Hansoh Pharma's HS-20093 ADC Granted Breakthrough Therapy Designation for SCLC in China
Key Insights
Jiangsu Hansoh (search)'s HS-20093, a B7-H3 (search)-targeted ADC, has received Breakthrough Therapy Designation from China's NMPA for extensive-stage small cell lung cancer (search) (ES-SCLC (search)) following first-line treatment.
HS-20093 is the first B7-H3 (search)-targeted ADC to enter Phase III development in China for second-line SCLC (search) treatment, potentially setting a new standard of care.
The prevalence of SCLC (search) in China is expected to rise significantly, underscoring the urgent need for innovative treatments like HS-20093 to improve patient outcomes.
Jiangsu Hansoh (search) Pharmaceutical Group's HS-20093, an antibody-drug conjugate (ADC) targeting B7-H3 (search), has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA) for the treatment of extensive-stage small cell lung cancer (search) (ES-SCLC (search)) after failure of standard first-line therapy. This designation highlights the potential of HS-20093 to address a critical unmet need in SCLC, a highly aggressive form of lung cancer.
The Need for Novel SCLC Therapies
SCLC (search) is characterized by rapid progression and a high rate of relapse despite initial responses to chemoimmunotherapy. The current treatment landscape in China includes monoclonal antibodies (mAbs) such as durvalumab (Imfinzi), atezolizumab (Tecentriq), toripalimab-tpzi (Tuoyi), adebrelimab (Ariely) and benmelstobart (Andervi), which are programmed cell death protein 1/death ligand 1 (PD-1/PDL-1) inhibitors. However, the need for more effective second-line treatments remains significant.
According to GlobalData’s Pharmaceutical Intelligence Center, the number of diagnosed prevalent cases of SCLC (search) in China is expected to increase at an annual growth rate (AGR) of 5.56% from 100,709 in 2023 to 129,505 in 2029, emphasizing the urgency for novel treatment options.
HS-20093: A Potential Game-Changer
B7-H3 (search), the target of HS-20093, is an immune regulatory protein highly expressed in SCLC (search) tissue samples. ADCs targeting B7-H3 have demonstrated promising antitumor activity in heavily pretreated SCLC patients across various clinical trial phases. HS-20093 is the first ADC to receive BTD for SCLC globally and the first B7-H3-targeted ADC to advance into Phase III development in China for second-line treatment of SCLC.
Nelluri Geetha, Pharma Analyst at GlobalData, notes that "ADCs targeting B7-H3 (search) have shown promising antitumor activity in different clinical trial phases in heavily pretreated SCLC (search)."
The Competitive Landscape
Currently, there are five ADCs targeting B7-H3 (search) for SCLC (search) in development in China, according to GlobalData’s Pharmaceutical Intelligence Center. These include HS-20093 (Phase III), IBI-129, YL-201, ILB-3101 (Phase II), and BGBC-354 (IND/CTA Filed). Another ADC in Phase III for SCLC in China is BLB-01D1 from Systimmune, a bispecific mAb targeting EGFR and HER3, being developed for third-line treatment. Both HS-20093 and BLB-01D1 utilize a DNA Topoisomerase I Inhibitor payload.
Hansoh Pharma's Oncology Portfolio
Jiangsu Hansoh (search) boasts a substantial oncology portfolio with 18 approved small molecule drugs in China, including innovator drugs like aumolertinib mesylate and flumatinib mesylate. In addition to HS-20093, the company is developing two other ADCs, HS-20089 (Phase II) and HS-20105 (IND/CTA), for various solid tumors. This robust ADC pipeline is expected to strengthen Jiangsu Hansoh's position in the Chinese oncology market and address critical unmet needs in cancer therapy.
Geetha concludes, "Jiangsu Hansoh (search) boasts an impressive portfolio in oncology... This emphasises the company’s commitment to advancing cancer therapies. Apart from HS-20093, two ADCs (HS-20089 (Phase II) and HS-20105 (IND/CTA)) are being developed by Jiangsu for different types of solid tumours. Jiangsu with ADCs pipeline portfolio will reinforce its position in the Chinese oncology market and address critical gaps."