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Wuxi Class 1 innovative drug—Bomitasae alfa for injection approved for market launch!

2026-06-25


On June 4, 2026, the National Medical Products Administration passed the priority review approval process and conditionally approved Jiangsu Beijietai Biotechnology Co., Ltd.'s independently developed Class 1 innovative drug—Bomitasae alfa for injection (brand name: Bojianing).

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The active ingredient of this drug is extracted from a protein found in snake venom. Its drug principle is to bypass the upstream coagulation pathway and directly activate coagulation factor X to activate the common pathway for hemostasis. Clinical data show that the drug has an effective hemostasis rate of 81.94% within 12 hours, and 77.12% of bleeding visits require only 1 to 2 doses to effectively stop bleeding; No adverse events of grade 3 or above were reported in clinical trials, no thrombosis risk occurred, medication safety performance was excellent, and clinical value was outstanding; This drug can be used to treat bleeding symptoms in adult patients with congenital hemophilia A and B with coagulation factor VIII or IX inhibitors greater than 5 Bethesda units (BU).

This drug is used to treat bleeding symptoms in adult patients with congenital hemophilia A and B who have coagulation factor VIII or IX inhibitors > 5 Bethesda units (BU). This is the first approved Class 1 innovative drug in Huishan District, Wuxi, the first national Class 1 therapeutic biological product successfully approved for market in the city, and the world's first original drug in the coagulation factor X activator category to be approved.

The world's first "Stopping Bleeding Agent"

During hemophilia treatment, patients are prone to the production of clotting factor inhibitors, causing conventional alternative therapies to fail—a medical challenge that had long remained unresolved. The newly approved "Bomitasae alfa for injection" uses a globally unique mechanism of action. Its active ingredient is purified from the venom of the round viper, bypassing suppressed upstream coagulation pathways and directly activating coagulation factor X to initiate a common pathway for hemostasis. Clinical data show that the drug has an effective hemostasis rate of 81.94% within 12 hours, and 77.12% of bleeding visits require only 1~2 doses to effectively stop bleeding. No adverse events of grade 3 or above were reported in clinical trials, no thrombosis risk was presented, drug safety performance was excellent, and clinical value was outstanding.

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Wuxi Further Pharmaceutical Co., Ltd. focuses on drug research and development  as its core, engaging in drug entrusted management and CRO & CDMO transformation as a service-oriented platform company. The company has built a first-class drug R&D platform, complete hardware facilities, and a comprehensive quality management system. It has passed the ISO9001:2015 certification as a company.

     With an experienced drug R&D team, we can quickly and effectively complete the development of innovative drugs and high-end generics, creating a first-mover advantage. The company has process technology packages for nearly a hundred pharmaceutical projects and possesses core key innovative technologies, enabling patent breakthroughs and creating new technical barriers, holding more than 40 patents.

 

Wuxi Further Pharmaceutical Co.,Ltd

Main Products

Palmitoylethanolamide(PEA) Micro (CAS 544-31-0)

Spermidine trihydrochloride(CAS 334-50-9)

Pterostilbene(CAS 537-42-8)

Luteolin (CAS 491-70-3)

Voglibose (CAS 83480-29-9) JP GMP

 

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