康 方 生 物 科 技（ 開 曼 ）有 限 公 司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） 香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 之 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部 或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Akeso, Inc. 茲 提 述 本 公 司 日 期 為 2020 年 4 月 14 日 的 招 股 章 程 ， 內 容 有 關 中 山 康 方 與 正 大 天 晴簽訂合資協議成立合資企業，天晴康方。根據合資協議，（ 其中包括 ）單抗產 品的生產將由中山康方及正大天晴共同安排，並根據雙方生產設施各自的批准 時間表進行相應規劃。 於2021年12月21日，天晴康方與中山康方訂立委託生產協議，以載納委託生產 安排的條款及條件。根據委託生產協議，天晴康方同意(i)委託中山康方生產單 抗產品及(ii)就生產並交付的所有單抗產品支付相關生產成本。 （股 份 代 號：9926） 根據上市規則第14A .60條的持續關連交易 委託生產協議及 ...

Group 1 - The core achievement of Zhongshan during the "14th Five-Year Plan" period includes a continuous increase in GDP, surpassing 3500 billion and 4000 billion yuan, with an expected breakthrough of 4200 billion yuan by 2025 [2] - The total number of business entities in Zhongshan reached 740,000, marking a 60% growth over five years [2] - The number of provincial industrial parks increased from 3 to 11, and the total scale of the ten major industrial clusters exceeded 7000 billion yuan, with industrial investment expected to double by 2024 compared to 2021 [2] Group 2 - Zhongshan emphasizes innovation as the primary driving force for development, focusing on strengthening innovation supply, activating enterprise innovation, and improving financial support ecosystems [3] - The city invested nearly 5 billion yuan over five years to build high-level innovation platforms, collaborating with institutions like the Chinese Academy of Sciences and various universities [3] - R&D expenditure in Zhongshan has exceeded 10 billion yuan for three consecutive years, with a growth rate of over 20% for the last two years [3] - The biopharmaceutical industry in Zhongshan has established an ecosystem with a production value of 18 billion yuan, gathering over 650 related enterprises [3] - Special policies have been introduced to support innovative drug research and development, with funding support of up to 40% and a maximum of 65 million yuan per product [3] - R&D investment in the biopharmaceutical sector is expected to double from 2021 to 2024, with an average growth rate of over 30% in the last two years [3]

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]

Group 1 - Hong Kong biopharmaceutical stocks weakened during trading on December 30, with Genscript Biotech falling nearly 4% [1] - Fuhong Hanlin declined by nearly 3%, while Kelun-Biotech dropped over 2% [1] - Other stocks such as CanSino Biologics, Rongchang Biologics, and Kanyin Biologics also experienced declines of over 1.5% [1]

Core Insights - The article discusses the transformation of Chinese pharmaceutical companies from merely selling products to actively participating in global value chains, with a significant increase in outbound licensing deals reaching over $100 billion by November 2025, a 75% increase year-on-year [3][4]. Group 1: Major Transactions - In 2024, major deals like Hengrui's $5 billion GLP-1 product and a $12.5 billion upfront payment from Pfizer to 3SBio for a dual antibody drug highlight the trend of billion-dollar collaborations becoming standard [4][6]. - Hengrui's partnership with GSK for $12.5 billion includes not only current products but also options for 11 early-stage projects, indicating a shift towards long-term strategic partnerships [4][10]. Group 2: Licensing Strategies - Chinese companies are moving from "one-off sales" to retaining rights in core markets while sharing rights in other regions, allowing them to benefit from both local and global markets [5][6]. - The new strategy involves keeping rights for the Greater China region while sharing development costs and rights for other markets, enhancing long-term revenue potential [6][10]. Group 3: Innovative Drug Categories - Antibody-drug conjugates (ADCs) and dual antibodies are emerging as key areas for Chinese companies, with significant deals reflecting their growing importance in the global market [6][7]. - The shift from traditional cancer drugs to innovative metabolic drugs like GLP-1 is notable, with companies like FOSUN and Hansoh making substantial deals in this area [14][15]. Group 4: Independent Global Expansion - Companies are increasingly opting for "self-driven" global expansion rather than simply licensing out, as seen with Kangfang Biopharma's approach to leading its own global clinical trials [8][9]. - This strategy, while riskier, offers higher potential returns compared to traditional licensing agreements [9]. Group 5: Platform-Based Collaborations - The trend is shifting from selling individual products to offering entire R&D platforms, as demonstrated by Hengrui's collaboration with GSK, which includes options for future projects [10][11]. - This model allows companies to monetize their ongoing research capabilities, enhancing their value proposition to partners [10][11]. Group 6: Regulatory and Pricing Developments - The introduction of a drug pricing registration system by China's National Healthcare Security Administration is expected to alleviate concerns about domestic pricing affecting global pricing strategies [12][13]. - This regulatory change has led to increased foreign investment in Chinese R&D, with a 28% year-on-year growth in 2025 [13]. Group 7: Market Valuation Changes - The market's evaluation criteria for Chinese innovative drug companies have shifted from focusing on generic drug revenues to assessing the value of outbound pipelines and global clinical progress [19][21]. - The average price-to-earnings ratio for innovative drug companies in China has risen significantly, reflecting a revaluation of their market potential [21].

Core Insights - 2025 marks a pivotal year for China's innovative pharmaceuticals, with a significant increase in international collaborations and licensing agreements, indicating a shift from a pharmaceutical giant to a stronghold in the industry [1][3] - The total amount of outbound licensing agreements exceeded $100 billion, with upfront payments reaching $8.1 billion, showcasing a transition to multi-layered cooperation models [1][3] - China's biopharmaceutical market remains the second largest globally, with innovative drugs accounting for approximately 30% of global research, reflecting a critical leap from following to competing on a global scale [1][3] Internationalization - The internationalization of China's pharmaceutical industry saw explosive growth in 2025, highlighted by a surge in business development (BD) transactions and the popularity of "A+H" listings [3][4] - The total amount of outbound licensing for innovative drugs reached over $100 billion, a 75% increase from 2024, indicating a shift from merely selling products to actively engaging in global markets [3][4] - Notable BD transactions include significant agreements between major Chinese pharmaceutical companies and international firms, such as a $12.5 billion deal between Hengrui Medicine and GSK [3][4] Innovation - In 2025, advancements in cutting-edge technologies such as antibody-drug conjugates (ADC) and dual antibodies have shown promising results in cancer treatment [7][8] - The third-generation ADC technology has become mainstream, with significant efficacy demonstrated in treating solid tumors [7] - The dual antibody sector continues to lead, with Chinese companies achieving remarkable results in clinical trials, such as a 91% improvement in progression-free survival compared to existing treatments [8] Policy Support - The policy support for innovative drugs in China has reached unprecedented levels, with a notable increase in the number of approved innovative drugs [10][11] - The National Medical Products Administration approved 69 innovative drugs in 2025, a 44% increase from the previous year, covering various therapeutic areas [10] - The payment system for innovative drugs has been significantly upgraded, enhancing accessibility and affordability for patients [10][11] Mergers and Acquisitions - The pharmaceutical sector has seen a surge in mergers and acquisitions, with over 400 transactions announced globally, totaling approximately $111 billion, marking a 50% increase from 2024 [13][14] - Domestic mergers also showed strong activity, with significant deals indicating a shift towards quality improvement and resource consolidation among leading companies [13][14] - The trend reflects a transition from scale expansion to enhancing quality and efficiency, with companies focusing on high-value clinical pipelines [14]

Investment Rating - The report suggests a positive investment outlook for the medical device sector, particularly in brain-computer interface devices, which are expected to see accelerated commercialization due to supportive policies [1][3]. Core Insights - Recent policies have significantly increased support for innovation in medical devices, with the National Medical Products Administration actively promoting faster market entry for brain-computer interface devices, indicating a diverse application landscape and substantial future potential [1][3]. - The pharmaceutical sector is witnessing positive developments, such as GSK's approval of mepolizumab for a new indication in COPD patients, marking it as the first monthly administered biologic in China, which is expected to reduce the annual incidence of severe exacerbations significantly [1][32]. - The report highlights the approval of Wegovy® tablets in the U.S. for weight management, emphasizing its potential impact on the market as the first oral GLP-1 receptor agonist for this purpose [37][40]. Summary by Sections Pharmaceutical Sector - Mepolizumab has been approved for COPD treatment in China, with a monthly dosing schedule, targeting a significant patient population [1][32]. - The A/H share innovation drug sector maintains high activity levels, with new drug approvals and cross-border transactions remaining robust [16][28]. Biologics - Wegovy® tablets have been approved in the U.S. for weight management, showing similar weight loss efficacy to its injectable counterpart, with a significant portion of participants achieving substantial weight loss [37][40]. CXO and Pharmaceutical Supply Chain - The CXO sector continues to show upward momentum, supported by a stable order backlog, with November financing levels slightly above the annual average [44][46]. Medical Devices - The centralized procurement process for high-value medical consumables is progressing steadily, with high selection rates in multiple rounds of bidding, indicating a favorable environment for leading domestic companies [2][52]. Retail Pharmacy - The industry is undergoing a consolidation phase, with leading companies expected to benefit from increased market share through mergers and acquisitions [2][3]. Medical Services and Consumer Healthcare - Aier Eye Hospital's acquisition of 39 institutions for 960 million yuan strengthens its market position, with the acquired entities showing signs of financial recovery [2][3].

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed down 0.26% with a trading volume of 221 million yuan on December 26 [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of December 25, 2024, the fund's latest share count was 10.467 billion shares, with a total size of 8.204 billion yuan, reflecting a year-to-date increase of 2547.36% in shares and 2071.41% in size [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 56.94% during the management period [2] - The top holdings of the fund include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant weightings in the portfolio [2] - The largest holding is BeiGene, accounting for 10.62% of the portfolio, followed by CanSino Biologics at 10.55% and Innovent Biologics at 10.21% [2]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Insights - The report highlights the promising data from CTLA-4 drugs, suggesting potential investment opportunities in related areas [3][5] - The pharmaceutical index experienced a slight decline of 0.14% from December 15 to December 19, 2025, but showed a relative outperformance of 0.14% against the CSI 300 index [5] - The report emphasizes the importance of innovative drugs as a key investment theme for 2026, with a focus on companies that are expected to show clear performance trends and potential reversals in operations [5][41] Summary by Sections 1. CTLA-4 Target - CTLA-4 is identified as a significant immune checkpoint that can inhibit T cell activation, presenting potential value in cancer immunotherapy [8][9] - The CTLA-4 monoclonal antibody Gotistobart shows promising clinical trial results for squamous non-small cell lung cancer (sqNSCLC) patients who are resistant to immunotherapy [14][15] - Gotistobart's innovative mechanism targets Treg cells in the tumor microenvironment, potentially leading to a new paradigm in tumor immunotherapy [20][24] 2. Industry Perspective - The report maintains that innovative drugs should be the main focus for the year, while also considering manufacturing exports and aging-related consumption as relatively undervalued assets [25][41] - The pharmaceutical index has shown a year-to-date increase of 14.49%, with a notable number of stocks experiencing significant gains [25][26] - The report suggests that the Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs opening new growth avenues for companies [41][42] 3. Investment Recommendations - Recommended stocks include innovative drug companies such as Xinyi Tai, Zai Jian Pharmaceutical, and others, as well as companies in the medical device sector [5][45] - The report advises focusing on companies with strong performance trends and those expected to benefit from the aging population and outpatient consumption [42][44] - The report also highlights the potential of AI in the pharmaceutical sector, suggesting that related stocks may perform well in the coming years [42][44]