Group 1 - The Hong Kong stock market for innovative drugs is showing signs of recovery, with the Hong Kong Stock Connect Innovative Drug ETF (159570) experiencing a slight increase of 0.06% and a trading volume exceeding 800 million CNY [1] - The ETF has seen a net inflow of over 18 million CNY yesterday and an additional 6 million CNY today, bringing its total scale to over 23.8 billion CNY, leading in its category [1] - Key stocks within the ETF have mixed performances, with notable gains from CSPC Pharmaceutical Group (up over 3%) and BeiGene (up over 2%), while Kangji Medical and 3SBio saw declines of over 5% and nearly 3%, respectively [1][2] Group 2 - AstraZeneca plans to invest over 100 billion CNY (approximately 15 billion USD) in China by 2030, focusing on expanding its drug production and R&D capabilities, particularly in cell therapy and radiolabeled drugs [3] - AstraZeneca has entered a strategic collaboration with CSPC Pharmaceutical Group in the weight management sector, involving a total potential deal value exceeding 25 billion USD, including a 1.2 billion USD upfront payment [4] - The FDA has accepted the Biologics License Application (BLA) for the innovative drug Ivosidenib, marking a significant step for Kangji Medical in expanding its global market presence [5] Group 3 - Recent market trends indicate a decline in overall risk appetite, with innovative drugs and hard technology entering a phase of valuation adjustment and expectation reshaping [6] - By 2025, the funding levels for Chinese pharmaceutical companies are expected to increase significantly, with a projected 145% year-on-year growth in IPO fundraising and a 185.9% increase in potential milestone payments from business development [7] - The new business model for external business development (BD) is expected to benefit early-stage research projects, enhancing the return on investment for R&D and driving growth in the early research industry chain [8]

证券研究报告 行业研究 / 行业点评 2026 年 02 月 02 日 行业及产业 医药生物 一年内行业指数与沪深 300 指数对比走势： 资料来源：聚源数据，爱建证券研究所 相关研究 《医药行业跟踪报告：医药板块迎来开门红， 2026 年继续看好创新出海和硬科技》 2026-01-13 《2026 年度医药行业策略：创新出海新征程， 寻找需求新增量》2026-01-05 张智聪 S0820525020002 021-32229888-25524 zhangzhicong@ajzq.com ——医药行业跟踪报告 MNC 重金加码中国创新药，中国 IO2.0 双抗出海迈出关键一步 强于大市 投资要点： 医药板块行情复盘：本周（1/26~2/1）市场以震荡调整为主，SW 医药生物指数下跌 3.31%， 在申万一级行业指数中排名 22/31，跑输沪深 300 指数（+0.08%）；各细分板块中，血液 制品（-0.99%）、疫苗（-1.65%）表现相对较好，主要与尼帕病毒概念相关，部分 CXO 个 股由于业绩催化表现较为突出，线下药店（-4.83%）和医院（-4.47%）表现较弱。港股创新 药回调明显，恒生生物科技指 ...

证 券 研 究 报 告 行业周报 技术加持稳定原料药出口竞争力 医药行业周报 分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 2 诚信、专业、稳健、高效 请阅读最后一页重要免责声明 医 药 行 业 观 点 投资评级： 报告日期： 推荐 （ 维持 ） 2026年02月01日 1.技术加持稳定原料药出口竞争力，重视供给变量 根据医保商会数据，2025年中国医药保健品出口额1113.41亿美元，增长3.14%，其中西药原料出口额428.67亿美元，占西 药总出口的76.8%，同比微降0.27%。原料药出口能保持出口总量的相对稳定，是克服全球贸易变局和内部价格竞争内卷下 实现的，是中国原料药产业竞争力的体现。受关税贸易影响，2025年中国对美国医药出口下降了10.6%，而非美市场，欧 盟增长11.38%，新兴市场增长4.49%。展望2026年原料药贸易依然存在较多的不确定性，中国与印度之间原料药竞争合作 将进一步演绎。价格方面，价格竞争内卷是一方面，另一方面合成生物学等新技术加持，新工艺新产能的投产，单位成本 下降是重要一面。 ...

Group 1 - The Hong Kong Innovation Drug ETF (159570) has seen a significant inflow of funds, with a recent trading volume exceeding 5 billion yuan and a net inflow of over 300 million yuan in the past five days [1] - As of January 20, the total size of the Hong Kong Innovation Drug ETF reached over 25.3 billion yuan, leading the market in terms of scale among innovation drug ETFs [1] - The index components of the ETF showed mixed performance, with notable gains from companies like Kingsoft Biotech and China Biologic Products, while companies like CanSino Biologics experienced declines [3][4] Group 2 - At the J.P. Morgan Healthcare Conference, several Chinese pharmaceutical companies showcased their advancements, including BeiGene's new drug approval in China and plans for accelerated approval in the U.S. [5] - Innovent Biologics and Pfizer are set to conduct five global Phase III trials for their drug SSGJ-707 by 2026, targeting various cancers [6] - The collaboration between NVIDIA and Eli Lilly aims to establish an AI innovation lab with a projected investment of up to 1 billion USD over five years, potentially transforming drug development processes [8] Group 3 - Tempus AI reported a revenue of approximately 1.27 billion USD for 2025, marking an 83% year-on-year increase, driven by significant growth in its diagnostic business [9] - The top ten components of the Hong Kong Innovation Drug ETF account for over 73% of its weight, highlighting the concentration of leading innovative drug companies within the ETF [10]

Investment Rating - The report indicates a strong investment opportunity for Rongchang Biopharma following the signing of a significant licensing agreement with AbbVie, which is expected to enhance the company's financial position and market presence [2][25]. Core Insights - Rongchang Biopharma has signed an exclusive licensing agreement with AbbVie for the novel PD-1/VEGF bispecific antibody drug RC148, which includes an upfront payment of $650 million (approximately 4.5 billion RMB) and potential milestone payments totaling up to $4.95 billion (approximately 34.5 billion RMB) [2][8]. - The total transaction value is close to $4 billion, marking a record for the company in terms of external licensing agreements [3][8]. - The PD-1/VEGF bispecific antibody market is identified as a "golden track" for Chinese innovative drugs going global, with increasing upfront payments reflecting the growing value of these assets [9][10]. Industry Overview - The number of BD licensing deals for Chinese innovative drugs has surged from 85 in 2023 to 157 in 2025, with a compound annual growth rate of 35.9% [11]. - The total transaction value for these deals has skyrocketed from $32 billion in 2023 to $135.7 billion in 2025, representing a growth of over three times [13]. - The industry is entering an accelerated growth phase, with a year-on-year growth rate of 161% for BD licensing deals in 2025, significantly outpacing previous years [15]. Financial Performance - Rongchang Biopharma's revenue for the first three quarters of 2025 reached 1.72 billion RMB, reflecting a year-on-year increase of 42.27% [16]. - Despite ongoing net losses exceeding 1 billion RMB from 2022 to 2024, the company has shown improvement, with losses narrowing to 551 million RMB in the first three quarters of 2025 compared to 1.071 billion RMB in the same period of 2024 [17][19]. - The anticipated upfront payment from the AbbVie deal is expected to further improve Rongchang Biopharma's profitability and cash reserves, potentially leading to profitability in 2026 if the payment is fully received [19]. Product Pipeline - Rongchang Biopharma's key products include Taitasip (IL-4Rα antibody) and Vidisicimab (HER2 ADC), which are currently the main sources of revenue [20]. - The RC148 bispecific antibody is a focus for the company, currently in I/II clinical stages, and the collaboration with AbbVie is expected to accelerate its global development [23].

Core Viewpoint - Kangfang Biopharma's innovative PD-1/VEGF dual antibody, Ivosidenib, has submitted a Biologics License Application (BLA) to the FDA for treating EGFR mutation non-squamous non-small cell lung cancer (NSCLC) [1] Group 1: Company Developments - Ivosidenib's BLA submission is based on the overall results of the global Phase III HARMONi trial [1] - The application was submitted by Summit Therapeutics, the overseas partner of Kangfang Biopharma [1] Group 2: Regulatory Timeline - The FDA is expected to make a review decision on the BLA by the fourth quarter of 2026 [1] - The BLA aims to support the use of Ivosidenib in combination with chemotherapy for patients with EGFR mutation NSCLC who have progressed after third-generation EGFR-TKI treatment [1]

Core Insights - The new medical insurance directory has entered a substantial implementation phase, with multiple innovative drugs, including Tislelizumab and Fuzhengzhu, being covered by insurance in various hospitals, indicating a rapid reduction in access barriers for patients [1][3] - The adjustment includes 114 new drugs and introduces a commercial health insurance innovative drug directory for 2025, marking a significant shift towards a multi-tiered insurance payment system [1][3] Group 1: Innovative Drug Inclusion - The new medical insurance directory reflects increased support for "true innovation" with 124 unique products included, showcasing a strong emphasis on high clinical value [3][4] - Notable drugs like Tislelizumab, the first targeted therapy for thyroid eye disease, and Fuzhengzhu, a biological agent for psoriasis, have been rapidly integrated into the insurance system, filling long-standing treatment gaps [3][4] - Heng Rui Medicine is highlighted as a major beneficiary, with 20 products and indications adjusted, including 10 new drugs, enhancing patient access to innovative therapies [3][4] Group 2: Biotech Sector Impact - Companies like BeiGene, Innovent Biologics, and Kangfang Biotech are also benefiting from the new directory, accelerating their commercialization processes [4] - BeiGene is the only company with two products included in the first commercial insurance innovative drug directory, addressing unmet needs in cholangiocarcinoma and neuroblastoma [4] - Innovent Biologics has expanded its offerings to 12 innovative drugs under the new directory, creating a robust product matrix [4] Group 3: Shift in R&D Strategies - The introduction of the commercial insurance innovative drug directory is seen as a solution to the payment challenges faced by high-value innovative drugs, encouraging companies to focus on true innovation rather than me-too products [5][6] - The directory allows for a second market for high-priced therapies, with price reductions between 15% and 50%, which is less severe than the typical cuts seen in basic insurance [6][7] - This dual-directory model is expected to drive pharmaceutical companies to align their R&D strategies with real-world clinical needs, particularly in oncology and rare diseases [7][9] Group 4: Drug Exclusions - The adjustment also involved the removal of 29 drugs from the insurance directory, including Benalutide injection, which faced competition from more effective alternatives [8][9] - This "one in, one out" approach aims to enhance the efficiency of insurance fund usage by prioritizing high-demand and effective medications [9]

Group 1 - Kangfang Biotech (09926) shares rose over 6% after the approval of an important update to the product label for its PD-1/VEGF bispecific antibody, Ivosidenib, which showed significant clinical benefits in treating advanced non-squamous non-small cell lung cancer [1] - Sunac China (01918) shares fell over 6% as the company reported a contract sales amount of 2.95 billion RMB in December, a year-on-year increase of 68.6%, but with a decrease in average sales price per square meter by 14.4% [1] - Nanshan Aluminum International (02610) saw a nearly 14% increase in shares, attributed to a tight global electrolytic aluminum market, with Indonesia being a key marginal supplier [1] Group 2 - Optical communication stocks rebounded, with Longi Fiber Optic (06869) up 7.46% and Cambridge Technology (06166) up 3.86%, following a significant rise in U.S. optical communication stocks [2] - Hengrui Medicine (01276) shares increased over 2.8% after announcing the approval of two innovative drugs for clinical trials targeting prostate cancer [2] - Cao Cao Travel (02643) shares rose over 7% following the announcement of acquisitions of Yao Travel and Geely Business Travel [2] Group 3 - Hutchison China MediTech (00013) shares increased over 5.3% after announcing positive results from a Phase III trial for a new treatment for autoimmune hemolytic anemia [3] - Geekplus Technology (02590) shares rose slightly by 0.51%, with a report highlighting its stable business model and growth potential due to AI applications [3] Group 4 - Xuan Bamboo Biotech (02575) shares surged over 11.6% after its drug, Pyrotinib, was included in the national medical insurance directory, providing new benefits for advanced breast cancer patients [4] Group 5 - Semiconductor equipment and materials stocks continued to rise, with significant gains for companies like Amkor Technology (AMKR.US) and Lam Research (LRCX.US) [5] - Chinese concept stocks mostly rose, with notable increases for Hesai (HSAI.US) and Pinduoduo (PDD.US), amid a bullish market sentiment [5] - Uber (UBER.US) and Lyft (LYFT.US) saw stock price increases following Nvidia's announcement of advancements in autonomous driving technology [5] Group 6 - Data center cooling stocks experienced a decline, with companies like Modine Manufacturing (MOD.US) and Johnson Controls (JCI.US) facing significant drops [6] - Copper stocks strengthened, with Freeport-McMoRan (FCX.US) and Southern Copper (SCCO.US) showing notable gains as copper futures reached a historic high [6] - The storage sector continued its upward trend, with SanDisk (SNDK.US) achieving a 27.56% increase after launching a new SSD product line [6] Group 7 - Alumis (ALMS.US) shares skyrocketed by 95.31% following positive results from clinical trials for its TYK2 inhibitor targeting psoriasis patients [7] - Tesla (TSLA.US) shares fell over 4.14% as BYD surpassed Tesla in electric vehicle sales in key European markets [7] - Zeta Global (ZETA.US) shares rose 9.83% after announcing a strategic partnership with OpenAI to enhance its product capabilities [7]

Core Insights - Chinese innovative pharmaceuticals are transforming from global followers to pioneers in new treatment paradigms, with local biopharmaceutical companies leading this change [1] - The pipeline of innovative drugs and newly launched drugs from China now accounts for one-third of the global total, showcasing the rapid growth of the industry [1] Company Overview - Kangfang Biopharma was founded in 2012 by Xia Yu and colleagues, focusing on the underexplored dual-antibody (bi-specific antibody) field in tumor immunotherapy [6] - The company invested heavily in developing comprehensive drug development platforms, including ACE and TETRABODY technologies, to support its innovative approach [6][7] - In 2022, Kangfang's dual-antibody drug, Cardunili (PD-1/CTLA-4), became the first of its kind approved globally, marking a significant milestone for dual-antibody drugs in China [6][10] Strategic Development - Kangfang's early licensing of CTLA-4 monoclonal antibodies for $200 million to Merck and subsequent commercialization of PD-1 monoclonal antibodies were strategic moves to build resources and credibility [7] - The company has successfully transitioned from single-target antibodies to dual-antibody innovations, demonstrating a commitment to long-term strategic vision [10] Production and Infrastructure - The establishment of a modern biopharmaceutical production base in Guangzhou took only 18 months, showcasing the efficiency of local support [11] - The rapid construction of the production facility allowed Kangfang to meet market demand effectively, particularly after the launch of Cardunili [12] Clinical Development and Global Impact - Kangfang has achieved a high success rate in clinical trials, with all drugs in clinical phase II successfully approved, contributing to China's position as a leader in innovative drug development [16] - The company licensed exclusive development and commercialization rights for its drug Yiwosi to Summit for $5 billion, reflecting its enhanced negotiation position and the global potential of its products [16] - Kangfang is building its global operational capabilities, with a research center in Shanghai and over 10 products undergoing early clinical trials in various countries [18] Industry Recognition - The success of Yiwosi in clinical trials against the global leader, Pembrolizumab, has garnered significant international media attention, positioning Chinese biopharmaceuticals alongside advancements in artificial intelligence [17]

Core Insights - Chinese innovative pharmaceuticals are undergoing a significant transformation, with local companies like Kangfang Biotech leading the way in developing new therapies and capturing a substantial share of the global market [3][10] Strategy - Kangfang Biotech was founded in 2012, focusing on the underexplored area of dual-target antibodies in tumor immunotherapy, investing heavily in developing comprehensive drug development platforms [5][6] - The company achieved a major milestone in 2022 with the approval of its dual-target antibody, Cardunili, marking a significant advancement in China's biopharmaceutical landscape [5][10] Technological Challenges - Developing dual-target antibodies presents greater complexity compared to single-target therapies, requiring advanced molecular design and production capabilities [4] Development and Production - Kangfang Biotech established a modern biopharmaceutical production base in Guangzhou within 18 months, significantly accelerating its product commercialization process [7][8] - The rapid establishment of the production facility allowed the company to meet strong market demand for Cardunili following its launch [8] Clinical Success - All drugs in clinical phase II have achieved successful trial outcomes and received market approval, showcasing a high success rate in research and development [10] Global Expansion - In 2022, Kangfang Biotech licensed exclusive development and commercialization rights for its drug, Iwosi, to a U.S. company for a total of $5 billion, reflecting its enhanced negotiation position in the global market [10] - The company is building its global operational capabilities, with a research center in Shanghai and ongoing clinical trials in multiple countries [12] Industry Impact - The rise of Kangfang Biotech and similar companies has positioned China as a significant player in the global pharmaceutical industry, with over 30% of new drug pipelines and approvals [10] - The success of Iwosi against the leading drug, Pembrolizumab, has garnered international media attention, likening the moment to breakthroughs in artificial intelligence [11]