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Henlius Biotech's HLX22 Receives Orphan Drug Designation for Gastric Cancer

Shanghai Henlius Biotech, Inc. has achieved a significant milestone as its innovative anti-HER2 monoclonal antibody, HLX22, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This designation is a critical forward movement in the fight against gastric cancer, a disease that remains a major global health challenge. In 2022, there were around 1 million new diagnoses of gastric cancer globally, alongside over 660,000 fatalities according to GLOBOCAN data. The disease is often diagnosed at advanced stages, leading to a dire prognosis with a 6% five-year survival rate.

Importance of Orphan Drug Designation

The ODD granted for HLX22 allows the drug to benefit from various incentives aimed at expediting its development. These include tax credits for clinical trial expenses, waivers of application fees for new drugs, and seven years of market exclusivity in the U.S. without being affected by patent issues. The aim of these provisions is to encourage further research and development in areas that have not been prioritized adequately, thus facilitating earlier access to new treatments for patients.

HLX22 marks a critical advancement in the ongoing evolution of treatment methodologies for gastric cancer, particularly focusing on those with HER2-positive tumours. Henlius previously initiated phase 3 clinical trials across multiple countries, reinforcing the global presence of this promising therapy. The drug is designed to effectively bind to HER2 receptors, operating through a unique mechanism that differentiates it from existing therapies, such as trastuzumab.

Clinical Trials and Efficacy

The results from earlier phase clinical trials support HLX22's promising role when combined with trastuzumab and chemotherapy. Data indicate that this trio of treatments significantly enhances survival rates and boasts improved tumor response in patients diagnosed with HER2-positive gastric cancer. The distinctive binding properties of HLX22 allow it to synergistically act alongside trastuzumab, boosting the internalization and degradation of HER2 dimers on the surface of cancerous cells.

Henlius is committed to leading innovative oncology solutions globally. Currently, its IND applications for the phase 3 study, HLX22-GC-301, has received approval across multiple jurisdictions including the U.S., Japan, and Australia. This substantial international study is already underway, with the first patient receiving treatment, demonstrating Henlius's commitment to patient-centric approaches.

Future Directions for Henlius

With a strategic focus on oncology and a pipeline that includes over 50 innovative molecules, Henlius is positioned to grow its presence in both established and emerging markets. The company’s strong foundation in biopharmaceutical development is evidenced by its operational capabilities that encompass research, manufacturing, and commercialization. Through ongoing efforts to deliver affordable and cutting-edge biopharmaceutical solutions, Henlius and its teams intend to address critical unmet needs in the healthcare sector.

As HLX22 progresses through clinical evaluation, Henlius anticipates that this treatment will not only reshape therapeutic paradigms for gastric cancer but also contribute to a broader array of impactful treatment options in the oncology field. By continuing to prioritize patient needs and invest in research, Henlius aims to enhance the quality of care available to those battling challenging diseases like gastric cancer.

Conclusion

In conclusion, the receipt of Orphan Drug Designation for HLX22 by Shanghai Henlius Biotech represents a pivotal moment for gastric cancer patients and is part of the broader advancements in the biopharmaceutical landscape targeting this serious illness. The ongoing clinical trials will further define HLX22's role in therapy, potentially paving the way for its widespread adoption in standard treatment protocols.