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- Drug Eluting Stent Market (2026-2031) - Rising Cardiovascular Disease Burden Drives GrowthAging populations, rising CAD and minimally invasive PCI drive demand. Opportunities center on bioresorbable, polymer-free, ultra-thin and magnesium stents, especially in Asia-Pacific.
- Fosun International Delivers 160.3% YoY Profit Growth in 1H2026Companies: Fosun International LimitedOn the evening of 27 August, Fosun International announced its 2026 interim results. During the Reporting Period, its total revenue reached RMB86.96 billion; profit attributable to owners of the parent reached RMB1.72 billion, representing a year-on-year increase of 160.3%; overseas revenue reached RMB49.16 billion, with its share of total revenue rising to 56.5%; total debt to total capital ratio decreased to 55.7%. These figures show that Fosun’s results fall in the upper-middle range of the Company’s profit alert (profit attributable to owners of the parent is expected to range from approximately RMB1.5 billion to RMB1.8 billion, representing a year-on-year increase of approximately 127% to 172%) issued on 29 July. This marks Fosun’s return to a growth trajectory following the completion of a systematic realignment of “repairing the roof on a sunny day”. Over the past few years, Fosun has taken a rather unconventional path. Since 2022, in response to the severe market disruption caused by the pandemic, the Company has advanced its business streamlining and core business-focused strategy, divesting assets and businesses and generating cumulative cash proceeds of approximately RMB75 billion. In March 2026, pursuant to the principle of prudence, Fosun made one-off, non-cash impairment provisions and value revaluations on certain real estate projects with impairment indicators and goodwill and intangible assets of certain non-core business segments. The move drew considerable market attention at the time. At the Company’s 2025 annual results presentation at the end of March, Guo Guangchang, Chairman of Fosun International, explained, “This is about ‘repairing the roof on a sunny day’, allowing Fosun to focus its resources and efforts more effectively on core, high-growth areas.” The market has now responded to Fosun’s “repairing the roof on a sunny day” initiative. From the announcement of profit alert in early March to 25 August, before its interim results announcement, Fosun’s share price rose sharply from HKD3.6 to HKD5.41, representing an increase of more than 50%. The market has gradually recognized and priced in the Group’s “risk clearance” efforts. More importantly, the earnings growth driven by the Group’s businesses has begun to materialize. At the 2026 interim results presentation held in Hong Kong on 28 August, Guo Guangchang said: “The strong results recovery we delivered in the first half of the year reflects the outcome of the strategic adjustments we have made over the past few years. Our ‘repairing the roof on a sunny day’ strategy has paid off, allowing us to put historical burdens behind us. These results mark the beginning of Fosun’s continued progress along a trajectory of steady growth.” Solid Core Businesses, with Pharmaceuticals and Insurance Posting Strong Results First, let us look at Fosun’s core businesses. In the first half of 2026, its four core businesses — Fosun Pharma, Yuyuan, Fosun Insurance Portugal (Fidelidade), and the Tourism segment — generated a total revenue of RMB63.88 billion, accounting for 73.5% of the Group’s total revenue, further demonstrating the results of its core business-focused strategy. Among them, the pharmaceutical and insurance segments delivered particularly strong performance. In the first half of the year, Fosun Pharma achieved operating revenue of RMB20.377 billion. Revenue from innovative drugs recorded a year-on-year increase of 13.84%, with their contribution to pharmaceutical business revenue rising to 33.35%, establishing innovative drugs as a key growth driver. Its innovative biopharmaceutical platform, Henlius, reported revenue of RMB3.5882 billion, representing a year-on-year increase of 27.3%, while net profit amounted to RMB430.4 million, up 10.3% year-on-year, sustaining growth momentum in revenue and profit. Commercialization of innovative drugs continued to gain traction. During the Reporting Period, Fosun Pharma had a total of 20 indications of 7 innovative drugs approved for launch both domestically and overseas. With their revenue share on a steady rise, innovative drugs have become the main growth engine driving the pharmaceutical business forward. The insurance segment delivered a stellar performance, with Fosun’s domestic and overseas insurance companies all posting broad-based improvements. Fidelidade’s overall market share in Portugal reached 30.1%, and its international business accounted for 26.7% of its consolidated total business. In the first half of the year, Fidelidade recorded net profit attributable to owners of the parent of EUR165 million, up 23.8% year-on-year, maintaining steady growth. In Chinese mainland, Pramerica Fosun Life Insurance recorded gross written premiums of RMB8.38 billion in the first half of 2026, up 52.2% year-on-year. Net profit reached RMB780 million, representing a year-on-year increase of 270% and exceeding its net profit for the full year of 2025. Fosun United Health Insurance reported a 36.2% year-on-year increase in revenue and net profit of RMB572 million. Peak Reinsurance’s reinsurance revenue and gross written premiums increased by 25% and 11.8% year-on- year, respectively, while net profit after tax reached USD89.70 million. In April 2026, Moody’s upgraded Peak Re’s rating from Baa1 to A3, with a “stable” outlook. Guo Guangchang said at the results presentation: “Integrating our insurance business with industries in which we have established competitive advantages has been a strategic priority for Fosun for over three decades — a critical linkage we have long sought to unlock. I believe we have now achieved it. This integration will significantly strengthen our industrial operational capabilities and future profitability, providing sustained momentum for Fosun’s development.” “Successfully navigating another cycle” is how the market has described Fosun’s latest round of adjustments. A closer look reveals how Fosun has successfully navigated the cycle. On the one hand, the Group has continued to streamline its business to generate cash proceeds. In the first half of the year, the Group generated proceeds equivalent to more than RMB12.0 billion from the divestment of non-strategic and non-core assets. Its total debt to total capital ratio was reduced to 55.7%, while its cash, bank balances and term deposits amounted to RMB61.214 billion. On the other hand, the innovation and globalization strategy that the Group has been pursuing for years has entered a value-realization phase, serving as the core engine driving profit recovery. Integrated Innovation Strategy Bears Fruit Since innovative drugs took off in the domestic market in 2025, Fosun has repeatedly broken into the spotlight, with multiple innovative drug business development (BD) drawing significant market attention. In fact, as the saying goes, “One minute on stage takes ten years of hard work off stage”. This series of innovation achievements is the result of Fosun’s forward-looking innovation strategy established nearly two decades ago. Notably, for more than a decade, Fosun has built a globally integrated innovation system across its core business areas, combining “independent R&D + investment incubation + ecosystem collaboration”, and has consistently made substantial investments in technology innovation. In the first half of this year alone, investment in technology innovation reached RMB4.2 billion, representing a year-on-year increase of 16.7%. In the first half of this year, Fosun saw a series of innovations come to fruition. HANSIZHUANG, independently developed by Henlius, received approval from the National Medical Products Administration (NMPA) for its perioperative indication in gastric cancer, pioneering a postoperative “chemo-sparing” regimen and making it the world’s first and only anti-PD-1 monoclonal antibody approved for this indication. Its core pipeline asset, HLX43, as a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC, has demonstrated preliminary clinical efficacy characterized by high efficacy and low toxicity across multiple solid tumors, including non-small cell lung cancer (NSCLC), with over 1,500 patients enrolled globally. To date, Henlius has 10 products approved in over 60 countries and regions, and has benefited over 1.1 million patients. In addition, FUMAINING (luvoxmetinib tablets), independently developed by Fosun Pharma, was approved for the treatment of paediatric and adolescent patients with relapsed or refractory Langerhans cell histiocytosis (LCH), continuing to fill the gap in the treatment of rare diseases. In terms of neurodegenerative diseases, Fosun Pharma expanded its global collaboration with AriBio on AR1001, extending its rights to develop and commercialize the product to key markets including the U.S., Europe and Japan. Meanwhile, post-marketing confirmatory clinical trials for sodium oligomannate capsules have progressed steadily, with more than 1,000 patients enrolled as of 31 July 2026. In addition, HT001, an oral NLRP3 inhibitor for the treatment of Parkinson’s disease in-licensed by Hengtai Bio, an investee and incubated company of Fosun Pharma, commenced its Phase I clinical trial in Australia. Fosun’s innovation achievements demonstrate the forward-looking nature of its innovation strategy and its ability to identify the right opportunities in R&D. As Guo Guangchang remarked at the results presentation, through years of effort, Fosun has built globally integrated innovation capabilities rooted in China. This distinctive strength of Fosun is expected to create greater value for all in the years ahead. “Fosun has never pursued innovation behind closed doors. Instead, we leverage our resource-integration capabilities and a global perspective to drive smart innovation, bringing together the best technologies, teams and supply chains from around the world to solve real problems. This is how we unlock vast market potential,” said Guo Guangchang. Unlocking Value through Global Operations Globalization has been another forward-looking strategic move for Fosun. Since its listing in Hong Kong in 2007, when many Chinese companies were still focused primarily on their domestic markets, Fosun had already begun expanding overseas ahead of its peers. Nearly two decades later, as a growing number of Chinese companies embrace the view that they must go global or risk being left behind, and seek to capture overseas markets by taking their products overseas, Fosun has already established a profound business presence in more than 40 countries and regions. With local teams operating overseas, it has successfully operated a number of companies within the Fosun ecosystem. “Global operations” have become a defining feature of Fosun’s globalization strategy and a core engine underpinning the development of its businesses. Guo Guangchang said at the interim results presentation that Fosun continues to strengthen its global operational capabilities. On the one hand, it is helping Chinese products and services enter overseas markets. On the other hand, it is introducing high-quality products and services from around the world into China. Drawing on the global resource-mobilization capabilities it has built over the years, Fosun is able to identify high-quality projects and technologies worldwide and rapidly mobilize the resources needed to advance them. In the first half of 2026, Fosun’s overseas revenue reached RMB49.16 billion, accounting for 56.5% of total revenue, up 3 percentage points as compared to the same period of 2025 and marking a record high in the proportion of overseas revenue. In the field of pharmaceuticals and healthcare, Fosun made substantial progress in the global expansion of innovative drugs and commercial business development. Henlius’ HANSIZHUANG was approved for three new indications in the European Union (EU), while HLX11 (pertuzumab injection) was approved in the EU and HLX14 (denosumab injection) was approved in Canada. At the beginning of 2026, Fosun Pharma entered into a strategic partnership with Eisai for HANSIZHUANG, with an aggregate potential consideration exceeding USD300 million, underscoring how the global value of Chinese innovative drugs is being repriced by international markets. In the first half of the year, Yuyuan generated revenue of RMB532 million in Hong Kong SAR and Macau SAR in the first half of 2026, representing a year-on-year increase of 285.83%, while revenue from the Japanese market reached RMB306 million, representing a year-on-year increase of 6.09%. Laomiao has 15 stores in Hong Kong SAR, Macau SAR, overseas markets and duty-free channels. Club Med has also continued to expand its global footprint, with Club Med Urban Oasis Hangzhou Longwu already open and Club Med South Africa Beach & Safari now in soft opening. Leveraging Fosun’s global ecosystem, Fidelidade in the insurance segment has expanded its business from Portugal to Portuguese-speaking countries and markets across Europe, Latin America, and Africa. Its international business now accounts for 26.7% of its consolidated total business, with continued growth in Portuguese-speaking countries. Meanwhile, Peak Reinsurance has maintained steady growth thanks to its global business footprint. The guiding principle behind Fosun’s globalization strategy is “Combining Global Resources with China’s Capabilities”, deeply integrating China’s manufacturing capabilities, service capabilities, and innovation dividends, with global markets. Starting with leveraging China’s growth momentum to establish its business presence, and progressing to a two-way engagement of “mutual empowerment between China and the world”, Fosun has now entered the 3.0 phase of “global organization + local operations”. In this phase, Fosun “truly operates with a global perspective”, having developed the ability to foster cross-regional, cross-cultural, and cross-organizational synergies within its business ecosystem and support the continued growth of its overseas revenue. At the interim results presentation held on 28 August, Guo Guangchang said: “Fosun’s future development goal is to ‘spur the horse to full speed’. We have already positioned ourselves on a trajectory of steady growth. Going forward, we will continue to advance innovation-driven and global development in industries where we have established competitive advantages, building on our momentum and accelerating further.”
- Akeso, Inc.Akeso 2026 Interim Results: Strong Commercialization Momentum; IO2.0+ Global Strategy Redefining Clinical Standards; Bispecific Advancement in ADC, I&I and Alzheimer'sAkeso, Inc. (9926.HK) ("Akeso" or the "Company") announced its 2026 interim results. During the reporting period, the Company achieved record-high drug sales revenue, further advanced its global immuno-oncology (IO) 2.0 strategy, progressively...
- 藥捷安康（02617.HK）公佈2026年中期業績 核心產品成功獲批上市 商業化佈局全面提速香港, 2026年8月28日 - 2026年8月27日，聚焦創新藥研發、以臨床需求為核心導向的生物醫藥企業——藥捷安康（南京）科技股份有限公司(「藥捷安康」「TransThera」或「公司」，股份代號：2617.HK)，公佈2026年中期業績。報告期內，公司核心產品替恩戈替尼成功獲批上市，收入實現歷史性突破，全球化研發管線穩步推進，商業化佈局全面提速，創新平台持續夯實。 藥捷安康深耕腫瘤、炎症及代謝疾病領域，專注小分子創新療法的發現與開發，致力於成為創新和高度差異化的小分子藥物全球領導者，以原創技術解決全球未滿足的臨床需求。核心產品捷恩泰(R)（中文通用名：替恩戈替尼片，英文通用名：Tinengotinib，英文商品名：Yochanra(R)）已於2026年8月6日獲得中國國家藥品監督局附條件批准上市。依託完善、一體化的自主研發體系，截至2026年6月30日，公司已搭建起豐富且層次清晰的產品管線，涵蓋六款臨床階段候選藥物及多款潛力臨床前在研藥物；與此同時，商業化團隊已開始建立並落地。公司將持續聚焦高臨床價值、高戰略意義的全球首創小分子藥物研發，以滿足患者迫切的臨床需求，給更多的患者帶來新的希望。 於報告期內，公司錄得總收入約人民幣35.5百萬元，主要為合作及授權協議收到的一次性、不可退款且不可抵扣的預付款。研發成本由截至2025年6月30日止六個月的人民幣98.4百萬元上升11.7%至公司截至2026年6月30日止六個月的人民幣109.9百萬元，保持相對穩定，略有增長。同時，公司現金儲備充裕，現金及現金等價物由截至2025年12月31日的人民幣415.4百萬元上升2.4%至截至2026年6月30日的人民幣425.3百萬元，初始期限大於三個月的定期存款由截至2025年12月31日的人民幣73.7百萬元上升577%至截至2026年6月30日的人民幣499.4百萬元。 核心產品獲批上市，多適應症拓展取得積極進展，管線價值持續釋放 腫瘤管線：捷恩泰(R)（替恩戈替尼，多靶點激酶抑制劑） 公司核心產品捷恩泰(R)（中文通用名：替恩戈替尼片，英文通用名：Tinengotinib，英文商品名：Yochanra(R)）為公司自主研發、擁有全球知識產權的激酶譜選擇性小分子多激酶抑制劑，主要靶向三個關鍵通路（即FGFR/VEGFR、JAK和Aurora激酶）。通過對生物學與目標疾病之間相關性基礎機制的深入探索與研究，公司科學團隊發現並進一步研究落地了產品的三大開發方向：精準靶向、譜系重塑和免疫激活。根據三大機制，除了已上市獲批的膽管癌之外，該產品正在開發的適應症還包括前列腺癌(PC)、乳腺癌(BC)、肝細胞癌(HCC)、膽道系統腫瘤(BTC)和泛FGFR實體瘤等。 替恩戈替尼已於2025年12月向國家藥品監督管理局(NMPA)遞交新藥上市申請並獲得受理，同時，該品種已獲國家藥品監督管理局授予治療膽管癌的突破性治療品種認定並被納入優先審評品種名單，歷經8個月成功上市獲批；此外，該品種獲得FDA授予治療膽管癌及轉移性去勢抵抗性前列腺癌(mCRPC)的快速通道認定(Fast-Track Designations, FTD)及用於治療膽管癌的孤兒藥認定(Orphan Drug Designation, ODD)；該品種也獲得了EMA授予用於治療膽道系統腫瘤的孤兒藥認定。 替恩戈替尼的多項臨床數據已在美國臨床腫瘤學會(American Society of Clinical Oncology)、歐洲腫瘤學會(European Society of Medical Oncology)、聖安東尼奧乳腺癌專題討論會(San Antonio Breast Cancer Symposium)和美國癌症研究協會(American Association for Cancer Research)等重要國際醫學會議上發表報告，並多次入選口頭報告環節。2026年上半年公司在多個適應症領域取得了進展或里程碑。 膽管癌(CCA) 替恩戈替尼為全球首個且唯一已獲批上市治療FGFR抑制劑治療後復發或耐藥膽管癌患者的研究藥物。該產品已在中國首先獲批上市，於美國、韓國、英國、歐盟及中國台灣開展的國際多中心III期臨床試驗已完成臨床入組。在中國首先實現商業化，代表中國患者可以首先獲得治療。 - 2026年1月，公司在2026年美國臨床腫瘤學會胃腸道腫瘤研討會(ASCOGI)上以壁報形式公佈了替恩戈替尼單藥治療晚期膽管癌患者的臨床數據。 - 2026年4月，替恩戈替尼單藥治療晚期膽管癌患者的確證性III期臨床研究完成首例患者給藥。 - 2026年5月，公司在2026年美國臨床腫瘤學會(ASCO)上以壁報形式公佈了替恩戈替尼單藥治療既往FGFR抑制劑經治的中國晚期膽管癌患者的最新研究成果。 - 海外方面，替恩戈替尼治療晚期膽管癌患者的全球多中心註冊性III期臨床試驗，已完成計劃受試者入組。 轉移性去勢抵抗性前列腺癌(mCRPC) 替恩戈替尼亦可能是全球首個和唯一一個同時抑制FGFR/JAK通路，且針對mCRPC有臨床療效證據的研究藥物。根據替恩戈替尼I/II期臨床試驗對22名既往接受過多線治療的激素治療耐藥的mCRPC患者進行單藥治療的結果，在13名有可評估病灶患者中觀察到的初步療效良好，ORR為46%(6/13)及DCR為85%(11/13)。43%的患者前列腺特異性抗原減少超過50%。影像學評估中位元PFS為5.6個月（N=22）。 - 2026年5月，替恩戈替尼聯合新型內分泌治療用於經治後進展的轉移性去勢抵抗性前列腺癌的II期臨床試驗獲國家藥品監督管理局批准。 截至2026年6月30日，替恩戈替尼國內聯合NHT治療mCRPC患者的II期臨床正在穩步推進中。在美國已開展研究者發起的用於對先前新型內分泌治療已耐藥的mCRPC患者的Ib/II期臨床試驗，目前Ib期已結束，II期拓展試驗的患者入組預計將於2026年內完成。 乳腺癌(BC) 替恩戈替尼的療效亦見於既往接受過多線治療的激素受體陽性(HR+)/人表皮生長因數受體2陰性(HER2-)乳腺癌患者及三陰乳腺癌(TNBC)患者。根據美國及中國的乳腺癌患者的匯總分析，替恩戈替尼單一療法對原先獲診斷為HR+/HER2－的患者，展示的ORR為50%(8/16)及DCR為88%(14/16)。值得注意的是，在16名患者中，5名轉化為TNBC患者，在這5名患者中，ORR達到了60%(3/5)，DCR達到了100%(5/5)。 - 2026年3月，替恩戈替尼聯合氟維司群用於經治失敗的HR+/HER2-的復發或轉移性乳腺癌患者的II期臨床研究完成首例患者給藥。 - 2026年4月，公司在2026年美國癌症研究協會年會(AACR)上以壁報形式披露了譜系重塑作為HR+乳腺癌內分泌耐藥的驅動機制及其臨床轉化意義。 替恩戈替尼作為一款能夠同時抑制FGFR/JAK雙靶點的抑制劑，可恢復腫瘤細胞的管腔特性，並使耐藥模型在體外和體內水平重新對內分泌治療恢復敏感。上述發現支持雙靶點FGFR-JAK阻斷作為克服譜系重塑驅動的內分泌耐藥的有效策略，替恩戈替尼有望填補HR+乳腺癌內分泌治療耐藥後患者的臨床需求空白。 截至2026年6月30日，公司正在穩步推進替恩戈替尼聯合氟維司群用於經治失敗的HR+/HER2－的復發或轉移性乳腺癌患者的II期臨床試驗。 肝細胞癌(HCC) 臨床前數據顯示替恩戈替尼對肝細胞癌表現出令人鼓舞的抗腫瘤活性。替恩戈替尼聯合卡度尼利或依沃西有望通過對腫瘤微環境的雙重免疫重塑和針對HCC的創新機制實現多層面腫瘤控制，克服現有靶向治療和免疫治療組合的耐藥性。對於不適合進行根治性手術切除或局部治療，或手術切除或局部治療後疾病進展的晚期HCC患者，該聯用方法具有一線治療潛力。 截至2026年6月30日，公司與康方生物合作的替恩戈替尼聯合卡度尼利或依沃西治療晚期肝細胞癌的開放性、多中心II期臨床研究正在穩步推進中。 其他管線穩步推進，非腫瘤領域佈局完善 其他適應症探索 - 2026年5月，公司在Nature Communications（IF=15.7）發表核心產品替恩戈替尼單藥及聯合阿替利珠單抗治療晚期實體瘤的探索性臨床結果。 TT-00973（AXL/FLT3抑制劑）：TT-00973是一款自主發現及開發的高效AXL/FLT3抑制劑。AXL激酶是癌症存活、轉移及耐藥性的關鍵因素，AXL信號的異常激活與多種癌症的不良預後有關。AXL是癌症治療的一個理想的治療靶點，無論是作為單一藥劑亦或是與其他療法聯合使用。TT-00973能有效幹擾AXL在腫瘤細胞中的激活，並在AXL過度表達的小鼠異種移植瘤模型中顯示出有效的抗腫瘤活性。 - 2026年5月，公司與上海艾力斯醫藥科技股份有限公司達成臨床合作及供藥協議，推進一項評估TT-00973聯合甲磺酸伏美替尼片治療EGFR敏感突變局部晚期或轉移性非小細胞肺癌患者的安全性及有效性的多中心、開放標籤II期研究。 TT-01488（非共價鍵可逆BTK抑制劑）：TT-01488是一款公司自主開發的新型的、非共價的BTK抑制劑。激酶譜篩選顯示其靶點活性優異，對EGFR、Tec親和力低，激酶選擇性更優，能減少脫靶抑制，降低房顫、出血等毒副作用，安全性潛力更佳，且在腫瘤淋巴細胞異種移植模型中展現出良好抗腫瘤活性。多項臨床證實BTK抑制劑聯合抗CD20單抗可提升套細胞淋巴瘤(MCL)一線治療療效。TT-01488在I期臨床中，10例療效可評估的非母細胞型MCL患者中，客觀緩解率為70%，包括4例完全緩解及3例部分緩解。其安全高效的特性搭配CD20單克隆抗體可協同靶向殺傷與免疫作用，有望構建高效、低毒的「去化療」一線方案。 非腫瘤管線產品 TT-01688（S1P1調節劑）：TT-01688是一款獲得授權的目前處於臨床階段的高選擇性口服S1P1調節劑，具有治療各種炎症性疾病的潛力。其對S1P1具有高活性，對S1P2和S1P3以及GIRK（與潛在心血管不良反應有關）的結合作用可忽略不計。其耐受性及PK/PD特性已在I期臨床試驗中得到證實。儘管並非頭對頭研究，但在I期臨床試驗中，TT01688的生物療效等同於或優於ozanimod及etrasimod，TT-01688在健康成人受試者的I期臨床試驗中具有良好的耐受性，所有不良事件（不良事件）均為輕度或中度。 公司已於2024年7月在中國完成TT-01688治療UC（潰瘍性腸炎）的Ib期臨床試驗。於2025年1月，公司在中國完成TT-01688治療AD（特異性皮炎）的II期臨床試驗。 TT-00920（PDE9抑制劑）：TT-00920是一款自主發現及開發的高選擇性口服PDE9抑制劑，針對慢性心力衰竭。臨床前研究表明，TT-00920可恢復心臟NP/cGMP信號，顯著增強心臟功能，並逆轉心力衰竭的心室重構。此外，與單一療法相比，TT-00920與纈沙坦（一種血管緊張素受體阻滯劑）的聯合療法顯示令人鼓舞的療效，表明TT-00920可能與現有的心力衰竭療法產生協同作用。於臨床前研究中，TT-00920亦表現出低中樞神經系統(CNS)暴露及高心臟分佈，有利於治療心力衰竭並避免CNS不良反應。 公司在中國及美國已完成的健康受試者的I期試驗中，觀察到TT-00920具有良好的耐受性，並顯示出良好的藥代動力學特性及預期的生物標誌物變化。 TT-01025（不可逆VAP-1抑制劑）：TT-01025是一款自主發現及開發的不可逆VAP-1抑制劑，擬用於NASH的口服治療。VAP-1是新型的臨床抗炎靶點。在臨床前研究的頭對頭比較，結果顯示TT-01025的腦滲透性極低，在100M水準下並無顯著的中樞神經系統MAO-B抑制作用，表示TT-01025發生相關藥物相互作用的風險極低。 公司已在中國、美國分別完成了TT-01025的I期臨床。在中國完成在健康受試者的I期研究，顯示TT-01025在單次給藥最高300mg及多次給藥最高100mg的水平下具有良好的安全和耐受性及優秀的PK/PD相關性。 創新平台持續深耕，原研技術壁壘不斷夯實 調控誘導鄰近靶向嵌合體(RIPTAC)技術平台 報告期內，公司持續深耕新一代蛋白誘導鄰近小分子藥物賽道，自主搭建RIPTAC原創技術平台，構建差異化抗腫瘤管線佈局，持續夯實公司前沿小分子創新研發壁壘。 RIPTAC為雙功能口服小分子，通過誘導腫瘤特異性靶蛋白(TP)與細胞生存必需蛋白(EP)形成三元複合物，僅在高表達腫瘤靶標的癌細胞內特異性破壞必需蛋白功能，實現選擇性殺傷腫瘤細胞。相較傳統抑制劑、蛋白降解藥物，該技術具備多重差異化優勢：不依賴泛素－蛋白酶體降解通路，可克服靶點突變耐藥問題；能夠靶向傳統手段難以干預的「不可成藥」靶點；口服小分子劑型保障患者用藥依從性，治療窗口更優，臨床轉化潛力突出。依托自主合成、藥理藥效篩選體系，公司已佈局RIPTAC臨床前分子篩選與優化，核心管線聚焦腫瘤賽道。 磷酸二酯酶4B(PDE4B)抑制劑：磷酸二酯酶4B(PDE4B)是炎症和纖維化信號網絡中的關鍵調控酶。其通過水解細胞內環磷酸腺苷(cAMP)，調控炎症因子釋放和TGF-β介導的纖維化信號，在炎症和纖維化疾病的發生發展中發揮重要作用，是特發性肺纖維化等疾病的重要靶點。與泛PDE4抑制劑相比，選擇性PDE4B抑制劑在保持抗炎和抗纖維化作用的同時，旨在通過減少對PDE4D的抑制，降低惡心、嘔吐等胃腸道不良反應，從而改善臨床耐受性。報告期內，公司成功獲得新型高選擇性PDE4B抑制劑先導化合物及初步成藥性評價，顯示出優異的藥效活性、選擇性和成藥潛力，並形成自主知識產權。 白細胞介素-2誘導性T細胞激酶(ITK)抑制劑：白細胞介素-2誘導性T細胞激酶(ITK)是T細胞受體信號轉導、活化及分化過程中的關鍵調控酶。研究表明，抑制ITK可以選擇性調節Th2和Th17免疫通路，降低炎症因子的產生，並促進免疫調節性T細胞(Treg)方向的平衡轉變，從而增強免疫穩態。基於Th2/Th17通路在自身免疫、炎症及纖維化疾病中的重要作用，ITK已成為相關疾病治療領域的重要潛在靶點。報告期內，公司已獲得具有自主知識產權的高選擇性ITK抑制劑先導化合物，該候選分子展現出優異的藥效活性、靶點選擇性、及高成藥潛力。 商業化佈局全面提速，運營體系日趨完善 公司的首個核心產品替恩戈替尼於2026年在國內獲批上市。公司商業化團隊的建設也在加速中。上半年，公司聘任孫德龍先生為首席運營官，負責公司商業化運營全部事務。孫德龍先生在生物醫藥行業擁有逾二十年的豐富經驗，具備從一線藥品營銷及學術推廣至企業全面運營的全鏈條管理能力。 2026年上半年，公司圍繞核心在研產品替恩戈替尼的商業化落地，系統性推進各項前置準備工作，產品、人員、管道、推廣、體系等各項關鍵模塊均取得階段性進展。市場策略層面，公司已完成核心區域目標醫院的調研與評估，初步形成產品戰略與管道佈局方案，為獲批後的快速市場准入奠定基礎。同時，公司積極參與行業重要學術會議，圍繞產品差異化定位逐步建立專業領域的品牌認知。組織建設層面，商業化核心管理團隊已組建到位，核心區域人員的招聘與培訓工作正有序推進。供應鏈層面，公司已與多家頭部商業流通企業開展深度對接，物流配送體系及院外服務網絡的建設工作同步推進，為產品上市後供應保障做好準備。此外，公司同步搭建內部培訓體系與嚴格的合規管理體系，確保團隊具備專業化學術能力。 加速商業化落地，深化全球創新佈局 藥捷安康的首個核心產品替恩戈替尼，治療既往接受過系統性治療和FGFR抑制劑治療的晚期、轉移性或不可手術切除的膽管癌成人患者的新藥申請已遞交並獲受理，並於2026年8月6日獲批上市；公司亦在全力推進膽管癌適應症的海外註冊性III期臨床及國內確證性III期臨床，為替恩戈替尼的全球上市及臨床應用提供更多循證支持。同時，公司將進一步推進替恩戈替尼治療前列腺癌、乳腺癌及肝細胞癌聯用方案的國內II期臨床試驗，以期本產品在更廣泛適應症治療方案的落地。 其他管線方面，公司與艾力斯合作探索TT-00973（AXL/FLT3抑制劑）聯合甲磺酸伏美替尼片的全新治療方案在非小細胞領域的國內II期臨床試驗正在穩步推進；TT-01488（可逆BTK抑制劑）聯合含抗CD20單克隆抗體方案治療套細胞淋巴瘤(MCL)的國內II期臨床試驗亦正在穩步推進中。 商業化方面，公司將根據監管審批進展，適時啟動替恩戈替尼的全面商業化運營。公司將聚焦核心醫院准入與管道覆蓋，推動產品快速進入臨床使用場景；同時，將依託已建立的醫學市場體系，持續深化與臨床專家及學術機構的合作，通過高質量臨床研究及真實世界數據積累，鞏固產品學術地位。團隊運營方面，公司將在核心人員到崗基礎上，建立合規標準化運營流程確保商業化執行效率與質量。公司將持續聚焦創新藥領域，以替恩戈替尼的商業化為重要抓手，逐步構建全鏈條運營能力，創造長期價值。 腫瘤管線方面，公司將持續以替恩戈替尼為核心，推進「T」字形戰略：橫向上探尋與其科學機制協同的靶點和技術，縱向上圍繞其主要機制拓寬適應症佈局。非腫瘤方面，公司將繼續圍繞炎症與代謝領域佈局全球首創及全球最佳的臨床前分子，用以支持實現早中期的國際合作。 為加快臨床分子商業化價值兌現，公司也將加強對外合作團隊能力的提升，持續關注、積極探索具有增值效益的戰略夥伴，以合作形式拓展海外各個國家的戰略佈局，在全球範圍內尋求更多以共贏為前提的合作機會。
- THE ROSEN LAW FIRM, P. A.SPRY Investors Have Opportunity to Lead ARS Pharmaceuticals, Inc. Securities Fraud LawsuitRosen Law Firm, a global investor rights law firm, reminds purchasers of securities of ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) between March 9, 2026 and June 24, 2026, inclusive (the "Class Period"), of the important October 5, 2026 lead plaintiff...
- Knight Therapeutics Announces Supplemental Regulatory Submission for MINJUVI® (tafasitamab) in BrazilKnight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.
- Gilead Sciences, Inc.U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex RegimensCompanies: Gilead SciencesFOSTER CITY, Calif., August 27, 2026--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed.
- Kane Biotech Announces Second Quarter 2026 Financial ResultsKane Biotech Inc. (TSX-V:KNE) (the “Company”, “Kane” or “Kane Biotech”) announces today its second quarter 2026 financial results.
- Robbins Geller Rudman & Dowd LLPINVESTIGATION ALERT: Investigation Launched into Sionna Therapeutics, Inc., Robbins Geller Rudman & Dowd LLP Attorneys Encourage Investors and Potential Witnesses to Contact Law Firm - SIONRobbins Geller Rudman & Dowd LLP is investigating potential violations of United States federal securities laws involving Sionna Therapeutics, Inc. (NASDAQ: SION). If you any have information that could assist in the Sionna Therapeutics...
- City of Irvine and SpyGlass PharmaSpyGlass Pharma Celebrates Grand Opening of New Irvine Headquarters, Positioning Itself for First Product Launch and Custom R&D SpaceFuture portfolio expansion will advance a new era of ophthalmic care while driving continued growth of Irvine's MedTech and life sciences sector. — SpyGlass Pharma, a biopharmaceutical clinical-stage company dedicated to transforming treatment...
- Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 VaccineCompanies: PfizerPfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.1
- Pfizer Inc.Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 VaccineCompanies: PfizerNEW YORK & MAINZ, Germany, August 27, 2026--Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying cond