To The Moon

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHSE: 600276) has announced that it, along with its subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration to proceed with clinical trials for three drug candidates.

The company obtained drug clinical trial approval notices for SHR-8068 injection, adebrelimab injection, and apatinib mesylate tablets, with trials set to commence in the near term.

Details on the Approved Drugs

The SHR-8068 injection is a fully human anti-CTLA-4 monoclonal antibody introduced by the company, designed to enhance anti-tumor immune responses. Currently, there are three similar products approved for market globally: Bristol Myers Squibb's ipilimumab, AstraZeneca's tremelimumab, and Innovent Biologics' ipilimumab N01 injection.

Adebrelimab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui. It works by specifically binding to the PD-L1 molecule, thereby blocking the PD-1/PD-L1 pathway responsible for tumor immune tolerance. This action reactivates the immune system's anti-tumor activity to achieve therapeutic goals.

This drug has already received approval for two indications. The first is for use in combination with carboplatin and etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer. The second is for use alongside platinum-based chemotherapy as neoadjuvant therapy, followed by continued use as a monotherapy for adjuvant treatment. This regimen is for adult patients with operable stage II, IIIA, and IIIB non-small cell lung cancer who do not have known EGFR mutations or ALK rearrangements.

Apatinib mesylate tablets are a small-molecule VEGFR-2 tyrosine kinase inhibitor that functions by inhibiting tumor angiogenesis. This product has already received approval in China for several indications, covering cancer types including gastric cancer, liver cancer, and breast cancer. Other similar products like sorafenib, sunitinib, and pazopanib are also approved for marketing both domestically and internationally.