Investment Rating - The report indicates a positive investment outlook for Changfeng Pharmaceutical, particularly due to the acceptance of the IND application for ICF004, a first-in-class inhalation powder for treating pulmonary fibrosis [2][5]. Core Insights - Changfeng Pharmaceutical's ICF004 has received IND acceptance, marking a significant milestone in the development of new treatments for progressive fibrosing interstitial lung disease (PF-ILD) [2][5]. - The drug aims to address unmet clinical needs in PF-ILD, which includes idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), both of which severely threaten patient survival [4][9]. - ICF004's unique delivery method allows for targeted lung delivery, achieving a lung/blood exposure ratio exceeding 100 times, which may enhance efficacy while minimizing systemic exposure [10][11]. Summary by Sections Section 1: Drug Development and Mechanism - ICF004 is classified as a first-in-class chemical drug candidate, designed for inhalation delivery to treat PF-ILD [4]. - The drug's development focuses on exploring mechanisms related to fibrosis, including inflammation and oxidative stress, aiming for a novel treatment approach distinct from existing oral therapies [5]. Section 2: Clinical Need and Current Treatments - PF-ILD is characterized by worsening respiratory symptoms and irreversible decline in lung function, with a median survival of approximately 2.8 years for IPF patients and a 5-year survival rate below 40% [6]. - Current treatment options are limited to two oral medications, which, while they can slow lung function decline, have significant side effects and limited survival benefits [7][8]. Section 3: Delivery and Pharmacokinetics - ICF004's inhalation delivery method is designed to target the lung lesions directly, showing a significant pharmacokinetic profile with over 100 times higher exposure in the lungs compared to the bloodstream [10][11]. - Preclinical studies suggest potential anti-fibrotic activity, although further clinical trials are necessary to confirm efficacy and safety in humans [12][13]. Section 4: Company Capabilities and Future Plans - Changfeng Pharmaceutical has a comprehensive capability in developing complex formulations and precision delivery technologies, which supports its innovative drug development strategy [14][16]. - The advancement of ICF004 reflects the company's ability to translate high-barrier delivery and formulation platforms into clinical development assets, with plans to actively pursue further clinical development while adhering to regulatory requirements [17].

Core Viewpoint - Changfeng Pharmaceutical's candidate drug ICF004 for treating pulmonary fibrosis has received acceptance for clinical trial application from the NMPA, marking a significant milestone in its drug development process [4][5]. Group 1: Drug Development Progress - ICF004 is a class 1 chemical drug candidate designed as an inhalation powder for treating progressive fibrosing interstitial lung disease (PF-ILD), which includes idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) [6][8]. - The acceptance of the IND indicates that ICF004 has passed preliminary regulatory review and is now entering the clinical trial preparation phase [7][8]. - The drug's development focuses on exploring mechanisms related to fibrosis, particularly inflammation, oxidative stress, and fibroblast activation, aiming to provide a novel treatment pathway distinct from existing oral therapies [7][8]. Group 2: Clinical Need and Market Potential - PF-ILD is characterized by worsening respiratory symptoms and irreversible decline in lung function, with a median survival of approximately 2.8 years for IPF patients and a 5-year survival rate of less than 40% [8]. - Current treatments for IPF are limited to two approved oral medications, which, while they can slow lung function decline, have limited survival benefits and significant side effects [8]. - ICF004 addresses an unmet clinical need, positioning it as a potentially groundbreaking "first-in-class" candidate drug [8]. Group 3: Pharmacokinetics and Delivery Mechanism - ICF004 utilizes an inhalation powder delivery method, targeting direct delivery to lung lesions, with preclinical studies showing a significant difference in drug exposure between lung tissue and systemic circulation, with a lung/blood exposure ratio exceeding 100 times [9][12]. - This pharmacokinetic profile suggests the potential for high local concentration in the lungs while minimizing systemic exposure, which may enhance the balance between efficacy and safety [12]. Group 4: Company Capabilities and Future Plans - Changfeng Pharmaceutical has capabilities in complex formulations, small nucleic acids, liposomal drugs, and precision delivery technologies, with a focus on respiratory diseases [14]. - The advancement of ICF004 reflects the company's ability to integrate complex formulations and delivery systems with unmet clinical needs, providing a methodological and organizational reference for future innovative projects [14]. - The company plans to actively promote the subsequent clinical development of ICF004 in accordance with NMPA regulations, evaluating strategies for independent advancement and collaborative development based on clinical progress and resource allocation [14].

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） （股份代號：2652） 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 本公司董事（「董事」）會（「董事會」）欣然宣佈，本公司自主研發的吸入粉霧劑候 選藥物ICF004（「產品」）之新藥臨床試驗（「IND」）申請（「該申請」）已獲中華人民 共和國國家藥品監督管理局（「NMPA」）受理。茲公告相關資訊如下： | 產品名稱 | : | ICF004（吸入粉霧劑） | | --- | --- | --- | | 申請類型 | : | 新藥申請 | | 註冊分類 | : | 化學藥品1類 | | 受理號 | : | CXHL2600132/CXHL2600133 | | 申請人 | : | 長風蘇粵藥業（廣州）有限公 ...