Once again, ABBISKO-B (02256)FIC/BIC variety BD continues to unleash its potential with the receipt of an additional $85 million in exercise fees from Merck.

date
02/04/2025
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GMT Eight
In 2024, the reason why ABBISKO-B (02256) was able to achieve annual profitability for the first time was partly due to a "high upfront payment, high milestone, high profit-sharing" BD deal with the well-known multinational pharmaceutical company Merck for its core product Pimicotinib (ABSK021), resulting in a $70 million upfront payment. On April 1st of this year, it was announced again that Merck had exercised the global commercialization option for Pimicotinib (ABSK021) according to the licensing agreement signed by both parties in December 2023, with an exercise fee of $85 million. This shows Merck's sincerity in the cooperation and positive attitude towards the global commercialization market of Pimicotinib. It is understood that relying on its strong innovation capabilities and BD transactions, in 2024, ABBISKO successfully achieved innovative revenue and turned losses into profits, generating abundant cash flow, and conveying sustainable and scalable profit expectations through its annual performance report. In addition to the exercise payment made by Merck, the BD cooperation between the two parties has brought over $150 million in cash to ABBISKO. According to the agreement, ABBISKO will also receive research milestone payments and sales milestone payments from Merck in the future, with a potential total payment of up to $606 million, not including double-digit net sales royalties. This undoubtedly provides the company with substantial financial security, shortens the development cycle, and paves the way for the smooth landing of multiple FIC/BIC blockbuster varieties in ABBISKO's future innovative R&D pipeline. Entering the next stage of development in a strong alliance The "highlight" of the cooperation between ABBISKO and Merck this time is undoubtedly the global development and commercialization of Pimicotinib. As the first Chinese independently developed CSF-1R inhibitor to enter global Phase III TGCT clinical trials, Pimicotinib has been recognized as a breakthrough therapy by regulatory agencies in China, the United States, and Europe. As a global potential BIC drug in the CSF-1R inhibitor field, Pimicotinib not only shows outstanding performance in TGCT indications but also has greater potential in various indications such as cGVHD. Merck's main reason for selecting Pimicotinib is the outstanding potential of this "billion-dollar molecule," indicating continuously un... According to GlobalData's prediction, by 2029, the global liver cancer market will be approximately $5.3 billion, with immunotherapy accounting for about 72.2% of the market share, reaching $3.8 billion. With reference to the previously launched small molecule kinase inhibitor sorafenib, its objective response rate (ORR) for liver cancer is less than 20%. Despite this, its global sales still exceeded $500 million in 2021, reflecting the significant unmet treatment needs in the current market.Compared with other FGFR4 targeted drugs, depagotinib has more compliance and economic advantages, and is expected to achieve higher sales ceiling in domestic and international markets with its strong BIC attributes, further increasing the certainty of becoming a "billion-dollar molecule" and possessing potential blockbuster BD value. As mentioned earlier, many of the innovative drugs under research at Heyu have FIC/BIC potential, indicating the continuous expansion of the company's variety queue with huge BD potential. On March 28th, Heyu announced that it will bring four research results to this year's AACR Annual Meeting, including PRMT5*MTA inhibitors and pan-KRAS inhibitors, which are worth noting for their huge BD potential. Taking the PRMT5*MTA inhibitor ABSK131 as an example, in recent years, the development of synthetic lethal targets has triggered a frenzy of research and development worldwide. Many multinational companies have laid out PRMT5 targets, but the development of first-generation products has not been smooth due to compound defects and significant toxic side effects. Among the new generation of PRMT5 target drugs developed worldwide, ABSK131 has strong BIC potential. Previous preclinical studies have shown that ABSK131 has good pharmacokinetic properties when taken orally and it has the ability to pass through the blood-brain barrier. In terms of progress, in December last year and March this year, Heyu's IND application for ABSK131 was successively approved by the FDA in the United States and the CDE in China, and has been recognized by global authoritative institutions. Currently, only PARP inhibitors have received approval for marketing in the field of synthetic lethal targets, but there has been a blockbuster bombshell with AstraZeneca's Lynparza exceeding $2.5 billion in sales, and recently, Bayer announced the introduction of Puhe Medicine's PRMT5 inhibitor, demonstrating the potential market and BD value of synthetic lethal targets. In addition to PRMT5*MTA inhibitors, the pan-KRAS inhibitors revealed by Heyu at this AACR meeting are also worth noting. As one of the hot cancer targets in recent years following PD-1, the pan-KRAS target has attracted international attention for its broad market prospects. Previously, Revolution supported a market value of over $7 billion with phase 2 data from pan-KRAS RMC-6236. Currently, Heyu not only has a forward-looking layout of pan-KRAS inhibitors, but also a layout in the direction of KRAS inhibitor resistance. Its innovative research and development of KRASG12D small molecule inhibitors also have the potential for significant BD transactions. In summary, all of the above reflect the certainty of Heyu in global commercialization and differentiation of original research and innovation. With further endorsement from Merck, the company is expected to boost its stock price continuously with multiple potential FIC/BIC products in its pipeline, significantly shortening the capital cycle of investors, enhancing their investment willingness and confidence, and laying a solid foundation for continued long-term holding of Heyu.

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