2025年8月25日，百济神州发布公告，与Royalty Pharma达成了一项特许权使用费购买协议。根据协议，Royalty Pharma在交割时支付8.85亿美元首付 款，购买DLL3/CD3双抗Imdelltra在中国以外的特许权使用费（中个位数百分比）的大部分权利。2026年8月25日即一年之内，百济神州有出售额外特许权 使用费的选择权，如行使选择权，Royalty Pharma支付6500万美元额外付款。该付款将根据额外价值按比例进行调整。对于中国外收入超出15亿美元的部 分，百济神州将分享特许权使用费的一部分。 百济神州此次转让的Imdelltra特许权使用费，来自2019年10月与安进达成的战略合作。安进购入百济神州20.5%的股份成为最大股东，同时就20余款创新 药达成全球开发合作协议，百济神州承担最多12.5亿美元全球开发成本，获得中个位数比例的特许权使用费。此次与Royalty Pharma一款产品的特许权使用 费转让合作，即回收了9.5亿美元以上的成本。 总结 百济神州与安进深度绑定，安进为百济神州最大股东，拥有安进多款新药中国商业化权益，同时直接参与到安进多款新药的全球开发和商业化，此 ...

2025 年 08 月 25 日 汇添富科创创新药 ETF：把握创新 药产业景气，双轮驱动捕捉成长标 的 ——指数基金产品研究系列报告之二百五十一 本研究报告仅通过邮件提供给 中庚基金 使用。1 证 券 研 究 报 证券分析师 邓虎 A0230520070003 denghu@swsresearch.com 肖逸芳 A0230524110001 xiaoyf@swsresearch.com 张静含 A0230522080004 zhangjh@swsresearch.com 陈田甜 A0230524080013 chentt@swsresearch.com 联系人 邓虎 (8621)23297818× denghu@swsresearch.com 权 益 量 化 研 究 量 化 策 略 告 相关研究 - 请务必仔细阅读正文之后的各项信息披露与声明 ⚫ 中国创新药行业迈向"全球引领"新阶段：在政策（如《全链条支持创新药发展实施方案》） 的全链条支持下，中国创新药行业正迎来历史性拐点。产业呈现出从"仿制跟随"到"源 头创新"的升级趋势，国际化进程通过火热的 BD 交易加速，同时多家企业商业化开始兑 现，逐步实现" ...

Company Developments - Meituan's international delivery brand Keeta has officially launched in Doha, Qatar, with plans to expand into more Gulf Cooperation Council (GCC) countries and enter the Brazilian market in a few months [2] - Great Wall Motors has completed the construction and production launch of its factory in Brazil, located in Iracemapolis, São Paulo, with an annual production capacity of 50,000 vehicles [2] - AliExpress has launched its "overseas hosting" model in Australia, following its implementation in several other countries including the US and Mexico [2] - Cha Bai Dao has announced the opening of its first North American store in New York, marking its entry into the US market, following successful expansions in Singapore and France [2] Strategic Expansion - Lenovo Group plans to establish a regional headquarters in Riyadh, Saudi Arabia, and has begun construction on a manufacturing facility expected to start trial production in 2026 [3] - MINISO's founder expressed intentions to expand the MINISO LAND stores overseas, emphasizing the importance of proprietary IP alongside global IP [3] - Leap Motor has achieved a milestone by reporting its first half-year profit, with overseas markets becoming a significant growth driver [3] - Pop Mart aims to expand into emerging markets such as the Middle East and South Asia, expecting to exceed 200 overseas stores by the end of the year [4] Financial Performance - Pop Mart reported a revenue of 13.88 billion yuan for the first half of 2025, a year-on-year increase of 204.4%, with adjusted net profit rising by 362.8% [4] - Xiaomi's automotive division is expected to start generating profits in the second half of the year, with plans to avoid price wars [4] - XGIMI's Vietnam factory has launched its first projector, with overseas revenue projected to reach 1.086 billion yuan in 2024, marking an 18.94% year-on-year increase [5] Market Trends - The user-side energy storage market is showing signs of recovery, with a focus on high-growth new markets and a concentration of market players [8] - Chinese innovative pharmaceutical companies are transitioning from followers to leaders in the market, with a focus on internationalization [8] - The global photovoltaic industry is experiencing increased competition, prompting Chinese companies to accelerate their global expansion efforts [9][10]

Group 1 - Tsinghua Unigroup's control will change as Hunan Sailuxian will acquire approximately 58.61 million shares from its controlling shareholder, Tsinghua Technology Service Co., Ltd, leading to a shift in control of Tsinghua Unigroup [1] - The new controlling shareholder will need to stabilize the company's operations amidst industry consolidation, and investors should pay attention to future asset integration and the new shareholder's resource injection capabilities, with potential short-term stock price volatility [1] Group 2 - Shuoshi Bio reported a revenue of 176 million yuan, a year-on-year decrease of 1.05%, and a net profit attributable to shareholders of 3.99 million yuan, down 86.35% year-on-year, primarily due to the deepening of centralized procurement in the in vitro diagnostic industry and an increase in the VAT rate to 13% [2] - The decline in net profit is attributed to pressure on product prices from industry procurement, a significant drop in gross margin, and a 13.11% reduction in R&D investment, which may weaken long-term competitiveness [2] Group 3 - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic cancer, marking a significant step in the internationalization of innovative drugs [3] - The drug's dual advantages of immune modulation and precise targeting position it competitively in the global market, with the potential to fill a treatment gap for thymic cancer if subsequent data is positive [3] Group 4 - Junshi Biosciences announced that the National Medical Products Administration has accepted the application for the 13th indication of its PD-1 monoclonal antibody, Toripalimab, for use in combination with HER2 ADC for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [4] - This combination is expected to further strengthen Junshi's differentiated positioning in the PD-1 market and enhance collaboration with Rongchang Bio on ADC development [4]

Group 1 - The Hong Kong innovative drug sector experienced a decline, with the Hang Seng Innovative Drug Index dropping by 1.2% as of 14:45, while the Hang Seng Innovative Drug ETF (159316) saw a net subscription of 40 million units during the day [1] - Recent data from Wind indicates that the scale of the Hang Seng Innovative Drug ETF has increased by over 110% in the past month, reaching a historical high [1] - On August 6, Heng Rui Medicine announced that its product, injection of Rui Kang Qu Mo Zhuan Tan combined with A De Bei Li injection and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, received orphan drug designation from the FDA [1] Group 2 - On the same day, Di Zhe Medicine announced that its product DZD8586 received "Fast Track Designation" from the FDA [1] - According to a report from Industrial Securities, the innovative drug sector's prosperity is sustainable, with the trend of "innovation + internationalization" remaining a core direction for the pharmaceutical sector, supported by ongoing policies and expected global competitiveness [1] - The Hang Seng Innovative Drug Index recently announced a revision to its compilation scheme, explicitly excluding CXO companies and focusing on core innovative drug companies, with the new rules set to take effect on August 11 [1] Group 3 - The revised index will become one of the first "pure" innovative drug indices with 100% purity among the ETFs it tracks, providing investors with a convenient way to invest in leading innovative pharmaceutical companies [1]

Core Viewpoint - The company is entering a new development stage with a dual focus on oncology and chronic diseases, showcasing strong competitiveness in both commercialization and early pipeline assets, such as Xinlidi (信迪利单抗), Marsudotide (玛仕度肽), and Tislelizumab (替妥尤单抗) [1][2] Oncology Development - The company maintains a leading position in China's PD-1 market, with Xinlidi showing excellent commercialization results. The early pipeline asset IBI363 (PD1/IL2α) has demonstrated outstanding data in non-small cell lung cancer, colorectal cancer, and melanoma, indicating potential for internationalization [1][2] - IBI363 is positioned as a "super blockbuster" with the potential to capture a significant share of the global $100 billion immuno-oncology market, improving upon the first-generation PD-1 drugs by enhancing immune activation in both "hot" and "cold" tumors [2][5] Chronic Disease Development - In the chronic disease sector, the core weight loss/diabetes product Marsudotide has been approved for weight loss indications, with promising commercialization prospects. Additionally, Tislelizumab and Toripalimab are progressing smoothly in commercialization, contributing to new revenue streams [2][3] - The pipeline includes promising candidates like IBI128 for gout and Pikanqibai monoclonal antibody for psoriasis, which are expected to provide new treatment options and further enhance commercialization potential [2][3] Pipeline and Revenue Forecast - The company has established a robust pipeline with nearly 20 products, balancing immediate sales with long-term potential projects. Key products like Marsudotide are expected to achieve peak sales exceeding 8 billion yuan, while Tislelizumab and Toriqalimab are projected to exceed 2 billion yuan each [3][4] - Revenue forecasts for the company are projected to reach 11.806 billion yuan, 15.382 billion yuan, and 21.092 billion yuan for the years 2025 to 2027, respectively, with a DCF valuation suggesting a reasonable market capitalization of 220.8 billion HKD and a target price of 129.15 HKD [3][4] Strategic Positioning - The company is well-positioned for international expansion, having established a strong competitive edge in both oncology and chronic disease sectors. The dual focus on these areas is expected to accelerate growth and enhance its global presence [5][6] - The company is anticipated to lead the second-generation immuno-oncology drug market, with IBI363 expected to be a key player in this competitive landscape [6]

Core Viewpoint - The announcement of a $180 million upfront payment from Novo Nordisk to Federated Pharmaceuticals marks the activation of a significant licensing agreement for the weight-loss drug UBT251, with potential total revenues reaching $2 billion [3][4]. Financial Performance - Federated Pharmaceuticals reported a slight revenue increase of 0.14% year-on-year, totaling 13.759 billion yuan for 2024, while net profit attributable to shareholders decreased by 1.54% to 2.66 billion yuan, breaking a multi-year trend of double-digit growth [3][4]. - The company's financial structure remains heavily reliant on traditional business segments, with intermediates and raw materials accounting for 60%-65% of revenue [6]. Market Reaction - The capital market's reaction to the licensing agreement was unexpectedly negative, with Federated Pharmaceuticals' stock price dropping 11.78% following the announcement, reflecting investor concerns over structural challenges during the company's transition [3][4]. Drug Development and Competition - The UBT251 project is entering a critical phase of clinical concept validation, with data expected in the next 18-24 months to determine its commercial viability [4][6]. - The competitive landscape for the generic version of semaglutide is intensifying, with multiple companies, including Jiuyuan Gene and Lijun Group, also developing similar products [4][5]. Strategic Challenges - The company faces significant challenges in balancing innovation investments with the need to stabilize its traditional business, particularly as the formulation product profits plummeted by 47% due to price reductions from national drug procurement policies [5][6]. - Novo Nordisk's substantial upfront payment is seen as a response to its urgent need for new products to maintain market leadership, especially as its flagship product's patent is set to expire in 2026 [6][7].

Market Overview - A-shares and Hong Kong stocks experienced a sudden drop but recovered shortly after, with the Shanghai Composite Index down 0.44%, Shenzhen Component Index down nearly 1%, and ChiNext Index down over 1% [1] - The Nikkei 225 and Nasdaq futures also saw a mysterious drop around the same time [1] Reasons for Market Movement - The first reason for the drop was portfolio rebalancing, as funds were eager to adjust their positions after a crowded phase in bank dividends and micro-cap stocks, leading to a sell-off when market volatility occurred [2] - The second reason was attributed to quantitative trading algorithms reacting to news about U.S.-China trade talks, which triggered sell signals based on keywords perceived as negative [3][4] U.S.-China Trade Negotiations - Recent U.S.-China talks lasted six hours, with both sides planning to meet again, focusing on issues like China's rare earth export controls and U.S. semiconductor restrictions [5][8] - The outcome of these negotiations is crucial for both parties, with implications for U.S. political interests and China's economic strategies [8][10] Innovation Drug Sector - The innovation drug sector has shown resilience, with stocks rising even when the broader market was down, driven by expectations of U.S. Federal Reserve rate cuts and domestic breakthroughs [14] - China is a key player in the global pharmaceutical supply chain, particularly in the API (Active Pharmaceutical Ingredient) sector, which is critical for drug manufacturing [15][16] - Chinese pharmaceutical companies are expected to see significant revenue growth by 2025, with many already integrated into national healthcare systems [18][21] - The innovation drug sector is less affected by tariffs due to the nature of clinical trials and the potential for technology transfer rather than traditional drug sales [22]

Core Viewpoint - The domestic innovative drug industry is experiencing a significant revaluation of value, with major indices showing substantial increases in 2023, indicating a potential turning point for the sector [1][3]. Group 1: Driving Factors for Growth - The innovative drug sector has seen a rise of over 20% in the index, driven by companies with sustainable innovation capabilities amidst constrained payment abilities in some medical fields [3][4]. - Key sustainable factors include the aging population leading to unmet clinical needs, supportive policies, enhanced R&D capabilities, emerging new technologies, and accelerated internationalization [4][5]. - The supportive policy environment and the increasing clinical value orientation have strengthened the business development logic for overseas expansion [5][6]. Group 2: Industry Development Stage - The Chinese innovative drug industry is in a rapid growth phase, transitioning from "follow-up innovation" to "global leadership," with many companies approaching profitability by 2025 [6][7]. - The industry is expected to enter a collective revenue growth phase starting in 2025, with a significant number of companies likely to cross the profitability threshold between 2025 and 2028 [4][6]. - The current R&D level is significantly improving, with China's contribution to global IP transactions rising to about 30% [6][7]. Group 3: Competitive Landscape - The competitive landscape varies by disease area, with the fastest or best products capturing significant market shares, indicating a "Matthew effect" where the first two drugs to market dominate [9][10]. - Chinese innovative drugs are showing notable global competitiveness, with expectations that they could capture 30% to 50% of the global market share in the future [9][10]. - The industry is witnessing a shift where Chinese companies are becoming preferred partners for multinational corporations in early-stage drug development [10][11]. Group 4: Valuation Levels - Despite recent gains, the valuation levels of innovative drug companies remain relatively low, with the PS ratio for the Wind pharmaceutical index at 2.75, indicating a historical low [11][12]. - The A-share market shows a higher absolute valuation compared to Hong Kong stocks, but with a lower historical percentile, suggesting a favorable valuation opportunity [11][12]. - The overall sentiment in the market is shifting towards a recovery in confidence and value reassessment for the pharmaceutical sector [12][13]. Group 5: Challenges Facing the Industry - The innovative drug sector faces challenges such as high costs, intense competition, and the need for improved international clinical trial capabilities [16][17]. - The industry is also grappling with a limited number of original disease targets and increasing internal competition, which could hinder growth [16][17]. - The payment market for innovative drugs in China requires further development, with commercial health insurance playing a crucial role in supporting long-term payment capabilities [16][17].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Views - The pharmaceutical and biotechnology industry index increased by 3.08%, ranking third among 31 primary industries, outperforming the CSI 300 index which rose by 0.94% [5][17] - The report highlights the acceleration of internationalization of innovative drugs, with a focus on two main directions: the global multi-center clinical capabilities and differentiated technology platforms, as well as short-term opportunities driven by ASCO data [8][9] Industry Performance - The valuation of the pharmaceutical and biotechnology industry as of May 23, 2025, is a PE (TTM overall method, excluding negative values) of 27.60x, up from 26.77x in the previous period, indicating an upward trend but still below the average [22] - The top three sub-industries in terms of PE are vaccines (52.08x), hospitals (37.38x), and medical devices (33.40x), while the lowest valuation is in pharmaceutical distribution (15.18x) [22] Important Industry News - The CDE released guidelines for clinical trials of Alzheimer's disease drugs, aiming to provide technical standards for drug development [27] - AbbVie’s c-Met ADC "Teliso-V" received FDA approval, marking it as the first of its kind globally [28] - The report mentions significant collaborations, such as Pfizer's partnership with 3SBio for a PD-1/VEGF bispecific antibody, valued at over $6 billion [8][51] Company Dynamics - Hengrui Medicine officially listed on the Hong Kong Stock Exchange with an IPO price of HKD 44.05 per share, achieving a market capitalization of over HKD 290 billion [44][45] - The report notes that 35 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to CNY 1.336 billion during the reporting period [5]