晨会纪要（2025/10/27） 编辑人 崔健 022-28451618 SAC NO：S1150511010016 cuijian@bhzq.com 渤海证券研究所晨会纪要（2025.10.27） 宏观及策略研究 请务必阅读正文之后的声明 渤海证券股份有限公司具备证券投资咨询业务资格 1 of 7 强调"高质量"发展要求，科技和改革将是主基调——二十届四中全会公报 点评 关注地缘风险，明确发展目标——宏观经济周报 固定收益研究 利率窄幅震荡，曲线走平——利率债周报 行业研究 中国药企 ESMO 表现亮眼，信达与武田达成高额合作——医药生物行业周报 证 券 研 究 报 告 晨 会 纪 要 晨会纪要（2025/10/27） 宏观及策略研究 强调"高质量"发展要求，科技和改革将是主基调——二十届四中全会公报点评 宋亦威（证券分析师，SAC NO：S1150514080001） 严佩佩（证券分析师，SAC NO：S1150520110001） 靳沛芃（研究助理，SAC NO：S1150124030005） 新华社 10 月 23 日授权发布了《中国共产党第二十届中央委员会第四次全体会议公报》，我们对此点评如下： 1 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injectable SHRA1811, a drug targeting HER2-positive breast cancer [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable SHRA1811 was accepted on July 31, 2025, and meets the requirements for drug registration, allowing the initiation of clinical trials [1]. - The trial will be a randomized, open-label, multi-center Phase III study comparing SHRA1811 with Docetaxel + Carboplatin + Trastuzumab + Pertuzumab for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1]. Group 2: Product Mechanism and Market Context - Injectable SHRA1811 binds to HER2-expressing tumor cells, inducing apoptosis through the release of toxins in the lysosomes of tumor cells, which enhances anti-tumor efficacy [2]. - Similar products currently available in the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which are already marketed in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, with a cumulative R&D investment of about 141.475 million yuan for injectable SHRA1811 [2].

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injectable Rikan Trastuzumab, marking a significant step in the development of new cancer therapies [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable Rikan Trastuzumab (SHR-A1811) was approved, allowing for a Phase III study comparing it to a combination of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab for the treatment of early or locally advanced HER2-positive breast cancer [1][2]. - The approval was based on compliance with the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1]. Group 2: Product Mechanism and Market Context - Injectable Rikan Trastuzumab works by binding to HER2-expressing tumor cells, inducing apoptosis through the release of toxins within the cells [2]. - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have been approved in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, indicating a robust market for HER2-targeted therapies [2]. - The cumulative R&D investment for injectable Rikan Trastuzumab has reached approximately 141.475 million yuan [2].

Company Updates - The company presented significant data at the ESMO conference on October 17, including the approval of sac-TMT for lung cancer in China on October 12, and the approval of trastuzumab deruxtecan on October 17 [1][2] - Sac-TMT demonstrated strong positive overall survival (OS) benefits in the second-line EGFRm non-small cell lung cancer (NSCLC) compared to chemotherapy, marking it as the first successful ADC drug in this indication globally [1] - In the domestic Phase III trial OptiTROP-Lung04, sac-TMT showed statistically and clinically significant improvements in progression-free survival (PFS) and OS, with a median follow-up of 18.9 months, PFS of 8.3 months vs. 4.3 months (HR=0.49), and OS not reached vs. 17.4 months (HR=0.6, p=0.0006) [1] Breast Cancer Insights - In the domestic Phase III trial OptiTROP-Breast02, sac-TMT also showed strong positive OS benefits in HR+ HER2- breast cancer, with PFS of 8.3 months vs. 4.1 months (HR=0.35), and OS not reached but with HR=0.33, indicating significant dual benefits [2] - The HER2 ADC trastuzumab deruxtecan showed clear benefits in a head-to-head trial against Roche's T-DM1, with PFS of 11.1 months vs. 4.4 months (HR=0.39) and OS HR=0.62, leading to its approval in China on October 17 [2] Financial Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at losses of 672 million yuan and 174 million yuan, respectively [2] - Based on a DCF model, the company maintains an outperform rating and a target price of 550 HKD, indicating a 20.0% upside potential from the current stock price [2]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index declined by 3.65% during the reporting period, ranking 21st among 31 primary industries, underperforming the CSI 300 index which fell by 2.73% [4][16] - The valuation of the pharmaceutical and biotechnology industry as of October 17, 2025, is a PE (TTM overall method, excluding negative values) of 30.08x, down from 31.23x in the previous period, indicating a downward trend and below the average [4][21] - Key sub-industries include vaccines (55.76x), hospitals (39.64x), and medical devices (38.84x), with the lowest valuation in pharmaceutical circulation (14.29x) [4][21] - The report highlights significant innovations presented at the 2025 ESMO conference, indicating a shift in global oncology drug development from "single-agent breakthroughs" to "combination therapy strategies" [6][8] - The newly released regulations by the State Council aim to standardize clinical research pathways, promoting innovation while ensuring safety [7][25][26] Industry Overview - The report notes that 26 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 501 million yuan, while 4 companies increased their holdings by 519 million yuan [4] - The report emphasizes the importance of monitoring third-quarter earnings to validate the fundamentals of companies, particularly those with innovative product launches and significant performance improvements [8] Important Industry News - The approval of the first domestic PDE4 inhibitor by He Mei Pharmaceutical marks a significant milestone in the industry [6][34] - The approval of a new indication for GSK's recombinant shingles vaccine expands its application to adults at increased risk due to immunodeficiency [6][36] - The U.S. Senate passed a revised version of the Biosecurity Act, which continues to impose restrictions on certain Chinese biotechnology companies [6][44] - The collaboration between Bai Li Tian Heng and BMS on the iza-bren project has reached a milestone, triggering a payment of 250 million USD [6][47] - The IPO of Xuan Zhu Biotechnology on the Hong Kong Stock Exchange saw a significant oversubscription and a substantial increase in share price during the dark trading period [6][49]

科伦药业公告，公司控股子公司科伦博泰在2025年欧洲肿瘤内科学会(ESMO)大会上公布了多项临床研 究成果。芦康沙妥珠单抗(sac-TMT)在治疗EGFR突变非小细胞肺癌(NSCLC)的随机、多中心3期 OptiTROP-Lung04研究中，中位无进展生存期(PFS)为8.3个月，较化疗组显著改善，疾病进展或死亡风 险降低51%。在治疗局部晚期或转移性激素受体阳性且HER2阴性(HER2+/HER2-)乳腺癌的随机、多中 心3期OptiTROP-Breast02研究中，芦康沙妥珠单抗(sac-TMT)较化疗组显著延长中位PFS至8.3个月，客 观缓解率提高至41.5%。博度曲妥珠单抗对比恩美曲妥珠单抗(T-DM1)治疗HER2+转移性BC的随机3期 研究中，中位PFS显著延长至11.1个月，客观缓解率高达76.9%。 ...

市场监管总局、国家药监局调研组在京开展《医疗器械管理法》立法调研 10月17日消息，市场监管总局副局长束为和国家药监局副局长徐景和率调研组10月15日在京就《医疗器 械管理法》草案开展立法调研。调研组一行先后走访瓦里安医疗设备（中国）有限公司、心诺普医疗技 术（北京）有限公司，了解医疗器械研发、生产、经营、使用等情况，并召开立法座谈会，听取北京市 药监局、北京市市场监管综合执法总队等监管部门、企业和医疗机构的意见建议，就进一步完善医疗器 械监管法律制度体系、强化全生命周期质量安全监管、促进产业高质量发展和高水平安全进行了深入交 流。调研组指出，医疗器械关系人民群众的生命健康，关系公共安全和国家安全。医疗器械管理立法要 坚持科学立法、民主立法、依法立法的要求，坚持问题导向，坚持国际视野，坚持改革创新，进一步提 高立法质量，推动法律实施。 药械审批 政策动向 华东医药全资子公司收到药品注册证书 10月17日，华东医药(000963.SZ)公告称，全资子公司中美华东收到国家药品监督管理局核准签发的 《药品注册证书》，由中美华东申报的瑞玛比嗪注射液的上市许可申请获得批准。该药物是一种注射用 外源性荧光示踪剂，需与Me ...

Policy Developments - The State Administration for Market Regulation and the National Medical Products Administration conducted legislative research on the draft Medical Device Management Law, emphasizing the importance of scientific, democratic, and legal legislation to enhance the quality of laws and promote implementation [1] Drug and Device Approvals - East China Pharmaceutical's subsidiary received a drug registration certificate for Remabizine injection, which is used in conjunction with MediBeacon's device to assess patients' glomerular filtration rate [2] - Kelun Pharmaceutical's subsidiary obtained approval for its ADC product, Botuzumab, for treating HER2-positive breast cancer, showing significant improvement in progression-free survival compared to T-DM1 [3] Financial Reports - WoHua Pharmaceutical reported a net profit increase of 179.34% year-on-year for the first three quarters, with revenue of 625 million yuan [4] - Pianzihuang's third-quarter net profit decreased by 28.82%, with revenue down 26.28% year-on-year, attributed to reduced sales in the pharmaceutical manufacturing sector [5] Capital Market Activities - Weigao Blood Products is planning to acquire 100% of Shandong Weigao Puri Pharmaceutical Packaging Co., leading to a stock suspension for up to 10 trading days [7] - Hansoh Pharmaceutical entered a licensing agreement with Roche, potentially earning up to $1.45 billion in milestone payments for the development of HS-20110, a targeted ADC for colorectal cancer [8] Industry Developments - Sanofi announced the launch of its insulin raw material project in Beijing, with a total investment of 1 billion euros, expected to be completed by 2032 [12]

Group 1: Novo Nordisk - Novo Nordisk's oral semaglutide (Rybelsus) has received FDA approval for a new indication to reduce cardiovascular risk in high-risk adults with type 2 diabetes, making it the first oral GLP-1 drug to do so [1] - The company has also submitted a supplemental new drug application for daily oral semaglutide (Wegovy) for obesity treatment, with approval expected later this year [1] - This new approval is expected to further solidify Novo Nordisk's market position in the GLP-1 segment [1] Group 2: Sunshine Guohe - Sunshine Guohe plans to invest 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, focusing on CAR-T cell therapy and nucleic acid drugs [2] - Yuanma Zhiyao specializes in the innovation and development of circular mRNA CAR-T nucleic acid drugs and is advancing towards clinical research [2] - This investment aligns with Sunshine Guohe's strategic layout in the CAR-T field and is expected to create synergies between the two companies [2] Group 3: Pian Zai Huang - Pian Zai Huang reported a 28.82% year-on-year decline in net profit for Q3, with revenue of 2.064 billion yuan, down 26.28% year-on-year [3] - For the first three quarters, the company’s revenue was 7.442 billion yuan, a decrease of 11.93%, and net profit was 2.129 billion yuan, down 20.74% [3] - The decline in performance is attributed to reduced sales in the pharmaceutical manufacturing industry and a decrease in gross margin [3] Group 4: Kelun Pharmaceutical - Kelun Pharmaceutical's subsidiary, Kelun Botai, received approval for its core product, trastuzumab deruxtecan (Bodutuzumab), for treating HER2-positive breast cancer [4] - The product showed significant improvement in progression-free survival compared to T-DM1 in interim analysis, indicating strong clinical efficacy [4] - This approval marks a key breakthrough for Kelun Botai in the breast cancer field and is expected to accelerate market penetration for the product [4]

Group 1: Novo Nordisk - Novo Nordisk's oral semaglutide (Rybelsus) has received FDA approval for a new indication to reduce cardiovascular risk in high-risk adults with type 2 diabetes, making it the first oral GLP-1 drug to do so [1] - The company has also submitted a supplemental new drug application for its once-daily oral semaglutide (Wegovy) for obesity treatment, with approval expected later this year [1] - The approval of the new indication for oral semaglutide is expected to further solidify Novo Nordisk's market position in the GLP-1 segment [1] Group 2: Sunshine Guohe - Sunshine Guohe plans to invest 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, focusing on CAR-T cell therapy and nucleic acid drugs [2] - Yuanma Zhiyao specializes in the innovation and research of circular mRNA CAR-T nucleic acid drugs and is advancing towards clinical research [2] - This investment aligns with Sunshine Guohe's strategic layout in the CAR-T field and is expected to create synergies between the two companies [2] Group 3: Pian Zai Huang - Pian Zai Huang reported a 28.82% year-on-year decline in net profit for Q3, with revenue of 2.064 billion yuan, down 26.28% year-on-year [3] - For the first three quarters, the company recorded a revenue of 7.442 billion yuan, a decrease of 11.93%, and a net profit of 2.129 billion yuan, down 20.74% [3] - The decline in performance is attributed to reduced sales in the pharmaceutical manufacturing industry and a decrease in gross margin [3] Group 4: Kelun Pharmaceutical - Kelun Pharmaceutical's subsidiary, Kelun Botai, received approval for its core product, trastuzumab deruxtecan (舒泰莱), for treating HER2-positive breast cancer [4] - The product showed significant improvement in progression-free survival (PFS) compared to T-DM1 in interim analysis, indicating strong clinical efficacy [4] - This approval marks a key breakthrough for Kelun Botai in the breast cancer field and highlights the ongoing advancements of domestic ADCs in high-end oncology treatment [4]