On August 22, 2023 Asieris Pharmaceuticals (Stock Code: 688176.SH) – a global innovative pharmaceutical company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary (GU) tumors and other related diseases – reported its 2023 Semi-Annual Report that highlights the accelerated progress in clinical trials, aiming to address the field’s highly unmet diagnostic and therapeutic needs (Press release, Asieris Pharmaceuticals, AUG 22, 2023, View Source [SID1234634632]). Meanwhile, Asieris is establishing a specialized commercial team to enhance in-house capabilities to help achieve successful commercialization. The team is implementing a multi-product synergistic strategy to provide patient-centric solutions, bolster customer engagement and brand impact, and reduce the operational costs. Furthermore, the company continues to increase its investments in research and development to expand and strengthen its R&D capabilities and quickly advance its R&D pipeline. With an ambition to become a global leader in GU cancer patient care, Asieris will continue to drive forward science in this field, strategically differentiate its product pipeline, and accelerate the time to market for its products to generate revenue.
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Phase III Clinical Trial Achieved Positive Results – a Key Milestone for Advancing Our Specialty Pharma Strategy
In August 2023, Asieris achieved positive results from the Phase III clinical trial in China for one of its core products within the field of urological diseases: APL-1706 (Hexvix). APL-1706 is the only imaging agent approved in the United States and the European Union for the diagnosis and surgical treatment of bladder cancer. The company is on track for the submission of its market authorization applications. When used in conjunction with blue-light cystoscopy, APL-1706 has demonstrated robust effectiveness in enhancing the detection rate of Non-Muscle Invasive Bladder Cancer (NMIBC), particularly in cases involving carcinoma in situ. It leads to more comprehensive resections during surgery, thereby contributing to a reduction in the rate of tumor recurrence.
Also in August, the Department of Health under the Government of the Hong Kong Special Administrative Region granted its approval for the registration applications of the Uro-G and Uro-V disposable cystoscopic systems. Notably, the registration application of the Uro-G had been previously accepted by the National Medical Products Administration (NMPA) of China in February 2023. Furthermore, the registration application of the Uro-3500, an electronic endoscope image processor used in tandem with the Uro-G, was accepted in July 2022.
APL-1202 (Vesique), another core in-house product for urological diseases, is undergoing a registrational clinical trial in China for the treatment of recurrent intermediate- and high-risk NMIBC, in combination with intravesically-instilled chemotherapy. Patients have been closely followed up in the trial. Upon reaching the predefined target number of events, subsequent phases, including database lock, unblinding, and statistical analysis, will be promptly initiated. Concurrently, Asieris is recruiting patients in China for the Phase III clinical trial of APL-1202, which is designed to assess its efficacy as the first-line monotherapy for previously untreated patients with intermediate-risk NMIBC.
The international multi-center Phase II clinical trial, which evaluates the combination of oral APL-1202 with tislelizumab, an anti-PD-1 antibody, as a neoadjuvant therapy for Muscle-Invasive Bladder Cancer (MIBC), is currently underway in both the United States and China. This trial completed its first-patient enrollment in December 2022. The safety and efficacy data from the Phase I clinical trial were presented at the American Society for Clinical Oncology Annual Meeting in May 2023. In this trial, a total of 9 patients were enrolled, the clinical data showed oral APL-1202 in combination with tislelizumab was well tolerated, and preliminary efficacy signals were observed in 8 evaluable patients.
APL-1202, a first-in-class orally available and reversible MetAP2 inhibitor for anti-tumor treatment, is now in the pivotal Phase III clinical trials for the treatment of NMIBC. It exhibits immense potential to bridge the existing gap for bladder cancer treatment.
Asieris has built a robust portfolio, including oral therapeutic drug APL-1202 (Vesique), imaging agent APL-1706 (Hexvix), and disposable bladder endoscope APLD-2101, to address the unmet needs in bladder cancer diagnosis, treatment, and post-treatment monitoring. These products offer integrated solutions to doctors and patients worldwide. With consistent progress in portfolio development, Asieris is steadily delivering on its specialty pharma strategy.
In the realm of women’s health, Asieris has strategically positioned its core product, APL-1702 (Cevira), as an innovative combination of drug and medical device designed for photodynamic therapy to address cervical precancerous lesions. In July 2023, Asieris concluded the patient follow-up phase for this trial. The company is dedicated to advancing pathological slice reading, database lock, and data analysis, in a bid to promptly disclose the trial results. APL-1702 serves as a primary non-surgical treatment option for High-grade Squamous Intraepithelial Lesions (HSIL) caused by all HPV subtypes. This combination holds the potential to offer a novel approach, especially to reproductive-age women, enabling them to circumvent the discomfort and side effects associated with surgical treatments.
The company’s products currently in preclinical development include ASN-1733(Acinetobacter baumannii infection), ASN-1764 (triple negative breast cancer, etc.), AT-012 (Ovarian cancer, breast cancer, etc.), and AT-014 (urogenital system tumors). Among them, ASN-1733 is in the IND application preparation stage. The company is quickly advancing the R&D process for these novel drugs.
Focused on Specialty Pharma Strategy and Multi-Product Synergistic Commercialization Within Our Therapeutical Areas of Interest
In mainland China, Asieris has obtained licenses for two medications in the field of genitourinary oncology, namely Pazopanib tablets (Dipeptid) and Neratinib tablets (Ouyoubi). The company will hold both the manufacture and commercialization rights for the two drugs within the territory. These oral tablets offer convenient administration, complemented by medical insurance coverage, which significantly alleviates the financial burden on patients.
Pazopanib (Dipeptid) is a multi-targeted tyrosine kinase inhibitor (TKI) for the first-line treatment of patients with advanced renal cell carcinoma, as well as those who have previously received cytokine therapy for advanced renal cell carcinoma. The Chinese Society of Clinical Oncology (CSCO) has recommended Pazopanib monotherapy as the standard first-line treatment for advanced Renal Cell Carcinoma (aRCC) in its Guidelines for Diagnosis and Treatment of Renal Cell Carcinoma.
Neratinib (Ouyoubi) is an irreversible human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitor (TKI) for the treatment of adult patients with early-stage HER2-positive breast cancer. This medication provides enhanced adjuvant treatment following trastuzumab-based adjuvant therapy. Both the most recent updates to the Guidelines for Diagnosis and Treatment of Breast Cancer by CSCO and the Guidelines and Standards for Diagnosis and Treatment of Breast Cancer by the China Anti-Cancer Association recommend Neratinib as an enhanced postoperative adjuvant treatment option for lymph node-positive patients.
Asieris has established an efficient system for commercial activities, while stepping up efforts to bolster its commercial team and support teams to expedite the entire commercialization process. Through the successful commercialization of Dipeptid and Ouyoubi, the company aims to cultivate a highly competent commercial team while enhancing synergy across pipelines, thereby enhancing customer engagement and brand impact, and driving down overall commercialization-related costs. By gaining more on-the-ground experience, the company is forging a dynamic, results-driven team, fully equipped to bring core in-house products to market and ultimately provide greater benefits to patients battling these cancers.
The company has also upgraded and launched the Hongyihui platform for online management. This strategic move is geared towards deepening the integration of diagnostic and treatment strategies in genitourinary oncology, while providing an array of superior, integrated solutions for medical professionals. The Hongyihui platform offers precise resource allocation, custom-tailored to individual products, effectively minimizing resource wastage, reducing costs, and enhancing overall efficiency. This platform is pivotal in achieving the company’s marketing objectives, as it bridges the gap between online and offline activities, thereby empowering commercial team to engage in precise interactions with doctors. This engagement occurs through a judicious blend of virtual and in-person interactions, all underpinned by evidence-based medicine principles.
Furthermore, the company will harness the full potential of the digital marketing platform to foster synergistic promotion across pipelines. Additionally, it is committed to validating and reinforcing its market positioning strategy within the field of GU oncology. The company will continue to enrich its marketing expertise to enhance commercialization capabilities.
Continued Increase in R&D Investment to Solidify Our Core Competitiveness
Asieris has been increasing its commitment to research and development, bolstering its core capacity for innovation and competitiveness. In the first half of 2023, investment in R&D amounted to RMB 177 million, representing growth of 90.12% compared with the same period last year. Moreover, the roster of R&D personnel has grown to 183, marking an increase of 45.24% year on year. As of the end of this reporting period, the company had approximately RMB 2.373 billion in cash and cash equivalents, ensuring ample financial resources to sustain its consistent growth and development.
"I am delighted to witness the initial triumph of our steadfast specialty pharma strategy," said Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals. "Our Phase III clinical trials have delivered inaugural positive results, and we are advancing commercialization through synergistic portfolio. This underscores our unwavering commitment to expediting commercialization. Looking ahead, we will continue to concentrate on clinical development and commercialization of our specialized pipelines. By doing so, we will not only fortify our innovation prowess but also forge ahead towards an expanded global presence, furthering our mission to alleviate the suffering of patients both in China and worldwide."