Hengrui Gets NMPA Nod for ADC Phase II Trial, Reports Positive Obesity Data
Hengrui Medicine won NMPA clearance for a Phase II NSCLC trial combining SHR-A2009 ADC with adebrelimab or EGFR-TKI, and with partner Kailera reported up to 12.1% weight loss in a Phase II obesity study of oral ribupatide. SHR-A2009 monotherapy NDA is under review for NSCLC, and cumulative R&D on SHR-A2009 has reached RMB 330 million.
Hengrui Medicine has received approval from China’s National Medical Products Administration (NMPA) to begin a Phase II clinical trial of its HER3-targeting antibody-drug conjugate SHR-A2009 in combination with adebrelimab or a third-generation EGFR TKI for non-small cell lung cancer (NSCLC). Separately, Hengrui Pharma and Kailera Therapeutics announced positive topline results from a Phase II trial of once-daily oral ribupatide, a GLP-1/GIP receptor dual agonist, showing a mean weight reduction from baseline of up to 12.1% in adults with obesity.
The NMPA accepted the clinical trial application for SHR-A2009 on May 13, 2026, and granted approval after confirming compliance with drug registration requirements. SHR-A2009 is an independently developed ADC that specifically binds to HER3 on tumor cells, is internalized, and releases a toxin to kill tumor cells. A marketing application for SHR-A2009 as a monotherapy for NSCLC is already under review, and no HER3-targeting ADC is currently approved globally for NSCLC.
Adebrelimab, a humanized anti-PD-L1 monoclonal antibody also developed by Hengrui, has been approved in China for two indications: first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide, and as neoadjuvant therapy with platinum-based chemotherapy for adult patients with resectable Stage II, IIIA, and IIIB NSCLC without EGFR mutations or ALK rearrangements. Cumulative R&D spending on injectable SHR-A2009 totals approximately RMB 330 million (about NT$1.5 billion), while the adebrelimab program has accumulated approximately RMB 1.25 billion.
The separate Phase II obesity trial of ribupatide (HRS9531 tablet; KAI-9531-T), conducted in China, evaluated once-daily oral dosing. At 26 weeks, participants achieved a mean weight reduction of up to 12.1% with no plateau in weight loss, and vomiting was reported in ≤11.4% of participants.
Comparable PD-L1 inhibitors on the market include Roche’s atezolizumab, Merck KGaA’s avelumab, and AstraZeneca’s durvalumab, which together recorded global sales of approximately $11.05 billion in 2025. Hengrui Medicine’s shares rose 1.675% on the news, with trading volume of HK$16.7 million.