LXH-1211片是针对肺动脉高压的临床表现和疾病病理本质设计的结构全新的化合物。研究显示LXH- 1211具有双重作用机制，既能通过刺激可溶性鸟苷酸环化酶(sGC)产生血管舒张效应，降低肺动脉高 压，也能通过抑制AMP-激活蛋白激酶(AMPK)阻止血管重构和纤维化进程。本品拟定的临床适应症为 治疗肺动脉高压。 智通财经APP讯，山东新华制药股份(00719)发布公告，近日，公司收到国家药品监督管理局核准签发的 LXH-1211片《药物临床试验批准通知书》。 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年7 月10 日受理的LXH-1211 片临床试 验申请符合药品注册的有关要求，同意本品开展肺动脉高压的临床试验。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets, aimed at treating pulmonary arterial hypertension [1] Group 1: Clinical Trial Approval - The clinical trial application for LXH-1211 was accepted on July 10, 2025, and the drug has been approved for clinical trials targeting pulmonary arterial hypertension [1] - The approval process included a communication meeting request submitted in September 2024, with feedback received in December 2024, leading to the final approval in September 2025 [1] Group 2: Drug Mechanism and Design - LXH-1211 is a novel compound specifically designed for the clinical manifestations and pathological essence of pulmonary arterial hypertension [1] - The drug exhibits a dual mechanism of action: it stimulates soluble guanylate cyclase (sGC) to induce vasodilation and lowers pulmonary arterial pressure, while also inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis [1]

新华制药公告，近日，公司收到国家药品监督管理局核准签发的 LXH-1211 片《药物临床试验批准通知 书》。药品名称为 LXH-1211 片，剂型为片剂，规格为 0.5mg；1mg；2mg；5mg，药品分类为处方药， 注册分类为化学药品 1 类。审批结论为根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 7 月 10 日受理的 LXH-1211 片临床试验申请符合药品注册的有关要求，同意本品开展肺动脉高压的 临床试验。 ...

Financial Performance - The company's operating revenue for the six months ended June 30, 2025, was approximately RMB 4.64 billion, a decrease of 1.98% compared to RMB 4.73 billion for the same period in 2024[10]. - Total profit for the same period was RMB 263.53 million, down 13.13% from RMB 303.36 million year-on-year[10]. - Net profit attributable to shareholders of the listed company was RMB 223.76 million, reflecting a decline of 15.69% from RMB 265.40 million in the previous year[10]. - The basic earnings per share for the first half of 2025 was RMB 0.32, down 17.95% from RMB 0.39 in the same period last year[10]. - The weighted average return on net assets decreased by 1.25 percentage points to 4.33% compared to 5.58% in the previous year[10]. - The total revenue for the reporting period was RMB 4.64 billion, a decrease of 1.98% year-on-year, with a gross profit margin of 20.04%[86]. - The consolidated operating revenue for the first half of 2025 was RMB 4,638,804,042.98, a decrease from RMB 4,732,481,467.24 in the same period last year, representing a decline of approximately 1.97%[127]. - The consolidated net profit for the first half of 2025 was RMB 231,168,471.79, down from RMB 272,766,347.86 in the previous year, indicating a decrease of about 15.25%[127]. Cash Flow and Liquidity - The net cash flow from operating activities increased significantly by 202.49%, reaching RMB 234.13 million compared to RMB 77.40 million in the same period last year[10]. - Cash inflow from operating activities is RMB 3.88 billion, down from RMB 4.13 billion in the previous period, reflecting a decrease of approximately 6.0%[130]. - Cash outflow for purchasing goods and services is RMB 2.78 billion, compared to RMB 2.92 billion in the previous period, showing a reduction of about 4.7%[130]. - The net increase in cash and cash equivalents for the current period is RMB 26.96 million, a significant decrease from RMB 69.24 million in the previous period[132]. - The ending balance of cash and cash equivalents is RMB 1.16 billion, up from RMB 850.92 million in the previous period, reflecting an increase of approximately 36.3%[132]. Assets and Liabilities - Total assets as of June 30, 2025, amounted to RMB 9.24 billion, representing a 2.42% increase from RMB 9.02 billion at the end of the previous year[10]. - Total liabilities increased by 1.86% to RMB 3.87 billion from RMB 3.80 billion at the end of the previous year[10]. - The current ratio as of June 30, 2025, was 126.64%, indicating a decrease from the previous year, while the quick ratio remained stable at 87.66%[88]. - The debt-to-asset ratio was 41.92%, reflecting the company's financial leverage as of June 30, 2025[94]. - The total current liabilities reached RMB 3,152,193,045.88, up from RMB 2,795,614,112.39, indicating an increase of approximately 12.78%[126]. Shareholder Information - The largest shareholder, China Hualu Holdings Group Co., Ltd., holds 29.70% of the shares, totaling 204,864,092 shares[21]. - The second largest shareholder, Hong Kong Central Clearing (Agent) Co., Ltd., holds 28.03% of the shares, totaling 193,314,037 shares[21]. - As of June 30, 2025, the total number of shareholders is 76,508, including 40 H-share shareholders and 76,468 A-share shareholders[22]. - The top ten unrestricted shareholders collectively hold significant stakes, with the largest three shareholders accounting for 63.11% of the total shares[24]. - The company has not experienced any changes in its controlling shareholder or actual controller during the reporting period[26]. Employee and Management Compensation - As of June 30, 2025, the total number of employees in the group is 7,159, with a total salary expenditure of RMB 378,972 thousand for the half-year period[35]. - The actual remuneration paid to directors, supervisors, and senior management during the reporting period amounts to RMB 2,255,934, with the exercised stock options valued at RMB 5,978,758.50[33]. - The remuneration for directors and supervisors is determined based on national policies, company economic performance, and individual work performance[33]. Research and Development - Research and development expenses decreased by 12.56% to RMB 202,782,438.85 from RMB 231,912,142.60 in the previous year[78]. - The company aims to obtain more than 10 new product approvals for raw materials and formulations in the second half of the year[64]. - The company is enhancing its R&D innovation system and focusing on developing high-value products to mitigate R&D risks associated with new drug development[98]. Market and Product Development - A total of 10 new formulation products were launched in the first half of the year, with 19 products and 25 specifications winning bids in national centralized procurement[56]. - The company obtained 21 drug approvals in the first half of the year, including 19 new formulation products and 2 raw material drug approvals[58]. - The company plans to develop key markets in South America and potential markets in the Middle East and Africa, focusing on specialty raw materials[63]. Stock Options and Incentives - The company granted a total of 23.15 million stock options under the 2021 A-share stock option incentive plan, with an exercise price of RMB 7.96 per share[39]. - The fair value of the initially granted stock options was calculated at RMB 5.31 per option, resulting in a total option cost of RMB 122.93 million[44]. - The company’s stock options incentive plan has resulted in the issuance of 772.48 million shares, with the first exercise date set for January 15, 2024[143]. Compliance and Risk Management - The company faces risks from industry policy changes, particularly in the pharmaceutical manufacturing sector, which may impact R&D, production, and sales[97]. - The company is monitoring bidding dynamics and adjusting strategies to address potential price reduction pressures on approved drugs[98]. - The company is committed to complying with environmental regulations and increasing investment in environmental protection measures to mitigate environmental risks[98]. Financial Reporting and Accounting - The company's financial statements are prepared in accordance with the Chinese Accounting Standards and are based on the going concern assumption[146]. - The financial statements comply with the requirements of the enterprise accounting standards, accurately reflecting the group's financial position as of June 30, 2025[149]. - Significant individual provisions for bad debts are recognized when the amount exceeds RMB 5 million[153].

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之任何損失承擔任何責任。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited （於中華人民共和國註冊成立之股份有限公司） （股份代碼：00719） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條作出。 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2025 年 9 月 26 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得藥物臨床試驗批准通知書的公告》,茲載列有 關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2025年9月25日 於本公告日期，本公司董事會之成員如下： | 執行董事： | 獨立非執行董事： | | --- | --- | | 賀同慶先生（董事長） | 潘廣成先生 | | 徐文輝先生 ...

Core Viewpoint - Recently, Xinhua Pharmaceutical received approval from the National Medical Products Administration for the registration certificate of Citrate Sildenafil Oral Disintegrating Tablets [2] Company Summary - Xinhua Pharmaceutical has announced the receipt of a drug registration certificate for Citrate Sildenafil Oral Disintegrating Tablets, indicating a significant regulatory milestone for the company [2]

Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Ursodeoxycholic Acid Capsules through its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd [2] Group 2 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio and market presence in the pharmaceutical industry [2] - The registration certificate may lead to increased sales and revenue opportunities for the company, as Ursodeoxycholic Acid is used in various therapeutic applications [2] - This development reflects the company's ongoing commitment to expanding its pharmaceutical offerings and adhering to regulatory standards [2]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for its Ursodeoxycholic Acid Capsules, which will enhance its product offerings in the digestive system medication sector [1] Group 1: Product Approval - The approval pertains to Ursodeoxycholic Acid Capsules, which are indicated for the treatment of cholesterol gallstones, cholestatic liver diseases, and bile reflux gastritis [1] - The product is specifically for X-ray penetrable gallstones and requires normal gallbladder contraction function [1] Group 2: Strategic Implications - The approval is expected to enrich the company's range of digestive system medications, thereby improving its overall competitiveness in the pharmaceutical market [1] - The product is anticipated to be officially approved by September 2025, indicating a future growth opportunity for the company [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the registration certificate of Ursodeoxycholic Acid Capsules, indicating a significant development in its product portfolio [1] Group 1: Product Details - Ursodeoxycholic Acid Capsules are classified as a Class 4 chemical drug with a specification of 250mg [1] - The drug is indicated for the treatment of cholesterol gallstones (specifically those that are X-ray penetrable and with normal gallbladder contraction function) [1] - It is also used for cholestatic liver diseases such as primary biliary cirrhosis and for bile reflux gastritis [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Sildenafil Citrate Orally Disintegrating Tablets, which are used to treat erectile dysfunction [1] Group 2 - The approval signifies a potential expansion in the company's product offerings in the pharmaceutical market [1] - Sildenafil Citrate is a well-known medication, and its approval may enhance the company's competitive position in the treatment of erectile dysfunction [1]