GRAND PHARMA(00512)

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远大医药(00512) - 自愿性公告: 本集团全球创新的血管内双模成像系统 NOVASYNC 获药...
2024-12-12 09:13
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 董事會欣然公告,本集團的用於冠狀動脈成像的全球創新血管內雙模成像系統 NOVASYNC HYBRID SYSTEMTM (「NOVASYNC」)近日獲得中華人民共和國國家 藥品監督管理局(「藥監局」)頒發醫療器械註冊證書。NOVASYNC 是本集團進口的 血管內雙模成像設備 NOVASIGHT HYBRID SYSTEMTM (「NOVASIGHT」)的國產 迭代產品,該產品的獲批標誌著本集團已成功完成了 NOVASIGHT 的技術轉移和全 面國產化,這是本集團在心腦血管精准介入診療領域血管介入方向的又一次里程碑 進展。 光學相干斷層成像(「OCT」)和血管內超聲(「IVUS」)是經皮冠狀動脈介入治療 (「PCI」)手術中最主要的兩種血管腔內影像學技術,可顯著提高接受 PCI 手術患者 的治療效果。但兩種影像學技術各有不足,OCT 雖然 ...
远大医药(00512) - 自愿性公告: 本集团获得治疗乾眼症的全球首创创新產品的独家开发及商业化权...
2024-12-11 08:59
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其 準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而 產生或因倚賴該等內容而引致的任何損失承擔任何責任。 本集團獲得治療乾眼症的全球首創創新產品的獨家開發及商業化權益 本公告乃遠大醫藥集團有限公司(「本公司」,連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告,近日,本集團與箕星藥業香港有限公司(「箕星」)達成產品引進戰略 合作協議。根據協議,在相關條件滿足後,本集團將獲得用於治療乾眼症的全球首創創 新產品酒石酸伐尼克蘭鼻噴霧劑「( OC-01」)及 OC-02(Simpinicline)鼻噴霧劑「( OC-02」) 在大中華區(中國大陸、中國香港特別行政區、中國澳門特別行政區、台灣地區)的獨 家開發及商業化權益。此次戰略合作將進一步深化本集團在眼科領域的創新產品佈局。 箕星是一家總部位於美國和中國的生物科技公司,致力於將創新科學和藥物帶給罹患嚴 重危及生命健康的全球患者,其重磅產品 OC-01 和 OC-02 是兩種高選擇性的乙醯膽鹼 能受體激動劑,可通過啟動三叉神經副交感神經 ...
远大医药(00512) - 自愿性公告: 全球创新放射性核素偶联药物 TLX250-CDx 在中国 ...
2024-11-28 09:10
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號: 00512) 自願性公告 本公告乃遠大醫藥集團有限公司(「本公司」,連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告,本集團用於診斷腎透明細胞癌(「ccRCC」)的全球創新放射性核素 偶聯藥物(「RDC」) TLX250-CDx 在中國開展的 III 期臨床研究,已於近日完成首例患 者入組並給藥。該研究是一項單臂、開放標籤的 III 期臨床研究,擬入組 82 名不確定 性腎腫塊患者,旨在評估 TLX250-CDx 通過正電子發射斷層顯像/電腦斷層掃描 (PET/CT)成像對患者進行無創檢測 ccRCC 的安全性、耐受性以及有效性。此次 TLX250-CDx 的 III 期臨床研究完成首例患者入組給藥是本集團在核藥抗腫瘤診療領域 的又 ...
远大医药(00512) - 持续关连交易: 与 Sirtex Medical 订立 2024 分销协...
2024-11-15 09:10
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 (股份代號: 00512) 持續關連交易 與 Sirtex Medical 訂立 2024 分銷協議 2024 分銷協議 茲提述本公司日期為二零二三年十二月十八日的公告,據此,北京普爾偉業與成都 普爾偉業(均為本公司的間接非全資附屬公司)已與 Sirtex Medical 訂立 2023 分銷 協議,其中 Sirtex Medical 已同意供應,而北京普爾偉業與成都普爾偉業已同意作為 中國獨家經銷商購買固定數量的產品以進行轉售。 2023 分銷協議有效期限至二零 二四年三月三十一日。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* 為了進一步購買 Sirtex Medical 的產品,於二零二四年十一月十五日(交易時間後), 北京普爾偉業與成都普爾偉業分別與 Sirtex Medical 簽訂了 2024 分銷協議,據此, Sirtex Medical 已指 ...
远大医药(00512) - 自愿性公告: 本集团全球创新眼科药物 GPN00833 完成国内ⅠⅠⅠ期...
2024-11-04 08:51
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其 準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而 產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕大註冊成立之有限公司 ) (股份代號:00512) 自願性公告 本集團全球創新眼科藥物 GPN00833 完成國內ⅠⅠⅠ期臨床研究並達到了臨床終點 本公告乃遠大醫藥集團有限公司(「本公司」,連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告,近日,本集團用於眼科術後抗炎鎮痛的激素納米混懸滴眼液 GPN00833 完成了在中國開展的 III 期臨床研究並成功達到了臨床終點,是本集團在五官科領域眼 科方向的又一次重大里程碑進展。 GPN00833 為抗炎鎮痛類激素納米混懸滴眼液,其主要活性成分丙酸氯倍他索是一種強 效的糖皮質激素,具有高效的局部抗炎活性和較強的毛細血管收縮作用,同時其獨特的 納米製劑工藝有效解決了激素產品低水溶性導致的生物利用度低及安全性風險。該產品 於二零二三 ...
远大医药(00512) - 2024 - 中期财报
2024-09-25 08:46
Acquisitions and Strategic Partnerships - The company acquired 100% of Tianjin Tanabe for approximately RMB 488 million, entering the chronic disease market and expanding its cardiovascular product portfolio [23]. - The acquisition of 100% of Baiji Pharmaceutical for about RMB 260 million positions the company as one of the leading firms in China for allergic rhinitis treatment, enhancing its nasal spray platform [23]. - The company has acquired 90% of the equity of DuPont Pharmaceutical Technology for approximately RMB 631.8 million, enhancing its market position in the treatment of cardiovascular and cerebrovascular diseases [26]. - The company has acquired 90% equity in Chongqing Duoputai Pharmaceutical Technology Co., Ltd. for approximately RMB 631.8 million, enhancing its traditional Chinese medicine product pipeline [172]. - The company completed a total acquisition of Tianjin Tanabe for approximately RMB 488 million, further strengthening its position in the cardiovascular emergency sector [176]. - The company has entered into a strategic cooperation agreement with LianTuo Biotechnology and Tarsus to acquire exclusive development, production, and commercialization rights for the innovative ophthalmic formulation TP-03 in Greater China for $15 million upfront and milestone payments [24]. Product Development and Innovation - The company aims to provide comprehensive coverage in cardiovascular disease treatment, from emergency rescue to chronic disease management, and from injectable to oral formulations [23]. - The company continues to strengthen its product pipeline and R&D capabilities, focusing on unmet clinical needs and technological innovation [17]. - The company is committed to becoming a respected international pharmaceutical enterprise through technological innovation and global outreach [17]. - The innovative drug ITM-11 for treating gastrointestinal pancreatic neuroendocrine tumors has received approval from the drug regulatory authority to commence Phase III clinical trials [24]. - The NDA application for the innovative nasal spray Ryaltris® for treating allergic rhinitis has been accepted by the drug regulatory authority [26]. - The innovative nuclear medicine product TLX250-CDx for diagnosing clear cell renal cell carcinoma has completed Phase I clinical trials in China and has entered confirmatory clinical research [40]. - The innovative drug GPN00187 for treating respiratory diseases has been approved to commence Phase I clinical trials [42]. - The innovative drug GPN00884 for delaying myopia progression in children has been approved to commence Phase I clinical trials in China [43]. - The therapeutic tumor vaccine ARC01 for HPV-16 positive advanced unresectable or recurrent/metastatic solid tumors has been approved to commence Phase I clinical trials in China [44]. - Five products have been approved for market launch, including three functional foods in China and six raw material drug products [47]. - The group has a total of 141 projects in the innovation pipeline, with 49 of them being innovative projects at various stages from preclinical to new drug application [159]. Financial Performance - The group’s revenue for the six months ended June 30, 2024, was approximately HKD 6,047,240,000, representing a year-on-year increase of about 1.0% [144]. - The net profit attributable to the company's owners for the same period was approximately HKD 1,557,950,000, an increase of about 51.4% year-on-year [144]. - The revenue from nuclear medicine oncology diagnosis and cardiovascular precision intervention technology products was approximately HKD 342,750,000, a year-on-year increase of about 140.8% [144]. - The amino acid segment (including taurine) generated revenue of approximately HKD 1,502,070,000, reflecting a stable growth of about 2.2% year-on-year [147]. - The group invested approximately HKD 1,480,000,000 in research and development and project inputs during the reporting period [151]. Corporate Governance and Compliance - The company is actively enhancing corporate governance and maintaining transparent communication with investors through various channels, including roadshows and conference calls [179]. - The company has established a remuneration committee to consider the compensation of all directors and senior management [195]. - The company has complied with all applicable corporate governance codes as of June 30, 2024 [193]. - The audit committee has reviewed the interim financial statements for the six months ending June 30, 2024, which are unaudited [194]. Research and Development - The company has established multiple R&D centers globally, including in Wuhan, Australia, and Nanjing, to support pharmaceutical technology innovation [87]. - The group has over 700 R&D personnel, with more than 450 holding master's or doctoral degrees, representing over 60% of the team [163]. - The group has established eight major technology platforms in synthetic biology, enzyme engineering, and fermentation, enhancing product development and industrialization capabilities [136]. Market Position and Product Offerings - The respiratory and critical care segment includes leading products like Qino® and Enzhuorun® with a strong market position and ongoing innovative product development [88]. - Qino® is a unique mucolytic agent in China, recommended in numerous clinical guidelines, and has been recognized as a potential brand in the retail market [90]. - Enzhuorun® Biselai (Indacaterol/Mometasone inhalation powder) is the first approved triple combination inhaler for asthma in China, showing a 43% reduction in the annualized risk of moderate acute exacerbations over 24 weeks compared to high-dose Salmeterol/Fluticasone [92]. - The cardiovascular intervention segment has launched 14 products, with 8 approved in China, including NOVASIGHT Hybrid, which was approved in May 2023 [72]. Litigation and Legal Matters - The company is involved in ongoing litigation related to a product quality incident, with a total compensation of approximately RMB 40.2 million paid as a result of 75 court judgments [180]. - The company has recovered RMB 10,000,000 from a bank account related to the acquisition of Tianjin Jingming, along with interest of RMB 644,135 [182]. - The seller is required to return an additional RMB 11,200,000 due to unmet performance commitments from the acquisition agreement [182].
远大医药:上半年营收同比微增,核药抗肿瘤板块进入快速放量期
Guoxin Securities· 2024-09-22 10:03
远大医药(00512.HK) 优于大市 上半年营收同比微增,核药抗肿瘤板块进入快速放量期 收入同比微增,扣除 Telix 投资的公允价值变动的正常化溢利快速增长。 2024 年上半年公司实现收入 60.47 亿港币,同比增长 1.0%,扣除汇率变动 影响同比增长约 5.4%;实现归母溢利 15.58 亿港币,同比增长 51.4%;若扣 除对 Telix 投资的公允价值变动收益(4.77 亿港币),正常化归母溢利约 10.81 亿港币,同比增长约 35.1%,进一步扣除汇率变动的影响后同比增长 约 41.0%。 呼吸类产品表现亮眼,核药抗肿瘤板块进入高速放量阶段。扣除汇率变动影 响,2024 年上半年制药科技板块实现收入 37.73 亿港币,同比基本持平,其 中呼吸及危重症业务收入 9.63 亿港币,同比增长约 21.0%,主要因为核心产 品切诺的临床需求持续增长以及新产品恩卓润、恩明润的放量增长;五官科 业务收入 12.31 亿港币,同比基本持平;心脑血管急救业务收入 11.67 亿港 币,同比下降 16.6%,主要因为肾上腺素产品受到集采降价影响。核药抗肿 瘤诊疗及心脑血管精准介入诊疗科技板块实现收入 3. ...
远大医药 -20240820
医药魔方· 2024-08-20 15:04
感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后感谢大家参加本次会议 大家好欢迎参加远大一二二零二四年中企业企业交流会目前所有参会者均处于静音状态下面开始公报声明本次会议仅服务邀请参会的广大投资者会以PPT音频及文字记录的内容仅供参会者内部使用不得公开发布 远大医药为授权人和媒体转发本次会议相关内容未经允许和授权的转载转发均属侵权远大医药将保留追究其法律责任的权利远大医药不承担因转载转发而产生的任何损失和责任市场有风险投资需谨慎提醒广大投资者谨慎做出投资决策在会议开始前我们提示各位投资者在主讲嘉宾翻译结束后将留有提问时间接下来有请公司主持人发言谢谢 各位投资人大家上午好非常感谢大家来参加中金公司中进证券华泰证券新业证券国进证券国源证券医药团队联合举办的远大医药2024年中期业绩交流会我本人是中金医药分析师朱元音在线的还有我的同事刘亚军博士 那今天呢我们先非常荣幸邀请到公司的各位管理层他们分别是广社会主席总裁唐伟坤博士行政总裁周超先生财务及运营副总裁姚薇女士来参加本次业绩电话会那么公司昨天也公布了202 ...
远大医药(00512) - 2024 - 中期业绩
2024-08-19 13:33
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其 準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而 產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 怈⣏慓喍普⛀㚱旸℔⎠* (㕤䘦ヽ忼姣Ⅎㆸ䩳ᷳ㚱旸℔⎠) (偉ấẋ嘇: 00512) 二零二四年中期業績公佈 | --- | --- | |---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | | | | 財務摘要 | ...
远大医药(00512) - 2024 - 年度财报
2024-07-05 09:55
Share Incentive Plan - The purpose of the share incentive plan is to recognize the contributions of selected participants and motivate them to remain with the group, thereby promoting the group's ongoing operations, growth, and development[2] - The remaining term of the share incentive plan is approximately seven and a half years, effective until December 31, 2033[3] Supplementary Information - The supplementary information provided does not affect other information disclosed in the annual report[4]