香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部 或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責任。 CanSino Biologics Inc. 康希諾生物股份公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6185） 海外監管公告 本 公 告 乃 康 希 諾 生 物 股 份 公 司（「本公司」）根 據 香 港 聯 合 交 易 所 有 限 公 司 證 券 上 市規則第13.10B條而發表。 茲 載 列 本 公 司 於 上 海 證 券 交 易 所 網 站 刊 發 的《康 希 諾 生 物 股 份 公 司2025年年度報 告摘要》《康希諾生物股份公司2025年年度報告》《康希諾生物股份公司第三屆董 事會第十次會議決議公告》《康希諾生物股份公司關於2025年度利潤分配方案的 公告》《康希諾生物股份公司關於續聘會計師事務所的公告》《康希諾生物股份公 司關於提請股東會授權董事會以簡易程序向特定對象發行股票的公告》《康希諾 生物股份公司關於2026年度對外擔保預計的公告》《康希諾生物股份公司2025年 ...

Core Viewpoint - The company, Olin Bio (688319.SH), is progressing towards a dual listing in Hong Kong, which could enhance its capital structure and international presence, while facing regulatory uncertainties regarding the approval process [1][2]. Stock Performance - As of February 13, 2026, Olin Bio's A-share price closed at 27.13 yuan, up 4.59%, with a trading volume of 255 million yuan and a turnover rate of 2.29% [1]. Strategic Advancement - The company aims to leverage the Hong Kong listing to accelerate its "bring in" (international patents and talent) and "go out" (global sales and technology transfer) strategies, focusing on differentiated areas such as superbug vaccines and adult vaccines [2]. - In November 2025, the company received a "satisfactory compliance" rating from the Philippines FDA, facilitating entry into the Southeast Asian market, and established a vaccine production partnership with Griffith University in Australia [2]. Project Development - The proceeds from the Hong Kong listing will be allocated to the clinical development of the rHPV (Helicobacter pylori) vaccine, expansion of the III phase clinical trials for the golden staph vaccine, and upgrades to production facilities [3]. - The restructured golden staph vaccine has completed enrollment of 6,000 cases for the III phase clinical trial, with complete data expected in the first half of 2026; the quadrivalent influenza virus split vaccine (MDCK cells) commenced its III phase clinical trial in October 2025 [3]. Future Development - The Hong Kong listing is anticipated to attract international investors, broadening financing channels, which is particularly beneficial for the long-term investment required in innovative vaccine research and development [4]. - A dual listing is expected to enhance the company's international visibility, promoting business development collaborations and expansion into overseas markets [5].

Leadership Change - Sanofi has announced the appointment of Belén Garijo as the new CEO, succeeding Paul Hudson, whose contract will not be renewed [1] - Garijo, currently the CEO of Merck KGaA, will assume her new role on April 29, 2026, after a five-year tenure at Merck KGaA [2] Financial Performance - Sanofi's vaccine revenue dropped by 5% in 2025, generating €7.9 billion compared to €8.3 billion in 2024, while overall net sales grew by 9.9% at constant exchange rates to reach €43.6 billion ($51.7 billion) [4] - The company is preparing for the loss of patent protection for Dupixent, which generated €14.7 billion last year [5] Challenges and Pipeline Issues - Sanofi is facing challenges in the US vaccine sector due to policy changes under the Trump administration, impacting immunization recommendations and new candidate approvals [3] - Recent pipeline disappointments include FDA rejections and failures in multiple sclerosis treatments, as well as mixed results for COPD candidates [6] Strategic Focus - Garijo's primary focus will be on enhancing the productivity, governance, and innovation capacity of Sanofi's R&D [7]

Group 1 - Company Changda Biological announced that its wholly-owned subsidiary, Changda Biological (Benxi) Co., Ltd., received approval from the National Medical Products Administration for clinical trials of a high-dose influenza virus split vaccine [1] - The approval highlights the long and uncertain development cycle of vaccine products, which may be influenced by various factors [1] Group 2 - Investors should exercise caution and consider investment risks associated with the vaccine development process [1] - Notable investments in the company include a joint investment of 1 billion yuan each from prominent investors Ge Weidong and Fang Wenyuan, leading to a significant increase in the company's stock price [1]

Core Viewpoint - The company, Green Bamboo Bio-B (02480.HK), focuses on the research and development of vaccines and therapeutic biological agents, with its core product being the recombinant herpes zoster candidate vaccine LZ901, which is not yet commercialized and relies on government subsidies for revenue [1] Recent Events - The Biologics License Application (BLA) for LZ901 was accepted by the National Medical Products Administration in February 2025 and is currently under normal review, making the review results and subsequent commercialization process a focal point for the market [2] Project Progress - The company has increased its pipeline of preclinical products to six, including recombinant HSV-1 vaccine (for oral herpes) and recombinant HSV-2 vaccine (for genital herpes), with potential disclosures regarding clinical trial applications or progress in the future [3] Financial Performance - The company regularly publishes monthly reports on share changes, with the latest report for the period ending December 31, 2024, to be disclosed on January 7, 2026, which may reflect changes in shareholder structure. Financial data for 2024 shows R&D expenses of 135 million yuan and a pre-tax loss of 168 million yuan, narrowing by 32.5% year-on-year. Investors should pay attention to the full-year performance announcement for 2025 to assess operational improvements [4] Company Status - The latest ESG rating from Huazheng Index as of October 31, 2025, is BB, ranking 25th in the industry. Any adjustments to this rating may impact the attention of institutional investors [5]

Core Viewpoint - The chairman of Wantai Biological Pharmacy, Qiu Zixin, plans to reduce his shareholding through a centralized bidding method, with all proceeds from the sale intended for donation to Xiamen University Education Development Foundation and Xiamen No.1 Middle School [2][5]. Company Overview - Wantai Biological Pharmacy was established in 1991 and focuses on the research, production, and sales of diagnostic reagents, vaccines, and medical devices. The company operates mainly in two sectors: in vitro diagnostics and vaccines [2]. - The actual controller of Wantai Biological is Zhong Shanshan, who holds 73.49% of the company's shares [2]. HPV Vaccine Development - Wantai Biological has a strong presence in the HPV vaccine sector, having launched its self-developed bivalent HPV vaccine (Xinkening) in 2019, which was the first domestically produced bivalent HPV vaccine in China. The nine-valent HPV vaccine (Xinkening 9) is expected to be approved for market release in 2025, marking it as the first domestically produced nine-valent HPV vaccine [2]. Shareholding Reduction Plan - Qiu Zixin announced a plan to reduce his shareholding by up to 5 million shares, which represents no more than 0.3954% of the company's total share capital. The reduction period is set from March 12, 2026, to June 11, 2026 [5]. - As of now, Qiu Zixin holds 3.5469% of Wantai Biological's shares [2]. Financial Performance and Market Reaction - In 2021, Wantai Biological's stock price peaked at 146.54 yuan, with a net profit exceeding 2 billion yuan. However, in 2025, the company's stock price fell by 36.22%, and it is projected to report a net loss of 330 million to 410 million yuan for the year [6]. - Following the announcement of the share reduction plan, Wantai Biological's stock price experienced a slight decline over three consecutive days, closing at 40.47 yuan, with a market capitalization of approximately 51.17 billion yuan. The stock has seen a decline of over 70% from its historical peak [6]. Investor Concerns - Investors have expressed concerns regarding the potential impact of the share reduction on market liquidity, questioned the choice of centralized bidding over block trading, and raised doubts about the complexity of the donation process [7].

Industry Overview - The overall number of vaccine batch approvals in 2025 is projected to be 3,793, representing a year-on-year decline of 11.3%, primarily due to significant decreases in approvals for polio, meningitis, encephalitis, and measles-mumps-rubella vaccines [2][4] - Key vaccines expected to be approved in 2025 include Consonance's PCV13 and Wantai's 9-valent HPV vaccine, with several others in the review stage [1][4] Vaccine Development Pipeline - The RSV vaccine development is competitive among domestic companies, focusing on mRNA and recombinant protein technologies [1] - The shingles vaccine has four products in the application stage, indicating a rich pipeline [1] - Consonance's PCV13 has been approved, enhancing its product pipeline [1] - Wantai's 9-valent HPV vaccine is the first domestically produced vaccine to be approved [1] - Two human diploid rabies vaccines have been approved, with multiple products submitted for approval [1] - The meningitis vaccine pipeline is concentrated on MCV4, with a five-valent meningococcal vaccine from Sinovac entering clinical phase I [1] - The flu vaccine market has several products approved, with many in clinical stages [1] - Multi-valent vaccines have fewer products on the market, but several companies are pursuing differentiated strategies [1] Company-Specific Insights - Zhifei Biological's vaccine batch approvals are expected to decline, with a significant drop in agency products, while several self-developed products are nearing market launch [4] - Kangtai Biological anticipates a slight decrease in batch approvals, with the varicella vaccine contributing to new growth, and multiple vaccines in the application stage [4] - Watson Biological expects a 16% year-on-year decline in batch approvals, with RSV and shingles mRNA vaccines approved for clinical trials [4] - Wantai Biological has seen a significant increase in 2-valent HPV batch approvals, with the 9-valent HPV vaccine approved for market [4] - Kangxino Biological's MCV4 batch approvals are expected to continue growing, with PCV13 approved for market [4] - Kanghua Biological's human diploid rabies vaccine batch approvals are projected to decline, while the acquisition of Namixin aims to expand its mRNA technology platform [4] - Olin Biological anticipates significant growth in tetanus batch approvals, with data from its pneumococcal vaccine expected in the first half of 2026 [4] - Baike Biological expects a 42% year-on-year decline in vaccine batch approvals, with a liquid nasal spray flu vaccine approved [4] Investment Recommendations - Companies with strong self-research capabilities and innovative vaccine pipelines, such as Kangtai Biological, Kanghua Biological, Kangxino Biological, and Olin Biological, are recommended for investment focus, especially those with products nearing market launch [4]

Summary of the Conference Call for Bio Co., Ltd. Industry and Company Overview - The conference call focused on Bio Co., Ltd., specifically its developments in the African Swine Fever (ASF) vaccine sector, which is a critical area in the animal health industry. Key Points and Arguments 1. **Positive Results from ASF Vaccine Trials** Bio Co., Ltd. reported successful results from its subunit ASF vaccine attack experiment, where no deaths occurred among the immunized group under an 8,000 HAD virus attack, indicating a high protection rate. This sets a solid foundation for subsequent clinical trials and approvals [2][3]. 2. **Upcoming Clinical Trials** The company plans to conduct a second attack experiment on April 12, aiming to verify the vaccine's effectiveness throughout its lifecycle. The completion of the second clinical trial is expected by late May or early June [2][3]. 3. **Market Approval Timeline** If the results are favorable, the China National Center for Animal Health (CNCA) may participate in the review process, potentially accelerating the approval timeline. The company anticipates obtaining a temporary production license by mid to late 2026, allowing for large-scale production [2][3]. 4. **Pricing Strategy** The initial pricing for the ASF vaccine is set at 25 RMB per dose, which balances affordability for farmers and the technological uniqueness of the product. The expected gross margin is projected to exceed 50%, indicating strong profitability potential [2][5]. 5. **Competitive Advantages** Bio Co., Ltd. is currently the only company certified by the Chinese Academy of Sciences to conduct clinical trials for the ASF vaccine, providing a significant competitive edge. The involvement of CNCA in the process is expected to expedite market entry [2][6][7]. 6. **Collaboration in Vietnam** The company is collaborating with local firms in Vietnam to promote the ASF vaccine, addressing the issue of local pig populations infected with recombinant viruses. They expect to obtain production licenses within six months and begin sales within 18 months [2][9]. 7. **Future Developments in mRNA Vaccines** Bio Co., Ltd. is also working on an mRNA vaccine for feline infectious peritonitis, projected to be launched domestically by 2028. The company is collaborating with two major U.S. pharmaceutical companies, utilizing a revenue-sharing model that could yield significant returns [3][10]. 8. **Overall Business Outlook for 2026** The company anticipates explosive growth in the ruminant service sector in 2026, driven by the ASF vaccine's market entry. The poultry business remains stable, and overall, the company expects positive trends across its various segments [3][12]. Additional Important Information - The company is currently focusing on testing the vaccine primarily for piglets, with plans for further discussions regarding its application for sows based on feedback from breeding farms [5]. - The competitive landscape includes other companies like Jinyu Biological, which has completed clinical trials but may face delays in large-scale production due to additional trial requirements [8]. - The fourth quarter's specific data on other products like swine foot-and-mouth disease vaccines is pending, but the ASF vaccine is expected to drive sales of existing products [11].

Core Viewpoint - Shenzhen Kangtai Biological Products Co., Ltd. has achieved significant recognition in the field of vaccine research and development, particularly through its subsidiary Beijing Minhui Biological Technology Co., Ltd., which recently won the second prize of the Jiangsu Provincial Science and Technology Progress Award for its project on rapid confirmation and precise prevention of emerging viral infectious diseases [1][2]. Group 1: Project Recognition - The project "Key Technology Innovation and Application for Rapid Confirmation and Precise Prevention of Emerging Viral Infectious Diseases" addresses critical challenges in the prevention and control of new viral infectious diseases [1]. - The project was led by the Jiangsu Provincial Center for Disease Control and Prevention and nominated by the Provincial Health Commission, highlighting the importance of collaboration in public health initiatives [1]. Group 2: Vaccine Development - Minhui Biological's independently developed inactivated virus vaccine platform is a core component of the project, receiving high recognition for its innovation, practicality, and scientific value [2]. - The company has successfully obtained clinical trial approval from the National Medical Products Administration for its bivalent and quadrivalent inactivated enterovirus vaccines, with the quadrivalent vaccine currently in Phase I clinical trials [2]. - There are currently no approved bivalent or quadrivalent enterovirus vaccines available globally, indicating a significant market opportunity for the company [2]. Group 3: Strategic Implications - The recent award is seen as a validation of the company's commitment to independent innovation and its comprehensive strength in vaccine research and development, which is expected to enhance its core competitiveness and influence in the market [2]. - Successful development of these vaccines could further enrich the company's multi-valent vaccine portfolio, solidifying its market position and providing a strong foundation for sustainable growth [2].

Core Viewpoint - The company Zhifei Biological (300122.SZ) has received approval from the National Medical Products Administration for clinical trials of its recombinant herpes zoster vaccine ZFA01 in individuals aged 40 and above, marking a significant advancement in its vaccine development efforts [1] Group 1: Vaccine Development - The recombinant herpes zoster vaccine ZFA01, developed by the company's wholly-owned subsidiary Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has been granted a clinical trial approval notice (Notice No. 2026LP00366) [1] - The vaccine utilizes a novel adjuvant developed in-house, which is expected to stimulate both cellular and humoral immune responses, potentially enhancing the vaccine's protective efficacy [1] Group 2: Market Position and Product Portfolio - As of the announcement date, there are only two approved herpes zoster vaccines available in the domestic market, indicating a competitive opportunity for the company [1] - The approval of the clinical trial application is a result of the company's focus on innovation and strengthening its core technology, which may enrich its adult vaccine offerings and enhance its market position [1]