Investment Rating - The report maintains a "Recommended" rating for the company, with projected net profits of 1.22 billion, 4.21 billion, and 5.10 billion for the years 2025-2027, corresponding to PE ratios of 151, 44, and 36 respectively [4]. Core Insights - The company achieved a significant increase in overseas revenue, amounting to 419 million, representing a year-on-year growth of 324.27%. This growth is attributed to the successful internationalization strategy and multiple product approvals in various countries [4]. - The company reported a total revenue of 2.063 billion for the first three quarters of 2025, a slight increase of 2.24% year-on-year, but faced a substantial decline in net profit, which fell by 86.0% to 49.16 million due to changes in product sales structure and increased costs [4]. - The company is actively advancing its research and development of multi-valent vaccines, with R&D expenses reaching 420 million, a 34.74% increase year-on-year, indicating a commitment to innovation and product development [4]. Financial Summary - For the first three quarters of 2025, the company reported a net cash flow from operating activities of 362 million, a year-on-year increase of 53.45%, primarily due to increased sales collections [4]. - The third quarter of 2025 saw a decline in revenue to 671 million, down 17.74% year-on-year, with net profit dropping 93.74% to 11.62 million, reflecting the impact of adjustments in the immunization program for the DTP vaccine [4]. - The financial forecast indicates a projected revenue of 3.148 billion for 2025, with a revenue growth rate of 18.7%, and a net profit of 122 million, reflecting a decrease of 39.3% [5][7].

Core Insights - 康希诺 reported strong financial performance in Q3 2025, with revenue of 310 million yuan, a year-on-year increase of 17.67%, and a net profit of 27.93 million yuan, up 842.01% [1] - For the first three quarters, the company achieved revenue of 693 million yuan, a 22.13% increase year-on-year, and a net profit of 14.44 million yuan, recovering from a loss of 222 million yuan in the same period last year [1] - The growth is primarily driven by the market performance of its core product, the four-valent meningococcal conjugate vaccine, Manhaixin®, which has established a significant market share due to its innovative advantages [1] Financial Performance - The comprehensive gross profit margin for the reporting period was 80.67%, an increase of 6.47 percentage points year-on-year, significantly exceeding the industry average [1] - Other income recognized from government grants and international funding reached 91.6 million yuan, a year-on-year increase of 233.63%, contributing to the improvement in overall performance [2] Product Development - 康希诺 is accelerating its R&D pipeline to diversify its product offerings, with the launch of the 13-valent pneumococcal polysaccharide conjugate vaccine, Youpeixin, which was approved in June and launched in September [2] - The new vaccine utilizes a dual carrier technology to reduce immune interference and induce higher antibody levels against prevalent serotypes in Chinese children, creating a new growth avenue for the company [2] - Other pipeline developments include a component DTP vaccine for infants, which is under priority review, and a component DTP vaccine for adolescents and adults that has completed Phase III clinical trials, aiming to establish a comprehensive prevention strategy across all age groups [2] Breakthroughs in Other Areas - 康希诺 has achieved significant breakthroughs in other vaccine areas, including the approval of a recombinant trivalent poliovirus vaccine and a combined vaccine for diphtheria, tetanus, pertussis, and meningococcal diseases for clinical trials [3] - The recombinant poliovirus vaccine has received ongoing funding from the Gates Foundation and is recognized by the World Health Organization as a preferred vaccine for global polio eradication [3]

Core Insights - The company reported a revenue of 2.063 billion yuan for the first three quarters of 2025, a year-on-year increase of 2.24%, while the net profit attributable to shareholders was 49.1577 million yuan, a significant decline of 86.0% due to changes in product sales structure and corresponding cost increases [1] - The company is actively pursuing an internationalization strategy, achieving overseas revenue of 41.9 million yuan, a remarkable growth of 324.27% year-on-year, with multiple product approvals in various countries [2] - The company maintains a high level of R&D investment, with R&D expenses reaching 420 million yuan, a year-on-year increase of 34.74%, indicating a strong pipeline of multi-valent vaccines in advanced clinical stages [3] - The company is expected to see net profits of 122 million yuan, 421 million yuan, and 510 million yuan from 2025 to 2027, with corresponding price-to-earnings ratios of 151, 44, and 36 times, maintaining a "recommended" rating [4] Financial Performance - For the first three quarters of 2025, the company's main revenue was 2.063 billion yuan, with a net profit of 49.1577 million yuan, reflecting an 86.0% decline [1] - The net cash flow from operating activities was 362 million yuan, a year-on-year increase of 53.45%, attributed to increased sales collections [1] - In Q3 2025, the company reported a single-quarter revenue of 671 million yuan, a year-on-year decrease of 17.74%, and a net profit of 11.6249 million yuan, down 93.74% [1] International Expansion - The company has made significant strides in international markets, with overseas revenue reaching 41.9 million yuan, a growth of 324.27% year-on-year [2] - Key product approvals include the 13-valent pneumococcal polysaccharide conjugate vaccine in Turkey, Indonesia, Nicaragua, and Pakistan, marking successful entries into various international markets [2] - The company's international footprint now spans over 20 countries, with ongoing collaborations in densely populated regions under initiatives like the "Belt and Road" [2] Research and Development - R&D expenses for the first three quarters of 2025 were 420 million yuan, representing a 34.74% increase, with an R&D expense ratio of 20.36% [3] - Several products are in critical clinical stages, including the Sabin strain inactivated polio vaccine and the oral pentavalent reconstituted rotavirus vaccine, among others [3] - The company is also proactively developing innovative vaccines targeting challenging pathogens, such as Klebsiella pneumoniae, which is known for its antibiotic resistance [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company is experiencing a recovery in performance, with a focus on the orderly advancement of non-epidemic vaccine clinical trials. The revenue for Q1-Q3 2025 reached 1.042 billion yuan, a year-on-year increase of 7.38%, while the net profit attributable to shareholders was 161 million yuan, a year-on-year decrease of 4.85%. In Q3 alone, revenue was 423 million yuan, up 17.76% year-on-year, and net profit increased significantly by 116.40% year-on-year [2][3] - The company maintains its profit forecast for 2025-2027, expecting net profits of 188 million yuan, 352 million yuan, and 508 million yuan respectively, with corresponding EPS of 0.17 yuan, 0.32 yuan, and 0.46 yuan. The current stock price corresponds to PE ratios of 65.4, 35.0, and 24.3 times for the respective years [2] Summary by Sections Financial Performance - For Q1-Q3 2025, the company reported a revenue of 1.042 billion yuan, a 7.38% increase year-on-year, and a net profit of 161 million yuan, down 4.85% year-on-year. Q3 revenue was 423 million yuan, up 17.76% year-on-year, with net profit soaring by 116.40% year-on-year [2] - The company forecasts net profits of 188 million yuan in 2025, 352 million yuan in 2026, and 508 million yuan in 2027, with EPS projected at 0.17 yuan, 0.32 yuan, and 0.46 yuan respectively [2][3] Market Position and Growth - The company is expanding its market share in the competitive pig vaccine sector, with Q1-Q3 2025 sales of pig foot-and-mouth disease vaccines increasing by 50% year-on-year. The revenue from non-foot-and-mouth vaccines also saw significant growth, with diarrhea vaccine revenue up 120% year-on-year [3] - Direct sales channels for poultry vaccines showed strong performance, with a 40% year-on-year increase in direct sales revenue. The company is also expanding its international business, with revenue growth exceeding 16 million yuan in Q1-Q3 2025 [3] Research and Development - The company emphasizes stable operations and innovation in R&D, with R&D expenses of 96 million yuan in Q1-Q3 2025, a 9.08% increase year-on-year. The non-epidemic vaccine development is progressing, with the first clinical trial expected to begin by the end of December 2025 [4]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported sales of €12.4 billion, representing a 7% increase compared to the previous year [3] - Business EPS reached €2.91, reflecting a robust growth of €0.19 or 13% compared to Q3 2024 [13] - The gross margin increased by 2.3 percentage points this quarter, driven by an improved product mix and productivity gains [11] Business Line Data and Key Metrics Changes - Sales growth was primarily driven by the pharmaceutical segment, particularly immunology and recent launches, with new launches contributing €1.8 billion, representing 15% of total sales [4][11] - Dupixent sales reached €4 billion in quarterly sales for the first time, with a 26% growth this quarter [5][11] - Vaccine sales were €3.4 billion, reflecting competitive price pressure and lower flu immunization rates in the U.S. [6] Market Data and Key Metrics Changes - Outside the U.S., sales grew by 21%, exceeding €1 billion in the quarter [6] - The U.S. market remains the largest, with Dupixent surpassing €3 billion in quarterly sales [5] Company Strategy and Development Direction - The company is focused on expanding access to treatments and improving patient affordability, as demonstrated by the expansion of its patient affordability program for insulins [4][10] - The company aims to maintain its profitable growth momentum and has reiterated its full-year guidance of high single-digit sales growth and low double-digit business EPS growth at constant exchange rates [13][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of the year, citing strong performance from new launches and Dupixent [3] - The company is committed to innovation in respiratory viruses and improving patient access to healthcare, with a goal of treating 2 million patients for non-communicable diseases by 2030 [10] Other Important Information - The company has completed acquisitions of Drensbios DR0201, Vigil Neuroscience, and Blueprint Medicines, which are factored into its guidance [13][15] - The company is advancing its flu pandemic preparedness with two programs and is working on flu-COVID combination vaccines [9] Q&A Session Summary Question: Update on Poly-SPMS regulatory debate and confidence in resolving FDA questions - Management confirmed ongoing dialogue with the FDA and submitted data sets, looking forward to the PDUFA date of December 28 [30][31] Question: Updates on U.S. policy conversations - Management stated that they have had ongoing dialogue with the U.S. government and are focused on demonstrating the value they can bring [36][37] Question: Q4 ordering trends for Bayfortis and competition impact - Management confirmed expectations for Q4 to be similar to Q3 for Bayfortis, with a focus on increasing vaccination coverage rates in the U.S. [39][41] Question: 2027 guidance and potential levers to mitigate EBIT gap - Management acknowledged a significant R&D reimbursement decrease in 2027 but indicated that they expect to grow at a reasonable pace despite the gap [45][49] Question: Update on relipiravir and timing dynamics - Management indicated that the outcome for the phase three studies for CIDP is delayed due to patient recruitment but remains optimistic about the results [59][60] Question: Dupixent gross margin improvement and COPD launch - Management noted that Dupixent's gross margin improvement was limited in Q3, with overall gross margin increasing by 2.5% [66][85]

Core Viewpoint - Moderna's candidate vaccine mRNA-1647 for congenital cytomegalovirus (CMV) has failed to meet primary efficacy endpoints in Phase III clinical trials, leading the company to terminate its development [1]. Group 1: Clinical Trial Results - The Phase III trial involved approximately 7,500 women aged 16-40 from around 300 research centers across 13 countries [1]. - The vaccine demonstrated an efficacy rate for primary CMV infection of only 6% to 23%, significantly below the company's target [1]. Group 2: Market Reaction - Following the announcement, Moderna's stock price dropped over 4%, trading at $25.77 in pre-market [1]. - The closing price before the announcement was $26.85, reflecting a decline of $1.08 or 4.02% in pre-market trading [2].

Group 1 - Haoyoubo signed a framework agreement with Roche Diagnostics for the procurement of chemiluminescent antibody detection products, which will enhance brand recognition and market share in China, although the agreement does not specify financial details and is not expected to significantly impact the company's performance this year [1] - Chengda Bio established a strategic cooperation with the Institute of Microbiology, Chinese Academy of Sciences, focusing on emerging infectious diseases and vector-borne disease prevention, which is expected to accelerate vaccine and biopharmaceutical development [2][2] - Shengxiang Bio plans to invest 20 million yuan in a new fund aimed at supporting innovative healthcare startups, aligning with the company's strategic development and investment direction [3] Group 2 - Guoyao Co. reported a net profit of approximately 1.492 billion yuan for the first three quarters of 2025, with revenue of about 39.381 billion yuan, reflecting a slight year-on-year increase despite intensified competition in the pharmaceutical industry [4] - Puluo Pharmaceutical announced a net profit of around 700 million yuan for the first three quarters of 2025, with revenue of approximately 7.764 billion yuan, indicating a year-on-year decline due to pressures in the formulation and raw material drug sectors, although the company anticipates a gradual recovery next year [5]

Core Viewpoint - Kanghua Biotech (300841.SZ) demonstrates resilience and growth potential with a 11.54% year-on-year revenue increase in Q3 2025, achieving revenue of 356 million yuan and a net profit of 189 million yuan for the first three quarters [1] Group 1: Financial Performance - In Q3 2025, Kanghua Biotech reported revenue of 356 million yuan, marking an 11.54% increase compared to the same period last year [1] - For the first three quarters, the company achieved total revenue of 840 million yuan and a net profit attributable to shareholders of 189 million yuan [1] - The decline in net profit for the first three quarters narrowed by 9.23 percentage points compared to the semi-annual report, indicating improved operational quality [1] Group 2: Product Development and Market Potential - The freeze-dried human rabies vaccine (human diploid cells) is a key product for Kanghua Biotech, recognized as the "gold standard" by WHO due to its safety and efficacy [2] - The company is expanding production capacity for the rabies vaccine, with the production expansion project nearing completion and awaiting drug production license approval [2] - Kanghua Biotech's six-valent norovirus vaccine, licensed to HilleVax for $270.5 million, showcases the company's strong technical capabilities and market potential [2] Group 3: Industry Context and Future Prospects - Norovirus is a major cause of acute gastroenteritis globally, with no vaccines currently available, presenting a significant market opportunity as the norovirus vaccine market in China is projected to grow from 1.53 billion yuan to 22.93 billion yuan from 2026 to 2031, with a CAGR of 71.85% [3] - The six-valent norovirus vaccine has received clinical research approval in Australia and the U.S., with plans for clinical trials in China starting in December 2024 [4] Group 4: Strategic Developments - The transition of control to a state-owned investment fund from Shanghai is expected to provide Kanghua Biotech with not only capital but also a robust industrial resource network and strategic development platform [5][6] - The investment from the Shanghai biopharmaceutical fund highlights Kanghua Biotech's long-term intrinsic value amid the industry's adjustment phase [5] - The company aims to accelerate the diversification of its vaccine product line, potentially becoming a key platform for the Shanghai pharmaceutical industry in the vaccine sector [7]

Core Viewpoint - Clover Biopharmaceuticals-B (02197) announced positive preliminary data from two ongoing clinical trials based on its proprietary and fully validated Trimer-Tag vaccine development platform, evaluating the company's PreF respiratory combination vaccine candidates (RSV+hMPV±PIV3) [1] Group 1: Clinical Trials - An ongoing Phase I clinical trial in Australia is assessing the combination vaccine candidates SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) against SCB-1019 (Clover's RSV candidate vaccine) in a head-to-head comparison, targeting elderly individuals who have not previously received any RSV vaccine [1] - A Phase I clinical trial in the United States is conducting a head-to-head evaluation of SCB-1019 (Clover's RSV candidate vaccine) against AREXVY (GSK's RSV vaccine) in elderly individuals who have received at least two seasonal doses of AREXVY prior to enrollment [1]

本公告由三葉草生物製藥有限公司（「本公司」或「三葉草生物」，連同其附屬公司統稱「本集團」）董事 （「董事」）會（「董事會」）自願作出，以知會本公司股東及潛在投資者本集團最新的業務發展狀況。 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份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。 自願公告 三葉草生物公佈其呼吸道聯合疫苗(RSV-hMPV-PIV3) 及 RSV 疫苗重複接種在老年人群的 I 期臨床試驗均獲得積極數據 本公司欣然宣佈兩項正在進行的臨床試驗的積極初步數據，基於公司自研獨有已获全面驗證的 Trimer-Tag （ 白質三聚體化）疫苗研發平台 ，於於估公公司的 PreF 呼吸道聯合疫苗候選產品（RSV+hMPV±PIV3），包括： 呼吸道聯合疫苗候選產品 RSV+hMPV±PIV3 I 期臨床試驗(澳大利亞)：完整初步數據 在澳大利亞進行的一項 I 期臨床試驗中，老年人群受試者（60-85 歲）入組後被隨機分配接種 SCB-1022 （RSV+hMPV）、SCB-1033 （RSV+ ...