理解 MNC 供应链的壁垒 医药生物 最近 12 月市场表现 -9% -2% 4% 11% 18% 25% 医药生物 沪深300 上证指数 分析师 华挺 SAC 证书编号：S0160523010002 huating@ctsec.com 联系人 宋田田 songtt@ctsec.com 证券研究报告 行业投资策略周报 / 2025.11.24 投资评级:看好(维持) 相关报告 1. 《关注小核酸产业链带来的投资机遇》 2025-11-17 2. 《疾病专题报告（四）-双抗在自免领域 潜力大》 2025-11-11 3. 《 MNC 在 小 核 酸 领 域 积 极 布 局 》 2025-11-10 理解 MNC 供应链的壁垒 核心观点 请阅读最后一页的重要声明！ ❖ 医药 MNC 供应链体系具有极高的准入壁垒。MNC 供应商认证周期通 常需要多年，需经历技术、质量、EHS 及合规等多部门交叉审计，且一旦纳 入合格供应商名录，便会形成强锁定效应——变更供应商需启动复杂的影响 评估与再验证流程，成本高昂，因此新进入者即便技术达标，也难以在短期内 撼动既有供应格局，具有较强的先发者优势。 ❖ MNC 对供应链的要求远 ...

2025 年 11 月 23 日 生物医药Ⅱ 新药周观点：小核酸药物治疗乙肝取 得突破性数据 本周新药行情回顾： 2025 年 11 月 17 日-2025 年 11 月 23 日，新药板块涨幅前 5：来凯医 药（+13.34%）、北海康成（+2.67%）、嘉和生物（+2.19%）、永泰生 物 （ +1.94% ）、 友 芝 友 （ +1.14% ）； 跌 幅 前 5 ： 药 明 巨 诺 （ - 15.75%）、艾迪药业（-14.56%）、盟科药业（-14.34%）、宜明昂科 （-13.40%）、凯因科技（-13.04%）。 本周建议关注标的： 考虑板块后续仍有多个催化值得期待，包括学术会议、数据读出、 多个 BD 兑现等，仍建议关注： 1）已获 MNC 认证未来海外放量确定性高的品种：三生制药、联邦制 药、科伦博泰等； 2）存在海外数据催化的品种：贝达药业、和黄医药、映恩生物等； 3）下一个可能海外授权 MNC 的重磅品种：复宏汉霖、石药集团、益 方生物等； 4）新的创新药技术突破领域：小核酸、体内 CAR-T、减脂增肌、自 免 CAR-T/双抗、基因疗法等。 本周新药行业重点分析： 小核酸药物治疗乙肝取得 ...

Macro and Strategy Research - The scale of off-balance sheet financing and direct financing has increased, with a notable rise in entrusted loans and corporate bond financing, while overall social financing showed a year-on-year decrease of nearly 600 billion yuan in October [2][3] - The loan data indicates a weak demand, with a year-on-year decrease of 280 billion yuan in RMB loans, and a significant increase in corporate bill financing, reflecting a trend of companies being cautious about expanding capacity [2][3] - M2 growth rate slightly declined to 8.2% in October, primarily due to base effects and reduced loan-generated deposits, while M1 growth rate fell to 6.2% [3] Mergers and Acquisitions - Mergers and acquisitions are seen as crucial tools for supporting economic transformation and achieving high-quality development, with a significant increase in market activity following the introduction of new policies in 2024 [4][5] - Historical trends show that the U.S. mergers and acquisitions market has experienced several waves, characterized by horizontal, vertical, diversification, and cross-border mergers [5] - The previous wave of mergers and acquisitions in China (2014-2015) positively impacted listed companies' performance, with a notable improvement in ROE following successful mergers [6] Economic Data Analysis - In October 2025, the industrial added value grew by 4.9% year-on-year, below expectations, while retail sales increased by 2.9% [7][8] - Seasonal factors and reduced working days contributed to the slowdown in industrial production, with certain sectors like transportation equipment manufacturing performing well [8] - Fixed asset investment showed a cumulative year-on-year decline of 1.7%, with manufacturing and infrastructure investments particularly affected by weak demand and policy implementations [10] Fund Research - The cross-border ETF market continues to see net inflows, with an expansion of the "Southbound ETF Connect" list, indicating growing interest in international investments [12][13] - The overall ETF market experienced a net inflow of 24.426 billion yuan, with significant contributions from cross-border ETFs [13][14] Industry Research - The medical and biological sector is witnessing a surge in flu cases, with the proportion of flu-like cases in the northern region reaching a four-year high, suggesting potential investment opportunities in diagnostics and vaccine production [16][17] - The light industry and textile sectors are benefiting from strong performance during the "Double Eleven" shopping festival, with apparel sales leading the growth [18][20]

Healthcare Policy - National Healthcare Security Administration held a series of discussions on the adjustment of the disease-based payment grouping scheme 3.0, involving over 70 representatives from medical institutions and industry associations [1] Drug and Medical Device Approvals - Shijiazhuang Pharmaceutical Group's application for the listing of Pertuzumab injection has been accepted by the National Medical Products Administration, targeting HER2-positive breast cancer [1] - Huason Pharmaceutical received a registration certificate for its special medical purpose formula food, Ganyimei®, designed for patients over 10 years old with strict fat restrictions and digestive absorption disorders [2] - United Imaging Healthcare's subsidiary obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system, enhancing its product range across various market segments [3] - Yiling Pharmaceutical's application for the listing of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, has been approved [4] - Zhifei Biological's clinical trial application for a freeze-dried varicella inactivated vaccine has been accepted by the National Medical Products Administration [10] - Changchun High-tech's subsidiary received approval for a clinical trial of an acellular pertussis-diphtheria-tetanus combined vaccine for adolescents and adults [11] Capital Market Activities - Peking University Pharmaceutical announced the release of 34,615,386 shares from pledge, representing 51.52% of the pledged shares and 5.81% of the total share capital [5] - Kelun Pharmaceutical received approval for a registration of 4 billion yuan in ultra-short-term financing bonds, with a validity period of 2 years [6][7] - Baili Tianheng decided to delay its global offering and listing of H-shares due to current market conditions [8] - Aipeng Medical announced a plan for a shareholder to reduce holdings by up to 1% of total shares, citing personal funding needs [12] - Hendi Pharmaceutical's shareholders plan to collectively reduce their holdings by up to 2.33% of total shares for personal financial planning [13] Financial Adjustments - Baihua Pharmaceutical plans to use 1.91 billion yuan from its capital reserve to cover losses, primarily due to goodwill impairment from a previous major asset restructuring [14]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a new drug application for its product, a monoclonal antibody injection for HER2-positive breast cancer, by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed a monoclonal antibody injection, Pertuzumab, which has received regulatory acceptance for marketing [1] - The product is classified as a Class 3.3 therapeutic biological product and is indicated for HER2-positive breast cancer [1] - Pertuzumab is a recombinant humanized anti-HER2 monoclonal antibody injection that requires administration every three weeks [1] Group 2: Product Mechanism and Clinical Trials - The product works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that Pertuzumab is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, with comparable safety and tolerability [1]

该产品为一款重组人源化抗HER2单克隆抗体注射液，患者每3周需使用一次。该产品通过特异性结合 HER2的细胞外二聚化结构域II，阻断HER2与HER2或其他HER家族成员之间的配体之间的二聚化作 用，从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作用。 本次申请主要基于一项Ⅲ期等效性临床试验，其入组对象为早期或局部晚期HER2阳性乳腺癌患者。临 床试验结果显示，该产品用于早期或局部晚期HER2阳性乳腺癌的新辅助治疗与原研参照药具有等效 性。同时，该产品的安全性和耐受性良好，与原研参照药相当。 智通财经APP获悉，石药集团(01093)涨超4%，截至发稿，涨4.05%，报7.96港元，成交额3.73亿港元。 消息面上，11月12日，石药集团发布公告，本公司附属公司石药集团巨石生物制药有限公司开发的帕妥 珠单抗注射液(该产品)的上市申请已获中华人民共和国国家药品监督管理局受理。该产品按照治疗用生 物制品3.3 类申报，其适应症为HER2阳性乳腺癌。 ...

Major Events - Hong Kong Stock Exchange (00388) plans to make a strategic investment in Xunqing Settlement Holdings Limited [1] - Lai Kai Pharmaceutical-B (02105) signs an exclusive licensing agreement with Qilu Pharmaceutical for LAE 002 (AFURESERTIB) in China [1] - TECHSTARACQ-Z (07855) is expected to inherit the company Tuda Tong's listing on the main board of the Stock Exchange on December 10 [1] - Superstar Legend (06683) intends to establish a joint venture with Yushu Technology to develop consumer-grade IP robots and IP derivative products [1] - Beijing Enterprises Holdings (00392) plans to acquire 100% equity of Beijing Beiran Special Equipment Inspection and Testing Co., Ltd. for 54.6 million yuan [1] - CSPC Pharmaceutical Group (01093) has its application for the marketing of Pertuzumab Injection accepted by the National Medical Products Administration [1] - Rongli Construction (09639) plans to collaborate with CATL to develop efficient energy storage systems and solutions [1] Operating Performance - BeiGene (06160) reports a net profit attributable to shareholders of 1.139 billion yuan for the first three quarters, turning from loss to profit year-on-year [1] - Tencent Music-SW (01698) reports a net profit attributable to equity holders of 2.15 billion yuan in the third quarter, a year-on-year increase of 36.0% [1] - Zhou Li Fu (06168) sees a 32% year-on-year increase in e-commerce revenue for the first ten months, with net profit rising 71% year-on-year [1] - China Resources Land (01109) reports a cumulative contract sales amount of approximately 169.6 billion yuan for the first ten months, a year-on-year decrease of 16.6% [1]

（编辑 楚丽君） 证券日报网讯 11月12日晚间，新诺威发布公告称，公司的控股子公司石药集团巨石生物制药有限公司 于近日收到国家药品监督管理局核准签发的《受理通知书》，帕妥珠单抗注射液的上市申请获得受理。 ...

公告显示，帕妥珠单抗注射液是一款重组人源化抗HER2单克隆抗体注射液，通过特异性结合HER2的细 胞外二聚化结构域II，阻断HER2与HER2或其他HER家族成员之间的配体之间的二聚化作用，从而阻断 细胞周期并诱导凋亡。 北京商报讯（记者 王寅浩 宋雨盈）11月12日，新诺威发布公告称，公司控股子公司石药集团巨石生物 制药有限公司于近日收到国家药品监督管理局核准签发的《受理通知书》，帕妥珠单抗注射液的上市申 请获得受理，拟申请适应症为HER2阳性乳腺癌。 ...

Group 1 - Longjian Co., Ltd. won a bid for a highway maintenance project in Heilongjiang with a contract value of 483 million yuan, accounting for 2.64% of the company's expected revenue for 2024 [1] - Transsion Holdings plans to issue H-shares and list on the main board of the Hong Kong Stock Exchange [1] - Good Home's controlling shareholder intends to reduce its stake by up to 2.7%, equivalent to no more than 39.4468 million shares [1][2] Group 2 - Xinhua Insurance reported a cumulative premium income of 181.973 billion yuan from January to October, representing a year-on-year growth of 17% [2][4] - Zhejiang Jiaokao is part of a consortium that plans to bid for a new urbanization project with an estimated total investment of 11.103 billion yuan [4] Group 3 - Changchun High-tech received approval for clinical trials of a vaccine for adolescents and adults [6] - XinNuoWei's application for the listing of Pertuzumab injection has been accepted, targeting HER2-positive breast cancer [8] - Dash Smart won a bid for an intelligent project at the new Huanggang Port inspection building, valued at 55.056 million yuan, which is 1.74% of its expected revenue for 2024 [8] Group 4 - Electronic City is involved in a lawsuit for debt recovery, with the amount in dispute estimated at 777 million yuan [9] - Haibo Technology signed a strategic cooperation agreement with CATL for a cumulative procurement of no less than 200 GWh of electricity from 2026 to 2028 [10] Group 5 - Renfu Pharmaceutical's HW231019 tablets have entered the second phase of clinical trials for postoperative pain relief [11] - Tonghua Dongbao received a drug registration certificate for Aspart Insulin injection from the Dominican Republic [11] Group 6 - Shaanxi Construction reported winning major projects worth a total of 1.016 billion yuan in October [12] - Fuzhou Environmental Protection plans to change its stock name to "Fuzhou Technology" [12] Group 7 - Panlong Pharmaceutical's gel patch for knee osteoarthritis has received approval for clinical trials [15] - Zhongyida's application for a specific stock issuance has been terminated by the Shanghai Stock Exchange [16] Group 8 - Zhizhong Home's controlling shareholder reduced its holdings of convertible bonds by 905,000 units, accounting for 13.51% of the total issued [19] - Haibo Co., Ltd. plans to establish a subsidiary with an investment of 1 billion yuan for high-end component projects [21] Group 9 - Caina Co. plans to use 57 million yuan of idle funds to purchase structured deposits [23] - Zhendong Pharmaceutical's new drug for acute ischemic stroke has entered the IIa phase of clinical trials [25] Group 10 - Weiman Sealing's overseas subsidiary plans to lease a factory in Saudi Arabia for 5 years at a total rent of approximately 54.039 million yuan [26] - Yiling Pharmaceutical's application for Memantine Hydrochloride has been approved for market entry [28] Group 11 - Dongfang Zhizao plans to acquire 70% of Saifu Machinery for 27.4887 million yuan [30] - JianKai Technology's actual controller intends to transfer 3% of the company's shares through inquiry [31] Group 12 - Rejing Bio plans to repurchase shares worth between 100 million and 200 million yuan [32] - Bangji Technology has decided to terminate a major asset restructuring project due to failure to reach an agreement [34] Group 13 - Huadong Pharmaceutical's application for the marketing license of a new drug has been accepted [36] - Zhonggu Logistics' shareholder plans to reduce its stake by up to 3% [38] Group 14 - Bohui Innovation's subsidiary received approval for a clinical trial of a vaccine for invasive infections [40] - Shannon Chip's shareholder pledged 0.27% of the company's shares for financing [42] Group 15 - Shanghai Petrochemical appointed a new general manager [44] - Jiaojian Co. plans to reduce the holdings of some directors and executives by up to 0.35% [46] Group 16 - Weiting Electric plans to raise no more than 300 million yuan through a private placement [47] - Zhongjin Irradiation plans to invest approximately 200 million yuan in an electronic accelerator manufacturing project [49] Group 17 - Tongxing Technology signed a framework agreement to invest 3.2 billion yuan in a sodium battery project [50] - Hongri Da plans to establish a subsidiary focused on semiconductor packaging [51] Group 18 - Shanghai Kaibao's new drug for acute ischemic stroke has received approval for clinical trials [53] - Yitong Century announced a change in its control structure, becoming a company without a controlling shareholder [55]