On May 26, ABBISKO-B (02256) officially announced that Ipagotini (ABSK011) has been included as a breakthrough therapy, intended for the treatment of patients with advanced hepatocellular carcinoma who have previously failed treatment with immune checkpoint inhibitors (ICIs) and multi-targeted tyrosine kinase inhibitors (mTKIs) and have FGF19 overexpression.
This is the second major product from ABBISKO to be included as a breakthrough therapy, following Pimicotinib (ABSK021).
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As the world's first small molecule inhibitor targeting the aberrant activation of the FGF19/FGFR4 signaling pathway, ABSK-011 has garnered significant attention from the global industry and market since its debut at the 2023 ESMO annual meeting, thanks to its remarkable efficacy and advantages in compliance and cost-effectiveness compared to other FGFR4-targeted drugs. The successful inclusion of ABSK-011 as a breakthrough therapy in China further increases the certainty of it becoming a &#34;billion-dollar molecule&#34; and highlights its potential heavyweight business development (BD) value.
Recently, a significant &#34;going abroad&#34; deal worth up to $6.05 billion between 3SBio and Pfizer has ignited interest in the Hong Kong stock market's innovative drug sector, drawing global industry and market attention to Chinese domestic innovative drugs and prompting investors to seek the next rare target with heavyweight BD capabilities. With two major breakthrough therapy designation (BTD) products in hand, ABBISKO undoubtedly deserves high attention.
<h2>Increased Certainty of &#34;Billion-Dollar Molecule&#34;</h2>
In recent years, ABBISKO has focused on precision oncology and immunotherapy, covering popular targets such as EGFR, FGFR, CSF-1R, and PMRT5, and has established 19 globally competitive differentiated innovative R&amp;D pipelines, several of which have &#34;best-in-class&#34; or &#34;first-in-class&#34; potential. Ipagotini (ABSK011), which is expected to become a global FGFR4 inhibitor and a first-in-class (FIC) drug, is undoubtedly among the best.
According to Zhito Finance APP, the company released the latest Phase I clinical data on the safety and efficacy of Ipagotini for treating previously treated aHCC patients at last year's ESMO annual meeting. The data showed that the 220mg BID group of Ipagotini demonstrated excellent efficacy in patients with FGF19 overexpressing hepatocellular carcinoma who had undergone treatment with ICIs and mTKIs, achieving an overall response rate (ORR) of 44.8%, a median duration of response (mDOR) of 7.4 months, and a median progression-free survival (mPFS) of 5.5 months, significantly surpassing currently marketed and other investigational therapies.
At the 2024 ESMO GI in June last year, the company reported that the 220mg BID of this product combined with Atezolizumab achieved a 50% ORR in treating 1/2L patients, once again breaking the record for investigational new drugs targeting treated hepatocellular carcinoma
It is particularly noteworthy that in the patient population previously treated with immune checkpoint inhibitors (ICIs), the efficacy of HeYu's combination therapy is also significant and has good safety, fully demonstrating that targeting the FGF19-FGFR4 novel mechanism may provide urgently needed differentiated treatment options for liver cancer, further enhancing the certainty of Ipagufin combined with PD-L1 as a first-line treatment.
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The market's sustained high attention to ABSK011 after the disclosure of the above clinical data is due to the fact that the FGFR4 target has caused several multinational pharmaceutical companies to fail. For example, Novartis's early candidate drug was discontinued due to severe skeletal toxicity, and Blueprint's BLU-554 was also paused in clinical trials due to efficacy not meeting expectations. In the high-threshold research and development environment, there are currently no FGFR4 inhibitors approved for marketing globally.
HeYu Pharmaceuticals' ability to rise to prominence is key to its innovative breakthroughs in molecular design. It is reported that HeYu's research and development team screened high-selectivity compounds through thousands of experiments, successfully avoiding the side effects caused by off-target FGFR1/2/3. Therefore, Ipagufin, with its leading position in the competitive landscape, has achieved a &#34;curve overtaking&#34; and is expected to become the first breakthrough drug for treating patients with FGF19 overexpressing HCC.
From a market perspective, GlobalData predicts that 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. Referring to the previously launched small molecule kinase inhibitor Sorafenib, its objective response rate (ORR) for liver cancer indications is less than 20%, yet its global sales still exceeded $500 million in 2021, reflecting the enormous unmet treatment needs in the current market.
In December last year, the CDE approved the company to conduct registration clinical research for Ipagufin (ABSK011) in HCC patients. Less than six months later, ABSK011 was included in the CDE's breakthrough varieties, indicating that the innovative value of Ipagufin has been highly recognized by domestic authoritative institutions, and it is expected to reverse its position as a Global FIC/BIC based on excellent efficacy and safety, thus achieving a higher sales ceiling in domestic and international markets, with the certainty of becoming a &#34;billion-dollar molecule&#34; further increasing.
<h2>Innovative Value Continues to Be Explored by the Market</h2>
In the current environment that encourages and supports &#34;original innovative drugs,&#34; &#34;true innovation&#34; is undoubtedly one of the important indicators for measuring the differentiated innovation capabilities of domestic innovative pharmaceutical companies.
The breakthrough therapy designation (BTD) is an important indicator for testing the true innovative power of a new drug. According to Zhitong Finance APP, BTD was initially introduced by the CDE in 2020, focusing on two points: to accelerate the landing of new drugs for diseases that are life-threatening or severely affect the quality of life; and for indications that have no effective treatment methods or drugs, the new drug must provide sufficient evidence of its clinical advantages compared to current treatment methods
In short, for a new drug to obtain breakthrough therapy designation, it must possess significant innovative attributes and reliable clinical value.
In recent years, domestic companies have gradually replaced multinational pharmaceutical companies (MNCs) as the new main players in CDE breakthrough therapies, greatly boosting confidence in local innovation within the industry. However, data from recent years shows that approvals for breakthrough therapies have mainly concentrated on large domestic Biopharma companies, with few heavyweight products from Biotech companies receiving continuous approvals.
Taking 2024 as an example, the CDE has granted breakthrough therapy designation to a total of 91 drugs (based on the acceptance number on the announcement date) in 2024, an increase of 32% compared to 2023. Among the top 30 companies by the number of acceptance numbers, 19 are domestic innovative drug companies, which collectively received 52 acceptance numbers, accounting for 57.14%. Among these 19 domestic innovative drug companies, there are fewer than 5 Biotech companies that possess two or more breakthrough therapy drugs.
This indirectly confirms that HeYu, holding two BTD heavyweight products, Pimiatinib and Ipatasertib, has significant innovative value and corporate investment value.
It is worth mentioning that, unlike most unprofitable Biotech companies, HeYu achieved full-year profitability for the first time in 2024, generating substantial cash flow and conveying expectations for sustainable and scalable profitability through its 2024 annual report. After years of high R&amp;D investment, HeYu's innovative pipeline includes several high-quality candidates in early clinical and preclinical stages; in terms of core products, the clinical progress of key pipelines such as Pimiatinib, Ipatasertib, and ABSK043 is steadily advancing, and they are about to enter a period of commercial value realization.
Based on the recognition of its &#34;innovation-profit&#34; positive cycle value, HeYu's management has continuously conducted share buybacks in recent years, using &#34;real money&#34; to reward investors while expressing strong confidence in the company's future development. On March 3 of this year, HeYu's board of directors approved the use of HKD 200 million to repurchase shares in the market.
According to data from Zhito Finance APP, from the beginning of this year to date, HeYu's management has conducted a total of 28 buybacks, with the number of shares repurchased reaching 7.895 million, and the total amount reaching HKD 59.3268 million.
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In the secondary market, although HeYu's stock price has recently experienced some fluctuations due to the impact of the Hang Seng Index, it has shown a continuous rebound after hitting a low on April 9. On May 23, the stock price reached a high of HKD 8.95 during intraday trading, with a maximum cumulative increase of 62.14% over the past one and a half months.
The rapid rebound and sustained rise in stock price indicate that HeYu is undergoing a strong valuation repair process, and also reflect the market's preference for fundamentally stable and improving value targets with higher valuation ceilings. As the valuation repair trend in the pharmaceutical sector gradually unfolds, HeYu is expected to become an important asset allocation target for investors in the future

02256

ABBISKO-B announced that its Ipagotene (ABSK011) has been included as a breakthrough therapy for patients with advanced hepatocellular carcinoma with FGF19 overexpression. This is its second drug to receive this certification, marking an increased potential to become a "billion-dollar molecule." ABSK-011 has garnered global attention due to its significant efficacy and economic advantages. ABBISKO focuses on precision oncology and has established 19 innovative research and development pipelines, with the expectation of launching multiple globally competitive drugs in the future

The second "billion-dollar molecule" has received BTD certification, and the value of the "true innovation" configuration of ABBISKO-B is highlighted