Hengrui Medicine (01276.HK) Adebrelimab Becomes First Domestic PD-L1 Inhibitor for NSCLC Perioperative Setting

NewTimeSpace · 2026/06/25 21:10 · By Jiayi Sun

Hengrui Medicine (1276.HK) announced three simultaneous developments on June 25, 2026: its subsidiary Shanghai Shengdi's adebrelimab injection was approved for a new NSCLC perioperative indication, becoming the first domestic PD-L1 inhibitor approved for this setting, with Phase III data showing a 53.8% MPR rate, 74.8% 2-year EFS rate and a 48% reduction in recurrence/progression/death risk, with cumulative R&D investment of approximately RMB1.225 billion; subsidiary Chengdu Shengdi's cyclosporine eye drops (IV) received marketing approval as China's first and only 0.1% anhydrous cyclosporine eye drop for dry eye, licensed from Novaliq with 17.6-fold improved bioavailability, with cumulative R&D investment of approximately RMB103 million; and HRS-4508 tablets were cleared for clinical trials in advanced solid tumors, with multiple Phase II trials underway covering breast and lung cancers, and cumulative R&D investment of approximately RMB82 million.

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (1276.HK) announced on June 25, 2026, three simultaneous disclosures via the Shanghai Stock Exchange website regarding the approval of a new indication for adebrelimab injection, the marketing approval of cyclosporine eye drops (IV), and the clinical trial approval for HRS-4508 tablets.

Adebrelimab injection granted new indication for NSCLC perioperative treatment. The Company's subsidiary Shanghai Shengdi Pharmaceutical Co., Ltd. received notice from the National Medical Products Administration (NMPA) approving a new indication for adebrelimab injection in the perioperative treatment of non-small cell lung cancer (NSCLC). The approved indication is: in combination with platinum-based chemotherapy as neoadjuvant therapy, followed by adjuvant monotherapy after surgery, for the treatment of adult patients with resectable stage II, IIIA and IIIB NSCLC without known EGFR mutations or ALK rearrangements. This is the second indication for adebrelimab in the lung cancer field, making it the first domestically developed PD-L1 inhibitor approved for NSCLC perioperative treatment in China. The approval was based on the interim analysis results of the Phase III stage of a randomized, double-blind, multi-center Phase Ib/III clinical study (SHR-1316-III-303) led by Professor Wu Yilong of Guangdong Provincial People's Hospital. Data showed that the adebrelimab plus chemotherapy arm achieved a major pathological response (MPR) rate of 53.8%, nearly triple that of the control arm; a 2-year event-free survival (EFS) rate of 74.8%, significantly reducing the risk of disease recurrence, progression or death by 48%; and a surgical resection rate of 88.8%. Adebrelimab injection was previously approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide. According to available data, combined global sales of Atezolizumab, Avelumab and Durvalumab in 2025 were approximately USD11.054 billion. Cumulative R&D investment for adebrelimab injection to date is approximately RMB1,225.10 million.

Cyclosporine eye drops (IV) approved for marketing. The Company's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. received NMPA approval to market cyclosporine eye drops (IV). This product is the first and only 0.1% anhydrous cyclosporine eye drop in China. The approved indication is: to promote tear secretion in patients with dry eye, applicable to patients with reduced tear production due to dry eye, to improve the signs of dry eye. Cyclosporine eye drops (IV) is the CyclASol (0.1% cyclosporine A formulation) licensed from Novaliq GmbH, developed based on the world's first anhydrous drug delivery technology platform EyeSol®. Compared with aqueous-based 0.05% cyclosporine, the bioavailability of cyclosporine eye drops (IV) is improved by 17.6-fold. Novaliq's cyclosporine eye drops were approved in the United States in May 2023. According to available data, combined global sales of similar products in 2025 were approximately USD2.106 billion. Cumulative R&D investment for cyclosporine eye drops (IV) to date is approximately RMB102.60 million.

HRS-4508 tablets receive clinical trial approval. The Company received the Drug Clinical Trial Approval Notification from the NMPA for HRS-4508 tablets, approving the initiation of clinical trials for advanced solid tumors. HRS-4508 tablets are a novel, highly efficient, and selective tyrosine kinase inhibitor that exerts anti-tumor effects by inhibiting tumor cell proliferation. Multiple Phase II clinical trials for this project are currently progressing steadily, covering indications including breast cancer and lung cancer. Cumulative R&D investment for HRS-4508 tablets to date is approximately RMB81.80 million.

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