Suzhou, Shanghai, China - Recently, GeneQuantum Healthcare (Suzhou) Co., Ltd. ("GeneQuantum") and Shanghai Henlius Biotech, Inc. ("Henlius", stock code: 2696.HK) held a signing ceremony for a strategic collaboration on the innovative HER2 antibody-drug conjugate (ADC) GQ1005. As agreed, Henlius will obtain the development and exclusive commercialization rights for GQ1005 in the cooperative regions (Mainland China, Hong Kong, Macau and other agreed overseas countries).

GQ1005 is a next-generation investigational HER2-targeted ADC developed by GeneQuantum using its proprietary enzymatic site-specific conjugation technology iLDC® and intelligent continuous conjugation process, featuring high homogeneity and stability. It conjugates a topoisomerase I inhibitor payload to an anti-HER2 monoclonal antibody via a stable, cleavable open-chain linker protected by GeneQuantum's patent. With a highly membrane-permeable topoisomerase I 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. Clinical studies involving hundreds of subjects across multiple indications, including breast cancer, gastric cancer, non-small cell lung cancer, and gynecological tumors, have been completed. In September 2024, it received approval to initiate a Phase 3 clinical trial for the second-line treatment of HER2-positive breast cancer to further evaluate its efficacy and safety, aiming to improve survival outcomes in HER2-positive breast cancer patients.

GQ1005 has a drug-to-antibody ratio (DAR) of 4. Preclinical studies have demonstrated that GQ1005 exhibited comparable anti-tumor efficacy to trastuzumab deruxtecan (T-DXd) in multiple xenograft models, with significantly superior in vitro and in vivo stability and a better safety profile. Consistent with this, the Phase 1 clinical trial data of GQ1005 showed excellent safety: treatment-related adverse events (TRAEs) of Grade 3 or higher were much lower than those of other ADC drugs of the same type on the market, and all were within controllable range. Among the subjects with HER2-overexpressing breast cancer, 70% had received ≥3 lines of treatment, 91% had received multiple HER2 TKI treatments, and 60.0% had received other HER2 ADC treatments. GQ1005 still achieved excellent efficacy in this post-line population who had undergone the aforementioned complex treatments, showing promising commercial prospects.

GQ1005 leverages a disruptive intelligent continuous production process—innovated locally yet leading globally—to establish a new paradigm for large-scale commercial ADC manufacturing worldwide.

Utilizing GQ’s proprietary iConjugation® , an intelligent conjugation manufacturing platform, GQ1005 achieves the world’s first production of high-quality ADC drugs in existing monoclonal antibody facilities. This innovation breaks through traditional ADC capacity expansion barriers, significantly reduces production costs, and greatly enhances both the product’s market competitiveness and the accessibility of innovative ADC therapies.

"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."

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."

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.

For more information, please visit: www.genequantum.com

About Henlius

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.