BIOLOGICS LICENSE APPLICATION OF RISVUTATUG REZETCAN (HS-20093) FOR INJECTION FOR SMALL CELL LUNG CANCER ACCEPTED BY THE NMPA
SHANGHAI, September 7, 2026 — Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma", 3692.HK) today announced that the biologics license application (BLA) of the Group’s innovative medicine HS-20093（risvutatug rezetecan, or Ris-Rez）for injection was been accepted by the National Medical Products Administration (the “NMPA”） of China on September 2, 2026, for the treatment of adult patients with small cell lung cancer (SCLC) after the failure of prior platinum-based chemotherapy.
Ris-Rez is a B7-H3–targeted antibody–drug conjugate (ADC) under clinical development for multiple solid tumors. The BLA is supported by results from a pivotal Phase 3 clinical trial (ARTEMIS-008) for patients with advanced or relapsed SCLC after prior platinum-based therapy.
In July 2026, the ARTEMIS-008 study met the primary endpoint of overall survival (OS) in SCLC. These results represent the first positive Phase 3 clinical trial to demonstrate an OS benefit for a B7-H3 directed ADC in any tumor type.
The full results from the ARTEMIS-008 study will be presented as a Late-Breaking Abstract (LBA) in an oral presentation at the first Presidential Symposium of the 2026 World Conference on Lung Cancer (WCLC) on September 13.
SCLC[1] accounts for approximately 15% of all lung cancers and is the most aggressive subtype, characterized by high malignancy, rapid disease progression, high relapse rates, and a generally poor prognosis. Although platinum-based chemotherapy remains the standard first-line treatment for SCLC, the vast majority of patients experience rapid relapse or develop resistance post-treatment. With extremely limited options for second-line and subsequent therapies, a substantial unmet clinical need exists.
As a core ADC in Hansoh Pharma’s B7-H3 pipeline, Ris-Rez is designed to precisely target the B7-H3 antigen on the surface of tumor cells and deliver a topoisomerase inhibitor payload directly into the tumor cells. This directed approach aims to achieve potent tumor cell killing while significantly reducing systemic toxicity.
To date, Ris-Rez has received 12 regulatory designations globally, including Breakthrough Therapy Designation, Orphan Drug Designation, and PRIME designation.
About HS-20093
HS-20093（Risvutatug rezetecan）is a B7-H3–targeted antibody–drug conjugate (ADC) discovered and developed by Hansoh Pharma. It comprises a fully human anti-B7-H3 monoclonal antibody conjugated to a number of topoisomerase I inhibitor (TOP1i) payloads via tetrapeptide-based cleavable linkers.
The program has entered Phase 3 clinical development in China for osteosarcoma, SCLC and NSCLC, and is also being evaluated in multiple proof-of-concept studies across additional indications, including head and neck cancer, prostate cancer, esophageal squamous cell carcinoma and colorectal cancer.
In December 2023, Hansoh Pharma granted GSK an exclusive worldwide license, excluding Chinese mainland, Hong Kong, Macau and Taiwan, to develop, manufacture and commercialize Ris-Rez. The program is being advanced globally by GSK, with Phase 1 and Phase 3 clinical studies ongoing outside of China.
References
[1] Saltos A, Shafique M, Chiappori A. Update on the biology, management, and treatment of small cell lung cancer(SCLC) [J]. Front Oncol, 2020, 10: 1074. DOI: 10.3389/fonc.2020.01074
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
Statements
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