Shanghai Henlius Biotech Announces First Patient Dosed in Groundbreaking HLX3902 Clinical Trial
Key Points for Investors
- First Patient Dosed: Shanghai Henlius Biotech has announced the dosing of the first patient in its Phase 1 clinical trial of HLX3902 injection (STEAP1×CD3×CD28 trispecific antibody) for metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumors.
- Innovation: HLX3902 is a first-in-class trispecific T-cell engager antibody, targeting STEAP1, CD3, and CD28. This approach is designed to enhance cytotoxic T cell responses against STEAP1-expressing tumor cells and optimize T cell activation, proliferation, and survival.
- Clinical Study Design: The Phase 1a trial is open-label and first-in-human, assessing safety, tolerability, pharmacokinetics, and preliminary efficacy. Eight dose levels are being studied, from 0.005mg to 1.5mg, with treatment cycles of 4 weeks. The lowest dose cohort uses an accelerated titration design, while higher doses follow a “3+3” dose escalation design.
- Expansion Plans: The company intends to commence clinical trials in Australia after fulfilling necessary requirements, indicating potential international expansion.
- Market Exclusivity: No trispecific antibody targeting STEAP1, CD3, and CD28 has been approved globally, positioning HLX3902 as a potential first-mover and providing a strong competitive advantage.
- Preclinical Promise: Preclinical studies have shown HLX3902 to have good anti-tumor efficacy and safety, suggesting possible clinical benefits for patients with mCRPC and other advanced solid tumors.
- Regulatory Milestones: HLX3902 was approved for Phase 1 clinical trials in Australia and China in May and June 2026, respectively.
Potential Price Sensitive Information for Shareholders
- Novelty and Exclusivity: HLX3902’s global first-mover status in trispecific antibody therapy targeting STEAP1, CD3, and CD28 could significantly impact Shanghai Henlius Biotech’s competitive positioning and future revenue streams.
- Clinical Progress: Initiating the Phase 1 trial and dosing the first patient marks a critical milestone, potentially increasing investor confidence and positively affecting share value.
- International Development: Plans to expand the clinical trial to Australia could open new markets and diversify regulatory and commercial risks.
- Risks: As per regulatory requirements, the company cautions that successful development and commercialization of HLX3902 cannot be guaranteed. Shareholders should remain vigilant as clinical trial setbacks or failures could negatively impact share prices.
- Leadership and Governance: The announcement was made by Chairman Wenjie Zhang, and details the composition of the Board, highlighting strong leadership and governance structure.
Full Article
Shanghai Henlius Biotech, Inc. has announced a major milestone in its pipeline development with the dosing of the first patient in a Phase 1 clinical trial of HLX3902 injection. HLX3902 is a highly innovative trispecific antibody, independently developed by Henlius, intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumors in mainland China. This marks the company’s entry into first-in-human studies for a globally novel therapy.
The clinical trial is designed as an open-label, first-in-human phase 1a study, evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy across eight dose cohorts (0.005mg to 1.5mg). Each cohort will undergo a 4-week treatment cycle, utilizing accelerated titration in the lowest dose group and a “3+3” dose escalation in subsequent groups. Primary endpoints include incidence of dose-limiting toxicities and determination of maximum tolerated dose.
HLX3902’s trispecific mechanism is cutting-edge, targeting STEAP1, CD3, and CD28 to boost T cell activation and cytotoxicity against prostate cancer and other solid tumors. Preclinical studies indicated promising anti-tumor activity and safety, suggesting the potential for meaningful clinical benefits.
Importantly, HLX3902 is the first trispecific antibody of its kind to enter clinical trials worldwide, giving Shanghai Henlius a potentially significant lead in this therapeutic class. With regulatory approvals secured in China and Australia, the company is poised for international clinical development, which could unlock new markets and revenue streams.
However, shareholders should note the inherent risks of drug development. Henlius has issued a caution that success in clinical trials or eventual commercialization cannot be guaranteed. Any adverse outcomes in the ongoing or future studies may impact investor sentiment and share price.
This announcement was made by Wenjie Zhang, Chairman of Shanghai Henlius Biotech, with an overview of the Board’s composition, underscoring the company’s strong leadership and governance.
Disclaimer
The information provided is for informational purposes only and does not constitute investment advice. Clinical trial outcomes are uncertain and may impact company valuation. Investors are advised to exercise caution and consult professional advisors before making investment decisions.
上海復宏漢霖生物技術：首名患者完成HLX3902三特異性抗體一級臨床試驗給藥
投資者需注意的重點
- 首名患者給藥： 上海復宏漢霖宣布，首名患者已完成其HLX3902（STEAP1×CD3×CD28三特異性抗體）針劑第一期臨床試驗給藥，主要針對轉移性去勢抵抗性前列腺癌（mCRPC）及其他晚期實體瘤。
- 創新突破： HLX3902為全球首款三特異性T細胞激動抗體，能同時靶向STEAP1、CD3及CD28，增強細胞毒性T細胞殺傷腫瘤能力及優化T細胞激活、增殖與存活。
- 臨床設計： 第一期a試驗為開放標籤、首次人體臨床，評估安全性、耐受性、藥代動力學及初步療效，設8個劑量組（0.005mg至1.5mg），每周期4周。最低劑量組採加速滴定設計，其餘採“3+3”劑量遞增設計。
- 國際拓展： 公司計劃滿足相應條件後於澳洲展開臨床試驗，顯示國際市場開發意向。
- 市場獨特性： 目前全球尚未有任何三特異性抗體（靶向STEAP1、CD3、CD28）獲批，HLX3902具有先發優勢。
- 前期成效： 動物前臨床顯示HLX3902具良好抗腫瘤效果及安全性，有望為晚期癌症患者帶來臨床益處。
- 監管里程碑： HLX3902已於2026年5月（澳洲）及6月（中國）獲批開展一期臨床。
股東需注意的可能價格敏感資訊
- 首發及專利優勢： HLX3902有機會成為全球首款三特異性抗體藥物，對公司競爭力及未來收入潛力具重大影響。
- 臨床進展： 臨床一期首名患者給藥為重要里程碑，有望提升投資者信心及推動股價。
- 國際開發： 澳洲臨床計劃將拓展市場及分散監管風險。
- 風險提示： 公司提醒，HLX3902開發及商業化成功不能保證，若臨床進展不如預期，可能影響股價。
- 領導及管治： 公告由董事長張文捷發布，並列出董事會成員，彰顯公司領導及管治能力。
詳細報導
上海復宏漢霖生物技術股份有限公司宣布，旗下自主研發的HLX3902（STEAP1×CD3×CD28三特異性抗體）正式進入一期臨床試驗，首名患者已完成給藥。HLX3902主要針對中國內地的轉移性去勢抵抗性前列腺癌及其他晚期實體瘤患者，標誌公司創新管線首次進入人體臨床階段。
該試驗採開放標籤設計，評估安全性、耐受性、藥代動力學及初步療效，共設8個劑量組（0.005mg至1.5mg），每組治療周期為4周。最低劑量組採加速滴定，其餘組採“3+3”遞增設計。主要終點為劑量限制性毒性和最大耐受劑量。
HLX3902為全球首創三特異性抗體，靶向STEAP1、CD3、CD28三個標靶，提升T細胞殺傷腫瘤能力與活化效果。前臨床數據顯示其具備良好抗腫瘤效能與安全性，預計能為晚期癌症患者提供新療法。
截至目前，全球尚無此類三特異性抗體獲批，公司已於中國和澳洲獲監管批准開展一期臨床，為後續國際市場鋪路。
但股東需留意，藥物開發存在不確定性，公司特此提醒臨床及商業化成果未必保證，如進展不順，或對股價構成負面影響。
公告由董事長張文捷發布，並列明董事會成員，顯示公司管治穩健。
免責聲明
本資訊僅供參考，不構成投資建議。臨床試驗結果存在不確定性，或影響公司估值。投資者請審慎評估及諮詢專業意見。
