Core Insights - Recently, Fuhong Hanlin announced key updates on its PD-L1 ADC (antibody-drug conjugate) HLX43 for treating non-small cell lung cancer (NSCLC), integrating results from an international multi-center Phase II clinical study, further validating its global clinical value [1] - The company also released follow-up data on its self-developed recombinant anti-EGFR monoclonal antibody HLX07, in combination with the anti-PD-1 monoclonal antibody H drug Hanshuozhuang, for first-line treatment of EGFR high-expressing advanced or metastatic squamous NSCLC [1] Group 1: Product Development - HLX43 aims to combine broad anti-tumor activity with immune function, distinguishing itself from other ADCs targeting driver gene mutations by focusing on the PD-L1 pan-tumor target [2] - HLX43 is the second PD-L1 ADC globally and the first in China to enter clinical development, utilizing a proprietary antibody framework and an innovative linker-toxin combination [2] - The company has received clinical trial approvals from both the NMPA and FDA for HLX43, with over 400 patients enrolled globally, including more than 170 NSCLC patients [2] Group 2: Clinical Trials and Future Plans - The company is confident in HLX43's Phase III clinical study, with plans to initiate at least eight Phase III projects focused on lung cancer treatment [3] - Fuhong Hanlin is enhancing its global competitive innovation platform, which includes proprietary ADC technology and early-stage drug development platforms, improving the efficiency and success rate of its R&D projects [3] Group 3: Global Expansion and Financial Performance - The trend of "license-out" transactions for Chinese innovative drugs is increasing, with 103 deals recorded in the first three quarters of 2025, surpassing the total for 2024, amounting to $92.03 billion [4] - The company reported a revenue of 2.82 billion yuan in the first half of 2025, a 2.7% year-on-year increase, with overseas product profits growing over 200% [5] - Fuhong Hanlin has successfully launched nine products globally and has six self-developed products that have "gone abroad," including the anti-PD-1 monoclonal antibody H drug Hanshuozhuang [5] Group 4: Clinical Trial Updates - The ASTRIDE study for H drug Hanshuozhuang has completed the enrollment of 200 patients in the U.S., comparing its efficacy and safety against the standard treatment drug Atezolizumab [5][6] - The company aims to expedite the trial process and plans to submit a Biologics License Application (BLA) to the FDA as soon as possible [6] Group 5: Strategic Vision - The company emphasizes a long-term development strategy of "innovation + internationalization," aiming to strengthen its competitive advantage through innovative R&D and partnerships with global collaborators [6]

Core Insights - The company has updated key data on HLX43 in the non-small cell lung cancer (NSCLC) research field, showing efficacy signals across various patient subgroups [2][4][5] - The CEO emphasized that the data provides a solid foundation for the selection of doses in Phase II and III clinical trials, with plans for at least eight Phase III studies in the lung cancer domain [2][6] Clinical Data Summary - HLX43 demonstrated an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 75.8% in squamous NSCLC patients at a dose of 2 mg/kg [4] - In non-squamous patients, the ORR increased to 48.6% and the DCR reached 94.3% at a dose of 2.5 mg/kg [4] - Among previously treated squamous NSCLC patients, the ORR was 38.5% and the DCR was 84.6% [4][5] Business Development Strategy - The CEO highlighted the importance of selecting strong partners for business development (BD) and the need for alignment on clinical development strategies [3] - The company aims to establish a solid revenue base of around $5 billion before targeting a peak sales estimate of $20 billion [3] - The potential for co-development with partners will depend on accumulating more clinical data [3] Future Clinical Research Plans - The company plans to conduct at least eight Phase III clinical studies for HLX43, including two first-line, four second-line, and two third-line studies [6] - Additional clinical research is planned for other cancers such as cervical cancer, esophageal squamous cancer, and colorectal cancer [6] Financial Overview - The company reported a revenue of 2.8195 billion RMB in the first half of the year, a year-on-year increase of 2.7%, with a net profit of 390.1 million RMB, remaining stable compared to the previous year [6][7] - The CEO acknowledged the financial challenges associated with launching multiple key clinical trials [6] Product Development and Market Expansion - The company is enhancing the sales potential of its PD-1 monoclonal antibody, H drug, through international expansion and new indications [7] - The H drug achieved nearly 600 million RMB in sales in the first half of the year, with a slight slowdown in growth compared to the previous year [7] - The company has completed the first batch of H drug supplies to the Indian market and received 100,000 orders from there [7]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 非上市股份 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 380,066,312 RMB | | | 1 RMB | | 380,066,312 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 380,066,312 RMB | | | 1 RMB | | 380,066,312 | 第 1 頁 共 10 頁 v 1.1.1 FF301 致：香港交易及結算所有限公司 公司名稱: 上海復宏漢霖生物技術股份有限公司 呈交日期: 2025年11月5日 I. ...

Core Insights - Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖) announced key updates on its investigational product HLX43, a PD-L1 targeted antibody-drug conjugate for non-small cell lung cancer (NSCLC) treatment at the 2025 International Lung Cancer Frontier and Innovation Forum [1] - HLX43 has received orphan drug designation from the FDA for thymic epithelial tumors, indicating its potential in treating advanced/metastatic solid tumors [1] - The company plans to initiate at least eight Phase III clinical trials for HLX43, with lung cancer indications prioritized [1] Company Developments - CEO Dr. Zhu Jun emphasized the commitment to developing HLX43 despite limited resources, highlighting lung cancer as the leading malignancy in both global and Chinese contexts [2] - Junshi has successfully launched nine products globally, including the first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer [2] - Goldman Sachs issued a research report covering Junshi, projecting HLX43 as a core driver for the company's global innovation pipeline and assigning a "buy" rating with a 12-month target price of HKD 100.70 per share [2] Clinical Data - As of October 22, 2025, 174 advanced NSCLC patients were enrolled in the study, with 89 receiving 2.0 mg/kg and 85 receiving 2.5 mg/kg of HLX43 [3] - The overall efficacy of HLX43 was promising, with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 75.8% in squamous NSCLC patients [3] - In non-squamous patients, the ORR increased to 48.6% and the DCR reached 94.3% [3] Treatment Potential - Among previously treated squamous NSCLC patients who had undergone docetaxel therapy, the ORR was 38.5% and the DCR was 84.6%, indicating HLX43's significant potential in this population [4] - Docetaxel is currently the standard second-line treatment for squamous NSCLC, with an ORR slightly above 10%, suggesting HLX43 may redefine treatment standards for this disease [4]

Group 1 - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies such as antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - Fuhong Hanhlin has successfully launched 9 products in the lung cancer field, benefiting over 900,000 patients globally, including the world's first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer, which is now available in nearly 40 countries [1] - The company plans to advance at least 8 Phase III clinical studies focused on lung cancer for its product HLX43, which combines the effects of PD-1 and ADC, and aims to expand into other cancers such as cervical, esophageal squamous cell, and colorectal cancers [1] Group 2 - HLX43, as the second ADC targeting PD-L1 globally, has shown promising treatment effects in advanced non-small cell lung cancer (NSCLC), with objective response rates (ORR) of 33.3% in previously treated squamous cell carcinoma patients and 47.4% in EGFR wild-type non-squamous NSCLC patients [2] - The drug demonstrated an ORR of 30% in patients with brain metastases and a disease control rate (DCR) of 90%, indicating its potential effectiveness across various patient subgroups [2] - Safety data for HLX43 indicates low hematological toxicity, providing a solid foundation for subsequent large-scale clinical studies [2]

Group 1 - The 2025 International Lung Cancer Frontier and Innovation Forum was held in Shanghai, focusing on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new advancements in immunotherapy for small cell lung cancer (SCLC) [1] - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies like antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - The global incidence of lung cancer remains the highest among malignant tumors, with the company having launched 9 products that benefit over 900,000 patients worldwide, including the first approved PD-1 monoclonal antibody for first-line treatment of SCLC [1] Group 2 - The company's R&D strategy focuses on antibodies and their derivatives, including monoclonal antibodies, bispecific antibodies, multi-specific antibodies, and ADCs, supported by three core technology engines [2] - High-value projects such as HLX3901 and HLX48 are prioritized for future development, while the company continues to build a robust pipeline [2] - Local innovative enterprises have made significant progress over the past decade, providing effective "Chinese solutions" for clinical challenges, emphasizing the need for international collaboration and continuous innovation in tackling lung cancer [2]

Core Viewpoint - The "International Lung Cancer Frontier and Innovation Forum" held in Shanghai highlighted the advancements in lung cancer treatment and provided a platform for Chinese innovative pharmaceutical companies to showcase their R&D capabilities, with a focus on the promising PD-L1 antibody-drug conjugate (ADC) HLX43 from Fuhong Hanlin [1][2]. Group 1: Company Overview - Fuhong Hanlin has successfully launched nine products, benefiting over 900,000 patients globally, and is recognized as a pioneer in the lung cancer treatment field [2]. - The company aims to leverage its innovative pipeline, particularly HLX43, to achieve breakthroughs in lung cancer treatment and expand its global presence [3][4]. Group 2: Product Highlights - HLX43 demonstrated broad efficacy without dependence on biomarkers, making it a potential "best-in-class" product for various lung cancer patients, regardless of their EGFR mutation status or PD-L1 expression levels [5][7]. - In clinical trials, HLX43 showed an objective response rate (ORR) of 48.6% in non-squamous NSCLC and 33.3% in squamous NSCLC, indicating its effectiveness in hard-to-treat patient populations [6][7]. - The drug also exhibited a high disease control rate (DCR) of 90.0% in patients with brain metastases, showcasing its ability to penetrate the blood-brain barrier [7][8]. Group 3: Market Potential and Strategic Positioning - The positive data from HLX43 has attracted attention from top investment institutions, with Goldman Sachs issuing a "buy" rating and setting a target price of HKD 100.70, indicating strong upside potential for the company [9][10]. - The company is positioned to transition from a biosimilar pioneer to a global innovative pharmaceutical player, with HLX43 as a key driver of its global pipeline [10][11]. Group 4: Future Outlook - The successful forum and HLX43 data release mark a milestone for Fuhong Hanlin, indicating that its "innovation-driven" strategy is yielding results and establishing its capability to produce globally competitive drugs [11]. - The anticipated expansion of HLX43's indications and continued clinical advancements are expected to solidify its role as a core growth driver for the company's future performance [11].

Core Insights - The "International Lung Cancer Frontier and Innovation Forum" held in Shanghai serves as a significant platform for discussing advancements in lung cancer treatment and showcases the R&D capabilities of local innovative pharmaceutical companies [1][2] - The company, Junshi Biosciences, presented its key innovative product, the PD-L1 antibody-drug conjugate (ADC) HLX43, which has garnered attention for its "high efficiency, low toxicity, and broad spectrum" data [1][2] Company Strategy - The CEO of Junshi Biosciences, Dr. Zhu Jun, emphasized the company's strategic vision in his keynote speech, highlighting lung cancer as the most prevalent malignant tumor globally and in China [2] - The company has successfully launched nine products, benefiting over 900,000 patients worldwide, and has introduced the world's first approved anti-PD-1 monoclonal antibody for first-line treatment of small cell lung cancer (SCLC) in nearly 40 countries [2][3] R&D Pipeline - Junshi Biosciences is focusing on a differentiated R&D platform and global integrated operational system to achieve breakthroughs in lung cancer treatment [3] - The PD-L1 ADC HLX43 is expected to overcome limitations related to PD-L1 expression levels and EGFR gene mutations, thus covering a broader patient population [3][4] HLX43 Data Highlights - The forum featured significant updates on HLX43's efficacy and safety for treating non-small cell lung cancer (NSCLC), combining data from Chinese Phase I and international Phase II studies [5][8] - HLX43 demonstrated a "biomarker-independent" broad efficacy, showing treatment effects across various patient demographics, including squamous and non-squamous NSCLC, regardless of EGFR mutation status or PD-L1 expression levels [8][10] Clinical Value - In difficult-to-treat patient populations, HLX43 achieved objective response rates (ORR) of 33.3% for squamous NSCLC and 48.6% for non-squamous NSCLC, addressing the pressing issue of immunotherapy resistance [10][11] - The drug also showed promising intracranial activity, with a 30.0% ORR and a 90.0% disease control rate in patients with brain metastases, indicating its potential for treating other solid tumors prone to brain metastasis [10][11] Market Recognition - Leading investment institutions, including Goldman Sachs, have recognized Junshi Biosciences' innovative transformation, issuing a "buy" rating with a 12-month target price of HKD 100.70, indicating strong potential upside [12][13] - The report highlights HLX43's dual potential as "first-in-class" and "best-in-class," with its global potential seen as a key driver for the company's valuation [12][13] Future Outlook - The successful forum and HLX43 data release mark a milestone for Junshi Biosciences, showcasing its capability to produce globally competitive innovative drugs [13] - The broad applicability and ability to address clinical challenges position HLX43 as a potential cornerstone product for the company, with expectations for significant market impact as clinical trials progress [13]

Core Insights - The company announced key update data for its PD-L1 ADC (HLX43) for the treatment of non-small cell lung cancer (NSCLC) [1] Group 1: Study Overview - A total of 174 advanced NSCLC patients were included in the study as of October 22, 2025, with 89 patients receiving 2.0 mg/kg HLX43 and 85 patients receiving 2.5 mg/kg [1] - All patients had previously undergone platinum-based chemotherapy, with approximately 80% and over 30% having received immunotherapy and targeted therapy, respectively [1] Group 2: Efficacy Results - In squamous NSCLC patients (2 mg/kg, n=33), the objective response rate (ORR) was 33.3%, and the disease control rate (DCR) was 75.8% [1] - In non-squamous patients (2.5 mg/kg, n=35, including EGFR wild-type and EGFR mutations), the ORR increased to 48.6%, and the DCR reached 94.3% [1] - Among squamous NSCLC patients who had previously received docetaxel treatment (2 mg/kg, n=13), the ORR was 38.5%, and the DCR was 84.6% [1] - The company indicated that these results suggest significant potential for HLX43 in the population of lung squamous cancer patients who have failed docetaxel treatment [1]

Summary of Henlius Biotech (2696.HK) Conference Call Company Overview - **Company**: Henlius Biotech (2696.HK) - **Industry**: Biopharmaceuticals, focusing on innovative therapies and biosimilars - **Market Cap**: HK$35.9 billion / $4.6 billion [7] Key Points Strategic Transition - Henlius is evolving from a biosimilar company to a global innovative biopharma player, supported by: 1. An expanding pipeline led by HLX43, a potential best-in-class PD-L1 ADC for global pivotal studies [1][2] 2. A biosimilar franchise with upcoming product launches that could generate significant cash flow for R&D [1] 3. Proven capabilities in clinical operations, regulatory affairs, and biomanufacturing [1] Pipeline and Valuation - **HLX43**: - Estimated to generate risk-adjusted sales of **US$3.8 billion** by **2036**, contributing approximately **54%** to the company's valuation [2][21] - Significant opportunity in **2L EGFRwt non-squamous NSCLC** based on clinical readouts [2] - Expected to enter pivotal studies for various cancers, including cervical and colorectal [2] - **Valuation**: - Target price set at **HK$100.70**, indicating a **52.3% upside** based on a **10% discount rate** and **3% terminal growth rate** [3][26] - Risks include potential failure to realize global value through partnerships, clinical development risks, and increasing competition [3][31] Financial Projections - **Revenue Forecast**: - Projected revenues for 2024: **Rmb 5,724.4 million**, increasing to **Rmb 9,437.1 million** by 2026 [7][17] - EBITDA expected to rise from **Rmb 1,227.9 million** in 2024 to **Rmb 3,931.7 million** in 2026 [7][17] - **Earnings Per Share (EPS)**: - EPS forecasted to be **Rmb 1.51** in 2024, peaking at **Rmb 5.43** in 2026 before declining [7][17] Product Portfolio - **ADC Portfolio**: - HLX43 is the cornerstone asset with potential in various solid tumors [19][20] - Other assets include HLX10 (PD-1) and HLX22 (HER2), with ongoing clinical trials and approvals [19][20] - **Biosimilar Franchise**: - Established portfolio with global partnerships, expected to generate stable cash flow [21][22] - Key candidates include HLX15 (daratumumab), projected to contribute significantly to revenue [21] Market Position and Competitive Landscape - **Market Opportunity**: - HLX43 positioned as a competitive option in the PD-L1 ADC space, with a projected **US$3.8 billion** peak sales potential [32][38] - The US market is expected to contribute **50%** of global sales, with significant addressable patient populations [35][38] Risks and Challenges - Key risks include: 1. Failure to fully realize pipeline drug values through partnerships [3][31] 2. Clinical development risks associated with early-stage products [3][31] 3. Increasing competition in late-line solid tumors [3][31] 4. Challenges in attracting and retaining talent [3][31] Conclusion - Henlius Biotech is strategically positioned for growth with a robust pipeline and a strong focus on innovative therapies. The company is expected to leverage its biosimilar franchise to support its transition into a global biopharma player, despite facing several market and operational risks.