HONG KONG, Sept. 28, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that the first patient has been enrolled in COMPASSION-37 (AK104-311), a global, multicenter Phase III head-to-head trial evaluating cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy versus chemotherapy with or without nivolumab as first-line treatment for patients with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

The study is designed to further evaluate the efficacy and safety of cadonilimab as first-line therapy for advanced gastric cancer across geographically and ethnically diverse patient populations worldwide, and to investigate whether dual PD-1/CTLA-4 immune checkpoint blockade can further improve outcomes beyond the current standard of care.

COMPASSION-37 is co-led by a distinguished international group of global principal investigators, including Dr. Yelena Y. Janjigian, Chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center (MSK); Professor Markus Möhler of Johannes Gutenberg University Mainz, Germany; Professor Jiafu Ji, Director of the Gastrointestinal Cancer Center at Peking University Cancer Hospital & Institute; and Professor Lin Shen, Director of the Department of Gastrointestinal Oncology at Peking University Cancer Hospital.

Dr. Janjigian, Professor Möhler, and Professor Shen were investigators on the CheckMate 649 trial, which established the clinical value of nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma and led to the adoption of PD-1 inhibitor plus chemotherapy as a key first-line treatment strategy for HER2-negative advanced gastric cancer.

As immunotherapy has become widely adopted in the first-line setting for gastric cancer, the relationship between PD-L1 expression and treatment benefit has drawn increasing attention. Studies including CheckMate 649 have shown that the benefit of PD-1 inhibitor plus chemotherapy is more pronounced in patients with high PD-L1 expression, while how to further improve immunotherapy outcomes in patients with low PD-L1 expression remains an important area of clinical investigation.

Chemotherapy with or without a PD-1 inhibitor remains the international standard of care for advanced gastric cancer; however, the disease is biologically and clinically heterogeneous. In the U.S., first-line PD-1 inhibitor indications in advanced gastric cancer are currently limited to PD-L1-positive patients, and current NCCN and ESMO guidelines preferentially recommend nivolumab-based regimens for patients with PD-L1 CPS ≥5. Consequently, effective immunotherapy options for PD-L1-low advanced gastric cancer remain a significant global unmet need.

"Immunotherapy has transformed the treatment of stomach and esophagus cancers, helping patients live longer and better," said Yelena Y. Janjigian, MD, FASCO, Chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center (MSK) and global principal investigator for the COMPASSION-37 study. "Through our evaluation of cadonilimab as a potential first-line treatment for advanced disease, we aim to better understand its potential to improve outcomes and support longer-term survival for patients." Dr. Janjigian previously served as the lead principal investigator for the CheckMate 649 trial, which established nivolumab-based therapy as a global standard of care.

Professor Jiafu Ji said: "COMPASSION-15 has already shown that cadonilimab plus chemotherapy significantly improves overall survival in patients with HER2-negative advanced gastric cancer, with a favorable survival trend also seen in patients with PD-L1 CPS <5, suggesting that dual PD-1/CTLA-4 blockade may expand the population that benefits from immunotherapy. COMPASSION-37 takes this further by evaluating the regimen in a global, multicenter, head-to-head Phase III trial against current international standards of care. Its greater value lies in rigorously testing the evidence we have generated on a worldwide scale. As clinicians, the key question is whether this innovation can offer more effective and broadly applicable first-line options for patients with advanced gastric cancer across different PD-L1 levels, regions, and populations. We look forward to COMPASSION-37 providing high-quality global evidence that can help bring clinically meaningful treatments to patients worldwide."

"Advanced gastric cancer is characterized by substantial biological and clinical heterogeneity. Previous studies have shown that the magnitude of benefit from PD-1 inhibitor therapy is closely associated with PD-L1 expression, and that there remains room to further improve outcomes, particularly in patients with low PD-L1 expression. How to broaden the population that effectively benefits from immunotherapy is an important and not yet fully addressed clinical question in gastric cancer. We look forward to COMPASSION-37 further clarifying the value of dual PD-1/CTLA-4 immune checkpoint blockade across PD-L1 expression subgroups," said Professor Lin Shen.

From COMPASSION-15 to COMPASSION-37: From Chinese Phase III Evidence to Global Head-to-Head Validation

COMPASSION-15 is a randomized, double-blind, placebo-controlled Phase III study that enrolled 610 patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. The study enrolled a notably high proportion of patients with low PD-L1 expression (49.8%) and PD-L1-negative disease (23%), far exceeding rates in comparable historical studies. This provides strong support for the benefit of cadonilimab in the overall population, irrespective of PD-L1 expression.

Results from COMPASSION-15 study showed that, in the overall population, cadonilimab plus chemotherapy significantly reduced the risk of death compared with the control group, regardless of PD-L1 expression status. These findings suggest that dual PD-1/CTLA-4 immune checkpoint blockade may offer new therapeutic options for gastric cancer patients across different PD-L1 expression levels and provide an important scientific basis for further international head-to-head Phase III validation.

Gastric Cancer Immunotherapy: From "Whether" to "Who Benefits Most"

At present, PD-1 inhibitor plus chemotherapy has become one of the key first-line treatment strategies for HER2-negative advanced gastric cancer. However, multiple studies consistently suggest that the magnitude of immunotherapy benefit is closely associated with PD-L1 expression, with more definitive survival benefits in high-expressing patients and relatively modest absolute benefit in low-expressing patients.

PD-L1 expression thresholds and treatment recommendations vary across regions and guidelines. A single CPS cutoff should not be applied uniformly across all settings.This means that the central question in gastric cancer immunotherapy is gradually shifting from "whether immunotherapy should be added" to "how to select the most appropriate immunotherapy strategy based on tumor biology, and how to further broaden the population that truly derives long-term benefit." COMPASSION-37 is being conducted against this backdrop.

Advancing Global Clinical Development

In addition to COMPASSION-37, an international study of cadonilimab in the perioperative setting for gastric cancer has also been initiated. A single-arm Phase II study (NCT07631000), led by Dr. Yelena Y. Janjigian at Memorial Sloan Kettering Cancer Center, is currently enrolling patients in the United States. The study evaluates cadonilimab in combination with FLOT chemotherapy as perioperative treatment in patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma, exploring whether dual PD-1/CTLA-4 immune checkpoint blockade can be extended to earlier-stage, curable gastric cancer.

From the randomized Phase III COMPASSION-15 study conducted in China, to the perioperative Phase II study being conducted in the United States, and now to the global, multicenter, head-to-head Phase III COMPASSION-37 study, the clinical development of cadonilimab in gastric cancer is progressively forming a complete pathway that spans from advanced disease to the perioperative setting and from Chinese evidence to global validation.

Whether COMPASSION-37 can further improve patient survival beyond the current standard of care—and, in particular, whether it can offer a new treatment option for patients with low PD-L1 expression—will ultimately be answered by the results of this rigorous Phase III trial. This is the key scientific question that COMPASSION-37 is designed to answer.

In addition to the COMPASSION-37 study, a Phase II study (NCT07631000) of perioperative cadonilimab with neoadjuvant chemotherapy in patients with localized, resectable HER2-negative gastric or gastroesophageal junction (GEJ) tumors, led by Dr. Yelena Janjigian, is currently enrolling patients in the United States. This study is expected to generate robust clinical evidence to support the initiation of an international multicenter Phase III trial evaluating the cadonilimab-based combination regimen for the perioperative treatment of patients with GC/GEJ adenocarcinoma.

As the first approved bispecific antibody for cancer treatment, cadonilimab continues to demonstrate clinical value across multiple pivotal registrational and Phase III studies. It is currently approved in China for first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer, and is widely used in clinical practice. Cadonilimab is being evaluated in more than 13 registrational or Phase III trials globally, spanning major tumor types including gastric, liver, lung, cervical, and pancreatic cancers. Two of these trials are international multicenter registrational/Phase III studies.

About cadonilimab

Cadonilimab is a first-in-class PD-1/CTLA-4 bispecific antibody developed by Akeso for cancer immunotherapy. In June 2022, it received initial marketing approval from China's National Medical Products Administration (NMPA) for the treatment of patients with relapsed or metastatic cervical cancer who had progressed on or after platinum-based chemotherapy. In September 2024, cadonilimab was approved in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In May 2025, cadonilimab plus platinum-based chemotherapy, with or without bevacizumab, was approved for the first-line treatment of persistent, recurrent, or metastatic cervical cancer.

By simultaneously targeting PD-1 and CTLA-4, cadonilimab delivers synergistic antitumor activity. It has shown robust efficacy with markedly lower toxicity and improved tolerability compared with conventional combination regimens, demonstrating potent activity across multiple tumor types independent of PD-L1 expression and offering breakthrough clinical value in immunotherapy-resistant and "cold" tumors.

To date, cadonilimab has been evaluated in more than 40 clinical studies spanning over 20 indications, including gastric, lung, liver, cervical, and pancreatic cancers. Thirteen Phase III/registrational studies are ongoing, three have met their primary endpoints, and two global Phase III/registrational trials are advancing.

About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms.

Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the Company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multi-specific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval.

Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world.

Forward-Looking Statements
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the P.R. China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

SAN FRANCISCO and SUZHOU, China, Sept. 28, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (HKEX Stock Code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases including oncology, autoimmune, metabolic, and ophthalmic diseases, announces expansion of the global Phase 3 MarsLight-11 (NCT07217301) trial, which is evaluating IBI363 (Takeda R&D code: TAK-928) in patients with squamous non-small cell lung cancer (NSCLC) whose disease has progressed on or after chemotherapy and immunotherapy, to include patients with non-squamous NSCLC. This expansion marks another important milestone in the development of this investigational innovative immunotherapy. IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being jointly developed by Innovent and Takeda globally.

The evaluation of IBI363/TAK-928 in non-squamous NSCLC will be conducted as a new substudy of MarsLight-11, a global, multicenter, randomized, controlled Phase 3 study. MarsLight-11 will therefore be comprised of two independent substudies—one in squamous NSCLC and the other in non-squamous NSCLC. Each substudy will evaluate the efficacy and safety of IBI363 monotherapy versus docetaxel in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed during or after treatment with platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

About IBI363 /TAK-928 (alpha-biased IL-2/PD-1 Bispecific Fusion Protein)

IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being co-developed by Innovent and Takeda. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363/TAK-928 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, with the aim of minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.

IBI363/TAK-928 is being evaluated in a series of clinical trials globally, including

• a pivotal Phase II study in China in previously untreated acral and mucosal melanoma
• a global multi-center Phase III trial in immunotherapy-resistant squamous and non-squamous NSCLC
• a pivotal Phase III study in China in advanced CRC refractory or intolerant to standard therapy.
• In parallel, multiple Phase Ib/II trials are evaluating IBI363/TAK-928 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types.

IBI363/TAK-928 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide other than the U.S. and greater China.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage.

Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the highquality outbound internationalization of China's innovative drug industry.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s).

(2) Ramucirumab Injection (Cyramza^®), Selpercatinib Capsules (Retsevmo^®), Pirtobrutinib Tablets (Jaypirca^®) and abemaciclib (Verzenios^®) are products discovered and developed by Eli Lilly.

Forward-Looking Statements

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

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

挪威奧斯陸2026年9月25日 /美通社/ -- 2026年9月24日，寧德時代在挪威奧斯陸開設了亞洲以外規模最大的「寧家服務」中心，進一步拓展其在歐洲的電池全生命週期服務網絡。

該中心佔地面積8000平方米，服務覆蓋挪威及整個北歐地區，將提供電池相關服務、開展本地技術人員培訓，並助力區域循環經濟發展。

挪威是全球電動汽車市場發展最為成熟的國家之一。今年8月，純電動乘用車占當地新車註冊量的98.7%，電動大巴占巴士及客車註冊總量的60%以上。隨著電動汽車保有量持續增長、車輛逐步老化，市場對於電池檢測診斷、維修以及延長使用壽命的需求不斷攀升，挪威"寧家服務"中心正是為滿足這一需求而設立。

全生命週期電池服務

• 依托寧德時代的研發與製造技術專長，「寧家服務」業務覆蓋電池完整生命週期，包含檢測、保養、維修、維保以及回收，服務場景涵蓋交通運輸、儲能以及機器人等領域。
• 寧家服務打破電池「只換不修」困局，真正做到「能修不換、精準維修」，將疑難故障處理時間由72小時壓縮至48小時。
• 其深度維修能力可覆蓋76.8%的電動汽車車型，且執行寧德時代生產線質量標準。依托自研「鷹眼系統」，覆蓋超過150個深度維修作業監控點，能夠實現全流程可追溯與質量管控。
• 該中心同時承擔品牌展示和體驗空間職能，也是船舶、eVTOL、機器人等新興電動應用產品的銷售代理中心。"寧家服務"已為峰飛航空、銀河通用機器人等寧德時代生態合作夥伴開展代理銷售業務。

踐行循環理念 培育本地技術人才

寧德時代與艾倫-麥克阿瑟基金會(Ellen MacArthur Foundation)達成戰略合作，共同發起《全球能源循環計劃》(GECC)。與此願景相契合，「寧家服務」正搭建後市場生態體系，延長電池使用週期，並將電池材料回收用於製造全新電池。

艾倫-麥克阿瑟基金會氣候負責人Miranda Schnitger表示：「在循環經濟模式下，電池會盡可能長時間保留在價值最高的應用場景中，電池材料也可回收再造新電池。檢測、保養與維修服務，是實現規模化落地的關鍵一環。」

該中心將創造大量高技能綠色崗位，同時成為「寧家服務」在北歐地區的主要培訓基地。依托覆蓋歐洲39個國家的培訓網絡與14名資深講師團隊，中心將提供寧德時代認證課程，面向本地技術人員開展實操培訓。「寧家服務」還計劃進一步深化與挪威高校及技術院校的合作，夯實本地專業人才儲備。

貼近客戶 本地化佈局提速

寧德時代正通過搭建本地基礎設施、開展生態合作，持續擴大全球本地化業務佈局。挪威中心將成為「寧家服務」歐洲網絡的關鍵樞紐，踐行「您身邊的新能源服務專家」的承諾，為客戶提供就近的高品質服務。

YES-EU集團創始人兼董事長Benedikt G. Gudmundsson表示：「寧德時代帶來了先進的技術、豐富的行業經驗以及值得信賴的品牌。加上YES-EU對本地市場的理解與服務能力，我們能夠在北歐打造更為完善的電池服務生態，助力歐洲電動汽車市場實現長期發展。」

寧德時代質量體系與後市場業務部總裁李偉表示：「客戶是『寧家服務』一切業務的核心。我們將攜手本地合作夥伴，輸出可靠的電池全生命週期服務，以滿足挪威電動汽車市場的需求，持續助力當地電動化進程。」

目前，「寧家服務」已在全球85個國家和地區佈局了1394個服務網點；公司計劃到2027年，業務覆蓋範圍增至100個國家和地區；到2030年，服務網點數量達到10000個。

Elon Musk said xAI's next-generation AI computer cluster Colossus 2 could more than double its number of NVIDIA Corporation (NVDA.US) chips by the end of this year.

Musk said in a post on social platform X that Colossus 2 so far has 110,000 Nvidia GB200 chips and 440,000 GB300 chips. Another 220,000 GB300 chips are expected to begin operations next week, with an additional 220,000 chips expected in November.

If all goes well, another 220,000 chips may be put into operation in late December, he added.
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AASTOCKS Financial News
Website: www.aastocks.com

Citi's research report cited management as saying that UBTECH ROBOTICS (09880.HK) maintained its 2026 industrial humanoid robot shipment target of 4,000-5,000 units, with bipedal and wheeled robots each accounting for half. Although around two-thirds of current humanoid robot demand comes from government data training centers, industrial user orders are expected to gradually replace training center demand over the next one to two years.

UBTECH ROBOTICS believed EBITDA may turn profitable in 2H26, and net profit may be recorded in 2027. In addition, UBTECH ROBOTICS is set to launch its self-developed simulation platform to reduce reliance on NVIDIA Corporation (NVDA.US) robotics toolkits and pave the way for import substitution across the broader ecosystem in the future.

The broker maintained its Buy rating on UBTECH ROBOTICS with a TP of HKD125.
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AASTOCKS Financial News
Website: www.aastocks.com

Chinese President Xi Jinping and his wife Peng Liyuan attended a welcome banquet hosted by US President Donald Trump and his wife Melania Trump at the White House.

According to a White House press release, more than 100 people attended the state dinner, mainly US government officials, business leaders and their spouses, including Apple Inc. (AAPL.US)'s Tim Cook, NVIDIA Corporation (NVDA.US)'s Jensen Huang and his wife, Tesla, Inc. (TSLA.US)'s Elon Musk, Meta Platforms, Inc. (META.US)'s Mark Zuckerberg, Amazon.com, Inc. (AMZN.US)'s Jeff Bezos and Advanced Micro Devices, Inc. (AMD.US)'s Lisa Su. Anthropic, however, was not on the guest list.

For China, the list included only seven officials accompanying Xi and Trump and their spouses, including Cai Qi, Wang Yi, He Lifeng, Zheng Shanjie, Wang Wentao, Ma Zhaoxu and Xie Feng.
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AASTOCKS Financial News
Website: www.aastocks.com

Google, OpenAI and Anthropic are pushing ahead with the establishment of an industry self-regulatory body named Standards Authority for Frontier AI (SAFA), which will operate independently without government regulation, The Information, citing sources, reported. The new organization could be established as early as the end of 2026 or early 2027.

The organization will focus on specific testing and audit frameworks, including support for third-party pre-deployment safety testing, incident reporting requirements and auditor qualification standards. The concept originated from a proposal put forward in July by Google DeepMind CEO Demis Hassabis.

The three companies initially sought to establish a public-private partnership mechanism under US federal regulation, but shifted to a purely industry self-regulatory approach after a draft White House executive order was shelved. Candidates for the organization's CEO role include former White House artificial intelligence policy adviser Sriram Krishnan. However, whether SAFA can gain broad industry recognition and clarify its division of responsibilities with government regulators remains to be seen.
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AASTOCKS Financial News
Website: www.aastocks.com

• This milestone marks the first IND submission from XtalPi's proprietary pipeline, recently unveiled in its interim results, validating the company's AI and robotics-driven drug discovery platform and its transition to a clinical-stage organization.
• Preclinical data demonstrate sub-nanomolar potency (< 1 nM) alongside a gut-to-blood exposure ratio exceeding 1,000:1, confining pharmacological activity to the gastrointestinal tract to limit systemic exposure.
• The candidate is the industry's first gut-restricted pan-TRK inhibitor developed for IBS and IBD, targeting a critical therapeutic gap in the long-term management of chronic pain without the neurological liabilities of systemic inhibitors.

BOSTON and SHENZHEN, CHINA, Sept. 25, 2026 /PRNewswire/ -- XtalPi (HKEX: 2228), an AI- and robotics-driven drug and materials discovery company, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for KQTD-126. Developed internally, the candidate is a potential first-in-class gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor designed to treat chronic intestinal pain associated with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

IBS affects approximately 10%–15% of the global population, while more than 10 million people live with IBD. Chronic abdominal pain is a major burden for patients with IBS and can persist in some patients with IBD even when standard therapies control their underlying inflammation. Despite available treatments, additional options that provide sustained pain relief and are suitable for long-term use remain an unmet clinical need. According to BCC Research, the global IBS and IBD therapeutics market is projected to reach US$52.6 billion by 2030.

KQTD-126 targets the TRK family of receptors (TRKA, TRKB, and TRKC), which directly regulate nerve activity and pain-signal amplification in the gut. While inhibiting these pathways can effectively manages this pain, TRK receptors also operate throughout the central nervous system. Consequently, traditional systemic TRK inhibitors carry a high risk of neurological side effects. A viable chronic pain treatment must therefore confine its activity strictly to the gastrointestinal tract.

Achieving this precise biological profile required navigating a vast chemical space to balance target affinity and kinase selectivity with properties governing tissue distribution. To resolve these competing design objectives, XtalPi leveraged its generative and predictive AI models integrated with its fleet of automated chemistry robots. This closed-loop process of computational design, automated synthesis, empirical screening, and molecular refinement allowed the company to iterate across structural variants and achieve robust gut restriction while preserving strong target activity and selectivity.

In preclinical studies, KQTD-126 achieved pan-TRK inhibition at sub-nanomolar concentrations (IC₅₀ < 1 nM) and maintained high selectivity over other kinases. The candidate also demonstrated a gut tissue-to-blood exposure ratio exceeding 1,000:1. Together, these findings support KQTD-126's development as a locally acting treatment intended to deliver sustained pain relief with a wider therapeutic window.

KQTD-126 is the first program in XtalPi's proprietary pipeline to reach an IND submission since the portfolio was unveiled in the company's recent interim results. As a global scientific utility platform, XtalPi draws on a shared foundation of quantum physics, AI, and robotics to deliver discovery capabilities spanning small molecules, antibodies, peptides, siRNA therapeutics, and molecular glues. This comprehensive infrastructure empowers the company and its partners to pursue high-value targets using the modality best suited to the underlying biology. By advancing internal assets alongside established collaborations, XtalPi maximizes the impact of its technology to resolve complex drug design challenges and deliver transformative therapies for patients worldwide.

About XtalPi

XtalPi Holdings Limited (XtalPi, 2228.HK) was founded in 2015 by three physicists from the Massachusetts Institute of Technology (MIT). It is an innovative R&D platform powered by quantum physics, artificial intelligence, and robotics. By integrating first-principles calculations, AI algorithms, high-performance cloud computing, and standardized automation systems, XtalPi provides digital and intelligent R&D solutions for companies in the pharmaceutical, materials science, agricultural technology, energy, new chemicals, and cosmetics industries.

ORACLE (ORCL.US) is taking measures to avoid incurring substantial costs related to a large data center being built in New Mexico. The company issued a force majeure notice to an affiliate of project developer BLUE OWL CAPITAL (OWL.US), requesting deferred payments if the data center fails to commence operations as scheduled in 2028.

The data center is facing regulatory hurdles due to local opposition. An Oracle spokesperson said force majeure notices are common in development projects of this scale and are typically used to preserve contractual rights. The notice itself does not constitute a project delay nor does it alter delivery expectations.

Overnight (24th), shares of ORACLE (ORCL.US) dived 3.5% to USD139.54, while BLUE OWL CAPITAL (OWL.US) also slid 3.6% to USD9.25.
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OSLO, Norway, Sept. 25, 2026 /PRNewswire/ -- On 24 September 2026, CATL opened its largest NING SERVICE centre outside Asia in Oslo, extending its battery lifecycle service network in Europe.

The 8,000 square metre centre will serve Norway and the wider Nordic region, providing battery services, training local technicians and supporting circular economy efforts across the region.

Norway is one of the world's most advanced EV markets. In August, battery electric vehicles made up 98.7% of new passenger car registrations, and electric buses accounted for more than 60% of bus and coach registrations. As this fleet grows and ages, demand for battery diagnostics, repair and life extension is rising. The Norway Centre is built to meet it.

Full-lifecycle battery services

• Drawing on CATL's R&D and manufacturing expertise, NING SERVICE covers the full battery lifecycle: testing, maintenance, repair, insurance, second life and recycling. Its services span transport, energy storage and robotics.
• NING SERVICE is helping shift the aftermarket from replacing batteries to repairing them, and has cut turnaround for complex repairs from 72 to 48 hours.
• Its deep repair capability covers 76.8% of EV models and applies CATL's production-line quality standards. The Intelligent Eagle Eye System, used in more than 150 repair facilities, provides full traceability and quality control.
• The centre will also serve as a brand experience space and sales agent for emerging electric applications, including vessels, eVTOL aircraft and robotics. NING SERVICE already manages agency sales for CATL's ecosystem partners, such as AutoFlight and Galbot.

Circularity and local skills

CATL launched the Global Energy Circularity Commitment (GECC) in strategic partnership with the Ellen MacArthur Foundation. In line with its vision, NING SERVICE is building an aftermarket ecosystem that keeps batteries in use for longer and returns their materials into new batteries.

"In a circular economy, batteries stay in use at their highest value for as long as possible, and their materials are recovered to make new ones. Inspection, maintenance and repair services are an important part of making that happen at scale," said Miranda Schnitger, Climate Lead at the Ellen MacArthur Foundation.

The centre will create skilled green jobs and become NING SERVICE's main training hub in the Nordics. Drawing on a training network across 39 European countries and a team of 14 experienced instructors, it will offer courses certified by CATL and practical training for local technicians. NING SERVICE also plans to work more closely with Norwegian universities and technical institutions to build local expertise.

Bringing service closer to customers

CATL is expanding its local presence worldwide through local infrastructure and ecosystem partnerships. The Norway Centre will be a key hub in NING SERVICE's European network, bringing high-quality service closer to customers in line with its promise to be "Your Nearby New Energy Service Expert."

"CATL brings technology, industry expertise and a trusted brand. Combined with YES-EU's local knowledge and service capabilities, we can build a stronger battery service ecosystem across the Nordics and support the long-term growth of Europe's EV market," said Benedikt G. Gudmundsson, Founder and Chairman of YES-EU Group.

"Customers are at the heart of everything we do at NING SERVICE. Working closely with our local partners, we will provide reliable battery lifecycle services that meet the needs of Norway's EV market and support its continued electrification," said Bruce Li, President of Quality Systems, Aftermarket Business Division, CATL.

NING SERVICE operates 1,394 service locations across 85 countries and regions. It aims to reach 100 countries and regions by 2027 and 10,000 service locations by 2030.