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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 ...
康哲药业:链接医药创新与商业化,新康哲新崛起
Southwest Securities· 2024-10-14 12:10
Investment Rating - The report does not specify a clear investment rating for 康哲药业 (0867.HK) [1]. Core Insights - The company has shown signs of a performance turnaround, with a 8.9% quarter-on-quarter increase in drug sales revenue and a 92.8% increase in profit for the first half of 2024 [2][19]. - The successful NDA approval of Lucozine cream positions it as the first domestic drug for treating vitiligo, targeting a significant market of 14 million existing patients [2][11]. - The company is entering a harvest period in its innovation transformation, with five innovative drugs launched and over ten self-research projects progressing steadily [2][11]. Summary by Sections 1. Performance Turnaround - The impact of centralized procurement has largely dissipated, with a notable improvement in performance indicators. The first half of 2024 saw a drug sales revenue of 12.3 billion yuan from three national procurement products, reflecting a 49.2% decline, but the negative effects are expected to lessen moving forward [2][19]. - The company reported a revenue of 42.9 billion yuan in the first half of 2024, down 22.6% year-on-year, but with a quarter-on-quarter improvement in both revenue and profit [19]. 2. Innovation Pipeline - 康哲药业 has made significant strides in its innovation strategy, with over 30 innovative products, primarily First-in-Class (FIC) and Best-in-Class (BIC) drugs. Five innovative drugs have been launched, including Diazepam nasal spray and Treziq monoclonal antibody injection [2][11]. - The company has ten self-research projects in progress, with three innovative drugs entering clinical development [2][11]. 3. Market Potential - The Lucozine cream targets a large unmet clinical need in the vitiligo market, with 14 million patients in China. It is the only drug approved globally for this indication [2][11]. - The company’s product lines include cardiovascular, digestive, ophthalmology, and dermatology, with a strong market presence across over 55,000 hospitals and approximately 280,000 retail pharmacies in China [11][19]. 4. Financial Forecast - The company’s projected revenues for 2024, 2025, and 2026 are 78.9 billion yuan, 88.9 billion yuan, and 98 billion yuan, respectively [3][4].
康哲药业:24年上半年环比重回增长
Investment Rating - The report assigns a "Buy" rating to the company with a target price of HKD 11.3, indicating a potential upside of 50.4% from the current price [2][3]. Core Insights - The company experienced a 6.1% quarter-on-quarter revenue growth in the first half of 2024, although year-on-year revenue decreased by 21.7% to RMB 3.61 billion [2]. - The sales of three national procurement products saw a significant decline of 49.2% year-on-year, while revenue from exclusive and innovative products reached RMB 2.41 billion, accounting for 56% of total revenue [2]. - The company is expected to see a gradual improvement in performance starting from the second half of 2024, driven by the commercialization of innovative products [2]. Financial Summary - Revenue for 2022 was RMB 9.15 billion, with a projected decline to RMB 8.01 billion in 2023 and further to RMB 7.60 billion in 2024, before recovering to RMB 8.75 billion in 2025 and RMB 9.83 billion in 2026 [4]. - The net profit attributable to shareholders is forecasted to decrease from RMB 3.26 billion in 2022 to RMB 2.40 billion in 2023, and further to RMB 1.75 billion in 2024, before increasing again in subsequent years [4]. - The company plans to launch 10-12 new drugs between 2025 and 2027, with a focus on innovative products that are expected to contribute significantly to revenue [2].
康哲药业:石以砥焉,化钝为利,老牌商业化龙头创新转型
Huaan Securities· 2024-09-26 00:37
Investment Rating - The report assigns a "Buy" rating for the company [1]. Core Views - The company is undergoing a successful transformation from a traditional pharmaceutical agent to an innovative drug enterprise, with multiple products launched in recent years [1]. - The company has increased its focus on self-research and innovation, aiming to change its product structure and has successfully launched five innovative drugs since 2023 [1]. - The company maintains market advantages with its exclusive products despite pressures from centralized procurement policies [1]. - The emerging ophthalmology and dermatology businesses are gaining scale, and international operations in Southeast Asia are expanding [1]. Summary by Sections Company Overview - The company is transitioning from a single-agent operation to an innovative pharmaceutical company, managing the entire product lifecycle through various means such as equity investments and strategic partnerships [6][16]. - It has a diverse portfolio covering cardiovascular, digestive, ophthalmology, and dermatology fields, with over 30 innovative products in development [6][16]. Financial Performance - The company experienced a revenue decline of 12.4% in 2023, with a further 21.7% drop in the first half of 2024 due to the impact of centralized procurement [19]. - Revenue is projected to recover with expected growth rates of -4%, 18%, and 21% from 2024 to 2026, respectively [1][19]. - Net profit is forecasted to decline by 28% in 2024 but is expected to grow by 22% and 31% in the following years [1][19]. Product Pipeline and Market Position - The company has launched several innovative products, including the first subcutaneous methotrexate injection for psoriasis and a novel monoclonal antibody for psoriasis treatment [10][19]. - The company has established a strong academic promotion team and a wide distribution network, covering over 55,000 hospitals and more than 280,000 retail pharmacies in China [17]. - The company’s innovative product pipeline includes 30 products, with five already approved for the Chinese market and more in clinical trials [17][19].