Recently, Shanghai Henlius Biotech, Inc. (2696.HK) has entered into a strategic collaboration with GeneQuantum Healthcare (Suzhou) Co., Ltd. ("GeneQuantum"). As agreed, Henlius will obtain the development and exclusive commercialization rights for the innovative HER2-targeted antibody-drug conjugate (ADC) GQ1005 in China and certain overseas markets. The drug candidate, currently in phase 3 clinical development, is being evaluated for HER2-positive breast cancer.
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, stated: "As a leader in breast cancer treatment, Henlius is dedicated to advancing treatment innovation and delivering clinical breakthroughs. Our core breast cancer therapies have now been approved in over 50 countries and regions worldwide. This collaboration will expand our end-to-end treatment paradigm across all breast cancer subtypes, further solidifying our leadership position. We look forward to bringing this innovative medicine to patients as soon as possible, igniting hope for more lives."
"We are thrilled to establish this partnership with Henlius," said Dr. Gang Qin, Founder and Chairman of GeneQuantum. "This collaboration is driven by a strong consensus on the clinical value of GQ1005 and represents a powerful alliance between two leading biopharma companies in China. By combining GeneQuantum’s expertise in ADC innovation with Henlius’ extensive experience in oncology drug development and commercialization, we are well positioned to deliver high-quality, safe and efficacious treatments to patients with HER2-positive tumors. Together, we aim to build a cornerstone therapy with blockbuster potential."
GQ1005 is an investigational HER2-targeted ADC developed by GeneQuantum using its proprietary enzymatic site-specific conjugation technology. The drug conjugates a topoisomerase I inhibitor payload to an anti-HER2 monoclonal antibody via a stable, cleavable open-chain linker. Featuring a highly membrane-permeable topoisomerase inhibitor payload, GQ1005 delivers potent bystander killing effects while minimizing systemic toxicity through its unique and stable linker design, achieving an optimal balance between efficacy and safety. Preclinical studies demonstrated comparable antitumor efficacy to trastuzumab deruxtecan (T-DXd) in multiple xenograft models, with a superior safety profile. At the 2024 American Association for Cancer Research (AACR) Annual Meeting, Phase 1 clinical data of GQ1005 in HER2-expressing or HER2-mutated advanced solid tumors were presented, showing favorable tolerability and safety across doses ranging from 2.0 mg/kg to 8.4 mg/kg, along with promising efficacy in patients with breast, gastric, and lung cancers. The drug has now entered phase 3 clinical trials to further evaluate its efficacy and safety, aiming to improve survival outcomes in HER2-positive breast cancer patients.
Breast cancer stands as a cornerstone therapeutic focus in Henlius' strategic development. The company has established a diversified product pipeline encompassing the entire disease course and all molecular subtypes of breast cancer. By building its own commercialization team and collaborating with overseas partners, Henlius has formed a global commercial network to continuously unlock the value of its breast cancer portfolio.The company has assembled a dedicated commercialization team of over 600 professionals, comprehensively covering critical areas such as market access, channel expansion, and medical promotion. Through refined operations and intelligent management, Henlius has achieved industry-leading commercialization efficiency. At present, the company’s flagship product, HANQUYOU (trade name: HERCESSI™ in the U.S., Zercepac® in Europe) has gained approvals in over 50 countries and regions worldwide and included in the reimbursement systems of China, the UK, France, Germany, and other nations, benefiting over 260,000 patients. HANNAIJIA (neratinib), a HER2-positive early breast cancer adjuvant therapy, can be used sequentially with HANQUYOU to reduce recurrence risk. Meanwhile, the marketing applications for HLX11, a pertuzumab biosimilar, have been accepted by regulatory authorities in China, the U.S., and Europe, with the potential to deliver dual-target synergistic effects in combination with HANQUYOU. Additionally, the company’s novel epitope anti-HER2 monoclonal antibody, HLX22, has entered phase 2 clinical trials in HR-positive/HER2-low breast cancer patients. Furthermore, leveraging its robust innovation platform and strategic collaborations, Henlius is accelerating the development of diverse therapeutic modalities, including ADCs and small-molecule targeted drugs. Promising candidates such as HLX78 (lasofoxifene) and HLX97 (KAT6A/B inhibitor) are under exploration, reinforcing the company’s commitment to delivering comprehensive and advanced treatment options for breast cancer patients worldwide.
In the future, Henlius will continue to strengthen its innovative presence in the breast cancer, delivering more breakthrough treatment options and creating greater clinical and social value through a diversified product portfolio and global clinical development efforts.
About GeneQuantum Healthcare
GeneQuantum, headquartered in Suzhou, China, is a global biopharmaceutical innovator specializing in field of bioconjugation therapeutics. Recognized as pioneer of applying enzymatic site-specific conjugation technology in bioconjugate development, GeneQuantum has built proprietary core conjugation platforms, iLDC® and iGDC®, validated by late clinical stage assets and strategic partnerships. GeneQuantum is committed to empowering global XDC industry through an open ecosystem construction.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANNAIJIA (neratinib) and FUTUONING (fovinaciclib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
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