Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer

SHANGHAI,March 19, 2025/PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. 

According to the U.S. FDA, the drug or biological product receives an ODD will be eligible for certain development incentives, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent, aiming to accelerate the development process so that patients can benefit from the products as soon as possible. Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence.

Until now, gastric cancer still constitutes a major global health problem.  According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally^[1]. Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%^[2,3]. Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years^[4], the disease's high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes^[5]. This underscores the urgent unmet clinical needs in the overall management of gastric cancer.

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® inEurope) demonstrate that the addition of HLX22 to trastuzumab plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles^[6-8]，expected to redefine the first-line standard treatment for advanced gastric cancer. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC have been approved inChina, the U.S,JapanandAustralia, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally. 

Looking forward, Henlius will adhere to patient-centricity, accelerating the multi-regional clinical trials of HLX22 to deliver this innovative therapy to patients worldwide. Meanwhile, the company will continue to delve into the oncology field, driving the development of more innovative therapeautics to provide high-quality and affordable treatment options.

References

[1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.

[2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92.

[3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70.

[4] Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022).

[5] Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023). 

[6]Jin Liet al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200/JCO.2024.42.3_suppl.354

[7] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016/annonc/annonc1482

[8] Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2.

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 inChina, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review inChina, 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 andShanghai-based commercial manufacturing facilities certificated byChina, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 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 firstChina-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® inEurope), aChina-developed mAb biosimilar approved inChina,Europeand U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly^® in the EU), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

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