中证报中证网讯（记者 李梦扬）近日，复宏汉霖正式公布了其PD-L1ADC（抗体药物偶联物）HLX43 用于治疗非小细胞肺癌（NSCLC）的关键更新数据。本次发布首次整合了该产品国际多中心II期临床研 究的结果，其全球临床价值得到进一步验证。与此同时，公司还公布了自主研发的重组抗EGFR单克隆 抗体HLX07，联合抗PD-1单抗H药汉斯状（通用名：斯鲁利单抗），用于一线治疗EGFR高表达晚期或 转移性鳞状非小细胞肺癌（sqNSCLC）II期剂量探索研究的最新随访数据。 "目前我们将大部分商业化收入投入到创新管线研发中。公司正持续推进H药汉斯状、PD- L1ADCHLX43等核心创新产品的开发进程。"复宏汉霖执行董事兼CEO朱俊在接受中国证券报记者采访 时表示。展望未来，依托差异化的创新研发平台、全球一体化的临床开发能力及国际领先的供应链体 系，复宏汉霖将通过丰富的在研管线，精准聚焦临床未尽需求，致力于在肺癌治疗领域实现多点突破。 强化差异化竞争优势 谈及HLX43的差异化优势，朱俊向记者介绍："这款PD-L1ADC在立项之初，我们就明确目标——研发 一款兼具广谱抗肿瘤活性与免疫功能的ADC，这一研发方向难度颇高 ...

在近日举行的"2025国际肺癌前沿及创新论坛"上，复宏汉霖更新了HLX43在非小细胞肺癌（NSCLC） 研究领域的关键数据。 研究数据显示，不论是在鳞状还是非鳞状NSCLC，无论EGFR突变状态、是否伴有脑转移或PD-L1表达 水平如何，HLX43均观察到疗效信号。复宏汉霖执行董事兼CEO朱俊在接受《每日经济新闻》记者采 访时表示，"这些数据为Ⅱ期和Ⅲ期临床试验的剂量选择提供了关键依据，为后续开展大规模临床研究 奠定了坚实基础"。未来，复宏汉霖计划围绕肺癌疾病领域推进至少8项HLX43的Ⅲ期临床研究。 复宏汉霖进一步披露PD-L1 ADC肺癌数据 "有BD（商务拓展）前景的中国创新药资产还远远未到池底。MNC（跨国医药企业）现在每年都来'扫 货'，已经变成一个常规性动作，'水下'也还有很多资产。但中国的创新药企业要敢想，敢于'掰手腕'， 如果是一个很小的交易那干脆不要做。"在近日举行的一场公开论坛会后，复宏汉霖执行董事兼CEO朱 俊对《每日经济新闻》记者表示。 略高于10%。 "整体来看，此次数据延续了WCLC大会所呈现的趋势，在纳入患者人数增加的基础上，疗效结果保持 稳定，部分指标甚至更为积极。"朱俊总结道 ...

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]

11月3日，记者获悉，2025国际肺癌前沿及创新论坛日前在上海召开。国内外肺癌领域专家齐聚一堂， 围绕肺癌临床防控、非小细胞肺癌（NSCLC）的破局之道、小细胞肺癌（SCLC）免疫治疗新进展等关 键议题展开深度探讨。 复宏汉霖执行董事兼CEO朱俊表示，肺癌始终高居全球恶性肿瘤发病率榜首，复宏汉霖深耕该领域，已 成功推出9款上市产品，惠及全球超90万名患者。其中，全球首个获批一线治疗小细胞肺癌的抗PD-1单 抗——斯鲁利单抗，已在全球近40个国家上市；第四款自主开发产品贝伐珠单抗为晚期、转移性或复发 性NSCLC带来了治疗新选择。 （文章来源：证券时报网） 复宏汉霖创新中心袁纪军系统阐述了公司的创新管线布局与战略展望。他表示，复宏汉霖的研发策略聚 焦于抗体及其衍生物，涵盖了单抗、双抗、多抗及ADC等前沿药物形式。在三特性T细胞衔接器、 Hanjugator ADC平台、HAI Club平台三大核心技术引擎的驱动下，公司已构建了多条中长期管线开发。 在稳固管线基础的同时，HLX3901、HLX48等高价值项目将成为未来研发的重中之重。 广东省人民医院首席专家吴一龙表示，靶向与免疫治疗的崛起，已彻底重塑肺癌的治疗版 ...

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.