Core Viewpoint - The announcement highlights that Changchun High-tech Industry (Group) Co., Ltd.'s subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of GenSci141 ointment from the National Medical Products Administration, indicating progress in the company's drug development efforts [1][3]. Group 1: Drug Information - Product Name: GenSci141 Ointment [1] - Application Type: Domestic production drug registration clinical trial [1] - Acceptance Numbers: CXHL2501394, CXHL2501395, CXHL2501396, CXHL2501397 [1] - Indications: Used to improve conditions related to hypergonadotropic hypogonadism, 5α-reductase type 2 deficiency, congenital adrenal hyperplasia due to reduced androgen synthesis, and idiopathic causes leading to micropenis in children [1]. Group 2: Drug Characteristics - GenSci141 ointment is a dihydrotestosterone ointment developed by Jinsai Pharmaceutical, primarily functioning through paracrine action in target tissues, classified as chemical drugs of categories 2.2 and 2.4 [2]. Group 3: Company Impact - If the clinical trial application progresses smoothly, it will help the company broaden its business structure, optimize its product structure, enrich its strategic product line, and enhance its core competitiveness [3]. - The company will actively promote the research and development of the project and fulfill its information disclosure obligations regarding subsequent progress [4].

Core Viewpoint - Beijing Zhongguancun Science and Technology Development (Holding) Co., Ltd. announced the withdrawal of the drug registration application for Acetaminophen and Oxycodone Tablets by its subsidiary Beijing Huasu Pharmaceutical Co., Ltd. to further improve the application materials [1][2]. Group 1: Basic Information - The drug name is Acetaminophen and Oxycodone Tablets, with a registration number of CYHS2404364 and a notification number of 2025L00518 [1]. - The National Medical Products Administration (NMPA) issued a termination notice agreeing to withdraw the registration application based on the applicant's request [1]. Group 2: Reasons for Withdrawal and Future Plans - The decision to withdraw the application was made after careful consideration, with plans to resubmit the application after improving the relevant research [2]. Group 3: Impact on the Company - The project for Acetaminophen and Oxycodone Tablets has seen a total investment of 8.861 million yuan, with 5.5371 million yuan capitalized and 3.3239 million yuan expensed as of the announcement date [3]. - The withdrawal of the drug registration application will not impact the company's current financial status or operating performance [4].

Core Viewpoint - Changchun Gaoxin's subsidiary, Jinsai Pharmaceutical, has received the acceptance notice for the clinical trial application of GenSci141 ointment from the National Medical Products Administration, indicating a potential expansion in the company's product line and core competitiveness [1] Group 1: Clinical Trial Approval - Jinsai Pharmaceutical's GenSci141 ointment is aimed at treating conditions such as hypergonadotropic hypogonadism, 5α-reductase type 2 deficiency, congenital adrenal hyperplasia, and idiopathic causes of micropenis in children [1] - The acceptance of the clinical trial application is a significant step that could enhance the company's business structure and product offerings [1] Group 2: Business Implications - Successful progress in the clinical trial could lead to a broader product line and improved strategic positioning within the industry [1] - The company aims to optimize its product structure and enhance its core competitiveness through this development [1] Group 3: R&D Challenges - The pharmaceutical industry is characterized by high technology, high risk, and high added value, with lengthy and complex processes from research and development to clinical trial approval and production [1] - There are inherent uncertainties in the clinical trial process that could impact the timeline and success of the product [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of GenSci141 ointment, which is a dihydrotestosterone ointment aimed at improving children's micropenis [1] Group 1 - The drug is classified as a chemical drug of categories 2.2 and 2.4 [1] - Successful progress in clinical trials could help the company expand its business and optimize its product structure [1] - The pharmaceutical product development cycle is long and involves multiple stages, leading to uncertainties in the clinical trial process [1]

Core Viewpoint - The company has received approval for clinical trials of its intravenous immunoglobulin (pH4) after a change in the production process, which is expected to enhance product quality and market competitiveness [1][2]. Group 1: Drug Information - The drug is named intravenous immunoglobulin (pH4) with a dosage form of injection, specified as 2.5g/bottle (5%, 50ml) [1]. - The clinical trial aims to evaluate the efficacy and safety of intravenous immunoglobulin (pH4) in treating primary immune thrombocytopenia (ITP) in adults and adolescents [1]. Group 2: R&D and Process Improvement - The production process has been upgraded from traditional low-temperature ethanol protein separation to a more advanced method involving caprylic acid precipitation and multi-step chromatography purification, significantly improving product yield and viral safety [2]. - This change aligns the domestic product's manufacturing standards with international practices, enhancing the competitiveness of the company's fourth-generation intravenous immunoglobulin products [2]. Group 3: Approval Process - Following the approval of the clinical trial notification, the company must conduct the clinical research as per the notification and obtain further approval from the National Medical Products Administration before the drug can be marketed [3].

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。 CF PharmTech, Inc. 長風藥業股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團就本公司自主研發的固定 複方製劑奧洛他定莫米松鼻噴霧劑（「產品」）作出的臨床試驗申請，已獲中國國家 藥品監督管理局（「NMPA」）發出受理通知書（「受理通知書」）。茲公告相關資訊如 下： 申請的適應症 : 治療成人及12歲以上青少年中重度過敏性鼻炎症狀 1 （股份代號：2652） 自願公告 奧洛他定莫米松鼻噴霧劑臨床試驗申請獲NMPA受理 本公告乃由長風藥業股份有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，以知會股東及潛在投資者有關本集團之最新研發進展。 緒言 主要摘要 產品為本集團自主研發的固定複方鼻噴霧劑。臨床試驗申請獲受理標誌著其正式 進入NMPA潛在臨床開發的監管審查階段。 產品名稱 : 奧洛他定莫米松鼻噴霧劑 申請類型 ...

Group 1 - The company has received clinical trial approval for its innovative small molecule drug SAL0140, aimed at treating primary hyperaldosteronism [1][2] - SAL0140 is a proprietary aldosterone synthase inhibitor, with potential indications including uncontrolled hypertension, primary hyperaldosteronism, and chronic kidney disease (CKD) [1] - The drug is expected to lower aldosterone levels in patients, potentially reducing blood pressure and organ damage, indicating significant development potential [1] Group 2 - The company’s drugs Xinchaotuo and Fulitan have been newly included in the National Medical Insurance Directory, while Ennaero has successfully renewed its inclusion [3][4] - Xinchaotuo is the first approved ARNI co-crystal drug in China, showing significant blood pressure reduction in clinical trials, with a notable average decrease of 25.07 mmHg to 28.22 mmHg after 12 weeks of treatment [7] - Fulitan is a compound formulation that effectively lowers blood pressure while minimizing adverse effects, making it suitable for salt-sensitive and elderly hypertensive patients [7][9] Group 3 - Ennaero is a new generation HIF-PHI drug approved for treating anemia in CKD patients, demonstrating high efficacy and safety [11][12] - The company has established an innovative product matrix in the cardiovascular chronic disease field, focusing on the heart-kidney metabolic syndrome [14] - The new medical insurance directory will be effective from January 1, 2026, and the company aims to enhance drug accessibility and meet unmet clinical needs [14]

Core Viewpoint - The company announced the withdrawal of its drug registration application for a new biological product aimed at treating severe lower limb ischemic diseases, indicating a proactive approach to meet regulatory and technical requirements [1] Group 1: Company Actions - The company’s subsidiary, Guanggu Renfu, received a termination notice from the National Medical Products Administration regarding its application for the recombinant plasmid-hepatocyte growth factor injection [1] - The company has decided to voluntarily withdraw the application and will improve research materials before reapplying [1] Group 2: Financial and Development Insights - The cumulative research investment for the drug development has reached approximately 160 million yuan [1] - The company expects that this withdrawal will not have a significant impact on its current financial performance [1] Group 3: Industry Context - The development cycle for pharmaceutical products is long and involves multiple stages, which introduces uncertainties [1] - The company commits to timely information disclosure in accordance with regulatory requirements [1]

Group 1 - Company provided a guarantee of 80 million RMB for its wholly-owned subsidiary, Shaanxi Buchang Pharmaceutical Co., Ltd., in a loan agreement with Huaxia Bank [2][7] - The board approved a total financing limit of up to 6.92 billion RMB for 2025, with specific guarantee limits for subsidiaries based on their debt ratios [3][12] - As of the announcement date, the total amount of guarantees provided by the company and its subsidiaries was 2.296 billion RMB, accounting for 22.48% of the company's audited net assets as of the end of 2024 [14] Group 2 - The company’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., signed a contract with Beijing Excellent Future International Pharmaceutical Technology Development Co., Ltd. for clinical trials of a new drug [17] - The total cost for the clinical trial is 60.338 million RMB, covering 480 cases, with provisions for adjustments based on the final sample size [19] - This contract is expected to enhance the company's drug research and development capabilities, potentially saving time and costs in clinical trials [34] Group 3 - The company’s subsidiary, Shaanxi Buchang, received approval for changes to its drug production license, allowing for the addition of a new production line for tablets [42] - The changes are anticipated to optimize production structure and maintain stable production capacity to meet market demand [43]

Core Viewpoint - The company announced the withdrawal of the drug registration application for "Chai Huang Li Dan Capsule" by its wholly-owned subsidiary, Beijing Yiling Pharmaceutical Co., Ltd, as per the notification from the National Medical Products Administration [1][2]. Group 1: Drug Registration Update - Beijing Yiling received approval to withdraw the registration application for "Chai Huang Li Dan Capsule," an innovative traditional Chinese medicine developed by the company [1]. - The capsule is intended for treating chronic cholecystitis with liver and gallbladder damp-heat, and related gastrointestinal symptoms [1]. - The new drug registration application was initially accepted by the National Medical Products Administration in June 2024 [1]. Group 2: Future Actions and Impact - Beijing Yiling will enhance the registration materials according to the latest requirements from the National Medical Products Administration and will resubmit the application promptly [2]. - The withdrawal of the registration application is not expected to have a significant impact on the company's current and future operations and performance [2]. - The company emphasizes the importance of drug research and development while managing R&D costs, acknowledging the high risks and long cycles associated with drug development [2].