Group 1 - The core point of the article is that Fuhong Hanlin (02696) is in negotiations with multinational pharmaceutical companies such as Johnson & Johnson and Roche to sell rights related to the PD-L1 antibody-drug conjugate HLX43, potentially receiving several hundred million dollars in upfront payments and milestone payments based on the drug's performance [1][1][1] Group 2 - Fuhong Hanlin's stock price increased by over 9% during trading, with a current price of 82.75 HKD and a trading volume of 114 million HKD [1][1][1] - Morgan Stanley recently upgraded the ratings for Fosun Pharma's A-shares and H-shares to "Overweight," raising the A-share target price to 42 HKD and the H-share target price to 33 HKD [1][1][1] - Morgan Stanley assigned a valuation of 720 billion HKD to Fuhong Hanlin, which is significantly higher than its current market value of approximately 440 billion HKD, translating to a per-share value of 143-145 HKD, with 73% of the valuation attributed to core candidate drugs including HLX43, HLX22, and serplulimab [1][1][1]

Core Insights - The company, Fuhong Hanlin, is deeply engaged in the biopharmaceutical sector, focusing on innovative strategies and solid actions to advance its development plans globally [1][2][3] Global Strategy - Fuhong Hanlin is committed to a globalization strategy, expanding its international market presence through collaborations with renowned global enterprises [1] - The establishment of a wholly-owned subsidiary in Japan allows the company to better understand local market demands and facilitate clinical development and registration of related drug candidates [1] - In Latin America, Fuhong Hanlin has successfully expanded its product coverage through partnerships with local companies, enhancing treatment options for patients and increasing its global market influence [1] Product Development - The company maintains a strong focus on product research and development, with a diverse pipeline addressing various disease treatment areas [2] - The development of the biosimilar HLX17 has gained significant attention, with the company receiving FDA approval to initiate Phase I clinical trials for treating various resected solid tumor patients by September 2025 [2] - Fuhong Hanlin emphasizes global resource integration and collaboration with domestic and international research institutions to enhance R&D efficiency and quality [2] Future Outlook - Fuhong Hanlin plans to strengthen innovation-driven initiatives, optimize global layouts, and accelerate product development processes [3] - The company aims to deepen collaborations with global partners and increase investments in R&D to bring more innovative products from the lab to clinical applications [3] - The commitment to innovation positions Fuhong Hanlin to contribute significantly to global health by providing high-quality biopharmaceuticals [3]

Investment Rating - The report maintains a "Buy" rating for the company with a target price raised from 78.01 HKD to 120.87 HKD per share [6]. Core Insights - The report highlights the impressive performance of HLX43 and HLX07, indicating that HLX43 shows excellent efficacy and safety, while HLX07 may provide new treatment options for first-line sqNSCLC patients [4][5]. Summary by Sections HLX43 Performance - HLX43 demonstrated a 37.0% overall objective response rate (ORR) and an 87.0% disease control rate (DCR) among evaluable patients [3]. - In a subgroup analysis of EGFR wild-type non-squamous NSCLC patients, the confirmed ORR reached 46.7%, indicating that HLX43's anti-tumor activity is not dependent on PD-L1 expression levels [3][4]. - The safety profile of HLX43 is manageable, with the most common grade ≥3 treatment-related adverse events (TRAEs) being anemia and leukopenia, both at 19.6% [4]. HLX07 Performance - HLX07 combined with a PD-1 antibody showed a median progression-free survival (mPFS) of 17.4 months in the high-dose group, significantly exceeding the standard therapy's mPFS of around 7 months [5]. - The safety profile during treatment was reported to be good, with manageable treatment-emergent adverse events (TEAEs) [5]. Financial Projections - The company is projected to achieve total revenues of 58.73 billion, 59.70 billion, and 71.25 billion CNY for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 2.60%, 1.64%, and 19.36% [6]. - Net profits attributable to shareholders are expected to be 8.27 billion, 7.97 billion, and 11.22 billion CNY for the same years [6].

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 15, 2025 [1] Core Insights - The trend of Chinese innovative drugs going overseas continues, with a focus on selective opportunities. The report highlights that the global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with upfront payments totaling $11.8 billion, a 136% surge, and total transaction value hitting $130.4 billion, up 58% year-on-year [2] - The report emphasizes the promising clinical data from Chinese innovative drugs presented at the World Lung Cancer Conference, particularly in the ADC (Antibody-Drug Conjugate) field, showcasing significant efficacy advantages [3] - The report discusses the potential of small nucleic acid drugs and innovative delivery systems, indicating new market opportunities arising from strategic collaborations between Chinese companies and multinational corporations [4] - The CXO (Contract Research Organization) sector is expected to gradually recover, with a notable increase in orders anticipated in the third quarter of 2025, driven by improved innovation environments and funding from license-out transactions [5] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 1.75% in the past week, with a recent one-month increase of 3.32%, lagging behind the CSI 300 by 5.81% [22][26] - The medical device sector showed the highest weekly increase of 2.23%, while the chemical pharmaceutical sector experienced a decline of 2.57% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index's current PE (TTM) stands at 40.60, above the five-year historical average of 31.60 [46] - The report notes that the pharmaceutical sector has shown a 15.06% increase over the past three months, outperforming the CSI 300 by 16.11% [43] 3. Recent Research Achievements - The report outlines recent research achievements by the Huaxin pharmaceutical team, including various in-depth and commentary reports on innovative drug developments and market trends [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Healthcare Security Administration regarding the 2025 drug directory adjustments and the approval of new drug applications [52][55]

Group 1 - Hansoh Pharmaceutical experienced a decline of 14.98% [1] - Fuhong Hanlin saw a drop of 11.84% [1] - Other companies such as CSPC Pharmaceutical, WuXi Biologics, and BeiGene also opened lower [1]

Core Viewpoint - Morgan Stanley's latest research report evaluates the innovative drug pipeline value of Fosun Pharma (02196) and its subsidiary, Hualan Biological (02696), indicating a total valuation contribution of approximately 72 billion RMB, suggesting nearly 80% upside potential from the current valuation of over 40 billion RMB, with a target price of around 145 HKD for Hualan Biological [1] Group 1: Innovative Drug Pipeline - Hualan Biological has established a diversified product portfolio consisting of antibodies and antibody-drug conjugates (ADCs), while also expanding into bispecific/trispecific antibody fields [1] - The company's sales have primarily been driven by biosimilars and PD-1 products, but its stock price has surged over 200% this year due to the promising potential of its innovative pipeline in clinical trials [1] Group 2: Key Products and Market Potential - HLX43 is positioned well for second-line/third-line treatment of EGFR wild-type non-small cell lung cancer (NSCLC), with a peak sales potential of 3.9 billion USD in the U.S. market, supported by encouraging objective response rates [2] - HLX22 has shown significant early signs of progression-free survival (PFS) and overall survival (OS) benefits in a Phase II trial for first-line HER2-positive gastric cancer, with a peak sales potential of 2.7 billion USD in the U.S., Japan, and Europe [3] Group 3: Competitive Landscape and Future Prospects - Serplulimab (PD-1) is expected to enter the Biologics License Application (BLA) stage in the U.S. in the first half of 2026, with a unique positioning in extensive-stage small cell lung cancer (ES-SCLC) and ongoing Phase III trials for colorectal cancer and gastric cancer [4] - Morgan Stanley anticipates that 73% of Hualan Biological's valuation growth will stem from the global potential of its core candidates—HLX43, HLX22, and Serplulimab—while its extensive biosimilar global layout will mitigate negative impacts from China's volume-based procurement [4]

Core Viewpoint - Morgan Stanley's latest research report evaluates the innovative drug pipeline value of Fosun Pharma (600196) and its subsidiary, Hualan Biological Engineering (02696), indicating a total valuation contribution of approximately 72 billion RMB, suggesting nearly 80% upside potential from the current valuation of over 40 billion RMB, with a target price of around 145 HKD for Hualan Biological Engineering [1] Group 1 - Hualan Biological Engineering has established a diversified product portfolio consisting of antibodies and antibody-drug conjugates (ADCs), while also expanding into bispecific/trispecific antibody fields [1] - The company's stock price has surged over 200% this year, primarily driven by the potential of its innovative pipeline in clinical trials, particularly HLX43 (PD-L1 ADC) and HLX22 (HER2 monoclonal antibody) [1] - The report highlights the promising prospects for out-licensing and increased diversity in product pipelines and international collaborations [1] Group 2 - HLX43 is positioned well for second-line/third-line treatment of EGFR wild-type non-small cell lung cancer (NSCLC), with a peak sales estimate of 3.9 billion USD in the U.S. market, showing encouraging objective response rates (ORR) of 46.7% and 30% in specific patient groups [2] - Hualan Biological Engineering is seeking FDA approval for HLX43 based on single-arm data for third-line treatment indications and is currently conducting a Phase II international multicenter clinical trial [2] - The company plans to initiate Phase III clinical trials within a year and is exploring additional indications for HLX43 in first-line NSCLC treatment [2] Group 3 - HLX22 has shown early signs of significant progression-free survival (PFS) and overall survival (OS) benefits in a Phase II trial for first-line HER2-positive gastric cancer, with adjusted peak sales estimates of 2.7 billion USD in the U.S., Japan, and Europe [3] - Hualan Biological Engineering is exploring the combination of HLX22 with Enhertu for HR-positive/HER2-negative breast cancer, with proof of concept data expected in the second half of 2026 [3] Group 4 - Serplulimab (PD-1) is expected to enter the Biologics License Application (BLA) stage in the U.S. in the first half of 2026, being the first PD-1 monoclonal antibody to show efficacy in first-line extensive-stage small cell lung cancer (ES-SCLC) [4] - The drug is also undergoing Phase III trials for new adjuvant treatment in pMMR/MSS colorectal cancer and gastric cancer, with unique positioning expected to capture significant market share despite competition [4] - Morgan Stanley anticipates that 73% of the valuation growth for Hualan Biological Engineering will stem from the global potential of its core candidates: HLX43, HLX22, and Serplulimab [4]

Core Viewpoint - Morgan Stanley has upgraded the ratings of Fosun Pharma's A-shares and H-shares to "Overweight," with target prices set at 42 CNY for A-shares and 33 HKD for H-shares [1] Group 1: Company Valuation - Morgan Stanley values Fosun Pharma's subsidiary, Fuhong Hanlin, at 720 billion CNY, while its current market capitalization is approximately 440 billion CNY [1] - This valuation translates to a share price of 143-145 HKD, with 73% of the valuation derived from the global potential of core candidate drugs: HLX43 (PD-L1 ADC), HLX22 (HER2 mAb), and serplulimab (PD-1) [1] Group 2: Product Portfolio and Market Potential - Fosun Pharma holds a 63.4% stake in Fuhong Hanlin, which has established a diversified product portfolio consisting of antibodies and antibody-drug conjugates (ADCs) [1] - Fuhong Hanlin's revenue primarily comes from biosimilars and PD-1, but this year's rebound is mainly attributed to its innovative product line, which has shown promising data in clinical trials [1] - The outlook for external licensing and the value in international markets is viewed positively [1]

（来源：衡水日报） 转自：衡水日报 复宏汉霖乳腺癌领域的核心产品汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名： Zercepac®），作为中国、欧盟、美国获批的"中国籍"单抗生物类似药，2025年上半年共计实现产品全 球销售收入14.442亿元。业绩期内，汉曲优®在墨西哥等国家获批，累计在全球50多个国家和地区获批 上市。针对HER2阳性乳腺癌治疗，复宏汉霖强化辅助治疗药物汉奈佳®（奈拉替尼）与汉曲优®形成 序贯治疗方案，以降低早期患者复发风险。此外，公司自研的帕妥珠单抗生物类似药HLX11已获中美 欧监管机构受理上市申请，有望于下半年在美国获得批准。 在其他疾病领域，复宏汉霖也有重要进展。公司与亿胜生物合作开发的重组抗VEGF单抗HLX04-O治疗 湿性年龄相关性黄斑变性（wAMD）已于2025年8月在中国获上市注册申请（NDA）受理，这是公司首 款申报上市的眼科产品。地舒单抗生物类似药HLX14用于治疗骨质疏松症等的上市注册申请已在美国 获得批准（美国商品名：BILDYOS® 60 mg/mL和BILPREVDA®120mg/1.7mL）美国，并于、欧盟和加 拿大获受理，有望于2025 ...

据复宏汉霖母公司复星医药（600196）(600196.SH/02196.HK)公告，截至2025年7月，复星集团针对 HLX17的累计研发投入约为人民币1.76亿元(未经审计)。 在中国，HLX17的临床试验申请已于2024年9月获国家药监局批准。 生物类似药，也被称为生物仿制药，是与已批准的生物原研药相似的一种药物。 帕博利珠单抗是一种PD-1抑制剂，可用于治疗黑色素瘤、肺癌、胃癌和结直肠癌等多种癌症。它是跨 国药企默沙东的王牌产品，又被称为"K药"，是2023年—2024年的全球"药王"，2024年"K药"的全球销 售额约为320.56亿美元。 "K药"的核心专利将于2028年过期。 经济观察报见习记者刘晓诺 9月8日，复宏汉霖(02696.HK)公告，其自主研发的帕博利珠单抗生物类似药HLX17的1期临床试验申 请，近日获得美国食品药品监督管理局批准。 复宏汉霖也有自主研发的PD-1靶点药物：斯鲁利单抗。复宏汉霖称之为"H药"，它是该公司第一款自主 研发并获批上市的生物创新药，于2022年3月在国内市场商业化上市，目前是复宏汉霖销售额最高的创 新药产品。2025年上半年，斯鲁利单抗在国内的销售收入为5 ...