On June 9, 2026, Jiangsu Beijietai Biotechnology Co., Ltd., a wholly-owned subsidiary of Shutaishan, received the Drug Registration Certificate for Bomitai Enzyme Alpha for Injection (trade name: Bojia Ning) issued by the National Medical Products Administration. This drug is a Class 1 therapeutic biological product manufactured domestically, with the approval number S20260040. This approval is conditional, and its indication is for the treatment of bleeding in adult patients with congenital hemophilia A or B whose factor VIII or IX inhibitors are >5 Bethesda units (BU).

Hemophilia is an X-linked recessive inherited bleeding disorder, characterized by male onset and female carrier status. Hemophilia can be divided into hemophilia A and hemophilia B. Hemophilia A is characterized by a deficiency of clotting factor VIII (FVIII), while hemophilia B is characterized by a deficiency of clotting factor IX (FIX), both caused by mutations in the corresponding clotting factor genes. The clinical feature of hemophilia is bleeding tendency, primarily manifesting as bleeding in joints, muscles, and deep tissues. Repeated bleeding, if left untreated, can lead to joint deformities and/or pseudotumor formation, and in severe cases, can be life-threatening.

The treatment of hemophilia with inhibitors is one of the challenges in the field of hemophilia, and there are still some challenges in the treatment of hemophilia with inhibitors in my country:

20%-30% of hemophilia A patients develop inhibitors against factor VIII. 3%-10% of hemophilia B patients develop inhibitors against clotting factor IX (FIX). Once these inhibitors form, the effectiveness of conventional clotting factor replacement therapy decreases significantly, the patient's bleeding risk increases 3-5 times, and the risk of complications such as joint bleeding and intracranial hemorrhage rises.

Based on the results of multiple clinical studies, the advantages of injectable omega-3 enzyme α are mainly reflected in its rapid onset of action, high hemostasis rate, good safety, innovative mechanism of action, and wide applicability.

1. Innovative Mechanism of Action: Its mechanism of action does not depend on coagulation factors VIII or IX, therefore the presence of inhibitors in the patient's body will not affect its efficacy. This is the fundamental approach to solving the inhibitor problem.

2. Wider coverage: Because it does not depend on specific factors, it is applicable to both hemophilia A and hemophilia B patients with inhibitors, which is a huge advantage over some drugs that can only be used for type A.

3. Significant Clinical Efficacy: In Phase Ib/II studies of hemophilia A or B patients with hemophilia and its inhibitors, the effective hemostasis rate of injectable omphalosporin α was reported to be >94%. In the Phase IIb study, a more stringent evaluation criterion was adopted—the 12-hour effective hemostasis rate was 81.94%, which was superior to the single-group target value (OPC) and the difference was statistically significant (P < 0.0001), meeting the pre-specified primary efficacy endpoint. Further analysis showed that the 12-hour effective hemostasis rate at the first bleeding visit was 88.00%, and the effective hemostasis rate at the target joint bleeding visit was 86.96%, achieving effective hemostasis regardless of whether the hemophilia type was A or B.

4. Rapid onset of hemostasis: Injectable omeprazole (Pomvitamin Alpha) has a rapid onset of hemostasis. In bleeding events where effective hemostasis was achieved, the average number of administrations was only 1.9 ± 0.7, with 77.12% of bleeding events achieving successful hemostasis after 1 to 2 administrations. This means patients can control bleeding more quickly, reduce pain, and lower long-term risks such as joint damage caused by bleeding.

5. Good Safety Profile: Based on Phase IIb clinical data, the safety profile of injectable bleomycin alpha (BMP-α) was good. Most adverse events reported by subjects were Grade 1 (mild) and resolved spontaneously without specific treatment. No Grade 3 or higher serious adverse events, investigational drug-related serious adverse events (SAEs), or thromboembolic events were reported in the study. Previous studies have also shown no development of investigational drug-related anti-antibodies, and its good safety profile provides important assurance for long-term use by patients.

For hemophilia patients who develop inhibitors, traditional clinical treatment options are limited and present numerous challenges . As a newly emerging bypass therapy, the coagulation factor X (FX) activator , Pometrazyme Alpha ( trade name: Bojia Ning), holds promise for improving the treatment outcomes for hemophilia patients and offering new hope for those who have already developed inhibitors.

About Shutaishan:

The company's main business is the research, development, production, and marketing of innovative drugs with independent intellectual property rights, especially biological drugs. In the China Securities Regulatory Commission's industry classification for listed companies, it belongs to the "C27 Pharmaceutical Manufacturing" category. As an innovative biopharmaceutical company, it has a complete industrial chain and a relatively complete system for R&D, production, quality management, marketing, and supporting facilities. It is a national high-tech enterprise.

The company is committed to the research, development, production and sales of therapeutic drugs for unmet clinical needs, mainly including protein drugs (including therapeutic monoclonal antibody drugs) and chemical drugs. The therapeutic areas focus on drugs for the treatment of infectious diseases, respiratory and critical care, autoimmune diseases and nervous system diseases.

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