Company Overview - Yimufeng Biotech is a leading global innovative cell therapy company, with its core product IMC002 being a potential best-in-class anti-CLDN18.2 CAR-T cell therapy candidate, currently in pivotal Phase III clinical trials for solid tumors [2] - The company also has a first-in-class anti-EpCAM CAR-T cell therapy candidate (IMC001) in Phase I/IIa clinical trials, targeting various epithelial-derived tumors, and a proprietary manufacturing process for cost-effective CAR-T production [3] - Yimufeng Biotech aims to leverage the large patient population for solid tumors in China and globally, creating significant market potential [2] Financial Information - For the fiscal year 2024, the company reported other income and revenue of approximately 3.36 million RMB, 2.137 million RMB for the nine months ended September 30, 2024, and 2.877 million RMB for the nine months ended September 30, 2025 [4] - Research and development expenses for the fiscal year 2024 were recorded at 54.44 million RMB, 38.574 million RMB for the nine months ended September 30, 2024, and 48.694 million RMB for the nine months ended September 30, 2025 [5] Industry Overview - CAR-T therapy is expanding significantly from hematologic malignancies to solid tumors and autoimmune diseases, presenting substantial growth opportunities [8] - The treatment shows promising efficacy against blood cancers, and researchers are developing innovative strategies to address challenges in solid tumor treatment [8] - The CAR-T field is evolving through traditional technology improvements and the development of new platforms, with next-generation CAR designs enhancing targeting precision and safety [8]

香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分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。 Shenzhen Immunofoco Biotechnology Co., Ltd. 深圳易慕峰生物科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證監 會」）的要求而刊發，僅用作提供資料予香港公眾人士。 本申請版本為草擬本，其內所載資料並不完整，亦可能會作出重大變動。 閣下閱覽本文件， 即代表 閣下知悉、接納並向深圳易慕峰生物科技股份有限公司（「本公司」）、本公司的獨家保 薦人、保薦人兼整體協調人、顧問及包銷團成員表示同意： 本公司招股章程根據香港法例第32章公司（清盤及雜項條文）條例送呈香港公司註冊處處長登記 前，本公司不會向香港公眾人士提出要約或邀請。倘在適當時候向香港公眾人士提出要約或邀 請，有意投資者務請僅依據於香港公司註冊處處長註冊的本公司招股章程作出投資決定，招股 章程 ...

Core Viewpoint - Legend Biotech's CAR-T therapy, Carvykti, is showing significant commercial success, particularly in the U.S. market, with projected revenues reaching $1.888 billion in 2025, a 95.9% increase from the previous year [2][3]. Group 1: Company Performance - Carvykti generated $1.888 billion in revenue for 2025, up from $963 million in the previous year [2]. - The therapy has treated over 10,000 patients since its approval in the U.S. in February 2022 [2]. - Legend Biotech expects Carvykti to become profitable in the fiscal year 2025 and anticipates overall profitability by 2026 [2]. Group 2: Market Expansion - Carvykti is currently available in over 279 treatment centers across 14 global markets, with the majority of revenue coming from the U.S. market, projected to reach $1.493 billion in 2025 [3]. - The therapy's pricing in the U.S. is significantly higher than that of CAR-T therapies available in China, despite also being approved in the Chinese market [3]. - The collaboration with Johnson & Johnson allows Legend Biotech to retain 70% of the rights in Greater China and 50% in Europe, the U.S., and Japan [3].

Core Viewpoint - Legend Biotech's CAR-T therapy, Carvykti, is showing significant commercial success, particularly in the U.S. market, with a reported revenue of $1.888 billion in 2025, marking a 95.9% increase from the previous year [3][4]. Group 1 - Carvykti is the first Chinese-origin CAR-T therapy approved for use in the U.S., having received approval in February 2022 [3]. - The cumulative number of patients treated with Carvykti has surpassed 10,000, indicating strong market penetration [3]. - The production facility for Carvykti in Raritan, U.S., is now the largest cell therapy manufacturing site in the country [3]. Group 2 - Legend Biotech holds 70% rights for Carvykti in Greater China and 50% rights in Europe, the U.S., and Japan, following a global collaboration agreement with Johnson & Johnson's Janssen in December 2017 [4]. - In 2025, Carvykti's revenue in the U.S. reached $1.493 billion, accounting for nearly 80% of its total revenue, highlighting the therapy's reliance on the U.S. market [4]. - Despite being approved in China, Carvykti has not yet commenced commercial sales in the Chinese market, and its pricing in the U.S. is significantly higher than that of CAR-T therapies available in China [4].

Group 1 - The company achieved a significant milestone by commercializing its CAR-T therapy, Zevokiorunsai (CT053), for the treatment of relapsed/refractory multiple myeloma (R/R MM), marking a successful transition from research to commercialization [1] - Zevokiorunsai received NMPA approval in February 2024, becoming one of the first BCMA-targeted CAR-T drugs approved in China, with a 71.6% sCR/CR rate among R/R MM patients [1] - The company has established a deep collaboration with East China Pharmaceutical, which has formed a dedicated commercialization team to promote Zevokiorunsai, with over 111 valid orders received [1] Group 2 - The company is advancing its pipeline in solid tumors with its core product, Shurujikiorunsai (CT041), targeting CLDN18.2 for gastric and gastroesophageal junction adenocarcinomas, which has entered the NDA stage [2] - CT041 demonstrated significant improvements in progression-free survival (mPFS) and overall survival (mOS) in clinical trials, particularly in patients with CLDN18.2 positive G/GEJC [3] Group 3 - The company is developing a universal CAR-T platform, THANK-u Plus, aimed at standardizing and scaling cell therapy production, with promising results in overcoming immune rejection issues [3] - CT0596, targeting BCMA, has received IND applications for clinical trials in R/R MM and primary plasma cell leukemia (pPCL), while CT1190B is in trials for R/R B-NHL [4] Group 4 - Preliminary results for CT0596 in R/R MM show a median follow-up of 4.14 months, with 6 out of 8 evaluable patients achieving at least partial response, and no severe adverse events reported [4] - The company has a pipeline for in vivo CAR-T therapies, demonstrating significant efficacy in mouse models for targeting CD19/CD20 [4] Group 5 - Revenue projections for the company are estimated at 118 million, 310 million, and 714 million yuan for 2025, 2026, and 2027 respectively, with net losses expected to decrease over the same period [4]

Group 1 - The National Medical Products Administration has approved the CAR-T cell therapy product, Nakiolunase injection, for the treatment of relapsed or refractory large B-cell lymphoma after second-line or higher systemic therapy, making it the only CAR-T product in China that covers both leukemia and lymphoma indications [1] - Lymphoma is one of the most common malignant hematological tumors, with large B-cell lymphoma being the most prevalent type of adult non-Hodgkin lymphoma. Approximately 40% of patients experience progression or relapse after first-line treatment, indicating a poor prognosis and significant clinical challenges [1] - Nakiolunase injection is China's first CD19 CAR-T cell therapy product with full independent intellectual property rights, developed from the long-term technological innovations of the Chinese Academy of Medical Sciences Hematology Hospital, featuring a unique global CD19scFv (HI19a) structure and internationally leading production processes [1] Group 2 - In November 2023, Nakiolunase injection was approved for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia, based on results from a pivotal phase II clinical study that evaluated its use in treating refractory large B-cell lymphoma [2] - The key clinical study was led by the Chinese Academy of Medical Sciences Hematology Hospital and Ruijin Hospital affiliated with Shanghai Jiao Tong University, conducted across more than ten clinical centers nationwide [2] - Clinical research data indicate that Nakiolunase injection provides durable remission and long-term survival benefits for lymphoma patients, demonstrating safety and offering a potential cure for patients facing significant treatment challenges [2]

Core Viewpoint - Anke Bio plans to invest 30 million yuan in a stake in Boshengji Pharmaceutical Technology, while also establishing an exclusive agency agreement for the PA3-17 injection product in Greater China [1][2] Group 1: Investment and Stake - Anke Bio will increase its stake in Boshengji from approximately 20% to 21.41% after the investment [1] - The pre-investment valuation of Boshengji is set at 1.74 billion yuan, consistent with its post-investment valuation from the previous financing round in December 2021 [1] Group 2: Product Collaboration - Anke Bio will act as the exclusive agent for the PA3-17 injection product in the Greater China market, with a formal agreement to be signed after the product's market application [2][3] - Boshengji has committed to prioritizing Anke Bio as the exclusive agency for future product launches [3] Group 3: Product Details and Market Potential - PA3-17 is the first targeted CD7 autologous CAR-T cell therapy product approved for clinical trials, aimed at treating adult relapsed and refractory CD7-positive hematological malignancies [3] - The product utilizes a non-gene editing strategy to address industry challenges and has established a new quality control system [3] - The market for follicle-stimulating hormone is projected to exceed 4 billion yuan by 2025, with Anke Bio aiming to capture market share quickly [4] Group 4: Financial Performance - In Q3, Anke Bio reported a revenue of 670 million yuan, a year-on-year increase of 7.7%, and a net profit of 185 million yuan, up 6.56% year-on-year [4]

Company Announcements - *ST Zhengping has completed the stock suspension review and will resume trading on November 12, confirming normal production and operation without significant changes [1] - Upwind New Materials is in the product development stage for its embodied intelligent robot business, which has not yet achieved mass production or revenue generation [2] - Shannon Chip Innovation's fourth largest shareholder, Shenzhen Xinlianpu, has pledged 1.27 million shares for financing purposes [3] - Qing Shui Yuan's phosphorus trichloride products are primarily used in the production of water treatment agents [4] - Midea Group announced a cash dividend plan of 5 yuan per 10 shares, totaling 3.448 billion yuan, with the record date on November 17 [4] - Huiyuan Communication is planning a change of control, leading to a stock suspension starting November 12 [5] - Shen Gong Co. has clarified that some research reports on its performance forecasts represent only analysts' personal views [6] - World is developing diamond micro-drills for PCB processing, which are still in the R&D phase [6] - Haike New Source has signed an agreement with Kunlun New Materials for the purchase of 596,200 tons of electrolyte solvent [7] - Tongxing Technology plans to invest 3.2 billion yuan in a project to produce 100,000 tons of sodium battery cathode materials and 6 GWh battery cells [8] Investments & Contracts - Zhongjin Irradiation is investing 200 million yuan to build an electronic accelerator intelligent manufacturing project [10] - Hongri Da is collaborating with Te Du Technology and Hongke Tongchuang to establish a joint venture for semiconductor packaging [10] Shareholding Changes - Jian Kai Technology's controlling shareholder Xuanzhao plans to transfer 3% of its shares through a pricing inquiry [12] - Yue Wannianqing's shareholder Hehe Investment intends to reduce its stake by up to 3% [14] Financing & Capital Increase - Weiteng Electric plans to raise up to 300 million yuan through a private placement for various manufacturing projects [22] Other Developments - Zhifei Biological has received approval for clinical trials of a vaccine for adolescents and adults [23] - Shanghai Kaibao has obtained approval for clinical trials of a drug for acute ischemic stroke [24]

Core Viewpoint - The company, Beijing Sunshine Nuohuo Pharmaceutical Research Co., Ltd., plans to invest 15 million yuan in Shanghai Yuanma Zhiyao Biotechnology Co., Ltd., acquiring an 8.20% stake, which aligns with its strategic focus on CAR-T cell therapy and nucleic acid drugs [2][4]. Investment Overview - The investment amount is 15 million yuan, with the company subscribing to an increase in registered capital of 110,556 yuan in Yuanma Zhiyao [2][4]. - The investment does not require board or shareholder approval as it has been approved by the company's general manager office [5]. Investment Characteristics - This investment is not classified as a related party transaction or a major asset restructuring according to relevant regulations [3][6]. Target Company Overview - Yuanma Zhiyao focuses on innovative research and development of circular mRNA-based CAR-T nucleic acid drugs, aiming to address unmet clinical needs in autoimmune diseases and tumors [8]. - The company has established a leading circular mRNA drug development platform with significant technological breakthroughs in various high-barrier processes [8][9]. Competitive Advantages - Yuanma Zhiyao possesses a globally leading full-chain technology platform, including three core technology platforms: byterna.AI for intelligent design, cmCAR for efficient expression, and CellectLNP for targeted delivery [9]. - The company has a differentiated pipeline layout with multiple CAR-T lines, enhancing treatment efficacy for autoimmune diseases and tumors [10]. Team Strength - The founding team consists of industry experts and returnee PhDs with notable achievements in both academia and industry, providing a strong foundation for drug development [11]. Impact of Investment - This investment aligns with the company's strategic layout in the CAR-T field and is expected to enhance collaboration in technology and resources, promoting global business development [12]. - The investment will not pressure the company's cash flow or affect its existing operations, ensuring no significant impact on financial status [12].

Core Insights - The article highlights the success of Carvykti (siltuximab), a CAR-T cell therapy developed by Legend Biotech, which has surpassed $1 billion in annual sales, categorizing it as a "blockbuster" drug in the biopharmaceutical industry [1][4]. Company Overview - Legend Biotech's Carvykti achieved third-quarter sales of $524 million, with total sales for the year reaching $1.332 billion, following first and second-quarter sales of $369 million and $439 million, respectively [1]. - The drug was first approved in the U.S. on February 28, 2022, and is the first Chinese-origin CAR-T cell therapy to be commercialized overseas [1][3]. Market Dynamics - Carvykti is marketed in collaboration with Johnson & Johnson, with Legend Biotech handling commercialization in Greater China and J&J managing the rest of the world. Revenue sharing is structured at 70:30 for Greater China and 50:50 for other global regions [1]. - As of now, there are seven CAR-T cell therapies approved in China, but high prices limit accessibility, with Carvykti not yet sold in the Chinese market [4]. Sales Performance - Carvykti's price in the U.S. has increased from $465,000 to $555,300, significantly higher than the domestic CAR-T therapies priced over 1 million yuan, attributed to its efficacy in treating multiple myeloma [4]. - The drug's sales in overseas markets are on a stable growth trajectory, with a notable performance in multiple myeloma indications [4]. Clinical Data - Recent long-term follow-up data from the CARTITUDE-1 study indicated that 33% of patients with relapsed or refractory multiple myeloma remained disease-free for five years or longer after a single infusion of Carvykti, marking a significant advancement in treatment outcomes [5]. - Carvykti is the first CAR-T therapy to demonstrate overall survival benefits compared to standard therapies in multiple myeloma treatment [5]. Financial Outlook - Legend Biotech is on track to turn a profit by 2026, following a net loss of approximately $101 million in the first quarter of 2025, driven by the increasing sales of Carvykti [5].