Core Insights - Watson Bio has received approval from the National Medical Products Administration for a clinical trial of its mRNA vaccine targeting respiratory syncytial virus (RSV) [1][2] Group 1: Clinical Trial Approval - The clinical trial approval notification for the RSV mRNA vaccine was issued with the registration numbers 2025LP02790 and 2025LP02791 [1] - The vaccine is classified as a preventive biological product and aims to prevent lower respiratory tract diseases caused by RSV infection [1] Group 2: Vaccine Development - The vaccine is developed through a collaboration between Watson Bio, Fudan University, and Blue Magpie Biopharmaceuticals, utilizing a self-established mRNA vaccine technology platform [2] - The vaccine design is based on a highly conserved sequence of the RSV-A strain F protein, incorporating various mutations for optimized antigen expression [2]

Core Insights - Yunnan Watson Bio-Technology Co., Ltd. has signed an agreement with Pharmaniaga Berhad's subsidiary for the distribution and local production of the 13-valent pneumococcal conjugate vaccine (PCV-13) in Malaysia [1][2] - The collaboration aims to enhance the local production and commercialization of PCV-13, which is crucial for preventing invasive diseases caused by pneumococcus, particularly in children under six years old [1] - The annual demand for PCV vaccines in Malaysia is approximately 1.5 million doses, with around 500,000 newborns each year, indicating a stable market demand [1] Company and Industry Summary - The partnership marks a significant achievement in Watson Bio's strategy to expand its "Chinese medicine" overseas, being the sixth localization project for PCV-13 after similar initiatives in Morocco, Indonesia, Egypt, Mexico, and Bangladesh [2] - The collaboration was facilitated by Revon Bio FZ-LLC through its resource network, highlighting the role of international partnerships in expanding vaccine accessibility [2]

云南沃森生物技术股份有限公司 疫苗），国内尚无呼吸道合胞病毒疫苗获批上市。根据公开资料显示，2023-2024 年度，RSV疫苗全球销售额约为40亿美元。 关于收到呼吸道合胞病毒 mRNA 疫苗《药物临床试验批准通 知书》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。 由云南沃森生物技术股份有限公司（以下简称"公司"或"沃森生物"）、 复旦大学、上海蓝鹊生物医药有限公司（以下简称"蓝鹊生物"）及公司子公司 玉溪沃森生物技术有限公司、北京沃森创新生物技术有限公司联合研发并共同申 请临床试验的呼吸道合胞病毒mRNA疫苗，于近日获得国家药品监督管理局签发 的《药物临床试验批准通知书》。通知书编号为：2025LP02790；2025LP02791。 注册分类：预防用生物制品。审批结论：根据《中华人民共和国药品管理法》《中 华人民共和国疫苗管理法》及有关规定，经审查，2025年7月31日受理的呼吸道 合胞病毒mRNA疫苗符合药品注册的有关要求，同意开展预防呼吸道合胞病毒感 染引起的下呼吸道相关疾病的临床试验。药物临床试验应当自批准之日起3年内 实施，3年内未有受 ...

Core Viewpoint - Watson Bio has received clinical trial approval for its respiratory syncytial virus mRNA vaccine, developed in collaboration with Fudan University and Shanghai Bluebird Biopharmaceuticals, marking a significant step in the company's vaccine development efforts [1] Group 1: Vaccine Development - The mRNA vaccine is based on an independently developed mRNA vaccine technology platform aimed at preventing lower respiratory tract diseases caused by respiratory syncytial virus infections [1] - Currently, there are three respiratory syncytial virus vaccines available in foreign markets, while no similar products have been approved in China [1] Group 2: Clinical Trial and Market Impact - The vaccine has been approved to enter clinical trials; however, it is noted that this approval will not significantly impact the company's performance for the current fiscal year [1] - There remains uncertainty regarding the results of the subsequent confirmatory Phase III clinical trials and the drug application for market approval [1]

Core Viewpoint - The domestic vaccine industry is experiencing significant pressure due to economic downturns, declining birth rates, reduced vaccination willingness, and intensified market competition, leading to frequent executive changes among companies [1][3]. Group 1: Executive Changes - Sun Wanfeng has resigned from his position as employee representative director and vice president of Baike Bio, but will continue as assistant to the chairman [1]. - There are rumors of changes in the management of Kangtai Bio, but the company has confirmed that Vice President Yu Bing remains in his position [1]. - Frequent executive turnover is noted in the domestic vaccine industry, with several companies undergoing leadership changes since late 2024 [3]. Group 2: Financial Performance - In the first half of 2025, only 5 out of 10 listed vaccine companies in A-shares reported revenue growth, with only 3 achieving positive net profit growth [3]. - Baike Bio reported a revenue of 284.9 million yuan with a net loss of 73.57 million yuan, marking a year-on-year revenue decline of 53.93% and a net profit decline of 153.47% [4]. - Kangtai Bio's revenue was 1.392 billion yuan with a net profit of 37.53 million yuan, showing a revenue growth of 15.81% but a significant net profit decline of 77.30% [4]. Group 3: Market Competition - The HPV vaccine market is experiencing aggressive price competition, with prices for the bivalent HPV vaccine dropping below 100 yuan, and the lowest price recorded at 27.5 yuan per dose [5]. - The flu vaccine market is also seeing price reductions, with prices for quadrivalent flu vaccines dropping from 128 yuan to 88 yuan per dose [6]. - The pneumococcal vaccine market is highly competitive, with Pfizer withdrawing from the market due to intense competition from domestic products [6]. Group 4: Growth Opportunities - Despite the challenges, there are structural growth opportunities in the vaccine market, exemplified by Olin Bio's adsorbed tetanus vaccine, which achieved a revenue growth of 35.17% in the first half of 2025 [7].

Group 1 - Watson Bio's subsidiary, Yuxi Watson Biotechnology Co., Ltd., has signed an agreement with Pharmaniaga Lifescience Sdn. Bhd. for the distribution and local production of the PCV-13 vaccine in Malaysia [1] - The agreement aims to facilitate technology transfer, local production, and commercialization of the PCV-13 vaccine, addressing the stable annual demand of approximately 1.5 million doses in Malaysia [1] - This collaboration is part of Watson Bio's strategy to expand its "Chinese medicine" overseas, marking the sixth localization project for the PCV-13 vaccine after similar initiatives in Morocco, Indonesia, Egypt, Mexico, and Bangladesh [2] Group 2 - Pharmaniaga Berhad is the largest listed integrated healthcare company in Malaysia, with its subsidiary having obtained EU GMP certification in 2013 and becoming the first Malaysian pharmaceutical company with human vaccine filling capabilities in 2021 [2] - Watson Bio, established in 2001, is the first company in China and the second globally to independently develop and successfully market the PCV-13 vaccine, maintaining a leading market share in China since 2021 [3] - RevonBio FZ-LLC, based in Dubai, supports Chinese biopharmaceutical companies in commercializing their products in emerging markets [4]

Group 1 - The company, Watson Bio, stated on October 24 that it will disclose any substantial and phase-related progress in the research and registration of its vaccines in a timely manner [2]

Core Viewpoint - Watson Bio stated on October 24 that updates regarding significant matters such as external investments should be based on the company's disclosed announcements and encouraged investors to stay informed [2] Group 1 - The company responded to investor inquiries on its interactive platform [2] - The company emphasized the importance of relying on official announcements for information regarding major developments [2] - Investors are encouraged to continuously monitor the company's disclosures for updates [2]

Core Viewpoint - Watson Bio (300142) is actively managing the production, approval, and sales of its bivalent HPV vaccine through its subsidiary Yuxi Zerun Biotechnology Co., Ltd, ensuring product availability and compliance with policy changes [1] Group 1 - The bivalent HPV vaccine's production and sales processes are currently operating normally [1] - The company is monitoring policy adjustments and is prepared to take proactive measures to respond [1] - The goal is to ensure product supply and benefit a wider audience [1]

Core Viewpoint - Watson Bio's subsidiary, Yuxi Zerun Biotechnology Co., Ltd., is actively engaged in the production, batch release application, and sales of its bivalent HPV vaccine, ensuring normal operations and product supply [1]. Group 1 - The company is closely monitoring policy changes and is prepared to take proactive measures to ensure product availability and accessibility to a wider audience [1]. - There have been inquiries from investors regarding the company's absence in recent HPV vaccine tenders in Liaoning Province, where only one competitor submitted a bid [3]. - The company has not disclosed any unknown information related to its bidding status in the HPV vaccine procurement processes in Guangdong Province, where a similar situation occurred [3].