“LEQEMBI” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in the United Arab Emirates JCN Newswire

“LEQEMBI” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in the United Arab Emirates

TOKYO and CAMBRIDGE, Mass., Aug 14, 2024 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (lecanemab) for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD), the population in which treatment was initiated in clinical trials.LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils*), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. LEQEMBI is also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, and is being marketed in the U.S., Japan, and China.LEQEMBI’s approval is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results.(1),(2) In the UAE, it is reported that 4.09% of those over 60 years old have dementia.(3) AD is considered the most common cause of dementia, typically accounting for 60-70% of cases.(4)Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Biogen will commercialize LEQEMBI in the UAE.* Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.(5) Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.(6) About lecanemab (LEQEMBI®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).LEQEMBI’s FDA approval was based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.1,2 The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with LEQEMBI and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P
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Sino Biopharmaceutical (1177.HK) Announces 2024 Interim Results ACN Newswire

Sino Biopharmaceutical (1177.HK) Announces 2024 Interim Results

Development Highlights- During the reporting Period, four of the Group’s innovative products were approved for marketing by the National Medical Products Administration of China (“NMPA”), namely Andewei (Benmelstobart Injection), Anboni (Unecritinib capsules), Anluoqing (Envonalkib capsules) and Beilelin (Liraglutide Injection), three of which are national category 1 innovative drugs.- In the first half of 2024, the Group's revenue from innovative products reached RMB 6.13 billion, a year-on-year increase of 14.8%. In addition to innovative products, the Group has 11 generic drugs approved by the NMPA for market launch. The overall revenue of generic drugs achieved positive growth in the first half of 2024. New products are an important driver of the Group’s revenue growth. In the first half of 2024, the Group’s revenue from new products launched within five years reached RMB 6.03 billion, representing a year-on-year increase of 39.6%.- As of 30 June 2024, the Group had a total of 43 innovative drug candidates in the field of oncology, 8 innovative drug candidates related to the respiratory system, 6 innovative drug candidates related to liver disease, and 4 innovative drug candidates in the field of surgery/analgesia in the process of clinical trial application or above. Of these, 3 innovative oncology drug candidates and 1 innovative surgery/analgesia drug candidate are in the marketing application stage, and 5 innovative oncology drug candidates, 1 innovative respiratory system drug candidate, 1 innovative liver disease drug candidate, and 1 innovative surgery/analgesia drug candidates are in Phase III clinical trials. In addition, the Group had a total of 18 biosimilar or generic drug oncology candidates, 3 additional biosimilar or generic liver disease drug candidates, 21 biosimilar or generic respiratory system drug candidates, and 10 biosimilar or generic surgical/analgesic drug candidates in the clinical trial application or above.- Focus V (Anlotinib Hydrochloride Capsules) is a new type of small molecule multi-target tyrosine kinase inhibitor. In February and July 2024, for anlotinib in combination with benmelstobart, two marketing applications were submitted to the Center for Drug Evaluation (“CDE”) of NMPA for the treatment of second- and third-line endometrial cancer, and first line renal cell carcinoma, respectively. In July 2024, the Phase III clinical study of anlotinib in combination with chemotherapy for the first-line treatment of advanced soft tissue sarcoma achieved positive results. The Group has submitted the marketing application and received acceptance for the new indication.- Yilishu (Efbemalenograstim Alfa Injection) was approved in May 2023 for the prevention and treatment of neutropenia in cancer patients taking chemotherapy drugs. In December 2023, Efbemalenograstim alfa was successfully included in the National Reimbursement Drug List (“NRDL”), and its sales volume accelerated in the first half of 2024, becoming an important contributor to the Group’s revenue growth.- Andewei (Benmelstobart Injection) is a humanized PD-L1 monoclonal antibody that was approved by the NMPA in April 2024 for use in combination with anlotinib, carboplatin, and etoposide in the first-line treatment of extensive-stage small cell lung cancer.- Anboni (Unecritinib Fumarate Capsules) is a small molecule inhibitor of tyrosine kinase ROS1/ALK/c-Met, which was approved by the NMPA in April 2024 for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer. It is the first domestically produced targeted drug approved for the treatment of ROS1-positive non-small cell lung cancer.- The clinical trial application of Lanifibranor was submitted to and accepted by CDE in March 2023. In July, Lanifibranor was included in the list of breakthrough therapeutics. Currently, Lanifibranor is conducting Phase III clinical trials globally and is actively advancing the enrollment of subjects. Lanifibranor is China's first oral MASH drug to enter Phase III clinical trials and is expected to fill the gap in China's MASH market.HONG KONG, Aug 14, 2024 - (ACN Newswire via SeaPRwire.com) - Sino Biopharmaceutical Limited (“Sino Biopharmaceutical” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2024 (the “Period”).During the Period, the Group recorded revenue of approximately RMB15.87 billion, a year-on-year increase of approximately 11.1%. Profit attributable to owners of the parent company was approximately RMB3.02 billion, a year-on-year increase of approximately 139.7%. Earnings per share attributable to owners of the parent company were approximately RMB16.39 cents. The significant year-over-year increase in profit attributable to owners of the parent company was mainly due to the gain on disposal of subsidiaries under discontinued operations during the current Period. Adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.54 billion, a YOY increase of approximately 14.0%. The Group's liquidity remains strong, with cash and bank balances classified as current assets of approximately RMB8.55 billion, bank deposits classified as non-current assets of approximately RMB9.18 billion, and wealth management products of approximately RMB4.61 billion in total, and total fund reserves amounting to approximately RMB22.34 billion at the end of the Period.The Board of Directors has recommended an interim dividend payment of HK3 cents per share (1H2023: HK2 cents).Miss Tse, Theresa Y Y, Executive Director and ChairwomanSales: Entering harvesting of innovative results period and sales revenue from generic products further risesAlways placing utmost importance on research and development (“R&D”), the Group leverages in-depth research and development to achieve significant benefits. At present, the Group has entered the harvest period of its innovative development, driving further growth in sales revenue. During the Period, sales of oncology drugs increased by 19.5% year-on-year to approximately RMB5.36 billion, accounting for approximately 33.8% of the Group's revenue. Sales of surgical/analgesic medications increased by 29.9% year-on-year to approximately RMB2.58 billion, accounting for approximately 16.3% of the Group's revenue. Sales of liver disease drugs amounted to approximately RMB2.03 billion, accounting for approximately 12.8% of the Group's revenue. In addition, the sales contributions of products in various areas such as respiratory system, cardio-cerebral vascular medicines, and others increased simultaneously, accounting for approximately 11.2%, 8.6%, and 17.3% of the Group's total revenue, respectively.In the field of respiratory system, The Group has taken a series of proactive management measures in a timely manner, including strengthening downstream channels, expanding market coverage and conducting secondary development in markets outside the scope of the volume-based procurement (VBP), enabling Tianqing Suchang’s sales to achieve steady growth during the Period. In the meanwhile, the Group continued to expand its market coverage through active academic promotion, and Tianyun’s sales grew rapidly during the Period.In the field of surgery/analgesia, the Group focuses on the development of high-potential areas, further expanding its market coverage and gradually increasing its production capacity to meet the booming market demand. Sales of flurbiprofen cataplasms have maintained a growth trend in recent years and achieved breakthrough growth during the Period.Mr. Tse, Eric S Y, Executive Director and Chief Executive OfficerR&D: R&D as the core for driving the Group's continuous innovation and developmentThe Group has continued to focus its R&D efforts on new medicines in the four therapeutic areas of oncology, liver disease, respiratory system and surgery/analgesia. As at the end of the reporting Period, the Group had 76 innovative products in development, including 46 oncology products, 6 liver disease products, 9 respiratory system products, 5 surgery/analgesia products, and 10 other products. In addition, the Group had 65 generic drug products in development.The Group has always put R&D at its core, and has continuously improved its R&D capabilities and speed by embracing the R&D concept of combining independent innovation, collaborative development, and the development of both innovative and generic drugs. It considers R&D as the foundation of its sustainable development. In the first half of 2024, it incurred R&D expenses of approximately RMB 2.58 billion, accounting for approximately 16.2% of the Group’s revenue. It is expected that the number of innovative products launched to the market will reach 25 by 2026. This will further strengthen the Group’s dominant position in the four main therapeutic areas and provide strong impetus for long-term sustainable growth.Sino Biopharmaceutical ManagementProspects: Keep up with national development strategy and accelerate globalization processThe pharmaceutical industry has become one of the fastest growing and most promising fields in China and even the world. As the world’s second largest pharmaceutical market, China’s demand for medical and healthcare products has grown rapidly in recent years, with breakthroughs being made in biotechnology. Innovation has become a new driving force for the high-quality development of China’s pharmaceutical industry. The Group has been closely monitoring the development of the country, society and the industry, and has continuously optimized its development strategy. Under the four main strategies of “organizational integration, comprehensive innovation, internationalization, and digitalization”, the Group will actively innovate its organizational structure, comprehensively improve its operational efficiency, focus on the innovation and development of the four main therapeutic areas of oncology, liver disease, respiratory system, and surgery/analgesia, and actively accelerate the global deployment of its business.The Group is committed to its mission of becoming a “leading global pharmaceutical company through delivering innovative therapies for patients”. It strives to promote innovative development through its dual engines of internal R&D and business development. Over the years, the Group has stepped up its R&D investment and built strong internal R&D capabilities. At the same time, it has vigorously promoted business development and strategic cooperation, striving to become the best partner for global pharmaceutical and biotechnology enterprises. In April 2024, the Group entered into a strategic partnership with Boehringer Ingelheim to bring Boehringer Ingelheim's innovative cancer therapies to the Mainland Chinese market. This move not only demonstrates The Group's innovative strength in the pharmaceutical field, but also reflects its far-reaching influence in international cooperation.Looking ahead, The Group will adhere to its dual-pronged approach in the implementation of its globalization strategy. Through this approach, the Group will bring global pharmaceutical innovations to China to benefit Chinese patients, and also go global and open up new markets to accelerate the satisfaction of unmet clinical needs worldwide. Copyright 2024 ACN Newswire via SeaPRwire.com.
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飛行員在未經授權飛行期間墜毀直升機於澳洲飯店屋頂,喪生 News

飛行員在未經授權飛行期間墜毀直升機於澳洲飯店屋頂,喪生

(SeaPRwire) - 澳洲当局表示,周一凌晨,一名飞行员驾驶直升机在未经授权的情况下,坠毁在一家酒店的屋顶上,导致飞行员死亡,其他人受伤。新西兰先驱报 (The New Zealand Herald) 确认飞行员是 23 岁的布雷克·威尔逊 (Blake Wilson),来自 。航空公司 Nautilus Aviation 向新闻媒体确认,威尔逊是该公司的一名员工,但之前从未在澳大利亚执飞过。该公司表示,他是该公司地面人员的成员,持有新西兰的直升机驾驶执照,但未获准驾驶该公司的直升机在澳大利亚飞行。Nautilus Aviation 表示,这名男子在 Nautilus Aviation 工作了四个月,最近被提升到该公司另一个基地担任地面人员的工作。在 之前,这名男子曾与同事参加了一场社交活动,以庆祝他前往新职位的告别。该公司补充说,这次飞行未经授权,直升机“被盗用”。周一凌晨的坠机事故导致数百人从大楼中撤离,因为飞机被大火吞噬。服务代理总警司 Shane Holmes 告诉记者,一对住在酒店的夫妇因吸入烟雾而被送往医院,两人现已出院。地面上没有其他人受伤。凯恩斯机场首席执行官 Richard Barker 表示,周一对事故进行的初步调查显示,“机场安保计划或流程没有受到影响”。Barker 表示,机场在“联邦批准的多层次运输安全计划”下运营。坠机事故发生在凯恩斯繁华的旅游区,凯恩斯是昆士兰州北部的一个热带城市,人口 15 万,目前正值旅游旺季。目击者告诉当地新闻媒体,坠机事故听起来像是炸弹爆炸。澳大利亚广播公司 (ABC) 报道称,浓烟滚滚,火焰从希尔顿逸林酒店 (DoubleTree Hilton) 的屋顶升起,直升机的其中一个旋翼叶片掉进了酒店的游泳池。酒店目前已被封锁,正在检查其结构完整性。 已联系 Nautilus Aviation 和昆士兰州警方,以获取最新信息。本文由第三方廠商內容提供者提供。SeaPRwire (https://www.seaprwire.com/)對此不作任何保證或陳述。 分類: 頭條新聞,日常新聞 SeaPRwire為公司和機構提供全球新聞稿發佈,覆蓋超過6,500個媒體庫、86,000名編輯和記者,以及350萬以上終端桌面和手機App。SeaPRwire支持英、日、德、韓、法、俄、印尼、馬來、越南、中文等多種語言新聞稿發佈。
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中國生物製藥(1177.HK)公佈2024中期業績 ACN Newswire

中國生物製藥(1177.HK)公佈2024中期業績

重點成果- 期內,集團共有4個創新產品獲中國國家藥品監督管理局(「NMPA」)批准上市,分別為安得衛(貝莫蘇拜單抗注射液)、安柏尼(富馬酸安奈克替尼膠囊)、安洛晴(枸櫞酸依奉阿克膠囊)和貝樂林(利拉魯肽注射液),其中3個為國家1類創新藥。- 2024年上半年,集團創新產品收入達到61.3億元,同比增長14.8%。除創新產品外,集團還有11個仿製藥獲NMPA批准上市,整體仿製藥收入在2024年上半年已實現正增長。新產品是驅動集團收入增長的重要動力,2024年上半年集團5年內上市的新產品收入達到60.3億元,同比增長39.6%。- 截至2024年6月30日,集團共有43個腫瘤領域、8個呼吸系統領域、6個肝病領域和4個外科╱鎮痛領域的創新候選藥物處於臨床申請及以上開發階段。其中,3個腫瘤領域、1個外科╱鎮痛領域產品處在上市申請階段;5個腫瘤領域、1個呼吸系統領域、1個肝病領域、1個外科╱鎮痛領域的創新候選藥物處於臨床III期;另有18個腫瘤領域、3個肝病領域、21個呼吸系統領域、10個外科╱鎮痛領域的生物類似藥或仿製藥候選藥物處於臨床申請及以上開發階段。- 福可維(鹽酸安羅替尼膠囊)是一種新型小分子多靶點酪氨酸激酶抑制劑。2024年2月和7月,安羅替尼聯合貝莫蘇拜單抗向中國國家藥品監督管理局藥品審評中心(「CDE」)遞交兩項新適應症上市申請,分別用於治療二三線子宮內膜癌和一線腎細胞癌。2024年7月,安羅替尼聯合化療用於晚期軟組織肉瘤一線治療的III期臨床研究取得陽性結果,集團已遞交新適應症上市申請並獲受理。- 億立舒(艾貝格司亭α)注射液於2023年5月獲批用於預防和治療腫瘤患者在接受化療藥物後出現的中性粒細胞減少症。2023年12月,億立舒被成功納入國家醫保目錄,並在2024年上半年加速放量,成為集團收入增長的重要貢獻品種。- 安得衛(貝莫蘇拜單抗注射液)是一款人源化PD-L1單克隆抗體,於2024年4月獲得NMPA的上市批准,用於聯合安羅替尼、卡鉑和依託泊甘一線治療廣泛期小細胞肺癌。- 安柏尼(富馬酸安奈克替尼膠囊)是一款酪氨酸激酶ROS1/ALK/c-Met小分子抑制劑,於2024年4月獲得NMPA的上市批准,用於治療ROS1陽性的局部晚期或轉移性非小細胞肺癌,是首個獲批用於治療ROS1陽性非小細胞肺癌的國產靶向藥。- 拉尼蘭諾(泛PPAR激動劑)於2023年3月向CDE遞交臨床試驗申請並獲得受理,7月,拉尼蘭諾被CDE納入突破性治療品種名單。目前該產品正在全球進行III期臨床試驗,是中國第一個進入臨床III期的MASH口服藥物,有望填補中國MASH市場空白。香港, 2024年8月14日 - (亞太商訊 via SeaPRwire.com) – 中國領先的創新研發驅動型醫藥集團—中國生物製藥有限公司(「中國生物製藥」或「公司」,連同附屬公司統稱「集團」)(股票編號:1177)公佈截至2024年6月30日止6個月(「期內」)之未經審核財務業績。回顧期內,集團收入同比增長11.1%至約158.7億元(人民幣,下同)。歸屬於母公司持有者應佔盈利約30.2億元,同比增長約139.7%,基於歸屬於母公司持有者應佔盈利計算之每股盈利約16.39分。歸屬於母公司持有者盈利同比顯著增加主要由於本期間錄得處置附屬公司收益並計入已終止經營業務導致。經調整非《香港財務報吿準則》歸母淨利潤約15.4億元,同比增長約14.0%。集團流動資金保持充裕,期內有計入流動資產之現金及銀行結餘約85.5億元、計入非流動資產之銀行存款約91.8億元,理財管理產品總額約46.1億元,資金儲備合共約223.4億元。董事會建議派發中期股息每股3港仙(2023上半年:2港仙)。中國生物製藥董事會主席謝其潤女士銷售:邁入創新成果收穫期 創新產品銷售收入持續增加集團一直以來重視研發,並憑藉高研發投入以獲得顯著收益。集團現已步入創新成果密集收穫期,帶動銷售收入進一步增長。期內,抗腫瘤用藥之收入同比增加19.5%,達約53.6億元,佔集團收入約33.8%。外科/鎮痛用藥之收入同比增加29.9%,達約25.8億元,佔集團收入約16.3%。肝病用藥收入錄得約20.3億元,佔集團收入12.8%。此外,呼吸系統、心腦血管用藥和其他等不同領域產品的銷售貢獻多輪並進,分別佔集團收入約11.2%、8.6%和17.3%。於呼吸系統領域,集團及時採取了一系列主動管理措施,包括管道下沉、拓展市場覆蓋和集採外市場的二次開發,使天晴速暢銷售額於期內實現了穩步增長。同時,集團通過積極的學術推廣,不斷拓展市場覆蓋,令天韻的銷售額於期內亦取得快速增長。於外科╱鎮痛領域,集團聚焦高潛地區開發,深入拓展市場覆蓋,並逐步擴大產能,以滿足市場的旺盛需求。氟比洛芬凝膠貼膏的銷售額在過去幾年保持增長態勢,並在期內實現了突破性增長。中國生物製藥董事會首席執行長謝承潤先生研發:以研發為核心,驅動集團持續創新與發展集團繼續專注腫瘤、肝病、呼吸系統和外科╱鎮痛四大治療領域的新產品研發。截至報告期日,集團有在研創新產品76個,其中腫瘤用藥46個、肝病用藥6個、呼吸系統用藥9個、外科╱鎮痛用藥5個,其他類用藥10個。另外,集團還有65個在研仿製藥產品。集團始終將研發置於核心位置,秉承自主創新、聯合開發及創仿開發相結合的研發策略,持續提高研發能力和效率,將其視為企業持續發展的關鍵。2024年上半年集團研發費用達到約25.8億元,佔集團收入約16.2%。預計到2026年,已上市創新産品的數量將達到25個,將進一步強化集團在四大治療領域的優勢地位,爲長期可持續增長注入強大動力。中國生物製藥管理層展望:緊跟國家發展戰略,加速國際化進程醫藥行業已成為中國乃至全球最具活力和發展潛力的領域之一。中國作為全球第二大醫藥市場,近年來醫療健康需求的快速增長和生物技術的持續突破,為醫藥產業的高質量發展注入了新動力。集團緊跟國家、社會及行業的最新動態,不斷優化發展策略,以「組織整合、全面創新、國際化、數字化」為四大戰略方向,積極革新組織架構,全面提升運營效率,專注於腫瘤、肝病、呼吸、外科/鎮痛四大治療領域的創新發展,並大力推進國際化佈局。集團秉承「專注創新、服務病患,成為全球領先的製藥企業」的願景,通過自主研發和商務拓展的雙引擎驅動,不斷推動創新發展。集團不斷加大研發投入,積累了強大的自主研發能力。同時,集團積極推進商務拓展和戰略合作,力爭成為全球製藥與生物科技公司的的最佳合作夥伴。2024年4月,集團與勃林格殷格翰建立戰略合作夥伴關係,將勃林格殷格翰的創新抗腫瘤療法引入中國大陸市場,這一舉措不僅展現了集團在醫藥領域的創新實力,也體現了其在國際合作中的深遠影響力。展望未來,集團將持續堅守「引進來」與「走出去」的雙重策略,以實現國際化發展。集團將全球的醫藥創新成果引入中國,為中國的病患帶來福祉;同時也將積極開拓新的市場,以加速滿足全球各地未被滿足的臨床需求。 Copyright 2024 亞太商訊 via SeaPRwire.com.
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