Shanghai Henlius Biotech: Key International Phase 2/3 Lung Cancer Study Commences

Key Highlights for Investors

• Milestone Achievement: The first patient has been dosed in an international, multicenter phase 2/3 clinical study evaluating HLX07 (pimurutamab, a recombinant anti-EGFR humanized monoclonal antibody) in combination with HANSIZHUANG (serplulimab) and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC) in mainland China.
• Innovative Approach: This is the first global study to evaluate this specific combination (HLX07 + HANSIZHUANG + chemotherapy) versus current standards, which may include pembrolizumab-based regimens.
• Potential Price Sensitivity: There is currently no similar combination approved for marketing globally. Positive results could position Henlius as a leader in a significant lung cancer treatment market and drive share value.
• Regulatory Progress: The investigational new drug (IND) application for this combination was approved by the NMPA in March 2026, and the trial is also commencing in Australia from April 2026.

Clinical Trial Design and Objectives

• Study Structure: The trial is a randomized, double-blind, parallel-controlled phase 2/3 study. It aims to evaluate the efficacy and safety of HLX07 with HANSIZHUANG and chemotherapy compared to placebo regimens (including pembrolizumab and chemotherapy) in first-line advanced sqNSCLC patients in mainland China.
• Phase 2 (Part I):
  • Patients are randomized 1:1:1 into three groups: HLX07 (1,000 mg) + serplulimab + chemotherapy; HLX07 (600 mg) + serplulimab + chemotherapy; or placebo + serplulimab + chemotherapy.
  • Treatment is administered every 3 weeks for 4 cycles, followed by maintenance therapy.
  • Primary Endpoints: Progression-Free Survival (PFS) and Objective Response Rate (ORR), assessed by Blinded Independent Central Review (BICR).
• Phase 3 (Part II):
  • Optimal dose from Phase 2 is chosen. Eligible participants are randomized 1:1 to HLX07 + HANSIZHUANG + chemotherapy vs. placebo + pembrolizumab + chemotherapy, with corresponding maintenance therapies.
  • Primary Endpoints: PFS (by BICR) and Overall Survival (OS).
  • Secondary Endpoints: Safety, pharmacokinetics (PK), immunogenicity, and the relationship between EGFR/PD-L1 expression and clinical efficacy.

About HLX07 and HANSIZHUANG

• HLX07: An innovative anti-EGFR biologic developed by Henlius, intended for advanced solid tumors. Earlier studies (phase 1b/2) showed it is safe and well tolerated. Ongoing studies include monotherapy and combinations for various advanced cancers.
• HANSIZHUANG (Serplulimab): Henlius’ proprietary anti-PD-1 monoclonal antibody, already approved in China for several major indications:
  • First-line therapy for sqNSCLC (with chemotherapy), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC.
  • NDA accepted for combination therapy in neo-/adjuvant gastric cancer (priority review status).
  • Approved in the EU, UK, and multiple Asian countries; received Orphan Drug Designations in the US, Switzerland, South Korea, and others.
  • Global clinical development ongoing for lung, head and neck, colorectal, and gastric cancers.

Market and Regulatory Context

• Competitive Edge: If successful, Henlius will be the first to market with this combination therapy for advanced sqNSCLC, potentially opening significant commercial opportunities both in China and internationally.
• Regulatory Progress: Recent approvals by the NMPA and initiation of the study in Australia highlight regulatory momentum and global ambitions.

Shareholder Considerations and Risk Warning

• Price Sensitivity: The success or failure of this trial is likely to significantly impact Henlius’ share price, given the global unmet medical need and potential first-mover advantage.
• Risks: There is no guarantee of eventual product approval or commercialization. Investors should be aware of clinical and regulatory uncertainties.

Management and Corporate Information

• Announcement made by the Board of Shanghai Henlius Biotech, Inc., chaired by Wenjie Zhang.
• Board consists of a mix of executive, non-executive, and independent directors, reflecting strong corporate governance.

復宏漢霖：國際II/III期肺癌臨床試驗首例患者給藥

投資者重點摘要

• 重大里程碑：首名患者已在國際多中心II/III期臨床研究中用藥，該研究評估HLX07（匹穆魯他單抗，重組人源化抗EGFR單抗）聯合HANSIZHUANG（賽普利單抗）及化療，作為中國內地晚期鱗狀非小細胞肺癌（sqNSCLC）一線治療。
• 創新方案：該組合療法（HLX07+HANSIZHUANG+化療）為全球首創，目前無同類療法獲批上市，一旦臨床結果積極，有望顯著提升公司市值。
• 潛在股價敏感因素：若試驗成功，公司將成為該領域首家上市企業，具備突破性商業潛力。
• 監管進展：2026年3月獲中國NMPA新藥臨床試驗批准，4月澳洲亦啟動試驗，標誌國際拓展步伐。

臨床設計與目標詳情

• 試驗結構：隨機、雙盲、平行對照多中心II/III期試驗，對比HLX07+HANSIZHUANG+化療與安慰劑方案（包括帕博利珠單抗+化療）在中國內地晚期sqNSCLC一線治療的療效與安全性。
• 第二期（I部分）：
  • 患者按1:1:1隨機分為三組：HLX07（1,000mg）+賽普利單抗+化療；HLX07（600mg）+賽普利單抗+化療；或安慰劑+賽普利單抗+化療。
  • 每3週給藥1次，共4週期，隨後進入維持治療。
  • 主要終點：盲法獨立中央評審（BICR）下的無進展生存期（PFS）及客觀緩解率（ORR）。
• 第三期（II部分）：
  • 根據I部分確定最佳劑量。患者1:1隨機分配，分別接受HLX07+HANSIZHUANG+化療或安慰劑+帕博利珠單抗+化療，隨後進入維持治療。
  • 主要終點：PFS及總生存期（OS）。
  • 次要終點：安全性、藥代動力學（PK）、免疫原性，以及EGFR/PD-L1腫瘤表達與療效關聯性。

關於HLX07及HANSIZHUANG

• HLX07：公司自主創新的抗EGFR生物藥，定位於多種晚期實體瘤。早期臨床證明安全耐受性佳，現正開展多項二期研究。
• HANSIZHUANG（賽普利單抗）：自主開發PD-1單抗，中國已獲批多項適應症：
  • 鱗狀NSCLC、廣泛期小細胞肺癌、食管鱗癌及非鱗狀NSCLC一線治療（聯合化療）。
  • 胃癌新/輔助治療NDA已獲受理（優先審評）。
  • 已在歐盟、英國及多個亞洲國家上市，並獲美國、瑞士、韓國等孤兒藥資格。
  • 全球多適應症臨床推進，包括肺癌、頭頸癌、結腸癌及胃癌。

市場及監管資訊

• 競爭優勢：若成功上市，公司將率先佔據全球sqNSCLC新療法領域，商業價值巨大。
• 監管推進：中國及澳洲均已啟動臨床，展現國際化戰略。

股東須知及風險提示

• 股價敏感：臨床試驗成敗或顯著影響公司估值，需密切關注進展。
• 風險：臨床及上市存在不確定性，最終成藥與否無保證，請股東審慎投資。

管理層及公司資訊

• 公告由董事會主席張文傑發佈，董事會組成多元，體現完善治理。

View HENLIUS Historical chart here