[Table_scodeMsg1] 公司研究丨深度报告丨欧林生物（688319.SH） [Table_Title] 破伤风疫苗龙头，金葡菌疫苗全球创新 丨证券研究报告丨 报告要点 [Table_Summary] 破伤风疫苗提供稳定现金流，金葡菌疫苗成为新的增长点。公司目前占据破伤风疫苗市场龙头 地位，在市场空间扩容过程中持续引领行业。随着金葡菌疫苗持续推进，公司新增长引擎出现， 打造可持续的增长曲线。长远来看，公司布局幽门螺旋杆菌疫苗、鲍曼不动杆菌疫苗、铜绿假 单胞菌疫苗等前沿/重磅品种，不断丰富研发管线深度和厚度，构筑深厚护城河。 分析师及联系人 [Table_Author] 彭英骐 张楠 SAC：S0490524030005 SAC：S0490524070006 SFC：BUZ392 %% %% %% %% research.95579.com 1 请阅读最后评级说明和重要声明 2 / 35 %% %% %% %% research.95579.com 2 [Table_scodeMsg2] 欧林生物（688319.SH） cjzqdt11111 [Table_Title2] 破伤风疫苗龙头，金葡菌疫苗全 ...

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].

Core Viewpoint - The company is actively exploring the potential of its recombinant Staphylococcus aureus vaccine, which currently targets closed orthopedic surgeries, with plans to expand its applications to other clinical indications, particularly pressure ulcers, which affect over 4 million patients annually in China [2] Group 1: Vaccine Development and Market Potential - The recombinant Staphylococcus aureus vaccine has a broad market outlook as it can be extended to multiple departments related to hospital infections [2] - The company has initiated work on the second indication for the vaccine, targeting pressure ulcers, which represents a significant patient population in China [2] Group 2: Infection Statistics and Medical Needs - According to Zhi Shi Consulting, the number of MRSA infections in China is projected to reach 2.3 million cases in 2024, increasing to 2.6 million by 2035, while global MRSA cases are expected to reach 7.4 million by 2035 [2] - The high medical burden of Staphylococcus aureus infections and the growing issue of antibiotic resistance highlight the urgent need for effective vaccines, which remain unmet globally [2] Group 3: International Expansion - The company’s recombinant Staphylococcus aureus vaccine not only has a market foundation in China but also possesses potential for international expansion, with ongoing efforts to pursue related overseas collaborations [2]

Core Viewpoint - The company is progressing normally with the Phase III clinical trial of the gold-staphylococcus vaccine, with no unblinding completed yet and no efficacy data results formed [2] Group 1: Clinical Trial Progress - The company expects to complete the initial and retesting of all serum samples by the end of Q1 this year [2] - Data cleaning is currently underway, with expectations to achieve a phase lock and conduct the first efficacy unblinding after obtaining serum test reports in the first half of this year [2] - The clinical trial progress and results may be influenced by various factors, and the final outcomes will be based on the company's public information [2]

Core Viewpoint - The company is focusing on the clinical application of the recombinant goldenseal vaccine, leveraging its existing promotion network established through the tetanus vaccine [1] Group 1: Clinical Application and Promotion Strategy - The primary use case for the recombinant goldenseal vaccine is clinical application [1] - The company has built a mature promotion network based on the tetanus vaccine promotion system [1] - The company plans to apply the successful experience from the tetanus vaccine to the recombinant goldenseal vaccine [1] Group 2: Market Education and Support - The company aims to support academic research and market education to standardize in-hospital diagnostic processes [1] - This initiative is intended to help reduce antibiotic-resistant bacterial infections [1] - The company is committed to ensuring efficient commercialization of the vaccine [1] Group 3: Sales and Promotion Activities - The sales team will initiate preliminary promotion activities based on the product application status of the recombinant goldenseal vaccine [1]

Group 1 - The company has completed the enrollment for the restructured gold-staphylococcus vaccine by the end of May 2025 and is actively advancing data cleaning and related research work [1] - Based on current progress, the company expects to complete the unblinding process in the first half of 2026 [1] - The clinical trial progress and results may be influenced by various factors, and the final outcomes will be based on the company's public information [1]

Core Viewpoint - The primary goal of the interim analysis for the recombinant goldenseal vaccine is to reduce the development risk of a Class 1 new drug, with an independent assessment by the DSMB to determine whether to continue clinical trials, rather than using interim analysis data to apply for new drug approval prematurely [1] Group 1 - The company clarified that the clinical trial plan established with the CDE requires that the new drug application can only be submitted after all participants have been enrolled and the observation endpoint has been reached, meaning interim analysis results will not serve as a basis for application [1] - The company has chosen to only unblind the DSMB, while the research team remains blinded, which helps in risk management and avoids premature unblinding that could deplete sample size and affect the final statistical power and integrity of the trial [1]

Core Viewpoint - Chengdu Olin Biological Technology Co., Ltd. has submitted its application for a mainboard listing on the Hong Kong Stock Exchange, marking a significant step towards a dual listing in both A-share and H-share markets [1] Group 1: Company Overview - Olin Bio, established in 2009 and headquartered in Chengdu, specializes in the research, development, and production of human vaccines, with its main product being the adsorbed tetanus vaccine, which dominates the domestic market [1] - The company has shifted its strategic focus towards the development of innovative vaccines targeting multi-drug resistant bacteria [1] Group 2: Financial Performance - Olin Bio's financial performance shows a duality; while revenue has been stable due to a nearly 70% market share of its core product, the net profit margin remains low, fluctuating between 2% and 5% [2] - In the first half of 2025, the company achieved a revenue of 305 million yuan and a net profit of 13.23 million yuan, successfully turning around from losses [2] - The company's sales and distribution expenses have consistently exceeded 50% of revenue, and R&D expenses have remained above 20%, with 134 million yuan allocated for R&D in 2024 [2] Group 3: Revenue Dependency and Risks - The adsorbed tetanus vaccine is the primary revenue driver, contributing 80.1% to 93.7% of total income from 2022 to 2024, with projected sales of 536 million yuan in 2024, accounting for 90.99% of total revenue [3] - The reliance on a single product poses significant risks, as any fluctuations in market demand or competition could severely impact the company's performance [3] - Market forecasts for the adsorbed tetanus vaccine have been downgraded, with projections for 2030 reduced from 2.434 billion yuan to 1.5 billion yuan [3] Group 4: Accounts Receivable and Liquidity Issues - The company's accounts receivable rose from 524 million yuan in 2022 to 694 million yuan by mid-2025, with over 53.2% of receivables aging over one year [4] - The lengthening collection period has negatively impacted cash flow, with accounts receivable turnover days increasing from 272 days in 2022 to 328 days in 2025 [4] - The accumulated impairment losses on accounts receivable exceeded 46 million yuan during the reporting period, further eroding already thin net profits [4] Group 5: Capital Market Activities - Olin Bio terminated a planned A-share private placement aimed at raising 175 million yuan, later reduced to 125 million yuan, due to market conditions and company development plans [5] - The controlling shareholder reduced their stake by approximately 12.18 million shares, cashing out around 279 million yuan, leading to a decrease in their ownership percentage [5][6] Group 6: Future Prospects and Challenges - To mitigate reliance on a single product, Olin Bio is focusing on developing a "super bacteria vaccine," with its core candidate, a recombinant Staphylococcus aureus vaccine, currently in Phase III clinical trials [7] - The company aims to launch this product by 2027, alongside other vaccines targeting antibiotic-resistant bacteria [7] - However, the high costs and risks associated with R&D pose significant challenges, as historical precedents indicate potential pitfalls in vaccine development [7]

Core Viewpoint - Chengdu Olin Biological Technology Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, aiming to become another "A+H" listed vaccine company, following its listing on the Sci-Tech Innovation Board in June 2021 [1] Financial Performance - The company has shown an upward trend in revenue, with figures of 547 million, 494 million, 586 million, and 305 million RMB for the years 2022, 2023, 2024, and the first half of 2025 respectively [2][3] - Net profit figures for the same periods were 26.58 million, 11.44 million, 15.72 million, and 13.23 million RMB, indicating a significant improvement in the first half of 2025 with a profit of 13.20 million RMB, reversing previous losses [2][3] - The gross margin has consistently remained above 92%, reflecting strong pricing power and cost control [2] Market Position - Olin Biological holds approximately 70% market share in the domestic tetanus vaccine sector, with its main product, the adsorbed tetanus vaccine, being a significant revenue contributor [1][4] - The company has established a strong sales network covering 30 provinces and municipalities in China, with over 2,000 direct commercial relationships with district and county-level disease control centers [4] Research and Development - The company is focusing on developing vaccines for "super bacteria" and adult vaccines, with a comprehensive pipeline that includes the recombinant Staphylococcus aureus vaccine, which is in Phase III clinical trials [4][9] - R&D investment is projected to reach 134 million RMB in 2024, a 17% increase year-on-year, with the R&D team expanding from 59 to 136 members since 2020 [4][11] Market Growth Potential - The tetanus vaccine market in China is expected to grow from 2 billion RMB in 2019 to 8 billion RMB by 2024, with a compound annual growth rate (CAGR) of 40.2% [6] - The global incidence of tetanus is around 1 million cases annually, with 300,000 to 500,000 deaths, highlighting the ongoing public health challenge [6] Cash Flow and Financial Health - The company is experiencing cash flow pressure, with a net cash flow from operating activities of -9.73 million RMB in 2024 and -20 million RMB in the first half of 2025 [5] - Despite raising 95.91 million RMB through financing activities, the company’s self-sustaining ability remains a concern [5]

Core Viewpoint - Chengdu Olin Biological Technology Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, aiming to become another "A+H" listed vaccine company, following its listing on the Sci-Tech Innovation Board in June 2021 [2] Financial Performance - The company's revenue has shown an upward trend, with figures of 547 million, 494 million, 586 million, and 305 million RMB for the years 2022 to the first half of 2025 respectively [3][4] - Net profit figures for the same period were 26.58 million, 11.44 million, 15.72 million, and 13.23 million RMB, indicating a significant improvement in the first half of 2025 with a profit of 13.20 million RMB, marking a turnaround from losses [3][4] - The gross margin has consistently remained above 92%, reflecting strong pricing power and cost control [3] Market Position - Olin Biological holds a dominant position in the domestic tetanus vaccine market, with its main product, the adsorbed tetanus vaccine, capturing approximately 70% of the market share [2][5] - The company has established a comprehensive pipeline for "super bacteria vaccines" and "adult vaccines," focusing on unmet medical needs [5][12] Research and Development - The company is heavily investing in the development of vaccines targeting "super bacteria," with the recombinant Staphylococcus aureus vaccine entering Phase III clinical trials, expected to be the first of its kind globally [5][12] - R&D expenditure is projected to reach 134 million RMB in 2024, a 17% increase year-on-year, with the R&D team expanding from 59 to 136 members since 2020 [5][12] Market Growth Potential - The tetanus vaccine market in China is expected to grow from 2 billion RMB in 2019 to 8 billion RMB by 2024, with a compound annual growth rate (CAGR) of 40.2% [7] - The market is projected to further expand to 26 billion RMB by 2035, maintaining a CAGR of 10.8% from 2024 to 2035, indicating long-term growth potential [7] Challenges - The company faces significant cash flow pressures, with negative operating cash flow reported for 2024 and the first half of 2025, highlighting concerns over its financial sustainability [6][13] - The reliance on a single product for revenue generation poses risks, as market demand fluctuations or competition could impact performance stability [5][13]