1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

Zenyaku Kogyo Receives Japanese Approval for Anti-CD20 Monoclonal Antibody, Rituxan

23 Nov 2024
Admin
News Article

Zenyaku Kogyo Receives Japanese Approval for Anti-CD20 Monoclonal Antibody, Rituxan

Zenyaku Kogyo receives Japanese approval for anti-CD20 monoclonal antibody, Rituxan to treat chronic ITP in children

Overview

Zenyaku Kogyo Co., Ltd. and Chugai Pharmaceutical Co., Ltd. announced that Zenyaku obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an additional dosage and administration of an anti-CD20 monoclonal antibody Rituxan intravenous injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] (Rituxan), which is co-marketed by both companies, for “chronic idiopathic thrombocytopenic purpura in children.” (Idiopathic Thrombocytopenic Purpura: ITP)

Addition of Rituxan for “Chronic ITP in Children”

Chronic ITP had previously only been approved for use in adults with specified dosage and administration, and its use in children had not been approved.
The Japanese Society of Paediatric Haematology/Oncology requested the addition of dosage and administration for Rituxan for “chronic ITP in children.”
It was evaluated that this request qualified for a public knowledge-based application at the “58th evaluation committee on unapproved or off-labeled drugs with high medical needs” held on March 22, 2024.
It was officially decided that a public knowledge-based application could be submitted at the “Pharmaceutical Affairs Council’s First Committee on Drugs” held on April 26, 2024.
In response to this, Zenyaku submitted a public knowledge-based application for the addition of dosage and administration on May 24, 2024, and obtained approval.

The Chronic Idiopathic Thrombocytopenic Purpura

ITP is an autoimmune disease in which autoantibodies against platelet membrane proteins are expressed, leading to thrombocytopenia due to platelet destruction and impaired production.
It is recognized as a designated intractable disease (designated intractable disease 63) by the national government.
The etiology of ITP is unknown, and the mechanism of autoantibody production has not been clearly elucidated.

ITP Symptoms

Many newly diagnosed paediatric ITP patients often exhibit severe thrombocytopenia.
However, serious bleeding such as intracranial hemorrhage is rare, and often resolve spontaneously. It is estimated that 30-56% of cases require treatment.
On the other hand, some cases may show resistance to primary treatments such as corticosteroids or intravenous immunoglobulin therapy.
Both domestic and international clinical guidelines recommend Rituxan as one of the treatment options for such paediatric ITP patients.

About Rituxan

Rituxan is an anti-CD20 monoclonal antibody that specifically binds to CD20, a protein expressed on B cells, excluding hematopoietic stem cells and plasma cells.
It attacks target B cells using the immune system equipped with the human body, and damages cells.
The influence of B cells has been suggested as a pathogenic factor in ITP, and by eliminating B cells with Rituxan, therapeutic effects are expected for chronic ITP that shows resistance to primary treatments.

Zenyaku and Chugai will continue working closely together so that Rituxan can further contribute to the treatment of chronic ITP not only in adults but also in children.