Core Viewpoint - The company has received approval for a new product, which is expected to enhance its product line in the respiratory system and complement its existing innovative drugs [2]. Group 1: Company Performance - As of December 24, 2025, the stock price of Zhongsheng Pharmaceutical (002317) closed at 19.46 yuan, down 0.05%, with a turnover rate of 7.28%, trading volume of 554,100 hands, and a transaction amount of 1.08 billion yuan [1]. - On the same day, the net outflow of main funds was 2.8084 million yuan, while the net inflow of speculative funds was 21.1941 million yuan, and the net outflow of retail funds was 18.3858 million yuan [1][3]. Group 2: Product Development - The company has obtained the drug registration certificate for Ambroxol Hydrochloride Oral Solution, with approved specifications of 10ml:30mg and 100ml:0.3g, classified as a Category 4 chemical drug, equivalent to passing the consistency evaluation for generic drugs [2]. - The Ambroxol Hydrochloride Oral Solution is indicated for the treatment of viscous phlegm and difficulty in expectoration caused by acute and chronic bronchitis, and it is listed as a Class B drug under medical insurance [2]. - The projected sales for this product in Chinese public hospitals and urban retail pharmacies are 710.84 million yuan for 2022, 817.66 million yuan for 2023, and 849.53 million yuan for 2024 [2].

本报讯 （记者李雯珊见习记者张美娜）12月23日，广东众生药业股份有限公司（以下简称"公司"）发 布公告，公司近日收到国家药监局核准签发的盐酸氨溴索口服溶液《药品注册证书》。根据公告，盐酸 氨溴索口服溶液适用于急、慢性支气管炎引起的痰液黏稠、咳痰困难，有明确的诊疗指南推荐。 （文章来源：证券日报） ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002317 公告编号：2025-118 广东众生药业股份有限公司关于获得盐酸氨溴索口服溶液《药品注册证书》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 广东众生药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管理局核准签发的盐酸氨溴索 口服溶液《药品注册证书》。现将相关情况公告如下： 一、药品注册证书主要信息 药品名称：盐酸氨溴索口服溶液 剂型：口服溶液剂 规格：10ml∶30mg、100ml∶0.3g 申请事项：药品注册（境内生产） 注册分类：化学药品4类 证书编号：2025S03794、2025S03795 药品批准文号：国药准字H20256278、国药准字H20256279 上市许可持有人：名称：广东众生药业股份有限公司，地址：广东省东莞市石龙镇西湖工业区信息产业 园 生产企业：名称：广东众生药业股份有限公司，地址：广东省东莞市石龙镇西湖工业区信息产业园 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册，发给药品注册证书。 ...

人民财讯12月23日电，众生药业（002317）12月23日公告，公司近日收到国家药监局核准签发的盐酸氨 溴索口服溶液《药品注册证书》。盐酸氨溴索口服溶液适用于急、慢性支气管炎引起的痰液黏稠、咳痰 困难，有明确的诊疗指南推荐。 ...

格隆汇12月23日丨众生药业(002317.SZ)公布，近日收到国家药品监督管理局核准签发的盐酸氨溴索口 服溶液《药品注册证书》。盐酸氨溴索是黏液溶解剂，能增加呼吸道黏膜浆液腺的分泌，减少黏液腺分 泌，从而降低痰液黏度；能促进肺表面活性物质的分泌，增加支气管纤毛运动，使痰液易于咳出。盐酸 氨溴索口服溶液适用于急、慢性支气管炎引起的痰液黏稠、咳痰困难，有明确的诊疗指南推荐。 ...

众生药业公告，近日收到国家药品监督管理局核准签发的盐酸氨溴索口服溶液《药品注册证书》。盐酸 氨溴索口服溶液为医保乙类药物，2022至2024年在中国公立医院及城市实体药店销售总额分别为7.11亿 元、8.18亿元、8.5亿元。此次获批标志着产品视同通过化学仿制药一致性评价，进一步丰富公司在呼吸 系统治疗领域的产品线。 ...

Core Viewpoint - Changfeng Pharmaceutical Co., Ltd. is preparing for an IPO to raise funds primarily for core pipeline research and development, production facility expansion, and commercialization capabilities [4] Company Overview - Established in 2007, Changfeng Pharmaceutical focuses on the research, production, and commercialization of inhalation technology and inhalation drugs, specifically targeting respiratory diseases [1] Market Opportunity - The global respiratory drug market is substantial, with nearly 2.5 billion people suffering from chronic respiratory diseases. The market is projected to grow from USD 99.9 billion (approximately RMB 729.2 billion) in 2024 to USD 157.2 billion (approximately RMB 1,147.4 billion) by 2033, reflecting a compound annual growth rate (CAGR) of 5.2% [3] Product Pipeline - The company has developed a pipeline of 16 products, with over 60% focused on respiratory diseases, addressing the clinical needs of 250 million respiratory disease patients in China. Key products include: - Recombinant human interferon β1b nebulized solution for viral pneumonia, currently in Phase III clinical trials - Salbutamol inhalation powder for asthma treatment, also in Phase III clinical trials, expected to submit for listing in 2026 [5][6] Technological Advantages - Changfeng Pharmaceutical's core technology is dry powder inhalation (DPI), supported by 32 Chinese patents and 11 international patents. Key advantages include: - Proprietary formulation technology that enhances drug stability by over 200% - Development of an active dry powder inhaler that improves patient compliance, especially among the elderly [7] Commercialization Capability - The company has achieved revenue scale through generic drug sales, with projected revenue of RMB 420 million in 2024, driven by two inhalation products contributing over 80% of revenue. Notable product performances include: - Ambroxol oral solution with a market share of 7.3% - Budesonide suspension with a projected sales growth of 56% year-on-year [8] Industry Landscape - The inhalation formulation market in China is expected to reach RMB 112 billion by 2024, with a CAGR of 18.7% from 2019 to 2024. There is significant potential for domestic companies to replace imported products, as foreign firms currently hold 72% of the market share. Changfeng aims to be the first domestic company to combine generic and innovative drug strategies in the respiratory field [9]

Core Viewpoint - The return of the original brand Mucosolvan (Ambroxol Hydrochloride) to the Chinese market is anticipated in December 2025, following its exit due to registration expiration and increased competition from generic drugs [1][2]. Group 1: Company Background - Mucosolvan was originally developed by Boehringer Ingelheim and launched in Germany in 1978, entering the Chinese market in 1991 [2]. - The product achieved peak sales exceeding 8 billion yuan in China, making it a highly competitive product in the market [2]. - The original manufacturer, Boehringer Ingelheim, ceased the product's registration in China in 2020, leading to its market exit [3]. Group 2: Market Competition - The return of Mucosolvan will face competition from 367 similar drug approvals in China, including significant price competition from generics [6]. - In the 2021 centralized procurement, Boehringer Ingelheim's bid was only a 0.3% price reduction, while competitors like Yunnan Longhai offered a 93.3% reduction [4]. - The market for expectorants is crowded, with other active ingredients available, such as bromhexine and acetylcysteine, which may affect Mucosolvan's market share [6]. Group 3: Future Outlook - The product's return is now under the management of Opella, a company that became independent from Sanofi in May 2025, which retains a 48.2% stake in Opella [4]. - The ability of Mucosolvan to regain consumer trust and willingness to pay a premium in a low-price environment remains uncertain [6]. - The performance of Mucosolvan post-return will be closely monitored, especially regarding its positioning in the OTC market [6].