may receive up to an additional USD 1.185 billion in clinical development, regulatory approval and commercialization milestone payments. In addition, Hanmi will be eligible to receive royalties following product launch.

About Hanmi Pharm. Co., Ltd.

 Hanmi is an R&D-focused pharmaceutical company committed to developing globally innovative therapies in areas of high unmet medical needs such as obesity/metabolism, oncology, and rare diseases. Hanmi leverages proprietary platform technologies, including long-acting biologics and bispecific antibodies, to address unmet medical needs. The company emphasizes open innovation and has established numerous global partnerships to advance its research and development efforts. For more information, please visit www.hanmipharm.com. 

Contact info:
Hanmi Pharm. Co., Ltd. (www.hanmipharm.com, www.linkedin.com/company/hanmipharm) 
innovation@hanmi.co.kr, +82-02-410-0467

Source: Hanmi Pharm. Co., Ltd.

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SYDNEY, June 1, 2026 /PRNewswire/ — Clean energy leader BLUETTI is unleashing massive EOFY deals during June 1–30, up to 44% off its diverse portable power stations and home backup systems. The world’s smallest 3kWh power station Elite 300, the best entry-level Elite 100 V2, and the versatile Apex 300 headline the shopping spree of the year, with exciting online activities unlocking additional discounts, gifts, and exclusive offers.

Must-Buy EOFY Power Station Deals

From weekend camping trips to reliable off-grid home backup, BLUETTI’s comprehensive energy solutions have every scenario covered. Most of them are now available at the lowest EOFY prices:

Elite 100 V2 (1,800W/1,024Wh): Now at $899 (was $1,299), this 11.5kg lightweight unit moves easily between homes and outdoors to run fridge freezers, microwaves, and e-bike chargers. Adding the Charger 1 completes a 560W car charging kit together for only $1,199 (was $1,699). With a 200W solar panel, the bundle is also marked down to $1,349(was $1,899).

Elite 300 (2,400W/3,014Wh): A 3kWh beast in a 2kWh size, for only $2,499(was $3,199). Eight useful outlets, with 12V/30A DC output, and multi-source charging make it well-suited for outdoor scenarios, caravans and home backup. The Charger 2 kit enables quick top-ups via solar and alternator inputs, which is reduced to $2,899(was $3,799), while the Sora 500 solar combo hits an all-time low of $3,499(was $4,898).

Apex 300 (3,840W/2,764.8Wh): Down to $2,999 (was $3,599), it evolves with needs using modular accessories, forming a 58kWh home storage or a 19.2kW solar setup.

More Savings From BLUETTI

Beyond direct markdowns, buyers can maximise their EOFY budgets by participating:

Buy More, Save More: Get $80 off orders over $1500, $135 off $2500, and $240 off $4,000.

Lucky Draws: Subscribe to win coupons, BLUETTI Bucks, or Lifestyle gifts.

Point Redemption: Redeem Bucks for cash-value discounts at checkout.

BLUETTI is also offering bulk purchase discounts, social media giveaways, and exclusive member-only deals throughout the EOFY sale.

From off-grid adventures to home backup, BLUETTI‘s EOFY Sale brings some of the year‘s best deals on portable power solutions. Explore the deals before June 30 on BLUETTI’s website.

About BLUETTI

Founded in 2013, BLUETTI is a technology pioneer in clean energy, specialising in top-notch portable power stations, home backup batteries, and solar solutions. Driven by a mission to provide sustainable power to all, BLUETTI is trusted by over 3.5 million households across 140 countries.

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SHANGHAI, May 31, 2026 /PRNewswire/ — The 28th Shanghai International Film Festival (SIFF) has officially unveiled the competition selections for the 2026 Golden Goblet Awards.

Held from June 12 to 21, the Festival received approximately 4,100 submissions from 125 countries and regions this year, setting a new historical record. According to the Festival, around 3,000 films met the eligibility requirements for competition, while 82% of the submitted entries are world or international premieres. The Festival also expanded its reach with first-time submissions from countries including Ghana and Mozambique.

Notably, all 12 films selected for the Golden Goblet Main Competition will make their world premieres in Shanghai. This marks the first time in the history of the Golden Goblet Awards that the Main Competition has achieved a 100% world-premiere lineup, underscoring Shanghai’s growing appeal as a launch platform for filmmakers from around the world.

The Golden Goblet Awards remain the centerpiece of SIFF’s international competition program, covering Main Competition, Asian New Talent, Documentary, Animation, and Short Film sections.

MAIN COMPETITION

ATLANTIC RHAPSODY
Director: ZHONG Kaifeng
（China）

HALIMA
Director: Yassine El Idrissi
（Morocco）

ILUMINADA
Director: Nicolás Rincón Gille
（Belgium）

LUIZA’S DESERT
Director: Alan Minas
（Brazil, United Kingdom）

MY OWN LAST SUPPER
Director: ismail BASBETH
（Indonesia）

NIGHT OF BLINDNESS
Director: Reis Çelik
（Turkey, Germany）

SEA SONS
Director: Daniil Merkulov
（Russia）

SECRET IN THE BOX
Director: Frankie Tam Kwong Yuen
（Chinese Mainland, Hong Kong China）

SUPERBUHEI
Director: Josef Brandl
（Germany）

THE GREAT SKULL
Director: LIU Xiaoyang
（China）

THE MISERABLE MOTHER
Director: Susanne Heinrich
（Germany, France）

THE PARKING SPOT
Director: Louis Godbout
（Canada）

ASIAN NEW TALENT

9 TEMPLES TO HEAVEN
Director: Sompot Chidgasornpongse
（Thailand）

ABOUT THE MOTHER
Director: Büşra Bülbül
（Turkey）

BOOMAH
Director: Zaid Abu Hamdan
（Jordan, Saudi Arabia）

CASSOWARY
Director: ZHANG Hanyi
（China）

DOG DAY EVENING
Director: Mak Tin Shu
（Chinese Mainland, Hong Kong China）

HER FIRST TASTE
Director: GONG Yiwen
（China）

HUNTER’S MOON
Director: Ridham Janve
（India, Germany）

NO GOOD IN SIGHT: A STORY
Director: Alibi Mukushev
（Kazakhstan）

NO HARD FEELINGS
Director: LIU Shichuan
（China）

SKYLARK
Director: Narghiza Dotieva
（Kyrgyzstan）

STRANGERS IN THE MOUNTAIN
Director: WAN Bo
（China）

THE BLIND GIRL AND AN ELEPHANT
Director: Ishtiyak Ahmad Zihad
（Bangladesh, Germany）

DOCUMENTARY

BENIGNO
Director: David Baute
（Spain）

NOTES UNHEARD
Director: GU Yun
（China）

RUINS
Director: Elena Chemerska
（North Macedonia, Croatia, Slovenia）

THE TIGER OF THE EAST
Director: Jorge Acevedo
（Chile）

WHEELS OF FORGOTTEN DREAMS
Directors: Milos Ljubomirovic, Danilo Lazovic
（Serbia, Bulgaria, Croatia）

ANIMATION

AMADEO AND THE HYPOTHETICAL NEW WORLD
Directors: Brenda Lígia, Edu Felistoque
（Brazil）

DANTE
Director: Linda Hambäck
（Sweden, Norway, Denmark）

GARUDA: DARE TO DREAM
Director: Ronny Gani
（Indonesia）

LUCY LOST
Director: Olivier Clert
（France）

WINNIPEG, SEEDS OF HOPE
Directors: Elio Guiroga, Beñat Beitia
（Spain, Chile, Argentina ）

SHORT FILM (LIVE ACTION)

2000
Director: Renata Lučić
（Croatia）

CHICKEN LADY
Director: YUAN Shuqi
（China, USA）

ELSEWHERE
Director: LIN Tingxuan
（China, Thailand）

KILL, KOKESH, KILL!
Director: Jan Míka
（Czech Republic）

LAST TRAIN
Director: XU Weihao
（China）

LAZARE
Director: Claire Dietrich
（France）

SITTING BIRD
Director: Athena Han
（Canada）

THE DROUGHT
Director: Cristian Popa
（Romania）

THE MATCHMAKER
Director: Sophia Kuestenmacher
（Germany）

ZAZA GOGOGO
Director: CHEN Kedi
（China）

SHORT FILM (ANIMATED)

IF ONLY
Director: Ada Guvenir
（Belgium）

JULKA
Director: Valeria Cozzarini
（Slovenia, Italy）

SHOES
Director: Salvatore Centoducati
（Italy）

UNPLUG
Director: Comandante Bebé
（Spain）

WATER’S TIME SLICE
Director: HE Jiaxuan
（China）

Hong Kong actor Tony Leung Chiu-wai serves as President of the Main Competition Jury, while Singaporean filmmaker Anthony Chen chairs the Asian New Talent section. Documentary filmmaker Geeta Gandbhir heads the Documentary Jury, British animator Will Becher leads the Animation Jury, and Portuguese filmmaker João Salaviza serves as President of the Short Film Jury.

This year’s Festival will present more than 420 international films across over 1,500 screenings throughout Shanghai.

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• Oral presentation of DZD6008 demonstrated strong and durable anti-tumor activity, excellent BBB-penetrant properties, and a favorable safety profile in patients relapsed from third-generation EGFR TKI
• In treatment-naïve patients with advanced NSCLC without driver mutations, Golidocitinib, a JAK-only inhibitor, in combination with anti-PD-1 antibody enhanced anti-tumor response. 

SHANGHAI, May 31, 2026 /PRNewswire/ — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, today announced the presentations of two studies in non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) 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.

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 3^rd 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.

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on LinkedIn or X.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, and “intend” and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal’s competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

Contacts

Investor Relations: ir@dizalpharma.com
Business Development: bd@dizalpharma.com
Media Contact: pr@dizalpharma.com

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CHENGDU, China, May 30, 2026 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”, 6990.HK) announced today that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company’s TROP2 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), was presented as an oral presentation by Professor Caicun Zhou from Shanghai East Hospital, Tongji University (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell).

Sac-TMT is designed with a unique, bifunctional linker and differentiated belotecan-derivative payload. The linker is conjugated via cysteine, which maximizes payload delivery to tumor cells both through its irreversible connection with the high-affinity and targeting anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a moderately toxic novel topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4.

In the OptiTROP-Lung05 study, a total of 413 patients were randomized (1:1) to receive either sac-TMT in combination with pembrolizumab or pembrolizumab monotherapy.

As of the data cutoff date (September 29, 2025), with a median follow‑up of 10.5 months, the study demonstrated that:

• Progression-free survival (PFS) showed statistically significant and clinically meaningful benefit in sac-TMT plus pembrolizumab compared with pembrolizumab alone. The median PFS assessed by blinded independent central review (BICR) was not reached (NR) vs 5.7 months (HR=0.35; 95% CI: 0.26-0.47; p<0.0001). The 12-month PFS rate was 62.4% vs 29.0%.

• Consistent benefit across prespecified subgroups: In patients with PD‑L1 TPS ≥50% and TPS 1–49%, the PFS HRs were 0.47 (95% CI: 0.29–0.77) and 0.28 (95% CI: 0.19–0.41), respectively. In patients with non‑squamous and squamous NSCLC, the PFS HRs were 0.28 (95% CI: 0.18–0.43) and 0.44 (95% CI: 0.29–0.66), respectively.

• Overall survival (OS) was not yet mature but showed a positive trend: median OS was NR vs 14.5 months (HR = 0.55; 95% CI: 0.36–0.85). The 12‑month OS rate was 80.4% vs 68.9%.

• The combination group showed improvements over pembrolizumab monotherapy group in objective response rate (ORR) (70.2% vs 42.0%), deep response rate (49.0% vs 25.9%), and 12-month duration of response rate (77.7% vs 59.4%).

The incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in the combination group, primarily driven by the expected hematologic adverse events of sac-TMT. Incidence of discontinuation of pembrolizumab due to TEAEs was similar in both groups. No sac-TMT-related deaths occurred. Adverse events of special interest (AEOSIs) were consistent with the known safety profiles of each individual agent, and no new safety signals were identified.

The interim analysis results show that sac-TMT plus pembrolizumab significantly prolonged PFS and reduced the risk of disease progression or death compared with pembrolizumab alone, with consistent PFS benefits observed across all prespecified subgroups (including PD‑L1 expression levels and histological subtypes). A positive trend in OS was also observed. 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.

Notably, the findings of OptiTROP-Lung05 have been simultaneously published in The Lancet（Impact Factor=88.5）, indicating that its clinical and academic value has received dual recognition from a leading international academic conference and an authoritative journal.

Professor Caicun Zhou, the national leading principal investigator from Shanghai East Hospital, Tongji University, said: “The positive results of the OptiTROP‑Lung05 study are encouraging. The study not only supports the application of sac‑TMT in an earlier-line setting for lung cancer, but also provides evidence of the ‘ADC+IO’ synergistic strategy being evaluated in the first-line setting for PD‑L1‑positive advanced NSCLC, potentially bringing a new option to a broad population of patients with lung cancer.”

About sac-TMT(佳泰莱^®)

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.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

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