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的內容概不負責，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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，HLX701（重組人SIRPα-IgG4 Fc 融合蛋白注射液）（「HLX701」）聯合西妥昔單抗和化療治療晚期結直腸癌的 1b/2期臨床研究於中國境內（不包括中國港澳台地區）完成首例患者給藥。 B. 臨床試驗設計及目的 本研究為一項在既往接受過化療的復發性、不可切除或轉移性RAS/BRAF野 生型結直腸癌患者中比較HLX701聯合西妥昔單抗和化療(FOLFOX/FOLFIRI) 對比安慰劑聯合西妥昔單抗和化療(FOLFOX/FOLFIRI)的1b/2期臨床研究。 該研究包括三個階段：第一階段為安全導 ...

Financial Data and Key Metrics Changes - In 2025, the company reported total revenue of CNY 2.06 billion, a 6.5% increase compared to the previous year, with commercialized revenue at CNY 540 million [45][46] - Gross margin increased by 16.1% to CNY 1.47 billion, benefiting from a favorable income mix [46][47] - Total loss for the year was CNY 380 million, slightly higher than the previous year, attributed to increased marketing and sales expenses due to the first year of commercialization [47][48] Business Line Data and Key Metrics Changes - The company has four products launched with multiple indications, marking the first year of complete commercialization [22][31] - The commercialization team has expanded to nearly 600 people, covering over 300 cities and 1,200 medical institutions in China [12][22] - The company has successfully included three products in the national reimbursement catalog (NRDL) [27][28] Market Data and Key Metrics Changes - The company has established partnerships with major distributors, accounting for 90% of its business, and expanded its presence in over 400 professional pharmacies [28][29] - The commercialization strategy focuses on brand building and expanding access to hospitals and pharmacies, with a goal to double sales in 2026 [22][67] Company Strategy and Development Direction - The company aims to advance its differentiated pipeline and address unmet clinical needs while optimizing its ADC platform [20][64] - Strategic collaborations are emphasized to enhance the value of the pipeline and expand commercial partnerships globally [10][20] - The focus is on developing new targets and integrating ADC with immunotherapy for enhanced efficacy [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving significant growth in commercialization, particularly after successful NRDL negotiations [68] - The company anticipates that NRDL revenue will account for over 80% of total revenue in the coming year [67] - The management highlighted the importance of building a strong commercial team to navigate the competitive landscape [22][68] Other Important Information - The company has a robust pipeline with over 30 R&D projects, including several in clinical development stages [6][10] - The company raised $250 million through H-share placement in 2025, enhancing its cash reserves to CNY 4.6 billion [13][52] Q&A Session Questions and Answers Question: What is the timeline for data availability on first-line lung cancer trials? - Management indicated that data for the first-line trials may be available by Q4 this year during the ASCO meeting [55][59] Question: What is the expected revenue from licensing and how does it relate to R&D expenses? - Management clarified that licensing revenue is accounted for differently and does not correspond directly to R&D expenses [70] Question: How will the staffing for breast cancer and lung cancer teams be adjusted? - The company plans to increase staffing for the lung cancer team due to its larger patient population, while maintaining a separate focus for breast cancer [72]

Financial Data and Key Metrics Changes - In 2025, the company reported total revenue of CNY 2.06 billion, a 6.5% increase compared to the previous year, with commercialized revenue at CNY 540 million [42][43] - Gross margin increased by 16.1% to CNY 1.47 billion, outpacing revenue growth due to a favorable income mix [43][44] - Total loss for the year was CNY 380 million, slightly higher than the previous year, attributed to increased marketing and sales expenses during the first year of commercialization [44][45] Business Line Data and Key Metrics Changes - The company has four launched products with multiple indications, including TROP-2 ADC and HER2 ADC, which have been successfully included in the national reimbursement catalog [4][10] - The commercialization team has expanded to nearly 600 people, covering over 300 cities and 1,200 medical institutions in China [11][19] - The company has over 30 R&D projects, with 10+ in clinical development stages and one in NDA [4][5] Market Data and Key Metrics Changes - The company has established partnerships for global phase III clinical trials, covering various cancers, including lung and breast cancer [8][9] - The commercialization efforts have led to positive prescriptions and recognition from international and domestic experts, with over 1,200 academic meetings held in 2025 [20][21] - The company is focusing on expanding its market access through national channels and professional pharmacies, with a significant increase in pharmacy coverage [25][26] Company Strategy and Development Direction - The company aims to advance its differentiated pipeline and address unmet clinical needs, focusing on innovative drug development and commercialization strategies [18][59] - There is a strong emphasis on international collaboration and partnerships to maximize the value of the pipeline and expand business footprints outside China [8][18] - The strategy includes a focus on combination therapies and expanding ADC technology to non-oncology diseases [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercialization efforts, anticipating a doubling of sales in 2026 compared to 2025 [62] - The company is optimistic about the inclusion of more products in the NRDL, which is expected to significantly boost revenue [60][61] - Management highlighted the importance of building a strong commercial team to navigate the competitive landscape and ensure successful market access [19][21] Other Important Information - The company raised $250 million through H-share placement in 2025, contributing to a significant increase in cash reserves [49] - The total assets reached close to CNY 6 billion, a 40% increase from the previous year, with cash and financial assets amounting to CNY 4.6 billion [48][49] - The company has made significant progress in clinical trials, with multiple studies showing promising results for various cancer treatments [28][29] Q&A Session Summary Question: What is the expected timeline for data readouts from ongoing clinical trials? - Management indicated that data for first-line lung cancer trials is expected to be available by Q4 this year, with ongoing studies showing promising results [51][52] Question: How does the company view the impact of NRDL price adjustments on revenue? - The CFO clarified that the revenue reported includes adjustments related to NRDL pricing, and the actual revenue before adjustments would be higher [51][52] Question: What are the sales expectations for products not yet included in NRDL? - Management expressed optimism for A140, anticipating rapid ramp-up post-hospital listing, while A166 will require a differentiated pricing strategy due to market competition [67][70]

Core Viewpoint - The FDA has officially approved Braftovi, an oral cancer drug developed by Pfizer and Ono Pharmaceutical, for the treatment of colorectal cancer, based on Phase 3 BREAKWATER clinical trial data [1][2]. Group 1: FDA Approval and Clinical Data - Braftovi is approved as part of a combination therapy for previously untreated patients with metastatic colorectal cancer carrying the BRAF V600E mutation [1]. - The approval was granted through the accelerated approval pathway after achieving one of the dual primary endpoints related to overall response rate in the BREAKWATER study [1]. - The combination of Braftovi and the anti-cancer drug cetuximab resulted in a median progression-free survival of 12.8 months for newly diagnosed patients with BRAF V600E mutated metastatic colorectal cancer [1]. Group 2: Drug Composition and Patient Demographics - The active ingredient in Braftovi, encorafenib, is an oral small molecule BRAF inhibitor [2]. - BRAF mutations occur in up to 15% of metastatic colorectal cancer patients, who generally have a poor prognosis [2]. - Patients with BRAF V600E mutations have more than double the mortality rate compared to those with wild-type BRAF [2].

Summary of Key Points from Conference Call Records Industry Overview - The records focus on the pharmaceutical industry, specifically highlighting developments from major companies such as Sanofi, AstraZeneca, Roche, Novartis, Pfizer, Bristol-Myers Squibb (BMS), Johnson & Johnson, and GSK. Core Insights and Arguments Sanofi - On February 12, the CEO Paul Hudson, who has been with the company since 2019, will not be renewed, and former Merck CEO Belén Garijo will take over, indicating a leadership change amidst a period of clinical failures and pipeline challenges [1] - On February 17, Sanofi and TEVA updated data from the Phase IIb trial of TL1A monoclonal antibody duvakitug, showing a clinical remission rate of 58% for ulcerative colitis (UC) patients receiving 900mg maintenance therapy at 44 weeks, which is a 27% improvement over placebo [1] - For Crohn's disease (CD) patients, the endoscopic response rate reached 55%, a 35% increase compared to placebo, demonstrating significant data improvements over the 16-week results [1] AstraZeneca - On February 20, the FDA approved AstraZeneca's acalabrutinib in combination with venetoclax for a fixed oral regimen targeting first-line chronic lymphocytic leukemia (CLL) indications [1] Roche - On February 20, Roche's oral SERD in combination with everolimus received FDA acceptance for a new drug application targeting second-line ESR1+ HR+/HER2- breast cancer, despite the Phase III trial being aimed at the entire population [1] Novartis - On February 18, Novartis reported successful Phase III clinical results for the oral BTK inhibitor remibrutinib targeting chronic inducible urticaria (CINDU), with good safety and no liver toxicity, leading to plans for a new drug application submission [1] Pfizer - A combination of BRAF V600E inhibitor encorafenib, cetuximab, and chemotherapy achieved progression-free survival (PFS) endpoints in a Phase III trial for first-line BRAF-mutant colorectal cancer, showing clinically meaningful overall survival (OS) improvements compared to bevacizumab and chemotherapy [1] Bristol-Myers Squibb (BMS) - On February 17, BMS's new generation molecular glue iberdomide received FDA acceptance for a new drug application based on Phase III clinical data showing minimal residual disease (MRD) negativity rates [1] Johnson & Johnson - On February 18, the FDA approved a new monthly subcutaneous administration regimen for the EGFR*CMET bispecific antibody evinacumab, improving safety compared to the previous biweekly intravenous administration [1] - Between February 18-19, the company continued to explore the EGFR*CMET bispecific antibody in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), as well as in head and neck squamous cell carcinoma (HNSCC) [1] GSK - On February 18, GSK disclosed final results from a Phase III trial of its subsidiary ViiV's long-acting HIV drug combination cabotegravir + rilpivirine, showing that over 48 weeks, the treatment demonstrated double the benefits compared to daily oral therapy [2] Additional Important Information - Johnson & Johnson's evinacumab received breakthrough therapy designation for PD1+ chemotherapy-experienced HNSCC in the second-line setting, with first-line data showing an overall response rate (ORR) of 56% and a PFS of 7.7 months, outperforming PD1+ chemotherapy/ADC combinations [2]

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for the treatment of advanced colorectal cancer [1] Group 1 - The approved drug, HLX701, is a recombinant human SIRPα-IgG4Fc fusion protein injection [1] - The clinical trials will be conducted in China once conditions are met [1]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1: Company Developments - The clinical trials for HLX701 will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - HLX701 was introduced by Fuhong Hanlin in June 2025 and has exclusive licensing rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, and certain Southeast Asian, Middle Eastern, and North African countries [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1 - The clinical trials for HLX701 will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection, licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in specified regions [1] - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1 - HLX701 is a recombinant SIRPα-IgG4Fc fusion protein injection licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in China and certain regions [1] - The company plans to initiate clinical trials for HLX701 in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, including licensing fees [1] Group 2 - As of the announcement date (January 20, 2026), there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1: Clinical Trial Approval - The approval allows for the clinical trials of HLX701 to be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection [1] Group 2: Licensing and Development - HLX701 was licensed from FBD Biologics Limited in June 2025, granting exclusive rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, Southeast Asia, the Middle East, and North Africa [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, which includes licensing fees [1] Group 3: Market Context - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]