On September 14, CSPC Innovation Pharmaceutical Co., Ltd. (Stock Code: 300765.SZ) issued an announcement stating that its holding subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd. (hereinafter referred to as “Jushi Bio”), presented oral data from the Phase I/II clinical study of SYS6010 combined with envafolimab at the 2026 World Conference on Lung Cancer (WCLC) held in Seoul, South Korea, from September 12 to 15, 2026.

SYS6010 is an antibody‑drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), independently developed by Jushi Bio. It consists of a humanized anti‑EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor payload. SYS6010 specifically binds to EGFR on the surface of tumor cells; upon internalization, it releases cytotoxic payloads intracellularly to exert anti‑tumor activity. Given the prevalent high EGFR expression across multiple solid tumors, SYS6010 boasts broad development prospects, and Jushi Bio has advanced development programs for SYS6010 in multiple solid tumor indications.

This multicenter Phase I/II clinical trial (ChiCTR2400089402), led by Professor Zhou Caicun from Shanghai East Hospital, was designed to evaluate the safety, tolerability, pharmacokinetic profiles and preliminary efficacy of SYS6010 in combination with envafolimab injection (a PD‑1 inhibitor), with or without chemotherapy, in patients with EGFR‑ and anaplastic lymphoma kinase (ALK)‑wild‑type advanced non‑small‑cell lung cancer and other advanced solid tumors. At the conference, Jushi Bio reported results from the randomized controlled trial investigating SYS6010 plus envafolimab injection for treatment‑naïve, driver‑gene‑negative advanced non‑small‑cell lung cancer. Two dosing regimens were assessed: Regimen 1: SYS6010 4.2 mg/kg plus envafolimab 360 mg administered once every three weeks; Regimen 2: SYS6010 3.6 mg/kg plus envafolimab 240 mg administered once every two weeks.

As of July 13, 2026, a total of 123 participants were enrolled and treated across the two regimens, including 62 patients in Regimen 1 and 61 patients in Regimen 2, with a median follow‑up of 10.8 months. Key safety and efficacy data are summarized below:

In terms of safety, both SYS6010‑plus‑envafolimab regimens demonstrated generally manageable safety profiles. The incidence of Grade ≥3 treatment‑related adverse events was 51.6% (Regimen 1) and 52.5% (Regimen 2), respectively. The incidence of treatment‑related adverse events leading to treatment discontinuation was 9.7% (Regimen 1) and 8.2% (Regimen 2), respectively.

For efficacy, both regimens showed preliminary anti‑tumor activity in the study population. Greater clinical benefit was observed among patients with non‑squamous histology and those with high PD‑L1 expression; efficacy was seen in both squamous and non‑squamous patients with high PD‑L1 expression. Confirmed objective response rates (ORR) for the overall population and subgroups are shown in the table below.

Currently, the combination therapy of SYS6010 and envafolimab injection has entered Phase III clinical trials. Jushi Bio intends to develop this regimen for first‑line treatment of PD‑L1‑positive locally advanced or metastatic non‑small‑cell lung cancer (NCT07633873).