CF017(吸入用布地奈德混悬液)

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长风药业(02652.HK)拟全球发售4119.8万股H股 预计10月8日上市
Ge Long Hui· 2025-09-25 22:53
格隆汇9月26日丨长风药业(02652.HK)发布公告,公司拟全球发售4119.8万股H股,中国香港发售股份 412万股,国际发售股份3707.8万股;2025年9月26日至10月2日招股;发售价将为每股发售股份14.75港 元,每手买卖单位为500股,中信证券及招银国际为联席保荐人;预期股份将于2025年10月8日开始在联 交所买卖。 如今,集团正在推进中国、美国及╱或欧洲等主要市场和东南亚及南美等新兴市场的20多款候选产品的 开发。集团积极探索如脂质体及siRNA在内的创新吸入制剂剂型,并将治疗领域扩展至包括中枢神经系 统(CNS)疾病及抗感染在内的新疾病领域。集团也在开发新的治疗方法,如支气管内活瓣(EBV),并为 治疗特发性肺纤维化(IPF)及肺动脉高压(PAH)等严重影响患者生活的疾病开发潜在的同类首创或中国首 创治疗方法。 假设发售价为每股股份14.75港元,集团估计将收取全球发售所得款项净额约5.254亿港元。集团目前拟 将该等所得款项净额用作以下用途:约40.0%将用于为集团国内及国际的吸入制剂候选产品的持续研 发、临床开发及商业化提供资金;约20.0%将用于为集团多个管线计划及技术的临床前研 ...
长风药业通过港交所聆讯,公司收入严重依赖单一产品
Zhong Guo Zheng Quan Bao· 2025-09-24 08:41
据港交所9月22日披露,长风药业股份有限公司通过港交所上市聆讯,中信证券及招银国际为其联席保 荐人。 长风药业披露的最新招股说明书显示,公司主要专注于吸入技术及吸入药物的研发、生产及商业化,专 注于治疗呼吸系统疾病。公司已开发出覆盖广泛患者、医学专科及治疗领域的产品组合。 公司的收入主要来自向公司的经销商销售吸入制剂产品。公司严重依赖产品CF017的销售,CF017销售 收入分别占2022年、2023年、2024年及2025年一季度总收入的96.2%、98.4%、94.5%及91.6%。 收入严重依赖单一产品 招股书显示,2022年、2023年、2024年以及2025年一季度,长风药业分别实现营业收入约为3.49亿元、 5.56亿元、6.08亿元和1.36亿元;分别实现净利润约为-4939.9万元、3172.6万元、2108.8万元以及1281.5 万元。 公司严重依赖CF017的销售,CF017销售收入分别占2022年、2023年、2024年及2025年一季度总收入的 96.2%、98.4%、94.5%及91.6%。 招股书显示,2022年、2023年、2024年以及2025年一季度,公司来自前五大客户的收 ...
新股消息 | 长风药业通过聆讯 CF017商业化推广成功 为中国销量最高的吸入药物类别
智通财经网· 2025-09-23 07:15
智通财经APP获悉,据港交所9月22日披露,长风药业股份有限公司(简称"长风药业")通过港交所上市聆讯,中信 证券及招银国际为其联席保荐人。 招股书显示,长风药业成立于2007年,专注于吸入技术及吸入药物的研发、生产及商业化,专注于治疗呼吸系统 疾病。 由于哮喘、COPD及过敏性鼻炎等呼吸系统疾病患病率不断上升,全球呼吸系统药物市场巨大。据估计,目前全球 有将近25亿人患有慢性呼吸系统疾病,预计该数字日后还会增加。2024年,全球呼吸系统药物市场规模估值为999 亿美元(约人民币7,292亿元),预计到2033年将达到1,572亿美元(约人民币11,474亿元),年复合增长率为5.2%。 CF017,即治疗支气管哮喘的吸入用布地奈德混悬液(中国销量最高的吸入药物类别),是长风药业的首个获批产 品。2021年5月获批后,CF017迅速纳入中国集中采购(VBP)计划,并实现了市场增长。根据弗若斯特沙利文的资 料,于2024年,按销量计,CF017占2024年中国布地奈德吸入药物市场约16%。 自2021年5月获批以来,长风药业的市场推广体系使CF017成功覆盖了中国超过一万家医疗机构。公司的CF018作 为中国首 ...
长风药业通过聆讯 CF017商业化推广成功 为中国销量最高的吸入药物类别
Zhi Tong Cai Jing· 2025-09-23 07:13
据港交所9月22日披露,长风药业股份有限公司(简称"长风药业")通过港交所上市聆讯,中信证券及招银国际为其 联席保荐人。 自2021年5月获批以来,长风药业的市场推广体系使CF017成功覆盖了中国超过一万家医疗机构。公司的CF018作 为中国首个获批用于治疗中重度过敏性鼻炎的氮斯汀氟替卡松鼻喷雾剂,在纳入2023年《国家医保药品目录》(国 家医保目录)之后,已渗透到多个省份的500多家医院及医疗机构。 招股书显示,长风药业成立于2007年,专注于吸入技术及吸入药物的研发、生产及商业化,专注于治疗呼吸系统 疾病。 由于哮喘、COPD及过敏性鼻炎等呼吸系统疾病患病率不断上升,全球呼吸系统药物市场巨大。据估计,目前全球 有将近25亿人患有慢性呼吸系统疾病,预计该数字日后还会增加。2024年,全球呼吸系统药物市场规模估值为999 亿美元(约人民币7,292亿元),预计到2033年将达到1,572亿美元(约人民币11,474亿元),年复合增长率为5.2%。 CF017,即治疗支气管哮喘的吸入用布地奈德混悬液(中国销量最高的吸入药物类别),是长风药业的首个获批产 品。2021年5月获批后,CF017迅速纳入中国集中采购( ...
长风药业,拟赴香港上市,获中国证监会备案通知书
Xin Lang Cai Jing· 2025-09-01 05:01
2025年8月29日,中国证监会国际合作司发布关于长风药业股份有限公司境外发行上市及境内未上市股 份"全流通"备案通知书(国合函[2025]1472号)。 根据备案通知书,长风药业拟发行不超过1.42132481亿股境外上市普通股并在香港联合交易所上市,以 及54名股东拟将所持合计2.61025586亿股境内未上市股份转为境外上市股份。 来源:瑞恩资本RyanbenCapital | 察 引 号 | A 三国历史,国立、比记国留学、欧洲国家学儿、学校为人口演、这年空国剧、同时时已止。就从而没的1》。2007年 bm56000001/2025-00010295 | ਦੇ 美 | | --- | --- | --- | | 发布机构 | | 发文日期 | | 称 ਸਮ | 关于长风药业般份有限公司 2外发行上市及境内未上市股份"全流通"备案通知书 | | | 文 号 | 国合函 [2025] 1472 号 | 主题词 | | 序号 | 股东名称 | 申请全流通股数 | | --- | --- | --- | | | | (股) | | 1 | 苏州岭头投资管理企业(有限合伙) | 15.677.427 | | 2 ...
长风药业IPO“三战”成谜:核心产品失势、研发销售失衡与股权架构的复杂隐忧|创新药观察
Hua Xia Shi Bao· 2025-06-26 12:51
Core Viewpoint - Changfeng Pharmaceutical is attempting to go public on the Hong Kong Stock Exchange after two unsuccessful attempts to list on the STAR Market, highlighting its urgent need for capital and the complexities of its financing structure [2][3]. Group 1: Company Background and IPO Attempts - Changfeng Pharmaceutical has faced challenges in its listing journey, having withdrawn its application for the STAR Market in April 2021 and again failing in June 2023 [2]. - The company has raised a total of 1.412 billion yuan through eight rounds of financing from December 2010 to June 2020, indicating strong investor interest [2]. - The complex equity structure involves over 40 investors and includes performance-based agreements that have reactivated due to the failed IPO attempts [2]. Group 2: Product Dependency and Financial Performance - The company heavily relies on its core product CF017, which accounted for 96.2%, 98.4%, and 94.5% of total revenue from 2022 to 2024, respectively [4]. - CF017 has been approved by both the National Medical Products Administration of China and the FDA, but the company has only a few other products in early commercialization stages, limiting revenue diversification [5]. - Revenue projections for Changfeng Pharmaceutical are 349 million yuan, 556 million yuan, and 608 million yuan for 2022, 2023, and 2024, respectively, with CF017 being the primary revenue driver [4]. Group 3: Market Competition and Challenges - The market share of CF017 is projected to decline from approximately 20% in 2023 to 16% in 2024, despite a revenue increase from 548 million yuan to 574 million yuan, indicating rising competition [7]. - The unit price of CF017 has decreased from 2.78 yuan in 2022 to 2.74 yuan in 2024, while sales volume growth has slowed significantly [7]. - The company’s profitability has fluctuated, with net profits of -49.4 million yuan in 2022, 31.7 million yuan in 2023, and a projected decline of 33.53% in 2024 [8]. Group 4: R&D and Sales Expenditure - Changfeng Pharmaceutical's R&D spending has decreased from 107 million yuan in 2022 to 122 million yuan in 2024, with a declining R&D expense ratio [10]. - In contrast, sales expenses have increased significantly, reaching 236 million yuan in 2024, with a sales expense ratio consistently above the industry average [10][12]. - The company has shifted its sales expense structure, with a significant portion now categorized as "business development expenses," raising concerns about transparency and compliance [14][15].
长风药业港股IPO:收入依赖单一产品,2024年利润下滑
Sou Hu Cai Jing· 2025-06-16 08:27
Core Viewpoint - Changfeng Pharmaceutical Co., Ltd. has updated its hearing materials for a Hong Kong IPO application, which was initially submitted in November 2024 but subsequently became invalid. The company previously attempted to list on the A-share market twice but withdrew its second application in June 2024 due to uncertainties regarding the timeline and the need to enter international capital markets. Financial Performance - From 2022 to 2024, the company's revenue increased from 349 million RMB to 608 million RMB. In 2023, the company achieved profitability with a profit of approximately 31.73 million RMB, but profits declined to 21.09 million RMB in 2024 [7][8]. Product Dependency - The company's revenue is heavily reliant on a single product, CF017, which accounted for 96.2%, 98.4%, and 94.5% of total revenue in 2022, 2023, and 2024, respectively. CF017 is an inhalation solution for bronchial asthma and is the highest-selling inhalation drug category in China [2][4][6]. Market Position - CF017 holds a significant market share, accounting for approximately 16% of the Chinese budesonide inhalation drug market by sales volume in 2024 [3]. Cost Structure - The sales and distribution expenses have consistently represented a high percentage of revenue, exceeding 38% from 2022 to 2024. The gross profit margin has shown some fluctuation, with 76.6% in 2022, 82.2% in 2023, and 80.9% in 2024 [8]. Future Development - The company is advancing the global development of over 20 candidate products in major markets such as China, the United States, and Europe, as well as emerging markets in Southeast Asia and South America [6].
两次冲A未果,长风药业身患“单品依赖症”转战港股!销售费用逐年增长
Shen Zhen Shang Bao· 2025-06-12 04:40
Core Viewpoint - Changfeng Pharmaceutical Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange after previous unsuccessful attempts to list on the STAR Market in China, focusing on the development and commercialization of inhalation drugs for respiratory diseases [1][3]. Financial Performance - The company reported revenues of RMB 349.1 million, RMB 556.4 million, and RMB 608 million for the years 2022, 2023, and projected for 2024, respectively, with net profits of -RMB 49.4 million, RMB 31.7 million, and RMB 21.1 million during the same periods [2][4]. - The gross profit margin improved from 76.6% in 2022 to 82.2% in 2023, indicating better cost management [4]. Product Dependency - The company heavily relies on its inhalation product CF017, which accounted for 96.2%, 98.4%, and 94.5% of total revenue in 2022, 2023, and projected for 2024, respectively [4][6]. - CF017 is the company's first approved product for treating bronchial asthma, highlighting the risk of revenue concentration [4][6]. Sales and Distribution - Approximately 98.8%, 99.5%, and 99.3% of the company's product sales revenue came from distributors during the reporting periods, indicating a strong dependence on the distribution network [7]. - The company has a high customer concentration, with revenue from the top five customers accounting for 60.2%, 69.4%, and 66.4% of total revenue in the respective years [8]. Cost Structure - Sales and distribution expenses have increased over the reporting periods, totaling approximately RMB 594 million over three years [9]. - Research and development expenses were RMB 1.07 billion, RMB 1.33 billion, and RMB 1.22 billion for the years 2022, 2023, and projected for 2024, with a noted decrease in 2024 due to outsourcing certain services [9].
国产吸入药物龙头长风药业闯关港交所 CF017放量驱动业绩高增
Zhi Tong Cai Jing· 2025-06-11 23:04
Core Viewpoint - Changfeng Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with CITIC Securities and China Merchants Jinling International as joint sponsors [1]. Group 1: Company Overview - Changfeng Pharmaceutical focuses on the research, development, production, and commercialization of inhalation technology and inhalation drugs, primarily targeting respiratory diseases [3]. - The company has developed a diverse product portfolio that addresses a wide range of patients, medical specialties, and treatment areas [3]. Group 2: Key Products and Market Position - CF017, an inhalation solution of budesonide for treating bronchial asthma, is the company's first approved product and the best-selling inhalation drug category in China. It was approved in May 2021 and has since been included in China's centralized procurement (VBP) plan, leading to market growth [3]. - By 2024, CF017 is projected to capture approximately 16% of the Chinese budesonide inhalation drug market by sales volume [3]. - The company is advancing over 20 candidate products for global development in major markets like China and the U.S., as well as emerging markets in Southeast Asia and South America [3]. Group 3: Recent Developments and Financial Performance - In May 2024, the company successfully obtained FDA approval for GW006, an aerosol solution of afromoterol for treating chronic obstructive pulmonary disease (COPD) [4]. - CF018, the first approved nasal spray for moderate to severe allergic rhinitis in China, has penetrated over 500 hospitals and medical institutions after being included in the 2023 National Medical Insurance Drug List [5]. - The commercialization of CF017 significantly boosted the company's revenue, with revenues of approximately RMB 349 million, RMB 556 million, and an estimated RMB 608 million for the years 2022, 2023, and 2024, respectively [5][6]. - The gross profit for the same years was approximately RMB 267 million, RMB 458 million, and RMB 491 million, indicating a strong growth trajectory [5][6].
长风药业港股IPO:业务严重依赖单一产品 研发投入持续加大
Sou Hu Cai Jing· 2025-06-11 15:52
Core Viewpoint - Changfeng Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on the research, production, and commercialization of inhalation technologies and drugs for respiratory diseases [1][2]. Group 1: Company Overview - Changfeng Pharmaceutical specializes in inhalation technology and drugs, targeting the treatment of respiratory diseases with a broad product portfolio [1]. - The company has received six product approvals from the National Medical Products Administration and the U.S. FDA, demonstrating its capabilities in clinical development, production, regulatory affairs, and commercialization [1]. - The first approved product, CF017 (inhaled budesonide suspension), was approved in May 2021 and has rapidly entered China's centralized procurement program, contributing to market growth [1]. Group 2: Product Development and Market Expansion - Changfeng is actively developing over 20 candidate products globally, including in major markets like China, the U.S., and Europe, as well as emerging markets in Southeast Asia and South America [1]. - The company is exploring innovative inhalation formulations such as liposomes and siRNA, and is expanding its treatment areas to include central nervous system diseases and infections [1]. - Potential first-in-class or China-first treatments are being developed for idiopathic pulmonary fibrosis and pulmonary hypertension [1]. Group 3: Financial Performance - Revenue increased significantly from RMB 349 million in 2022 to RMB 608 million in 2024, with a compound annual growth rate of 31.9% [2]. - The company recorded a net loss of RMB 49.4 million in 2022, but achieved net profits of RMB 31.73 million and RMB 21.09 million in 2023 and 2024, respectively [2]. - Research and development expenses were RMB 107 million, RMB 133 million, and RMB 122 million for 2022, 2023, and 2024, respectively, with capitalized R&D costs recognized during the same period [2]. Group 4: Revenue Dependency and Risks - Changfeng Pharmaceutical heavily relies on the sales of CF017, which accounted for 96.2%, 98.4%, and 94.5% of total revenue in 2022, 2023, and 2024, respectively [2]. - The company faces uncertainties from China's centralized procurement program, which may adversely affect market share and profitability [2].