复宏汉霖(02696)发布公告，近日，HLX22(重组人源化抗HER2单克隆抗体注射液)(HLX22)联合注射用 HLX87(靶向HER2抗体偶联药物)(HLX87)一线治疗HER2阳性复发或转移性乳腺癌(BC)患者的2/3期临床 研究于中国境内(不包括中国港澳台地区，下同)完成首例患者给药。 本研究是一项评估HLX22联合HLX87一线治疗HER2阳性复发或转移性乳腺癌患者的开放、随机、多中 心的2/3期临床研究。研究包括两个阶段，第一阶段是一项开放、多中心、随机、平行对照的2期临床研 究，合格受试者将按照2:2:1:1的比例随机分配接受HLX22联合HLX87、帕妥珠单抗联合HLX87、帕妥珠 单抗联合德曲妥珠单抗或帕妥珠单抗联合曲妥珠单抗及多西他赛治疗。第一阶段的主要终点是独立影像 评估委员会(BICR)评估的客观缓解率(ORR)及无进展生存期(PFS)。第二阶段是一项开放、多中心、随 机、平行对照的3期临床研究，合格受试者将按照1:1的比例随机分配接受HLX22联合HLX87或帕妥珠单 抗联合曲妥珠单抗及多西他赛治疗。第二阶段的主要终点是BICR评估的PFS。本次研究的主要目的是 评估HLX22联合H ...

本研究是一项评估HLX22联合HLX87一线治疗HER2阳性复发或转移性乳腺癌患者的开放、随机、多中 心的2/3期临床研究。研究包括两个阶段，第一阶段是一项开放、多中心、随机、平行对照的2期临床研 究，合格受试者将按照 2:2:1:1的比例随机分配接受HLX22联合HLX87、帕妥珠单抗联合HLX87、帕妥 珠单抗联合德曲妥珠单抗或帕妥珠单抗联合曲妥珠单抗及多西他赛治疗。第一阶段的主要终点是独立影 像评估委员会(BICR)评估的客观缓解率(ORR)及无进展生存期(PFS)。第二阶段是一项开放、多中心、 随机、平行对照的3期临床研究，合格受试者将按照1:1的比例随机分配接受HLX22联合HLX87或帕妥珠 单抗联合曲妥珠单抗及多西他赛治疗。第二阶段的主要终点是BICR评估的PFS。本次研究的主要目的 是评估HLX22联合HLX87一线治疗HER2阳性复发或转移性乳腺癌的临床疗效，次要目的包括评估 HLX22联合HLX87的安全性、耐受性、药代动力学(PK)特征及免疫原性，探索潜在的预测性或耐药性 生物标志物。 智通财经APP讯，复宏汉霖(02696)发布公告，近日，HLX22(重组人源化抗HER2单克隆抗体注射 ...

Group 1 - AstraZeneca disclosed multiple lawsuits related to personal information infringement and illegal trade in its 2025 annual report [1] - In October 2025, AstraZeneca (China) received a final assessment from Shenzhen Customs indicating unpaid import taxes totaling 24 million RMB (approximately 3.5 million USD) related to specific drugs [1] - AstraZeneca (China) prepaid the compensation amount in full, but could face fines of 1 to 5 times the unpaid import tax if found liable for illegal trade [1] Group 2 - In November 2025, the Shenzhen People's Procuratorate completed its assessment, leading to public prosecution of AstraZeneca (China), a former executive vice president, and a former senior employee for illegal collection of personal information and illegal trade [1] - The former executive vice president and senior employee were additionally charged with medical insurance fraud, although AstraZeneca (China) was not prosecuted for this charge [1] - The mentioned cases have been consolidated into a single litigation process at the Shenzhen Intermediate People's Court, with no trial date scheduled yet [1]

Group 1 - The National Health Commission and 11 other departments issued the "National Essential Drug Directory Management Measures," revising six key areas to enhance the essential drug system in China [1] - The revised measures include optimizing the directory structure, categorizing drugs into chemical drugs, biological products, and traditional Chinese medicine based on clinical pharmacology and functionality [1] - The management mechanism for the directory has been improved, emphasizing the clinical value of drugs and considering factors such as disease spectrum changes and drug supply assurance [1] Group 2 - Reborna Biotech and Madrigal Pharmaceuticals entered a global exclusive licensing agreement worth $4.4 billion to develop innovative siRNA therapies for metabolic dysfunction-related fatty liver disease (MASH) [2] - Reborna will receive a $60 million upfront payment and is eligible for additional payments upon achieving clinical development and regulatory milestones, along with royalties based on global net sales [2] - The agreement highlights the international value of domestic innovative drugs and the urgent demand for effective therapies in the MASH field, indicating significant market potential [2] Group 3 - Watson Bio announced plans to invest 450 million yuan to establish a biological industry investment fund, targeting a total fund size of 1 billion yuan [3] - The fund will primarily invest in the synthetic biology manufacturing sector, including areas such as synthetic biology, health, bio-agriculture, bio-energy, and bio-materials [3] - This initiative is expected to help Watson Bio capture industry benefits and lay the groundwork for future strategic mergers and acquisitions [3] Group 4 - Hengrui Medicine's subsidiary, Suzhou MSD Biopharmaceutical Co., has had its drug SHR-A1811 included in the list of breakthrough therapies by the National Medical Products Administration [4] - SHR-A1811 is intended for first-line treatment of locally advanced or metastatic non-small cell lung cancer patients with HER2 (ERBB2) activating mutations [4] - The inclusion of SHR-A1811 reflects Hengrui's research achievements in the ADC field, although it will face competition from several already approved similar products [4]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Suzhou Merdia Biopharmaceutical Co., Ltd., has received inclusion of its injectable SHR-A1811 (Rocatinib) in the list of breakthrough therapies by the National Medical Products Administration (NMPA), marking the 10th indication for which it has received breakthrough therapy certification [1] Group 1: Drug Information - Drug Name: Injectable Rocatinib (SHR-A1811) [1] - Acceptance Number: CXSL2000087 [1] - Drug Type: Therapeutic biological product [1] - Registration Category: Class 1 [1] - Application Date: December 2, 2025 [1] - Proposed Indication: First-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations [1] Group 2: Approved Indications - The injectable Rocatinib was approved for domestic market launch in May 2025, indicated for adult patients with unresectable locally advanced or metastatic NSCLC who have previously received at least one systemic therapy and have HER2 (ERBB2) activating mutations [2] Group 3: Market Context - Primary lung cancer is the most common malignant tumor globally, with GLOBOCAN 2022 data indicating approximately 2.48 million new cases and 1.82 million deaths annually, making it the leading cause of cancer mortality [3] - In 2022, China reported 1.06 million new lung cancer cases, accounting for 22.0% of all malignant tumors, and 733,300 deaths, representing 28.5% of all cancer deaths [3] - NSCLC accounts for about 85% of lung cancer cases, with approximately 2%-4% of NSCLC patients experiencing HER2 mutations, which are associated with high tumor invasiveness and poor prognosis [3] - Recent advancements in antibody-drug conjugates and highly selective HER2-TKIs have provided new treatment options for patients with advanced NSCLC harboring HER2 mutations [3] Group 4: Drug Mechanism and Competition - Injectable Rocatinib binds to HER2-expressing tumor cells, inducing cell cycle arrest and apoptosis through the release of toxins in the tumor cell lysosome [4] - Competing intravenous products in the domestic market include Roche's Ado-trastuzumab emtansine, AstraZeneca and Daiichi Sankyo's Fam-trastuzumab deruxtecan, Rongchang Biopharmaceutical's Vidisichu monoclonal antibody, and Kelun-Biotech's Bodo-trastuzumab [4] - According to EvaluatePharma, the global sales of similar products are projected to reach approximately $6.557 billion by 2024 [4] - Cumulative R&D investment for injectable Rocatinib is approximately 1.7725 billion yuan (unaudited) [4]

评级：中性(维持) 曹泽运(证券分析师) 李畅(证券分析师) S0350525110001 S0350524010004 caozy@ghzq.com.cn lic05@ghzq.com.cn 证券研究报告 2026年01月30日 医药生物 生物医药深度报告：国产ADC药物即将迎来高光时刻 ——ADC子行业专题研究 最近一年走势 相关报告 《医药生物行业动态研究：中国独立医学实验室行业的先行者（中性）*医药生 物*曹泽运，林羽茜》——2026-01-27 《医药生物行业动态研究：AI药研或引产业革命，JPM大会再推行业新峰（中 性）*医药生物*曹泽运，林羽茜》——2026-01-20 相对沪深300表现 | 表现 | 1M | 3M | 12M | | --- | --- | --- | --- | | 医药生物 | 2.0% | -2.7% | 21.1% | | 沪深300 | 2.1% | 1.3% | 24.5% | 请务必阅读报告附注中的风险提示和免责声明 2 -9% 0% 9% 19% 28% 37% 2025/02/05 2025/05/06 2025/08/04 2025/11/02 医药生物 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index experienced a decline of 1.07%, ranking 26th among 31 primary industries, outperforming the CSI 300 index which fell by 1.19% [4][15] - The valuation of the pharmaceutical and biotechnology industry as of January 23, 2026, is a PE (TTM overall method, excluding negative values) of 30.31x, down from 30.56x in the previous period, indicating a downward trend below the average [4][19] - The top three sub-industries by PE are vaccines (47.34x), hospitals (44.94x), and other medical services (40.38x), while the lowest valuation is in pharmaceutical circulation (15.31x) [4][19] - During the reporting period, 34 listed companies in the pharmaceutical and biotechnology sector saw a net reduction of 2.125 billion yuan in shareholder holdings, with 2 companies increasing holdings by 63 million yuan and 32 companies reducing holdings by 2.189 billion yuan [4] Industry Review - The report highlights significant developments in the pharmaceutical retail sector, emphasizing the need for transformation from traditional drug sales to comprehensive health services [24][25] - The Ministry of Commerce and other departments issued opinions to promote high-quality development in the pharmaceutical retail industry, projecting a market size increase from 2.41 trillion yuan in 2020 to 2.95 trillion yuan by 2024, a growth of 22.4% [24][25] - The report also discusses the approval of new drugs and treatments, including the PD-1/VEGF bispecific antibody RC148 by Rongchang Biopharmaceuticals, which has a potential total payment of up to 4.95 billion USD [7][50] Investment Recommendations - The report suggests focusing on innovative pharmaceutical companies with differentiated pipelines that have received validation from high-quality collaborations with multinational pharmaceutical companies, particularly in key areas such as ADC, bispecific antibodies, and siRNA therapies [7]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index experienced a decline of 1.07%, ranking 26th among 31 primary industries, outperforming the CSI 300 index which fell by 1.19% [4][15] - The valuation of the pharmaceutical and biotechnology industry as of January 23, 2026, is a PE (TTM overall method, excluding negative values) of 30.31x, down from 30.56x in the previous period, indicating a decline in valuation below the average [4][19] - The top three sub-industries by PE (TTM overall method, excluding negative values) are vaccines (47.34x), hospitals (44.94x), and other medical services (40.38x), while the lowest valuation is in pharmaceutical circulation (15.31x) [4][19] - During the reporting period, 34 listed companies in the pharmaceutical and biotechnology sector saw a net reduction in shareholder holdings amounting to 2.125 billion yuan, with 2 companies increasing holdings by 63 million yuan and 32 companies reducing holdings by 2.189 billion yuan [4] Industry Trends - The 2026 JPM Conference highlighted Chinese innovative drugs as a global focus, with several Chinese companies showcasing advancements in PD-1/VEGF bispecific antibodies, ADCs, and cell therapies [7] - The report suggests focusing on innovative pharmaceutical companies with differentiated pipelines that have received validation through high-quality collaborations with multinational pharmaceutical companies, particularly in key areas such as ADCs, bispecific antibodies, and siRNA therapies [7] Important Industry News - The Ministry of Commerce and eight other departments issued opinions on promoting high-quality development in the drug retail industry, projecting a growth in the drug circulation market from 2.41 trillion yuan in 2020 to 2.95 trillion yuan by 2024, a 22.4% increase [24] - The National Healthcare Security Administration released guidelines for pricing projects related to surgical and treatment auxiliary operations, aiming to standardize and promote the use of advanced medical technologies [27][28] - Notable approvals include Daiichi Sankyo's "Trastuzumab Deruxtecan" for advanced HER2-positive gastric cancer, and AbbVie’s "Risankizumab" for ulcerative colitis, showcasing significant advancements in treatment options [38][44]

Core Viewpoint - The article discusses the investment framework for the pharmaceutical industry ETF in 2026, emphasizing a dual-driven approach of demand and innovation to navigate the market recovery and differentiation after a prolonged bear market since 2021 [29]. Market Review - The CITIC Pharmaceutical Index decreased by 0.38%, outperforming the CSI 300 Index by 0.24 percentage points, ranking 25th among 30 primary industries [9]. - The top ten stocks by increase this week included ST Changyao, Hualan Biological Engineering, and Kangzhong Medical, with gains ranging from 6% to 70.38% [9]. - The bottom ten stocks by decrease included Kain Technology and Aidi Pharmaceutical, with declines of up to 45% [9]. Industry and Stock Events - The article highlights a shift in funding from active to passive management in the pharmaceutical sector, with passive funds becoming a significant part of the long-term funding structure [18]. - The article notes that the innovation drug sector is expected to see a transition from quantity to quality, focusing on differentiated products and internationalization by 2025 [12]. - The medical device sector is experiencing a recovery in bidding volumes, particularly in imaging equipment, and is benefiting from policies promoting home medical devices and accelerated overseas expansion [12]. - The article discusses the favorable conditions for the blood products industry, with relaxed approval for plasma stations and a clear growth path for the industry during the 14th Five-Year Plan period [13]. Investment Strategy - The article proposes a dynamic ETF configuration framework for the pharmaceutical sector, categorized into three layers: a core base of broad-based ETFs, a dual-driven layer focusing on innovative drugs and medical devices, and a defensive layer using traditional Chinese medicine and overseas biotech [22]. - The article emphasizes the importance of a systematic approach to ETF selection, considering liquidity, tracking quality, and cost [24]. - It suggests that the pharmaceutical sector is entering a new growth cycle driven by rigid demand and continuous innovation, necessitating a more structured and rhythmic ETF combination strategy [22].

Core Viewpoint - The approval of trastuzumab deruxtecan for a new indication in China marks a significant milestone for Daiichi Sankyo and AstraZeneca, expanding its use in treating HER2-positive gastric cancer patients [1] Group 1: Drug Approval and Indication - Trastuzumab deruxtecan has received approval from the National Medical Products Administration of China for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received a treatment regimen containing trastuzumab [1] - This new indication is the sixth approved use of trastuzumab deruxtecan in China and the second indication related to HER2-positive gastric cancer [1] Group 2: Clinical Trial Results - The approval is based on results from the international, multicenter, randomized, open-label phase 3 study DESTINY-Gastric04, which demonstrated statistically significant and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) [1] - The safety profile of trastuzumab deruxtecan was found to be acceptable and manageable, consistent with known safety characteristics, with no new safety issues identified [1] - Results from the DESTINY-Gastric04 study were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and published in the New England Journal of Medicine [1]