Jiangsu Hansoh ADC HS-20093 holds potential to set new standard in SCLC second-line treatment in China: GlobalData

Jiangsu Hansoh Pharmaceutical Group has recently obtained approval for HS-20093, a B7-H3-targeted antibody-drug conjugate (ADC) to be included as Breakthrough-Therapy-Designated (BTD) Drug by the National Medical Products Administration (NMPA) of China for extensive stage small cell lung cancer (ES-SCLC) after standard first-line treatment. Against this backdrop, HS-20093 is expected to strengthen Jiangsu Hansoh position in the Chinese oncology market, says GlobalData.

The current marketed drug space for SCLC in China is occupied by monoclonal antibodies (mAbs) and small molecules. The mAbs approved for the treatment of SCLC in China are programmed cell death protein 1/death ligand 1 (PD-1/PDL-1) inhibitors: durvalumab (Imfinzi), atezolizumab (Tecentriq), toripalimab-tpzi (Tuoyi), adebrelimab (Ariely) and benmelstobart (Andervi).

Nelluri Geetha, Pharma Analyst at GlobalData, states, “SCLC represents a highly aggressive form of lung cancer. Although SCLC initially responds to chemoimmunotherapy, it inevitably relapses. B7-H3 is an immune regulatory protein that is highly expressed in SCLC tissue samples. ADCs targeting B7-H3 have shown promising antitumor activity in different clinical trial phases in heavily pretreated SCLC.”

According to GlobalData’s Pharmaceutical Intelligence Center, five ADCs targeting B7-H3 for SCLC are in development in China: HS-20093 (Phase III), IBI-129, YL-201, ILB-3101 (Phase II), and BGBC-354 (IND/CTA Filed). Moreover, globally HS-20093 is the first ADC to receive BTD for SCLC and is the first B7-H3-targeted ADC to advance into Phase III stage of development in China for second-line treatment of SCLC.

In China, eight ADCs have been approved and three are in the pre-registration stage for different cancer types. The first approved ADCs in China are trastuzumab emtansine (Kadcyla) for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) in January 2020 and brentuximab vedotin (Adcetris) for B-Cell Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL) in May 2020.

There is no approved ADC yet for SCLC globally and in China. The two ADCs in Phase III for SCLC in China are HS-20093 from Jiangsu Hansoh and BLB-01D1 from Systimmune. BLB-01D1 is a bispecific mAb targeting EGRF and HER3 in development for third line. Both drugs carry DNA Topoisomerase I Inhibitor payload.

According to GlobalData’s Pharmaceutical Intelligence Center, the number of diagnosed prevalent cases of SCLC in China is expected to increase at an annual growth rate (AGR) of 5.56 per cent from 100,709 in 2023 to 129,505 in 2029. Therefore, there is an urgent need for novel and innovative treatment options to improve survival in this patient population.

There are 12 ADCs in the pipeline (Phase I & II) in China for the second-line treatment of SCLC. Five are in Phase II and seven are in Phase I development.

Geetha concludes, “Jiangsu Hansoh boasts an impressive portfolio in oncology with 18 approved small molecules drugs in China, of which two are innovator drugs (aumolertinib mesylate and flumatinib mesylate). 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.”