Healthcare · Automotive
Berlin, September 9, 2026 – Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI).
“The FDA’s accelerated approval of sevabertinib marks an important advance for treatment-naïve patients with HER2-mutated NSCLC who historically have a poor prognosis,” said SOHO-01 lead investigator, Xiuning Le, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. “This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.”
The FDA approved this indication for sevabertinib under accelerated approval based on objective response rate (ORR) and duration of response (DOR) demonstrated in a cohort of treatment-naïve patients (N=69) in the ongoing Phase I/II SOHO-01 trial (NCT05099172), evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC. In this cohort, the ORR was 75% including complete responses in 6% of patients and partial responses in 70% of patients, with 73% of responders maintaining response for at least six months. The safety profile of sevabertinib was consistent with previous findings. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277), which is evaluating sevabertinib versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC.
“Today’s FDA approval of sevabertinib as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.”
In November 2025, sevabertinib received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2-targeted therapy and cohort E - patients who had previously received HER2-directed antibody-drug conjugates). Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. The approval follows the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for this patient population. The CDE has also granted sevabertinib Breakthrough Therapy Designation to expedite its development for first-line use in patients with advanced HER2-mutant NSCLC. Sevabertinib has also recently been approved as the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment, by the Ministry of Health, Labour, and Welfare in Japan.
About sevabertinib
Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.
As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with HER2-activating mutations, excluding advanced NSCLC.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Sep 9 · 18:20·Bayer
Sustainability
Global finance executive brings more than 20 years of leadership experience driving growth, transformations, and value creation across multinational organizations TRENTON, N.J., Sept. 9, 2026 -- TerraCycle, Inc., an international leader in innovative sustainability solutions,...
Sep 9 · 15:16·PR Newswire
AI · SaaS
HONG KONG, Sept 9, 2026 - The 11th Belt and Road Summit, co-organised by the Government of the Hong Kong Special Administrative Region (HKSAR) and the Hong Kong Trade Development Council (HKTDC), opened today at the Hong Kong Convention and Exhibition Centre in Wan Chai. Under the theme Advancing High-Quality Development • Embarking on a New Journey, the Summit brings together more than 100 government officials, business leaders and professionals from Belt and Road countries and regions to jointly explore new opportunities in high-quality Belt and Road development, to promote cross-regional trade and industrial matching, and accelerate the implementation of concrete outcomes.
The Summit has achieved significant results in promoting international cooperation and facilitating business partnerships. Multiple memoranda of understanding (MoUs) and agreements were signed on the first day, spanning sectors such as finance, professional services, industry and construction, and involving organisations from the Chinese Mainland, Australia, Indonesia, Kazakhstan, Laos, Malaysia, Oman, Qatar and Uzbekistan. More MoUs and agreements are expected to be signed tomorrow, helping to transform connections forged and ideas exchanged at the Summit into tangible collaborations and business opportunities.
The Opening Session featured opening remarks by John Lee, Chief Executive of the HKSAR, and welcome remarks by Professor Frederick Ma, Chairman of the HKTDC. Abdulla Aripov, Prime Minister of Uzbekistan, Carolina Cosse, Vice President of Uruguay, and Saleumxay Kommasith, Deputy Prime Minister of Laos, delivered special addresses. Yan Dong, Vice Minister of the Ministry of Commerce of the People’s Republic of China, and Li Zhen, Vice Chairman of the State-owned Assets Supervision and Administration Commission of the State Council of the People’s Republic of China, delivered special remarks.
John Lee said in his opening remarks: “Hong Kong is an ideal two-way springboard for Mainland enterprises expanding overseas, and for international companies looking to enter the Mainland market. Our GoGlobal Task Force, established last October, has assisted more than 300 Mainland enterprises in establishing or expanding their businesses in Hong Kong, and our world-class professional services are ready to support their overseas expansion plans.” He continued: “In addition to strengthening our relations with traditional partners, Hong Kong continues to expand our network of friends along the Belt and Road. Since 2022, I have led high-level business delegations to explore opportunities in 13 Belt and Road countries across ASEAN, the Middle East, and Central Asia. These missions delivered over 250 MOUs (Memorandum of Understanding) and other agreements, from policy co-ordination and trade and investment, to expanded connectivity and support for companies. They underline Hong Kong's long-standing focus on opening new markets, forming new partnerships and advancing regional co-operation.”
John Lee, Chief Executive of the HKSAR, delivered opening remarks at the Opening Session.
Professor Frederick Ma said in his welcome remarks: “In a world full of risks and uncertainties, diversification is a necessity, not a choice. We must seize new opportunities even as we navigate new challenges. That is why the Belt and Road Initiative has never been more relevant. At its core, the Initiative is about forging new connections, turning potential into opportunity and opportunity into tangible development that benefits communities around the world. ASEAN, Central Asia, the Middle East, Africa and Latin America are among the regions with the greatest growth potential. As an important commercial platform for the Belt and Road Initiative, Hong Kong will continue to leverage its unique strength in connecting the Chinese Mainland with global markets. This year's Summit introduces new thematic zones, including the ‘GoGlobal Connect’ zone, bringing Hong Kong’s professional services expertise to support enterprises to expand internationally and capture new opportunities in global markets.”
Professor Frederick Ma, Chairman of the HKTDC, delivered welcome remarks at the Opening Session.
Abdulla Aripov said in his special address: “Uzbekistan regards the Belt and Road Initiative as an effective platform for reviving the ancient Silk Road in a modern format and advancing cooperation in trade, transport, investment, industrial collaboration, technology, capital, and human resources. Today, our cooperation with Belt and Road countries has been elevated to comprehensive strategic partnerships. Undoubtedly, the close and trusting relationship between the leaders of our two nations, President Shavkat Mirziyoyev of the Republic of Uzbekistan and President Xi Jinping of the People’s Republic of China, plays a crucial role in this development. Uzbekistan is ready to be a reliable, long-term partner in building a Belt and Road community of shared development and prosperity. We invite all participants to join us in creating new manufacturing and technology value chains in Uzbekistan, expanding investment and financial cooperation, and using Uzbekistan as a gateway to Central Asia and neighboring markets.”
Abdulla Aripov, Prime Minister of Uzbekistan, delivered a keynote special address at the Opening Session.
Carolina Cosse said in her special address: “In 2018, Uruguay was the first country in Mercosur to formally express its support of the Belt and Road Initiative. We were also the first country in South America to sign a memorandum of understanding on the Belt and Road Initiative with the People's Republic of China. The BRI pillars of infrastructure, connectivity, trade facilitation, and financial integration aligned with Uruguay's long-standing belief in multilateral cooperation and free trade. Uruguay stands ready to translate our commitment to the Belt and Road into tangible cooperative outcomes with Hong Kong and with all partners assembled here. thus facilitating capital flows, trade financing, and project development into Latin America and Asia.”
Carolina Cosse, Vice President of Uruguay, delivered a keynote special address at the Opening Session.
Saleumxay Kommasith said in his special address: “We regard the Belt and Road Initiative as a vital cornerstone of our long-term country development agenda. It has contributed significantly to expanding trade, attracting foreign direct investment, developing modern infrastructure, and strengthening people-to-people connection across the border.The most tangible evidence under the framework of high-quality BRI cooperation is the historic achievement of the Lao-China Railway since its launch in 2021. Today, it has facilitated over 70 million passengers and transported over 90 million metric tons of freight, contributing to expanding our trade profile from just 13 regional commodity categories to more than 4,000 types of products today. Driven by this advanced connectivity, bilateral trade between Lao PDR and China has achieved a new milestone, surpassing 9.8 billion US dollars. It has successfully transformed the Lao PDR from a landlocked country into a land-linked regional logistics hub. It has significantly reduced logistics costs and integrated Lao PDR into the regional supply chain.”
Saleumxay Kommasith, Deputy Prime Minister of Laos, delivered a keynote special address at the Opening Session.
Yan Dong said in his special remarks: “We will support Hong Kong in leveraging its professional service advantages to participate deeply in Belt and Road cooperation projects, guide Hong Kong enterprises to provide professional services such as legal consultation, financial and insurance services, mediation and arbitration for project implementation, strengthen information exchange between Chinese Mainland and Hong Kong enterprises, with the aim of achieving mutual benefit and win-win outcomes through joint ventures and other means.”
Yan Dong, Vice Minister of Minister of Commerce of the People’s Republic of China, delivered a special remarks at the Opening Session.
Li Zhen said in his special remarks: “We support Hong Kong and Macao in better integrating into the new policies for national development - we guide central state-owned enterprises to establish treasury and trade centres, research and development institutions and international business headquarters in Hong Kong; and we support Hong Kong in consolidating and enhancing its status as an international financial, shipping and trade centre, as well as an international aviation hub. Looking ahead, drawing on the unique advantages of ‘One Country, Two Systems’, Hong Kong is bound to play a significant role as a ‘super connector’ and ‘super value-adder’”
Li Zhen, Vice Chairman of the State-owned Assets Supervision and Administration Commission of the State Council of the People’s Republic of China, delivered a special remarks at the Opening Session.
Government and business leaders explore new avenues for cross-regional cooperation
Against a backdrop of a reshaped global trade landscape, ongoing supply chain reconfiguration and increasing geopolitical uncertainty, enhancing trade and investment resilience has become a key priority for economies worldwide. Following the Opening Session, the Policy Dialogue, themed Building Resilient Trade and Investment Frameworks in a Diverse Global Landscape was moderated by Algernon Yau, Secretary for Commerce and Economic Development of the HKSAR. Distinguished government officials participating as speakers included Khandakar Abdul Muktadir, Minister for Commerce, Industries, Textiles and Jute, Bangladesh, Arman Shakkaliyev, Minister of Trade and Integration, Kazakhstan, Wasantha Samarasinghe, Minister of Trade, Commerce, Food Security and Co-operative Development, Sri Lanka, Filipus Nino Pereira, Minister of Commerce and Industry, Timor-Leste, Dr Ahmed bin Mohammed Al-Sayed, Minister of State for Foreign Trade Affairs, Qatar, and Dr Kirida Bhaopichitr, Vice Minister for Commerce, Thailand. They exchanged views on promoting cross-border trade, facilitating investment flows and strengthening economic resilience.
The Policy Dialogue, themed Building Resilient Trade and Investment Frameworks in a Diverse Global Landscape, was chaired by Algernon Yau, Secretary for Commerce and Economic Development of the HKSAR. Senior officials from Bangladesh, Kazakhstan, Sri Lanka, Timor-Leste, Qatar and Thailand were invited to discuss ways to strengthen cross-border trade and investment cooperation and enhance economic resilience.
The Business Plenary I: Harnessing Business Opportunities for Sustainable Growth and Shared Prosperity session was chaired by Dr Victor K Fung, Chairman of Fung Investments. Joining the discussion were Dr Jonathan Choi, Chairman of Sunwah Group; Shinta Widjaja Kamdani, CEO of Sintesa Group and Chairman of Indonesian Employer Association: Vikrom Kromadit, CEO of Amata Corporation PCL; Farkhad Rashidovich Okhonov, Member of the Board of Directors, Chairman of the Management Board of Halyk Finance, Somboun Phongsavanh, Chairman of Shareholder Committee at Phongsavanh Group, and Professor Zhou Yong, Chairman of Jiangsu SOHO Holdings Group Co., Ltd. The speakers explored the development potential of ASEAN and Central Asian markets, and discussed how businesses can seize a new wave of regional growth opportunities through cross-border investment, industrial collaboration and innovation-driven development.
The first-day Business Plenary: Harnessing Business Opportunities for Sustainable Growth and Shared Prosperity, brought together business leaders from ASEAN, Central Asia and the Chinese Mainland to explore new opportunities in cross-border investment, industrial cooperation and sustainable development, jointly driving regional economic integration and prosperity.
The first-day Business Plenary: Harnessing Business Opportunities for Sustainable Growth and Shared Prosperity, brought together business leaders from ASEAN, Central Asia and the Chinese Mainland to explore new opportunities in cross-border investment, industrial cooperation and sustainable development, jointly driving regional economic integration and prosperity.
In addition to in-depth discussions on a wide range of topics, the Summit also provided valuable networking opportunities, enabling participants to forge new connections and explore potential partnerships. At a luncheon, Paul Chan, Financial Secretary of the HKSAR, delivered welcome remarks, while Wang Shuguang, Vice Chairman of the Board, President and Member of the Management Committee of China International Capital Corporation Limited, gave the opening remarks. Dr Kao Kim Hourn, Secretary-General of ASEAN, delivered the keynote address. Dr. Kao said: “Hong Kong can link ASEAN's growing and resilient pipeline of sustainable investment opportunities with global capital. The opportunity is to bridge two sides of the equation: ASEAN's growing pipeline of green, circular, blue, and digital economy projects, and the capital, expertise, and financing capabilities needed to bring those opportunities to reality. Together with Belt and Road partners, we can turn sustainable initiatives into bankable projects, and bankable projects into a greener, more connected, and more resilient ASEAN—and, of course, offer opportunities to all partners, including Hong Kong, China.”
A cocktail reception will be held this evening, featuring special remarks by Paul Lam, Secretary for Justice of the HKSAR, welcome remarks by Prof Frederick Ma, Chairman of the HKTDC, and opening remarks by Wang Huabin, Deputy Chief Executive of Bank of China (Hong Kong) Ltd. Bringing together government and business leaders from around the world, the reception will foster exchanges and mutual learning, while laying the groundwork for broader collaboration, business matching and partnership opportunities on the following day.
New GoGlobal, Central Asia and Middle East Chapters spotlight opportunities in emerging markets
In support of the national strategy to encourage enterprises to pursue high-level going global, the HKTDC, as a member of the GoGlobal Task Force established by the HKSAR Government, introduced a new GoGlobal Chapter at this year’s Summit, creating a one-stop platform for networking and business matching to support enterprises in exploring international markets. On the first day, the Thematic Breakout Session Hong Kong: Super Connector ・ World-class Springboard – Professional Services Empowering Global Expansion was staged, co-organised with the Department of Justice of the HKSAR Government. The session opened with welcome remarks by Paul Lam, Secretary for Justice of the HKSAR, followed by a keynote address by Umiraliyev Zhandos Zhanibekovich, First Deputy Prosecutor General of the Republic of Kazakhstan, and a moderated session by other industry leaders, who examined how Hong Kong’s legal, financial and professional services can help enterprises expand overseas through Hong Kong.
Tomorrow’s Thematic Breakout Session, Chinese Mainland Enterprises Going Global: Driving Mutual Growth Across Belt and Road Economies, will begin with welcome remarks by Algernon Yau, Secretary for Commerce and Economic Development of the HKSAR, followed by a panel discussion, sharing practical insights on expanding businesses into overseas markets. Beyond the Thematic Breakout Sessions, the Summit offers comprehensive support for enterprises seeking international expansion through newly introduced initiatives, including the GoGlobal Connect Zone, GoGlobal-themed roundtable discussions, deal-making sessions for global investment projects, and the GoGlobal Business Study Mission, fully leveraging Hong Kong’s role as the preferred platform for enterprises going global.
Building on Hong Kong’s recent progress in cultivating emerging markets such as Central Asia and the Middle East, this year’s Summit features a dedicated Central Asia Chapter and a Middle East Chapter, focusing on investment opportunities and development potential in these markets, driving cross-regional cooperation and project implementation. During the first day of the Signature Projects Session, Bakhtiyar Mukhametkaliyev, Vice Minister of Artificial Intelligence and Digital Development of the Republic of Kazakhstan, and Dr Bayan Konirbayev, Chief Digital & AI Officer of Alatau City Authority, presented major development projects including Alatau City and the Data Center Valley, showcasing opportunities across innovation and technology, smart city development, infrastructure and professional services.
The Project Investment Sessions over the next two days will respectively explore the investment opportunities arising from development projects in Central Asia and the Middle East.
In addition, new Central Asia and Middle East Zones have been established in the exhibition area, bringing together consulates, organisations and business representatives from the respective regions to showcase investment projects and commercial opportunities.
Project matching creates a platform for cooperation while exhibition zones connect global business opportunities
The Summit fosters cross-regional partnerships among enterprises, investors and professional service providers through investment project presentations, business matching and exhibition platforms. The Summit continues to feature the Project Investment Sessions, Belt and Road Summit Deal-Making and Exhibition Zone, covering more than 300 investment projects and facilitating over 800 one-to-one business matching meetings, helping participants uncover investment and collaboration opportunities.
The Project Investment Sessions continue to focus on key areas including energy, natural resources and public utilities, urban development, transport and logistics infrastructure, and innovation and technology. A new session, New Market Focus: The Middle East, Africa and Latin America will showcase the investment potential and development prospects of different markets. The Belt and Road Summit Deal-Making takes place during the Summit and will be extended online to 14 and 15 September, helping participants connect with potential partners from around the world through one-on-one business matching to further facilitate project implementation.
The Exhibition Zone brings together more than 120 exhibitors across multiple thematic zones, including the Hong Kong Zone, Global Investment Zone, Chinese Mainland Zone, ASEAN Zone, as well as the newly established University Zone, GreenTech Zone, GoGlobal Connect Zone, Central Asia Zone and Middle East Zone, comprehensively showcasing investment opportunities, innovative technology, and professional service solutions from diverse markets. Among the highlights, the University Zone brings together local institutions to showcase Hong Kong’s strengths in research, innovative and talent development. The GreenTech Zone focuses on innovative applications in artificial intelligence, green technology, and smart city solutions, fostering collaboration among technology companies, investors and industry stakeholders. Meanwhile, the GoGlobal Connect Zone gathers professional service providers in legal, accounting, finance, risk management, and consultancy fields to provide practical support for enterprises expanding overseas. Returning this year, the Chinese Mainland Zone and the ASEAN Zone spotlight high-potential investment projects and business opportunities, promoting cross-border exchanges and collaboration.
The 11th Belt and Road Summit is supported by a strong line-up of partners and sponsors. China International Capital Corporation Limited serves as Strategic Partner, while Bank of China (Hong Kong) is the Banking Partner. Other key supporters include Standard Chartered Bank (Hong Kong) as the Cross-border Business Partner, the Hongkong and Shanghai Banking Corporation Limited as the Global Connectivity Partner, Huatai International Financial Holdings Company Limited as the Innovative Finance Partner, International Financial Centre of Oman as Diamond Sponsor, and CCB International (Holdings) Limited and China Mobile International Limited as Platinum Sponsors.
Unlocking opportunities at the ASEAN Market Day held concurrently during the Belt and Road Week
The Belt and Road Summit is one of the key flagship events of Belt and Road Week. Belt and Road Week features a series of activities related to the Belt and Road Initiative. With representatives of ASEAN member states coming to Hong Kong to participate in the Summit, the HKTDC will introduce a new flagship event, ASEAN Market Day, which will be held on the afternoon of 10 September. The event will feature business leaders and industry experts with extensive experience in the ASEAN market, including Anthony Lam, Group CEO and Vice-Chairman, Golden Resources Development International Limited; Dr Brian Li, Vice Chairman and Executive Vice President, Gold Peak Technology Group Limited; Clara Chan, Chief Executive Officer, Lee Kee Group; Yu Wing Keung, Managing Director, Novostal Limited and Vice President, Thai-Hong Kong Trade Association; and Aero Wong, Deputy General Manager, Commercial Banking Department, Bank of China (Hong Kong) Ltd. They will share practical insights on expanding into ASEAN markets and highlight business opportunities across the region, helping Hong Kong companies, particularly SMEs, gain a deeper understanding of market trends and grow their presence in ASEAN. Following the session, participants will be arranged to visit the ASEAN Zone at the Summit and take part in consultation sessions with representatives from the HKTDC’s offices in ASEAN and various ASEAN Consulates General and associations to exchange views, connect with potential partners and gain a deeper understanding of development opportunities in ASEAN markets.
The Belt and Road Global Forum Annual Roundtable will be held on the morning of 11 September, bringing together Hong Kong, Chinese Mainland and international organisations and associations to share information, deepen exchanges and explore new opportunities for multilateral cooperation.
The 11th Belt and Road Summit
Date
9 to 10 September 2026
Venue
Hall 5B-E, Hong Kong Convention and Exhibition Centre
Websites
Belt and Road Summit: https://www.beltandroadsummit.com/conference/bnr/en
Programme: https://www.beltandroadsummit.com/conference/bnr/en/programme
Speaker list: https://www.beltandroadsummit.com/conference/bnr/en/speaker
Photo download: https://bit.ly/4cC23FI
The Keynote Luncheon featured welcome remarks by Paul Chan, Financial Secretary of the HKSAR, and opening remarks by Wang Shuguang, Vice Chairman of the Board, President and Member of the Management Committee of China International Capital Corporation Limited. Dr Kao Kim Hourn, Secretary-General of ASEAN, delivered the keynote speech.
As part of the Summit’s newly launched GoGlobal Chapter, the thematic breakout session, Hong Kong: Super Connector・World-class Springboard – Professional Services Empowering Global Expansion, was co-organised by the HKTDC and the Department of Justice of the HKSAR Government. Paul Lam, Secretary for Justice of the HKSAR Government, delivered welcome remarks, followed by a keynote address by Umiraliyev Zhandos Zhanibekovich, First Deputy Prosecutor General of Kazakhstan.
Media Enquiries
Yuan Tung Financial Relations:
Louise SongTel: (852) 3428 5691Email: lsong@yuantung.com.hk
Tiffany LeungTel: (852) 3428 2361Email: tleung@yuantung.com.hk
Fung WongTel: (852) 3428 3122Email: hfwong@yuantung.com.hk
HKTDC’s Communications & Public Affairs Department:
Navin LawTel: (852) 2584 4525Email: navin.cm.law@hktdc.org
Serena CheungTel: (852) 2584 4572Email: serena.hm.cheung@hktdc.org
Winnie KanTel: (852) 2584 4055Email: winnie.wy.kan@hktdc.org
HKTDC Media Room: https://mediaroom.hktdc.com/en
About HKTDC The Hong Kong Trade Development Council (HKTDC) celebrates its 60th anniversary this year. The HKTDC is a statutory body established in 1966 to promote, assist and develop Hong Kong's trade. With over 50 offices globally, including 13 in the Chinese Mainland, the HKTDC promotes Hong Kong as a two-way global investment and business hub. The HKTDC organises international exhibitions, conferences and business missions to create business opportunities for companies, particularly small and medium-sized enterprises (SMEs), in the mainland and international markets. The HKTDC also provides up-to-date market insights and product information via trade publications, research reports and digital news channels. For more information, please visit: www.hktdc.com/aboutus.
Sep 9 · 13:53·ACN Newswire
SaaS · Healthcare
SHENZHEN, Sept 9, 2026 - On 9 September, China Medical System Holdings Limited (867.HK/8A8.SG) (“CMS” or the “Group”) is pleased to announce that the initial prescriptions for the Class 1 innovative drug Silevimig Injection (the “Product”) have recently been issued in multiple hospitals across China, including Beijing Luhe Hospital of Capital Medical University, Wenzhou People’s Hospital, Kaiping Central Hospital, Dongguan Guangji Hospital and Huidong Jilong Ankang Hospital. This marks that the world’s first bispecific antibody for passive immunization against rabies has officially commenced its large-scale clinical application, offering a better solution for urgent post-exposure management against rabies in China.
Dual-Epitope Neutralization with Low Dosing, Addressing Clinical Pain Points
Silevimig Injection is the world’s first fully human bispecific antibody targeting dual epitopes (G protein epitopes I and III) of the rabies virus, which is consistent with the World Health Organization (“WHO”) recommendation for a “cocktail” therapeutic paradigm. It can effectively neutralize different viral strains or genotypes of the rabies virus, providing immediate protection before the establishment of full protection by active rabies vaccination, and building a critical line of defense against viral infection.
The Product is currently the passive immunization product with the smallest dose for rabies (0.05 mg/kg); compared with human rabies immune globulin (“HRIG”), it requires less injection volume and easier administration, which can effectively reduce pain and improve compliance for patient. Manufactured using recombinant technology, the Product is non-plasma-derived and carries no risk of blood-borne infections. It can be manufactured at scale through standardized and stable processes, with controllable production costs, while offering a single active ingredient, consistent quality and minimal batch-to-batch variability. These advantages open up new possibilities for improving the safety, standardized supply and patient accessibility of rabies passive immunization products, with the potential to further increase market penetration.
Initial Prescriptions Issued Within About Two Months After Approval, Academic-Driven Commercialization Platform Accelerating Value Realization
Silevimig Injection was approved for marketing in China in June 2026. Following the approval, CMS worked closely with its partner Genrix Bio to advance critical workstreams including drug supply, market access and academic promotion, while integrating expert networks and market resources. The inital prescriptions were issued in China within approximately two months, accelerating the translation of innovation outcomes into a clinically accessible new treatment option.
Currently, CMS has nine commercialized innovative drugs that are progressively achieving large-scale clinical application across China, accelerating the realization of the clinical value of each quality medicine. Going forward, CMS will remain focused on clinical unmet needs and continue to build a differentiated innovative product portfolio through a dual-track system of in-house R&D and collaborative R&D, accelerating accessibility of quality innovative drugs and taking concrete action to safeguard patients’ lives and health.
About Rabies
Rabies is an acute zoonotic disease caused by RABV, clinically characterized by aerophobia, hydrophobia, pharyngeal muscle spasms and progressive paralysis[1], with a case-fatality rate approaching 100%. At present, there is no proven treatment for rabies once clinical symptoms appear. Standardized post-exposure management, comprising wound care, vaccination and passive immunization administered as needed, remains the most effective strategy[2]. As vaccine-induced antibodies require 1-2 weeks after the first dose of vaccine injection to reach protective levels, passive immunization provides immediate coverage [1].
According to the National Technical Guidelines for the Rabies Exposure Prophylaxis (2023 Edition), patients with Category III exposure, patients with confirmed Category II exposure involving severe immunodeficiency, and patients with Category II exposure involving wounds to the head or face while the health status of the offending animal cannot be determined should receive passive immunization at the same time as the first dose of rabies vaccine[3]. In China, more than 40 million people are exposed to rabies annually, of whom approximately 40% fall under Category III exposure[1]. However, due to factors such as limited awareness, high price, and restricted accessibility, only about 15% of Category III cases receive passive immunization[1]. Currently, the primary passive immunization option in China is HRIG. However, HRIG must be sourced from healthy donors, making it difficult and costly to obtain. Furthermore, it carries potential risks of blood-borne infections. This has led to a low penetration rate of passive immunization products in China.
More Information about Silevimig Injection
In a Phase III clinical trial in adults in China, Silevimig Injection met its primary efficacy endpoint, demonstrating non-inferior protective efficacy compared with HRIG, the currently most used passive immunization product in China. The Product provides immediate protection during the early stages of rabies virus exposure without compromising the active immune response induced by vaccination. In addition, a Phase III clinical trial in children and adolescents aged 2 to <18 years is currently ongoing in China. The Product has been granted a patent in China.
In September 2025, the Group through subsidiaries of the Company entered into an Exclusive Collaboration Agreement (the “Agreement”) with Chongqing Genrix Biopharmaceutical Co., Ltd. In accordance with the Agreement, the Group has obtained exclusive commercialization rights for the Product in mainland China and exclusive licensing rights for the rest of the Asia-Pacific region, the Middle East and North Africa. The collaboration term extends until ten years after the Product receives the marketing approval in Mainland China (the “Initial Term for the Product”). Unless terminated or dissolved under the terms set forth in the Agreement, the Agreement will automatically renew for successive ten-year periods upon expiration of the Initial Term for the Product.
About CMS
CMS is an innovative pharmaceutical company focused on the identification, building, and full lifecycle management of differentiated specialty pharmaceuticals. With a dual-engine approach of in-house R&D and collaborative R&D, and leveraging its core capability to build markets and brands from the ground up, the Group enables each medicine to fully realize both its clinical value and commercial value.
CMS has established an end-to-end capability loop across the full product lifecycle—precisely identifying quality innovation targets, matching them with optimal development pathways, and efficiently advancing clinical development and registration; developing medical strategies aligned with clinical needs, and driving scaled clinical adoption through a professional academic promotion system and network.
CMS focuses on advantaged specialties including cardiovascular-kidney-metabolic, central nervous system, gastroenterology, ophthalmology, and skin health. Through professional academic promotion and academic resources across multiple disease areas, CMS has built sustainable scale advantages in specialties, with its skin health business becoming a leading player in its segment. Meanwhile, CMS continues to strengthen its international replication capabilities, validating the transferability of its business model in emerging markets such as Southeast Asia and the Middle East, and injecting long-term momentum for the Group’s high-quality, sustainable development.
Reference:
1. Chinese Center for Disease Control and Prevention. Technical Guidelines for Human Rabies Prevention and Control (2016). https://www.chinacdc.cn/jkyj/crb2/yl/kqb/jswj_kqb/202409/P020240906525420231910.pdf
2. Yin Wenwu, Wang Chuanlin, et al. Expert consensus on rabies exposure prophylaxis [J]. Chinese Journal of Preventive Medicine, 2019, 53(7): 668–679. DOI: 10.3760/cma.j.issn.0253-9624.2019.07.004
3. Chinese Center for Disease Control and Prevention. National Technical Guidelines for the Rabies Exposure Prophylaxis (2023 Edition). https://www.chinacdc.cn/jkyj/crb2/yl/kqb/jswj_kqb/202409/P020240906525421817465.pdf
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.
Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/
Sep 9 · 09:40·ACN Newswire
Healthcare · Travel
BALI, INDONESIA, September 9, 2026 - Indonesian premium service carrier, TransNusa, today officially launched its maiden nonstop flight between Bali and Phuket, creating a dream pathway for tropical travellers.
Flight 8B 541 departed I Gusti Ngurah Rai International Airport this morning at 11.30 AM, seamlessly linking two of Southeast Asia’s most iconic beach destinations. The new route eliminates tedious layovers, turning a previously long travel day into a smooth four-hour flight.
"Today we celebrate more than just a new flight; we are bridging two world-class tourism capitals," said Datuk Bernard Francis, TransNusa Group Chief Executive Officer.
"As Bali's International Premium Airline, our goal is to design ultimate island experiences that bring the best of sun, sea and healing straight to our passengers. This route was established to boost tourism in the region, create new economic opportunities, and further strengthen TransNusa's hub in Bali. By providing a direct link, we make it easier than ever for global travellers to experience the unique cultures of Phuket, Bali and beyond Bali in a single itinerary," Datuk Francis explained.
Datuk Bernard Francis... TransNusa becomes Bali's Premium Airline
"Our vision for TransNusa extends far beyond connecting domestic and international corridors or enhancing and enlarging just network connectivity," Datuk Francis explained.
"We are committed to unlocking the unparalleled beauty of Indonesia's hidden gems. By expanding our domestic network directly beyond Bali, we are giving global travellers immediate access to pristine, untouched island destinations that showcase the true beauty and paradise of the Indonesian archipelago."
Connecting Bali to Indonesia's Hidden Paradises
TransNusa has recently started introducing new launches connecting directly island destinations directly with Bali, simultaneously creating new direct routes where non was available before and reducing travelling time by more than half, enabling travellers’ direct access to Indonesia’s hidden gems such Wakatobi, Lombok, Manado, and Bima, which are some of the country’s most spectacular, biodiversity-rich islands:
Wakatobi: Globally celebrated for hosting the world's second-largest barrier reef, this remote marine haven is a top spot for world-class diving and pristine underwater ecosystems.
Lombok: A premier leisure escape centered on elite wellness programs featuring holistic health retreats, oceanside yoga, and traditional Sasak healing therapies. In addition, Lombok is also known for its pristine coastal and volcanic adventures and high-octane sports tourism like world-class surfing and the Mandalika international racing circuit.
Manado: Located in North Sulawesi, this diving destination is framed by dramatic volcanic beauty and serves as the gateway to the world-renowned Bunaken National Marine Park.
Bima: Situated on Sumbawa Island, Bima offers rugged landscapes, rich cultural heritage, and serves as an ideal entry point for surfers and adventure seekers looking for raw natural beauty.
Expanding Horizons: Gateway to Singapore and Perth
Further positioning itself as a key regional player, TransNusa also bridges Bali with major international hubs beyond Thailand. The airline operates highly sought-after routes from Bali to the cosmopolitan global financial hub of Singapore as well as to Perth, marking a highly successful expansion that connects Western Australia directly to the Island of the Gods.
Inaugural Flight Schedule & Premium Comfort
The new Bali–Phuket route operates four times weekly on Monday, Wednesday, Friday, and Sunday, and will scale up to a daily service beginning October 3, 2026.
TransNusa’s scheduled flight, 8B 541, will depart Bali at 11.30 from I Gusti Ngurah International Airport and arrive at the Phuket International Airport at 14.35 while the return flights, 8B 542, will depart the Phuket International Airport at 15.35 and arrive at I Gusti Ngurah International Airport in Bali at 20.35.
For the four-hour scheduled flight from Bali to Phuket, TransNusa will be utilising its Airbus A320, which has 174 seats.
To celebrate the launch, TransNusa continues to offer introductory promotional fares starting from IDR2,399,000 / USD135 one-way, bookable via the official airline website at transnusa.co.id. Travelers can customize their experience through three-tiered product offerings: SEAT (includes 20kg baggage), SEAT-PLUS, and FLEXI-PRO (includes 30kg baggage, hot meals, priority boarding, and flexible flight changes).
About TransNusa
TransNusa Airline, is a Premium Service Carrier. In February 2024, the airline rebranded itself to a Premium Service Carrier in line with its upgraded aircrafts that offers better comfort as well as based on the flexibility and quality of the services offered. TransNusa, which received its AOC certification on 9th September 2022, launch its first three A320 operations on 6th October, 14th October and 12th December, 2022.
In 2023, TransNusa introduced a new business model making it the first Premium Service Carrier in the Asia Pacific region. TransNusa introduced its first international flight on 14th April, 2023. The airline is currently based in Jakarta and Bali.
On the international front, TransNusa flies to Singapore, Guangzhou, Kuala Lumpur, Penang, Perth, Shenzhen and Bangkok. The airline became the second Indonesian airline to fly to China and the first Indonesian airline to launch a Premium Service Carrier business model. Passengers can book their flights on the TransNusa website at www.transnusa.co.id, through any secure online travel agent, through authorized travel agents in Singapore and Indonesia.
International Media Contact
Email: transnusamedia@alphaaccesspr.my
Website: transnusa.co.id. Passengers can purchase tickets directly from TransNusa or any primary online travel agent
Sep 9 · 03:20·ACN Newswire
Energy · Automotive
Hyundai Motor Group and AfDB signing Letter of Intent for long-term strategic collaboration
Partnership combining Hyundai Motor Group's business capabilities with AfDB's development financing to unlock tangible growth opportunities across Africa
Collaboration across six areas including clean energy transition, transport infrastructure and EV value chain development
Foundation for long-term partnership supporting Africa's energy transition, industrial capacity building, and competitiveness
Sep 8 · 23:30·Hyundai Motor Company
Energy · Food & drink
New York State Fair’s 800-pound butter sculpture gets a second life as renewable energy, powering homes and businesses at a Western New York dairy farm.
Sep 8 · 21:09·GlobeNewswire
Finance · Sustainability
WESTFORD, Mass., Sept. 08, 2026 -- Kadant Inc. (NYSE: KAI) has been named to Newsweek's list of America's Greatest Companies 2026, recognizing organizations that excel in financial performance, workplace culture, innovation, and sustainability.
Sep 8 · 16:43·GlobeNewswire
Finance · Energy
Hong Kong, Sept. 08, 2026 -- Green Circle Decarbonize Technology Limited (the “Company”) (NYSE:GCDT), a premier provider of customized energy-saving solutions, today announced it has entered into a strategic partnership agreement (“Partnership Agreement”) with SANVO Fine Chemicals Group Limited (“SANVO”).
Sep 8 · 14:15·GlobeNewswire
Finance · Energy
Austin, Texas—Sep 8, 2026 Oracle today announced up to $1 million in funding to support research into the potential for carbon capture and sequestration (CCS) at Project Jupiter and across New Mexico. The research will examine how carbon dioxide associated with Bloom Energy fuel cells could be captured safely and efficiently, create a pathway for permanent storage, and a viable commercial model for transportation and
Sep 8 · 13:00·Oracle
Sustainability
Lerøy Seafood Group ASA, rated BBB/Stable by Nordic Credit Rating, has mandated Danske Bank and DNB Carnegie as Joint Bookrunners to explore the potential issuance of new senior unsecured green bonds. Subject to inter alia market conditions, NOK-denominated fixed and/or floating rate bonds with an expected tenor of 6 years and an expected size of NOK 750 million may follow.
Sep 8 · 06:00·GlobeNewswire
Finance · AI
HONGKONG/BEIJING, Sept 8, 2026 - September 7, 2026, Crealights (01191.HK) today officially announced a landmark partnership, establishing a long-term, in-depth strategic collaboration with GlobalFoundries (NASDAQ: GFS, "GF"), a leading global semiconductor manufacturer. Leveraging GF's industry-leading silicon photonics technology, Crealights will vigorously advance the engineering deployment and mass production of its 6.4T NPO (Near-Package Optics) products, accelerating the industrialization of next-generation AI silicon photonic interconnect technologies. This strategic move will empower Crealights to consolidate its domestic market position while continuously expanding its footprint in North America and its global business landscape, marking a new phase in the company's global commercialization journey.
Currently, global AI computing clusters are rapidly evolving from horizontal scaling (Scale-out) to vertical scaling (Scale-up). Facing the extreme demands of 10,000-card-scale hyperscale data centers for bandwidth density, power efficiency, and latency, Near-Package Optics (NPO) and Co-Packaged Optics (CPO) have emerged as mainstream solutions to overcome next-generation AI interconnect bottlenecks. By integrating and packaging the optical engine directly adjacent to the compute chip, these technologies significantly shorten the optoelectronic signal transmission path. Backed by its comprehensive and mature full-stack silicon photonic technology moat in both NPO and CPO, Crealights has taken the lead in launching 3.2T and 6.4T NPO optical engine products, demonstrating a robust technological advantage in next-generation high-speed AI interconnects.
To comprehensively solidify the technological foundation for high-density optical interconnects in next-generation AI systems, Crealights has entered into a deep partnership with GlobalFoundries (GF). By deeply integrating GF's silicon photonics platform with SCALE™ Co-Packaged Optics (CPO) solutions, Crealights continues to build a comprehensive advantage integrating photonic integration, high-performance RF CMOS, advanced optical devices, and fiber optic connectivity. Currently, Crealights is collaborating with GF to establish a broad ecosystem of partners spanning design, packaging, connectivity, and system layers, fully supporting the deployment and implementation of diverse next-generation optical architectures.
Meanwhile, leveraging GF’s scalable global manufacturing footprint and proven high-volume production capabilities, Crealights has established a "dual-track" global manufacturing system that operates in parallel both domestically and internationally. Through the efficient synergy of capacity at home and abroad, this strong alliance has not only significantly shortened the R&D cycle for next-generation optical interconnect products, but also achieved end-to-end integration across the entire chain—from local chip design to scaled delivery for customers in North America and worldwide. Together, they are paving a clear path from technology development to large-scale commercialization, effectively addressing the increasingly urgent demand for optical connectivity in AI computing clusters and hyperscale data centers.
A spokesperson for Crealights stated: "Having consolidated our position in the domestic AI computing infrastructure market, Crealights is now driving its global expansion with core NPO and CPO technologies. Adding GF's global manufacturing network and silicon photonics process technology to our current silicon photonics ecosystem ensures a stable supply of next-generation silicon photonic products and completes the commercial closed-loop from local R&D to global delivery, continuously providing core interconnect solutions for large-scale AI computing clusters worldwide."
Thomas Barber, Vice President of Communications Infrastructure and Data Center End Markets at GlobalFoundries, commented: "Crealights' comprehensive full-stack silicon photonic design capabilities are highly aligned with GF's strengths in scaled wafer manufacturing. Through global capacity synergy and advanced packaging technology empowerment, both parties will drive the large-scale market deployment of Crealights' products in North America and globally, jointly promoting the widespread application of silicon photonic technology in global AI computing infrastructure."
Looking ahead, Crealights will continue to deepen their collaboration with GF across three key areas: joint R&D of cutting-edge technologies, global manufacturing capacity synergy, and the industrialization of NPO and CPO, as well as the co-building of the industry ecosystem. This will drive the global scaled deployment of silicon photonic solutions, unlocking more technological possibilities for AI-driven diverse application scenarios.
About Crealights
Crealights is a globally leading provider of AI silicon photonic interconnect solutions, dedicated to delivering high-speed, low-power optical interconnect products for AI data centers and hyperscale computing clusters. The company possesses end-to-end technical capabilities spanning silicon photonic chip design, wafer testing, and optical module manufacturing. Its core product portfolio covers 400G, 800G and 1.6T optical modules, Active Optical Cables (AOC), as well as NPO and CPO optical engines. Backed by its deep domestic industry foundation and global capacity layout, Crealights has become a key player in global AI computing interconnects.For more information, visit www.crealights.com.
About GlobalFoundries
GlobalFoundries (GF) is a leading manufacturer of essential semiconductors, enabling AI at scale from the cloud to the physical world. Through deep partnerships with customers, GF delivers differentiated, power-efficient and high-performance solutions for automotive, aerospace and defense, data center, smart mobile devices, internet of things and other high-growth markets. With global manufacturing operations across the U.S., Europe and Asia, GF is a trusted and holistic technology partner for customers around the world. GF’s talented, global team remains focused every day on security, longevity and sustainability. For more information, please follow the WeChat Official Account: GLOBALFOUNDRIES_CN.
Media Contact
Ms. Claire Zhang
TEL: (852) 5427 3696
E-mail: projectcrealights.list@everbloom.com.cn
Sep 8 · 05:00·ACN Newswire