In recent years, the U.Sstock market has emerged as a prime destination for numerous domestic enterprises seeking to go public, especially among innovative biopharmaceutical companiesLeading examples include BeiGene (BGNE.US), Legend Biotech (LEGN.US), and Zai Lab (ZLAB.US). As of December 23, 2024, news has surfaced regarding Ascentage Pharma's intent to offer up to approximately 33.74 million shares of common stock on the NASDAQ, marking yet another pivotal move in the capital markets landscape.

This announcement had a significant impact, with Ascentage Pharma's stock price surging by 4.16% on December 24, reflecting an impressive year-to-date increase of over 65%. Such performance underscores the growing investor confidence in the company, fueled by its innovative drug pipeline and commercial accomplishments.

Founded in 2009, Ascentage Pharma is a comprehensive global biopharmaceutical company dedicated to discovering, developing, and commercializing novel therapies aiming to address unmet medical needs in hematologic malignancies

Its primary asset, olverembatinib (brand name: Nilotinib), represents a groundbreaking third-generation tyrosine kinase inhibitor (TKI) targeting the BCR-ABL1 pathwayParticularly notable is its approval in China as the first and only third-generation BCR-ABL inhibitor for chronic myeloid leukemia (CML) patients with the T315I mutation.

As of June 2024, the company established significant collaborations to further its market reachNotably, it partnered with Innovent Biologics for domestic commercialization of Nilotinib in 2021. The following year, Ascentage Pharma inked an agreement with Takeda Pharmaceuticals to explore international markets, enhancing the drug's global footprintFurthermore, by November 2024, Nilotinib had been added to the updated National Medical Insurance Drug List in China, a vital step that could accelerate its sales.

Another promising candidate in Ascentage's portfolio is the BCL-2 inhibitor, APG-2575. The drug is currently undergoing review for market approval in China as of November 2024 and is positioned to become the second BCL-2 inhibitor globally to gain regulatory approval

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This drug is being studied for various indications, including first-line treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).

Beyond these key products, Ascentage Pharma is also focusing on agents that leverage apoptosis pathways, including APG-115, a small molecule MDM2-p53 inhibitor, and APG-1252, which targets both BCL-2 and BCL-xL proteinsCurrently, both compounds are progressing through phase 1b/2 clinical trials, reflecting the company’s commitment to expanding its therapeutic options.

As Ascentage Pharma works toward profitability, the company recently reported a turnaround in performanceUp until 2024, it had consistently posted losses, but a remarkable leap in revenue has changed this narrativeIn the first half of 2024, the company’s revenue skyrocketed by 477.25%, reaching approximately 824 million yuan (RMB), with significant contributions derived from intellectual property revenues alongside product sales.

The surge in sales for Nilotinib accounted for approximately 113 million RMB, marking a 120% quarter-over-quarter increase

This positive trend is attributed to Ascentage's strategic establishment of a sales team of around 100 members to drive Nilotinib's domestic promotional effortsCollaborations with innovent Biologics have also enabled the company to enhance its presence in hospitals and specialty pharmacies across China.

One of the most significant elements contributing to its recent profitability lies in intellectual property revenue, which registered at 678 million RMBIn June 2024, Ascentage Pharma signed an exclusive agreement with Takeda regarding global rights to Nilotinib outside of China and selected regions, which resulted in the immediate receipt of a $100 million upfront paymentThis deal positioned Ascentage to potentially earn up to $1.2 billion in milestone payments and a double-digit royalty based on annual sales.

Furthermore, Takeda's investment of $75 million for a 7.73% equity stake in Ascentage Pharma deepens the partnership, fortifying the companies' alliances

As of mid-2024, Ascentage reported a robust cash balance of 1.1 billion RMB, providing a strong financial cushion for its operations and future projects.

Looking ahead, the prospects for Ascentage Pharma appear promising, particularly with the market-readiness of Nilotinib and the anticipated launch of APG-2575. Chronic myeloid leukemia, which accounts for 15% of adult leukemia cases globally, has a projected annual incidence rate of 1.6 to 2 per 100,000. In China, the incidence rate ranges from 0.39 to 0.55 per 100,000, highlighting a substantial market potential for effective therapies like Nilotinib.

According to recent reports from Ping An Securities, the approval of Nilotinib in November 2021 for T315I mutation-resistant CML was just the beginningUpcoming indications for its efficacy in both Ph+ ALL and gastrointestinal stromal tumors (GIST) are anticipated, with potential approvals projected for 2027 and 2029 respectively

The market potential is further amplified by forecasts suggesting that Nilotinib’s domestic sales could reach 1.03 billion RMB by 2033.

As for APG-2575, it is set to be pivotal as wellThe drug has demonstrated significant efficacy in treating CLL/SLL, and with five pivotal clinical trials underway, hopes are high for its approval and commercialization in the domestic market by 2025. In foreign markets, after receiving FDA approval in August 2023 for registration trials, it is projected that APG-2575 will be available for broader patient populations by 2027, with potential sales exceeding 5.84 billion RMB by 2033.

In conclusion, Ascentage Pharma's landscape is rapidly evolving, particularly as it pivots towards heightened revenues and budding profitability driven by its innovative drug pipelineThe impending US listing could serve as a vital means to enhance liquidity and bolster its international market presence