Core Viewpoint - The company announced that its inhaled human interferon α1b solution has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration (NMPA) of China, marking a significant advancement in its antiviral drug development [1][2]. Group 1: Drug Information - The inhaled human interferon α1b solution is designed for pediatric patients suffering from respiratory syncytial virus (RSV) infections, which are a leading cause of acute respiratory infections in children [2]. - RSV infections accounted for over 60% of acute respiratory infections in children, with 33 million cases reported globally in 2019 among children under five years old [2]. - In China, approximately 3.5 million cases of RSV infections were reported in 2019, representing over 10% of the global total, with hospitalization rates between 620,000 to 950,000, accounting for 18-27% of global hospitalizations [2]. Group 2: Clinical Development Status - As of the date of the announcement, the inhaled human interferon α1b solution is in the Phase III clinical trial stage [3]. Group 3: Impact on the Company - The inclusion of the inhaled human interferon α1b solution in the breakthrough therapy list will not have a significant immediate impact on the company's financial performance [5]. - The company acknowledges the long and uncertain nature of drug development, which involves substantial investment and multiple stages, and will continue to communicate progress in accordance with regulatory requirements [5].

Group 1: Company Announcements - Ganli Pharmaceutical signed a technology transfer and supply agreement with FZ and BIOMM, with a total supply framework agreement amount expected to be no less than 3 billion RMB [1] - Upwind New Materials completed the transfer of 121 million shares, changing its controlling shareholder to Zhiyuan Hengyue, associated with Zhiyuan Robotics [2] - Poly Developments plans to publicly issue corporate bonds not exceeding 15 billion RMB for various purposes including debt repayment and project construction [3] Group 2: Shareholder Actions - Lenovo Holdings reduced its stake in Lakala by 8.0781 million shares, decreasing its ownership from 25.00% to 23.97% [4] - Fenghuo Communication plans to repurchase shares with a budget between 75 million and 150 million RMB, with a maximum repurchase price of 40.53 RMB per share [5] - Hualing Cable intends to acquire control of San Bamboo Intelligent for no more than 270 million RMB to enhance its capabilities in robotics and high-frequency transmission [6] Group 3: Market Developments - Guiguang Network clarified that rumors regarding major collaborations with Huawei Cloud and restructuring with state-owned enterprises are untrue [7] - Dongshan Precision is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international presence [8] - Wolong Nuclear Materials' subsidiary plans to invest up to 1 billion RMB in a new materials project in Suzhou [9] Group 4: Other Corporate Activities - Chao Xun Communication's management completed their share reduction plan, with specific shares sold by board members [10] - Various companies are involved in significant project bids and collaborations, including China Electric Research and others [15]

Core Viewpoint - The company has announced that its subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has developed an inhalation solution of human interferon α1b, which has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center [1] Group 1 - The inhalation solution is indicated for pediatric respiratory syncytial virus lower respiratory tract infections, including pneumonia and bronchiolitis [1]

Core Viewpoint - The announcement by the company regarding its inhalation solution for human interferon α1b being included in the list of breakthrough therapies by the National Medical Products Administration indicates a significant step in addressing respiratory syncytial virus (RSV) infections in children, although it will not have a major impact on the company's recent performance [1] Group 1: Product Development - The inhalation solution is specifically designed for children and is administered via nebulization, allowing the active ingredient to reach the site of infection more quickly [1] - The indication for the product is for pediatric lower respiratory tract infections caused by RSV, including pneumonia and bronchiolitis [1] - As of the announcement date, the product is in the Phase III clinical trial stage [1] Group 2: Market Context - According to a study published in The Lancet, there were 33 million cases of acute lower respiratory infections caused by RSV in children under five globally in 2019 [1] - The inclusion of the product in the breakthrough therapy list reflects its potential significance in the market, although future research progress, results, and competitive landscape remain uncertain [1]

证券代码：688136 证券简称：科兴制药 公告编号：2025-078 科兴生物制药股份有限公司 自愿披露关于人干扰素α1b 吸入溶液 纳入突破性治疗品种名单的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 科兴生物制药股份有限公司（以下简称"公司"）全资子公司深圳科兴药业 有限公司（以下简称"深圳科兴"）自主研发的人干扰素α1b吸入溶液已被国家 药品监督管理局药品审评中心（以下简称"药审中心"）纳入突破性治疗品种名 单，近日已完成公示，现将主要情况公告如下： 二、药品的其他相关情况 干扰素（interferon，IFN）是一类具有广谱抗病毒、抗肿瘤和免疫调节作 用的蛋白质，是机体天然免疫的关键组成部分。人干扰素α1b吸入溶液是公司在 抗病毒领域的又一大突破，该药品属儿童专用药，通过雾化给药，有效成分可以 直达病灶，起效更快，相比注射剂，儿童患者无需承受注射的疼痛，接受度和安 全性更高。 公司人干扰素α1b吸入溶液适应症为小儿呼吸道合胞病毒性下呼吸道感染 （肺炎、毛细支气管炎）。呼吸道合胞病毒（RSV）是引起婴幼儿急 ...

Core Viewpoint - The announcement highlights that the company's subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has developed an inhalation solution of human interferon α 1b, which has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center [1] Group 1: Product Development - The inhalation solution is a significant breakthrough in the antiviral field, specifically designed for children [1] - The product is administered via nebulization, allowing the active ingredient to reach the site of infection more quickly compared to injection [1] - The solution is indicated for pediatric respiratory syncytial virus lower respiratory tract infections, including pneumonia and bronchiolitis [1] Group 2: Advantages of the Product - The inhalation method eliminates the pain associated with injections, leading to higher acceptance and safety for pediatric patients [1] - The broad-spectrum antiviral, antitumor, and immune-regulating properties of interferon make it a key component of the body's natural immunity [1]

Core Viewpoint - The announcement highlights that the inhalation solution of human interferon α 1b, developed by the company's wholly-owned subsidiary, has been included in the list of breakthrough therapies by the National Medical Products Administration [1] Group 1: Product Development - The human interferon α 1b inhalation solution is a significant breakthrough in the antiviral field for the company [1] - This medication is specifically designed for children and is administered via nebulization, allowing the active ingredient to reach the site of infection more quickly [1] - Compared to injectable forms, this inhalation solution offers higher acceptance and safety for pediatric patients, as they do not have to endure the pain of injections [1] Group 2: Indications and Applications - The indication for the human interferon α 1b inhalation solution is for pediatric respiratory syncytial virus (RSV) lower respiratory tract infections, including pneumonia and bronchiolitis [1]

Core Viewpoint - The announcement highlights that the inhalation solution of human interferon α1b, developed by the wholly-owned subsidiary of the company, has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] Group 1: Product Development - The inhalation solution is intended for the treatment of pediatric respiratory syncytial virus lower respiratory tract infections, including pneumonia and bronchiolitis [1] - As of the date of the announcement, the human interferon α1b inhalation solution is in the Phase III clinical trial stage [1] Group 2: Company Actions - The company will actively promote the research and development project and fulfill its information disclosure obligations in a timely manner [1]

Group 1 - The core point of the news is that Kexing Pharmaceutical's stock price has dropped by 5.03%, currently trading at 38.50 yuan per share, with a total market capitalization of 7.748 billion yuan [1] - Kexing Biopharmaceutical Co., Ltd. is primarily engaged in the research, production, and sales of recombinant protein drugs and micro-ecological preparations, with 97.38% of its revenue coming from pharmaceutical products [1] - The company was established on August 22, 1997, and went public on December 14, 2020 [1] Group 2 - Huatai Baoxing Fund holds a significant position in Kexing Pharmaceutical, with its Huatai Baoxing Kexing A fund (009124) owning 21,000 shares, representing 1.59% of the fund's net value [2] - The fund has experienced a floating loss of approximately 42,800 yuan today [2] - The fund was established on May 11, 2020, and has a current scale of 20.8067 million yuan, with a year-to-date return of 7.86% [2] Group 3 - The fund managers of Huatai Baoxing Kexing A are Zhou Yongmei and Chen Qiwei, with Zhou having a tenure of 7 years and 232 days and Chen having a tenure of 2 years and 98 days [3] - Zhou's fund has a total asset scale of 8.897 billion yuan, with the best return during her tenure being 43.64% [3] - Chen's fund has a total asset scale of 24.594 billion yuan, with the best return during his tenure being 18.95% [3]

Market Overview - On September 22, the biopharmaceutical sector experienced a slight decline of 0.15%, with Kanglaosheng leading the drop [1] - The Shanghai Composite Index closed at 3828.58, up 0.22%, while the Shenzhen Component Index closed at 13157.97, up 0.67% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Aipumai (688293) with a closing price of 58.70, up 9.90% on a trading volume of 47,100 shares and a turnover of 267 million yuan [1] - Baipusais (301080) closed at 61.75, up 5.05% with a trading volume of 38,300 shares and a turnover of 231 million yuan [1] - Muli Pharmaceutical (603087) closed at 73.60, up 3.76% with a trading volume of 182,000 shares and a turnover of 134.2 million yuan [1] - Conversely, the following stocks saw significant declines: - Kanglaosheng (833575) closed at 14.71, down 6.90% with a trading volume of 90,400 shares and a turnover of 137 million yuan [2] - Kexing Pharmaceutical (688136) closed at 40.54, down 3.20% with a trading volume of 47,600 shares and a turnover of 194 million yuan [2] - Changchun High-tech (000661) closed at 122.10, down 2.49% with a trading volume of 102,800 shares and a turnover of 1.265 billion yuan [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 473 million yuan from institutional investors, while retail investors contributed a net inflow of 418 million yuan [2] - The following stocks had notable capital flows: - Ganli Pharmaceutical (603087) had a net inflow of 58.16 million yuan from institutional investors [3] - Rongchang Biotechnology (688331) saw a net inflow of 43.73 million yuan from institutional investors [3] - ZhiXiangJinTai (688443) had a net inflow of 6.53 million yuan from retail investors [3]