Creating differentiated innovative products and focusing on unmet clinical needs as a foundation for future commercialization has always been the core focus of innovation and R&D.
Five years ago, the STAR Market (Science and Technology Innovation Board) introduced the fifth set of listing standards, paving the way for the listing of innovative pharmaceutical and medical device companies. Five years later, 20 companies have gone public on the STAR Market under the fifth set of standards, with Asieris Pharmaceuticals being one of them. By leveraging the capital market, Asieris continues to innovate and grow.
The company’s core product, APL-1702, is expected to become the world’s first and China’s first non-invasive photodynamic therapy for cervical precancerous lesions, filling a treatment gap in China.
“From the perspective of an innovative pharmaceutical company, we hope to further broaden refinancing channels under the premise of addressing unmet clinical needs and improving treatment paradigms,” said Asieris Pharmaceuticals. “The funding required for innovative drug R&D is often significant, and the need for timely financing is urgent. With more support from the capital market, the explosive power of pharmaceutical innovation in the future will be unlimited.”
Significant progress in several innovative products
Over the past two years, the company has successfully advanced the development of several innovative products, addressing unmet clinical needs and offering more options to patients in scenarios with limited treatment options.
In May 2024, a core product of Asieris Pharmaceuticals achieved significant R&D progress: the new drug application for APL-1702, a non-surgical treatment for high-grade squamous intraepithelial lesions (HSIL), was accepted.
“The company is actively promoting the review and approval process for its market launch,”
Asieris Pharmaceuticals explained. APL-1702 features innovations in formulation improvement, clinical development, registration procedures, and treatment pathways, primarily in the following three areas:
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Global First, China First: APL-1702 is expected to become the world’s first non-invasive therapy for HSIL supported by high-level clinical evidence, and the first to be launched in China. It could be the first globally validated HSIL non-invasive therapy proven effective through international phase III clinical trials.
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Drug-Device Combination: APL-1702 addresses issues that cannot be solved by drugs or devices alone, representing a pioneering approach. This innovation sets a practical example for the evaluation and management processes of drug-device combinations.
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Redefining Treatment Goals for Cervical Precancerous Lesions: Traditionally, HSIL treatment often involves cervical excision, but APL-1702 aims to reverse the disease progression while preserving the cervix, thereby avoiding the damage associated with delayed excision. This approach supports long-term disease management and better addresses recurrence.
Previously, in November 2023, the new drug application for Asieris Pharmaceuticals’ bladder cancer diagnostic and management drug APL-1706 was also accepted. This product is currently the world’s only approved contrast agent for assisting in bladder cancer diagnosis or surgery.
"We hope to obtain market approval in the first half of 2025," Asieris Pharmaceuticals stated.
"Asieris Pharmaceuticals is very optimistic about the market potential of these products, particularly APL-1702.
Each year, 600,000 to 700,000 women are diagnosed with high-grade cervical lesions, and 90% of these patients undergo cervical excision. The launch of APL-1702 could help hundreds of thousands of women annually avoid cervical excision, eliminate lesions or clear HPV infection, reverse disease progression, preserve fertility, and address unmet clinical needs. We believe that the product’s market launch will not only benefit more patients but also contribute significantly to the company’s performance," Asieris Pharmaceuticals noted.
Multiple Measures to Promote Commercialization
“Being fully prepared for success or failure and having a meticulous development strategy are crucial,” Asieris Pharmaceuticals emphasized. Unlike biotech companies that broadly research multiple indications around popular targets, Asieris has focused its resources from the outset on a specialized strategy, targeting two niche areas: bladder cancer and cervical precancerous lesions. This focused strategy has gradually yielded significant results.
Beyond its focused R&D efforts, Asieris Pharmaceuticals has also developed a clear strategy for operations and commercialization. The company emphasizes cost control and efficiency in operations, ensuring that resources are allocated effectively to key projects. In terms of commercialization, Asieris has quickly built a capable marketing team through product acquisitions and is fully committed to the successful market launch of APL-1702 in China to achieve commercial success as soon as possible.
Furthermore, Asieris Pharmaceuticals is actively pursuing overseas development and partnership opportunities for APL-1702 and APL-1202/APL-1501, aiming to reduce overseas development costs through out-licensing and increase the company’s cash flow.
