证券研究报告：医药生物 | 公司点评报告 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 研究助理:徐智敏 SAC 登记编号:S1340125080012 Email: xuzhimin@cnpsec.com 股票投资评级 买入|首次覆盖 个股表现 资料来源：Wind，中邮证券研究所 -100% 0% 100% 200% 300% 400% 500% 2024-09 2024-12 2025-02 2025-05 2025-07 2025-09 三生制药 恒生指数 公司基本情况 | 最新收盘价（港元） | 30.94 | | | --- | --- | --- | | 总股本/流通股本（亿股）24.32/24.32 | | | | 总市值/流通市值（亿港 | 752/752 | | | 元） | | | | 52 周内最高/最低价 | 36.80/ 5.43 | | | 资产负债率(%) | 25.51 | | | 市盈率 | 27.4 | | | 第一大股东 | Decade | Sunshine | | Limited | | | 研 ...

天风证券主要观点如下： 事项 智通财经APP获悉，天风证券发布研报称，近期，NMPA批准科伦博泰生物-B(06990)SKB264新增 100mg规格上市，新规格的引入将进一步优化临床给药方案，提升治疗便捷性与依从性，为晚期乳腺癌 及非小细胞肺癌(NSCLC)患者提供更可及、更经济的治疗选择。考虑到公司核心产品商业化进程顺利， 预计公司2025-2027年营业收入分别为20.84亿元、28.76亿元和46.63亿元，上调为"买入"评级。 除在经典突变TKI耐药领域的突破，SKB264高效覆盖各类罕见突变 SKB264-II-08研究(Cohort5a和5b)是一项关于SKB264单药治疗经治的罕见EGFR突变NSCLC的II期临 床。研究结果显示，在包括G719X、S768I、L861Q和Exon20ins在内的罕见EGFR突变患者中，SKB264 的ORR达到35.7%，DCR为85.7%，mPFS为9.5个月，且这些罕见突变均在获批适应症范围内，为长期缺 乏标准治疗的罕见EGFR突变患者提供了新的有效治疗手段。此外，关于wt NSCLC1L治疗，SKB264正 在开展PD-L1TPS<1%的中国内地III ...

研究早观点 2025 年 10 月 9 日 星期四 市场走势 【今日要点】 【公司评论】三生制药(01530.HK)：三生制药公司点评-PD-1/VEGF 双 抗是潜在的肿瘤基石药物，拓展传统 PD-(L)1 单抗治疗边界 资料来源：最闻 国内市场主要指数 | 指数 | | 收盘 | 涨跌幅% | | --- | --- | --- | --- | | 上证指数 | | 3,882.78 | 0.52 | | 深证成指 | | 13,526.51 | 0.35 | | 沪深 | 300 | 4,640.69 | 0.45 | | 中小板指 | | 8,380.38 | 0.62 | | 创业板指 | | 3,238.16 | 0.00 | | 科创 | 50 | 1,495.29 | 1.69 | 研究早观点 【今日要点】 资料来源：最闻 分析师： 彭皓辰 执业登记编码：S0760525060001 邮箱：penghaochen@sxzq.com 2019 年 2 月 21 日 星期四 请务必阅读最后股票评级说明和免责声明 1 【公司评论】三生制药(01530.HK)：三生制药公司点评-PD-1/VEGF 双 ...

北京商报讯（记者 丁宁）10月8日晚间，东北制药（000597）发布公告称，公司控股子公司北京鼎成肽 源生物技术有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，经审查，2025 年7月9日受理的DCTY0801注射液符合药品注册的有关要求，同意开展EGFRvIII阳性的复发或进展高级 别脑胶质瘤的临床试验。 公告显示，DCTY0801注射液是针对EGFRvIII突变抗原的CAR-T细胞产品。东北制药表示，本次 DCTY0801注射液临床试验获批，是该款产品研发进程中的重要里程碑，将进一步加快公司在研产品的 进度，提升公司在肿瘤治疗领域的核心竞争力。 ...

东北制药公告，控股子公司北京鼎成肽源生物技术有限公司收到国家药品监督管理局核准签发的《药物 临床试验批准通知书》。药物名称为 DCTY0801 注射液，适应症为 EGFRvIII 阳性的复发或进展高级别 脑胶质瘤。此次临床试验获批是该款产品研发进程中的重要里程碑，将加快公司在研产品的进度，提升 公司在肿瘤治疗领域的核心竞争力。 ...

Core Insights - Gilead Sciences, Inc. (GILD) has demonstrated strong performance in 2025, with shares rising 26.5% year to date, significantly outperforming the industry growth of 6% [1][9] - The FDA approval of lenacapavir, branded as Yeztugo, for HIV prevention has been a pivotal event, marking it as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option in the U.S. [3][7] Gilead's HIV Portfolio - Gilead holds a leading position in the HIV treatment market, with its flagship drug Biktarvy commanding over 51% market share in the U.S. [4] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue, driven by strong performances from Biktarvy and Descovy [5] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as Truvada faces generic competition [6] Oncology and Cell Therapy - Gilead's oncology portfolio includes Trodelvy, which has shown strong performance in treating metastatic triple-negative breast cancer, with plans for further approvals [11] - However, the Cell Therapy franchise, including Yescarta and Tecartus, is facing competitive pressures in the U.S. and Europe [12] - Gilead's subsidiary Kite has acquired Interius BioTherapeutics for $350 million, enhancing its capabilities in CAR T-cell therapies [13] Liver Disease Portfolio - The FDA approval of seladelpar, branded as Livdelzi, for primary biliary cholangitis (PBC) has strengthened Gilead's liver disease portfolio [14][15] Financial Performance and Estimates - Gilead's shares are currently trading at a price/earnings ratio of 13.62x forward earnings, lower than the large-cap pharma industry's average of 14.83x [16] - Earnings estimates for 2025 have increased to $8.10 from $8.02, while the estimate for 2026 has slightly decreased to $8.50 from $8.53 [17] Strategic Collaborations - Gilead has partnered with the U.S. State Department to deliver lenacapavir, indicating a commitment to expanding its HIV prevention efforts [10] - The company is also collaborating with Merck to evaluate a combination treatment for HIV, with updates expected in 2026 [20] Dividend and Cash Position - Gilead has maintained a strong cash position, with $7.1 billion in cash and equivalents as of June 30, 2025, supporting its sustainable dividend yield of 2.76% [22] - In Q2 2025, Gilead paid out $994 million in dividends and repurchased $527 million of common stock, reflecting its commitment to returning value to shareholders [21]

Core Insights - The 28th Annual Academic Conference of the Chinese Society of Clinical Oncology (CSCO) showcased significant research findings on innovative cancer treatments, particularly focusing on the efficacy and safety of Anlotinib in various cancer types [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Non-Small Cell Lung Cancer (NSCLC) - Anlotinib combined with immune checkpoint inhibitors (ICIs) shows potential as an adjuvant therapy for non-pathological complete response (non-pCR) NSCLC patients post-neoadjuvant immunotherapy, with manageable safety profiles and promising disease-free survival [1]. - A prospective study indicates that the combination of Tislelizumab, Anlotinib, and chemotherapy is effective for resectable NSCLC, achieving a major pathological response (MPR) rate of 81.3% [2]. - Anlotinib combined with Pembrolizumab demonstrates efficacy in elderly patients with advanced PD-L1 positive NSCLC, with a median progression-free survival (PFS) of 8.2 months [3][4]. - The combination of Anlotinib, Pembrolizumab, and chemotherapy shows promising results in treating pulmonary sarcomatoid carcinoma, with an overall response rate (ORR) of 80% [5]. - Real-world data suggests that Anlotinib combined with PD-1/PD-L1 inhibitors is effective for advanced NSCLC, with a median PFS of 7.8 months and an overall survival (OS) of 17.0 months [6]. - A retrospective analysis indicates that Anlotinib combined with ICIs is a viable option for advanced NSCLC patients who have progressed after prior immunotherapy, showing an ORR of 28.6% [8]. Small Cell Lung Cancer (SCLC) - A study on the combination of liposomal Irinotecan, platinum-based chemotherapy, and Anlotinib for extensive-stage SCLC shows promising results, with a focus on maintaining treatment efficacy post-induction therapy [9]. - The combination of Surufatinib, albumin-bound Paclitaxel, and Anlotinib in second-line treatment for extensive-stage SCLC demonstrates a high ORR of 73.33% [10]. - Anlotinib combined with ICIs shows improved efficacy compared to Anlotinib alone in treating extensive-stage SCLC, with a median PFS of 6.5 months [11]. Gastrointestinal Tumors - Anlotinib combined with TAS-102 shows potential as a third-line treatment for metastatic colorectal cancer, with a DCR of 95% and a median PFS of 5.6 months [12]. - The combination of Anlotinib and chemoradiotherapy demonstrates significant efficacy in treating postoperative lymph node recurrence of esophageal squamous cell carcinoma, with a median PFS of 20.2 months [13]. Soft Tissue Sarcoma - Anlotinib combined with Cadonilimab shows promising results in advanced soft tissue sarcoma patients who have failed first-line treatment, with a median PFS of 6.9 months [14]. - The combination of Atezolizumab and Anlotinib in treating advanced liposarcoma and leiomyosarcoma shows a DCR of 89.5% [15]. Thyroid Cancer - Anlotinib combined with Sintilimab shows efficacy in treating BRAF wild-type anaplastic thyroid cancer, with an ORR of 47.6% and a median PFS of 9.63 months [17][18]. Other Cancers - The combination of Sintilimab and Anlotinib shows efficacy in treating advanced SMARCA4-deficient thoracic tumors, with an ORR of 51% [19]. - A real-world study indicates that prior treatment with Bevacizumab does not affect the efficacy of Anlotinib in treating solid tumors, with significant benefits observed in combination therapies [20]. Neutropenia Prevention - The Guard-04 study demonstrates that Aibegersit can effectively prevent chemotherapy-induced neutropenia in colorectal and pancreatic cancer patients, with manageable safety profiles [22].

Group 1 - The core viewpoint of the article highlights the successful IPO of Jinfang Pharmaceutical-B (02595), with shares priced at HKD 20.39 and a total issuance of 89.24 million shares, raising approximately HKD 1.6699 billion in net proceeds [1] - As of the report, the stock price surged by 128.05%, reaching HKD 46.50, with a trading volume of HKD 651 million [1] - Jinfang Pharmaceutical focuses on developing new treatment solutions for oncology, autoimmune, and inflammatory diseases, with a product pipeline that includes eight candidate products, five of which are in clinical development [1] Group 2 - The company’s core products include GFH925, the first KRAS G12C inhibitor approved in China and the third globally, which received approval from the National Medical Products Administration for non-small cell lung cancer (NSCLC) in August 2024 [1] - GFH375 is an oral KRAS G12D inhibitor currently undergoing Phase II clinical trials in China [1] - Jinfang Pharmaceutical has entered into a licensing agreement with Verastem for three candidate products, including GFH375, granting Verastem development and commercialization rights outside Greater China [1]

财务方面，劲方医药在2023年、2024年及2025年前四个月分别实现营业收入0.74亿元、1.05亿元和0.82 亿元；同期研发开支分别为3.13亿元、3.32亿元和0.698亿元；净亏损分别为5.08亿元、6.78亿元和0.66亿 元。两年多时间合计亏损超过12亿元。 据悉，劲方医药目前已有1款核心产品GFH925(商品名：达伯特)获批上市，但该产品在国内市场的商业 化依赖于合作伙伴。2024年1月，劲方医药与信达生物订立补充协议，终止GFH925授权协议项下的中国 境外选择权，劲方医药须向信达生物退还2000万美元等。 劲方医药成立于2017年，专注于肿瘤(涵盖多种实体瘤的不同治疗线)以及自体免疫和炎症性疾病领域的 开发新治疗方案。 生物制药公司劲方医药-B(2595.HK)今日首日在港挂牌上市，高开115.79%报44港元，市值达152亿港 元。 ...

Group 1 - The core viewpoint of the article highlights the successful listing of Jinfang Pharmaceutical-B (02595) with a share price of HKD 20.39, raising approximately HKD 1.6699 billion from the issuance of 89.24 million shares [1] - As of the report, the stock surged by 115.79%, trading at HKD 44 with a transaction volume of HKD 491 million [1] - Jinfang Pharmaceutical focuses on developing new treatment solutions for tumors, autoimmune, and inflammatory diseases, with a product pipeline that includes 8 candidate products, 5 of which are in clinical development [1] Group 2 - GFH925, one of the core products, is the first KRAS G12C inhibitor approved in China and the third globally, having received approval from the National Medical Products Administration for non-small cell lung cancer (NSCLC) in August 2024 [1] - The company is conducting a Phase II trial of GFH925 in the EU under the KORCUS study [1] - GFH375, an oral KRAS G12D inhibitor, is currently undergoing Phase II clinical trials in China, and the company has entered into a licensing agreement with Verastem for GFH375 and two other candidate products, granting Verastem development and commercialization rights outside Greater China [1]