Shanghai, China, August 24, 2022 – Asieris Pharmaceuticals, a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, issued its 2022 semi-annual report today. As disclosed in the report, the company has made significant progress in multiple global and China clinical trials for its core investigational products and is making steady progress in implementing its strategy of providing integrated diagnosis-treatment commercial solutions. In the meantime, Asieris has continued its investment in the R&D, including the expansion of its Shanghai R&D Center, to support the advancement of Asieris’ innovative drug discovery programs. Looking into the future, the company will continue to implement its R&D strategy that, identify and address unmet medical needs, create an advantageous product portfolio from disease diagnosis to treatment, and become a global leader in diagnosis and treatment of genitourinary cancers and other related diseases.
Rapid Advancement of Key Innovative Projects and Strengthened Global Coverage of Product Pipelines
In the women’s health area, Asieris’ core product APL-1702 (trade name: Cevira®), a drug-device combination photodynamic therapy product for non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL) caused by any HPV subtypes, has received regulatory approvals for its international multi-center Phase III clinical trial in China, Hungary, Ukraine, Germany, Slovakia, the Czech Republic, the Netherlands, and Poland. Patient recruitment was complete at the end of July 2022. APL-1702’s Phase III study protocol was also published in June 2022 in BMJ Open. At present, non-surgical options do not exist on the market for HSIL patients. APL-1702 could provide patients with a new option that alleviates the pain and risky side effects commonly associated with surgical treatments. APL-1702 would be especially beneficial to women of childbearing age by eliminating the adverse effects of surgical treatment on reproductive functions.
In the genitourinary (GU) disease area, Asieris independently developed the core product APL-1202 (trade name: VesiqueTM). APL-1202’s ANTICIPATE study, examining combination of oral APL-1202 with tislelizumab as a neoadjuvant therapy for muscle-invasive bladder cancer (MIBC), has completed treatment of the first dose cohort and is currently in dose escalation phase. It will enter Phase II Proof-of-Concept (PoC) stage once the recommended Phase II dose level is selected. In addition, the ANTICIPATE study was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022. APL-1202’s ACCRUE trial, examining oral APL-1202 in combination with intravesically instilled chemotherapy in relapsed intermediate- and high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients, continues to collect target events. The company will actively conduct follow-up clinical data review and NDA filing preparations as soon as the clinical endpoint event number fulfills protocol requirements. As an oral drug with a novel antitumor mechanism and the world’s first oral targeted therapy for NMIBC in the pivotal Phase III trial, APL-1202 is expected to avoid adverse events such as urethra irritation caused by intravesical administration, potentially lower the recurrence rate of NMIBC, and help patients avoid or delay radical cystectomy.
APL-1706 (trade name: Hexvix®), another core product in the GU area from Asieris Pharmaceuticals, received approval from China NMPA for a Phase III clinical trial in February 2022. It was also approved by the CDE to be included in the Real-World Data pilot program in March 2022. As the world’s only approved imaging agent indicated for the diagnosis and surgical treatment of bladder cancer, APL-1706 has been approved and launched in over 30 countries around the world. Combined with blue light cystoscopy, APL-1706 has proven to be able to effectively improve the detection rate of NMIBC (especially on carcinoma in situ), resulting in more complete resection and reduction of tumor recurrence rate.
Asieris’ First Integrated Bladder Cancer Center Launched, Demonstrating the Steady Progress of its Commercialization Strategy
Positioned as an integrated diagnosis-treatment solution in the genitourinary area, Asieris Pharmaceuticals has built and launched a comprehensive product portfolio covering bladder cancer diagnosis, treatment, and surveillance. Its Uro-3500 (electronic endoscope image processor) and Uro-G (disposable flexible cystoscope) for bladder cancer diagnosis and follow-up were first used in Hainan General Hospital in Bo’ao Lecheng in August 2022. This is the second product Asieris launched in Bo’ao, after APL-1706. The company also independently developed an online doctor service platform called “Miyihui” to integrate online disease management with offline in-person clinical diagnosis and treatment services, to provide full-range disease management to benefit more patients with innovative drug and device products and diagnosis-treatment solutions. In August 2022, the company launched its first Integrated Bladder Cancer Center (IBCC) in Hainan Province, introducing the latest technologies, products, academic and scientific research in the bladder cancer diagnosis and treatment area, and providing strong support to doctors for comprehensive disease management. The establishment of IBCC lays a solid foundation for the company to steadily advance its comprehensive disease management strategy with integrated diagnosis and treatment solutions. Asieris will continue to broaden its strategy in integrated diagnosis and treatment and gradually implement its commercialization strategy.
R&D Expansion and Improved Incentive Program
The R&D capability in Asieris Pharmaceuticals is in a period of rapid expansion, with continued increase in its core innovation and competitiveness. In the first half of 2022, Asieris’ R&D team has grown to 126 staff members, a 38% increase over the same period last year, together with an R&D expenditure totaling RMB 93 million. The company also expanded its R&D Center in Shanghai and reported steady development progress across multiple core products in the pipeline. At the end of this reporting period, the monetary funds and trading financial assets amounted to RMB 2.892 billion, a capital reserve sufficient to enable the company to move forward at a steady pace over next several years. In July 2022, Asieris also optimized its long-term incentive program through implementation of the “2022 Restricted Stock Incentive Plan (Draft)”, which aims to create more value for its stakeholders by aligning key employees’ performance with the company performance.
“Despite the pandemic and challenging international environment, we still made significant advancement in the first half of 2022, marked by our steady progress in globalization and commercialization,” summarized Dr. Kevin Pan, Founder, Chairman, and CEO of Asieris Pharmaceuticals. “Next, we will continue to adhere to our differentiated development strategy, focus on genitourinary tumors and related diseases, expand global reach of our innovation, accelerate the implementation of the integrated diagnosis-treatment commercialization strategy, and bring innovative drug-device products to benefit patients worldwide.”
Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.