Core Viewpoint - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received approval for Finasteride tablets, which are indicated for the treatment of benign prostatic hyperplasia (BPH) and prevention of urinary system events, enhancing the company's product portfolio and market opportunities [2] Group 1: Product Approval and Market Impact - Xinda Pharmaceutical has been granted a drug registration certificate for Finasteride tablets by the National Medical Products Administration [2] - The Finasteride tablets are classified as a Category B drug under the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [2] - The estimated sales revenue for Finasteride tablets in Chinese public medical institutions is approximately RMB 1.45 billion in 2024 [2] Group 2: Strategic Implications - The approval of Finasteride tablets is expected to enrich the company's product line and explore new market segments [2] - The pharmaceutical sales business is subject to uncertainties due to potential changes in domestic pharmaceutical policies and market conditions [2]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Finasteride tablets, which will enhance its product portfolio and open new market opportunities [1] Group 1 - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Finasteride tablets from the National Medical Products Administration [1] - The registration certificate for Finasteride tablets was granted in August 2025, indicating a future product launch [1] - This development is expected to contribute positively to the company's growth by diversifying its product offerings [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Finasteride tablets, which are used to treat benign prostatic hyperplasia (BPH) and prevent urinary system events [1] Company Summary - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., is responsible for the newly approved Finasteride tablets [1] - Finasteride tablets are indicated for reducing the risk of acute urinary retention and the need for surgical procedures such as transurethral resection of the prostate (TURP) and prostatectomy [1] - The medication is designed to shrink enlarged prostates, improve urinary flow, and alleviate symptoms associated with prostatic hyperplasia [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 8 月 6 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於子公司獲得非那雄胺片藥品註冊證書的公告》, 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8月5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 ...

FF301 致：香港交易及結算所有限公司 公司名稱: 山東新華製藥股份有限公司 呈交日期: 2025年8月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00719 | 說明 | H股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 195,000,000 | RMB | | 1 | RMB | | 195,000,000 | | 增加 / 減少 (-) | | | | | | | RMB | | | | 本月底結存 | | | 195,000,000 | RMB | | 1 | RMB | | 195,000,000 | | 2. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. actively participated in a voluntary blood donation campaign, demonstrating corporate social responsibility and employee engagement [1] Group 1: Company Initiatives - The company organized a blood donation event involving its first and second plants and the security department, showcasing a collective effort to contribute to society [1] - A total of 103 employees participated in the blood donation, contributing 38,450 milliliters of blood, highlighting the company's commitment to social causes [1] Group 2: Employee Engagement - Employees expressed a sense of fulfillment and purpose in donating blood, with one employee mentioning he has donated four times and plans to continue annually [1] - The event fostered a sense of community and solidarity among employees, reinforcing the company's internal cohesion and shared values [1]

Group 1 - The core stock price of Xinhua Pharmaceutical (000756) closed at 17.07 yuan, down 0.93% with a turnover rate of 5.31% and a trading volume of 261,800 hands, amounting to 451 million yuan [1] - The latest financial report for Q1 2025 shows total revenue of 2.43 billion yuan, a year-on-year decrease of 1.81%, and a net profit attributable to shareholders of 112 million yuan, down 20.99% year-on-year [1] - The company has a current ratio of 1.236, a quick ratio of 0.872, and a debt-to-asset ratio of 41.86% [1] Group 2 - Xinhua Pharmaceutical has made investments in 19 companies and participated in 5,000 bidding projects [2] - The company holds 402 trademark registrations and 521 patent registrations, along with 855 administrative licenses [2]

Group 1 - The core viewpoint of the article highlights that Xinhua Pharmaceutical is one of the major global manufacturers of antipyretic and analgesic drugs [2] - The company provided information about its product catalog, which can be accessed on its official website [2] Group 2 - The company actively engages with investors through platforms to address inquiries [2] - The focus on antipyretic and analgesic drugs indicates a strategic positioning within the pharmaceutical industry [2]

证券日报网讯新华制药7月29日在互动平台回答投资者提问时表示，公司围绕心脑血管类、解热镇痛 类、消化系统类、抗代谢类、神经系统等12个方向开展研发工作，包括创新药物和仿制药。进入研发管 线的药物有100多个。在创新药领域已构建多个大研发平台（如新型给药系统、小分子创新等），在研 产品包括进入Ⅱ期临床的OAB14（用于阿尔茨海默病治疗）等多个创新药物进展顺利。 （文章来源：证券日报） ...

Core Viewpoint - The article discusses the challenges and opportunities faced by Xinhua Pharmaceutical as it enters the competitive market for the drug Maleate Avatrombopag, highlighting its recent licensing change and the pressures on its financial performance and R&D efforts [2][12]. Financial Performance - In 2024, Xinhua Pharmaceutical reported a revenue of 8.466 billion yuan, a year-on-year increase of 4.51%, marking a historical high, but its net profit fell by 5.33% to 470 million yuan, indicating a "revenue increase without profit increase" phenomenon for the first time since 2013 [7][11]. - The company's revenue sources in 2024 included 4.072 billion yuan from formulations, 2.736 billion yuan from chemical raw materials, and 1.658 billion yuan from intermediates, with significant declines in gross margins across these categories [7][11]. - In Q1 2025, Xinhua's revenue was 2.43 billion yuan, down 1.81% year-on-year, and net profit decreased by 20.99% to 112 million yuan [8]. R&D Investment - Xinhua's total R&D investment in 2024 was 397 million yuan, a decrease of 2.23% from the previous year, with R&D expenditure accounting for 4.69% of revenue, down 0.32 percentage points [9][12]. - Despite a reduction in R&D spending, the company achieved several product approvals, including 7 products with 9 specifications receiving consistency evaluation [8][9]. Market Competition - The market for Maleate Avatrombopag is highly competitive, with 18 companies, including Fosun Pharma and others, vying for market share through price competition and channel expansion [4][5]. - The original drug, Su Ke Xin® by Fosun Pharma, has a first-mover advantage and has been included in the national medical insurance catalog, further intensifying competition [4][5]. Strategic Opportunities - Xinhua's acquisition of the Maleate Avatrombopag marketing license is seen as a potential opportunity to enhance its product portfolio in blood system disease medications and improve its competitive edge [12]. - The company needs to focus on optimizing its product structure and increasing R&D investment to maintain innovation and competitiveness in the market [12].