2025.8 Disclaimer This presentation has been delivered to interested parties for information purposes only and upon the express understanding that such parties will use it only for the purposes set forth above, and it is not intended to form the basis of any investment decision or any decision to purchase securities of Akeso, Inc. (the "Company"). This presentation does not constitute or contain an offer or invitation to sell, or any solicitation of any offer to subscribe for or purchase any securities in a ...

Core Viewpoint - The article discusses the significant investment by Bristol-Myers Squibb in the development of the cancer treatment drug BNT327, highlighting the rapid increase in its valuation and the potential for substantial returns in the innovative drug sector, particularly from Chinese companies [2][10]. Group 1: Drug Development and Valuation - Bristol-Myers Squibb has entered a partnership with BioNTech to develop and sell the dual-specific antibody BNT327, with an initial payment of $1.5 billion and potential total payments reaching $11.1 billion (approximately 800 billion RMB) [2]. - BNT327, originally developed by Chinese company Biotheus, was acquired by BioNTech for $1.055 billion, indicating a tenfold increase in its value within a year and a half [2]. - The dual-specific antibody targets both PD-1 and VEGF, enhancing immune response against tumors while inhibiting their blood supply, representing a significant advancement over traditional single-target therapies [6][8]. Group 2: Market Trends and Investment Opportunities - The innovative drug sector in China is experiencing a boom, with substantial investments and partnerships being formed, as evidenced by multiple large-scale deals in late 2024 [12][14]. - Notable transactions include GSK's $300 million upfront payment for a targeted therapy and other significant licensing agreements, indicating a strong market for innovative drugs [12]. - The Chinese biopharmaceutical industry is becoming increasingly attractive to global pharmaceutical companies, with a reported $45.5 billion in business development transactions in 2024, highlighting the competitive edge of Chinese drug developers [14][15].

Investment Rating - The report assigns an "Overweight" (OW) rating to Innovent, Akeso, and Kelun Biotech, indicating an expectation that these stocks will outperform the average total return of their coverage universe [4][7]. Core Insights - Innovent has shown strong investor interest, with a recent stock increase of approximately 3% following a share sale by Lilly Asia Ventures. The company achieved its first-ever non-IFRS positive profit and EBITDA in 2024, and this trend is expected to continue into 2025 and beyond. Innovent is anticipated to secure an outlicensing deal for IBI363, which holds significant value in the immuno-oncology therapy space [4]. - Akeso's share price rose by 10% on June 10, attributed to comments from its U.S. partner, Summit, regarding avoiding a cash raise and manufacturing Ivonescimab in-house. Summit plans to recruit participants for global trials from multiple regions, including China, the U.S., and the EU. The BLA filing strategy for HARMONi is still under discussion [4]. - Kelun Biotech completed an equity raise and does not require additional cash due to solid reserves. Promising ASCO data for Sac-TMT in treating triple-negative breast cancer and non-squamous non-small cell lung cancer indicates a higher probability of success in Phase 3 trials. The domestic Phase 3 trial is enrolling patients rapidly, with potential for an interim analysis this year [4][5]. Summary by Company Innovent - Innovent's stock increased by ~3% after a secondary share placement by Lilly Asia Ventures, which still holds a ~2% stake. The company achieved its first non-IFRS positive profit and EBITDA in 2024, with expectations for continued growth in 2025. Anticipated catalysts include an outlicensing deal for IBI363 [4][5]. Akeso - Akeso's share price increased by 10% following positive comments from Summit, its U.S. partner. Summit is working on in-house manufacturing of Ivonescimab and plans to recruit trial participants from various regions. The BLA filing strategy for HARMONi is still being evaluated [4][5]. Kelun Biotech - Kelun Biotech completed an equity raise and has solid cash reserves. Promising data for Sac-TMT in treating specific cancers suggests a high probability of success in upcoming trials. The company is rapidly enrolling patients for a domestic Phase 3 trial, with potential for an interim analysis this year [4][5].

Core Viewpoint - The article highlights the growing recognition and success of Chinese biotech companies in the global market, particularly through the development of proprietary technologies and platforms, exemplified by the recent patent authorization of the RenMab® platform by BaiOsaite [1][2][4]. Group 1: Technological Advancements - BaiOsaite's RenMab® platform received a patent from the Japan Patent Office, marking a significant achievement in China's biotech innovation [1]. - The platform utilizes a proprietary technology called SUPCE® to humanize mouse antibody variable region genes, addressing key challenges in antibody drug development [2]. - The platform has gained international attention, with collaborations established with major companies like Merck and Johnson & Johnson, resulting in a large-scale antibody discovery project targeting over 1,000 potential drug targets [4]. Group 2: Market Trends and Collaborations - In 2024, over 94 license-out transactions for Chinese innovative drugs were recorded, with 41 occurring in the first quarter of 2025, totaling over $36.9 billion in transaction value [6]. - Notable deals include IBI3009's global licensing agreement with Roche, which includes an upfront payment of $80 million and potential milestone payments up to $1 billion [5]. - The focus on PD-1/VEGF bispecific antibodies has attracted significant international interest, with major agreements involving Pfizer and Merck [6]. Group 3: Intellectual Property and Global Strategy - Chinese biotech companies are shifting their focus from merely exporting products to also exporting platforms and intellectual property, recognizing the higher commercial potential in original technologies [7][8]. - Companies like BaiOsaite and Innovent Biologics are demonstrating systematic capabilities in intellectual property layout, enhancing their negotiating power in international collaborations [8]. - The future of competition in biomedicine will hinge on establishing ecosystems and standards, with a focus on building technological barriers and deep collaborations with upstream and downstream partners [9][10].

Investment Rating - The report maintains a "Outperform" rating for Kangfang Biopharma (09926) with a target price of HKD 112.6 [1] Core Insights - Kangfang Biopharma and its partner Summit Therapeutics released global Phase III clinical trial data for Ivonescimab, used for second-line treatment of EGFR+ non-small cell lung cancer (NSCLC), which is consistent with last year's clinical trial data in mainland China [1] - The company plans to submit a Biologics License Application (BLA), and future consultations with the U.S. Food and Drug Administration (FDA) will be a key focus [1]

Financial Data and Key Metrics Changes - The company ended 2024 with a strong cash position of approximately $412 million and is now debt-free [37] - GAAP R&D expenses for 2024 were $150.8 million, up from $59.4 million in the previous year, reflecting the expansion of clinical trials related to Ivonescimab [39] - Non-GAAP R&D expenses were $134.8 million in 2024 compared to $55 million in 2023 [39] - GAAP G&A expenses increased to $60.5 million in 2024 from $30.3 million in the previous year, primarily due to stock-based compensation charges [41] - Overall, non-GAAP operating expenses decreased to $175.3 million in 2024 from $596.5 million in 2023, mainly due to a reduction in acquired in-process R&D expenses [42] Business Line Data and Key Metrics Changes - The company has completed enrollment in four Phase III trials, with two awaiting top-line data readout, including the HARMONi trial [16] - Five Phase III trials are currently ongoing, with two sponsored by the company and three by Akeso, focusing on various cancer types [17] Market Data and Key Metrics Changes - The addressable market for non-small cell lung cancer (NSCLC) could approach $20 billion for checkpoint inhibitors, with a broader market potential of approximately $90 billion globally for all checkpoint inhibitor indications [30][32] - The company is exploring over 50 indications where PD-1, PD-L1, or VEGF therapies have been approved, indicating a significant market opportunity beyond NSCLC [32] Company Strategy and Development Direction - The company aims to expand its clinical development plan beyond NSCLC in 2025 and 2026, with a focus on improving patient lives facing high unmet medical needs [33] - A collaboration with Pfizer was announced to evaluate Ivonescimab in combination with multiple Pfizer antibody drug conjugates (ADCs) in various solid tumor settings [9][10] - The company is committed to exploring additional tumor settings and identifying biomarkers through collaborations, including a $15 million commitment to MD Anderson [21] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the potential of Ivonescimab and its ability to address serious unmet medical needs in oncology [15] - The company is optimistic about the upcoming top-line data from the HARMONi trial, expected in mid-2025, which could provide a path for marketing authorization [24] - Management emphasized the importance of combining Ivonescimab with the best available treatments to enhance therapeutic outcomes [106] Other Important Information - The company has received Fast Track designation for the HARMONi trial, which is a global Phase III trial in patients with EGFR mutated advanced non-small cell lung cancer [11] - The HARMONi-3 trial has been amended to include a larger patient population, significantly expanding the number of patients that Ivonescimab can potentially help [12] Q&A Session Summary Question: Timing for HARMONi-2 overall survival (OS) data - Management indicated that Akeso expects to reach the number of events required for interim analysis by the end of 2025 [49] Question: Need for statistical significance in OS for approval - Management stated that while statistical significance for OS is desired, previous approvals in this space have not required it, as progression-free survival (PFS) has been adequate [52] Question: Timing for top-line readout for HARMONi-3 - Management noted it is too early to provide clarity on the completion of enrollment for HARMONi-3 until all sites are activated [55] Question: Details on the Pfizer collaboration - Management confirmed that multiple ADCs from Pfizer will be involved, with trials expected to start in mid-2025 [58][61] Question: Confidence in ADC targets - Management expressed confidence in the potential of ADCs in solid tumor oncology, noting that data outside of lung cancer has been stronger [66] Question: Plans for future business development opportunities - Management indicated that the collaboration with Pfizer does not preclude additional partnerships and that they are open to exploring various opportunities [115]