Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapeutic products by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted HBV siRNA drug independently developed by the company [1] - The phase II clinical study results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B, while also demonstrating good safety characteristics [1]

Core Viewpoint - Heng Rui Medicine's subsidiary has two products included in the list of proposed breakthrough therapies by the National Medical Products Administration, indicating significant progress in their development pipeline [1] Group 1: Product Development - The injection of SHR-A1811 (Rui Kang Qu Mo Zhu) has been included in the proposed breakthrough therapy list for the ninth time, highlighting its potential in treating non-small cell lung cancer (NSCLC) [1] - SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release within the tumor cells [1] - The product has received approval for market launch in May 2025, specifically for adult patients with unresectable locally advanced or metastatic NSCLC who have previously undergone at least one systemic therapy [1] Group 2: New Drug Approvals - The injection of Adalimumab (Aide Beili) is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Adalimumab was approved for market launch in March 2023, with its indication for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [1]