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CHENGDU, China, Oct. 17, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company’s human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (also known as A166)  was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have received one or more prior anti-HER2 therapy.

The approval is based on a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study that evaluates the efficacy and safety profile of trastuzumab botidotin versus T-DM1 in patients with HER2-positive unresectable or metastatic BC who have received prior trastuzumab and taxane-containing regimens. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR) compared with T-DM1; the beneficial trend for overall survival (OS) of trastuzumab botidotin was also observed. Results from this study will be presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany (Presentation # LBA24, Proffered paper session 1: Breast cancer, metastatic).

The Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

Dr. Michael Ge, CEO of Kelun-Biotech said, “We are thrilled to see our first HER2 ADC drug, trastuzumab botidotin, successfully approved for market. This marks a significant advancement in the treatment of HER2-positive breast cancer. As China’s first domestically developed HER2 ADC capable of broadly covering 2L+ HER2 BC patients, trastuzumab botidotin leverages its differentiated structural design to deliver superior efficacy while addressing unmet clinical needs in this population.”

About HER2+ BC

Breast cancer, as the most common malignant tumor, poses a serious threat to women’s health. Among its subtypes, HER2-positive breast cancer accounts for approximately 15%–20% of all breast cancer cases^[1], and is characterized by its aggressiveness and high malignancy. According to the 2025 CSCO guidelines, first-line treatment for HER2-positive breast cancer primarily consists of trastuzumab and pertuzumab in combination with taxane-based chemotherapeutic agents. Second-line treatment regimens comprise tyrosine kinase inhibitors (TKIs, such as pyrotinib) and antibody-drug conjugates (ADCs, such as T-DM1 and T-DXd). Following disease progression on second-line therapy, subsequent treatment strategies are determined based on prior second-line regimens, the patient’s tolerance to therapy, tumor burden, and other relevant factors. Despite recent advances in anti-HER2 therapeutics, a significant number of patients still experience drug resistance or severe adverse effects, highlighting an urgent need for agents with improved safety profiles to address the treatment requirements of patients with recurrent or drug-resistant HER2-positive breast cancer.

A bout trastuzumab botidotin

Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a drug-to-antibody-ratio (DAR) of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

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. The company 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. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, and more than 10 projects are in the clinical stage. The company 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://kelun-biotech.com/

SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Singapore, 17 October 2025 – ST Engineering’s Marine business and Siemens Energy have been awarded a second contract by Transcontinental Capital Corporation (Bermuda) Ltd., a subsidiary of Seaboard Corporation, to deliver Estrella del Mar IV, a state-of-the-art barge-mounted power plant to Santo Domingo, Dominican Republic.

The new power plant will be based on its predecessor, the Estrella del Mar III. When completed, it will enhance the Dominican Republic’s energy infrastructure with greater efficiency, flexibility and sustainability. The Estrella del Mar IV is expected to be delivered in 2028 where it will be installed alongside the Estrella del Mar III off the shores of Santo Domingo.

“Transcontinental Capital’s decision to award a follow-on project demonstrates confidence in our proven engineering, construction, and project management capabilities, and is also a testament to our successful collaboration with Siemens Energy in delivering a highly efficient power generation facility,” said Tan Leong Peng, President of Marine, ST Engineering.

ST Engineering’s Marine business will be responsible for supplying the engineering design, procurement, construction of the floating power plant, as well as its transportation and installation. By constructing the plant in Singapore and delivering it as a complete plug-and-play solution, the project reduces both cost and construction time compared to a land-based power facility.

Under the agreement, Siemens Energy will supply a 145-megawatt (MW) combined cycle power plant featuring two SGT-800 gas turbines, one SST-600 steam turbine, and an innovative storage system. Based on its visionary SeaFloat concept, this hybrid approach combines high-efficiency power generation with advanced lithium-ion battery storage to maximise performance, improve fuel efficiency and reduce emissions.

“Floating power plants like Estrella del Mar IV demonstrate how innovative engineering can overcome land and infrastructure constraints, while delivering reliable and resilient energy,” said Andreas Pistauer, Global Head of Sales for Gas Services at Siemens Energy.

The Estrella del Mar III was commissioned in 2022. Its innovative integration of marine engineering and energy generation received the Plant of the Year accolade from Power Magazine for its pioneering floating combined-cycle gas turbine power barge. 

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Join us for our half-day event on ‘BESS Route-to-Market: New Models and Impact of Regulatory Challenges on Bankability’, taking place on 18 November 2025 in Frankfurt.

Germany is experiencing a surge in interest around Battery Energy Storage Systems (BESS), positioning them as a key pillar of the energy transition. Yet, while the market gains momentum, standardised route-to-market contracts are still in their infancy. Initial agreements based on UK-style templates are entering the scene, but without careful alignment to the German regulatory framework, they risk legal pitfalls and challenges to bankability. What does this mean for investors, developers and lenders? How can risks be managed effectively while ensuring compliance and financial viability?

Join us for an insightful discussion with leading experts on approaches to shaping robust, future-oriented contract models for BESS in Germany, bringing in latest insights from the UK market. This event is designed to help utilities, funds, financial institutions and asset owners.

KEY TOPICS

• regulatory challenges and their impact on credit structures;
• grid connection: A critical factor in project development and transactions;
• transition in Tolling Agreements; and
• perspectives from lenders and legal experts.

Details and speaker line-up will be announced in early November. Please note: the event will be held in English.

Be part of the conversation – and help shape the future of energy storage.

We kindly ask you to register your interest in attending this in-person event via the ‘Register your interest’ button or by emailing events_germany@wfw.com at your earliest convenience and no later than Monday 10 November. Attendees will be confirmed on a first-come, first-served basis.