In recent years, leveraging its strong new drug research and development capabilities, comprehensive global clinical development capabilities, high-standard quality management system, and deepening international cooperation, HeYu-B (02256) has made significant strides on the path of &#34;source innovation.&#34;
In this process, HeYu has continuously strengthened and consolidated its leadership in small molecule platforms and pipelines, forming a full-cycle team layout from preclinical to registration clinical stages, and establishing various potential best-in-class or first-in-class assets and combinations. The company currently has 22 drugs under research, with more than 10 drugs having entered the clinical development stage. Today, these achievements were showcased at the company's R&amp;D Day event held on October 30.
According to the Zhitong Finance APP, this R&amp;D Day event, themed &#34;HeLi JuMeng, Yu Chuang WeiLai,&#34; gathered representatives from dozens of domestic and international investment institutions, clinical experts, and media personnel, who discussed the company's innovative R&amp;D layout and clinical progress with the management and R&amp;D team of HeYu Pharmaceuticals.
During the event, relevant leaders, including founder and CEO Xu Yaochang, Chief Medical Officer Ji Jing, co-founder and Chief Scientific Officer Yu Hongping, Executive Director of Biology Ying Haiyan, and Executive Director of Pharmaceutical Chemistry Deng Haibing, disclosed the latest R&amp;D progress of the overall innovative pipeline, including the core product Pimitinib. They particularly highlighted the small molecule FGFR4 inhibitor Ipagotini (ABSK-011) with significant clinical potential, as well as other heavyweight research products like ABSK-43 and ABSK-61, and shared the company's innovative explorations in non-tumor fields such as autoimmune diseases.
This not only reflects HeYu's consistent &#34;depth + breadth&#34; dual-driven strategy but also demonstrates the company's strong endogenous growth power centered on global innovation.
<h2>Continuously Exploring the Development Potential of &#34;Billion-Dollar Molecules&#34;</h2>
Xu Yaochang, founder and CEO of HeYu Pharmaceuticals, stated in his opening speech at the R&amp;D Day event, &#34;HeYu is committed to developing differentiated innovative therapies in the fields of oncology and other diseases to meet the critical clinical needs of patients in China and globally that remain unmet. To achieve this goal, the company places R&amp;D at the strategic core, viewing it as the core engine driving future growth and achieving sustainable returns, and continues to increase R&amp;D investment.&#34;
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Currently, the key vehicle for continuously releasing the company's innovative value is its core product Pimitinib.
According to the Zhitong Finance APP, as the first CSF-1R inhibitor independently developed in China to enter global Phase III TGCT clinical trials, Pimitinib has already received breakthrough therapy designation from regulatory agencies in multiple countries, including China, the United States, and Europe. As a potential best-in-class drug in the CSF-1R inhibitor space, Pimitinib not only performs outstandingly in the TGCT indication but also has greater imaginative potential in various indications such as cGVHD
It is precisely because of the drug's outstanding &#34;billion-dollar molecule&#34; potential that at the end of 2023, the company reached a &#34;high upfront payment, high milestone, high revenue share&#34; BD deal with the well-known multinational pharmaceutical company Merck, and on April 1 of this year, received a total of $85 million in option fees from Merck. Together with the previous upfront payment, the BD cooperation between the two parties has brought over $150 million in cash to HeYu.
Recently, Merck stated at its capital market day that it is &#34;fully focused on growth,&#34; and one of the key elements mentioned to achieve this goal is HeYu's pimitinib, which it referred to as one of the assets that can maximize potential, and stated that it is &#34;actively preparing for the global launch of pimitinib in 2026,&#34; which shows Merck's high regard for this product. Previously, Haitong Securities released a research report, giving HeYu an &#34;outperform&#34; rating while also predicting that the global sales peak of pimitinib is expected to exceed $2 billion.
The key supporting factor for the above commercialization forecast lies in the significant R&amp;D achievements of pimitinib. At this year's European Society for Medical Oncology Congress (ESMO Congress 2025), HeYu presented long-term efficacy and safety data from the global Phase III MANEUVER study of pimitinib in patients with tenosynovial giant cell tumor (TGCT) in an oral presentation.
The results showed that, according to the RECIST v1.1 criteria assessed by a blinded independent review committee (BIRC), pimitinib demonstrated strong and durable tumor remission efficacy in TGCT patients, with clinical outcome assessments (including joint mobility, stiffness, pain, and physical function) showing clinically meaningful sustained improvement, and safety consistent with previous analyses, further validating its feasibility for long-term treatment of TGCT.
In short, the efficacy, safety, and tolerability of long-term application in TGCT patients have been further substantiated by more data, confirming the potential of pimitinib as a best-in-class treatment option, and it is expected to redefine the treatment standards for TGCT.
Currently, pimitinib has been accepted for NDA in China and included in priority review, while the NDA in the United States is expected to be submitted within the year, with approval anticipated in 2026 in both China and the U.S. In the future, with the support of Merck's global market layout, it will become a heavyweight product contributing stable output, continuously releasing its &#34;billion-dollar molecule&#34; potential.
<h2>Deepening FIC/BIC Variety Development, Forming a Multi-Category Full-Cycle Team Layout</h2>
HeYu Pharmaceutical has always adhered to a &#34;depth + breadth&#34; dual-driven strategy, continuously strengthening its pipeline layout. In terms of depth, the company relies on a rich pipeline covering precise targeting, immunotherapy, synthetic lethality, and antibody conjugates to achieve broad target coverage and diversified combination therapy design, while also laying out multiple candidate compounds around key target families to ensure robust results transformation; in terms of breadth, HeYu is expanding its existing oncology assets to non-oncology indications, while extending its professional advantages and experience in small molecule drug development to more potential therapeutic areas.
According to Xu Yaochang, founder and CEO of HeYu Pharmaceutical, during this R&amp;D day event, HeYu has always insisted on investing substantial resources in R&amp;D to develop differentiated best-in-class and first-in-class drugs, with an average annual compound growth rate of 54% in R&amp;D investment since its establishment
Currently, the company has established more than 10 clinical-stage oncology product pipelines, covering various common cancers such as liver cancer, gastric cancer, lung cancer, colorectal cancer, and breast cancer. At the same time, HeYu Pharmaceuticals has built a solid barrier for its core assets through over 500 patent applications and the design of combination use among pipelines.
In addition to further developing Pimicotinib, HeYu is also deeply exploring two major target categories: FGFR and KRAS, with a focus on the FGFR target to drive the next round of innovative product development cycles. Among them, the second &#34;billion-dollar molecule&#34; in the company's pipeline, the global FGFR4 inhibitor class FIC drug Absk011, is continuously being explored for its development potential.
According to the content disclosed during this R&amp;D day event, in terms of monotherapy, the ABSK-011-101 study shows that the ORR for ABSK011 monotherapy in advanced HCC patients with failed immunotherapy and multi-targeted tyrosine kinase inhibitors (mTKI) and FGF19 overexpression reached 46.7%, with an mPFS of 5.5 months. The key registration study ABSK-011-205 is currently progressing smoothly. In terms of combination therapy, the ABSK-011-201 study shows that the ORR for ABSK011 combined with Atezolizumab in advanced HCC patients with FGF19 overexpression exceeds 50%, with a median PFS of over 7 months, demonstrating the potential to impact first-line treatment options for HCC.
With strong clinical data, ABSK-011 has now received breakthrough therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and ABSK011 is expected to become the world's first truly precision-targeted liver cancer drug.
On the commercialization front, patients with FGF19 overexpressing hepatocellular carcinoma account for about 30% of the total global HCC patient population, currently with poor prognosis. The urgent clinical need is expected to bring a broad and highly certain global commercialization market for Absk011 after it is approved for market launch.
In addition to the FGFR target, HeYu's innovative pipeline also includes several high-quality pipelines in early clinical and preclinical stages, forming a multi-category full-cycle echelon layout. With several innovative R&amp;D pipelines reaching milestone assets, the company's development has entered a new stage of intensive catalysis.
For example, the oral small molecule PD-L1 inhibitor ABSK043 has demonstrated antibody-like efficacy and excellent oral convenience in clinical studies, while its good safety profile shows potential to overcome the safety risks of multi-drug combination therapy. A Phase II clinical study of ABSK043 combined with other drugs for first-line treatment of advanced NSCLC and gastric cancer is currently underway; meanwhile, ABSK061 is the first highly selective oral FGFR2/3 inhibitor to show efficacy in combination with immunotherapy in gastric cancer, and a Phase II clinical study of ABSK061 combined with ABSK043 and chemotherapy for first-line treatment of advanced gastric cancer is currently being conducted.
Additionally, the CSF-1R inhibitor Pimicotinib (ABSK021) and the PRMT5*MTA inhibitor ABSK131, among other potential best-in-class pipelines, are also progressing steadily
All of the above reflects HeYu's certainty in global commercialization and differentiated original research innovation. HeYu is expected to open up more valuation imagination space through multiple potential FIC/BIC products in its pipeline.
It is worth mentioning that although HeYu is currently in the early stages of commercialization, the company already holds over 2 billion yuan in substantial cash and is one of the few innovative pharmaceutical companies in Hong Kong's 18A that enhances investor returns through stock price appreciation while continuously rewarding investors through share buybacks.
In this regard, several brokerage firms, including China Merchants Securities Hong Kong, Tianfeng Securities, and Guoyuan International, have recently updated their ratings on HeYu, giving it a &#34;Buy&#34; or &#34;Overweight&#34; rating and providing positive evaluations of the company's innovative research and subsequent growth.
Among them, Guoyuan International recently released a new research report stating that based on the excellent data of the global BIC product Pimitinib announced at ESMO, the accelerated advancement of the company's innovative drug research and development, and the broad prospects of the liver cancer new drug Ipagufinib, it gives the company a &#34;Buy&#34; rating with a target price of HKD 22.06, indicating nearly 50% upside potential from the current price

02256

ABBISKO-B has made significant progress in new drug development, with 22 drugs in the pipeline, of which more than 10 have entered the clinical stage. On October 30, the company held its 2025 R&D Day event, bringing together investment institutions, clinical experts, and media to share its innovative R&D layout and clinical progress. CEO Xu Yaochang emphasized the company's commitment to developing differentiated innovative therapies in the fields of oncology and other diseases, showcasing its leadership in the small molecule platform and the endogenous growth of global innovation

Through the ABBISKO-B R&D Day, we can see the depth and breadth of its FIC/BIC innovative pipeline