Steady Progress in Commercialization, APL-1702 Submits NDA in China
www.eastmoney.com
August 30, 2024
Southwest Securities
Du Xiangyang, Tang Taimeng
nvestment Highlights
Event: The company released its 2024 semi-annual report, achieving operating revenue of 80.49 million RMB and R&D investment of 150 million RMB during the reporting period. The growth in operating revenue is attributed to the steady progress in the commercialization of Pazopanib tablets (brand name: Dipate) and Neratinib Maleate tablets (brand name: Ouyoubi?) during the reporting period.
APL-1702 Submits NDA in China, Actively Seeking Overseas Collaboration Opportunities.
APL-1702 (Xivita) is a photodynamic therapy product that combines both drug and device components. The international multicenter Phase III clinical trial of APL-1702 was successful, with the response rate in the APL-1702 treatment group increasing by 89.4% compared to the placebo control group (41.1% vs. 21.7%, p=0.0001), demonstrating significant efficacy. The NDA submission for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024. The company plans to submit a pre-submission communication application to the European Medicines Agency (EMA) in the fourth quarter of 2024, and aims to engage with the U.S. FDA on the design of the registration clinical trial protocol for the North American market, with the goal of submitting an application to conduct a Phase III registration clinical study in North America in due course.
APL-1202 in Combination with Tislelizumab for Neoadjuvant Treatment of MIBC Expected to Read Out Phase II Data in September.
APL-1202 is a first-in-class oral, reversible MetAP2 inhibitor that has entered Phase III clinical development. The interim analysis of the Phase II clinical trial for the combination of APL-1202 and Tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC) showed positive results, with a significant increase in the pCR rate compared to the Tislelizumab monotherapy group. The data from the Phase II trial for the APL-1202 and Tislelizumab combination is expected to be read out in September 2024.
Marketing Team and System Maturing, Strong Sales Growth.
The company has introduced Pazopanib tablets and Neratinib Maleate tablets, both of which are oral medications that are convenient to take and have been included in the medical insurance reimbursement list, focusing on urogenital disorders and breast cancer. The company continues to refine its marketing plan for APL-1706, actively exploring outpatient examination scenarios and third-party strategic partnerships, in addition to the existing surgical treatment scenarios, to further expand the commercial opportunities for APL-1706 and benefit more patients. The company is gradually planning and implementing post-marketing access, pricing, expert support, clinical cooperation, and distributor system development.
Earnings Forecast:
With the commercialization of APL-1702, APL-1706, and generic drugs, we expect the companyâs revenue for 2024-2026 to be 200 million, 370 million, and 620 million RMB, respectively.
Potensielt inntekter pÄ 500 millioner til 1 milliard kr om 1-2 Är.