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，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Ab&B Bio-Tech CO., LTD. JS 江蘇中慧元通生物科技股份有限公司 （於中華人民共和國成立的股份有限公司） （股份代號：2627） 自願性公告 mRNA猴痘疫苗獲美國FDA的IND許可 本公告由江蘇中慧元通生物科技股份有限公司（「本公司」或「中慧生物」，連同其 附屬公司，統稱「本集團」）自願刊發，以告知本公司股東及潛在投資者有關本集 團最新業務發展的資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，於美國（「美國」），美國食品藥物 監督管理局（「FDA」）已許可本集團自主研發的在研mRNA猴痘疫苗的臨床研究用 新藥（「IND」）申請。 猴痘由猴痘病毒引發，而猴痘病毒是痘病毒科正痘病毒屬的一員。該病毒屬包括 廣泛的病毒群，包含牛痘病毒、天花病毒及鼠痘病毒等。在臨床前研究中，與中 國所用的天花病毒減毒活疫苗天壇株相比，我們的在研mRNA猴痘疫苗引發的猴 痘中和抗體水平明顯更高，而且 ...

Group 1 - The Hong Kong stock market's innovative drug sector is performing well, with the Hong Kong Stock Connect Innovative Drug ETF (159570) rising by 0.56% and achieving a trading volume exceeding 700 million CNY [1] - Over the past 10 days, the ETF has attracted over 360 million CNY in capital, with its latest scale surpassing 25 billion CNY, leading its peers significantly [1] - Key stocks within the ETF, such as Federated Pharmaceutical and Rongchang Biopharmaceutical, have shown notable gains, with Federated Pharmaceutical increasing by over 6% [1][2] Group 2 - The innovative drug business development (BD) is focused on unmet clinical needs, technological differentiation, and global value, with significant transactions in oncology and metabolic disease sectors [3][4] - In oncology, notable advancements include Rongchang Biopharmaceutical's PD-1/VEGF dual antibody RC148, which received a substantial upfront payment of 650 million USD from a partnership with Aibowei [3] - The metabolic disease sector is highlighted by Shiyao Group's GLP-1 receptor agonist SYH2082, which secured a 1.2 billion USD upfront payment from AstraZeneca [3] Group 3 - The mRNA vaccine sector is experiencing rapid approvals, with several domestic products receiving IND approvals, indicating a swift advancement in local innovation [5] - The FDA has relaxed its drug review policies, allowing for a single key clinical trial to suffice for new drug approvals, which is expected to significantly reduce development timelines and costs [6] - New drug approvals include Hansoh Pharmaceutical's lung cancer drug "Amatinib," which has been granted marketing authorization in the EU for specific NSCLC patient populations [6]

Core Viewpoint - Moderna's stock price surged 7.58% to $43.15 after the release of its Q4 and full-year 2025 financial results, reaching a new high for the year [1] Financial Performance - Q4 revenue was $678 million, exceeding market expectations of $625.1 million, despite a 30% year-over-year decline; strong sales of COVID-19 vaccines in the U.S. alleviated concerns about ongoing revenue shrinkage [2] - Full-year operating expenses for 2025 were revised down to $5-5.2 billion, a reduction of $200 million from previous guidance; year-end cash reserves are expected to reach $8.1 billion, up from earlier estimates of $6.5-7 billion, enhancing financial resilience [3] - Q4 loss per share was $2.11, an improvement from a loss of $2.91 in the same period last year, indicating a contraction in losses [3] Business Developments - The RSV vaccine mRESVIA has been approved in 40 countries; although the flu vaccine mRNA-1010 was rejected by the FDA, the company plans to reapply with additional data; the personalized cancer vaccine mRNA-4157, in collaboration with Merck, has entered Phase III clinical trials, indicating progress in a diversified pipeline [4] - Management emphasized a shift of resources towards high-margin beauty and health businesses, optimizing the brand portfolio [4] Market Performance - On the same day, the Nasdaq index rose by 0.42%, and the biotechnology sector increased by 1.85%, reflecting positive industry sentiment [5] Capital and Technical Aspects - Low valuation (negative TTM P/E) and high volatility attracted short-term capital inflows, with a daily price fluctuation of 8.90% and trading volume at 1.6 times the recent average [6] Future Outlook - The setback in flu vaccine approval may delay the 2028 breakeven target; the company remains reliant on COVID-19 vaccine revenue, which constitutes the majority of Q4 2025 revenue, and the commercial success of new pipelines is yet to be observed [7]

Core Insights - Moderna's Chief Medical Officer Jacqueline Miller, who played a pivotal role in the development of the mRNA-based COVID-19 vaccine Spikevax, will resign effective March 2 [1] Company Summary - The announcement of Jacqueline Miller's resignation was made by Moderna on a Friday [1]

Core Viewpoint - Chengdu Kanghua Biological Products Co., Ltd. plans to acquire 100% equity of Naimixin (Shanghai) Biotechnology Co., Ltd. through phased capital increase and equity transfer, aiming to integrate Naimixin's mRNA vaccine technology platform to accelerate its new generation vaccine R&D pipeline [1][2]. Group 1: Acquisition Details - The acquisition will proceed in three phases, starting with an investment of up to 120 million yuan for a 27.27% stake in Naimixin [1]. - Subsequent phases will depend on the clinical progress of Naimixin's core product, the RSV mRNA vaccine, and the development milestones of the HPV therapeutic vaccine project [1][2]. Group 2: Naimixin's Technology and Products - Naimixin has developed a comprehensive mRNA drug technology system covering sequence design, delivery systems, and production processes, with its core product being an RSV mRNA vaccine currently in Phase I clinical trials [2]. - The RSV vaccine utilizes a self-developed LNP delivery system and has shown over five times the neutralizing antibody levels compared to traditional inactivated vaccines in preclinical studies [2]. Group 3: Valuation and Milestones - The transaction employs a phased valuation linked to R&D progress, with pre-investment valuations set at a maximum of 320 million yuan, 440 million yuan, and 830 million yuan for each phase [3]. - The final transaction will be directly tied to clinical data from the RSV vaccine and results from the HPV therapeutic vaccine's dose escalation trials [3]. Group 4: Strategic Implications - This acquisition is the first significant merger since a state-owned investment group became the controlling shareholder of Kanghua Biological, potentially providing stronger financial and policy support for innovative drug development [3]. - The domestic market currently lacks a domestic RSV vaccine, and successful development of Naimixin's RSV mRNA vaccine could fill this market gap, marking a critical step in Kanghua Biological's strategic positioning in the biopharmaceutical frontier technology sector [3].

Core Viewpoint - The vaccine sector is experiencing strong performance due to the emergence of Nipah virus cases in India, leading to increased investment in related biopharmaceutical ETFs [1][3]. Group 1: Market Performance - The biopharmaceutical ETF Huatai (159839) saw a significant increase of 2.13% with a trading volume exceeding 60 million yuan, marking a 133% increase compared to the previous period [1]. - The ETF received a net subscription of 16.5 million shares today, accumulating nearly 40 million yuan in the last five days [1]. - Major component stocks of the ETF showed positive performance, with Zhifei Biological rising nearly 15%, Watson Bio increasing over 11%, and Hualan Biological up nearly 7% [3]. Group 2: Nipah Virus Impact - Five confirmed cases of Nipah virus infection have been reported in West Bengal, India, including healthcare workers, with nearly 100 individuals under home quarantine [3]. - The Nipah virus can attack the lungs and brain, with symptoms including fever, headache, drowsiness, and confusion, and a mortality rate of over 40% [3]. - There is currently no specific vaccine or effective treatment for the Nipah virus [3]. Group 3: Vaccine Development and Innovation - Hualan Biological received approval for clinical trials of its recombinant shingles vaccine, while Zhifei Biological's CA111 injection has entered Phase I clinical trials [7]. - The vaccine industry is focusing on technological upgrades and exploring new markets, particularly in the Middle East [8]. - The growth of the vaccine sector is expected to be driven by the increasing immunization needs of the aging population, shifting focus from children to a broader demographic [8]. Group 4: mRNA Vaccine Developments - Recent positive clinical data from mRNA vaccine leaders indicate a breakthrough development window for therapeutic cancer vaccines [9]. - mRNA technology offers significant advantages over traditional methods, including rapid production capabilities and enhanced safety profiles [9].

Group 1: Business Performance and Growth - The company's core products continue to drive growth, with the vaccine business accounting for over 50% of the overall business, becoming a key driver for product structure upgrade [2] - In 2025, the company achieved significant progress in R&D, obtaining the world's first clinical approval for an mRNA vaccine for food animals, and established a GMP mRNA vaccine production line [2] - The company has optimized internal management, resulting in a net profit growth rate significantly higher than revenue growth, showcasing operational resilience [2] Group 2: Market Expansion and Future Plans - In 2025, the company completed multiple overseas product registrations, laying the foundation for future large-scale exports [3] - Future global expansion will focus on new product registrations, acquisitions of overseas companies, and increased R&D investment to gradually enhance the export share of formulations and vaccines [3] - The company aims to deepen its market presence in the pet sector and synthetic biology, contributing to performance growth [2] Group 3: Supply Chain and Coverage - As of 2025, the company's supply chain covers approximately 7,000 pet hospitals and 4,000 pet stores, achieving a national coverage rate of about 35% [3] - Key provinces for supply chain expansion include Guangdong, Jiangsu, and Shandong, while regions like Sichuan and Fujian present untapped market opportunities [3] Group 4: Product Focus and Cost Management - The raw material drug segment will focus on high-margin products such as enrofloxacin and tobramycin, while enhancing production efficiency and reducing unit costs [3] - The company is monitoring the impact of the declining pig cycle on its livestock formulation business, maintaining profitability through comprehensive solutions for poultry clients [4] Group 5: Synthetic Biology Project - The synthetic biology project, initiated in 2025 with a total investment of 680 million yuan, aims to establish a demonstration project for the industrialization of microbial protein [3] - The project is on track, with equipment commissioning and trial production expected to commence by the end of 2026 [3]

Core Viewpoint - The company has developed an mRNA vaccine for shingles, which has received acceptance for clinical trial application from the National Medical Products Administration [1] Group 1 - The company's wholly-owned subsidiary, Zhifei Longkema, is responsible for the research and development of the shingles mRNA vaccine [1] - The clinical trial application for the shingles mRNA vaccine has been officially accepted, indicating progress in the vaccine's development [1]

Core Viewpoint - Youcare Pharmaceutical Group Co., Ltd. (悦康药业) has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, aiming to expand its market presence after being listed on the A-share market since December 2020, with a current market capitalization of approximately RMB 10.4 billion [1][16]. Business Overview - Established in 2001, Youcare Pharmaceutical is a biopharmaceutical company with a diverse portfolio of commercially recognized products, focusing on research, development, production, and commercialization of therapies including oligonucleotides, mRNA vaccines, peptides, and innovative traditional Chinese medicine [2][17]. - Key products include Youcare Tong® (Ginkgo biloba extract injection) for managing cerebrovascular and peripheral vascular disorders, Ailisi® (Sildenafil citrate tablets) for treating erectile dysfunction, and other significant products like Liweike® (Omeprazole enteric-coated capsules) and Yuedaning® (Metformin sustained-release tablets) [2][17]. Pipeline and R&D - The company's pipeline includes innovative candidates across various stages, focusing on four core modalities: oligonucleotides, mRNA vaccines, peptides, and innovative traditional Chinese medicine [4][19]. - Notable projects include YKYY013 for chronic hepatitis B, YKYY015 targeting PCSK9 for cardiovascular metabolism, and YKYY029 for hypertension, all of which have received clinical trial approvals in China and the U.S. [4][19]. - In the mRNA vaccine segment, projects YKYY025 and YKYY026 aim to prevent RSV and varicella-zoster virus infections, respectively, with U.S. clinical trial approvals [4][19]. Financial Performance - For the fiscal years ending December 31, 2022, 2023, and 2024, and the first seven months of 2025, Youcare Pharmaceutical reported revenues of RMB 4.52 billion, RMB 4.18 billion, RMB 3.77 billion, and RMB 1.30 billion, respectively, with corresponding net profits of RMB 339 million, RMB 187 million, RMB 121 million, and a loss of RMB 146 million [12][27]. - The revenue breakdown shows significant contributions from cardiovascular, anti-infection, digestive system, and diabetes-related products, with cardiovascular products generating RMB 2.76 billion in 2022 [6][21]. Shareholding Structure - Prior to the Hong Kong listing, the major shareholders include Mr. Yu Weishi and Ms. Ma Guiying, who collectively hold approximately 48.65% of the company, making them the controlling shareholders [7][22]. Board of Directors - The board consists of 11 members, including 7 executive directors led by Mr. Yu Weishi as Chairman and Mr. Yu Fei as General Manager, along with 4 non-executive directors with diverse backgrounds in finance and healthcare [10][25].

Company Overview - Yuyuan Pharmaceutical is a biopharmaceutical company focused on the research, development, production, and commercialization of therapies in four modalities: oligonucleotides, mRNA vaccines, peptides, and innovative traditional Chinese medicine [3] - The company leverages its commercial product portfolio, cross-modal R&D technology platform, GMP-certified production system, and nationwide commercialization network to advance differentiated innovation pipelines in major therapeutic areas with significant unmet needs and long-term growth potential [3][4] - Key products such as Yuyuan Tong (Ginkgo biloba extract injection) and Ailisi (Sildenafil citrate tablets) contribute significantly to the company's revenue and cash flow, providing a financial foundation for ongoing R&D investment and capacity expansion [3] Product Pipeline - The company's pipeline includes innovative candidates across discovery, preclinical, and clinical stages, addressing significant unmet needs in major disease areas, with a focus on development in China and potentially overseas [4] Financial Performance - The company recorded revenues of approximately RMB 4.52 billion, RMB 4.18 billion, RMB 3.77 billion, and RMB 1.30 billion for the fiscal years ending December 31, 2022, 2023, 2024, and the seven months ending July 31, 2025, respectively [10] - Gross profit for the same periods was approximately RMB 2.87 billion, RMB 2.58 billion, RMB 2.15 billion, and RMB 596 million, with corresponding gross margins of 63.5%, 61.6%, 56.9%, and 45.7% [12] - The company reported a net loss of approximately RMB 146 million for the seven months ending July 31, 2025, primarily due to decreased revenue from cardiovascular products and significant investments in marketing and R&D activities [11] Industry Overview - The global and Chinese pharmaceutical markets are expected to continue expanding from 2020 to 2024, driven by increasing medical demand, a growing burden of chronic diseases, and improvements in drug innovation and access [13] - The top five therapeutic areas by revenue in 2024 globally will be digestive and metabolic, oncology, systemic anti-infectives, nervous system, and respiratory [14] - The cardiovascular drug market is projected to grow from USD 87.3 billion in 2020 to USD 106.5 billion in 2024, with a compound annual growth rate (CAGR) of 5.1%, expected to reach USD 165.5 billion by 2035 [19]