一、《药品生产许可证》基本信息 企业名称：成都康华生物制品股份有限公司 注册地址：四川省成都经济技术开发区北京路 182 号 社会信用代码：91510112758779783Q 有效期至：2025 年 12 月 09 日 证券代码：300841 证券简称：康华生物 公告编号：2025-041 成都康华生物制品股份有限公司 关于公司药品生产许可证变更的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 成都康华生物制品股份有限公司（以下简称"公司""企业"）于近日获 得了四川省药品监督管理局下发的变更后的《药品生产许可证》，公司 ACYW135 群脑膜炎球菌多糖疫苗生产车间符合 GMP 要求，可正式复产。现将 有关情况公告如下： | 生产地址 | 车间 | 生产线 | 范围 | | --- | --- | --- | --- | | | 细菌性疫苗 | 群脑膜炎球菌多糖疫 ACYW135 | 预防用生物制品 群脑 | | 成都经济技术开发 | 车间 | 苗原液生产线 | （ACYW135 | | 区北京路 182 号 | 分包装车间 | ACYW135 群脑膜 ...

Policy Developments - The National Medical Products Administration (NMPA) reported five cases of illegal online sales of medical devices, including companies selling products without proper licenses and failing to meet regulatory requirements [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received approval for clinical trials of HDM2012, a novel antibody-drug conjugate targeting mucin-17, marking it as a global first-class biological product [3] - Novo Nordisk announced that the NMPA approved the new indication for Ozempic (semaglutide injection) for chronic kidney disease, making it the first GLP-1 receptor agonist approved for this use in China [4] - Wanfu Bio received a medical device registration certificate for its MSI detection kit, which is significant for various solid tumor patients [5] Financial Reports - Fuan Pharmaceutical projected a net profit decline of 39.95% to 53.81% for the first half of 2025, primarily due to price reductions from national procurement policies [6] Capital Market Activities - Kanghua Bio announced a transfer of shares that will change its controlling shareholder to Wanke Xin Bio, with a total transfer price of approximately 1.85 billion yuan [8] - Jichuan Pharmaceutical's stock will resume trading after a tender offer by Cao Fei, who will control 56.07% of the company post-offer [9] Industry Developments - A new oral antiviral drug for influenza, Marselevosavir, developed by Zhengxiang Pharmaceutical, has been approved for use in treating uncomplicated influenza in previously healthy adults [10] Public Opinion Alerts - Notai Bio is facing other risk warnings due to a prior administrative penalty for false reporting, which included inflating revenue and profits [11]

Group 1 - The core point of the news is that Kanghua Biotech's controlling shareholder will change to Wankexin Biotech, with the stock resuming trading on July 21 after a five-day suspension [1][3] - Wankexin Biotech will acquire 28.4666 million shares from existing shareholders, representing 21.91% of the total share capital after excluding repurchased shares, at a price of approximately 65.03 yuan per share, totaling about 1.851 billion yuan [3][4] - Following the share transfer, Wankexin Biotech will hold 29.99% of the voting rights in Kanghua Biotech, while the previous controlling shareholder, Wang Zhentao, will retain 8.08% of the shares but delegate voting rights to Wankexin Biotech [4][5] Group 2 - Wankexin Biotech was established on July 8, 2025, with a total investment of 763 million yuan, and is primarily controlled by the Shanghai Biomedical M&A Fund, which holds 80.209% of the partnership shares [6][8] - The Shanghai Biomedical M&A Fund was officially established on March 26, 2025, with a total target management scale of 10 billion yuan, aimed at supporting mergers and acquisitions in the biopharmaceutical industry [8][13] - The fund's partners include notable figures from the biopharmaceutical sector, with connections to various companies and investment backgrounds, indicating a strong network for potential growth and collaboration [10][11]

Core Viewpoint - Kanghua Biotech's controlling shareholder will change to Wankexin Biotech, leading to a significant stock price increase of 16.2% prior to the announcement [1][4]. Group 1: Shareholder Change - Kanghua Biotech announced on July 20 that its controlling shareholder will be transferred to Shanghai Wankexin Biotech, with a total of 28.4666 million shares, accounting for 21.91% of the total share capital, being sold at approximately 65.03 yuan per share, totaling about 1.851 billion yuan [4][5]. - After the transfer, Wankexin Biotech will hold 29.99% of the voting rights in Kanghua Biotech, while the previous controlling shareholder, Wang Zhentao, will retain 8.08% of the shares but delegate voting rights to Wankexin Biotech [4][5]. Group 2: Financial Commitments - Wang Zhentao and Aokang Group have committed that the net profit attributable to the parent company, after deducting non-recurring gains and losses, will not be less than 728 million yuan for the years 2025 to 2026, with R&D expenses not less than 260 million yuan [6]. Group 3: Wankexin Biotech Structure - Wankexin Biotech was established on July 8, 2025, with a total capital contribution of 763 million yuan, where the main controlling entity is Shanghai Shenshi Pharmaceutical Management Consulting Co., which holds 0.001% of the partnership shares [8][12]. - The Shanghai Biopharmaceutical M&A Fund holds 80.209% of the partnership shares in Wankexin Biotech, indicating significant involvement from this fund in the transaction [8][10]. Group 4: Background of Partners - The partners of Lubu Ka, which is involved in Wankexin Biotech, include individuals with significant roles in the Shanghai Biopharmaceutical M&A Fund, suggesting potential overlaps in management and strategic direction [12][16]. - Key figures such as Jiang Junhang and Liu Dawei have held prominent positions in both Wankexin Biotech and the Shanghai Biopharmaceutical M&A Fund, indicating a strong connection between the two entities [16].

Market Overview - The market experienced fluctuations with the Shanghai Composite Index reaching a new high for the year, while the ChiNext Index also hit a yearly peak before retreating [1] - The total trading volume in the Shanghai and Shenzhen markets was 1.57 trillion yuan, an increase of 31.7 billion yuan compared to the previous trading day [1] - The number of stocks that rose and fell was roughly equal, with sectors such as rare earth permanent magnets, lithium mining, non-ferrous metals, and coal showing significant gains [1] Company Announcements - Xiling Information announced that its controlling shareholder is planning a change in control, leading to a temporary suspension of its stock for up to two trading days [2] - Kanghua Bio disclosed that its controlling shareholder intends to transfer 28.47 million shares, representing 21.91% of the total share capital, to Shanghai Wankexin Biotechnology, with a total transaction value of approximately 1.85 billion yuan [3] - Qidi Design, in a consortium with other companies, has been pre-awarded a project for the Henan Airport Intelligent Computing Center, with a bid amount of 860 million yuan, which is expected to positively impact the company's performance [4] New Stock Subscription - A new stock, Hanguo Group, is available for subscription with an issue price of 15.43 yuan, and the subscription date is set for July 21, 2025 [6] External Market - The Nasdaq Composite Index slightly increased by 0.05%, continuing to set new closing highs, while Netflix shares fell over 5% [8] - Over the past week, the S&P 500 Index rose by 0.59%, the Nasdaq gained 1.51%, and the Dow Jones experienced a slight decline of 0.07% [8]

Core Viewpoint - Several listed companies in the Shanghai and Shenzhen markets have announced significant developments, including administrative penalties, stock suspensions, changes in control, and new project contracts, which may present investment opportunities and risks for investors [2]. Regulatory Actions - ST Renzihang received an administrative penalty from the China Securities Regulatory Commission for inflating revenue by 112 million yuan and profits by 73.2852 million yuan from 2020 to mid-2022, resulting in a fine of 5 million yuan for the company and 12 million yuan for four responsible individuals [3]. - ST Zitian's stock may be terminated due to failure to correct false financial reports as mandated by the Fujian Securities Regulatory Bureau, leading to a suspension of trading starting July 21 [4]. Changes in Control - Kanghua Biological announced a transfer of 28.466 million shares (21.91% of total shares) to Shanghai Wankexin Biological, changing its controlling shareholder, with the transfer price around 1.851 billion yuan [5]. - Xiling Information's actual controllers are planning a change in control, leading to a stock suspension starting July 21, with the suspension expected to last no more than two trading days [6]. Delisting and Termination - Zhongcheng Tui's stock has been decided to be terminated by the Shenzhen Stock Exchange, with the delisting date set for July 21, following a 15-day trading period after entering the delisting preparation phase [7]. Financial Developments - Morning Feng Technology plans to increase capital by 90 million yuan to its wholly-owned subsidiary, aiming to enhance its business in the integrated power and computing sectors [9]. - China First Heavy Industries expects a net loss of 90 million to 108 million yuan for the first half of 2025, an improvement from a loss of 173 million yuan in the same period last year [14][15]. - Shaanxi Guotou A reported a 5.74% increase in net profit for the first half of 2025, totaling 726 million yuan, despite a 2.95% decline in total revenue [16]. Shareholding Changes - Hengtong Co., Ltd. plans to reduce its shareholding by up to 3%, with a maximum of 21.425 million shares to be sold [17]. - Jinma Leisure's controlling shareholder plans to reduce holdings by up to 4.83%, totaling 471,200 shares [18]. - Tianli Lithium Energy's shareholder plans to reduce holdings by 4.55%, equating to 5.4 million shares, due to the fund's operational period nearing its end [24]. Major Contracts - Qidi Design, in a consortium, won a bid for the Henan Airport Intelligent Computing Center project, with a contract amount of 859 million yuan [29]. - Donghong Co., Ltd. secured a procurement project for pressure steel pipes and fittings, with a bid price of 109 million yuan [30]. - Dash Intelligent signed a contract worth 122 million yuan for the Shenzhen Urban Rail Transit Line 13 Phase II monitoring system [31].

Core Viewpoint - The control change of Kanghua Biotech has been revealed, with Shanghai Wankexin Biotechnology Partnership taking over from founder Wang Zhentao, marking a new strategic phase for the leading domestic innovative vaccine company [1][2] Group 1: Share Transfer Details - Kanghua Biotech announced the transfer of approximately 28.46 million shares, accounting for 21.9% of the total share capital after excluding repurchased shares, to Shanghai Wankexin for a consideration of 1.851 billion yuan [1] - After the transfer, Wang Zhentao will delegate voting rights for 10.5 million shares (8.08% of total shares) to Wankexin, resulting in Wankexin holding approximately 29.99% of voting rights [1] Group 2: Strategic Intent of the Acquisition - The acquisition by Wankexin reflects the strategic intent of Shanghai state-owned assets in the biopharmaceutical sector, emphasizing the importance of innovative vaccine assets [2] - The Shanghai Biopharmaceutical M&A Fund, which has significant backing from various state and private investors, aims to enhance Shanghai's position in the global biopharmaceutical industry [2] Group 3: Company Performance and Market Position - Kanghua Biotech has shown steady growth, achieving a revenue of 1.432 billion yuan and a net profit of 457 million yuan in 2024, supported by its innovative rabies vaccine [3][4] - The company has successfully transitioned from a technology breakthrough to capitalized operations since its listing on the Growth Enterprise Market in 2020, marking a significant milestone in its development [4][5] Group 4: Industry Context and Future Prospects - The Chinese vaccine industry is undergoing a transformation, shifting from scale expansion to innovation-driven growth, which presents both challenges and opportunities [4] - The integration and acquisition trends in the pharmaceutical industry are intensifying, with a focus on pipeline layout, technology platform integration, and global operational capabilities [4][5] - The collaboration between Kanghua Biotech and Wankexin is expected to unlock the company's research potential and market value, facilitating its transition from a vaccine powerhouse to a vaccine leader on the global stage [5]

Group 1 - The core point of the news is the accelerated pace of capital integration, with Kanghua Biological's major shareholder transferring a significant stake to Wankexin Biological, resulting in a change of control [1][2] - Kanghua Biological's major shareholder, Wang Zhentao, and his associates plan to transfer a total of 28.4666 million shares, representing 21.91% of the total share capital, for approximately 1.851 billion yuan at a price of 65.03 yuan per share [1][2] - Following the transfer, Wankexin Biological will hold 29.99% of the voting rights in Kanghua Biological, effectively making it the new controlling entity, while Wang Zhentao will retain 8.08% of the shares without control [1] Group 2 - Wankexin Biological will finance the acquisition through a combination of self-owned funds (700 million yuan) and bank loans (1.15 billion yuan), with a loan term of no less than 7 years [2] - The repayment of the acquisition loan is expected to come from contributions from Shanghai Biomedical M&A Private Equity Fund and Shanghai Pharmaceutical Group, along with Wankexin Biological's legal earnings [2] - Kanghua Biological has committed to a net profit of no less than 728 million yuan for the years 2025 and 2026, along with a minimum of 260 million yuan in R&D expenses during the same period [2] Group 3 - Kanghua Biological is engaged in the human vaccine business, with registered products including rabies vaccines and meningococcal polysaccharide vaccines, and is developing a six-valent norovirus vaccine [3] - The vaccine industry has seen significant changes since 2021, leading to a decline in Kanghua Biological's profits, although it remains profitable, with an estimated net profit of around 400 million yuan in 2024 [3] - Wankexin Biological's acquisition is based on recognizing the intrinsic value of Kanghua Biological and its future growth prospects in the industry [3]

Group 1 - The company, Chengdu Kanghua Biological Products Co., Ltd., has announced a suspension of trading due to the planned change of control involving its controlling shareholder, Wang Zhentao, which carries uncertainties [1][2] - The stock will resume trading on July 21, 2025, following the completion of the necessary agreements and regulatory approvals [3] - A share transfer agreement has been signed, where Wan Kexin Biological Technology Partnership intends to acquire a total of 28,466,638 shares from Wang Zhentao, Aokang Group, and Jinan Kangyue Qiming Investment Partnership, with a transfer price of 65.0266 yuan per share, totaling approximately 1.851 billion yuan [1][2] Group 2 - After the completion of the share transfer and voting rights delegation, Wan Kexin Biological will hold the voting rights of the company, effectively changing the actual controller from Wang Zhentao to no actual controller [2] - The company will continue to monitor the progress of the share transfer and ensure compliance with relevant laws and regulations, fulfilling its information disclosure obligations [3]

Core Viewpoint - The special verification opinion issued by Beijing Hankun Law Firm confirms that Shanghai Wankexin Biotechnology Partnership (Limited Partnership) does not have an actual controller, which is significant for its equity changes [2][9]. Group 1: Company Overview - Shanghai Wankexin Biotechnology Partnership (Limited Partnership) is registered in the China (Shanghai) Free Trade Zone with a total capital contribution of 763.01 million RMB [3][5]. - The executing partner of Wankexin is Shanghai Shanshi Biomedical Management Consulting Co., Ltd., which holds a 0.001% partnership share [4][6]. Group 2: Equity Structure - The partnership structure includes Shanghai Shanshi Biomedical Management Consulting Co., Ltd. (0.001%), Shanghai Biomedical M&A Private Fund Partnership (Limited Partnership) (80.209%), and Shanghai Pharmaceutical (Group) Co., Ltd. (19.790%) [5][6]. - The total capital contribution of the partnership is set to change to 763.01 million RMB following the entry of a new partner, Shanghai Pharmaceutical (Group) Co., Ltd., which will contribute 151 million RMB [5][6]. Group 3: Control Structure - The executing partner, Shanghai Shanshi Biomedical, has the authority to represent the partnership and make decisions regarding partnership affairs, indicating that it acts as the controlling entity [6][9]. - Shanghai Shanshi Biomedical is jointly owned by Shanghai Shanshi Capital Management Co., Ltd. and Lubuqa Enterprise Management Consulting Partnership (Limited Partnership), each holding 50% of the shares [7][9]. Group 4: Conclusion - The verification opinion concludes that there is no single shareholder capable of controlling the shareholder meeting or board of directors of Shanghai Shanshi Biomedical, thus confirming that both Shanghai Wankexin and Shanghai Shanshi Biomedical do not have an actual controller [9][10].