Blue Whale Finance Tu Jun.
On the evening of February 4, Yahong Pharmaceutical (688176SH) announced the progress of a pivotal clinical trial of its core product APL-1202 in combination with chemoperfusion in intermediate- and high-risk non-muscle-invasive bladder cancer.
According to the announcement, the results of statistical analysis showed that although the study showed a certain trend of superiority in some patient populations, the study did not meet the primary study endpoint, and Yahong Pharma decided to terminate the further development of APL-1202 in combination with chemotherapy perfusion in this indication.
According to the information on the official website of Yahong Pharmaceutical, APL-1202 (trade name Weishike) and APL-1702 (Xiveta) are the two most important and fastest-growing products in Yahong Pharmaceutical's current pipeline.
Will the failure of the trial of APL-1202 in combination with chemotherapy affect the pace of marketing of APL-1202?
In this regard, Dr. Pan Ke, founder, chairman and CEO of Yahong Pharmaceutical, pointed out at the ** communication meeting held on the evening of February 4 that the above trial did not meet the primary endpoint of the study, which does not mean that the APL-1202 study is terminated. At the beginning of the R&D of APL-1202, Yahong Pharma has laid out three R&D directions, including combination with chemotherapy, single agent versus chemotherapy, and combination with immunology drugs.
In addition to the above clinical trials, Yahong Pharma is also conducting two other clinical trials of APL-1202. The previously announced phase 1 clinical trial of APL-1202 oral in combination with the PD-1 immunosuppressant tislelizumab as a neoadjuvant for muscle-invasive bladder cancer (MIBC) has completed the enrollment of all subjects, and the topline data is expected to be read out in the third quarter of 2024. Pan Ke introduced.
Pan Ke said that although the combination of APL-1202 and chemotherapy did not meet the primary endpoint and delayed the marketing of the drug to a certain extent, Yahong Pharma has established a complete anti-tumor drug commercialization system and team, and its current operating income is mainly for two imported products, pazopanib tablets (trade name: Dipate) and neratinib maleate tablets (trade name: Oyubi), in order to further recoup funds for the company.
Bladder cancer is the 10th most common cancer worldwide, with muscle-invasive bladder cancer (MIBC) accounting for about 20% of newly diagnosed cases. According to public information, the recommended regimen for MIBC is cystectomy (RC) with bilateral pelvic lymph node dissection, and adjuvant chemotherapy (NAC) will be administered before RC is administered for patients who are eligible to receive cisplatin. However, about half of the patients were unable to receive cisplatin due to contraindications**, and some patients refused chemotherapy. At present, there are many challenges that need to be solved urgently for MIBC.
APL-1202 (trade name Weishike) is an orally administered reversible metap2 inhibitor with anti-angiogenic and anti-tumor activities and modulation of the tumor immune microenvironment. This product is expected to fill the gap of oral targeted drugs in the field of bladder cancer**.
The current trial results show that APL-1202 with tislelizumab in combination with neoadjuvant ** muscle-invasive bladder cancer has good potential, and this combination is expected to provide a ** regimen for MIBC patients who are cisplatin-intolerant or refuse to receive cisplatin**.
According to the announcement, as of December 31, 2023, the cumulative investment in the pivotal clinical trial of APL-1202 in combination with chemoperfusion and the use of **chemoperfusion** in medium- and high-risk NMIBC has exceeded 1200 million. In accordance with the relevant accounting standards and the company's accounting policies, the above-mentioned R&D expenses have been included in the profit or loss of the corresponding accounting period when they are incurred, and will not have a significant impact on the company's current performance.
In addition to APL-1202, it is reported that the international multi-center phase III clinical trial of APL-1702, another important product of Yahong Pharmaceutical, for the treatment of **cervical high-grade squamous intraepithelial lesions (HSIL) reached the primary endpoint in September 2023 and is expected to submit a new drug application in the second quarter of 2024.
It is worth mentioning that APL-1702 is expected to be the world's first non-surgical** cervical HSIL product with confirmed efficacy.
We are confident that the peak sales of APL-1702 will exceed 1 billion in the future, and as a specialized innovative drug company focusing on genitourinary tumors and women's health, a number of products in the core product development of Yahong Pharma have completed clinical trials, have achieved marketing application acceptance or are about to apply for marketing, and are about to enter the harvest period. Pan Ke said.