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Timekettle Announces 2026 Breakthroughs in AI Interpretation, Introducing Its State-of-the-Art Translation Engine Selector and Next-Generation Bone-Conduction Voice Capture

Flagship W4 Earbuds Become the Most Accurate Interpreter Device Ever Released

LAS VEGAS, Jan. 5, 2026 /PRNewswire/ — Timekettle, the global leader in AI-powered cross-language communication, today announces a major system-wide upgrade that redefines what real-time translation can achieve. Central to this leap forward is Timekettle’s new SOTA (State of the Art) Translation Engine Selector, a behind-the-scenes but transformative capability that dynamically identifies the optimal translation model for each language pair and conversational scenario in real time.

SOTA Translation Engine Selector
SOTA Translation Engine Selector

While invisible to the user, the impact is unmistakable: the fastest, most precise, and most natural translations Timekettle has ever delivered, regardless of accent, grammar structure, or speaking style. This upgrade arrives alongside an enhanced Bone-Conduction & Hybrid Algorithm, now offering even cleaner, more accurate voice capture by improving the purity of the user’s vocal signal before it reaches the translation pipeline.

Together, these advancements make the flagship W4 Interpreter Earbuds the most accurate in company history, surpassing the already industry-leading performance showcased at IFA 2025 that leaves its competition lost in translation. 

Since, hearing is believing, this innovation along with the full Timekettle portfolio can be experienced throughout CES at the Timekettle booth [LVCC, North Hall — 9163].

A Leap Forward in Machine Understanding: SOTA Translation Engine Selector

Different language pairs behave like entirely different systems—English to Korean follows different logic than German to English; Spanish to Chinese requires different segmentation, prediction, and contextual inference than Japanese to French. Timekettle’s SOTA Translation Engine Selector resolves this fundamental problem by:

  • Detecting the language pair and context in real time
  • Selecting the specialized AI engine best suited to that specific pair
  • Optimizing accuracy, fluency, and naturalness for each exchange

This is equivalent to assigning a “native specialist” to every conversation. This capability is made possible by Timekettle’s advanced Large Language Model and the ongoing evolution of its Babel OS platform now updated with new machine-learning layers trained on millions of linguistic samples.

The result: translations that sound less like a machine “attempting” to interpret—and more like a system that genuinely understands the intent, tone, and structure of what is being said. To Timekettle users, this means that no matter what languages they speak, Timekettle can always match them with the world’s best translation engines to serve their needs, enabling them to enjoy the most accurate cross-language communication experience without fear, awkwardness, or hesitation; to truly express themselves boldly and communicate naturally.

Next-Generation Bone-Conduction & Hybrid Algorithm: Superior Voice Capture for Superior Accuracy

Building on its proprietary bone-voiceprint sensor technology, the enhanced 2026 algorithm upgrade extracts cleaner vocal vibrations to improve signal purity, isolates noise more effectively in chaotic environments, and more accurately identifies speakers during multi-voice conversations. These improvements work together to deliver far clearer acoustic input—the foundation of any high-precision translation—and ensure that the system captures meaning with exceptional fidelity. Because AI translation quality is only as strong as the audio it receives, this upgrade dramatically elevates performance across business meetings, travel scenarios, classrooms, and multilingual events.

Rolling Out Across the Entire Timekettle Portfolio

Beginning in early 2026, the SOTA Translation Engine Selector, updated Hybrid Algorithm, and extended Babel OS enhancements will roll out across the full Timekettle product family, including:

  • W4 Interpreter Earbuds: Now the most accurate consumer translation earbuds Timekettle has produced
  • W4 Pro: Elevated for professional meetings and enterprise use
  • T1 AI Translator: The world’s fastest offline translator now combines Edge AI with the SOTA Engine Selector to boost accuracy beyond its already industry-leading offline performance and ultra-fast 0.2-second response time.
  • WT2 Edge, M3 Earbuds, and X1 Interpreter Hub: Each gaining improvements in context prediction, segmentation, and tonal translation

Shared Capabilities Across the Timekettle Portfolio

Across its expanding lineup of earbuds and handheld translators, Timekettle delivers a unified experience built around seamless, natural, real-time communication. All devices support instant translation across 43 languages and 96 accents, covering more than 95% of global regions to enable smooth, uninterrupted conversations anywhere in the world. Users benefit from all-day practicality as well, with long-lasting battery performance designed for travel, business, and extended multilingual interactions.

Timekettle’s conversation modes are consistent across the portfolio, offering flexible ways to communicate in different settings. One-on-One Mode allows two people to share earbuds for fluid, face-to-face dialogue. Listen & Play Mode records spoken audio through the app and provides translations that can be reviewed or replayed later. Speak Mode enables users to talk into their device and have translated speech broadcast clearly through the phone’s speaker, ideal for group discussions, classroom settings, tours, or presentations.

Whether using earbuds like the W4 or handheld devices such as the T1, the Timekettle ecosystem is designed to make multilingual communication effortless, intuitive, and adaptable to nearly any scenario.

“Accuracy is the result of perfect collaboration between hardware and software,” said Leal Tian, Founder & CEO of Timekettle. “With the introduction of our SOTA Translation Engine Selector and the next-generation bone-conduction algorithm, we’ve elevated that collaboration to a new level. W4 becomes the most accurate interpreter device we’ve ever created—and this upgrade strengthens every product across our portfolio.”

Availability

The 2026 SOTA Translation Engine Selector upgrade and enhanced Hybrid Algorithm will begin rolling out via over-the-air updates across supported Timekettle devices starting January 2026, with the full portfolio supported throughout Q1. The Timekettle portfolio is available to buy at www.timekettle.co and Amazon. Prices include W4 Interpreter Earbuds ($349), W4 Pro ($449), T1 AI Translator ($299.99), WT2 Edge ($349.99), M3 Earbuds ($149.99), and X1 Interpreter Hub ($699.99).  

About Timekettle

Since 2016, Timekettle has led innovation in AI-driven cross-language communication, with award-winning devices used by travelers, businesses, educators, and multilingual teams worldwide. Its products—including the W4 and W4 Pro Interpreter Earbuds, WT2 Edge/W3 series, X1 Interpreter Hub, and T1 AI Translator—deliver seamless, natural, and secure communication across nearly all global regions.

Kardome Launches Cognition AI: On-Device, Context-Aware Voice UI


Tel Aviv, Israel – Newsfile Corp. – January 5, 2026 – Kardome, a pioneer in voice AI solutions, today introduced Cognition AI, a breakthrough technology designed to make on-device voice interfaces truly intelligent and bring natural voice interaction to cars, homes, and the workplace, where traditional systems often struggle.

Cognition AI, combined with Spatial Hearing AI, serves as the core engine powering Kardome’s next-generation on-device voice AI solutions. It enables systems to identify who is speaking and understand their intent, without relying on rigid commands or constant cloud connectivity. This marks a significant step toward creating voice interactions that are more natural, responsive, and reliable in everyday life.

“The integration of AI devices into everyday life won’t happen until those devices can continuously listen to their environment and understand the context of what’s happening around them-and that processing must occur on the device itself,” said Dani Cherkassky, CEO of Kardome, underscoring the importance of on-device intelligence for privacy and responsiveness.

“Cognition AI enables exactly that: on-device, intent-aware voice UI that works reliably, even in noisy, complex environments.”

Image caption: Cognition AI empowers systems to understand who is speaking and their intent, without relying on rigid commands or constant cloud connectivity.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/8225/279375_d6291e71e45028a9_001full.jpg

Powered by On-Device Intelligence

Cognition AI reflects a shift from cloud-dominated architecture to on-device, low-latency hybrid systems. It allows voice interfaces to operate naturally and privately, handling everyday variability without requiring pre-scripted inputs.

Cognition AI is an on-device Small Language Model that mimics the human auditory-cognition system. It enables faster, more reliable, and more private voice interactions by interpreting intent and context in real time-handling simple tasks directly on the device and activating cloud LLMs only when deeper reasoning is required. This hybrid-AI approach brings voice interfaces closer to natural human communication.

Stacked for Seamless Interaction

Cognition AI and Spatial Hearing AI create a robust, full-stack voice AI solution for smart devices. Together, they deliver:

  • 3D sound localization and identification
  • Real-time multi-speaker separation
  • Context-based interaction

The result is a new class of voice-first products that feel less like talking to a machine and more like talking to humans. That is the on-device voice AI that will enable the integration of AI devices into everyday life.

Live at CES 2026

Kardome will demonstrate Cognition AI live at CES 2026, Booth #4117 (West Hall), showcasing real-time demos across automotive, smart home, and industrial applications. More information can be found here.

About Kardome
Kardome delivers on-device Voice AI that makes voice UI perform reliably in real-world conditions. Powered by Spatial Hearing AI and Cognition AI, it localizes sound sources, identifies who’s speaking, and understands what they mean in context, enabling hands-free, frustration-free voice-led experiences from noisy car cabins to shared living spaces and beyond. Trusted by leading automotive and smart home brands, Kardome works with technology partners such as NVIDIA and is deployed in more than 11 million devices to date. More information can be found at Kardome.com.

For Media Inquiries
Laura Tate
VP Marketing, Kardome
323-205-6436
Laura.tate@kardome.com

The issuer is solely responsible for the content of this announcement.

About Kardome Technology

Meraas unveils Dubai Design District residential masterplan, introducing a world-class waterfront neighbourhood

DUBAI, UAE, Jan. 5, 2026 /PRNewswire/ — Meraas, a member of Dubai Holding Real Estate, has unveiled an expanded residential masterplan for Dubai Design District (d3), transforming the district into one of Dubai’s most desirable creative-led waterfront neighbourhoods.

 

Design District Masterplan 1
Design District Masterplan 1

 

Located between Downtown Dubai and Dubai Creek Harbour, the enhanced masterplan spans 18 million sqft of land. Designed and delivered by Meraas, the neighbourhood blends residential, cultural, retail and hospitality experiences, reinforcing Dubai’s ambition to strengthen its position as a global centre for design, innovation and culture in line with the Dubai Economic Agenda D33.

A defining feature of the new masterplan is the Design Line, a fully shaded, pedestrian-first spine that seamlessly connects the entire district. Activated through public art, creative installations, community spaces and landscaped green corridors, it will support walkable, human-centric living while strengthening d3’s identity as one of Dubai’s most design-forward urban neighbourhoods.

Five distinct areas will shape the character of the new neighbourhood. Along the canal, the first will introduce contemporary residences and boutique hospitality set against an activated waterfront promenade. The urban core will unite residential offerings with curated retail and dining, integrated with d3’s established global creative ecosystem. A third area will become the cultural heart of the community, featuring performance venues and mid-rise residences overlooking the d3 Bowl. Another will offer a wellness-focused residential setting defined by parks, sports facilities and a mangrove-inspired landscape. The final area will become a centre for creativity, with galleries, studios and loft-style spaces designed to support collaboration, creativity and artistic production.

Khalid Al Malik, Chief Executive Officer of Dubai Holding Real Estate, said: “Expanding the Dubai Design District masterplan into a fully integrated creative neighbourhood is a significant step in advancing the ambitions of the Dubai Economic Agenda D33. This development strengthens Dubai Design District’s position as a global benchmark for design-focused urban living and reaffirms Dubai’s status as a destination of choice for long-term investment, talent and innovation.”

With its expanded vision, new residential offering and distinctive creative identity, the enhanced d3 masterplan will establish the district as one of Dubai’s most inspiring and globally relevant neighbourhoods – a place where creativity shapes everyday life and where the world’s creative community can truly belong.

Click here to watch the video

 

Design District Masterplan 2
Design District Masterplan 2

 

Design District Masterplan 3
Design District Masterplan 3

 

Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC SKB105 from the NMPA

CHENGDU, China, Jan. 5, 2026 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company”, 6990.HK) announced that its Investigational New Drug (IND) application for SKB105 (also known as CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors.

In December 2025, Kelun-Biotech and Crescent Biopharma, Inc. (“Crescent”) entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD-1 x VEGF bispecific antibody, also known as CR-001). Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. The IND application for SKB118/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. Kelun-Biotech plans to submit an IND application for SKB118/CR-001 to the Center for Drug Evaluation of the National Medical Products Administration of China in the near future.

About SKB105 (also known as CR-003)

SKB105 is a differentiated ADC targeting ITGB6 with a topoisomerase I inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 incorporates proprietary Kthiol® irreversible conjugation technology, linking an anti-ITGB6 fully human Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) to a clinically validated cleavable linker. This design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.

About SKB118(also known as CR-001)

SKB118/CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, SKB118/CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118/CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, particularly in conjunction with ADCs. 

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), 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, inflammatory, 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 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 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/.

Cango Inc. Announces December 2025 Bitcoin Production and Mining Operations Update

DALLAS, Jan. 5, 2026 /PRNewswire/ — Cango Inc. (NYSE: CANG) (“Cango” or the “Company”), a leading Bitcoin miner leveraging its global operations to develop an integrated energy and AI compute platform, today published its Bitcoin production and mining operations update for December 2025.

Bitcoin Mining Production and Mining Operations Update for December 2025

Metric

December 2025 [1]

November 2025 [1]

Number of Bitcoin produced

569.0

546.7

Average number of Bitcoin produced per day

18.35

18.22

Total number of Bitcoin held [2]

7,528.3

6,959.3

Deployed hashrate

50 EH/s

50 EH/s

Average operating hashrate [3]

43.36 EH/s

44.38 EH/s

 

1.       Unaudited, estimated.

2.       As of month-end.

3.       Average over the month.

Note: Cango holds Bitcoin for the long term and does not currently intend to sell any of its Bitcoin holdings.

Paul Yu, CEO and Director of Cango, commented, “Throughout 2025, Cango delivered strong and consistent operational growth. In December, due to favorable network difficulty adjustments, we maintained stable operating hashrate levels and achieved higher daily Bitcoin production, bringing our total Bitcoin holdings to 7,528.3 BTC. Additionally, in late December, a major shareholder decided to increase its investment in Cango with a US$10.5 million commitment, which expected to close in January 2026, representing a powerful vote of confidence in our strategic roadmap. This commitment will enable us to drive greater Bitcoin mining efficiency, and accelerate the parallel development of our energy and AI compute platform in 2026.”

About Cango Inc.

Cango Inc. (NYSE: CANG) is a Bitcoin mining company with a vision to establish an integrated, global infrastructure platform capable of powering the future digital economy. The Company’s mining operations span over 40 sites across North America, the Middle East, South America, and East Africa.

Since entering the digital asset space in November 2024, Cango has activated pilot projects in both integrated energy solutions and distributed AI computing. In parallel, Cango continues to operate an online international used car export business through AutoCango.com. 

For more information, please visit: www.cangoonline.com.

Investor Relations Contact
Juliet Ye, Head of Communications
Cango Inc.
Email: ir@cangoonline.com 

Christensen Advisory
Tel: +852 2117 0861
Email: cango@christensencomms.com

 

Bybit Launches Program to Upskill Sri Lankan Creators with Fully Sponsored Market Education Program

DUBAI, UAE, Jan. 5, 2026 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, has launched a fully sponsored market literacy education initiative aimed at supporting financial literacy and responsible market understanding among Sri Lanka-based creators, in partnership with Mastering the Markets.

The online initiative is designed to upskill creators by providing a structured foundation in how financial markets operate, with an emphasis on accurate and responsible financial communication. Selected participants will receive access to a structured 10-week course covering market structure, technical analysis fundamentals, risk awareness, and disciplined decision-making.

Creators are selected through an application-based competition to participate in the fully sponsored market education initiative focused on foundational market knowledge and responsible financial communication.

The curriculum covers core principles of technical analysis and market behavior, including market structure, price action, trends, support and resistance, and risk management. The initiative is educational in nature and does not constitute financial, investment, or trading advice.

While certain examples within the course may reference digital asset markets, the analytical frameworks taught are broadly applicable across global financial markets. The program is intended to help creators develop a clearer understanding of market behavior and communicate financial concepts clearly and responsibly to their audiences.

“This structured 10-week program is designed to help creators strengthen their foundational market knowledge and communicate responsibly,” said David Bird, Founder & Chief Education Officer at Mastering the Markets. “By focusing on strong foundations and disciplined thinking, we help people build the knowledge and confidence needed to engage with markets responsibly and over the long term.”

“Education plays an important role in how people engage with financial markets,” said Nazar Tymoshchuk, Bybit’s Mini-Global Regional Manager. “This initiative supports structured learning by giving creators access to a clear, curriculum-based foundation that can be communicated in an accessible and responsible way.”

The initiative is open to Sri Lankan key opinion leaders who demonstrate a commitment to educating themselves and their communities. By combining foundational market education with exposure to both traditional financial markets and digital asset concepts, participants gain a broader educational framework for understanding global market behavior.

Upon completion of the course, participants will gain a clearer understanding of market dynamics, technical frameworks, and how structured market analysis methodologies are applied. The initiative aims to support the creation of more educational, accurate, and responsible financial content within Sri Lanka’s creator community.

Following earlier community-focused initiatives in Sri Lanka, the program reflects Bybit’s continued investment in education-focused engagement through partnerships with established market educators.

Sri Lankan creators interested in participating may submit their details through the official application form. Shortlisted participants will be contacted separately. More information about the initiative is available here.

#Bybit / #TheCryptoArk / #IMakeIt

Bybit Launches Program to Upskill Sri Lankan Creators with Fully Sponsored Market Education Program
Bybit Launches Program to Upskill Sri Lankan Creators with Fully Sponsored Market Education Program

About Bybit

Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving a global community of over 80 million users. Founded in 2018, Bybit is redefining openness in the decentralized world by creating a simpler, open and equal ecosystem for everyone. With a strong focus on Web3, Bybit partners strategically with leading blockchain protocols to provide robust infrastructure and drive on-chain innovation. Renowned for its secure custody, diverse marketplaces, intuitive user experience, and advanced blockchain tools, Bybit bridges the gap between TradFi and DeFi, empowering builders, creators, and enthusiasts to unlock the full potential of Web3. Discover the future of decentralized finance at Bybit.com.

For more details about Bybit, please visit Bybit Press
For media inquiries, please contact: media@bybit.com
For updates, please follow: Bybit’s Communities and Social Media

Discord | Facebook | Instagram | LinkedIn | Reddit | Telegram | TikTok | X | Youtube

 

Sisram Medical Reports Completion of NIFDC Testing for DAXXIFY in China

Marking a Key Milestone Toward Market Launch and Strengthening Sisram’s Premium Aesthetics Portfolio

HONG KONG, Jan. 5, 2026 /PRNewswire/ — Sisram Medical Ltd (the “Company” or “Sisram”, 1696.HK; together with its subsidiaries collectively referred to as the “Group”), a global wellness group offering Energy-Based Devices (EBD), injectables, diagonostics, and other complementary solutions, today announced that its long-acting botulinum toxin type A product, DAXXIFY (trademark in Chinese Mainland达希斐®), has passed the quality testing from National Institutes for Food and Drug Control of the People’s Republic of China (“NIFDC”). This milestone confirms that DAXXIFY meets the rigorous requirements set by China’s national drug regulatory system regarding quality, safety, and efficacy, successfully completing the final critical step towards market launch.

DAXXIFY is the world’s first and only long-acting peptide-formulated neuromodulator, containing the active pharmaceutical ingredient botulinum toxin type A (DaxibotulinumtoxinA). It is also the first and only botulinum toxin type A product approved in mainland China featuring proprietary Peptide Exchange Technology (PXT) and a stabilized peptide formulation. Designed to deliver both a long duration of effect and a rapid onset of action, DAXXIFY addresses the temporary improvement of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Currently, Sisram has reached initial commercial orders with several core medical aesthetic institutions, fully validating market expectations and recognition for this long-acting innovative product and marking its transition from the preparation stage to the sales phase.

To advance the commercialization of DAXXIFY, the Company has established a comprehensive professional team responsible for market expansion, clinical support, and supply chain management. The experienced sales and marketing team continues to cultivate core medical networks, deepening strategic collaborations with medical aesthetics institutions. A dedicated medical affairs team empowers physicians to provide standardized and precise treatments through systematic training programs and clinical evidence generation. In operations and supply chain management, the Company has partnered with industry leaders, including Fosun Wanbang (Jiangsu) and Shanghai Pharmaceuticals, to establish an efficient, reliable, and fully traceable supply chain system. This collaborative approach ensures that all stages, from production and logistics to final clinical delivery, adhere to stringent quality and compliance standards, supporting market readiness and reinforcing confidence across the medical aesthetics community. 

Leading a New Premium Choice in Medical Aesthetics and Powering the New Engine of Business Growth

As the first injectable product launched in mainland China, DAXXIFY offers a premium choice for consumers seeking higher standards of quality and exceptional aesthetic experiences. This successful testing signifies the final regulatory milestone before the market launch. Supported by a well-defined differentiation strategy, a structured value system, and a robust operational framework, the Company believes that DAXXIFY is set to become a cornerstone of Sisram’s injectable portfolio and a key driver of business growth. Furthermore, the product is poised to support Sisram’s strategic expansion into injectables, creating a “second growth curve” and strengthening the Company’s competitiveness through an integrated wellness ecosystem encompassing EBD technologies, injectables, diagnostics, and complementary solutions. The team is fully dedicated to bringing DAXXIFY to market, with the product expected to be available for clinical application soon. Sisram looks forward to providing DAXXIFY to partner institutions across mainland China, enabling a wide range of consumers to experience the outstanding effects while reinforcing its commitment to delivering diverse and reliable wellness solutions to the market.

About Sisram Medical Ltd

Sisram Medical Ltd (1696.HK) is a global leader in medical aesthetic solutions with over 25 years of expertise in Energy-Based Devices (EBD). Built on a legacy of innovation and clinical excellence, the Company’s synergistic ecosystem spans EBD technologies, injectables, diagnostics, and complementary solutions. Serving customers in over 110 countries and regions, Sisram delivers award-winning products that set new standards in safety, efficacy, and personalized aesthetic care for millions of patients worldwide. Majority-owned by Fosun Pharma, Sisram has been listed on the Main Board of the Hong Kong Stock Exchange since September 2017.

For more information, please visit: https://sisram-medical.com/.

Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) in Combination with Immunotherapy Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC

CHENGDU, China, Jan. 5, 2026 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company,” 6990.HK) today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) in combination with MSD’s anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[1]) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and ALK-negative. 

BTD is granted for treatment regimens that provide effective treatment or prevention for conditions with no currently available therapy, or that demonstrate significant clinical advantages over currently available treatments. For drugs included in the breakthrough therapy process, if relevant conditions are met, applications for conditional approval and priority review and approval can be submitted when applying for marketing authorization.

Previously, the company announced that results from the Phase III clinical trial of OptiTROP-Lung05, evaluating sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC, demonstrated a statistically significant and clinically meaningful improvement in its primary endpoint of progression-free survival (PFS). A positive trend was also observed in overall survival (OS). OptiTROP-Lung05 is the first Phase III study of an immunotherapy and ADC combination to meet its primary endpoint in the first-line treatment of NSCLC. Granting of BTD for the first-line treatment of PD-L1-positive NSCLC indication offers pathways to expedite the review and potential approval process of sac-TMT for this indication.

To date, sac-TMT has received five BTDs for:

  • locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
  • locally advanced or metastatic EGFR-mutant NSCLC after progression on EGFR-TKI therapy in January 2023;
  • locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023;
  • first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024;
  • In combination with anti-PD-L1 monoclonal antibody tagitanlimab for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations in June 2025.

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, gastric cancer (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: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; Unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. The first two indications listed above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of cancer patients.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for second-line and above treatment of HR+/HER2- BC was accepted by the Center for Drug Evaluation of the National Medical Products Administration, and was included in the priority review and approval process.

As of today, Kelun-Biotech 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.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), 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, inflammatory, 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 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 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/.

[1] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.