REMEGEN (09995.HK) saw its stock price soar by 7.75% in Monday's intraday trading, as investors reacted positively to news about the company's promising drug candidate for treating IgA nephropathy. The biotechnology firm's shares reached HK$109.4, with trading volume hitting HK$357 million by press time.

The surge in REMEGEN's stock price comes after the Chinese Center for Drug Evaluation (CDE) proposed including the company's drug, telitacicept, in the priority review category for treating adult patients with primary immunoglobulin A (IgA) nephropathy at risk of progression. This development, announced on September 28, signifies a potential acceleration in the drug's approval process and has boosted investor confidence in the company's prospects.

Adding to the positive sentiment, REMEGEN had previously reported successful results from the domestic Phase III study of telitacicept for IgA nephropathy treatment. The study, which achieved its primary endpoint in Stage A, demonstrated a significant 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) in patients treated with telitacicept compared to the placebo group after 39 weeks of treatment. Telitacicept's unique mechanism of action, which simultaneously inhibits both B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), positions it as a promising treatment option for IgA nephropathy patients. The stock's strong performance today reflects growing optimism about REMEGEN's potential in the biotechnology sector and its innovative approach to addressing unmet medical needs.