证券研究报告 | 行业深度报告 2025 年 08 月 20 日 创新器械系列专题研究报告（一） 高血压迎来创新疗法，RDN 开启微创降压新时代 消费品/生物医药 本文系统梳理了肾动脉去交感神经消融术（Renal Denervation，RDN）治疗 高血压的发展脉络，随着循证医学证据的不断积累，RDN 有效性和安全性逐步 被临床认可，有望成为药物难治性高血压的一线治疗选择。 ❑ 当前高血压治疗面临着何种瓶颈？ 高血压人群基数庞大，防控高血压对降低心血管风险具有重要意义。根据中 国心血管健康与疾病报告（2023），我国心血管疾病患病率持续上升，推算 高血压现患人数 2.45 亿。高血压是心血管病最主要的危险因素，心血管疾病 位居我国居民死因首位，占比近 50%，预防和控制高血压是降低心脑血管发 病率的核心策略之一。 药物治疗是当前高血压最主要的治疗方案，但存在局限性：（1）全球高血压 患者的药物治疗依从性普遍偏低，影响血压控制效果；（2）降压药物对于人 群庞大的顽固性和未控高血压患者疗效有限。因此，高血压亟需药物治疗以 外的、能长期平稳控制血压的全新治疗方式。 ❑ RDN 疗法作为一种创新疗法的优势? RDN ...

Core Viewpoint - The company is enhancing its strategic focus on major clients by establishing a dedicated service team to improve customer response efficiency and satisfaction, while expanding its collaboration with multinational corporations (MNCs) across the entire drug development cycle [1] Group 1: Strategic Initiatives - The company has initiated a major client strategy since last year, forming a "triangular" business team consisting of client managers, solution managers, and delivery managers to provide in-depth services to strategic clients [1] - A specialized major client service team has been established this year to coordinate business development resources across regions including China, the US, and Europe, significantly improving customer response efficiency and satisfaction [1] Group 2: Collaboration with MNCs - The collaboration with MNCs has evolved from supplying molecular building blocks to a comprehensive CMC (Chemistry, Manufacturing, and Controls) service, with increasing depth and project scale [1] - The company now covers the entire R&D cycle for MNCs, including drug discovery, clinical development, and CMC services from clinical phases I-III to commercialization [1] Group 3: Innovation and Project Development - The company is leveraging its solid foundation of cooperation and client trust to enter the new molecular pipeline development field for MNCs, with ongoing projects in cutting-edge areas such as peptides (non-natural amino acid building blocks) and ADC (antibody-drug conjugates) design [1] - The company is continuously deepening its collaborative efforts in innovative therapies [1]

智通财经APP获悉，和黄医药(00013)跌超13%，截至发稿，跌13.06%，报24.36港元，成交额4.01亿港 元。 据悉，和黄医药今年1月份宣布以6.08亿元出售其在上海和黄药业45%股份。花旗表示，出售事项将进 一步加强其资本和债务结构，并使其能够集中资源到核心业务领域。国泰君安表示，上述交易并有助于 公司专注于发现、开发和商业化治疗癌症和免疫性疾病的创新疗法的核心业务。 消息面上，和黄医药发布中期业绩，期内收入2.78亿美元，同比下降9.2%，主要由于内地市场销售额下 降，但呋喹替尼收入平稳，抵销相关影响。受惠出售非核心合资股权收益，录得纯利4.55亿美元，增长 16.6倍，每股盈利0.53美元。不派息。 ...

Group 1 - The core viewpoint of the article highlights the successful IPO of Nanjing Weili Zhizhi Bio-Tech Co., Ltd. on the Hong Kong Stock Exchange, with a first-day opening increase of 106.86% and a closing price of 67.1 HKD per share, resulting in a total market capitalization of 13 billion HKD [1] - The company aims to raise approximately 189 million USD through this issuance, with cornerstone investors including Zhengxin Valley Capital, Gao Yi Investment, Tencent, and E Fund [1][3] - Weili Zhizhi is a clinical-stage biotech company founded in 2012, focusing on the discovery, development, and commercialization of innovative therapies, with its founders having experience in tumor immunotherapy research at the National Cancer Institute in the United States [3] Group 2 - The company has a diversified product portfolio consisting of 14 innovative drug candidates, including 4 core products, all of which are among the leading candidates in global clinical progress [4] - Despite the long R&D cycles and heavy upfront investments typical in the biopharmaceutical industry, Weili Zhizhi reported a revenue of 8.865 million CNY in 2023, with net losses of 362 million CNY, 301 million CNY, and 75.367 million CNY for the first three months of 2023, 2024, and 2025 respectively, alongside R&D expenditures of 231 million CNY, 186 million CNY, and 57.751 million CNY during the same periods [5] - The company experienced significant market interest prior to its IPO, with cumulative fundraising exceeding 1 billion CNY and a subscription multiple of 3029 times, amounting to nearly 340 billion CNY in subscription amounts [5]

Core Viewpoint - Nanjing Valiant Biotech Co., Ltd. (referred to as "Valiant Biotech") has successfully listed on the Hong Kong Stock Exchange under the stock code 9887, raising a total of HKD 1.29 billion through the issuance of 36.8625 million shares at HKD 35 per share [1][3]. Company Overview - Valiant Biotech was established in 2012 and began operations in May 2014, with its registered location in Nanjing Jiangbei New District. The company focuses on the discovery, development, and commercialization of innovative therapies, particularly targeting diseases that existing PD-1/PD-L1 antibody therapies cannot treat, addressing unmet medical needs in oncology, autoimmune diseases, and other significant illnesses globally [4]. - The company currently has 14 innovative drugs in development, with 6 in clinical stages. Its core product, LBL-024, is set to enter a single-arm registration clinical trial in China for the treatment of advanced pulmonary neuroendocrine carcinoma in July 2024, potentially becoming the first approved drug specifically for this indication [5]. Founders and Management - The company was co-founded by Kang Xiaoqiang and Lai Shoupeng. Kang, aged 64, has extensive experience in the pharmaceutical industry, previously serving as Chief Immunology Scientist at Eli Lilly after ImClone Systems was acquired. He currently serves as the Executive Director, CEO, and General Manager of Valiant Biotech [6]. - Lai, aged 80, has nearly 30 years of experience in the biopharmaceutical industry and currently holds the position of Executive Director, Chief Strategy Officer, and Executive Vice President, overseeing strategic planning and overall operations [8]. Financial Performance - Valiant Biotech has not yet achieved profitability, reporting no revenue for the previous year and the first three quarters of this year. The company incurred a pre-tax loss of RMB 362.249 million for the last year, with significant research and development expenses amounting to RMB 230.858 million [9][10]. - Despite the lack of revenue, the company experienced high market interest, with a subscription rate of 3029 times and a total subscription amount nearing HKD 340 billion during its IPO [10]. Market Context - The successful listing of Valiant Biotech adds to the growing number of pharmaceutical companies from Nanjing on the Hong Kong Stock Exchange, following the recent IPO of another local company, Jiangsu Hengrui Medicine, among others [12].

Group 1 - The core viewpoint of the articles highlights the challenges and opportunities in the field of innovative therapies, particularly gene and cell therapies, as they seek to break through regulatory barriers and establish a supportive ecosystem for development [1][2][3] - The recent changes in the national medical insurance directory, including the introduction of a commercial health insurance innovation drug directory, represent a significant step forward for high-value new drugs, although policy barriers still exist in gene and cell therapy [2][3] - Companies like Shanghai Ruihongdi and Tongjin are leveraging the supportive policies in the Shanghai Free Trade Zone to enhance their development confidence, benefiting from proactive government services in talent recruitment and regulatory approvals [2][3] Group 2 - AI technology is transforming the research and production processes in the biotech industry, significantly improving efficiency in data processing and standardizing cell drug production, which is crucial for meeting the demands of a large patient population [3][4] - The evolution of international collaboration models, such as equity partnerships, allows Chinese companies to secure long-term benefits and participate in global decision-making, thus enhancing their international presence [4][5] - The potential of cell therapies to extend human health spans and contribute to economic productivity underscores the broader societal value of these innovations, which could lead to significant improvements in national competitiveness [5]

Group 1 - Morgan Stanley analyst Judah Frommer raised the target price for Apellis Pharmaceuticals (APLS.US) from $25 to $26 while maintaining a "Hold" rating, based on the company's market position and recent financial strategy [1] - The significant licensing agreement between Apellis and Sobi is strategically important, ensuring Apellis can receive up to $300 million in revenue, including a $275 million upfront payment, while reducing Sobi's royalty obligations on Aspaveli sales by 90% [1] - This agreement provides immediate financial benefits to Apellis and may alleviate investor concerns regarding its profitability [1] Group 2 - Apellis is a commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative therapies for unmet medical needs [2] - The company's core product lines include EMPAVELI, used for treating paroxysmal nocturnal hemoglobinuria (PNH), and SYFOVRE, which treats geographic atrophy (GA) secondary to age-related macular degeneration [2]

Financial Performance - The company achieved total revenue of 381 million RMB in Q1 2025, a 129.92% year-over-year increase[9] - Sales revenue from Orelabrutinib reached 311 million RMB, an 89.22% year-over-year increase[9] - The company reported a net profit of 14 million RMB in Q1 2025[9] - Gross profit margin reached 90.5%, a 5.1 percentage point increase compared to the same period last year[9] - The company holds a strong cash reserve of 7800 million RMB[9] Orelabrutinib (BTK Inhibitor) - Orelabrutinib was approved in China for 1L CLL/SLL[9] - NDA submissions for multiple indications of Orelabrutinib are underway overseas[9] - Orelabrutinib is recommended in the 2025 CSCO lymphoma guidelines for CLL/SLL, MZL and MCL[20, 21] Pipeline Progress - Tafasitamab BLA for r/r DLBCL was accepted and granted priority review in mainland China[9] - Zurletrectinib NDA was submitted at the end of March 2025 and granted priority review[9] - A Phase III registrational clinical trial of Mesutoclax in combination with Orelabrutinib for 1L CLL/SLL is ongoing[9] Strategic Collaborations - Prolium Bioscience will gain rights to develop, register, produce, and commercialize ICP-B02 globally in non-oncology fields and in oncology fields outside of Asia[15] Autoimmune Disease - Phase III registrational clinical trials for Orelabrutinib in PPMS and SPMS are expected to enroll the first patient in the second half of 2025[9] - A Phase III registrational clinical trial for Orelabrutinib in ITP is expected to submit an NDA in the first half of 2026[9] - A Phase IIb trial for Orelabrutinib in SLE has completed patient enrollment, with data readout expected in Q4 2025[9]

Group 1: Circle Internet Group - Circle Internet Group went public on June 5, 2025, under the ticker "CRCL," becoming the first global stablecoin stock, raising $1.1 billion with a share price of $31, up from an initial range of $24 to $26, and saw over 25 times oversubscription [2][3] - On its first trading day, Circle's stock opened 122% higher and closed at $83.23, a 168.48% increase from the IPO price, giving it a market capitalization of $18.356 billion [3] - Circle, founded in 2013, primarily issues two stablecoins: USDC and EUDC, with USDC holding approximately 29% market share as of March 2025 [4] - As of March 31, 2025, Circle reached over 600 million users globally, with total revenue and reserve income of $1.676 billion and a net profit of $156 million for 2024 [5] Group 2: Zhou Li Fu Jewelry - Zhou Li Fu Jewelry passed the Hong Kong Stock Exchange hearing and disclosed its information on June 3, 2025, with CICC and CITIC International as joint sponsors [7] - Established in 2004, Zhou Li Fu operates 4,129 stores across 31 provinces and has four overseas stores, ranking among the top five jewelry brands in China for eight consecutive years [7][8] - The company reported revenues of 3.102 billion yuan, 5.150 billion yuan, and 5.718 billion yuan from 2022 to 2024, with a compound annual growth rate (CAGR) of 35.8%, significantly outpacing the industry average of 2.7% [8] Group 3: 51WORLD - 51WORLD updated its prospectus on May 30, 2025, to continue its listing process on the Hong Kong Stock Exchange, with CICC and Huatai International as joint sponsors [11] - Founded in 2015, 51WORLD focuses on the digital twin industry, offering three core business platforms: 51Aes, 51Sim, and 51Earth, and is the first in the industry to propose a comprehensive digital twin solution [12][13] - The company achieved revenues of 170 million yuan, 256 million yuan, and 287 million yuan from 2022 to 2024, with gross margins of 65.0%, 54.2%, and 51.0% respectively [14] Group 4: Xi Puni - Xi Puni updated its prospectus on June 3, 2025, to advance its listing on the Hong Kong Stock Exchange [17] - Established in 2013, Xi Puni is a designer and manufacturer of precious metal watches, with its flagship brand "HIPINE" being the largest gold watch brand in China, holding a market share of 24.98% [18] - The company reported revenues of 324 million yuan, 445 million yuan, and 457 million yuan from 2022 to 2024 [19] Group 5: Weili Zhibo - Weili Zhibo updated its prospectus on June 4, 2025, aiming to become the first stock in the TCE field in China [21][22] - Founded in 2012, Weili Zhibo focuses on innovative therapies for cancer and autoimmune diseases, with 14 candidate drugs in its pipeline, including a core product in clinical registration [23] - The company secured investments from various institutions and achieved a post-C round valuation of 3.13 billion yuan in 2024 [25]

Core Viewpoint - Nanjing Weilizhibo Biotechnology Co., Ltd. has submitted an updated prospectus for its IPO on the Hong Kong Stock Exchange after a previous application was deemed "invalid" [1] Financial Performance - For Q1 2025, Weilizhibo reported zero revenue and a net loss of approximately RMB 75.37 million, compared to a net loss of RMB 86.57 million in Q1 2024, which also had zero revenue [3][4] - In 2023, the company generated revenue of approximately RMB 8.87 million, while 2024 revenue was zero. The net losses for 2023 and 2024 were approximately RMB 362.25 million and RMB 301.22 million, respectively, indicating a narrowing loss [3][5] - Adjusted net losses (non-IFRS) for 2023, 2024, and Q1 2025 were approximately RMB 226.88 million, RMB 202.66 million, and RMB 66.52 million, respectively [5][6] Business Overview - Established in 2012, Weilizhibo is a clinical-stage biotechnology company focused on discovering, developing, and commercializing innovative therapies for unmet medical needs in oncology and autoimmune diseases [6][8] - The company has a pipeline of 14 major assets, with 6 in clinical stages, including its core product LBL-024, a novel PD-L1 and 4-1BB bispecific antibody [6][8] - LBL-024 has entered a pivotal clinical trial for the treatment of advanced pulmonary neuroendocrine carcinoma as of July 2024, with ongoing evaluations for its efficacy against various cancers [6][8] Shareholder Information - The company has a registered capital of approximately RMB 157 million, with major shareholders including Nanjing Lizhi Enterprise Management Consulting Center and Loyal Valley Capital Advantage Fund III LP [8]