NAIROBI, Kenya, Dec. 9, 2025 /PRNewswire/ -- Zoomlion Heavy Industry Science & Technology Co., Ltd. ("Zoomlion"; 1157.HK) is helping Kenyan farmers navigate the country's shifting seasons, where heavy rains turn fields to mud and the dry months leave soil unworkable. In Nakuru, Zoomlion's agricultural machinery is increasing land productivity and giving farmers tools suited to local field conditions. Around 70 percent of Kenya's population depends on farming but progress has been stymied by limited mechanization. Extreme weather strains traditional labor, and used equipment often falls short of demand. Reliable, efficient machines have become essential.

At a Zoomlion warehouse, engineer Solomon inspects a tractor before delivery. Every unit undergoes a strict check. That day's shipment includes RC110 tractors heading to Angata Sugar Mills. March to May and September to November mark the country's busiest seasons. John, head of logistics at the sugar mills, prepares fleets of machines to move into the fields. Sugarcane is a vital cash crop, and the mill has planted 1,000 hectares with support from around 60 Zoomlion machines. Output and efficiency, he said, have climbed sharply.

Farmers and operators have embraced the tractors for their power, low fuel use, and simple controls, said Kenneth, a local Zoomlion service engineer. One storage site now holds almost 300 pieces of equipment including tractors, harvesters, and transplanting machines. Zoomlion's technology has also cut transportation costs. "After our tractors were deployed, operating costs for short-distance hauling dropped about 30 percent," said Zhu Wenxi, Zoomlion's Deputy General Manager for East Africa. For operators such as Malala, the change is personal, sharing: "We used to carry everything manually. Now the work is easier."

To keep equipment running smoothly, Zoomlion stations Kenyan engineers in the sugar factory for immediate support. John said their constant presence has been invaluable. Service teams also train local technicians, preparing them to handle issues independently. Climate challenges have pushed further innovation. Frequent braking on muddy roads caused early wear, prompting Zoomlion to upgrade brake pads on later models. Service engineer Ken Gang recently returned from a technical training trip in China. The experience, he said, helps him teach Kenyan operators safer and more efficient practices.

As machinery spreads through Kenya's fields, farmers are seeing higher yields and lighter workloads. And as cooperation deepens, Zoomlion is helping shape a modern agricultural path for the region, one rooted in shared innovation and growing opportunity.

A Medal Haul: Xtep Athletes Secure 6 Golds, 2 Silver, 2 Bronzes

HO CHI MINH CITY, Vietnam, Dec. 9, 2025 /PRNewswire/ -- Attracting 23,000 runners globally, the 8th Edition of the Techcombank Ho Chi Minh City International Marathon successfully launched on December 7. After an intense competition, Xtep-sponsored elite athletes delivered a dominant performance. In the men's full marathon, Ethiopian international elites swept the podium: Ayalew Seleshi Simaneh claimed victory with an impressive time of 02:23:12, followed by Wondale Melsew Baye (02:23:23) and Kebede Leta Girma (02:23:32). In the women's race, Xtep's local brand ambassador Phạm Thị Hồng Lệ secured first place with 02:48:07, while Ethiopian athletes Mohamed Yenework Husen (02:48:45) and Zega Mestu Sirabzu (02:50:52) took second and fourth places respectively. Additionally, Vietnamese runner Bá Văn Hân, representing the local Xtep team, achieved third place in the men's category with 02:33:01. As a long-standing and committed partner of the event, technical footwear and apparel brand Xtep marked its 4th consecutive year as the Exclusive Apparel Sponsor, further underscoring the brand's professional spirit and enduring dedication to high-performance running and athlete-focused innovation.

Ho Chi Minh City is rapidly emerging as a leading running hub in Southeast Asia. According to data from the event organizers, registrations for this year's race increased by approximately 28% compared with last year, continuing a multi-year trend of strong growth. This momentum reflects the city's improving running environment and its increasingly dynamic sports culture. Mr. Le Truong Hien Hoa, Deputy Director of the Ho Chi Minh City Department of Tourism, highlighted the event's broader significance, stating, "This is one of the city's most distinctive sports-tourism events, attracting international visitors while inspiring and uniting the community." Echoing this view, Mr. Nguyen Nam Nhan, Deputy Director of the Ho Chi Minh City Department of Culture and Sports, added, "The race also helps position Ho Chi Minh City as an attractive international destination for regional sporting events. Moving forward, we remain committed to supporting the growth of the marathon, so it becomes one of the region's leading community marathons, contributing meaningfully to the city's sustainable development and international reputation." Ho Chi Minh City has been systematically accelerating the development of urban green spaces and public areas to provide better conditions for residents and running enthusiasts. These initiatives are translating into consistently rising public enthusiasm and participation across the community.

At the pre-race Marathon Expo which opened on December 5, Xtep's lineup of high-performance running products drew significant attention from participants. Ms. Đào Thị Thu Hương, Deputy General Director of Xtep Vietnam, highlighted the philosophy behind these innovations at the race opening ceremony: "Guided by our mission to become a top global sports brand that blends performance with style, Xtep is committed to continuous innovation. We are dedicated to providing athletes with the best possible equipment, empowering them to perform at their peak." This commitment was on full display with products like the championship-caliber 160X 7.0, designed to help runners feel comfortable, confident, and at ease on every stretch of the course. The brand's professional proposition was further evidenced through its sponsorship of elite athletes, backing a local team of 6 and an international team of 6 competitors. This strategic blend of top-tier international talent and dedicated local runners does more than secure victories; it actively elevates the competitive landscape for all participants, setting a new benchmark for the event and accelerating its journey toward becoming a world-class race. Furthermore, Xtep's running club, X-Run, demonstrated its strength, with many of its members achieving outstanding results across various race distances and leaving a remarkable impression. These achievements not only highlight the individual prowess of the runners but also reflect the effective support system and community that Xtep has cultivated.

Building on this successful track record of empowering runners, Xtep is committed to further deepening its engagement with the running community in Vietnam. Looking ahead, Xtep is committed to deepening its support for the runners of the Ho Chi Minh City Marathon. This commitment will be realized through continuous product innovation, including introducing advanced footwear like the 160X series adapted to local conditions, and through community initiatives such as organizing running clinics and training workshops. These multifaceted efforts embody Xtep's core philosophy of "Influencing the Masses through Professionalism"—aiming to elevate the running experience for athletes at all levels, promote a scientific approach to the sport, and contribute to a lasting, vibrant running culture in Vietnam.

About XTEP

XTEP Group, one of the leading sports brands in China, was founded in 1987 and officially established as the brand XTEP in 2001. The Group was listed on the Hong Kong Stock Exchange on June 3, 2008 (01368.hk). In 2019, the Group launched its global strategy, incorporating Saucony, Merrell, K•SWISS, and Palladium to become a leading international sports group with multiple sports brands. For more about XTEP, please visit https://www.globalxtep.com/

US President Donald Trump announced that, subject to a series of conditions, Nvidia (NVDA.US) will be allowed to deliver its AI Chip H200 to approved customers in China and other regions.

Guo Jiakun, the spokesperson for the Ministry of Foreign Affairs of the PRC (MoFA), said at a regular press conference that China has consistently advocated that China and the US achieve mutual benefit and win-win outcomes through cooperation.
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HONG KONG, Dec. 9, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO Asia Congress.

Currently, Akeso is running the pivotal Phase III study (AK104-310/COMPASSION-33) investigating cadonilimab combined with the SOX regimen for perioperative treatment of resectable G/GEJ adenocarcinoma. This regimen is expected to further push the efficacy boundaries beyond existing single-target immunotherapies and establish a new standard for perioperative immunotherapy in gastric cancer.

Promising Pathologic Complete Response (pCR) Rate

Among all evaluable patients, the overall pCR rate was 28.6%. Notably, in patients receiving the cadonilimab Q3W dosing regimen, the pCR rate reached 50.0%. pCR, defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes upon surgical resection, is considered the "gold standard" surrogate endpoint for evaluating neoadjuvant treatment efficacy and predicting long-term survival benefits.

High Rate of Major Pathologic Response (MPR)

The overall MPR rate (defined as ≤10% residual viable tumor cells) across all evaluable patients was 71.4%. For the cadonilimab Q3W regimen, the MPR rate was as high as 85.7%. This suggests that the cadonilimab-based regimen induces substantial tumor regression in the majority of patients.

100% R0 Resection Rate

All patients who underwent surgery achieved an R0 resection (microscopically margin-negative resection), providing a solid foundation for curative intent and potentially reducing the risk of recurrence.

Significant Tumor Downstaging

Among all evaluable patients, 85.7% achieved downstaging of the primary tumor (ypT), and 75.0% achieved nodal downstaging (ypN). These results confirm the efficacy of the cadonilimab regimen in reducing tumor burden and lowering the pathological stage, thereby improving the conditions for successful surgical intervention.

Manageable Safety Profile with Good Tolerability

Treatment-related adverse events were consistent with the known safety profiles of the SOX regimen and immune checkpoint inhibitors. No new or unexpected safety signals were observed, indicating an overall manageable and favorable safety profile.

In perioperative treatment of resectable G/GEJ adenocarcinoma, chemotherapy remains the standard therapy for locally advanced gastric cancer. However, chemotherapy has limited efficacy. Cadonilimab, the first PD-1/CTLA-4 bispecific antibody, works by synergistically activating the immune system, achieving a dual blockade of the tumor immune suppressive microenvironment. This mechanism provides a stronger anti-tumor effect compared to PD-1/L1 monotherapies.

Currently, cadonilimab's clinical value in gastric cancer is scientifically well-established. Beyond its ongoing phase III clinical trial in the perioperative setting, cadonilimab combined with chemotherapy as a first-line treatment for advanced gastric cancer (with survival benefits across the PD-L1 expression levels) has been approved for commercialization in China. Additionally, a pivotal phase III trial exploring cadonilimab in combination with pulocimab (VEGFR-2) for immune therapy-resistant advanced gastric cancer is currently ongoing and is expected to offer a new therapeutic option for later-line gastric cancer. Collectively, these pivotal phase III studies will expand the use of cadonilimab, paving the way for a comprehensive gastric cancer treatment options that spans from advanced, unresectable gastric cancer to early-stage, resectable disease.

Forward-Looking Statement of Akeso, Inc.

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 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 the 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.

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, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

北京2025年12月9日 /美通社/ -- 晶泰科技（股票代碼：2228.HK）今日宣佈與中國代謝疾病治療領域領軍企業甘李藥業達成人工智能（AI）多肽創新藥研發全球戰略合作及平台授權協議。根據合作條款，晶泰科技將依管線進度獲得平台授權費用、首付款、臨床與商業化里程碑付款及管線再授權收益分成。 這一合作是晶泰科技在AI 多肽研發領域的又一商業化里程碑，標誌著晶泰科技在AI驅動多肽藥物研發平台經過豐富的成功驗證後，其技術實力與商業價值獲得行業頂尖藥企的高度認可。兩家公司將在 AI 賦能多肽藥物創新與海外市場拓展中深度協同，在新靶點、新機制、新療法展開全面佈局，並驅動晶泰科技 AI 多肽研發平台的持續技術升級與價值兌現，向著「定義下一代代謝疾病多肽療法、惠及全球患者」的戰略願景攜手邁進。

根據合作協議，甘李藥業將依托晶泰科技自主研發的AI多肽研發專有平台PepiX™，聚焦代謝疾病領域核心治療需求，加速新型多肽藥物的發現與開發進程。晶泰科技將運用AI生成式多肽設計、穩定性提升、修飾策略優化、成藥性預測等全鏈條「AI+濕實驗」技術能力，完成候選藥物的精準設計、高效篩選與性能優化，覆蓋從分子設計到臨床前候選化合物確定的關鍵環節，從而顯著縮短研發週期，提升候選藥物的開發效率與成功率。

雙方還將組建戰略協作團隊，通過「AI驅動研發-臨床轉化-商業化落地」的合作閉環生態，深度集成甘李藥業在代謝疾病研發領域的核心資源與晶泰科技的AI 多肽研發技術平台，依托甘李藥業成熟的多肽生產銷售網絡與晶泰科技橫跨中歐美的合作夥伴矩陣，加速新藥管線的商業轉化，並持續推動晶泰科技的平台升級。

作為國內AI多肽製藥領域的先鋒企業，晶泰科技長期聚焦人工智能、自動化技術與多肽藥物研發的深度融合，其構建的一體化多肽研發平台PepiX™涵蓋了分子從頭設計、自動化合成以及高通量建庫篩選的序列優化等技術能力，可以短時間內大幅提升藥物分子的穩定性、半衰期及口服利用度等關鍵藥物屬性。這一AI多肽研發平台已在多個內外部研發項目中獲得成功驗證，能有效設計出極具競爭優勢與可開發性的創新多肽分子，顯著縮短研發週期，提高創新回報率。

本次合作是雙方基於行業需求與技術優勢的精準契合——甘李藥業在內分泌代謝疾病領域擁有領先的成果和近30年深耕積澱，同時北京總部具備3.5噸級原料藥產能與覆蓋4.5萬家醫院的商業化網絡。晶泰科技的AI多肽研發平台在新靶點發現、化合物快速篩選方面具備獨到的優勢，可與甘李藥業形成高效協同，助力甘李藥業豐富差異化管線創新，並持續驅動晶泰科技AI 研發平台的優化升級，為創新夥伴與投資人創造價值。

依托與甘李藥業等產業龍頭的前沿研發實踐，以及全球領先的 AI 製藥商務合作進展，晶泰科技正全力拓展其 AI 多肽研發平台的產業級合作。此舉也將進一步強化晶泰科技覆蓋多肽、抗體、小分子、ADC及分子膠的多維度AI藥物研發平台的稀缺價值與整合優勢，加速其技術壁壘與規模化效益向商業收益的高效轉化。

晶泰科技首席創新官賴力鵬博士表示：「此次與代謝疾病領域的頭部企業甘李藥業達成合作， 標誌著晶泰科技的 AI 多肽研發平台經過多年深耕與豐富的實戰驗證，全面進入產業級賦能階段。我們將與甘李深度攜手，充分利用雙方團隊在多肽設計與開發領域的深厚積累，從源頭提升候選藥物的差異化優勢，構建端到端的高效開發閉環，共同推動多肽藥物研發範式升級。期待晶泰科技的 AI 多肽研發平台助力更多突破性的多肽療法早日惠及全球患者，為代謝疾病治療創造全新臨床價值。」

甘李藥業董事長兼CEO陳偉博士表示：「我們始終關注前沿科技在藥物研發中的應用，AI技術正引領生物醫藥行業的變革浪潮。本次與晶泰科技的合作，是踐行公司創新戰略與融合發展的重要一環，將為我們帶來全新的研發視角和技術路徑。我們期待通過AI賦能，進一步提升研發效率，加速優質多肽藥物的研發進程，解決內分泌代謝疾病治療的未被滿足臨床需求，為全球患者提供更多高質量的創新治療方案。」

此次戰略合作標誌著晶泰科技 AI 多肽研發平台的合作規模躍升，進一步鞏固了其在 AI 賦能大分子藥物創新領域的領跑地位。未來，雙方將以此次合作為起點，AI+自動化實驗平台與甘李藥業的產業縱深，持續深化AI技術與多肽藥物研發的融合創新，加速實現下一代多肽療法突破，引領全球多肽藥物研發範式升級，並攜手行業夥伴共同構建開放共贏的創新生態，為全球代謝疾病防治事業貢獻更多中國智慧和中國力量。

關於甘李藥業

甘李藥業股份有限公司（簡稱：甘李藥業）是中國首家成功實現重組胰島素類似物產業化生產的高科技生物製藥企業，在內分泌代謝治療領域處於國內領先地位。公司已形成完整的胰島素產品矩陣，全面覆蓋第二代及第三代胰島素，包括長效、速效、預混胰島素，現有六款核心產品。2024年，公司胰島素類似物集采協議量高居中選企業榜首，並順利通過歐洲藥品管理局（EMA）的GMP檢查，生產質量管理體係獲國際認可。立足中國，放眼全球，甘李藥業始終致力於為全球患者提供更高質量的藥品與服務。

關於晶泰科技

晶泰科技（「XtalPi Holdings Limited」，股份簡稱：晶泰控股，XTALPI，股票代碼：2228.HK）由三位麻省理工學院的物理學家於 2015 年創立，是一個基於量子物理、以人工智能賦能和機器人驅動的創新型研發平台。公司採用基於量子物理的第一性原理計算、人工智能、高性能雲計算以及可擴展及標準化的機器人自動化相結合的方式，為製藥及材料科學（包括農業技術、能源及新型化學品以及化妝品）等產業的全球和國內公司提供藥物及材料科學研發解決方案及服務。

US President Donald Trump announced that he will sign an executive order this week to establish a unified national framework for artificial intelligence.

Trump did not provide details, but reports last month indicated that he is considering challenging state AI regulations through lawsuits and withholding federal funds.
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• New index tracks 100 companies listed in Hong Kong across six major technology-focused themes
• HKEX's first Hong Kong equity index, marking a significant milestone in Group's index and data business development
• HKEX enters licensing agreement with E Fund Management to issue an ETF in Chinese Mainland market

HONG KONG, Dec. 9, 2025 /PRNewswire/ -- Hong Kong Exchanges and Clearing Limited (HKEX) is pleased to announce a major expansion of its index portfolio with the launch of the HKEX Tech 100 Index (HKEX Tech 100), the Group's first Hong Kong equity index that underscores its ongoing investment in building the vibrancy of the region's capital market ecosystem.

HKEX Tech 100 is a broad-based benchmark that tracks the performance of 100 of the largest Hong Kong-listed companies across six innovative themes: Artificial Intelligence, Biotech & Pharmaceutical, Electric Vehicles & Smart Driving, Information Technology, Internet, and Robotics. All constituents are eligible for Stock Connect Southbound trading, ensuring broad accessibility for global and Chinese Mainland investors.

HKEX is also pleased to announce it has entered into a licensing agreement with E Fund Management Company Limited (E Fund Management), a leading Chinese Mainland asset management company, for the introduction of an exchange traded fund (ETF) based on HKEX Tech 100 in the Chinese Mainland.

HKEX Chief Executive Officer, Bonnie Y Chan, said: "We are delighted to announce the launch of the HKEX Tech 100 Index, a significant milestone in HKEX's journey to build its index and data business. This new broad-based index covers the leading innovative sectors in our listed issuer universe that have transformed the DNA of Hong Kong's markets, and its launch underscores the critical role our markets play in nurturing these emerging industries. This new benchmark provides investors with an effective and comprehensive tool to capture opportunities in some of the most exciting and transformative sectors in our market."

The index incorporates a fast-entry mechanism, enabling newly-listed companies that meet specific criteria to join the index outside of the regular review cycle after they become eligible for Stock Connect Southbound trading.

Ms Chan added: "Our licensing arrangement with E Fund Management will help support the further development of a product suite linked to Hong Kong equities in the Chinese Mainland, meeting the strong market demand in the region for opportunities in Hong Kong's vibrant tech sector. We look forward to working closely with E Fund Management and other industry partners, as we develop innovative indices and products that meet evolving investor needs and support the creation of new investment tools."

Dr Liu Xiaoyan, Chairwoman of E Fund Management, stated: "We are pleased to work with HKEX to develop an ETF for the Chinese Mainland market that tracks the HKEX Tech 100 Index. This index brings together a comprehensive group of 100 leading technology companies listed in Hong Kong, reflecting the vibrancy and innovation of the city's tech sector. We look forward to the launch of this ETF, which will aim to provide investors with an efficient way to tap into the growth opportunities of Hong Kong-listed tech companies while also supporting the real economy and fostering the ongoing development of emerging industries."

With the licensing agreement, E Fund Management plans to launch an ETF in the Chinese Mainland based on HKEX Tech 100, subject to regulatory approval and the issuer's further announcements. Going forward, HKEX will explore other index opportunities and work with industry partners in product development around its indices.

Index methodology and additional information about HKEX Tech 100 are available on the HKEX website.

HONG KONG, Dec. 9, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that at the 2025 ESMO Asia Congress, updated results from the pivotal Phase III HARMONi-6 study (AK112-306) were shared in an oral presentation by Professor Shun Lu from Shanghai Chest Hospital. The study evaluates ivonescimab (a first-in-class PD-1/VEGF bispecific antibody) combined with chemotherapy versus tislelizumab combined with chemotherapy in first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC).

Beyond the previously reported efficacy data presented at the ESMO 2025 Presidential Symposium and simultaneously published in The Lancet, this presentation further disclosed patient-reported quality of life outcomes based on the EORTC QLQ-C30 questionnaire.

Both prolonging survival and improving quality of life are core indicators for evaluating cancer treatments. The results published at 2025 ESMO Asia demonstrate that, compared to the tislelizumab-based regimen, treatment with ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also offers better tolerability, enables higher treatment adherence, and provides patients to maintain better overall health status and quality of life over a longer period. These findings highlight the comprehensive clinical value of the ivonescimab regimen in delivering both survival and quality-of-life benefits for patients.

• Quality of life (QoL) assessments from the HARMONi-6 study show that, compared with PD-1 inhibitor plus chemotherapy, ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also helps patients maintain better overall health status. Time to deterioration in "Global Health Status/Quality of Life" was meaningfully delayed in the ivonescimab arm (HR = 0.94), indicating a trend toward reduced risk of QoL worsening versus the control group.
• The ivonescimab-based regimen met the primary PFS endpoint versus the tislelizumab-based regimen, delivering a decisive, strongly positive outcome with both statistical significance and clear clinical benefit. PFS was substantially prolonged with ivonescimab plus chemotherapy compared with tislelizumab plus chemotherapy.
• The hazard ratio for PFS between the ivonescimab and tislelizumab arms was 0.60 (P < 0.0001), corresponding to an absolute PFS improvement (ΔPFS) of 4.24 months (11.14 months vs. 6.90 months). This benefit was consistent across all PD-L1 expression subgroups.

The HARMONi-6 study enrolled 532 patients with well-balanced baseline characteristics. Among these patients, 92.3% had stage IV disease at enrollment. The squamous histology profile of the patients reflected real-world patterns, with approximately 63% of patients exhibiting the central squamous subtype (66.9% in the ivonescimab arm vs. 59.4% in the control arm). PD-L1 expression levels were also aligned with clinical expectations.

The results from the HARMONi-6 study further validate the breakthrough clinical value of the ivonescimab-plus-chemotherapy regimen compared to PD-1-plus chemotherapy regimen. The ivonescimab-plus chemotherapy regimen addresses a critical clinical gap when anti-angiogenic agents such as bevacizumab demonstrated severe safety considerations in the treatment of sq-NSCLC. Since ivonescimab's initial approval in 2024, it has been evaluated in multiple clinical studies and used in real-world settings involving over 40,000 patients, where its transformative clinical benefits have been consistently demonstrated.

Across the immuno-oncology landscape, ivonescimab has shown clinical superiority to both PD-1 based treatments, which are currently the optimal standard of care for many cancers, and to also VEGF-targeted therapies in anti-angiogenesis based treatments.

In July 2025, based on the HARMONi-6 study results, the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as first-line treatment for sq-NSCLC was accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Akeso's partner, Summit Therapeutics, is currently carrying out a global multicenter Phase III HARMONi-3 study, evaluating ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy as first-line therapy for advanced NSCLC (both squamous and non-squamous subtypes).

Forward-Looking Statement of Akeso, Inc.

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 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 the 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.

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, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

• 耐立克^®治療組的中位無事件生存期（EFS）為21.2個月，明顯優於對照組的2.9個月
• 耐立克^®顯示了良好的安全性，血管閉塞事件發生率為7%
• 耐立克^®受試患者廣泛獲益，其中包括不伴T315I突變的患者（EFS為11.9個月，對照組則為3.1個月）

美國馬里蘭州羅克維爾市和中國蘇州2025年12月9日 /美通社/ -- 致力於在腫瘤等領域開發創新藥物的領先的生物醫藥企業——亞盛醫藥（納斯達克代碼：AAPG；香港聯交所代碼：6855）宣佈，公司已在美國佛羅里達州奧蘭多市舉辦的第67屆美國血液學會（American Society of Hematology，ASH）年會上，以壁報展示形式公佈了其核心產品奧雷巴替尼（商品名：耐立克^®）治療酪氨酸激酶抑制劑（TKI）耐藥/不耐受慢性髓細胞白血病（CML）-慢性期（CP）患者的隨機對照註冊II期研究的4年隨訪數據。這是對該研究在2023ASH年會口頭報告研究結果的持續更新，進一步證實了耐立克^®的長期療效與安全性優勢。

ASH年會是全球血液學領域規模最大的國際學術盛會之一，彙集了最前沿的研究進展及最新的藥物研發數據，展示全球血液學領域的最高學術水平。在此次會議上，亞盛醫藥的多個創新成果再度獲得國際學術界的關注， 三個品種（耐立克^®、利生妥^®、APG-5918）有多項臨床和臨床前進展入選展示及報告，其中一項獲口頭報告。

此次展示的4年隨訪數據顯示，耐立克^®在TKI耐藥/不耐受的CML-CP（包括不伴T315I突變）患者中，持續展現出優於研究者決定的現有最佳可用療法（BAT）的顯著療效。在所有CML-CP患者中，耐立克^®治療組的中位無事件生存期（EFS）達到21.2個月，顯著優於BAT組的2.9個月；在不伴T315I突變CML-CP患者中，耐立克^®治療組的EFS為11.9個月，顯著優於BAT組的3.1個月。值得關注的是，長期隨訪數據證實其安全性良好，血管閉塞事件發生率為7%。

耐立克^®是亞盛醫藥原創1類新藥，為中國首個獲批上市的第三代BCR-ABL抑制劑。其在中國的商業化推廣由亞盛醫藥和信達生物共同負責。目前，耐立克^®已在中國獲批的適應症為：治療任何TKI耐藥、並伴有T315I突變的CML-CP和加速期（-AP）的成年患者；以及治療對一代和二代TKI耐藥和/或不耐受的CML-CP成年患者，且所有獲批適應症均已被納入國家醫保藥品目錄。目前，亞盛醫藥正開展耐立克^®三項全球註冊III期臨床研究，涉及CML-CP、新診斷的費城染色體陽性急性淋巴細胞白血病（Ph+ ALL）、琥珀酸脫氫酶（SDH）缺陷型胃腸道間質瘤（GIST）幾大適應症。此外，亞盛醫藥已經與跨國製藥企業武田就耐立克^®簽署了一項獨家選擇權事宜。一旦行使選擇權，武田將獲得開發及商業化耐立克^®的全球權利許可，惟中國大陸、中國香港特別行政區、中國澳門特別行政區、中國台灣等地區除外。

此項研究的報告人、北京大學血液病研究所、北京大學人民醫院江倩教授表示： 「這項註冊II期臨床研究的最新數據，再次驗證了耐立克^®在TKI耐藥/不耐受CML-CP患者，包括無T315I突變人群中的卓越療效，表現出的長期安全性特徵——特別是血管閉塞事件發生率為7%，為臨床醫生與患者提供了至關重要的長期用藥信心。這些數據進一步夯實了該藥在臨床實踐中的重要地位。」

亞盛醫藥首席醫學官翟一帆博士表示： 「這項關鍵研究經過4年隨訪，其數據的持續成熟讓我們倍感鼓舞。它不僅證實了藥物的持久療效，更重要的是展現了出色的長期安全性，這直接關乎患者的生活質量與長期獲益。我們將繼續秉持初心，堅守『解決中國乃至全球患者尚未滿足的臨床需求』這一使命，加快臨床開發，讓更多安全有效的藥物盡快上市，早日惠及患者。」

此項研究在2025 ASH年會上展示的核心要點如下：

Olverembatinib (HQP1351) demonstrates efficacy vs. best available therapy (BAT) in patients (pts) with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) in a registrational randomized phase 2 trial: up to 4-year follow-up including patients without T315I mutations
在一項隨機、註冊性2期臨床試驗中奧雷巴替尼（HQP1351）對酪氨酸激酶抑制劑（TKI）耐藥的慢性期慢性髓系白血病（CML-CP），包括無T315I突變患者的治療療效優於現有最佳可用療法（BAT）：4年隨訪期
展示形式：壁報展示
摘要編號：3788
分會場：632. 慢性髓細胞白血病：臨床及流行病學研究：壁報展示II
報告時間：
2025年12月7日，星期日，下午18:00 – 20:00（美國東部時間）
2025年12月8日，星期一，上午7:00 – 9:00（北京時間）
第一作者：北京大學血液病研究所、北京大學人民醫院，江倩教授
報告人：北京大學血液病研究所、北京大學人民醫院，江倩教授 
核心要點：
研究背景：
CML 是一種獲得性造血干細胞惡性克隆性疾病，TKI的出現使CML患者的治療徹底改觀但仍有相當比例的患者在治療中出現耐藥或因安全性不耐受停藥，進而面臨更為嚴重的後果。因此，許多對一代二代TKI 均耐藥/不耐受的CML 患者，目前仍缺乏有效的治療選擇，且該類患者有著明確病情進展的風險。奧雷巴替尼是一種強效的第三代BCR-ABL酪氨酸激酶抑制劑，對攜帶野生型BCR-ABL的CML和攜帶BCR-ABL-T315I突變（可導致對於伊馬替尼和第二代TKI耐藥）的CML患者均有較強療效，且安全性良好。

研究介紹：

• 該研究（NCT04126681）是一項開放性、隨機對照、多中心的關鍵註冊II期臨床研究，旨在評估奧雷巴替尼在對一代和二代TKI均耐藥和/或不耐受的CML-CP患者中的療效和安全性。本報告為一項2023ASH年會口頭報告的研究更新數據。截至2025年1月13日，共有144例CML-CP患者入組，其中105例為不伴T315I突變患者。
• 在本研究中，患者被按照2:1 比例隨機分組進入奧雷巴替尼治療組和研究者決定的BAT對照組。
• 主要終點為無事件生存期（EFS）。事件的定義為：疾病進展、達到又消失的完全血液學緩解（CHR）、主要細胞遺傳學反應、完全細胞遺傳學反應（CCyR）；治療失敗；3個治療週期內未達CHR；任何原因導致的死亡；不可接受的藥物毒性。

療效數據：

• 奧雷巴替尼治療組的中位EFS顯著長於BAT治療組：在所有CMP-CP患者中，奧雷巴替尼治療組和BAT治療組的中位EFS分別為21.2個月和2.9個月（P < 0.0001）；在不伴T315I突變CML-CP患者中，奧雷巴替尼治療組和BAT治療組的中位EFS分別為11.9 和3.1個月（P = 0.0159）。
• 奧雷巴替尼治療組的其他療效指標顯著高於BAT治療組：在所有CML-CP患者中，奧雷巴替尼治療組和BAT治療組的CHR率分別為85% 和35%， CCyR率分別為38%和19%，主要分子學反應（MMR）率分別為30%和8%；在不伴T315I突變CML-CP患者中，CHR率分別為82% 和50%，CCyR率分別為26%和21%，MMR率分別為16%和10%。

安全性數據：奧雷巴替尼治療組在伴或不伴T315I突變的CML-CP患者中均展示出良好的安全性，且未觀察到新的安全性信號。≥3級不良事件主要為血液毒性。值得一提的是，奧雷巴替尼治療組的血管閉塞事件發生率為7%。

結論：奧雷巴替尼在治療對一代和二代TKI均耐藥和/或不耐受的CML-CP受試者，包括不伴T315I突變CML-CP患者時，較BAT治療組展示出明顯治療優勢。

關於亞盛醫藥

亞盛醫藥是一家綜合性的全球生物醫藥企業，致力於研發創新藥，以解決腫瘤等領域全球患者尚未滿足的臨床需求。2019年10月28日，公司在香港聯交所主板掛牌上市，股票代碼：6855.HK；2025年1月24日，公司在美國納斯達克證券交易所掛牌上市，股票代碼：AAPG。

亞盛醫藥已建立豐富的創新藥產品管線，包括抑制Bcl-2和 MDM2-p53 等細胞凋亡通路關鍵蛋白的抑制劑；新一代針對癌症治療中出現的激酶突變體的抑制劑等。

公司核心品種耐立克^®是中國首個獲批上市的第三代BCR-ABL抑制劑，且獲批適應症均被成功納入國家醫保藥品目錄，目前，亞盛醫藥正在開展耐立克^®一項獲美國FDA許可的全球註冊III期臨床研究（POLARIS-2），用於治療既往接受過治療的慢性髓細胞白血病慢性期（CML-CP）成年患者。此外，耐立克^®聯合治療新診斷費城染色體陽性急性淋巴細胞白血病（Ph+ ALL）患者和治療琥珀酸脫氫酶（SDH）缺陷型胃腸道間質瘤（GIST）患者的全球註冊III期研究正在開展中。

公司另一重磅品種利生妥^®是中國首個獲批上市的國產原創Bcl-2抑制劑，已獲批用於既往經過至少包含布魯頓酪氨酸激酶（BTK）抑制劑在內的一種系統治療的成人慢性淋巴細胞白血病/小淋巴細胞淋巴瘤（CLL/SLL）患者。目前，亞盛醫藥正在開展利生妥^®四項全球註冊III期臨床研究，分別為獲美國FDA許可的治療經治CLL/SLL患者的GLORA研究；治療初治CLL/SLL患者的GLORA-2研究；治療新診斷老年或體弱急性髓系白血病（AML）的GLORA-3研究；以及獲美國FDA、歐洲EMA與中國CDE同步批准開展的治療新診斷中高危骨髓增生異常綜合征（MDS）患者的GLORA-4研究。

截至目前，公司4個在研新藥共獲16項FDA和1項歐盟孤兒藥資格認定，2項FDA快速通道資格以及2項FDA兒童罕見病資格認證。憑借強大的研發能力，亞盛醫藥已在全球範圍內進行知識產權佈局，並與武田、默沙東、阿斯利康、輝瑞、信達等領先的生物製藥公司，以及梅奧醫學中心（Mayo Clinic）、丹娜法伯癌症研究院（Dana-Farber Cancer Institute）、美國國家癌症研究所（NCI）和密西根大學等學術機構達成全球合作關係。

亞盛醫藥已在原創新藥研發與臨床開發領域建立經驗豐富的國際化人才團隊，以及成熟的商業化生產與市場營銷團隊。亞盛醫藥將不斷提高研發能力，加速推進公司產品管線的臨床開發進度，真正踐行「解決中國乃至全球患者尚未滿足的臨床需求」的使命，以造福更多患者。

前瞻性聲明

本新聞稿包含根據美國《1995年私人證券訴訟改革法案》，以及經修訂的《1933年證券法》第27A條和《1934年證券交易法》第21E條所界定的前瞻性陳述。除歷史事實陳述外，本新聞稿中的所有內容均可能構成前瞻性陳述，包括亞盛醫藥對未來事件、經營成果或財務狀況所發表的意見、預期、信念、計劃、目標、假設或預測。

這些前瞻性陳述受到諸多風險和不確定性的影響，具體內容已在亞盛醫藥向美國證券交易委員會（SEC）提交的文件中詳細說明，包括2025年1月21日提交的經修訂的F-1表格註冊說明書和2025年4月16日提交的20-F表格中的「風險因素」和「關於前瞻性陳述及行業數據的特別說明」章節、2019年10月16日提交的首次發行上市招股書中的「前瞻性聲明」、「風險因素」章節，以及我們不時向SEC或HKEX提交的其他文件。這些因素可能導致實際業績、運營水平、經營成果或成就與前瞻性陳述中明示或暗示的信息存在重大差異。本前瞻性聲明中的陳述不構成公司管理層的利潤預測。

因此，該等前瞻性陳述不應被視為對未來事件的預測。本新聞稿中的前瞻性陳述僅基於亞盛醫藥當前對未來發展及其潛在影響的預期和判斷，且僅代表截至陳述發表之日的觀點。無論出現新信息、未來事件或其他情況，亞盛醫藥均無義務更新或修訂任何前瞻性陳述。

• 既往使用二代TKI一線治療失敗的患者的完全細胞遺傳學反應率為76.7%
• 分子學反應隨著治療時間的延長持續加深，第21週期評估的主要分子學反應率達60%
• 優異的療效數據支持向針對更廣泛患者的前線治療的適應症擴展

美國馬里蘭州羅克維爾市和中國蘇州2025年12月9日 /美通社/ -- 致力於在腫瘤等領域開發創新藥物的領先的生物醫藥企業——亞盛醫藥（納斯達克代碼：AAPG；香港聯交所代碼：6855）宣佈，公司已在美國佛羅里達州奧蘭多市舉辦的第67屆美國血液學會（American Society of Hematology，ASH）年會上，以壁報展示形式公佈了其核心產品奧雷巴替尼（商品名：耐立克^®） 二線治療慢性髓細胞白血病（CML）慢性期（-CP）患者的最新數據。此次公佈是對該研究在2024 ASH年會口頭報告結果的持續更新，展現了更長時間的隨訪療效與安全性特徵。

ASH年會是全球血液學領域規模最大的國際學術盛會之一，彙集了最前沿的研究進展及最新的藥物研發數據，展示全球血液學領域的最高學術水平。在此次會議上，亞盛醫藥的多個創新成果再度獲得國際學術界的關注， 三個品種（耐立克^®、利生妥^®、APG-5918）有多項臨床和臨床前進展入選展示及報告，其中一項獲口頭報告。

此次更新的研究結果進一步提示耐立克^®有望為二線CML-CP患者帶來一種安全有效的治療選擇，尤其對那些一線使用二代BCR-ABL1酪氨酸激酶抑制劑（TKI）治療失敗的患者。至數據截止時，耐立克^®在既往使用過一種TKI治療後耐藥/不耐受非T315I突變CML-CP患者中的完全細胞遺傳學反應（CCyR）率和主要分子學反應（MMR）率分別達到71.8%和43.6%；在既往使用二代TKI一線治療失敗的患者中，CCyR率和MMR率分別達到76.7%和43.3%，且療效隨著治療時間的延長持續加深。安全性特徵與既往報告一致，未觀察到新的風險信號。

耐立克^®是亞盛醫藥原創1類新藥，為中國首個獲批上市的第三代BCR-ABL抑制劑。其在中國的商業化推廣由亞盛醫藥和信達生物共同負責。目前，耐立克^®已在中國獲批的適應症為：治療任何TKI耐藥、並伴有T315I突變的CML -CP和加速期（-AP）的成年患者；以及治療對一代和二代TKI耐藥和/或不耐受的CML-CP成年患者，且所有獲批適應症均已被納入國家醫保藥品目錄。亞盛醫藥正開展耐立克^®三項全球註冊III期臨床研究，涉及CML-CP、新診斷的費城染色體陽性急性淋巴細胞白血病（Ph⁺ ALL）、琥珀酸脫氫酶（SDH）缺陷型胃腸道間質瘤（GIST）幾大適應症。此外，亞盛醫藥已經與跨國製藥企業武田就耐立克^®簽署了一項獨家選擇權事宜。一旦行使選擇權，武田將獲得開發及商業化耐立克^®的全球權利許可，惟中國大陸、中國香港特別行政區、中國澳門特別行政區、中國台灣等地區除外。

此項研究的報告人、武漢協和醫院黎緯明教授表示： 「自去年該項研究結果在ASH年會首次以口頭報告形式公佈以來，其因在CML-CP二線患者中展現的高緩解率與良好安全性獲得了國際血液學領域的廣泛關注。此次更新的數據再次證實了此前的積極結果，隨著治療時間延長，患者取得更深程度的療效，這為耐立克^®作為CML-CP患者二線治療的重要選擇提供了更強有力的證據，也為其未來更為廣泛的臨床應用奠定了更堅實的基礎。」

亞盛醫藥首席醫學官翟一帆博士表示： 「很高興看到這項研究再一次在ASH年會上展示最新進展。此次數據的更新，進一步體現了耐立克^®為更廣泛的CML患者群體提供安全有效治療選擇的潛力。我們將繼續秉持初心，堅守'解決中國乃至全球患者尚未滿足的臨床需求'這一使命，加快臨床開發，讓更多安全有效的藥物盡快上市，早日惠及患者。」

此項研究在2025 ASH年會上展示的核心要點如下：

Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic phase-chronic myeloid leukemia (CP-CML)

更新奧雷巴替尼二線治療CP-CML患者數據

展示形式：壁報展示

摘要編號：3782

分會場：632. 慢性髓細胞白血病：臨床及流行病學研究：壁報展示II

報告時間：

2025年12月7日，星期日，下午18:00 - 20:00（美國東部時間）

2025年 12月8日，星期一，上午7:00 - 9:00（北京時間）

第一作者：武漢協和醫院 黎緯明教授

報告人：武漢協和醫院 黎緯明教授

核心要點：

研究背景：

BCR-ABL1 酪氨酸激酶抑制劑（TKI）顯著改善了慢性髓性白血病（CML）患者的預後，但仍有部分患者在TKI治療過程中出現耐藥或不耐受。既往研究顯示，接受伊馬替尼治療的CML患者中，1 年內20％～30％患者發生耐藥或者不耐受，接受第二代TKI達沙替尼或尼洛替尼一線治療的CML 患者中，1年內均有超過10% 患者發生耐藥或者不耐受。因此，在我國對一種TKI耐藥或者不耐受的CML-CP 患者的治療是一個亟需解決的問題。

研究介紹：

該研究（ChiCTR2200061655）是一項開放性、單臂、多中心臨床研究，旨在評估隔日口服40mg奧雷巴替尼在既往使用過一種TKI治療後耐藥或不耐受（包括伊馬替尼、氟馬替尼、尼洛替尼及達沙替尼等）的非T315I突變CP-CML中國患者中的療效和安全性。截至2025年7月24日，共入組非T315I 突變的CP-CML 患者47例。

療效數據：

• 截至2025年7月24日，39例（83.0%）患者接受了至少1次療效評估，36例（76.6%）接受了至少2次療效評估，34例（72.3%）接受了至少3次療效評估。2例患者尚未進行首次療效評估。
• 至截止日期，71.8%（28/39）的患者獲CCyR，43.6%（17/39）獲MMR。第6、9、12、15、18、21、24個週期評估的CCyR率和MMR率分別為54.3%和25.7%、66.7%和33.3%、74.2%和35.5%、84.6%和46.2%、85.7% 和 47.6%、90.0% 和 60.0%、89.5% 和 57.9%。提示療效隨用藥時間延長而逐漸加深。
• 在39例療效可評估的患者中，有30例患者既往以二代TKI作為一線治療，其中76.7%（23/30）獲得CCyR，43.3%（13/30）獲得MMR；在既往接受伊馬替尼治療的9例患者中，55.6%（5/9）獲得CCyR，44.4%（4/9）獲得MMR。

安全性數據：中位（區間）治療時間16.0（1-18）個週期。共有42例（89.4%）患者發生了任何級別的治療相關不良事件（TRAEs），其中21例（44.7%）發生了≥3級TRAEs，6例（12.8%）發生了與奧雷巴替尼相關的嚴重不良事件（SAEs）。≥3級血液學不良反應包括血小板減少（42.6%）、中性粒細胞減少（25.5%）和貧血（8.5%）。奧雷巴替尼相關SAEs包括血小板計數減少（6.4%）、貧血、骨髓抑制和發熱（各2.1%）。無死亡報告。

結論：奧雷巴替尼可能為二線CP-CML患者提供一種安全有效的治療選擇，尤其是對於一線使用二代 TKIs治療失敗的患者。

關於亞盛醫藥

亞盛醫藥是一家綜合性的全球生物醫藥企業，致力於研發創新藥，以解決腫瘤等領域全球患者尚未滿足的臨床需求。2019年10月28日，公司在香港聯交所主板掛牌上市，股票代碼：6855.HK；2025年1月24日，公司在美國納斯達克證券交易所掛牌上市，股票代碼：AAPG。

亞盛醫藥已建立豐富的創新藥產品管線，包括抑制Bcl-2和 MDM2-p53 等細胞凋亡通路關鍵蛋白的抑制劑；新一代針對癌症治療中出現的激酶突變體的抑制劑等。

公司核心品種耐立克^®是中國首個獲批上市的第三代BCR-ABL抑制劑，且獲批適應症均被成功納入國家醫保藥品目錄，目前，亞盛醫藥正在開展耐立克^®一項獲美國FDA許可的全球註冊III期臨床研究（POLARIS-2），用於治療既往接受過治療的慢性髓細胞白血病慢性期（CML-CP）成年患者。此外，耐立克^®聯合治療新診斷費城染色體陽性急性淋巴細胞白血病（Ph+ ALL）患者和治療琥珀酸脫氫酶（SDH）缺陷型胃腸道間質瘤（GIST）患者的全球註冊III期研究正在開展中。

公司另一重磅品種利生妥^®是中國首個獲批上市的國產原創Bcl-2抑制劑，已獲批用於既往經過至少包含布魯頓酪氨酸激酶（BTK）抑制劑在內的一種系統治療的成人慢性淋巴細胞白血病/小淋巴細胞淋巴瘤（CLL/SLL）患者。目前，亞盛醫藥正在開展利生妥^®四項全球註冊III期臨床研究，分別為獲美國FDA許可的治療經治CLL/SLL患者的GLORA研究；治療初治CLL/SLL患者的GLORA-2研究；治療新診斷老年或體弱急性髓系白血病（AML）的GLORA-3研究；以及獲美國FDA、歐洲EMA與中國CDE同步批准開展的治療新診斷中高危骨髓增生異常綜合征（MDS）患者的GLORA-4研究。

截至目前，公司4個在研新藥共獲16項FDA和1項歐盟孤兒藥資格認定，2項FDA快速通道資格以及2項FDA兒童罕見病資格認證。憑借強大的研發能力，亞盛醫藥已在全球範圍內進行知識產權佈局，並與武田、默沙東、阿斯利康、輝瑞、信達等領先的生物製藥公司，以及梅奧醫學中心（Mayo Clinic）、丹娜法伯癌症研究院（Dana-Farber Cancer Institute）、美國國家癌症研究所（NCI）和密西根大學等學術機構達成全球合作關係。

亞盛醫藥已在原創新藥研發與臨床開發領域建立經驗豐富的國際化人才團隊，以及成熟的商業化生產與市場營銷團隊。亞盛醫藥將不斷提高研發能力，加速推進公司產品管線的臨床開發進度，真正踐行「解決中國乃至全球患者尚未滿足的臨床需求」的使命，以造福更多患者。

前瞻性聲明

本新聞稿包含根據美國《1995年私人證券訴訟改革法案》，以及經修訂的《1933年證券法》第27A條和《1934年證券交易法》第21E條所界定的前瞻性陳述。除歷史事實陳述外，本新聞稿中的所有內容均可能構成前瞻性陳述，包括亞盛醫藥對未來事件、經營成果或財務狀況所發表的意見、預期、信念、計劃、目標、假設或預測。

這些前瞻性陳述受到諸多風險和不確定性的影響，具體內容已在亞盛醫藥向美國證券交易委員會（SEC）提交的文件中詳細說明，包括2025年1月21日提交的經修訂的F-1表格註冊說明書和2025年4月16日提交的20-F表格中的「風險因素」和「關於前瞻性陳述及行業數據的特別說明」章節、2019年10月16日提交的首次發行上市招股書中的「前瞻性聲明」、「風險因素」章節，以及我們不時向SEC或HKEX提交的其他文件。這些因素可能導致實際業績、運營水平、經營成果或成就與前瞻性陳述中明示或暗示的信息存在重大差異。本前瞻性聲明中的陳述不構成公司管理層的利潤預測。

因此，該等前瞻性陳述不應被視為對未來事件的預測。本新聞稿中的前瞻性陳述僅基於亞盛醫藥當前對未來發展及其潛在影響的預期和判斷，且僅代表截至陳述發表之日的觀點。無論出現新信息、未來事件或其他情況，亞盛醫藥均無義務更新或修訂任何前瞻性陳述。