On April 17, 2024 Asieris Pharmaceuticals reported its 2023 Annual Report, revealing impressive outcomes achieved through its specialty pharma strategy, which has facilitated rapid progress in clinical development, early research, and commercialization (Press release, Asieris Pharmaceuticals, APR 17, 2024, https://www.prnewswire.com/news-releases/asieris-pharmaceuticals-unveils-2023-annual-report-core-product-apl-1702-succeeds-in-global-phase-iii-clinical-trials-apl-1706-obtains-nda-acceptance-domestically-specialty-commercial-team-generates-sustained-revenue-streams-302119669.html [SID1234642143]). Asieris boasts a robust pipeline now consisting of 13 products and 16 ongoing research projects. By the end of 2023, cash and cash equivalents along with financial assets held for trading totaled approximately RMB 2.333 billion, ensuring ample capital reserves for sustainable growth.
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Multiple Assets Achieved Clinical Milestones, Paving Way for New Products Launch
In September 2023, APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), met its primary endpoint in the international multi-center phase III clinical trial. Results showed that the APL-1702 treatment group had a significantly higher response rate on the primary efficacy endpoint, with a response rate 89.4% higher than the placebo group (41.1% vs. 21.7%, p = 0.0001). Additionally, APL-1702 demonstrated a 103.9% improvement in the clearance rate of high-risk HPV16 and/or HPV18 compared to controls (31.4% vs. 15.4%). APL-1702 also showed low incidence of treatment-emergent adverse events. These findings were featured in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting.
APL-1702 is a first-in-class, non-surgical treatment for cervical HSIL with its efficacy proven in an international phase III trial. It heralds a potential paradigm shift in the treatment of precancerous cervical lesions, with the clinical focus moving from excision to long-term disease management. Emphasis lies in optimizing the delicate balance between treatment risks and benefits, striving to minimize or delay invasive procedures while effectively reversing the progression of the disease.
The company is gearing up to submit a market approval application for APL-1702 to China’s National Medical Products Administration (NMPA), with acceptance anticipated in the second quarter of 2024.
Looking ahead, the company plans to facilitate localized production and initiate development of a second-generation product for APL-1702. It also intends to submit a pre-NDA communication application to the European Medicines Agency (EMA) in the third quarter of 2024. Additionally, the company expects to be in discussions with the US FDA in second half of 2024 to align with the agency on the registration requirements in the US. It is also actively exploring opportunities for overseas development partnership for APL-1702.
In August 2023, the multi-center phase III clinical trial of APL-1706, an imaging drug used for the diagnosis or surgery of bladder cancer, met its primary endpoint. The study confirmed that, in Chinese patients, APL-1706, in combination with blue light cystoscopy (BLC), outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability. The company presented the phase III clinical data and real-world research findings at several international conferences, including the 2023 Congress of the Société Internationale d’Urologie (SIU) and the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU).
APL-1706 is the only imaging agent approved worldwide for the diagnosis and surgical treatment of bladder cancer. APL-1706, in combination with BLC for managing non-muscle invasive bladder cancer (NMIBC), has been endorsed in the global expert consensus as well as in the Chinese guidelines for urological and andrological diseases. While not yet available in China, a market approval application for APL-1706 was accepted by the NMPA in November 2023. The company is progressing through the review process and anticipates an NMPA approval by June 2025.
Although a pivotal trial of APL-1202 plus intravesical chemotherapy for the treatment of NMIBC failed to meet the primary endpoint on efficacy in early 2024, the combination of APL-1202 and tislelizumab, an immune checkpoint inhibitor, as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) demonstrated positive results in the interim analysis of the phase II trial in September 2023. The study showed a significant improvement in pathologic complete response rate among patients who received APL-1202 plus tislelizumab compared with those who received tislelizumab alone (39% vs. 21%). The safety profile in the combination arm was deemed acceptable. These results were selected for a rapid oral abstract presentation at the 2024 ASCO (Free ASCO Whitepaper) GU.
The interim analysis results indicate that APL-1202 significantly enhances the histological response rate of tislelizumab. Based on this, the company plans to conduct clinical studies of APL-1202 in combination with immune checkpoint inhibitors in the population of Chinese patients who have failed platinum-based chemotherapy for bladder cancer. The company intends to promptly communicate with the National Medical Products Administration’s Center for Drug Evaluation (CDE) and submit an application for clinical trials. Furthermore, the company plans to initiate clinical studies of its second-generation compound, APL-1501, in combination with immune checkpoint inhibitors for the treatment of non-muscle invasive bladder cancer with BCG-unresponsive carcinoma in situ (CIS), either with or without papillary tumors, in the United States. The company also aims to engage in communication and regulatory discussions with the FDA regarding the registration clinical development plan in 2024.
Additionally, it is actively pursuing overseas development and collaboration opportunities for APL-1202 and APL-1501, aiming to lower overseas development costs and boost cash flow through out-licensing.
Enhancing Early Research Technology Platforms in Areas of Focus, Generating a Steady Flow of Drug Candidates
Along with advances in clinical development, the company’s early research platform has undergone a process strengthening three core pillars: Targeted Immunomodulator Normalization (TIMN), Targeted & AI-driven Drug Discovery (TAIDD), and Drug Device Combination (DDC). Concurrently, it is actively exploring innovative technologies such as antibody drug conjugate (ADC) and in situ orthotopic bladder cancer (IOBC) model, while consistently generating new drug candidates.
Utilizing the TAIDD platform, APL-2302 (for ovarian and breast cancer), AT-014 (for urinary system tumors), AT-017 (for breast cancer), and AT-018 (for ovarian and breast cancer) have been successfully discovered. Utilizing the DDC platform, APLD-2304 (for NMIBC diagnosis and surgery) has been developed, along with preclinical products such as AT-020 (for various solid tumors) and AT-021 (for breast cancer and other solid tumors) that are based on ADC technology.
In 2023, the company invested approximately RMB 365 million in R&D, representing a 49.49% increase from the previous year. It employeed 198 R&D staff members, marking a 12.50% year-over-year increase.
Specialty Commercial Team Bolstered Capabilities to Drive Revenue Growth
Asieris also continued to strengthen the capabilities of its commercial team for generating sustained revenue streams. During the reporting period, the company achieved an operating revenue of RMB 13.7533 million, which represents an increase of RMB 13.7272 million compared to the same period last year. This revenue primarily stemmed from product sales and fees generated from data out-licensing.
The company has established dedicated business units for oncology and for women’s health to drive commercialization in the targeted areas. The oncology unit has obtained licenses of Neratinib tablets (Ouyoubi) for intensive adjuvant treatment of early breast cancer and Pazopanib tablets (Dipeptid) for the treatment of advanced renal cell carcinoma. The company also promptly assembled a robust commercial team following the introduction of these two products, Dipeptid and Ouyoubi were commercially launched in October and December 2023, respectively, achieving sales revenue of RMB 9.2892 million by the end of 2023.
As of now, the oncology unit has established a sound framework and is well positioned for substantial sales growth of Dipeptid and Ouyoubi in 2024. It targets sales revenue exceeding RMB 100 million and is set to achieve internal breakeven for the entire business unit, aiming to position the company as an industry leader in commercialization capabilities and operational efficiency.
Simultaneously, a women’s health business unit was swiftly established following the success of the international phase III trial for APL-1702 in treating HSIL. This unit will focus on commercializing APL-1702 in the Chinese market and expanding the company’s pipeline in women’s health, with the goal of addressing the unmet clinical needs of female patients.
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, said, "The company has maintained a steadfast focus on addressing underserved needs in genitourinary tumors and related diseases, particularly in the specialized areas of early-stage bladder cancer and precancerous cervical lesions. Through our specialty R&D strategy and leveraging our three major technology platforms alongside unique innovations, we’ve generated a suite of highly differentiated drug candidates in 2023. While the clinical trial of APL-1202 in combination with chemotherapy didn’t meet expectations, our overall portfolio has achieved significant milestones in clinical development. Notably, the successful phase III trial of APL-1702 signifies the potential to revolutionize the landscape with the non-surgical treatment for precancerous cervical lesions. We’ve also built up a robust specialty commercial team to generate sustainable revenue streams. Looking ahead, we will step up efforts to strengthen our specialty pipeline and commercial capabilities in diagnosis and treatment realms. We’ll actively pursue international development and collaboration opportunities and aim to create substantial value for both communities and shareholders."