ON February 25,2025,Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK),announces that the Group's self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for the treatment of patients with osteosarcoma who have progressed on at least two prior lines of therapy.
HS-20093 is an investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload and being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumors in multiple clinical trials in China, with the highest research stage being Phase III clinical trials.
On November 1, 2024,the NMPA listed HS-20093 as a Breakthrough-Therapy-Designated Drug, with the indication being extensive-stage small-cell lung cancer (ES-SCLC) developed after standard first-line treatment (platinum doublet chemotherapy combined with immuno-therapy).
About Osteosarcoma
Osteosarcoma is the most common primary malignant bone tumor, accounting for 35% of all malignant bone tumors and it has been included in China's “List of Rare Diseases" [1].The median age of onset for osteosarcoma is 20 years old, making it the most prevalent primary malignant bone tumor in children and adolescents. Approximately 20-30% of patients who present with localized (non-metastatic) osteosarcoma and 80% of those who present with metastatic osteosarcoma will progress to an advanced stage (recurrence or metastasis) [2]. The 5-year survival rate for patients with advanced osteosarcoma is only about 20% [3]. Globally, treatment options for relapsed or refractory osteosarcoma following first-line chemotherapy are extremely limited, with no clear standard of care available [4-5]. After patients progress after two prior lines of treatment, treatment options are even more limited, with no approved therapies, highlighting a significant unmet clinical need.
About Hansoh Pharma
Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. To date, Hansoh Pharma has launched 7 innovative drugs to form a diverse commercial portfolio. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com.
References
1. Strauss SJ, Frezza AM, Abecassis N, et al. Bone sarcomas: ESMO-EURACAN-GENTURIS-ERN PaedCan Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(12):1520-1536.
2. Durfee RA, Mohammed M, Luu HH. Review of Osteosarcoma and Current Management. Rheumatol Ther. 2016 Dec;3(2):221-243. doi: 10.1007/s40744-016-0046-y. Epub 2016 Oct 19. PMID: 27761754; PMCID: PMC5127970.
3. Meltzer PS, Helman LJ. New Horizons in the Treatment of Osteosarcoma. N Engl J Med. 2021;385(22):2066-2076.
4. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology (NCCN Guidelines): bone cancer. August 20, 2024. Version 1.2025. Accessed 24 October 2024.https://www.nccn.org/professionals/physician_gls/pdf/bone.pdf
5. Chinese Society of Clinical Oncology (CSCO). CSCO clinical practice guidelines: bone and soft tissue cancer (2024)
Statements
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Forward-Looking Statements
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