其他全面收入 其後可能重新分類至損益的項目： －換算海外業務產生的匯兌差額 94 | --- | --- | |-----------------|-----------------| | (293) | | | (211,527) | (203,413) | | 人民幣元 (0.22) | 人民幣元 (0.21) | 年內全面開支總額 每股虧損 10 基本及攤薄 16 綜合財務狀況表 | --- | --- | --- | --- | |-----------------------------------------------------------------------------------------|-------------------|------------------------------------------------|----------------------------------------------| | | 附註 | 於 2023 年 12 月 31 日 人民幣千元 （經審核） | 於 2022 年 12 月 31 日 人民幣千元 （經審核） | | 非流動資產 ...

我們主要在中國經營業務，大部分交易以人民幣結算，且我們的財務報表以人民幣呈列。人民幣並非可自由轉換貨 幣。中國人民銀行轄下機關國家外匯管理局對人民幣轉換為外幣實行管控。人民幣價值受中央政府政策及影響中國外 匯交易中心市場供需的國際經濟及政治發展的變動所影響。我們認為，我們現時並無任何重大直接外匯風險，且並無 使用任何衍生金融工具對沖有關風險。 下表載列截至所示日期我們的主要財務比率： 根據上市規則第13.20條至第13.22條的披露 首次公開發售前股份獎勵計劃的重大條款詳情載於本公司截至2022年12月31日止年度的年報，以及於報告期內根據 首次公開發售前股份獎勵計劃（將以現有股份支付）授出的未行使購股權變動詳情將載於本公司截至2023年12月31日 止年度的年報。 (4) 根據吾等的審閱，吾等並無發現任何事項，令吾等認為，簡明綜合財務報表在各重大方面未有根據國際會計準則第34 號編製。 持有的 1.1 一般資料 截至6月30日止六個月 31 華領醫藥 | --- | --- | --- | |--------------------------------------|------------------- ...

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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 截至2023年6月30日止六個月的中期業績公告 | --- | --- | |-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

中國建設銀行股份有限公司上海張江分行 中國上海科苑路232號 | --- | |----------------------------------| | | | 招商銀行股份有限公司臨港藍灣支行 | | 上海臨港區雲櫻路 271 號 | | 本公司網站 | | www.huamedicine.com | | 股份代號 | | 2552 | 華領醫藥 年度報告 2022 4 業務及財務摘要 業務摘要 • 於2022年10月，我們收到中國國家藥品監督管理局(NMPA)就華堂寧®（又名dorzagliatin）的商業批准發出的正式 通知。華堂寧®是全球範圍內首個獲批上市的葡萄糖激酶激活劑(GKA)藥物。 • 華堂寧®獲批兩個適應症，用於改善2型糖尿病(T2D)患者的血糖控制，即單獨用藥治療T2D患者，或者在單獨使 用二甲雙胍血糖控制不佳時，與二甲雙胍聯合使用，以控制成人T2D患者的血糖水平。 • 此外，華堂寧®的批准包含三項許可。對於慢性腎病(CKD)及2型糖尿病（即糖尿病腎病）患者，無需調整劑 量。華堂寧®聯合恩格列淨（SGLT-2抑制劑）或西格列汀（DPP-4抑制劑），聯合用藥的效果優於單獨用藥， 有望更好地 ...

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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 截至2022年12月31日止年度的年度業績公告 | --- | --- | |-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 業務摘要 | | • | 於 2022 年 10 月，我們收到中國國家藥品監督管理局 (NMPA) 就 華堂寧 ® （又 名 dorzagliatin ）的商業批准發出的正式通知。 華堂寧 ...

Hua Medicine 華領醫藥 ( 於開曼群島註冊成立的有限公司 ) 股份代號 : 2552 2022 中期報告 目錄 頁次 公司資料 2 業務與財務摘要 4 管理層討論及分析 6 簡明綜合財務報表審閱報告 20 簡明綜合損益及其他全面收益表 21 簡明綜合財務狀況表 22 簡明綜合權益變動表 23 簡明綜合現金流量表 24 簡明綜合財務報表附註 26 其他資料 43 釋義 49 中期報告 2022 2 | --- | --- | |-------------------------------------------|-----------------------------------------------| | | 公司資料 | | 執行董事 | 戰略委員會 | | 陳力 （行政總裁及首席科學官） | 陳力 （主席） | | 林潔誠 （執行副總裁及首席財務官） | Robert Taylor NELSEN 劉峻嶺 | | 非執行董事 | 公司秘書 | | Robert Taylor NELSEN （主席） | | | 趙瑋（於 2022 年 3 月 16 日獲委任） | 袁頴欣 | | 陳連勇（於 ...

Hua Medicine 同 （於開曼群島註冊成立的股份有限公司 ) 股份代號 :2552 F3.5 ISO 100 L Human RIMIN FINANIA 年 報 2021 目錄 頁次 公司資料 2 業務及財務摘要 4 主席及行政總裁報告書 6 管理層討論及分析 8 董事及高級管理層 18 董事會報告 26 企業管治報告 50 獨立核數師報告 66 綜合損益及其他全面收益表 70 綜合財務狀況表 71 綜合權益變動表 73 綜合現金流量表 74 綜合財務報表附註 76 五年財務概要 136 釋義 138 華領醫藥 年度報告 2021 2 公司資料 | --- | --- | |--------------------------------------------|-------------------------------------------------------------------| | | | | 執行董事 | 戰略委員會 | | 陳力 （行政總裁及首席科學官） | 陳力 （主席） | | 林潔誠 （執行副總裁及首席財務官） | Robert Taylor NELSEN 劉峻嶺 | | ...

CI 1835 Hua Medicine 華領醫藥 ( 於開曼群島註冊成立的有限公司 ) 股份代號 : 2552 N 2 2 2 0 1 2 2 2 1 2021 中 期 報 告 目錄 | --- | --- | |------------------------------|-------| | | 頁次 | | 公司資料 | 2 | | 財務摘要 | 4 | | 管理層討論及分析 | 5 | | 簡明綜合財務報表審閱報告 | 18 | | 簡明綜合損益及其他全面開支表 | 19 | | 簡明綜合財務狀況表 | 20 | | 簡明綜合權益變動表 | 21 | | 簡明綜合現金流量表 | 22 | | 簡明綜合財務報表附註 | 24 | | 其他資料 | 41 | | 釋義 | 49 | 中期報告 2021 2 | --- | --- | |-----------------------------------|------------------------------------------------------------------| | | 公司資料 | | 執行董事 | 戰略委員會 | | 陳力 ...

Financial Performance - Total expenses for the year ended December 31, 2020, were approximately RMB 367.2 million, with about RMB 221.0 million allocated for R&D expenses[3]. - Pre-tax loss decreased by approximately RMB 32.1 million or about 8% to approximately RMB 393.1 million for the year ended December 31, 2020[3]. - Total loss and comprehensive expenses for the year decreased by approximately RMB 31.7 million or about 7% to approximately RMB 393.6 million[3]. - Other income decreased from RMB 296 million in 2019 to RMB 159 million in 2020, primarily due to a reduction in government subsidies[30]. - The company reported a loss of RMB 418 million in other income and losses due to currency fluctuations, compared to a gain of RMB 163 million in the previous year[31]. - The company has not generated any revenue from product sales or services, relying instead on government subsidies and interest income[28]. - The company anticipates significant losses in the foreseeable future until the commercialization of dorzagliatin is achieved[28]. - Administrative expenses decreased from RMB 146.6 million in 2019 to RMB 140.1 million in 2020, primarily due to a reduction in share-based payment costs by RMB 10.6 million[33]. - Operating cash flow used was RMB 20.9 million in 2020, compared to RMB 342.1 million in 2019, indicating a significant reduction in cash outflow[42][43]. - The company’s net current assets decreased from RMB 1,011.7 million as of December 31, 2019, to RMB 938.7 million as of December 31, 2020[46]. Research and Development - Total expenses for the year ended December 31, 2020, were approximately RMB 367.2 million, with about RMB 221.0 million allocated for R&D expenses[3]. - R&D expenses decreased by approximately RMB 100.9 million or about 31% to approximately RMB 221.0 million for the year ended December 31, 2020[3]. - The company is advancing the fructose kinase inhibitor (FKI) project to strengthen its drug discovery pipeline[10]. - The company has completed eight Phase I clinical trials in China and four in the U.S., with two Phase II and two Phase III trials conducted in China, recruiting a total of 1,230 patients[11]. - The company is evaluating the combination of dorzagliatin with GLP-1R agonists and insulin in T1D and late-stage T2D patients[10]. - The company is developing a globally innovative oral drug for diabetes treatment, Dorzagliatin (HMS5552), which is a glucose kinase activator aimed at restoring glucose homeostasis in Type 2 Diabetes patients[83]. - The company has invested significant resources to ensure the quality and development of Dorzagliatin, with key registration trials ongoing in China[148]. - The company has a limited operating history and has incurred losses, requiring necessary regulatory approvals to generate revenue from Dorzagliatin[148]. Clinical Trials and Regulatory Approvals - Completed two large Phase III registration trials in China with a total of over 1,200 patients across 110 hospitals, demonstrating the efficacy of dorzagliatin in lowering blood glucose levels[4]. - The first 52-week study results showed that dorzagliatin effectively reduced blood glucose levels while exhibiting safety and tolerability[4]. - In 2020, the company announced successful completion of the Phase III SEED trial for dorzagliatin, demonstrating sustained efficacy over 52 weeks with a very low incidence of hypoglycemic events[5]. - The Phase III DAWN trial also achieved its primary efficacy endpoint, showing good safety and low hypoglycemic event rates in T2D patients inadequately controlled on maximum tolerated doses of metformin[6]. - The combined results of SEED and DAWN trials confirmed dorzagliatin's clinical advantages in glycemic control and insulin sensitivity compared to existing therapies[7]. - The company received drug production licenses from Chinese regulatory authorities, allowing for the submission of the NDA in 2021[5]. - The company aims to submit the NDA for dorzagliatin in China in 2021 and establish commercial partnerships for global distribution[10]. - Dorzagliatin's NMPA NDA submission process is complex and costly, with potential additional research required even if Phase III results are successful[143]. - Delays in clinical trial recruitment and completion may increase costs and hinder regulatory approval for Dorzagliatin[144]. Partnerships and Collaborations - Achieved commercial cooperation agreements with Bayer Healthcare in mainland China and established a commercial supply agreement with Zhejiang Ruibo Pharmaceutical[3]. - The company announced a strategic partnership with Bayer AG to promote dorzagliatin in the Chinese market, leveraging Bayer's 20+ years of experience in the diabetes sector[5]. - The company has entered a commercial cooperation agreement with Bayer, receiving an upfront payment of RMB 300 million and potential milestone payments up to RMB 4.18 billion[152]. Financial Position and Cash Flow - Cash and cash equivalents as of December 31, 2020, were RMB 1,032.1 million[39]. - The company's lease liabilities amounted to RMB 80.7 million as of December 31, 2020, down from RMB 90.0 million as of December 31, 2019[48]. - The current ratio decreased from 10.3 to 9.8, and the quick ratio also decreased from 10.3 to 9.8 as of December 31, 2020, attributed to research activities and operational costs[56]. - The company has raised funds through multiple rounds of overseas financing, receiving funds in USD, HKD, and RMB[51]. - The company has no other debt obligations apart from lease liabilities as of December 31, 2020[48]. Governance and Management - The board of directors consists of two executive directors, two non-executive directors, and four independent non-executive directors, ensuring compliance with listing rules regarding independent directors[159][162]. - The company has established a compensation committee to formulate a remuneration policy for directors and senior management based on performance and market practices[104]. - The independent non-executive directors confirmed their independence according to the guidelines set out in the listing rules[109]. - The board believes it has complied with all applicable code provisions during the reporting period, maintaining high corporate governance standards[157]. - The company has established clear written terms of reference for all board committees to define their powers and responsibilities[168]. Shareholder Communication and Relations - The company has established a shareholder communication policy to ensure shareholder opinions and concerns are properly addressed[194]. - The company is committed to continuous communication with shareholders, particularly through annual general meetings[192]. - The company emphasizes the importance of effective communication with shareholders to enhance investor relations[192]. Stock Options and Employee Incentives - The total unexercised stock options as of December 31, 2020, amounted to 126,128,867[134]. - The total stock options granted during 2020 were 10,255,000, while 3,817,764 options were exercised[134]. - The company has a stock option plan effective for 10 years from the IPO date, expiring on September 14, 2028[133]. - The company granted a total of 7,422,975 restricted shares to an executive under the pre-IPO share incentive plan, with 1,855,752 units vested by the end of the fiscal year 2020[141]. Risks and Challenges - The company faces various risks and uncertainties that could impact its performance and operations, including inherent risks in the pharmaceutical industry[142]. - The company relies on third-party CROs and SMOs for clinical trials, and any performance issues could adversely affect business operations[145]. - Dorzagliatin's potential adverse side effects as a monotherapy or in combination with other T2D treatments may delay regulatory approval[146].

H Hua Medicine 華領醫藥 ( 於開曼群島註冊成立的有限公司 ) 股份代號： 2552 中期報告 2020 ATP 目錄 頁次 公司資料 2 財務摘要 4 管理層討論及分析 5 簡明綜合財務報表審閱報告 20 簡明綜合損益及其他全面開支表 21 簡明綜合財務狀況表 22 簡明綜合權益變動表 23 簡明綜合現金流量表 24 簡明綜合財務報表附註 26 其他資料 44 釋義 51 g7t 中期報告 2020 2 郭德明（主席） William Robert KELLER 徐耀華（於2020年6月25日獲委任） 陳連勇（於2020年6月25日不再為成員） | --- | --- | |-----------------------------------|-----------------------| | | 公司資料 | | 執行董事 | 戰略委員會 | | 陳力 （行政總裁兼首席科學官） | 陳力 （主席） | | 林潔誠 （執行副總裁兼首席財務官） | Robert Taylor NELSEN | | 非執行董事 | 劉峻嶺 | | Robert Taylor NELSEN （主席） | 公司秘 ...