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2025-11-07
16:33
TSMC Reportedly Notifies Apple of Further Chip Price Hikes Next Yr

TSMC (TSM.US) has begun notifying major clients of price hikes for chips below 5 nanometers starting next year, according to South Korean social media platform Naver. This will include Apple (AAPL.US)'s A16, A17, A18, A19, M3, M4 and M5 chips, as well as all future iterations. The anticipated price hike is expected to range between 8% and 10%.

There have been rumors that the price of Apple's A20 chip, designed for 2026 new iPhone models, may see a significant increase. The A20 chip is likely to be the first widely adopted 2-nanometre chip, with its launch expected alongside the iPhone 18 series next year.
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16:00
Trip.com Group Shapes Global Travel Trends through AI Innovation, Sustainability and New Consumer Insights at WTM London 2025

LONDON, Nov. 7, 2025 /PRNewswire/ -- As World Travel Market (WTM) 2025 draws to a close at Excel London, Trip.com Group showcased its global leadership by sharing insights and innovations shaping the future of travel. Across key sessions, the company led conversations from global and European perspectives, focusing on the strategic evolution of travel, from digital transformation and personalisation to sustainability.

Evolving Travel Motivations

Second from right, Mr Boon Sian Chai, Managing Director and Vice President of International Markets at Trip.com Group, discusses the Chinese traveller
Second from right, Mr Boon Sian Chai, Managing Director and Vice President of International Markets at Trip.com Group, discusses the Chinese traveller

In his panel on From Snowfields to Screens: How Sports, Stories and AI Are Powering the Next Wave of Chinese Outbound Travel, Mr Boon Sian Chai, Managing Director and Vice President of International Markets at Trip.com Group, highlighted how the company is driving the next phase of global travel recovery through collaboration and technology. Drawing on insights from the Group's joint report with Google, Why Travel?, he noted that the motivations behind travel have shifted from escape to connection.

"Travellers today are more intentional, seeking meaning, authenticity, and value in every journey," he shared. "Our Why Travel? report shows a shift from escape to connection, with longer stays, rising interest in nature- and culture-based itineraries, and greater engagement with eco-certified accommodation. For Trip.com Group, that means partnering globally to create accessible, personalised, and responsible travel experiences."

For instance, the report notes a 53% year-on-year rise in searches for slower-paced cultural experiences such as "Japanese tea ceremonies," alongside surging wellness demand, with searches for wellness-sport pairings such as "golf & spa resorts" up 300% and "ski & spa" packages up 250% year-over-year.

AI-Driven Personalisation and Support

Mr Andy Washington, General Manager for Europe, is taking interviews at the Trip.com Group booth
Mr Andy Washington, General Manager for Europe, is taking interviews at the Trip.com Group booth

At the Future of Travel Technology session, Mr Andy Washington, General Manager for Europe, introduced Trip.Planner, a one-stop travel planning hub that combines trip building, bookings, and curated inspiration to enable travellers to seamlessly design end-to-end trips.

"Trip.Planner combines itinerary creation, dynamic recommendations, and real-time updates in a single intuitive platform," said Mr Washington. "It is built for today's travellers who crave flexibility, transparency, and inspiration in how they explore the world."

He added that the UK launch marks the start of broader European expansion, aligning with the Group's mission to localise innovation. "Our investment in smart planning tools is about empowering both travellers and partners, making travel hyper-personalised to the unique needs of every market and individual."

Mr James Spalding, Regional Flights Director at Trip.com Group, on the Purple Theatre stage, discussing AI efficiency and personalisation
Mr James Spalding, Regional Flights Director at Trip.com Group, on the Purple Theatre stage, discussing AI efficiency and personalisation

Building on this, Mr James Spalding, Regional Flights Director at Trip.com Group, highlighted how the Group's AI systems are redefining customer engagement and supportive service across the customer journey.

"AI isn't replacing the human touch, it's amplifying it," he emphasised. "By combining data intelligence with empathy, we're transforming how travellers interact with us before, during, and after their trip."

Sustainability: Turning Intent into Action

Ms Jane McFadzean, Senior Director of Global Sustainability, talking at the Cool Tripping panel
Ms Jane McFadzean, Senior Director of Global Sustainability, talking at the Cool Tripping panel

In a session on Cool Tripping, Slow Tourism and the Sophisticated Traveller, Ms Jane McFadzean, Senior Director of Global Sustainability, highlighted rising interest in more responsible travel and emphasised the travel industry's role in turning consumer intent into action.

"Our research shows that 92% of travellers express interest in more sustainable travel, but fewer than 60% have acted on it," Ms McFadzean noted. "The gap between awareness and action shows why platforms like Trip.com play a role in making responsible choices visible and effortless."

Trip.com Group's presence at WTM London 2025 highlights the full breadth of its global expertise, spanning AI innovation, sustainability leadership, and insights into evolving travel trends. Together, these pillars underscore the company's commitment to shaping a smarter, more sustainable future for global travel.

About Trip.com Group

Trip.com Group is a leading global travel service provider comprising of Trip.com, Ctrip, Skyscanner, and Qunar. Across its platforms, Trip.com Group helps travellers around the world make informed and cost-effective bookings for travel products and services and enables partners to connect their offerings with users through the aggregation of comprehensive travel-related content and resources, and an advanced transaction platform consisting of apps, websites and 24/7 customer service centres. Founded in 1999 and listed on NASDAQ in 2003 and HKEX in 2021, Trip.com Group has become one of the best-known travel groups in the world, with the mission "to pursue the perfect trip for a better world". Find out more about Trip.com Group here. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

 

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15:18
Jensen Huang Says No Plans to Sell Blackwell AI Chips to CN

Nvidia (NVDA.US) CEO Jensen Huang denied rumors that the company is attempting to re-enter China, the world's largest chip market. He stressed that no negotiations are underway actively with Chinese companies over the sale of Blackwell AI chips.

That said, Huang added that whether Nvidia's products can return to the Chinese market will hinge on Beijing's decision.
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14:31
Musk Hopes for Full FSD Feature Approval in CN by Feb 2026

Tesla (TSLA.US) CEO Elon Musk expects China to fully greenlight the company's Full Self-Driving (FSD) feature, foreign media reported. Currently, FSD has received partial approval in China, and he hopes for full approval by February or March next year.

In lack of full approval from Chinese regulators, broader testing of FSD has been forced to pause. Besides, Musk has called on European customers to pressure local regulators to approve FSD.
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11:54
US Said to Block Nvidia from Selling New AI Chip B30A to CN

The White House has informed other federal agencies that it will not allow Nvidia (NVDA.US) to sell the newly developed AI chip B30A, designed for the Chinese market, to China, according to The Information.

The B30A chip is capable of training large language models (LLMs). While Nvidia reportedly provided samples of the B30A to several Chinese clients, the company is working on modifying the design of the B30A in hopes that the US government will reconsider its decision.

A spokesperson for Nvidia stated that the company does not have any market share in China's competitive data center computing market, and therefore, the B30A has not been included in their performance forecasts.
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10:45
Musk Says Tesla May Build Mega Chip Factory, Does Not Bar Co-op w/ Intel

Tesla (TSLA.US) CEO Elon Musk stated that it may be essential to build a mega chip factory to produce AI chips, and there may be a need to cooperate with Intel (INTC.US).

At the moment, Tesla is designing its fifth-generation AI chip to support its autonomous driving program. Musk mentioned that no agreement has been signed with Intel yet, but discussions with Intel are possible.

Spurred by the news, Intel's stock price jumped up 2.6% in after-hours trading to US$38.21.
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09:00
Fosun International Honored with Gold Award and Best Sustainability Team at The Asset Corporate Sustainability Leadership Awards 2025

HONG KONG, Nov. 7, 2025 /PRNewswire/ -- On the evening of 6 November 2025, The Asset, a renowned Asian financial magazine, hosted "The Asset Corporate Sustainability Leadership Awards 2025" ceremony in Singapore. Fosun International Limited ("Fosun International" or the "Company") (HKEX stock code: 00656) was awarded "The Asset Corporate Sustainability Leadership Awards 2025 – Gold Award" and the "Best Sustainability Team".

Coinciding with The Asset's 25th anniversary, the highly regarded "The Asset ESG Corporate Awards" was renamed "The Asset Corporate Sustainability Leadership Awards" this year, underscoring the winning companies' more comprehensive and holistic commitment to advancing sustainable development. After years of refinement in its selection process, the awards have become one of the most authoritative and influential ESG awards in the Asia-Pacific region. Fosun International received "The Asset Corporate Sustainability Leadership Awards 2025 – Gold Award" in recognition of its outstanding performance in areas including financial performance, corporate governance, social responsibility, environmental protection, investor relations, information disclosure and corporate communication.

Fosun's remarkable ESG performance has been widely recognized by the international market

Looking back on the past, Fosun has always paid attention to the reform and development of the global policies in the field of sustainable development. It has established a robust ESG governance structure and management system, embedding sustainability principles into its operations over the years. It has actively responded to national and global strategies in relation to sustainable development, ensured information security, promoted technology innovation, implemented "dual carbon" goals, protected the rights and interests of employees to promote sustainable management and value creation.

Thanks to its sustained commitment to ESG over the years, Fosun International has consistently achieved excellent results in ESG ratings globally. As of now, Fosun International has maintained an MSCI ESG rating of AA. In 2025, it has been once again included in the S&P Global Sustainability Yearbook 2025 and has been selected as the top 1% in S&P Global Sustainability Yearbook 2025 (China Edition). It has received an HSI sustainability rating of AA- and has been consecutively included in the Hang Seng Corporate Sustainability Benchmark Index. Fosun has also retained a leading FTSE Russell ESG score and has continued to be selected as a constituent stock of the FTSE4Good Index Series.

Driven by innovation, committed to social contribution

Fosun adheres to an innovation-driven strategy, continuously delivering innovative achievements across its businesses to better serve society. To date, Fosun's innovative biopharmaceutical products have reached nearly 60 countries and regions, benefiting more than 850,000 patients worldwide. Among them, HANQUYOU, a core product in breast cancer treatment, is a China-developed monoclonal antibody biosimilar approved in China, the European Union, and the United States. It has been approved for marketing in more than 50 countries and regions worldwide. In addition, HANSIZHUANG, an innovative anti-PD-1 monoclonal antibody independently developed by Fosun, is the world's first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer (SCLC). To date, it has been approved for marketing in nearly 40 countries and regions, including China, the European Union, the United Kingdom, Singapore, and India, benefiting more than 110,000 patients worldwide.

Since the beginning of this year, Fosun has achieved multiple breakthroughs in the field of innovative drugs. HLX43, a PD-L1-targeting antibody-drug conjugate (ADC) is undergoing clinical studies for solid tumors such as non-small cell lung cancer and thymic carcinoma in countries including China, the United States, Japan, and Australia. Currently, no PD-L1 ADC has been approved globally, positioning HLX43 as a potential highly effective and safe broad-spectrum anticancer drug. Additionally, in the field of innovative small molecule drugs, FUMAINING, a targeted drug independently developed by Fosun, has been approved for two rare disease indications, filling the treatment gap in the field of rare tumors.

Fosun Pharma has consistently contributed the "China Solution" to the fight against malaria in Africa. As at the end of June 2025, its independently developed artesunate for injection had been used to treat more than 84 million patients with severe malaria worldwide. Additionally, Fosun Pharma had cumulatively supplied over 420 million doses of artesunate for injection globally.

In order to better promote the fulfillment and implementation of corporate social responsibility, Fosun Foundation was established in 2012. It has been making unremitting efforts in the fields of global emergency relief, rural revitalization, health, education, culture and art, youth development, etc. to create social value. Of which, since its launch at the end of 2017, Fosun Foundation's Rural Doctors Program has covered 78 counties in 16 provinces, cities, and autonomous regions, supported 25,000 rural doctors, and benefited 3 million rural families.

Actively responding to climate change and promoting low-carbon transformation

Fosun has moved beyond passive adaptation to actively driving climate action through innovation. Under the leadership of its Board of Directors (the "Board") and Carbon Neutrality Committee, the Group has integrated carbon neutrality into management performance appraisal, established a carbon emission management system, and provided greenhouse gas inventory training. Advancing its low-carbon transformation, Fosun is harnessing innovative technologies to create a more sustainable industrial chain and eco-friendly consumer products.

With climate change being one of the most severe long-term risks, Fosun recognizes the importance of global cooperation to tackle this challenge. Fosun remains committed to advancing China's "dual carbon" goals by promoting carbon neutrality and energy conservation and emission reduction. In 2021, Fosun made a commitment to society – "strive to peak carbon emissions by 2028 and achieve carbon neutrality by 2050". Fosun has formulated strategies for climate change mitigation and adaptation to align with the 1.5°C temperature control target set in the Paris Agreement.

Built a comprehensive mechanism for ESG management to effectively implement ESG strategies and actions

Fosun has been actively focusing on how to undertake more social responsibility. It is also committed to further optimizing corporate governance, focusing on the healthy development of sustainable businesses, extending from the Board of Directors to daily operations. Fosun has set up an ESG Board Committee under the Board to assist the Board in guiding and overseeing the Group's ESG development and implementation. At the management and decision-making level, Fosun has established an ESG Executive Committee to provide decision support for the implementation of ESG strategies. At the implementation level, the Group has also set up an ESG Management Committee and an ESG Working Group to implement ESG strategies and related actions and ensure the establishment of appropriate and effective ESG risk management and internal control system.

Fosun prioritizes sustainability and fosters an ESG culture from the top down. Fosun's ESG Management Committee and ESG Working Group regularly hold meetings and workshops including ESG global networking workshop, ESG culture week, ESG digital platform, encourage knowledge and experience sharing related to ESG among employees and subsidiaries, to help establish open communication channels within the Group and assist in promoting ESG development in subsidiaries. The Asset awarded Fosun International "Best Sustainability Team", which reflects the market's recognition of the Company's ESG management and the Company's active promotion of environmental protection, social responsibility, and corporate governance.

Looking ahead, as a global enterprise rooted in China, Fosun will continue to uphold its original aspiration of "Contribution to Society". Through continuous innovation and responsible global operations, Fosun will actively shoulder more social responsibility, striving to build a more responsible, inclusive, and sustainable future.

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09:00
復星國際榮獲《財資》雜誌頒發的「2025年財資企業永續領導獎金獎」及「最佳可持續發展團隊獎」

香港2025年11月7日 /美通社/ -- 2025年11月6日晚上,亞太區知名金融財經行業雜誌《財資》於新加坡舉行「2025年財資企業永續領導獎」頒獎典禮。復星國際有限公司(簡稱「復星國際」或「公司」)(香港聯交所股份代號:00656)獲該雜誌授予的「2025年財資企業永續領導獎金獎」(The Asset Corporate Sustainability Leadership Awards 2025 – Gold Award)及「最佳可持續發展團隊獎」(Best Sustainability Team)。

恰逢《財資》創刊25周年,原本備受矚目的「ESG企業大獎」於今年更名為「財資企業永續領導獎」,彰顯得獎企業在推動永續發展方面展現出更全面、更深層的承諾。該獎項歷經多年評選機制的淬煉,已成為亞太地區最具權威與影響力的 ESG 獎項之一。本次復星國際獲評「2025年財資企業永續領導獎金獎」,表彰公司在財務業績、企業管治、社會責任、環境保護、投資者關係、信息披露及企業傳播等範疇的卓越表現。

復星ESG表現獲國際市場廣泛認可

回顧過往,復星一直關注全球可持續發展領域的變革和發展,已建立完善的ESG管治架構及管理體系。多年來,復星將可持續發展理念融入經營管理中,並積極響應國家及全球可持續發展戰略、保障信息安全、促進科技創新、落實「雙碳」目標、保障員工權益,助力可持續管理與價值創造。

憑藉多年來在ESG領域的持續努力,復星國際全球ESG評級方面屢獲佳績。截至目前,復星國際MSCI ESG評級持續保持AA;復星國際於2025年再度成功入選標普全球《可持續發展年鑑2025》,並在《可持續發展年鑑》(中國版)2025名列最佳1%;恒生可持續發展評級持續取得AA-,並連續入選恒生可持續發展企業基準指數成份股;富時羅素FTSE ESG評分保持領先,並持續入選富時羅素社會責任指數(FTSE4Good Index Series)成份股。

創新驅動,積極回饋社會

復星堅持創新驅動戰略,推動旗下業務不斷結出創新成果,以更好服務社會。截至目前,復星旗下生物藥創新產品已觸達近60個國家和地區,惠及全球超85萬患者。其中,乳腺癌治療核心產品漢曲優,是中國、歐盟、美國獲批的「中國籍」單抗生物類似藥,累計在全球50多個國家和地區獲批上市。此外,復星自主研發的創新型抗PD-1單抗H藥漢斯狀,是全球首個獲批用於一線治療小細胞肺癌的抗PD-1單抗。截至目前,H藥已在中國、歐盟、英國、新加坡、印度等近40個國家和地區獲批上市,惠及全球逾11萬名患者。

今年以來,復星在創新藥領域實現多點破局。HLX43是一款靶向PD-L1的抗體偶聯藥物(ADC),正在中、美、日、澳等國家開展非小細胞肺癌、胸腺癌等實體瘤的臨床研究。目前,全球範圍內尚無PD-L1 ADC獲批上市,HLX43有潛力成為高效、安全的「廣譜抗癌藥」。此外,在小分子創新藥方面,復星自研的靶向藥物復邁寧獲批兩項罕見病適應症,填補了相關罕見病腫瘤領域的治療空白。

復星醫藥亦持續為援非抗瘧貢獻「中國方案」。截至2025年6月底,自主研發的注射用青蒿琥酯已累計救治全球逾8,400萬重症瘧疾患者,累計供應超過4.2億支。

為更好地推動企業社會責任的履行和實施,復星基金會於2012年成立,在全球應急馳援、鄉村振興、健康、教育、文化藝術及青少年發展等領域不懈努力,創造社會價值。當中,復星基金會的鄉村醫生項目自2017年底開展以來,已覆蓋全國16個省、市、自治區的78個縣守護2.5萬名鄉村醫生,惠及300萬戶農村家庭。

積極應對氣候變化,推動低碳轉型發展

面對氣候變化,復星已從被動適應轉為通過創新主動引領氣候行動。在頂層架構方面,在董事會與碳中和委員會引領下,復星國際已達成多個關鍵階段性目標,如將碳中和指標納入管理層績效考核;建立碳排放管理體系與審核標準;開展集團範圍的溫室氣體盤查培訓等。在推進低碳轉型過程中,復星正以創新技術為驅動,借助創新技術推動產業鏈低碳轉型,為消費者提供更多可持續產品與服務。

面對氣候變化這個嚴峻的長期風險,復星深刻認識到全球協作應對這一挑戰的重要性。復星一方面積極響應國家「雙碳」目標,推動碳中和與節能減排,另一方面,已於2021年向社會做出承諾:「力爭於2028年實現碳達峰、2050年實現碳中和」,通過制訂氣候變化緩解和適應策略,支持《巴黎協定》的1.5℃控溫目標。

建立完善ESG管理體系,全面落實ESG策略及行動

復星一直積極關注如何承擔更多社會責任,也致力推進公司管治的進一步優化,圍繞可持續業務健康發展,由董事會至各個日常營運環節層層滲透。復星在董事會下設立了ESG董事委員會,協助董事會指導及監察集團發展及落實ESG工作。在管理及決策層面,復星設立ESG決策委員會,對ESG戰略落地提供決策支持。在執行層面,集團亦成立了ESG管理委員會及ESG工作小組,確保設立合適及有效的ESG風險管理及內部監控系統,全面落實本公司的ESG策略及相關行動。

復星將可持續發展作為優先事項,上行下效培養ESG文化。復星ESG管理委員會和ESG工作小組,更會定期舉辦會議及工作坊,包括ESG全球網絡工作坊、ESG文化周、ESG學堂數字平台等,在集團各成員企業之間分享最佳實踐,建立開放、透明的溝通渠道,增進員工的參與,並與各個附屬公司分享ESG最佳實踐案例,從而協助推動附屬公司ESG專項的發展。此次獲《財資》授予復星國際「最佳可持續發展團隊獎」,足見市場對公司ESG管理及公司積極推動環境保護、社會責任、公司治理各項工作的認可。

面向未來,作為一家植根中國的全球化企業,復星將繼續秉承「助天下」的初心,繼續通過創新和負責任的全球運營,積極承擔更多社會責任,矢志創造更加負責任、包容和可持續的未來。

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05:06
DJIA Slips 398 Pts at Close; Nasdaq Falls 1.9%, as Nvidia Leads Decline with ~4% Slide

High-valuation AI stocks were under another round of sell-offs, prompting a weak opening and persisted decline in the US bourse on Thursday. The DJIA tumbled as much as 523 points or 1.1% at its lowest. At close, it dived 398 points or 0.8% at 46,912. The S&P 500 settled down 75 points or 1.1% at 6,720. The Nasdaq plunged 445 points or 1.9% to 23,053.

AI chip stocks were the top loser, with Nvidia (NVDA.US) slipping 3.7%, AMD (AMD.US) cratering 7.3%, and Palantir (PLTR.US) diving 6.8%. Qualcomm (QCOM.US) logged a net loss of US$3.12 billion for 4FQ, with its stock price shedding 3.6%. Arm (ARM.US) posted a 34% rise in revenue for 2FQ, with guidance beating expectations, but its stock dipped 1.2%.

Techs waned, with Meta (META.US) and Microsoft (MSFT.US) both fading around 2%, Tesla (TSLA.US) losing 3.5%, and Amazon (AMZN.US) sliding 2.9%. Apple (AAPL.US) held sturdy.
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00:05
再鼎醫藥公布 2025年第三季度財務業績和近期公司進展

10Triple MeetingAACR-NCI-EORTC)上公布的zocilurtatug pelitecan (zoci, DLL3 ADC)(前稱ZL-1310)的數據,持續展現出同類首創與同類最佳潛力,近期啟動的用於治療2L+廣泛期小細胞肺癌(ES-SCLC)的全球注冊研究提供了有力支持

推進其他高潛力全球項目,包括啟動ZL-1503IL-13/IL-31R雙特異性抗體)的全球1期研究,以及計劃在2025年底前提交ZL-6201LRRC15 ADC)的新藥臨床試驗申請(IND

KarXT近期被納入了中國國家級治療指南,凸顯了精神分裂症領域對新療法的迫切需求;其上市准備工作正在推進中

2025年第三季度總收入同比增長14%,達1.161億美元;經營虧損為4,880萬美元,同比收窄28%,調整後的經營虧損1收窄42%2,800萬美元;調整2025年全年總收入指引為至少4.60億美元 

公司將於美國東部時間116日上午 8:00(香港時間116日晚上21:00)舉行電話會議和網絡直播

上海和馬薩諸塞州劍橋市2025年11月7日 /美通社/ -- 再鼎醫藥有限公司(納斯達克股票代碼:ZLAB;香港聯交所股份代號:9688)今日公布了 2025 年第三季度的財務業績,以及近期的產品亮點和公司進展。

再鼎醫藥創始人、董事長兼首席執行官杜瑩博士表示:「隨著全球管線的快速推進,並依托我們在中國的商業化盈利能力和規模化業務發展,再鼎醫藥正在邁入全新的增長階段。在IND提交後短短不到兩年,zoci便已進入關鍵性開發階段,以及有多個差異化的全球項目並行推進,這展現了我們研發引擎的速度、科學嚴謹性和全球雄心。與此同時,我們在中國的商業化平台依然強勁,包括KarXT、povetacicept和艾加莫德在內的新產品及適應證正在拓寬我們的長期增長前景。我們正在共同打造一家能夠為患者帶來深遠影響並為股東創造長期價值的公司。」

再鼎醫藥總裁兼首席運營官 Josh Smiley 表示:「本季度,我們繼續深化夯實艾加莫德上市的基礎。在全身型重症肌無力領域,得益於治療指南的更新和真實世界經驗的支持,我們看到啟動治療的新患者數量在穩步增加,治療持續時間也在延長。雖然治療觀念還在逐步建立,但醫生對艾加莫德的信心在持續增長,這進一步鞏固了其作為這一慢性疾病的全新標准治療方式的長期潛力。展望未來,我們正在為接下來預期的KarXT在精神分裂症領域的上市做准備。依托於持續增長的區域業務和快速推進的全球管線,我們在為未來重大機遇做好布局的同時,始終保持穩健的運營。」

1指調整後的經營收入(虧損)(非美國公認會計准則),計算方法為將美國公認會計准則經營收入(虧損)經過扣除某些非現金支出(包括折舊、攤銷和以股份為基礎的酬金)的調整。有關此調整後的盈利指標的更多信息,請參閱「非美國公認會計准則指標」部分。 

近期管線亮點

自上次財報發布以來的重要產品進展包括:

腫瘤領域管線

  • Zocilurtatug Pelitecan (zoci, DLL3 ADC)(前稱ZL-1310:
    • 2025年10月,再鼎醫藥啟動了zocilurtatug pelitecan單藥治療二線及以上廣泛期小細胞肺癌(ES-SCLC)的全球注冊性研究。
    • 2025年10月,再鼎醫藥在美國癌症研究協會-美國國家癌症研究所-歐洲癌症研究與治療組織(AACR-NCI-EORTC)主辦的國際會議上公布了1期臨床研究數據更新:在二線廣泛期小細胞肺癌治療中,1.6mg/kg劑量組患者最佳總體緩解率為68%。所有劑量組和所有治療線數的患者中位緩解持續時間(DoR)預計為6.1個月,作為單藥療法,這對於重度經治且難治的患者群體而言極為令人鼓舞。在腦轉移患者中也觀察到了具有臨床意義的抗腫瘤活性,其中未經治療的腦轉移患者緩解率為80%。1.6mg/kg劑量組顯示出耐受性良好的安全性,≥3級治療相關不良事件發生率為13%,未發生≥2級的間質性肺病,且未出現停藥。綜上,這些結果強化了zoci的同類最佳潛力,並支持啟動全球注冊性研究。
  • 腫瘤電場治療(TTFields):2025年8月,再鼎醫藥宣布,基於3期PANOVA-3研究的陽性結果,中國國家藥品監督管理局(NMPA)授予腫瘤電場治療用於胰腺癌患者的創新醫療器械認定。我們計劃於2025年第四季度在中國遞交上市許可申請。
  • 貝瑪妥珠單抗(FGFR2b:2025年11月,再鼎醫藥合作伙伴安進宣布,停止貝瑪妥珠單抗聯合化療及納武利尤單抗用於一線胃癌患者治療的1b/3期FORTITUDE-102研究。

免疫領域管線

  • ZL-1503 (IL-13/IL-31R):2025年11月,再鼎醫藥啟動了一項全球1/1b期研究,旨在評估ZL-1503在健康志願者及中重度特應性皮炎受試者中的安全性、耐受性和藥代動力學特性。
  • 艾加莫德(FcRn):
    • 干燥綜合征:2025年9月,再鼎醫藥在大中華區(中國大陸(內地)、香港、澳門和台灣地區的統稱)加入了艾加莫德預充式皮下注射治療干燥綜合征的注冊性研究UNITY。
    • 血清陰性gMG: 2025年8月,再鼎醫藥合作伙伴argenx公布了衛偉迦用於乙酰膽鹼受體抗體血清陰性gMG患者的3期關鍵性臨床研究ADAPT-SERON的主要結果。研究達到了主要終點(p=0.0068),這是首個在所有三種亞型——MuSK+、LRP4+和三重血清陰性中,疾病活動度顯示出具有臨床意義改善的全球3期研究。再鼎醫藥在大中華區參與了這項全球3期研究,基於此有望在中國遞交上市許可申請。
  • 呫諾美林-曲司氯銨(或 KarXT)(M1/M4型毒蕈鹼乙酰膽鹼受體激動劑):2025年9月,《中國精神分裂症防治指南(2025版)》正式發布,KarXT首次被納入指南,這也是KarXT在全球被納入的首個國家級指南。該指南強調了KarXT在三大症狀領域(陽性症狀、陰性症狀和認知症狀)的廣泛有效性及其獨特的安全性,有助於實現長期依從性和功能恢復。2025年1月,中國國家藥品監督管理局受理了KarXT用於治療精神分裂症的新藥上市申請。
  • Povetacicept2025年9月,美國食品藥品監督管理局(FDA)授予povetacicept突破性療法認定,用於治療IgA腎病。隨後,FDA還授予了povetacicept用於此適應證的生物制品許可申請(BLA)提交的滾動審評。Vertex已經完成了3期研究的全部患者入組,其中包括有望在美國獲得加速批准的中期分析部分。再鼎醫藥在大中華區參與了其用於治療IgA腎病患者的全球3期RAINIER研究。

2025年第季度財務業績

  • 2025 年第三季度產品收入淨額為1.154億美元,2024年同期為1.018億美元,同比增長13%,按固定匯率(CER)計算同比增長14%。這一增長主要是由紐再樂和鼎優樂銷售額增長所驅動,部分被則樂銷量放緩所抵銷。
    • 衛偉迦和衛力迦: 2025年第三季度產品收入淨額為2,770萬美元,其中包括在中國國家醫保藥品目錄談判前對衛力迦進行主動價格調整後減少的240萬美元,2025年第二季度為2,650萬美元,銷售環比增長4.6%。這一增長主要是由於治療時間的延長和市場滲透率的提升。
    • 則樂:2025年第三季度產品收入淨額為4,240萬美元,2024年同期為4,820萬美元。銷售放緩是由於 PARP抑制劑類產品競爭態勢的變化。
    • 鼎優樂:於2024年第四季度上市,2025年第三季度產品收入淨額為640萬美元。
    • 紐再樂: 2025年第三季度產品收入淨額為1,540萬美元,2024年同期為1,000萬美元。這一增長是由於紐再樂市場覆蓋范圍的擴大和滲透率的提升。
  • 2025年第三季度的研發開支為4,790萬美元,2024年同期為6,600萬美元。這一下降主要是由於與預付款和裡程碑付款相關的許可費用減少。
  • 2025年第三季度的銷售、一般及行政開支為7,010萬美元,2024年同期為6,720萬美元。這一增長主要是由於支持紐再樂和衛偉迦增長的一般銷售費用的增加,部分被與則樂相關的銷售費用減少所抵銷。
  • 2025年第三季度的經營虧損為4,880萬美元,經調整後扣除包括折舊、攤銷和以股份為基礎的報酬在內的特定非現金支出後為虧損2,800萬美元。本新聞稿末尾附有經營虧損(美國公認會計准則)和調整後的經營虧損(非美國公認會計准則)的對比。
  • 2025年第三季度的虧損淨額為3,600萬美元,歸屬於股東的每股普通股虧損為0.03美元(每份美國存托股份(ADS)虧損為0.33美元),2024年同期虧損淨額為4,170萬美元,每股普通股虧損0.04美元(每份ADS虧損為0.42美元)。虧損淨額減少主要是由於產品收入的增長和運營開支的下降。
  • 截至2025年9月30日,現金及現金等價物、短期投資和流動受限制現金總計為8.172億美元,截至2025年6月30日為8.323億美元。

2025年第四季度和2026年的預期重要裡程碑事件

預期的臨床開發和數據公布

全球權利管線

Zocilurtatug Pelitecan (zoci, DLL3 ADC)(前稱ZL-1310

  • 二線及以上ES-SCLC再鼎醫藥將於2026年上半年公布正在進行的1期臨床研究中顱內抗腫瘤活性的數據更新。
  • 一線 ES-SCLC再鼎醫藥將於2026年上半年公布評估zoci聯合療法(與阿替利珠單抗和/或化療聯用)的1期研究的數據讀出,並基於新數據在2026年推進至注冊性研究階段。再鼎醫藥還計劃於2026年啟動一項1期研究,探索zoci的新型聯合療法方案。
  • 其他神經內分泌癌:再鼎醫藥將於2026年上半年公布針對特定實體瘤患者的全球1/2期臨床研究的數據讀出,並計劃在2026年推進至注冊支持性隊列研究階段。

ZL-1503IL-13/IL-31R

  • 再鼎醫藥將於2026年公布全球1/1b期研究在健康志願者和中重度特應性皮炎受試者中的初步數據讀出。

ZL-6201 (LRRC15 ADC)

  • 再鼎醫藥計劃於2025年第四季度向美國FDA提交新藥臨床試驗申請,啟動用於治療肉瘤患者及其他潛在LRRC15陽性實體瘤患者的全球1期臨床研究。

有望近期向NMPA提交的申請

  • 腫瘤電場治療:2025年第四季度提交用於一線胰腺癌治療的上市許可申請
  • 艾加莫德(FcRn): 2025年第四季度提交艾加莫德預充式皮下注射用於治療全身型重症肌無力(gMG)和慢性炎性脫髓鞘性多發性神經根神經病(CIDP)的上市許可申請

近期有望獲得NMPA批准的上市許可申請

  • 呫諾美林-曲司氯銨(或KarXT)(M1/M4型毒蕈鹼乙酰膽鹼受體激動劑)用於精神分裂症
  • 維替索妥尤單抗(組織因子ADC用於化療期間或之後病情進展的復發或轉移性宮頸癌
  • 瑞普替尼(ROS1/TRK用於NTRK陽性實體瘤

區域權利管線

艾加莫德(FcRn

  • 眼肌型重症肌無力:再鼎醫藥合作伙伴argenx將於2026 年上半年公布全球 3 期 ADAPT-OCULUS 研究的主要結果。再鼎醫藥在大中華區參與了這項研究。
  • 肌炎:再鼎醫藥合作伙伴argenx將於2026年下半年公布全球2/3期ALKIVIA研究的主要結果,該研究旨在評估艾加莫德用於治療免疫介導的壞死性肌病、抗合成酶綜合征和皮肌炎三種肌炎亞型。再鼎醫藥在大中華區參與了這項研究。
  • 甲狀腺眼病(TED):再鼎醫藥合作伙伴argenx將於2026年下半年公布2項注冊性研究UplighTED的主要結果。再鼎醫藥在大中華區參與了這2項研究。

Povetacicept (APRIL/BAFF)

  • 原發性膜性腎病(pMN):再鼎醫藥將於2025年第四季度在大中華區加入povetacicept用於pMN的全球關鍵性2/3期OLYMPUS研究。
  • IgA腎病(IgAN):再鼎醫藥合作伙伴 Vertex 將在 36 周治療後對全球 3 期 RAINIER 研究進行中期分析。Vertex預計在2025年底前向FDA提交用於IgA腎病治療的BLA的首個模塊,並計劃於2026年上半年完成BLA提交,以期在美國獲得加速批准。

VRDN-003(胰島素樣生長因子1受體抑制劑, 皮下注射)

  • 再鼎醫藥將於2025年第四季度在大中華區啟動用於TED的注冊性研究。
  • Viridian將於2026年第一季度公布用於活動性TED患者的全球注冊性研究REVEAL-1的主要結果,並於2026年第二季度公布用於慢性TED的全球注冊性研究REVEAL-2的主要結果。再鼎醫藥通過與Zenas訂立的許可協議,獲得了Viridian胰島素樣生長因子1受體抗體的分許可,並正在推進臨床開發。

2025年全年業績展望

再鼎醫藥調整2025年全年總收入指引為至少4.60億美元。

電話會議和網絡直播相關信息

再鼎醫藥將於今日,2025年11月6日,美國東部時間上午8點(香港時間晚上9點)舉行電話會議和網絡直播。與會者可以訪問公司網站http://ir.zailaboratory.com參與實時網絡直播。如要參加電話會議,需提前注冊。

注冊鏈接的詳細信息如下:

所有與會者都必須在電話會議之前通過上方鏈接完成在線注冊流程。注冊完成後,您將收到內含撥號詳情的確認郵件。 

會議結束後,您可通過訪問再鼎醫藥網站觀看回放。

關於再鼎醫藥

再鼎醫藥(納斯達克股票代碼:ZLAB; 香港聯交所股份代號:9688)是一家以研發為基礎、處於商業化階段的創新型生物制藥公司,總部位於中國和美國。我們致力於通過創新產品的發現、開發和商業化解決腫瘤、免疫、神經科學和感染性疾病領域未被滿足的巨大醫療需求。我們的目標是利用我們的能力和資源為人類健康帶來積極影響。

有關再鼎醫藥的更多信息,請訪問www.zailaboratory.com或關注https://x.com/ZaiLab_Global

非美國公認會計准則指標

除了根據美國公認會計准則呈現的業績外,我們還披露了經調整的增長率,以排除由於外幣折算為美元產生差異的影響。我們還提供了調整後的經營虧損指標,該指標對美國公認會計准則經營虧損進行了調整,以排除某些非現金支出(包括折舊攤銷以及以股份為基礎的酬金)的影響。我們稱之為「實現非美國公認會計准則經營利潤盈利」。這些調整後的增長率和調整後的經營虧損是非美國公認會計准則財務指標。我們認為這些非美國公認會計准則財務指標對於了解我們的經營業績和財務業績非常重要,並為投資者提供了趨勢的更多視角。盡管我們認為非美國公認會計准則財務指標可以增強投資者對我們業務和業績的了解,但這些非美國公認會計准則財務指標不應被視為相應的美國公認會計准則財務指標的唯一替代指標。

再鼎醫藥前瞻性聲明

本新聞稿包含了與以下方面相關的前瞻性陳述,包括:我們的策略和計劃;我們的業務、商業化產品和管線項目的潛力和預期;我們的目標、目的和重點事項以及我們基於增長戰略的預期(包括我們對商業化產品和上市、臨床階段產品、收入增長、盈利能力和現金流的預期);臨床開發計劃和相關臨床研究;臨床研究數據、數據解讀和發布;與藥物開發和商業化相關的風險和不確定性;注冊相關的討論、提交、申請、獲批和時間線;我們及我們合作伙伴的產品和候選產品的潛在裨益、安全性和有效性;投資、合作和業務拓展活動的預期收益和潛力;我們的盈利能力和實現盈利的時間線;我們未來的財務和經營業績;以及財務指導(包括我們的資本配置和投資策略以及我們預期實現盈利的途徑)。除對過往事實的陳述外,本新聞稿中包含的所有陳述均屬前瞻性陳述,並可通過諸如「旨在」、「預計」、「認為」、「有可能」、「估計」、「預期」、「預測」、「目標」、「打算」、「可能」、「計劃」、「准備」、「定位」、「可能的」、「潛在」、「將會」、「將要」等詞匯和其他類似表述予以識別。該等陳述構成《1995年美國私人證券訴訟改革法案》中定義的「前瞻性陳述」。前瞻性陳述並非對未來表現的擔保或保證。前瞻性陳述基於我們截至本新聞稿發布之日的預期和假設,並且受到固有不確定性、風險以及可能與前瞻性陳述所預期的情況存在重大差異的情勢變更的影響。對於我們在前瞻性陳述中披露的計劃、意圖、預期或預測,我們可能無法實際實現、執行或滿足,請勿過分依賴此等前瞻性陳述。實際結果可能受各種重要因素的影響而與前瞻性陳述所示存在重大差異,該等因素包括但不限於:(1)我們成功商業化自身已獲批上市產品並從中產生收入的能力;(2)我們為自身的運營和業務活動獲取資金的能力;(3)我們候選產品的臨床開發和臨床前開發的結果;(4)相關監管機構對我們的候選產品作出審批決定的內容和時間;(5)與在中國營商有關的風險;和(6)我們向美國證券交易委員會(SEC)提交的最新年報和季報以及其他報告中指出的其他因素。我們預計後續事件和發展將導致我們的預期和假設改變,但除法律要求之外,不論是出於新信息、未來事件或其他原因,我們均無義務更新或修訂任何前瞻性陳述。該等前瞻性陳述不應被視為我們在本新聞稿發布之日後任何日期的意見而加以信賴。 

如需查閱公司向SEC提交的文件,請訪問公司網站www.zailaboratory.com 和SEC網站www.SEC.gov

 

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