Business News

7Moon23Day, a national project independently developed by Haisco Medicine Group1Classic innovative drug Sorpupenib succinate tablet (Youkupan)®, R&D code:HSK39297）Passed the priority review and approval process, officially approved by the drug regulatory department for market release, and used to treat paroxysmal nocturnal hemoglobinuria that has not been treated with complement inhibitors before.PNH) adult patients. This is Haisco's... [End]5The approved and launched innovative drug is also a significant breakthrough for China in the treatment of complement diseases. It is the world's first once-daily oral complement factor.B（FB) inhibitor; Supracetam tablets will be usedPNHPatients now have new options for safe and convenient treatment.

Focus on rare diseases to meet unmet clinical needs.

paroxysmal sleep hemoglobinuriaPNH) is a rare acquired hematopoietic stem cell clone disease. Patients mainly present with intravascular hemolysis, bone marrow hematopoietic failure, and venous thrombosis. Persistent hemolysis can cause symptoms such as fatigue, renal function impairment, pain, and dyspnea. Studies indicate that before the use of complement inhibitors,PNHThe patient has a poor prognosis.

Traditional PNH treatment mainly includes symptomatic support therapy, thrombosis prevention and control, and allogeneic hematopoietic stem cell transplantation; for patients with bone marrow failure, immunosuppressive therapy can be used. According to the “Chinese Guidelines for the Diagnosis and Treatment of Paroxysmal Insomnia Hemoglobinuria (2024 edition)”, PNH treatment should be based on clinical classification, and the first-line treatment for classic PNH is complement inhibitors.

In recent years, with the continuous development in the field of complement therapy,PNHTreatment has improved, but patient needs remain unmet fully.C5The inhibitor can control intravascular hemolysis, but it cannot block upstream complement activation. Some patients still experience residual anemia, fatigue, or the need for blood transfusion. Daily2The traditional administration method poses a risk of breakthrough hemolysis. Patients require new treatment options that are effective, convenient, and suitable for long-term management.

Saprophenpropane tablets are a highly effective selective complement factor with proprietary intellectual property rights.B（FBSmall molecule inhibitors. The Haisco R&D team identified potential optimization points based on structure, introduced groups with enhanced metabolic stability, targeted key steps in the complement pathway, and blocked metabolic sites at the source to inhibitAPThe starting process of the routeAPPathway-mediated amplification cycles, thereby blocking the activation of the entire complement system, to treat complement-mediated related diseases.

As an oral small molecule innovative drug, Supucopan succinate tablets are administered orally once a day for patients with mild or moderate renal impairment and those with light to moderate conditionsdegree[1] Patients with impaired liver function do not need dose adjustment; compared to potentCYP2C8When using inhibitors together, there is no need to adjust the dosage, and taking the medication is not affected by food intake, improving the convenience and compliance of patient treatment.

Adhere to innovation and expand the innovation drug product portfolio.

Innovation is a major strategy for Hisicor. From project initiation to clinical development, from technical exploration to successful market launch, Supracetam tablets are an important outcome of Hisicor's continuous research investment and innovation.

Adhering to the strategies of innovation and internationalization, with the supportive innovative ecosystem and medical industry development environment in Sichuan Province, Haisco continues to increase its investment in innovation. It has formed a research and development team of over a thousand people. Focusing on key treatment areas such as anesthesia and analgesia, chronic disease metabolism, digestive liver diseases, respiratory system, autoimmunity, and tumors, the R&D investment has remained consistent for many years.10Over 100 million yuan, accelerate the transformation of innovative achievements.

Haisco Medicine Group has established operations across the country5a modern production base,30The remaining production lines should accelerate the industrialization of innovation achievements. Group layout27one1Classic innovative drug projects, forming a coverage of pre-clinical research,ⅠPeriod,ⅡPeriod,ⅢThe hierarchical R&D system for phase I clinical trials, previously, ringponol injection, Anruikefen, canagliflozin, Kligabalin, etc.4Item1Classic innovative drugs have been approved for market release, and all of them have been included in the national basic medical insurance catalog.

Among them, ringponol injection, as an innovative intravenous anesthetic with independent intellectual property rights in China, this year5At the end of the month, receive from the U.S. Food and Drug AdministrationFDAThe approval for market launch makes it the first innovative intravenous anesthesia drug from China to reach international markets, achieving a breakthrough from “new in China” to “new globally”.

The successful launch of succinate spaponate tablets marks a new breakthrough for Hexo in the global innovative field of complement disease treatment, further enhancing the company's portfolio of innovative drugs.

International cooperation to drive "China's New" towards "Global New

Haisco Co. Promotes Innovation and Internationalization2.0Strategy: Expand the global innovation market, continuously enhancing international clinical development capabilities and global cooperation abilities.

The succinic acid spikonapam tablets are also an important part of Haixike's internationalization strategy.2026Year6Moon, Haisco Co. and the United StatesNuvectis Pharma,Inc.Sign an exclusive license agreement, grantingNuvectisDevelopment, production, and commercialization on a global scale beyond the Greater China regionHSK42360Project (BRAFexclusive rights to the inhibitor, as well as development, production, and commercialization on a global scale outside of Greater China, Southeast Asia, and IndiaHSK39297Exclusive rights to the project (saprophenone project).

As part of the compensation for the external licensing transaction, Hisisco will receive fromNuvectisObtainHSK42360andHSK39297The licensing fee for the project (including4000The $10,000 payment, recent milestone payments, and the maximum...14.21Additional milestone payments in billions of US dollars, along with royalties that can reach double digits based on future product net sales. Both parties will work together to enable the product to benefit more patients worldwide.

In recent years, Haisco has accelerated its internationalization process and has partnered with AbbVie, Eli Lilly,NuvectisMany international pharmaceutical companies are collaborating on innovative drug research and development and obtaining overseas licenses. These activities cover various key areas such as tumors and autoimmune diseases. This is helping Chinese original innovative drugs to enter the international market, and China's ability to develop innovative drugs is being recognized by the international market.

In the future, Hisicore will continue to adhere to its innovation and internationalization strategies, focusing on major diseases and unmet clinical needs, accelerating the development of original innovative drugs and its international expansion, continuously enhancing its independent innovation capabilities, creating a competitive innovation drug product portfolio on the global stage, and enabling more Chinese original innovative drugs to benefit patients worldwide, contributing further to the construction of a healthy China and the development of global pharmaceutical innovation.

Extended Reading

Regarding paroxysmal nocturnal hemoglobinuria (PNH）】

paroxysmal sleep hemoglobinuriaPNH) is a rare acquired hematopoietic stem cell clonal disease. Acquired hematopoietic stem cellsPIGACaused by gene mutationsCD55、CD59The absence of complement regulatory proteins leads toPNHThe main molecular basis of complement-mediated intravascular hemolysis.PNHThe main symptoms of the patient include intravascular hemolysis, bone marrow hematopoietic failure, and venous thrombosis. Persistent hemolysis can cause fatigue, renal function impairment, pain, and breathing difficulties. Studies show that before the use of complement inhibitors,PNHThe patient has a poor prognosis.

traditionalPNHThe treatment mainly includes symptomatic supportive therapy, thrombosis prevention and control, and allogeneic hematopoietic stem cell transplantation; for patients with bone marrow failure, immunosuppressive therapy can be used. According to the “Chinese Guidelines for the Diagnosis and Treatment of Paroxysmal Insomnia Hemoglobinuria”2024“edition”),PNHTreatment should be based on clinical classification, classic typePNHThe first-line treatment is complement inhibitors.

Clinical benefits of spironolactone succinate3Re-upgrade]

Succinate spironolactone is driven by deuterated technologyPNHClinical benefits have seen a triple improvement——China head to headIIIResearch shows that,HbStandard Achievement Rate59.5%，HbImprovement48.35 g/L, and reduce the need for blood transfusions; there is94.6%Patients who are off blood transfusion can save medical resources; in terms of safety,TEAEThe incidence is lower, and no adverse events leading to drug withdrawal or trial withdrawal occurred; in terms of convenience, it can be taken orally once daily, with a half-life of up to21-38hours.

Results of Some Academic Conferences on succinic propranolol

Two items for spironolactone succinateⅢClinical study results show that the participants were selected2026Year of the European Hematology AssociationEHA）annual meeting, a procedure for those who have not received complement inhibitor treatment beforePNHRandom controlled study in patients, the other being used consistently in the pastC5Single-arm study in patients with anemia after monoclonal antibody treatment.

Two studies coverPNHA broad patient population achieves positive results, demonstrating excellent efficacy and good safety. The once-daily oral monotherapy can be used for treatment.PNHThe patient achieves sustained and comprehensive disease control, along with good safety and long-term treatment potential, demonstrating the effectiveness of spirostamine succinate.PNHThe innovative value and global competitiveness in the field of treatment.

[References] [End]

1. Blood Society of the Chinese Medical Association - Erythrocyte Disease (Anemia) Group. Chinese Guidelines for the Diagnosis and Treatment of Paroxysmal Insomnia Hemoglobinuria2024edition). Chinese Journal of Hematology, 2024, 45(8): 727-737. 

2. Hillmen P, Lewis SM, Bessler M, et al. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med, 1995, 333(19): 1253-1258.

3. Dingli D. Improved therapy for paroxysmal nocturnal hemoglobinuria. Ann Blood. 2026;11:8. doi:10.21037/aob-2025-1-62

4. Xu G, et al. Efficacy and safety of switching to oral HSK39297 monotherapy in paroxysmal nocturnal hemoglobinuria patients with persistent anemia despite anti-C5 therapy: a phase 3 study (HSK39297-302). Presented at EHA 2026; Abstract PS1786.

5. HSK39297sliceIIIClinical Research Report

6. Sipcapan tablets instruction manual;

7. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296-1310.

8. Risitano AM, et al. Br J Haematol. 2022;196:288-303.

9. Hillmen P, et al. N Engl J Med. 2006;355:1233-1243.

10. Peffault de Latour R, et al. Blood. 2015;125(5):775-783.4. Panse J, et al. Value Health. 2023;26(Suppl):S468..

11. Dingli D, et al. Ann Hematol. 2022;101:251-263.

Statement:

This information is intended to provide cutting-edge medical insights and research progress. It is for reference only by healthcare professionals and is not intended for product promotion or advertising purposes. The content cannot replace professional medical guidance, and should not be considered as medical advice. When prescribing any medication mentioned in this document, healthcare professionals should strictly follow the latest detailed prescribing information. For more detailed statements, please visit: https://www.haisco.com/statement.html。