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康哲药业(00867) - 截至二零二四年十二月三十一日止年度之末期股息
2025-03-17 14:06
第 1 頁 共 2 頁 v 1.1.1 EF001 發行人所發行上市權證/可轉換債券的相關信息 發行人所發行上市權證/可轉換債券 不適用 其他信息 其他信息 不適用 發行人董事 於本公告日期,本公司董事包括(ⅰ)執行董事:林剛先生及陳燕玲女士;(ⅱ)非執行董事:陳洪兵先生;(iii)獨立非執行董事:梁創 順先生、羅瑩女士及馮征先生。 免責聲明 第 2 頁 共 2 頁 v 1.1.1 | 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的內容概不負責,對其準確性或完整性亦不發表任何聲明,並明確表示,概不對因 公告全部或任何部份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。 | | | --- | --- | | 股票發行人現金股息公告 | | | 發行人名稱 | China Medical System Holdings Limited 康哲藥業控股有限公司* (*僅供識別) | | 股份代號 | 00867 | | 多櫃檯股份代號及貨幣 | 不適用 | | 相關股份代號及名稱 | 不適用 | | 公告標題 截至二零二四年十二月三十一日止年度之末期股息 | | | 公告日期 | 2025年3月 ...
康哲药业(00867) - 2024 - 年度业绩
2025-03-17 13:59
Financial Performance - Revenue decreased by 6.8% to RMB 7,469.0 million, compared to RMB 8,013.3 million in 2023; pharmaceutical sales revenue decreased by 9.0% to RMB 8,621.6 million from RMB 9,472.2 million[4] - Gross profit declined by 11.2% to RMB 5,422.2 million, down from RMB 6,109.2 million in 2023; pharmaceutical sales gross profit decreased by 10.7% to RMB 5,405.4 million from RMB 6,053.7 million[4] - Annual profit fell by 32.3% to RMB 1,613.1 million, compared to RMB 2,384.4 million in 2023; normalized annual profit decreased by 36.7% to RMB 1,713.7 million from RMB 2,709.3 million[4] - Basic earnings per share decreased by 31.9% to RMB 0.6673, down from RMB 0.9792 in 2023[4] - Cash and cash equivalents as of December 31, 2024, amounted to RMB 3,706.5 million, with bank acceptance bills of RMB 198.8 million[4] - Proposed final dividend per share is RMB 0.1174, resulting in a total dividend of RMB 0.2681 per share for the year, a decrease of 31.6% from RMB 0.3917 in 2023[4] - Profit before tax for 2024 was RMB 2,010,307 thousand, a decline of 30.1% compared to RMB 2,873,771 thousand in 2023[14] - Net profit for the year was RMB 1,613,080 thousand, down 32.3% from RMB 2,384,430 thousand in the previous year[14] - Total annual profit attributable to the company's owners for 2024 was RMB 1,619,788 thousand, down 32.6% from RMB 2,400,940 thousand in 2023[40] Revenue Sources - Three national procurement products generated pharmaceutical sales revenue of RMB 2,691.0 million, a year-on-year decline of 28.8%[5] - Non-national procurement exclusive and innovative products generated pharmaceutical sales revenue of RMB 4,551.3 million, a year-on-year increase of 4.1%, accounting for 52.8% of total revenue[5] - Revenue from cardiovascular-related diseases was RMB 2,917.7 million, a decrease of 17.1% year-on-year, representing 47.4% of total pharmaceutical sales revenue[93] - Revenue from dermatology and aesthetic medicine increased by 18.2% year-on-year to RMB 672.6 million, accounting for 7.8% of total pharmaceutical sales revenue[93] Research and Development - Research and development expenses increased significantly to RMB 329,982 thousand, up 68.9% from RMB 195,134 thousand in 2023[14] - Five innovative drugs have entered the commercialization stage[6] - Over 10 clinical trials are progressing smoothly[9] - The company expanded its innovative product pipeline to approximately 40 items, with five innovative drugs approved for market in China[56] - The company is focused on a dual approach of collaborative and independent research and development to drive innovation[60] - The company is advancing approximately ten projects in clinical trials, focusing on registration-based randomized controlled trials (RCTs) to ensure continuous innovation[61] - The company has made progress in self-innovation with around twenty projects in development, including four innovative drugs entering clinical development in China[61] Market Strategy and Expansion - The company aims to enhance its commercialization system with a focus on specialty areas such as cardiovascular, central nervous system, digestive, dermatology, and ophthalmology[56] - The company is continuously improving its Southeast Asia business system to support international expansion[59] - The company is actively capturing market opportunities through cross-departmental collaboration and dynamic updates to its promotional strategies[88] - The group is focusing on expanding its outpatient market presence, enhancing coverage and service quality through training systems for retail pharmacies[89] - The group plans to deepen its international presence starting from Southeast Asia, building a comprehensive business system covering research, production, and sales[117] Financial Management - Cash generated from operating activities was RMB 1,268.5 million, a decrease of 49.3% compared to RMB 2,502.9 million in the previous year[138] - The group's cash and cash equivalents at year-end were RMB 3,706.5 million, down from RMB 4,311.1 million at the end of the previous year[135] - Financial expenses decreased to RMB 38,610 thousand in 2024 from RMB 46,251 thousand in 2023, a reduction of 16.5%[33] - The net cash used in financing activities for the reporting period was RMB 1,261.0 million, a decrease of 40.7% compared to RMB 2,125.0 million in 2023, primarily due to reduced dividend payments[140] - The group reported a debt of RMB 831.3 million in bank loans as of December 31, 2024, down from RMB 1,269.7 million in 2023, resulting in a decrease in the debt-to-asset ratio from 7.2% to 4.6%[145] Product Development and Launches - The company successfully launched a new innovative drug (Leflan) and an additional indication for an existing drug, enhancing its product offerings[59] - The innovative product Lai Fulan (Methylene Blue Enteric-Coated Sustained-Release Tablets) was approved in June 2024, significantly improving the detection rate of non-polyp colorectal lesions during colonoscopy[62] - Mei Tai Tong (Methotrexate Injection) was approved in March 2023 for severe psoriasis and received additional approval for rheumatoid arthritis in July 2024, demonstrating non-inferiority to oral Methotrexate[63][64] - The innovative oral drug Daxidustat for treating anemia in non-dialysis adult chronic kidney disease patients received NDA acceptance from NMPA in April 2024, with positive results from Phase III clinical trials showing improved hemoglobin levels compared to placebo[70] - Ruxolitinib cream, the first and only topical JAK inhibitor for vitiligo, received NDA acceptance from NMPA in September 2024, with real-world studies showing consistent efficacy and safety[71] Shareholder Returns and Dividends - The company declared a mid-year dividend of RMB 0.1507 per share for 2024, compared to RMB 0.3134 per share in 2023, reflecting a decrease of 52.0%[40] - The group paid dividends of RMB 364.2 million for the 2024 interim and RMB 192.0 million for the 2023 final, compared to RMB 768.5 million and RMB 591.9 million in the previous year, reflecting a significant reduction in dividend payouts[151] Governance and Compliance - The board of directors includes both executive and independent non-executive members, ensuring a diverse governance structure[164] - The company has adopted a written guideline for securities trading by directors, ensuring compliance with the standards set forth[160] - There have been no reported violations of the securities trading guidelines by employees during the reporting period[160]
康哲药业(00867) - 自愿性及业务进展公告 创新药心肌肌球蛋白抑制剂CMS-D003获药物临床...
2025-03-12 13:10
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 *僅供識別 1 自願性及業務進展公告 創新藥心肌肌球蛋白抑制劑CMS-D003獲藥物臨床試驗批准通知書 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 欣然宣佈,本集團自主研發的創新藥CMS-D003膠囊(「CMS-D003」)於二零二五年 三月十一日獲得中國國家藥品監督管理局(「NMPA」)簽發的藥物臨床試驗批准通知 書,於三月十二日收到藥物臨床試驗批准通知書。NMPA同意本集團在中國健康以及症 狀性梗阻性肥厚型心肌病(oHCM)成人受試者中開展評價CMS-D003安全性、耐受性 及藥代動力學和藥效學特徵的臨床試驗。 CMS-D003 CMS-D003是一種小分子心肌肌球蛋白抑制劑,是靶向治療肥厚型心肌病的藥物。通過 靶向抑制心肌肌球蛋白三磷酸腺苷(ATP)酶,抑制肌球蛋白-肌動蛋白相互作用,減少 肌絲滑動,抑制心肌的過度收縮,改善心 ...
康哲药业(00867) - 董事会会议通告
2025-03-05 09:25
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 China Medical System Holdings Limited(「本公司」)董事會(「董事會」)茲通告,本公 司謹定於二零二五年三月十七日(星期一)召開本公司董事會會議,其中包括考慮及擬 批准本公司及其附屬公司截至二零二四年十二月三十一日止之年度業績,及考慮派發末 期股息(如有)。 承董事會命 China Medical System Holdings Limited 主席 林剛 香港,二零二五年三月五日 董事會會議通告 於本公告日期,本公司董事包括 (i) 執行董事:林剛先生及陳燕玲女士; (ii) 非執行董事: 陳洪兵先生; (iii) 獨立非執行董事:梁創順先生、羅瑩女士及馮征先生。 *僅供識別 1 ...
康哲药业(00867) - 自愿性及业务进展公告 就1类新药MG-K10人源化单抗注射液签订合作协议
2025-01-24 12:42
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 自願性及業務進展公告 就1類新藥MG-K10人源化單抗注射液簽訂合作協議 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 欣然宣佈,於二零二五年一月二十四日,本集團通過本公司附屬公司與湖南麥濟生物技 術股份有限公司(「麥濟生物」)及其附屬公司就1類新藥抗IL-4Rα人源化單抗注射液 MG-K10(「MG-K10」或「產品」)簽訂合作協議(「協議」)。 根據協議,本集團獲得產品在中國大陸、香港特別行政區、澳門特別行政區、台灣地區 及新加坡(「區域」)的協議所約定之共同開發權及獨家商業化權利;麥濟生物配合商 業化活動,並銷售、供應產品。合作期限為永久。 MG-K10 MG-K10是一種創新的長效抗IL-4Rα人源化單抗,能同時阻斷關鍵2型炎症因子IL-4和 IL-13的信號傳導,用於治療2型炎症性疾病,如特應性皮炎(Atopic Derma ...
康哲药业(00867) - 自愿性及业务进展公告 就治疗轻度至中度阿尔茨海默型痴呆症状的改良型新药Z...
2025-01-08 13:38
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 * 僅供識別 1 在更優的胃腸道安全性,有望提高阿爾茨海默病患者的用藥依從性,從而使患者獲益。 與ZUNVEYL相關的用途專利,已在中國獲得授權。 自願性及業務進展公告 就治療輕度至中度阿爾茨海默型痴呆症狀的 改良型新藥ZUNVEYL簽訂許可、合作與經銷協議 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 欣然宣佈,於二零二五年一月八日,本集團通過本公司全資附屬公司與Alpha Cognition Inc.(「Alpha」)就用於治療輕度至中度阿爾茨海默型痴呆症狀的改良型新藥ZUNVEYL (benzgalantamine delayed-release tablets)(「ZUNVEYL」或「產品」)簽訂許可、合 作與經銷協議(「協議」)。 根據協議,本集團獲得了在亞洲(除日本)、澳洲、新西蘭(「區域」)開發、註冊、 生產、進口、出口 ...
康哲药业:创新药进一步丰富,即将放量再造新康哲
国元国际控股· 2024-12-31 05:53
Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 10.38, indicating a potential upside of 38.78% from the current price of HKD 7.48 [3][27][47]. Core Insights - The company has a robust pipeline of innovative drugs, with four new drugs recently included in the national medical insurance directory, expected to contribute approximately RMB 400-500 million in revenue in 2024 [2][6][39]. - The company is expanding its market presence in Southeast Asia, leveraging local talent and establishing a management center in Singapore to cater to the growing demand for pharmaceuticals in the region [44][46]. - The company has signed an exclusive commercialization agreement for a new drug, ABP-671, aimed at treating gout and hyperuricemia, which is currently undergoing clinical trials [26][37]. Financial Summary - The company reported a revenue of RMB 42.88 billion in the first half of 2024, a year-on-year decrease of 22.6%, but a quarter-on-quarter increase of 8.9% [30]. - The net profit for the same period was RMB 9.03 billion, reflecting a year-on-year decline of 52.8%, but a significant quarter-on-quarter increase of 92.8% [30]. - Revenue projections for 2024, 2025, and 2026 are estimated at RMB 79.25 billion, RMB 89.49 billion, and RMB 108.85 billion, respectively, with EPS expected to rise from RMB 0.71 in 2024 to RMB 1.01 in 2026 [13][38]. Product Pipeline - The company has a diverse pipeline with 30 innovative drugs, including CMS-D005, which has shown promising preclinical results for weight loss and safety [2][41]. - The company is also advancing the development of Lurconidine cream for vitiligo, with a significant market potential given the large patient population in China and Southeast Asia [9][10]. - The innovative drugs recently launched include a nasal spray for epilepsy, a monoclonal antibody for psoriasis, and a methotrexate injection for autoimmune diseases, showcasing the company's strong R&D capabilities [39][40].
康哲药业(00867) - 自愿性及业务进展公告 获得治疗痛风及高尿酸血症的1类新药的独家商业化权利
2024-12-02 11:26
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 自願性及業務進展公告 獲得治療痛風及高尿酸血症的1類新藥的獨家商業化權利 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 欣然宣佈,於二零二四年十二月二日,本集團通過本公司全資附屬公司與杭州新元素藥 業有限公司(以下称「新元素藥業」,曾用名「江蘇新元素醫藥科技有限公司 」)就 治療痛風及高尿酸血症的1類新藥ABP-671(「ABP-671」或「產品」)簽訂獨家商業化 協議(「協議」)。 根據協議,本集團獲得產品在中國大陸、香港特別行政區及澳門特別行政區的獨家商業 化權利。合作期限開始於協議生效之日,自產品首次在中國大陸獲批上市起擁有十年的 授權期限(「授權期限」)。授權期限屆滿後,根據協議約定的特定條件,授權期限可 自動續期十年。 治療痛風及高尿酸血症的1類新藥ABP-671 ABP-671是用於治療痛風及高尿酸血症的化藥1類創新藥,目 ...
康哲药业(00867) - 自愿性及业务进展公告 创新药GLP-1R/GCGR双重激动剂CMS-D0...
2024-11-27 11:12
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 *僅供識別 1 良好前景。 自願性及業務進展公告 創新藥GLP-1R/GCGR雙重激動劑CMS-D005 獲藥物臨床試驗批准通知書 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 欣然宣佈,本集團自主研發的創新藥CMS-D005注射液(「CMS-D005」)於二零二四 年十一月二十七日獲得中國國家藥品監督管理局(「NMPA」)簽發的藥物臨床試驗批 准通知書。NMPA同意本集團在中國健康以及超重和肥胖成人受試者中開展評價 CMS-D005安全性、耐受性及藥代動力學和藥效學特徵的臨床試驗。 CMS-D005 CMS-D005是高活性、高選擇性的胰高血糖素樣肽-1受體(GLP-1R)和胰高血糖素受體 (GCGR)雙重激動劑,激動胰高血糖素樣肽-1(GLP-1)途徑可中樞性抑制食慾,減 少攝食,同時抑制胃排空,增加飽食感以達到減重的作用,GLP ...
康哲药业(00867) - 自愿性及业务进展公告 磷酸芦可替尼乳膏(白癜风适应症)香港新药上市申请获...
2024-11-05 14:25
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的內容概不負責,對其 準確性或完整性亦不發表任何聲明,並表明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。 自願性及業務進展公告 磷酸蘆可替尼乳膏(白癜風適應症)香港新藥上市申請獲批 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集團」) 欣然宣佈,中華人民共和國香港特別行政區(「香港」)政府藥劑業及毒藥管理局(PPBHK) 已於二零二四年十一月四日批准磷酸蘆可替尼乳膏(「蘆可替尼乳膏」或「產品」)新 藥上市申請,於二零二四年十一月五日收到藥品/製品註冊證明書。產品用於治療12歲及 以上青少年和成人患者伴面部受累的非節段型白癜風。 關於蘆可替尼乳膏 急需進口,並於八月十八日正式落地海南博鰲樂城國際醫療旅遊先行區,用於治療12歲 及以上青少年和成人患者伴面部受累的非節段型白癜風。受益於國家賦予海南自由貿易 港、海南博鰲樂城國際醫療旅遊先行區「先行先試」特許政策,中國白癜風患者可在博 鰲超級醫院先行申請使用產品並接受專家團隊的治療。此外,蘆可替尼乳膏亦於 ...