---
title: "BTBP: Intravenous immunoglobulin has received approval for a supplemental drug application"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/247605993.md"
description: "BTBP's Chengdu Rongsheng Pharmaceutical recently received approval from the National Medical Products Administration to launch a 2.5g/bottle specification of \"Intravenous Human Immunoglobulin.\" This product is suitable for the treatment of primary immunoglobulin G deficiency, secondary immunoglobulin G deficiency diseases, and autoimmune diseases. It must pass GMP compliance inspection before being launched, and there are currently no products of the same specification in the domestic market"
datetime: "2025-07-08T09:18:00.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/247605993.md)
  - [en](https://longbridge.com/en/news/247605993.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/247605993.md)
generator: "portal-rs"
---

# BTBP: Intravenous immunoglobulin has received approval for a supplemental drug application

BTBP announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. recently received the "Drug Supplement Application Approval Notice" issued by the National Medical Products Administration. The 2.5g/bottle specification of "Intravenous Immunoglobulin" developed by Chengdu Rongsheng meets the relevant requirements for drug registration. The indications for this product include the treatment of primary immunoglobulin G deficiency, secondary immunoglobulin G deficiency diseases, and autoimmune diseases, among others. The main approval procedures that need to be fulfilled before production and market sales include passing the GMP compliance inspection and obtaining the "Drug GMP Compliance Inspection Notification" issued by the Sichuan Provincial Drug Administration. There are currently no 2.5g/bottle specification "Intravenous Immunoglobulin" products available in the domestic market

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**