Emicizumab‑kxwh bulk supplier for pharma manufacturers

Emicizumab‑Kxwh Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL

Reference Brands: Hemlibra (USA/EU)

Emicizumab-kxwh is a humanized bispecific monoclonal antibody (IgG4) that simultaneously binds activated factor IX (FIXa) and factor X (FX), thereby functioning as a factor VIII cofactor‐mimetic in patients with congenital haemophilia A. It is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A, with or without factor VIII inhibitors. It offers subcutaneous administration (once weekly, biweekly or every 4 weeks) compared to more frequent intravenous factor VIII infusions.

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Product Description:

Emicizumab is a bispecific antibody that does not replace factor VIII but imitates what it does. Factor VIII's role in the clotting cascade is to hold activated factor IX and factor X close enough together to react. Emicizumab grips one with each arm and performs the same bridging function. Because it bears no structural resemblance to factor VIII, the inhibitor antibodies that some haemophilia A patients develop against factor VIII do not recognise it and cannot neutralise it.

It is used for routine prophylaxis in congenital haemophilia A, with or without inhibitors, and has changed what daily life looks like for these patients: a subcutaneous injection weekly, fortnightly or monthly replaces intravenous factor infusions several times a week, often through a central line in small children. Injection site reactions are common. The serious risk is thrombotic microangiopathy when activated prothrombin complex concentrate is given alongside it for breakthrough bleeding, which requires specific protocols.

Sourcing notes. Originator biologic, on patent, and not a plasma-derived product — it is recombinant, with no donor-derived material and none of the associated viral safety considerations. Several vial strengths support weight-based dosing and different intervals; a course needs the right combination. Cold chain at 2–8 degrees, do not freeze or shake.

How Emicizumab‑Kxwh is supplied today, and licensing ahead of patent expiry

Emicizumab‑Kxwh is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Emicizumab‑Kxwh, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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Frequently Asked Questions

Emicizumab-kxwh is used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. It helps restore the function of missing activated factor VIII, thereby improving blood clotting.

Emicizumab-kxwh is made from a recombinant humanized monoclonal antibody. It is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.

The trade name of Emicizumab-kxwh is Hemlibra.

Emicizumab-kxwh is manufactured by Genentech, a member of the Roche Group.

The generic name of this product is Emicizumab-kxwh.

The brand name is Hemlibra.

Emicizumab-kxwh (Hemlibra) is manufactured by Genentech, Inc., South San Francisco, California, USA, and also produced at Roche facilities in Japan and Switzerland.

Hemlibra (Emicizumab) is developed and sold by Roche / Chugai. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.