Asieris Reports 2023 Success: APL-1702 Phase III Triumph and APL-1706 NDA Approval, Fueling Revenue Growth

Asieris Pharmaceuticals has announced its 2023 Annual Report, highlighting significant advancements in its specialty pharmaceutical strategy. The company has seen swift progress in clinical development, initial research, and commercialization, with a strong pipeline comprising 13 products and 16 research projects underway. Financially, Asieris ended 2023 with a healthy cash reserve of approximately RMB 2.333 billion.

APL-1702, a novel drug-device combination for photodynamic therapy of high-grade cervical lesions, has shown remarkable results in a global phase III clinical trial. The treatment demonstrated a notably higher response rate compared to a placebo, with a 89.4% increase (41.1% vs. 21.7%). Additionally, APL-1702 showed a 103.9% improvement in clearing high-risk HPV strains. The product is poised to revolutionize cervical precancer treatment by shifting the approach from surgical to long-term management, aiming to minimize invasive procedures.

The company is preparing to submit APL-1702 for market approval to China's NMPA, with an expected acceptance in the second quarter of 2024. It also plans to initiate local production and develop a second-generation version of APL-1702. Asieris intends to engage with the EMA and FDA for regulatory alignment and is exploring international partnerships.

APL-1706, an imaging drug for bladder cancer diagnosis and surgery, also achieved its primary endpoint in a phase III trial. It was found to be more effective than traditional methods in detecting bladder cancer, especially CIS, and showed good tolerability. APL-1706 is the first imaging agent globally approved for bladder cancer diagnosis and surgery. The NMPA accepted its market approval application in November 2023, with an expected approval by June 2025.

Despite a setback with APL-1202 in NMIBC treatment, the drug showed promise when combined with the immune checkpoint inhibitor tislelizumab for muscle-invasive bladder cancer. The company plans to conduct further clinical studies in China and initiate trials for APL-1501 in the US, focusing on non-muscle invasive bladder cancer.

Asieris has bolstered its early research capabilities with advancements in Targeted Immunomodulator Normalization (TIMN), Targeted & AI-driven Drug Discovery (TAIDD), and Drug Device Combination (DDC). Several new drug candidates have been discovered, and the company increased its R&D investment by 49.49% in 2023.

The commercial team at Asieris has also been strengthened to ensure sustained revenue growth. The company reported an operating revenue increase and has established business units for oncology and women's health. The oncology unit has licensed two new drugs and aims for substantial sales growth in 2024. A women's health unit has been created to commercialize APL-1702 in China and expand the company's presence in women's health.

Dr. Kevin Pan, CEO of Asieris Pharmaceuticals, emphasized the company's commitment to addressing unmet needs in genitourinary tumors and diseases. Despite some clinical trials not meeting expectations, the company has achieved significant milestones and is building a strong commercial team to generate a sustainable revenue stream. Asieris is looking forward to strengthening its pipeline and capabilities and pursuing international opportunities for substantial value creation.